In this issue of Noverra Partners Pharma and Healthcare Insight we have made an effort to include all the pertinent developments in the pharmaceuticals and healthcare sector during the month of March, April, and May 2025. This newsletter aims to cover local, regional, and global news as well as regulatory updates, new government initiatives, and technological advancements etc.
Regulatory Update
• DTAB recommends all antimicrobials to be considered as new drug under NDCT Rules.
The Drugs Technical Advisory Board (DTAB) has recommended that, in the public interest, all antimicrobials should be classified as new drugs under the New Drugs and Clinical Trials (NDCT) Rules, 2019. This recommendation follows the Board’s earlier proposal to the Drugs Consultative Committee (DCC), urging the inclusion of all antibiotics within the definition of new drugs as a measure to combat antimicrobial resistance (AMR). The latest decision was made after a thorough review of DCC’s observations and recommendations.
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• The Health Ministry notifies rules on compounding offences.
The Union Health Ministry has officially notified the rules for compounding minor offences under drug regulations. This long-anticipated move, following the draft issued nearly nine months ago, aligns with the Jan Vishwas (Amendment of Provisions) Act, 2023. The newly introduced Drugs and Cosmetics (Compounding of Offences) Rules, 2025, aim to ease legal burdens, enhance compliance, and promote ease of doing business. As per the final notification dated April 24, 2025, the rules will come into effect from the date of their publication in the Official Gazette.
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• DTAB agrees with the sub-committee report recommending prohibition of 16 FDCs.
The Drugs Technical Advisory Board (DTAB), in its 92nd meeting held on April 24, 2025, endorsed the findings of its sub-committee led by Dr. Nilima Kshirsagar, which identified 16 fixed dose combinations (FDCs) as irrational and recommended their prohibition due to potential risks to human health. Additionally, the Board has referred 29 FDCs—previously deemed irrational by the Prof. Kokate Committee—to the Kshirsagar sub-committee for further evaluation.
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• CDSCO revises guidelines for issuance of export NOC for unapproved, approved new drugs.
The Central Drugs Standard Control Organisation (CDSCO) has revised its procedure for issuing Export No Objection Certificates (NOCs) for the manufacture of unapproved and approved new drugs intended solely for export purposes. Key changes include the discontinuation of quantity-specific and purchase order-specific NOCs, except in the case of Narcotic Drugs, Psychotropic Substances (NDPS), and banned drugs. CDSCO has also released a revised guidance document outlining the updated process, which follows the centralisation of the NOC issuance system implemented last year.
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• DGFT eases pharma export rules for SCOMET items for testing and evaluation.
In a bid to promote technological advancement and streamline pharmaceutical export processes, the Government of India has proposed amendments to the Handbook of Procedures (HBP) 2023, allowing the export of SCOMET (Special Chemicals, Organisms, Materials, Equipment and Technologies) items for the purpose of testing and evaluation. The Directorate General of Foreign Trade (DGFT) has issued a draft public notice seeking feedback from stakeholders, including exporters, industry associations, and technical experts, on the proposed changes.
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• NPPA fixes retail prices of 84 drugs, including empagliflozin combos.
The National Pharmaceutical Pricing Authority (NPPA), in its 132nd meeting held on April 29, has fixed the retail prices for 84 drug combinations, including 36 generic versions of empagliflozin, a diabetes medication originally developed by Boehringer Ingelheim. The move follows the expiry of empagliflozin’s patent on March 11, which opened the market to multiple generic manufacturers, resulting in a significant price drop of 80–85%. In response to this surge in competition and to ensure price regulation, the NPPA intervened under the Drug Price Control Order (DPCO). Alongside empagliflozin-based formulations, the updated price list also covers several anti-hypertensive drug combinations.
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• DGFT amends import norms for Di-octyl phthalate to enhance export efficiency.
In a strategic effort to align export-import ratios with industry requirements and enhance trade efficiency, the Directorate General of Foreign Trade (DGFT) has amended the Standard Input Output Norms (SION). The revision specifically adjusts the permissible import quantity of a key raw material used in the production of Di-octyl phthalate (DOP), a crucial plasticizer. This move is aimed at streamlining trade practices and better supporting the operational needs of manufacturers.
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• Substandard Drugs Flagged Across Multiple States, over 130 Batches Fail Quality Tests in April.
The Central Drugs Standard Control Organisation (CDSCO), in its April 2025 alert, has flagged 136 drug batches as Not of Standard Quality (NSQ). The list includes widely used medications such as paracetamol, amoxicillin, cefixime, telmisartan, various dermatological products, and several veterinary formulations. Issued as part of CDSCO’s routine regulatory surveillance, the alert also draws attention to repeated quality violations by certain manufacturers, particularly involving albendazole and ivermectin-based products.
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• The Health Ministry restricts use of common cold medicine in children under four years.
The Union Health Ministry has restricted the use of the commonly used cold medication combination, Chlorpheniramine Maleate and Phenylephrine Hydrochloride, for children under four years of age. Manufacturers have been directed to include a warning on the drug’s label and package insert. The decision was made after the Central Government concluded that the fixed dose combination (FDC) poses potential risks to children in this age group and that safer alternatives are available.
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• NABL issues updated accreditation criteria for biobanks aligned with ISO 20387:2018.
The National Accreditation Board for Testing and Calibration Laboratories (NABL) has released an amended version of its Specific Criteria for Accreditation of Biobank, marking a significant step toward standardizing and enhancing biobanking practices across India. The revised criteria are specifically designed to align Indian biobanking systems with international standards, particularly ISO 20387:2018. This move reflects the growing global emphasis on quality, consistency, and ethical practices in the handling and storage of biological materials, which are foundational to scientific research and innovation.
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• CDSCO launches online registration for CROs.
The Central Drugs Standard Control Organization (CDSCO) has mandated online registration for Clinical Research Organizations (CROs) via the Sugam portal from April 1, 2025. Under the amended New Drugs and Clinical Trials Rules (NDCTR), 2019, CROs must register with the Central Licensing Authority (CLA) to conduct clinical trials, paying Rs. 5 lakhs only for a five-year license. Approvals take 45 working days, with appeal options available. Authorities can inspect and penalize non-compliance. The Ninth Schedule outlines staffing, quality control, and data retention norms. Finalized after public consultation, these rules enhance oversight and transparency in clinical research.
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• Centre Bans Chloramphenicol and Nitrofurans for Use in Food-Producing Animals:
The Union Health Ministry has banned the import, manufacture, sale, and distribution of chloramphenicol and nitrofurans (including furaltadone, furazolidone, nitrofurantoin, and nitrofurazone) for use in food-producing animals. The decision follows recommendations from the Drugs Consultative Committee (DCC) and the Drugs Technical Advisory Board (DTAB), citing misuse in poultry and livestock feed. The ban aligns with the Food Safety and Standards Authority of India (FSSAI) guidelines, which already prohibited these drugs in meat, poultry, and seafood processing. Chloramphenicol, an antibiotic used to treat bacterial infections, and nitrofurans, used for urinary tract infections, poses health risks such as bone marrow suppression and antibiotic residues in food.
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Approvals
• Glenmark’s cancer drug ISB 2001 gets fast track designation from US FDA.
Ichnos Glenmark Innovation (IGI) has received Fast Track designation from the US FDA for its investigational trispecific antibody, ISB 2001, intended for the treatment of relapsed or refractory multiple myeloma (RRMM) in adults who have received at least three prior lines of therapy. ISB 2001 is designed to simultaneously target BCMA and CD38 on myeloma cells and CD3 on T cells, enhancing immune-mediated tumor cell killing. The candidate is currently undergoing evaluation in a Phase 1 dose-expansion study.
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• Zydus gets USFDA nod for generic drug to treat multiple sclerosis.
Zydus Lifesciences has received approval from the US Food and Drug Administration (USFDA) to market its generic version of Glatiramer Acetate Injection, available in 20 mg/mL and 40 mg/mL single-dose prefilled syringes. This medication is the generic equivalent of Copaxone, a treatment indicated for relapsing forms of multiple sclerosis (MS). The approval marks a significant milestone for the company in expanding its presence in the central nervous system (CNS) therapeutic area within the US market.
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• AstraZeneca Pharma India gets CDSCO approval to import, sell cancer treatment medicine.
AstraZeneca Pharma India Ltd announced on Monday that it has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute the cancer treatment drug Durvalumab solution in India. According to a regulatory filing, the approval covers the import, sale, and distribution of Durvalumab infusion solutions in 120 mg/2.4 ml and 500 mg/10 ml (marketed as Imfinzi) for an additional indication. Durvalumab, when used in combination with Tremelimumab, is indicated for the treatment of patients with unresectable hepatocellular carcinoma.
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• The US FDA approves the first at-home test for cervical cancer screening.
The U.S. Food and Drug Administration (FDA) has approved the first-ever at-home test for cervical cancer screening, announced Teal Health on Friday. This new option provides an alternative to traditional Pap smears, which require an in-office visit. While Pap smears have played a crucial role in reducing cervical cancer incidence over the past 80 years, many women find the in-clinic procedure uncomfortable. The FDA’s approval was supported by a study involving over 600 women, demonstrating that self-collected samples using Teal Health’s test perform comparably to those collected by clinicians. Click to read more.
• US FDA approves Novavax’s BLA for Covid-19 vaccine, Nuvaxovid.
Novavax, Inc. has announced that the US Food and Drug Administration (FDA) has approved its Biologics License Application (BLA) for Nuvaxovid, a vaccine for active immunization against COVID-19 caused by SARS-CoV-2. The approval covers adults aged 65 and older, as well as individuals aged 12 to 64 with at least one underlying condition that increases their risk of severe COVID-19 outcomes, such as asthma, cancer, diabetes, obesity, or smoking. Following this US license approval, Sanofi has triggered a milestone payment of $175 million to Novavax.
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• UK MHRA approves Janssen-Cilag’s guselkumab for Crohn’s disease and ulcerative colitis.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved guselkumab (Tremfya) for the treatment of Crohn’s disease and ulcerative colitis (UC). Previously approved for plaque psoriasis and psoriatic arthritis, guselkumab has now demonstrated efficacy in clinical studies for adults with moderately to severely active Crohn’s disease and UC who have either not responded adequately to other therapies or have experienced intolerable side effects.
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• US FDA grants IDE approval to Innoblative’s SIRA RFA electrosurgical device for breast cancer treatment.
The US Food and Drug Administration has approved Innoblative Designs Inc.’s, Investigational Device Exemption application, paving the way for the company to initiate its US feasibility study. Through this safety and effectiveness of the company’s SIRA RFA electrosurgical device in patients undergoing breast-conservation surgery will be evaluated. Click to read more.
• UK MHRA approves eplontersen to treat adults with rare inherited nerve disease or polyneuropathy.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved eplontersen for the treatment of adults with polyneuropathy linked to hereditary transthyretin amyloidosis (ATTRv), a rare inherited and progressive disorder. The condition is caused by abnormal transthyretin (TTR) protein, which forms amyloid deposits that accumulate in nerves, the heart, and other organs, impairing their function. Click to read more.
• AstraZeneca’s Imfinzi receives US FDA approval for patients with muscle-invasive bladder cancer.
The U.S. Food and Drug administration has approved AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as a neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy, for adult patients with muscle-invasive bladder cancer (MIBC).
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• US FDA grants breakthrough device designation to Roche’s companion diagnostic, VENTANA TROP2 (EPR20043) RxDx Device for non-small cell lung cancer.
The US Food and Drug Administration (FDA) granted Breakthrough Device Designation to the VENTANA TROP2 (EPR20043) RxDx Device. It is the first Breakthrough Device Designation to be granted for a computational pathology companion diagnostic device.
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• US FDA approves celecoxib capsules of Strides.
Strides Pharma announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte., Singapore, has received U.S. FDA approval for celecoxib capsules in 100 mg, 200 mg, and 400 mg strengths. Celecoxib is a selective COX-2 inhibitor used to manage pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis, acute pain, and dysmenorrhea. Click to read more.
• US FDA grants Breakthrough Device Designation to Mursla Bio’s EvoLiver test.
Mursla Bio, a pioneer in Extracellular Vesicle (EV) science, has announced that the U.S. FDA has granted Breakthrough Device Designation to its lead product, EvoLiver. This Dynamic Biopsy-based blood test leverages organ-specific EVs to aid in the surveillance of hepatocellular carcinoma (HCC), the most common type of primary liver cancer, in high-risk cirrhotic patients. The designation highlights EvoLiver’s potential to significantly improve cancer outcomes through early detection.
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International Pharma News
• Minghui Pharma enters strategic partnership and licensing pact with Qilu Pharma to develop B7-H3 ADC in Greater China.
Minghui Pharmaceutical has signed an exclusive licensing and collaboration agreement with Qilu Pharmaceutical for the development, manufacturing, and commercialization of its B7-H3 ADC (MHB088C) in Greater China (Mainland China, Hong Kong, Macau, and Taiwan). Qilu will have exclusive rights in the region, while Minghui will receive up to 1.345 billion RMB, including 280 million RMB upfront, milestone payments, and royalties. Minghui retains global rights outside Greater China and will continue development there. MHB088C is an innovative antibody-drug conjugate developed using Minghui’s proprietary SuperTopoi ADC platform.
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• GSK to buy Boston Pharma’s efimosfermin, a phase III-ready potential best-in-class specialty medicine to treat and prevent progression of SLD.
GSK plc and Boston Pharmaceuticals have announced an agreement for GSK to acquire Boston’s lead asset, efimosfermin alfa phase III-ready, potential best-in-class investigational treatment for steatotic liver disease (SLD). Under the deal, GSK will pay $1.2 billion US dollars upfront, with up to $800 million US dollars in additional success-based milestone payments.
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• US President Trump announces ‘equalisation’ policy for medicines prices in the US.
US President Donald Trump announced that the United States will no longer subsidize healthcare costs for other countries, as part of his efforts to negotiate medicine price reductions ranging from 59% to as much as 80-90%. Describing his “equalization” policy, President Trump highlighted that while the US represents less than five percent of the global population, it accounts for nearly three-quarters of worldwide pharmaceutical profits. He clarified that the directive targets developed countries that set drug prices lower than those in the US, rather than pharmaceutical companies themselves. Additionally, Trump introduced the “Most Favoured Nation” policy, which aims to align US drug prices with the lowest prices available in any other country.
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• US FDA to expand use of unannounced inspections at foreign manufacturing facilities.
The US Food and Drug Administration (FDA) has announced plans to increase the use of unannounced inspections at foreign manufacturing facilities producing food, essential medicines, and other medical products for American consumers and patients. Expanding on its existing Foreign Unannounced Inspection Pilot program in India and China, the agency aims to ensure that foreign manufacturers are held to the same rigorous regulatory standards and oversight as domestic companies.
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• Ethiopian Food and Drug Authority revise GMP Rules, mandates re-inspection every 3 years.
The Ethiopian Food and Drug Authority (EFDA) has updated its pharmaceutical inspection directive to align with global standards, aiming to improve the safety, quality, and efficacy of health products in Ethiopia. The revised rules shorten the Good Manufacturing Practice (GMP) re-inspection interval for compliant facilities from five to three years, reflecting EFDA’s commitment to stricter oversight. Additionally, GMP inspection fees and waivers will now be valid for only three years. Manufacturers holding a five-year cGMP certificate must apply for re-inspection after three years under the new framework. Click to read more.
• Kaushik Desai has been appointed as a member of the WHO Expert Committee on ECSSP.
Kaushik Desai has been appointed as a member of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) for the 2025–2027 term. In this role, he will contribute to the development and revision of WHO pharmaceutical guidelines. The ECSPP is a high-level advisory body that provides expert guidance to the WHO Director-General and Member States on pharmaceutical quality assurance and is responsible for creating and updating international standards published in the WHO Technical Report Series.
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• India initiates anti-dumping investigation on imports of MIPA from China.
The Directorate General of Trade Remedies (DGTR) has initiated anti-dumping investigation concerning the import of monoisopropylamine (MIPA) originating in or exported from China PR. This move follows an application filed by Alkyl Amines Chemicals Limited, alleging material injury to the domestic industry due to unfair trade practices.
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• India initiates crucial oral hearing in anti-dumping probe on TDI imports from EU & Saudi Arabia.
In a move to safeguard India’s domestic industry, the Directorate General of Trade Remedies (DGTR) has scheduled an oral hearing in its ongoing sunset review anti-dumping investigation concerning the import of Toluene Di-Isocyanate (TDI) from the European Union (EU) and Saudi Arabia.
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• Bioxodes announces positive data from BIRCH phase 2a trial of BIOX-101 to treat patients with intracerebral hemorrhagic stroke.
Bioxodes SA, a clinical-stage biopharmaceutical company, reported promising interim results from the BIRCH phase 2a trial of its lead drug BIOX-101 for intracerebral hemorrhagic stroke (ICH). Analysis of the first 16 patients in this randomized, standard-of-care controlled study showed that both primary safety and secondary efficacy goals were achieved. The Data Monitoring Committee found no safety issues related to ICH volume changes, serious adverse events, neurological outcomes, or mortality.
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• Zealand Pharma begins patient enrolment in phase 2b ZUPREME-2 trial of petrelintide in people with overweight or obesity and type 2 diabetes.
Zealand Pharma A/S, specializing in peptide-based medicines, has enrolled the first participant in ZUPREME-2, a phase 2b trial testing petrelintide—a long-acting amylin analog—in people with overweight or obesity and type 2 diabetes. This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of three doses of once-weekly subcutaneous petrelintide versus placebo, alongside a reduced-calorie diet and increased physical activity.
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• Orion & Criceto signs agreement to develop and commercialize Aporon, an innovative apomorphine spray to treat OFF episodes in Parkinson’s disease.
Orion Corporation, a Nordic pharmaceutical company, and Criceto IKM B.V., an innovation-focused pharma firm, have signed an exclusive license agreement for the development and commercialization of Aporon. Aporon is a novel apomorphine oromucosal spray in phase 3 trials, aimed at treating OFF episodes in Parkinson’s disease patients. Designed as a rescue therapy, Aporon targets the difficult OFF episodes that greatly affect patients’ quality of life.
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• WHO issues its first-ever reports on tests and treatments for fungal infections.
The World Health Organization (WHO) released its first reports highlighting a critical shortage of medicines and diagnostic tools for invasive fungal diseases, underscoring the urgent need for innovative research and development to address these gaps. Fungal infections, such as candida causing oral and vaginal thrush, are becoming a growing public health concern due to increasing resistance to treatments. These infections particularly affect severely ill and immunocompromised individuals, including cancer patients, people living with HIV, and organ transplant recipients.
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Domestic Pharma News
• PETA writes to discontinue forced swimming test.
People for the Ethical Treatment of Animals (PETA) recently wrote to the Pharmacy Council of India (PCI), urging the discontinuation of the Forced Swim Test (FST) in thousands of pharmacy institutions nationwide. In response, the PCI has circulated PETA India’s request to all pharmacy institutions for appropriate action. The Forced Swim Test involves placing small animals, such as mice and rats, into tanks of water from which they cannot escape. Some researchers interpret the time animals spend floating rather than attempting to escape as an indicator of ‘depression,’ using the test to model human depression or evaluate antidepressant drugs. However, animal rights activists argue that the test lacks scientific credibility and is unnecessarily cruel.
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• Hyderabad emerges as one of the top global centres of life sciences manufacturing: CBRE report.
CBRE, a leading global real estate firm, released its ‘Global Life Sciences Atlas’ report highlighting key life sciences hubs and investment trends. The growing life sciences sector is driving significant real estate development, with over 35 million sq. ft. of lab and R&D space under construction last year. While the largest R&D centers remain in the US, major hubs also include cities in Asia-Pacific (Hyderabad, Beijing, Shanghai, Greater Tokyo), Canada (Toronto, Montreal), and Europe (Cambridge, Paris). Notably, Hyderabad has emerged as a major life sciences manufacturing center in India.
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• Senores Pharma acquires ANDA for enalapril maleate tablets 2.5mg, 5mg, 10mg and 20mg from Wockhardt.
Senores Pharmaceuticals, through its wholly owned US subsidiary Senores Pharmaceuticals, Inc., has signed an agreement to acquire the US FDA-approved Abbreviated New Drug Application (ANDA) for enalapril maleate tablets (2.5mg, 5mg, 10mg, and 20mg) from Wockhardt. Enalapril is used to treat hypertension, heart failure, and asymptomatic left ventricular dysfunction. The US market for enalapril tablets was valued at approximately US$ 28.6 million (MAT December 2024, IQVIA) and US$ 109.24 million (MAT March 2025, Symphony specialty data).
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• Centre reinstates RoDTEP for AAs, SEZs, and EOUs from June 1 to boost pharma export competitiveness.
In a major relief for pharma exporters, the Union Ministry of Commerce and Industry has restored RoDTEP (Remission of Duties and Taxes on Exported Products) benefits for holders of Advance Authorisations (AAs), Special Economic Zones (SEZs), and Export-Oriented Units (EOUs), effective June 1, 2025. This decision follows industry pressure after the government had withdrawn these benefits from February 6, 2025. Pharma exporters had strongly opposed the exclusion, highlighting that AA-manufactured goods involve significant domestic inputs and that removing RoDTEP benefits conflicted with the government’s Make in India initiatives.
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• CDSCO cancels registration of certain products from Spanish skincare brand Mesoestetic.
The Central Drugs Standard Control Organisation (CDSCO) has cancelled the registration of certain products from Spanish skincare brand Mesoestetic after finding salicylic acid levels exceeding prescribed limits. These products, imported into India by Mesoestetic’s official partner Spectra Medical India, based in Tamil Nadu, will be voluntarily surrendered by the importer, according to CDSCO. The original registration certificate, issued in 2023, was valid for imports until May 31, 2027.
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• Parliamentary Panel recommends setting up of institutional mechanism for integration of systems of medicine.
The Parliamentary Panel on Health and Family Welfare has recommended an institutional mechanism to bring modern medicine and traditional medicine systems on a common platform and adapt a cooperative and collaborative approach for an integrated system for treatment of various diseases.
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• Indian pharma researchers are now focusing on monoclonal antibodies to treat malaria.
Indian pharmaceutical researchers are increasingly focusing on monoclonal antibodies as a promising approach to treat and prevent malaria. Current studies include exploring new antimalarial drugs and strategies, with institutions like the Indian Institute of Science (IISc), Bengaluru, investigating innovative treatments such as combining garlic oil with artemether. This combination has shown encouraging results in mice, highlighting its potential in malaria therapy.
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• CCI approves merger between Aster DM Healthcare and Quality Care India.
Competition Commission of India (CCI) has approved the proposed merger between Aster DM Healthcare and Quality Care India under Section 31(1) of the Competition Act, 2002.
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• Gujarat FDCA to equip drug inspectors with high-tech spectrophotometers for onsite drug testing.
In a significant step towards strengthening drug regulation and ensuring public safety, the Gujarat Food and Drug Control Administration (FDCA) will be equipping its drug inspectors with advanced handheld spectrophotometers for onsite drug testing. This initiative aims to enhance the efficiency and accuracy of drug quality assessments, reducing the reliance on laboratory testing and expediting the detection of substandard or counterfeit drugs in the market. Dr Hemant Koshia, Commissioner of Gujarat FDCA, informed that the state government has sanctioned an amount of Rs. 10 crore for procuring these cutting-edge devices. The spectrophotometers, which use advanced light absorption techniques to analyse drug composition, will enable inspectors to conduct real-time quality checks, thereby improving regulatory oversight and protecting consumer health.
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• Indian pharma working to strengthen PMS & supply chain transparency for OTC drugs.
Indian pharma is working to enhance post-marketing surveillance (PMS) and supply chain transparency for over the counter (OTC) drugs to ensure patient safety and improve medicine quality. Raghuram Nidavanda, in his thesis, compares the regulatory frameworks for OTCs in India and the US. He highlights India’s need for clearer regulations, unlike the US, which has a well-established FDA system. While OTCs offer significant growth and cost-saving potential, regulatory challenges persist. Raghuram emphasizes the importance of adopting global best practices and leveraging emerging technologies to improve regulatory standards and ensure OTC product safety and efficacy.
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• Punjab FDA directs zonal officers to track manufacture and sale of seven H and H1 drugs.
The Punjab Food and Drugs Administration (FDA) has directed zonal officers to track the manufacture and sale of seven Schedule H and H1 drugs—Pregabalin-300 mg, Gabapentin-400 mg, Dicyclomine, Tapentadol, Zopiclone, Flupentixol, and Carisoprodol—due to concerns about their misuse for intoxication. Manufacturers, Carrying and Forwarding Agents (C&FAs), Wholesalers, and Retailers must report sales and stock movement to the Drugs Control Office. Large transactions require additional reporting, and monthly data submission is mandated. The move aims to curb drug abuse while ensuring availability for genuine patients. A meeting with stakeholders has been held to address the issue.
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• Bharat Biotech launches $75 million cell and gene therapy facility in Hyderabad.
Bharat Biotech on Thursday launched vertically integrated cell and gene therapy, viral production facility at Genome Valley in Hyderabad. The company has invested around $75 million US dollars, which it says first of its kind in the country. The 50,000-square-foot dedicated state-of-the-art cell and gene therapy facility is designed to produce high-titer viral vectors (AAV, Lentivirus, Adenovirus), which are essential for gene therapy applications – the crucial material for anti-cancer and genetic disorders and robust clinical development abilities for quality control (QC) releases.
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• Apollo Hospitals in Hyderabad becomes India’s first AHA-certified comprehensive stroke centre:
Apollo Hospitals in Hyderabad has become India’s first AHA-certified Comprehensive Stroke Centre, meeting the highest standards for emergency response, specialized stroke teams, advanced imaging, and critical care. The hospital’s multidisciplinary team, available 24/7, includes experts in neurosurgery, emergency medicine, critical care, neuro-radiology, and neurology. The certification highlights the hospital’s commitment to world-class healthcare, with a focus on timely, accurate care. The integrated stroke-alert system and advanced imaging ensure quick diagnosis and treatment, significantly improving patient outcomes. This achievement marks a major milestone in stroke care, addressing India’s growing health crisis and enhancing emergency response.
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• Allo Health Raises ₹16 Crore to Expand India’s Largest Sexual Health Ecosystem.
Allo Health, India’s leading sexual health platform, has secured Rs. 16 crores only in a Pre-Series A funding round led by Rainmatter and existing investors. With 35+ clinics in major cities, Allo has treated over 200,000 patients, achieving an 85% improvement in patient outcomes. Unlike digital-only health tech startups, Allo employs a hybrid model combining physical clinics, AI-powered treatment protocols, and structured medical training. The funds will be used for clinic expansion, technology development, and deeper patient engagement. The company is also exploring mental health as a new category, aiming to build a comprehensive, structured healthcare ecosystem in India.
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• Mankind Pharma Launches Affordable Generic Empagliflozin:
Mankind Pharma has introduced a generic variant of the diabetes drug Empagliflozin in India. Mankind Pharma has launched a generic version of Empagliflozin in India under the brands Empaglyde, Empagreat, and Dynaduo. The launch breaks cost barriers, offering the medication at competitive prices. According to Mankind Pharma Vice Chairman and Managing Director Rajeev Juneja, the launch aims to make high-quality diabetes treatment affordable. Prices for Empagliflozin start at Rs 5.49 for 10 mg and Rs 9.90 for 25 mg tablets. Click to read more.
• Expert Panel Reaffirms Beta-Blockers as First-Line Therapy for Hypertension in India
An expert panel in India came together to develop a consensus on the role of beta-blockers in managing hypertension. Hypertension, a condition affecting millions worldwide, remains a significant health challenge, especially in India, where early cardiovascular disease (CVD) is a growing concern. Despite advances in treatment, the management of essential hypertension continues to be difficult, with control achieved in fewer than 1 in 10 cases, particularly when aligned with updated guidelines from the American College of Cardiology (ACC) and the International Society of Hypertension (ISH).
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• Exporters raise alarm over new Export NOC Guidelines, seek Urgent Resolution.
According to the pharma exporters, the recently implemented Export NOC system, effective from March 7, 2025, introduces stringent documentation and compliance requirements that create unnecessary bottlenecks for exporters. Expressing its dissatisfaction, an expert stated, “These new requirements pose a severe threat to the ease of doing business for pharma exporters and could severely impact the industry’s contribution to India’s export economy.” Key concerns raised include mandatory undertaking from active pharmaceutical ingredient (API) manufacturers. The new rule mandates a legal undertaking from the API manufacturer, a requirement that is difficult to fulfil as APIs are often procured through traders. Since manufacturers typically source APIs from multiple approved vendors, obtaining such undertakings on legal stamp paper is practically unfeasible. Exporters assert that this requirement, which was not mandatory earlier, serves no effective purpose and will disrupt the supply chain.
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Innovations
• Akums’ patented ‘Tablet-in-Tablet’ Technology brings relief to expectant mothers.
Akums Drugs & Pharmaceuticals, a CDMO, has received a patent for its innovative extended-release formulation of doxylamine and pyridoxine, targeting nausea and vomiting in pregnancy (NVP). This advanced “tablet-in-tablet” technology features a unique dosage form with an outer layer that delivers immediate relief and an inner core that provides sustained drug release for prolonged therapeutic effect.
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• India joins global ranks with Enliva’s accelerator-free nitrile gloves from Wadi Surgicals.
Wadi Surgicals, India’s leading nitrile glove manufacturer has achieved a significant innovation milestone with the launch of accelerator-free nitrile gloves under its flagship brand Enliva. Developed through extensive R&D and global collaboration, these are India’s first accelerator-free nitrile gloves, offering enhanced skin safety and allergy-free protection. With a commitment to research, regulatory compliance, and export excellence, Wadi Surgicals is setting new benchmarks in Indian glove manufacturing.
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• A non-invasive breast cancer screening test, Revealia Breast offers a glimpse of the future of early cancer detection.
Enterprises, Inc., a biotech firm specializing in mRNA diagnostics and AI-driven health solutions, has announced the upcoming launch of its flagship product, Revealia Breast—a non-invasive breast cancer screening test in advanced development. Using a simple cheek swab, the test detects cancer-related inflammation, aiming to identify breast cancer even before symptoms emerge. Revealia Breast offers a more affordable, accessible, and comfortable alternative to traditional mammograms, supporting earlier and less invasive diagnosis. Click to read more.
• Researchers get breakthroughs in non-invasive methods to decode speech directly from brain signals.
Jihwan Lee, a leading researcher at the University of Southern California’s Ming Hsieh Department of Electrical and Computer Engineering and USC’s Signal Analysis and Interpretation Laboratory (SAIL), is pioneering non-invasive techniques to decode speech directly from brain signals. His work aims to benefit individuals with speech and communication disorders. Traditionally, this required invasive methods like electrocorticography (EcoG), involving implanted electrodes. Instead, a non-invasive electroencephalography (EEG) to achieve similar outcomes is being leveraged, potentially revolutionizing brain-computer interfaces.
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• Abbott’s Libre technology is first CGM associated with reduced hospitalizations for heart complications in people with diabetes.
Abbott has announced new findings from its REFLECT real-world studies showing that its FreeStyle Libre continuous glucose monitoring (CGM) system significantly reduces the risk of heart-related hospitalizations in people with diabetes. For the first time, data indicates that CGM use can lessen cardiovascular complications in individuals with Type 1 diabetes, regardless of prior low blood sugar episodes or heart disease history. Similar benefits were also observed in people with Type 2 diabetes on insulin using the Libre bio wearable technology.
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• Oxford Brain Diagnostics launches groundbreaking dementia diagnosis technology.
Oxford Brain Diagnostics (OBD) is aiming to transform early dementia detection with its patented Cortical Disarray Measurement (CDM®) technology. This software analyzes standard MRI scans to objectively assess neurodegeneration, providing a more precise evaluation of brain health. With FDA 510(k) clearance and UKCA self-certification secured, OBD is set to commercially launch its technology in the UK and US. The company’s goal is to improve global diagnostics for conditions like Alzheimer’s by enabling earlier and more accurate detection.
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• NICE recommends sparsentan for IgA nephropathy.
The National Institute for Health and Care Excellence (NICE) has recommended FILSPARI (sparsentan) for NHS use in England to treat primary IgA nephropathy. It is the first non-immunosuppressive, dual-action therapy approved for eligible patients. This follows UK regulatory approval and is backed by data from the Phase 3 PROTECT trial. NICE advises its use in adults with urine protein excretion 1.0 g/day or a protein-to-creatinine ratio 0.75 g/g and recommends continuing treatment only in those who show a positive response.
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• Medkart introduces India’s first room-temperature stable Nicorandil tablets for cardiac care.
Ahmedabad-based Medkart has launched India’s first room-temperature stable generic Nicorandil tablets, a breakthrough that enhances accessibility and affordability of heart medication. Nicorandil, used to treat chronic stable angina, traditionally requires cold-chain storage due to its sensitivity to heat and humidity. Medkart’s innovation eliminates this need, easing distribution challenges, especially in rural and semi-urban areas and ensuring wider, more cost-effective patient access.
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• Autonomix Medical’s innovative catheter-based platform technology receives US patent.
Autonomix Medical, Inc., a medical device company focused on precision nerve-targeted therapies, announced that the U.S. Patent and Trademark Office has granted Patent No. 12,257,071 titled “Controlled sympathectomy and micro-ablation systems and methods.” This patent covers advanced catheter-based systems that integrate nerve mapping with radiofrequency (RF) ablation, enabling precise, minimally invasive treatment of overactive peripheral nerves.
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• Breakthrough in bowel cancer research will speed up diagnosis.
British company Xgenera, in collaboration with the University of Southampton, has developed technology that could enable earlier and more accurate detection of bowel cancer. This innovation promises faster, cheaper diagnosis, reducing the need for invasive procedures like colonoscopies and biopsies. Announced by the government on April 23, technology could save valuable time and resources for patients and the NHS.
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• ISRO and SCTIMST sign MoU in space medicine.
ISRO has signed a Framework Memorandum of Understanding with Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST) to collaborate on space medicine. This partnership is a key step forward in advancing space medicine and its applications in India. ISRO highlighted that the Gaganyaan human space program presents a unique opportunity for national agencies, academia, and industry to engage in human health research, microgravity studies, space medicine, and space biology.
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• Personalized Medicine and Genomic Advancements.
As of April 2025, personalized medicine is advancing rapidly, fueled by breakthroughs in AI, molecular biology, and genomics. Pharma companies are increasingly developing treatments tailored to individual genetic profiles and lifestyles, especially for complex diseases like cancer. Targeted therapies—such as HER2 inhibitors for breast cancer and PARP inhibitors for ovarian cancer—are boosting treatment effectiveness and patient outcomes. Additionally, the use of real-world data (RWD) and real-world evidence (RWE) is enhancing personalization by providing valuable insights into how patients respond to therapies.
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• Tech Mahindra and NVIDIA to advance drug safety with AI-powered pharmacovigilance solution.
Tech Mahindra, in collaboration with NVIDIA, has developed an AI-powered pharmacovigilance (PV) solution to enhance drug safety management. Using agentic AI and automation, the system optimizes PV workflows, reducing manual delays, human errors, and data overload. Built on Tech Mahindra’s TENO framework and powered by NVIDIA AI Enterprise, the solution automates case intake, classification, quality control, and compliance management. It reduces turnaround times by 40%, enhances data accuracy by 30%, and lowers operational costs by 25%. The AI-driven approach transforms pharmacovigilance from a reactive to a predictive model, ensuring faster, more reliable drug safety monitoring.
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• Smart Labels in Pharma: A New Era of Patient Safety.
Smart labels are revolutionizing the pharmaceutical industry by enhancing patient safety, improving drug authentication, and streamlining logistics. Technologies like QR codes, Near-Field Communication (NFC) tags, and Radio-Frequency Identification (RFID) tracking allow real-time monitoring of medications, ensuring drug integrity and reducing counterfeit risks. These labels provide instant access to drug details, dosage instructions, and expiry dates, fostering better patient compliance. Additionally, smart labels can track medication usage, assist in clinical research, and improve emergency medical responses. As digital health advances, smart labels are set to bridge the gap between technology and patient care, creating a more transparent and efficient healthcare system.
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• Gastrointestinal cancer diagnosis with AI: Faster, more accurate abdominal CT scan analysis.
Gastrointestinal cancers pose a significant global health challenge, with over 1.2 million cases diagnosed annually, nearly 40% in China. Abdominal body composition plays a crucial role in prognosis, influencing treatment outcomes. By automating the segmentation of abdominal CT images, this AI tool offers a faster and more accurate method for body composition analysis. Clinicians can use it to identify high-risk patients early, develop more personalized treatment strategies, and monitor treatment progress over time.
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• NURA Launches Mobile Health Screening Facility ‘NURA Express’ in Kozhikode.
NURA, a joint venture between Fujifilm Healthcare and Dr. Kutty’s Healthcare, has launched its mobile health screening service, ‘NURA Express,’ in Kozhikode, Kerala. This mobile unit offers cancer screenings and tests for lifestyle diseases via on-site CT scans, catering to employees and residents. The results are analyzed remotely and shared through a dedicated app. NURA plans to expand by partnering with local governments for municipal health screenings, aiding in early disease detection. This initiative utilizes Fujifilm’s advanced imaging and AI-driven medical IT systems to enhance health outcomes.
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• Harbour BioMed Inks Global Strategic Collaboration with AstraZeneca to discover and develop Next-Generation Therapeutic Antibodies.
Harbour BioMed, a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics in immunology and oncology, announced a global strategic collaboration with AstraZeneca to discover and develop next-generation multi-specific antibodies for immunology, oncology and beyond. Under the terms of the agreements, AstraZeneca will obtain the option to license two preclinical immunology programs and will nominate further targets for Harbour BioMed to discover the next-generation multi-specific antibodies. AstraZeneca will have the option to license these programs for advancement into clinical development.
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• Lupin Digital Health introduces comprehensive post-procedure home-based care guide with American College of Cardiology.
Lupin Digital Health, in partnership with the American College of Cardiology, has introduced a home-based care guide for heart patients. The guide covers recovery, medication management, lifestyle changes, and cardiac rehabilitation. It aims to support patients post-procedure and reduce hospital readmissions. Leading cardiologists contributed to developing the guide, ensuring its medical accuracy. This initiative enhances patient care and promotes better health outcomes.
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• Monash University and Peninsula Health develop AI methods to improve dementia diagnosis.
The National Centre for Healthy Ageing (NCHA), a joint initiative between Monash University and Peninsula Health, has introduced an advanced approach to enhance dementia detection in hospitals by integrating traditional screening techniques with artificial intelligence (AI). Researchers from NCHA’s Healthy Ageing Data Platform, along with clinicians from Australia and the USA, used a specific AI technique—natural language processing (NLP)—to analyze written medical records, significantly improving the accuracy of dementia identification.
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Trends
• Vaccine preventable diseases rising.
Vaccine-preventable diseases like measles, meningitis, and yellow fever are making a comeback due to disrupted immunisation programs and funding cuts, global health leaders have warned. In a joint statement, the WHO, UNICEF, and Gavi highlighted that misinformation, population growth, and ongoing humanitarian crises are further undermining vaccination efforts. They called on world leaders to prioritise and reinforce immunisation programmes with urgent and sustained political commitment.’
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• Neurocrine Biosciences announces new survey revealing need for routine screening and earlier diagnosis for people living with tardive dyskinesia.
Neurocrine Biosciences, Inc., a leading neuroscience-focused biopharmaceutical company, announced the release of findings from a new survey conducted by The Harris Poll highlighting the profound negative impact of tardive dyskinesia on patients and reinforcing the need for routine screening, earlier diagnosis and treatment. The findings revealed that 80% of people living with tardive dyskinesia surveyed wished they had been screened for the condition earlier, and 86% wished their provider had discussed available treatment options for their uncontrolled movements sooner.
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• India-UK FTA will be a game-changer for ceramic & pharmaceutical exports: Gujarat industry players.
Upbeat about the free trade agreement (FTA) between India and the United Kingdom, ceramic and pharmaceutical players in Gujarat have described the deal as a “game-changer.” Pharmaceutical players in Gujarat also felt that the deal with the UK will ease regulatory approvals for generic drugs, improve market access and thus boost pharmaceutical exports from India.
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• Oracle, Cleveland Clinic & G42 enter into a strategic partnership to launch an AI-based global healthcare delivery platform.
Oracle Health, Cleveland Clinic, and G42 announced a strategic partnership to develop a groundbreaking AI-based healthcare delivery platform. This initiative aims to improve patient care and public health management by leveraging AI, nation-scale data analytics, and intelligent clinical applications to create secure, scalable, and accessible care models that positively impact people’s health and longevity. The platform will serve as the foundation for an AI-driven healthcare hub, combining Oracle Cloud Infrastructure, Oracle AI Data Platform, and Oracle Health applications, Cleveland Clinic’s world-class clinical expertise, and G42’s capabilities in sovereign AI infrastructure, health data integration, and advanced clinical AI models.
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• VITU and Gleneagles Hospital Chennai sign MoU to collaborate on AI-driven neuroscience innovation.
Vellore Institute of Technology University (VITU) has signed a Memorandum of Understanding (MoU) with Gleneagles Hospital Chennai to foster collaboration in research and innovation in artificial intelligence (AI) and neurosciences. The MoU was formalised by Dr. Nageshwar Rao, CEO of Gleneagles Hospital Chennai, and Dr. T. Thyagarajan, Pro Vice-Chancellor of VIT University.
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• Global Pharma Investment and Power Shifts: Roche and Eli Lilly Take the Lead.
In April, Roche announced a $50 billion investment to expand its U.S. R&D and manufacturing, creating 12,000 jobs across eight states. Although the company didn’t comment on political motives, the move followed a Swiss-U.S. diplomatic call, sparking speculation about tariff-related factors. Meanwhile, Eli Lilly is gaining market share over Novo Nordisk in diabetes and obesity treatments, with its drugs Mounjaro and Zepbound outperforming Novo’s Ozempic and Wegovy. Supported by a strong pipeline including orforglipron and retatrutide, Lilly’s 32% annual growth has analysts optimistic, prompting BMO to downgrade Novo’s outlook amid intensifying competition.
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• Biotech Boom and EU Pressure: Investment Trends and Geopolitical Tensions.
Venture capital investment in biotech remains strong in early 2025, with median funding rounds reaching $93 million US dollars. Investors are focusing on late-stage, clinic-ready startups, particularly in China, aiming for faster regulatory approvals and quicker returns. However, experts warn that IPO delays and regulatory uncertainties may pose valuation risks. Meanwhile, 32 pharma CEOs from companies like Roche, Novartis, and Pfizer have urged the EU to enact policy reforms to avoid losing up to €103 billion Euros in investments. Facing U.S. drug import tariffs, pharma leaders are pushing for faster drug approvals, stronger IP protections, and eased environmental penalties to maintain Europe’s competitiveness in global life sciences innovation.
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• Startoon Labs signs MoU with Medplus to initiate Pheezee assessment.
Startoon Labs Private Limited, a Hyderabad-based medical device R&D and manufacturing company specializing in joint and muscle health, has signed an MoU with Medplus to introduce the Pheezee assessment at Medplus diagnostic centres. Medplus Diagnostics, part of the well-known Medplus pharmacy retail chain, offers pathology and radiology services and will now provide muscle and joint health diagnostics using the Pheezee device.
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Law and Order Briefs
• Delhi High Court sets aside patent office’s order rejecting Taiho Pharma’s application.
The Delhi High Court has set aside a Patent Office order refusing patent to an anticancer compound from Japanese pharma firm Taiho Pharmaceutical, part of Otsuka Group, remanding back the matter for fresh consideration of the Patent Authority. The High Court observed that while the patent application was rejected on various grounds including Section 3(d) of the Patents Act, 1970, the Patent Office did not identify any particular ‘known substance’ in the hearing notice, providing a fair opportunity to the applicant to respond to the same. By not sharing the information the applicant could not have defended his case.
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• The Supreme Court Criticizes Pharmacy Council of India for Arbitrary Rejection of Pharma College Approvals.
The Supreme Court has recently expressed serious concern over the Pharmacy Council of India (PCI) for acting irresponsibly in rejecting approvals for pharma colleges. The court highlighted that PCI, an expert body in pharmacy education, should be more diligent and avoid arbitrary actions that affect students’ futures. The Court set aside PCI’s rejection orders and directed the Registrar to forward a copy of the judgment to the Secretary, Ministry of Health and Family Welfare. The intent is to ensure that such unnecessary litigations do not happen again. Click to read more.
• The Supreme Court says doctors must prescribe only generic drugs, not branded medicines.
The Supreme Court on Thursday stated that doctors nationwide should be required to prescribe only generic medicines instead of branded ones. The top court was hearing a Public Interest Litigation (PIL) seeking the stringent regulation of the marketing and promotion of drugs by pharmaceutical firms. This observation came during the hearing of a petition filed by the Federation of Medical & Sales Representatives Associations of India (FMSRAI) and others. The plea emphasised that large sums of money are spent on sales and promotional activities aimed at influencing doctors to increase prescription volumes.
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• The Supreme Court Challenges Health Insurance Policy on Epilepsy Exclusion.
The Supreme Court has requested the government’s response to a petition challenging the omission of epilepsy from health insurance coverage. The plea, filed by Sanvedana Foundation, argues that excluding epilepsy violates constitutional rights and restricts healthcare access for affected individuals. The existing policy, as stated by IRDA, deems epilepsy a permanent exclusion.
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• Bombay HC Notice to CDSCO on Denial of Phase I Trial for Indigenous Cancer Drug.
The Bombay High Court has issued a notice to the Central Drugs Standard Control Organisation (CDSCO) and the Union government following a petition by Nashik-based Datar Cancer Genetics. The company challenges the CDSCO’s rejection of its application to conduct Phase I human trials for its indigenous cancer immunotherapy drug, Per-C-Vax, intended for patients recently diagnosed with solid organ cancers. A division bench comprising Chief Justice Alok Aradhe and Justice M.S. Karnik is reviewing the case, where Datar alleges that the CDSCO’s April 22, 2025, rejection was “arbitrary,” “unscientific,” and a “fraud on the statute.”
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• Delhi High Court quashes Indian Patent Office’s decision to hear pre-grant opposition after signing patent approval.
The Delhi High Court invalidated the Indian Patent Office’s (IPO) decision to entertain a pre-grant opposition against Vertex Pharmaceuticals’ patent for a cystic fibrosis drug, ruling that the opposition was filed after the patent was already granted by the controller. Although the patent grant order had not yet been uploaded online, the Court found this delay was due to technical issues on the IPO’s side, not Vertex’s fault. Consequently, the absence of the patent certificate or delay in its publication did not affect the validity of the patent grant, rendering the pre-grant opposition invalid.
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• Relatives of rare disease requests CJI to help them access life-saving medicines at affordable cost.
Mothers and caregivers of children with rare diseases like spinal muscular atrophy (SMA) and cystic fibrosis have appealed to the Chief Justice of India, Justice Sanjiv Khanna, seeking access to life-saving medicines at affordable prices. In a letter signed by around 220 parents and caregivers, they urged the Supreme Court to take suo motu cognizance of the urgent situation and expedite the resolution of pending legal cases related to rare disease treatments.
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• The Supreme Court issues notice to Roche on risiplam matter.
The Supreme Court of India (SCI) has issued a notice to Swiss pharmaceutical company F Hoffmann-La Roche Ltd, maker of the spinal muscular atrophy (SMA) drug risdiplam, seeking clarity on whether the drug can be supplied in India at a lower price if offered at such rates in neighboring countries. This follows a Special Leave Appeal filed by the Union of India challenging a Kerala High Court order that directed the government to cover the cost of one month’s medicine for a patient, Seba PA, who sought help to continue treatment beyond the Rs. 50 lakhs only limit set by the National Rare Disease Policy (NRDP).
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• The Supreme Court pushes for expert recommendations on Food Labelling.
The Supreme Court has directed an expert committee to recommend amendments to food safety regulations requiring warning labels on packaged foods, focusing on sugar, salt, and unhealthy fats. This initiative aims to help consumers make healthier dietary choices amid rising non-communicable diseases. The Court acknowledged the efforts of the Centre and the Food Safety and Standards Authority of India (FSSAI), which received around 14,000 public objections and suggestions on the proposed changes. The expert committee will review these inputs and suggest appropriate amendments to the regulations.
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• The Supreme Court mandates immediate cancellation of hospital licenses in case of child trafficking.
The Supreme Court has issued strict guidelines to curb newborn trafficking, including the immediate suspension of hospital licenses where such cases occur. Justices JB Pardiwala and R Mahadevan warned that any violation of these directions would be treated as contempt of court. Highlighting the severity of child trafficking, the Court described its impact as worse than death and called for greater parental vigilance. Additionally, state governments were urged to implement recommendations from a human trafficking report by the Bharatiya Institute of Research and Development.
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• Kerela Doctor moves HC seeking Regulations for Home Births:
A medical officer from Malappuram, Dr Pratibha K, has approached the Kerela High Court seeking clear legal provisions and penalties to regulate childbirth outside medical facilities. She has urged for establishment of proper guidelines to ensure the safety of both mothers and newborns. The issue came in light after a woman gave birth at her rental home in November, but officials refused to issue the certificate as no formal records of the delivery existed.
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• Apollo Hospitals Bengaluru slammed, slapped Compensation by Consumer Court.
The Bengaluru Urban District Consumer Disputes Redressal Commission has ordered Apollo Hospitals in Seshadripuram to compensate a senior patient Rs 1 lakh only for the harassment and rude behaviour he endured during his treatment. The forum observed that “the complainant has suffered mental agony and discomfort at the hands of hospital staff. It is the responsibility of the doctor and medical staff to prove that due care was taken in discharge of their duties. The complainant is entitled to compensation for harassment and mental agony and financial loss suffered by him for the harassment given by the staff of the hospital”.
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• Patients and experts urge Court to ensure access to cystic fibrosis in India.
Patients with cystic fibrosis (CF), along with public health experts, are urging the Karnataka High Court to facilitate the availability of affordable treatment for CF patients in India. The petitioners seek the government’s approval for generic production of the CF drug, which would allow for compulsory licensing and lower prices. The drug, a combination of three CFTR modulators, is lifesaving for CF patients, improving lung function and reducing hospitalizations. However, despite the drug being available in high-income countries, its cost in India exceeds Rs. 2.5 crores annually, and it is not marketed or approved in India by Vertex Pharmaceuticals, which holds the patents. The petitioners argue that the drug’s monopoly prevents access and call for remedies to introduce generic competition, making the drug affordable. The case could have significant implications for rare disease patients in India.
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• False Advertising, Misrepresentation- CCI Clears Hospital in Unregistered Surgeon Row.
The Competition Commission of India (CCI) has dismissed a complaint filed against Victor Hospital, Margao, Goa, regarding allegations of misleading consumers by employing an unregistered surgeon and engaging in anti-competitive practices. The commission stated that misleading consumers by misrepresenting a surgeon’s qualifications and engaging in false advertising, while serious, do not amount to anti-competitive behavior under the Competition Act, 2002. It was noted that such issues should be dealt with by medical regulatory bodies rather than CCI. Click to read more.
• Big pharma faces heat as India records 307 drug pricing violations.
Pharmaceutical companies have repeatedly violated drug pricing regulations by exceeding permitted price hikes, according to a report by the Parliamentary Standing Committee on Chemicals and Fertilizers. As of 6 March 2025, the National Pharmaceutical Pricing Authority (NPPA) recorded 307 cases of violations under Paragraph 20 of the Drugs (Prices Control) Order (DPCO), 2013, which governs price increases for non-scheduled drugs. These violations highlight growing concerns over the unchecked rise in medicine prices and their impact on affordability.
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• Karnataka Government. proposes to establish Special Court to hear cases related to Supply of fake and spurious drugs.
A special court to hear cases related to the supply of fake and spurious drugs would be specifically designated to deal with cases involving counterfeit, adulterated, or substandard drugs that pose a significant risk to public health. This type of court would help address the growing problem of drug-related fraud, ensuring swift trials and harsher penalties for those involved in such activities. The department is making sure the company which supplies fake medicines are imposed huge fines and taken to task. We are also bringing the Drug Recall Policy so that fake medicine suppliers and manufacturers are taken to task. According to the data furnished to the House, a total of 20 cases have been registered in the last three years against the companies which supplied fake medicines.
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• BIS Cracks Down on E-Commerce Platforms Selling Non-Certified Products.
The Bureau of Indian Standards (BIS) has conducted search and seizure operations at multiple Amazon and Flipkart warehouses in Lucknow, Gurugram, and Delhi, confiscating thousands of non-certified consumer products such as toys, hand blenders, electric heaters, and gas stoves. The raids also uncovered large-scale violations by Tech vision International Pvt Ltd, leading to legal action under the BIS Act, 2016. BIS has filed cases and warned e-commerce platforms to ensure only BIS-certified products are sold. Consumers are urged to use the BIS Care app to verify certification and report violations. The crackdown aims to enhance product safety and protect public interest.
Click to read more.In this issue of Noverra Partners Pharma and Healthcare Insight we have made an effort to include all the pertinent developments in the pharmaceuticals and healthcare sector during the month of March, April, and May 2025. This newsletter aims to cover local, regional, and global news as well as regulatory updates, new government initiatives, and technological advancements etc.
Regulatory Update
• DTAB recommends all antimicrobials to be considered as new drug under NDCT Rules.
The Drugs Technical Advisory Board (DTAB) has recommended that, in the public interest, all antimicrobials should be classified as new drugs under the New Drugs and Clinical Trials (NDCT) Rules, 2019. This recommendation follows the Board’s earlier proposal to the Drugs Consultative Committee (DCC), urging the inclusion of all antibiotics within the definition of new drugs as a measure to combat antimicrobial resistance (AMR). The latest decision was made after a thorough review of DCC’s observations and recommendations.
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• The Health Ministry notifies rules on compounding offences.
The Union Health Ministry has officially notified the rules for compounding minor offences under drug regulations. This long-anticipated move, following the draft issued nearly nine months ago, aligns with the Jan Vishwas (Amendment of Provisions) Act, 2023. The newly introduced Drugs and Cosmetics (Compounding of Offences) Rules, 2025, aim to ease legal burdens, enhance compliance, and promote ease of doing business. As per the final notification dated April 24, 2025, the rules will come into effect from the date of their publication in the Official Gazette.
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• DTAB agrees with the sub-committee report recommending prohibition of 16 FDCs.
The Drugs Technical Advisory Board (DTAB), in its 92nd meeting held on April 24, 2025, endorsed the findings of its sub-committee led by Dr. Nilima Kshirsagar, which identified 16 fixed dose combinations (FDCs) as irrational and recommended their prohibition due to potential risks to human health. Additionally, the Board has referred 29 FDCs—previously deemed irrational by the Prof. Kokate Committee—to the Kshirsagar sub-committee for further evaluation.
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• CDSCO revises guidelines for issuance of export NOC for unapproved, approved new drugs.
The Central Drugs Standard Control Organisation (CDSCO) has revised its procedure for issuing Export No Objection Certificates (NOCs) for the manufacture of unapproved and approved new drugs intended solely for export purposes. Key changes include the discontinuation of quantity-specific and purchase order-specific NOCs, except in the case of Narcotic Drugs, Psychotropic Substances (NDPS), and banned drugs. CDSCO has also released a revised guidance document outlining the updated process, which follows the centralisation of the NOC issuance system implemented last year.
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• DGFT eases pharma export rules for SCOMET items for testing and evaluation.
In a bid to promote technological advancement and streamline pharmaceutical export processes, the Government of India has proposed amendments to the Handbook of Procedures (HBP) 2023, allowing the export of SCOMET (Special Chemicals, Organisms, Materials, Equipment and Technologies) items for the purpose of testing and evaluation. The Directorate General of Foreign Trade (DGFT) has issued a draft public notice seeking feedback from stakeholders, including exporters, industry associations, and technical experts, on the proposed changes.
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• NPPA fixes retail prices of 84 drugs, including empagliflozin combos.
The National Pharmaceutical Pricing Authority (NPPA), in its 132nd meeting held on April 29, has fixed the retail prices for 84 drug combinations, including 36 generic versions of empagliflozin, a diabetes medication originally developed by Boehringer Ingelheim. The move follows the expiry of empagliflozin’s patent on March 11, which opened the market to multiple generic manufacturers, resulting in a significant price drop of 80–85%. In response to this surge in competition and to ensure price regulation, the NPPA intervened under the Drug Price Control Order (DPCO). Alongside empagliflozin-based formulations, the updated price list also covers several anti-hypertensive drug combinations.
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• DGFT amends import norms for Di-octyl phthalate to enhance export efficiency.
In a strategic effort to align export-import ratios with industry requirements and enhance trade efficiency, the Directorate General of Foreign Trade (DGFT) has amended the Standard Input Output Norms (SION). The revision specifically adjusts the permissible import quantity of a key raw material used in the production of Di-octyl phthalate (DOP), a crucial plasticizer. This move is aimed at streamlining trade practices and better supporting the operational needs of manufacturers.
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• Substandard Drugs Flagged Across Multiple States, over 130 Batches Fail Quality Tests in April.
The Central Drugs Standard Control Organisation (CDSCO), in its April 2025 alert, has flagged 136 drug batches as Not of Standard Quality (NSQ). The list includes widely used medications such as paracetamol, amoxicillin, cefixime, telmisartan, various dermatological products, and several veterinary formulations. Issued as part of CDSCO’s routine regulatory surveillance, the alert also draws attention to repeated quality violations by certain manufacturers, particularly involving albendazole and ivermectin-based products.
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• The Health Ministry restricts use of common cold medicine in children under four years.
The Union Health Ministry has restricted the use of the commonly used cold medication combination, Chlorpheniramine Maleate and Phenylephrine Hydrochloride, for children under four years of age. Manufacturers have been directed to include a warning on the drug’s label and package insert. The decision was made after the Central Government concluded that the fixed dose combination (FDC) poses potential risks to children in this age group and that safer alternatives are available.
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• NABL issues updated accreditation criteria for biobanks aligned with ISO 20387:2018.
The National Accreditation Board for Testing and Calibration Laboratories (NABL) has released an amended version of its Specific Criteria for Accreditation of Biobank, marking a significant step toward standardizing and enhancing biobanking practices across India. The revised criteria are specifically designed to align Indian biobanking systems with international standards, particularly ISO 20387:2018. This move reflects the growing global emphasis on quality, consistency, and ethical practices in the handling and storage of biological materials, which are foundational to scientific research and innovation.
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• CDSCO launches online registration for CROs.
The Central Drugs Standard Control Organization (CDSCO) has mandated online registration for Clinical Research Organizations (CROs) via the Sugam portal from April 1, 2025. Under the amended New Drugs and Clinical Trials Rules (NDCTR), 2019, CROs must register with the Central Licensing Authority (CLA) to conduct clinical trials, paying Rs. 5 lakhs only for a five-year license. Approvals take 45 working days, with appeal options available. Authorities can inspect and penalize non-compliance. The Ninth Schedule outlines staffing, quality control, and data retention norms. Finalized after public consultation, these rules enhance oversight and transparency in clinical research.
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• Centre Bans Chloramphenicol and Nitrofurans for Use in Food-Producing Animals:
The Union Health Ministry has banned the import, manufacture, sale, and distribution of chloramphenicol and nitrofurans (including furaltadone, furazolidone, nitrofurantoin, and nitrofurazone) for use in food-producing animals. The decision follows recommendations from the Drugs Consultative Committee (DCC) and the Drugs Technical Advisory Board (DTAB), citing misuse in poultry and livestock feed. The ban aligns with the Food Safety and Standards Authority of India (FSSAI) guidelines, which already prohibited these drugs in meat, poultry, and seafood processing. Chloramphenicol, an antibiotic used to treat bacterial infections, and nitrofurans, used for urinary tract infections, poses health risks such as bone marrow suppression and antibiotic residues in food.
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Approvals
• Glenmark’s cancer drug ISB 2001 gets fast track designation from US FDA.
Ichnos Glenmark Innovation (IGI) has received Fast Track designation from the US FDA for its investigational trispecific antibody, ISB 2001, intended for the treatment of relapsed or refractory multiple myeloma (RRMM) in adults who have received at least three prior lines of therapy. ISB 2001 is designed to simultaneously target BCMA and CD38 on myeloma cells and CD3 on T cells, enhancing immune-mediated tumor cell killing. The candidate is currently undergoing evaluation in a Phase 1 dose-expansion study.
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• Zydus gets USFDA nod for generic drug to treat multiple sclerosis.
Zydus Lifesciences has received approval from the US Food and Drug Administration (USFDA) to market its generic version of Glatiramer Acetate Injection, available in 20 mg/mL and 40 mg/mL single-dose prefilled syringes. This medication is the generic equivalent of Copaxone, a treatment indicated for relapsing forms of multiple sclerosis (MS). The approval marks a significant milestone for the company in expanding its presence in the central nervous system (CNS) therapeutic area within the US market.
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• AstraZeneca Pharma India gets CDSCO approval to import, sell cancer treatment medicine.
AstraZeneca Pharma India Ltd announced on Monday that it has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute the cancer treatment drug Durvalumab solution in India. According to a regulatory filing, the approval covers the import, sale, and distribution of Durvalumab infusion solutions in 120 mg/2.4 ml and 500 mg/10 ml (marketed as Imfinzi) for an additional indication. Durvalumab, when used in combination with Tremelimumab, is indicated for the treatment of patients with unresectable hepatocellular carcinoma.
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• The US FDA approves the first at-home test for cervical cancer screening.
The U.S. Food and Drug Administration (FDA) has approved the first-ever at-home test for cervical cancer screening, announced Teal Health on Friday. This new option provides an alternative to traditional Pap smears, which require an in-office visit. While Pap smears have played a crucial role in reducing cervical cancer incidence over the past 80 years, many women find the in-clinic procedure uncomfortable. The FDA’s approval was supported by a study involving over 600 women, demonstrating that self-collected samples using Teal Health’s test perform comparably to those collected by clinicians. Click to read more.
• US FDA approves Novavax’s BLA for Covid-19 vaccine, Nuvaxovid.
Novavax, Inc. has announced that the US Food and Drug Administration (FDA) has approved its Biologics License Application (BLA) for Nuvaxovid, a vaccine for active immunization against COVID-19 caused by SARS-CoV-2. The approval covers adults aged 65 and older, as well as individuals aged 12 to 64 with at least one underlying condition that increases their risk of severe COVID-19 outcomes, such as asthma, cancer, diabetes, obesity, or smoking. Following this US license approval, Sanofi has triggered a milestone payment of $175 million to Novavax.
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• UK MHRA approves Janssen-Cilag’s guselkumab for Crohn’s disease and ulcerative colitis.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved guselkumab (Tremfya) for the treatment of Crohn’s disease and ulcerative colitis (UC). Previously approved for plaque psoriasis and psoriatic arthritis, guselkumab has now demonstrated efficacy in clinical studies for adults with moderately to severely active Crohn’s disease and UC who have either not responded adequately to other therapies or have experienced intolerable side effects.
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• US FDA grants IDE approval to Innoblative’s SIRA RFA electrosurgical device for breast cancer treatment.
The US Food and Drug Administration has approved Innoblative Designs Inc.’s, Investigational Device Exemption application, paving the way for the company to initiate its US feasibility study. Through this safety and effectiveness of the company’s SIRA RFA electrosurgical device in patients undergoing breast-conservation surgery will be evaluated. Click to read more.
• UK MHRA approves eplontersen to treat adults with rare inherited nerve disease or polyneuropathy.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved eplontersen for the treatment of adults with polyneuropathy linked to hereditary transthyretin amyloidosis (ATTRv), a rare inherited and progressive disorder. The condition is caused by abnormal transthyretin (TTR) protein, which forms amyloid deposits that accumulate in nerves, the heart, and other organs, impairing their function. Click to read more.
• AstraZeneca’s Imfinzi receives US FDA approval for patients with muscle-invasive bladder cancer.
The U.S. Food and Drug administration has approved AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as a neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy, for adult patients with muscle-invasive bladder cancer (MIBC).
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• US FDA grants breakthrough device designation to Roche’s companion diagnostic, VENTANA TROP2 (EPR20043) RxDx Device for non-small cell lung cancer.
The US Food and Drug Administration (FDA) granted Breakthrough Device Designation to the VENTANA TROP2 (EPR20043) RxDx Device. It is the first Breakthrough Device Designation to be granted for a computational pathology companion diagnostic device.
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• US FDA approves celecoxib capsules of Strides.
Strides Pharma announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte., Singapore, has received U.S. FDA approval for celecoxib capsules in 100 mg, 200 mg, and 400 mg strengths. Celecoxib is a selective COX-2 inhibitor used to manage pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis, acute pain, and dysmenorrhea. Click to read more.
• US FDA grants Breakthrough Device Designation to Mursla Bio’s EvoLiver test.
Mursla Bio, a pioneer in Extracellular Vesicle (EV) science, has announced that the U.S. FDA has granted Breakthrough Device Designation to its lead product, EvoLiver. This Dynamic Biopsy-based blood test leverages organ-specific EVs to aid in the surveillance of hepatocellular carcinoma (HCC), the most common type of primary liver cancer, in high-risk cirrhotic patients. The designation highlights EvoLiver’s potential to significantly improve cancer outcomes through early detection.
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International Pharma News
• Minghui Pharma enters strategic partnership and licensing pact with Qilu Pharma to develop B7-H3 ADC in Greater China.
Minghui Pharmaceutical has signed an exclusive licensing and collaboration agreement with Qilu Pharmaceutical for the development, manufacturing, and commercialization of its B7-H3 ADC (MHB088C) in Greater China (Mainland China, Hong Kong, Macau, and Taiwan). Qilu will have exclusive rights in the region, while Minghui will receive up to 1.345 billion RMB, including 280 million RMB upfront, milestone payments, and royalties. Minghui retains global rights outside Greater China and will continue development there. MHB088C is an innovative antibody-drug conjugate developed using Minghui’s proprietary SuperTopoi ADC platform.
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• GSK to buy Boston Pharma’s efimosfermin, a phase III-ready potential best-in-class specialty medicine to treat and prevent progression of SLD.
GSK plc and Boston Pharmaceuticals have announced an agreement for GSK to acquire Boston’s lead asset, efimosfermin alfa phase III-ready, potential best-in-class investigational treatment for steatotic liver disease (SLD). Under the deal, GSK will pay $1.2 billion US dollars upfront, with up to $800 million US dollars in additional success-based milestone payments.
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• US President Trump announces ‘equalisation’ policy for medicines prices in the US.
US President Donald Trump announced that the United States will no longer subsidize healthcare costs for other countries, as part of his efforts to negotiate medicine price reductions ranging from 59% to as much as 80-90%. Describing his “equalization” policy, President Trump highlighted that while the US represents less than five percent of the global population, it accounts for nearly three-quarters of worldwide pharmaceutical profits. He clarified that the directive targets developed countries that set drug prices lower than those in the US, rather than pharmaceutical companies themselves. Additionally, Trump introduced the “Most Favoured Nation” policy, which aims to align US drug prices with the lowest prices available in any other country.
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• US FDA to expand use of unannounced inspections at foreign manufacturing facilities.
The US Food and Drug Administration (FDA) has announced plans to increase the use of unannounced inspections at foreign manufacturing facilities producing food, essential medicines, and other medical products for American consumers and patients. Expanding on its existing Foreign Unannounced Inspection Pilot program in India and China, the agency aims to ensure that foreign manufacturers are held to the same rigorous regulatory standards and oversight as domestic companies.
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• Ethiopian Food and Drug Authority revise GMP Rules, mandates re-inspection every 3 years.
The Ethiopian Food and Drug Authority (EFDA) has updated its pharmaceutical inspection directive to align with global standards, aiming to improve the safety, quality, and efficacy of health products in Ethiopia. The revised rules shorten the Good Manufacturing Practice (GMP) re-inspection interval for compliant facilities from five to three years, reflecting EFDA’s commitment to stricter oversight. Additionally, GMP inspection fees and waivers will now be valid for only three years. Manufacturers holding a five-year cGMP certificate must apply for re-inspection after three years under the new framework. Click to read more.
• Kaushik Desai has been appointed as a member of the WHO Expert Committee on ECSSP.
Kaushik Desai has been appointed as a member of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) for the 2025–2027 term. In this role, he will contribute to the development and revision of WHO pharmaceutical guidelines. The ECSPP is a high-level advisory body that provides expert guidance to the WHO Director-General and Member States on pharmaceutical quality assurance and is responsible for creating and updating international standards published in the WHO Technical Report Series.
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• India initiates anti-dumping investigation on imports of MIPA from China.
The Directorate General of Trade Remedies (DGTR) has initiated anti-dumping investigation concerning the import of monoisopropylamine (MIPA) originating in or exported from China PR. This move follows an application filed by Alkyl Amines Chemicals Limited, alleging material injury to the domestic industry due to unfair trade practices.
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• India initiates crucial oral hearing in anti-dumping probe on TDI imports from EU & Saudi Arabia.
In a move to safeguard India’s domestic industry, the Directorate General of Trade Remedies (DGTR) has scheduled an oral hearing in its ongoing sunset review anti-dumping investigation concerning the import of Toluene Di-Isocyanate (TDI) from the European Union (EU) and Saudi Arabia.
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• Bioxodes announces positive data from BIRCH phase 2a trial of BIOX-101 to treat patients with intracerebral hemorrhagic stroke.
Bioxodes SA, a clinical-stage biopharmaceutical company, reported promising interim results from the BIRCH phase 2a trial of its lead drug BIOX-101 for intracerebral hemorrhagic stroke (ICH). Analysis of the first 16 patients in this randomized, standard-of-care controlled study showed that both primary safety and secondary efficacy goals were achieved. The Data Monitoring Committee found no safety issues related to ICH volume changes, serious adverse events, neurological outcomes, or mortality.
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• Zealand Pharma begins patient enrolment in phase 2b ZUPREME-2 trial of petrelintide in people with overweight or obesity and type 2 diabetes.
Zealand Pharma A/S, specializing in peptide-based medicines, has enrolled the first participant in ZUPREME-2, a phase 2b trial testing petrelintide—a long-acting amylin analog—in people with overweight or obesity and type 2 diabetes. This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of three doses of once-weekly subcutaneous petrelintide versus placebo, alongside a reduced-calorie diet and increased physical activity.
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• Orion & Criceto signs agreement to develop and commercialize Aporon, an innovative apomorphine spray to treat OFF episodes in Parkinson’s disease.
Orion Corporation, a Nordic pharmaceutical company, and Criceto IKM B.V., an innovation-focused pharma firm, have signed an exclusive license agreement for the development and commercialization of Aporon. Aporon is a novel apomorphine oromucosal spray in phase 3 trials, aimed at treating OFF episodes in Parkinson’s disease patients. Designed as a rescue therapy, Aporon targets the difficult OFF episodes that greatly affect patients’ quality of life.
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• WHO issues its first-ever reports on tests and treatments for fungal infections.
The World Health Organization (WHO) released its first reports highlighting a critical shortage of medicines and diagnostic tools for invasive fungal diseases, underscoring the urgent need for innovative research and development to address these gaps. Fungal infections, such as candida causing oral and vaginal thrush, are becoming a growing public health concern due to increasing resistance to treatments. These infections particularly affect severely ill and immunocompromised individuals, including cancer patients, people living with HIV, and organ transplant recipients.
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Domestic Pharma News
• PETA writes to discontinue forced swimming test.
People for the Ethical Treatment of Animals (PETA) recently wrote to the Pharmacy Council of India (PCI), urging the discontinuation of the Forced Swim Test (FST) in thousands of pharmacy institutions nationwide. In response, the PCI has circulated PETA India’s request to all pharmacy institutions for appropriate action. The Forced Swim Test involves placing small animals, such as mice and rats, into tanks of water from which they cannot escape. Some researchers interpret the time animals spend floating rather than attempting to escape as an indicator of ‘depression,’ using the test to model human depression or evaluate antidepressant drugs. However, animal rights activists argue that the test lacks scientific credibility and is unnecessarily cruel.
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• Hyderabad emerges as one of the top global centres of life sciences manufacturing: CBRE report.
CBRE, a leading global real estate firm, released its ‘Global Life Sciences Atlas’ report highlighting key life sciences hubs and investment trends. The growing life sciences sector is driving significant real estate development, with over 35 million sq. ft. of lab and R&D space under construction last year. While the largest R&D centers remain in the US, major hubs also include cities in Asia-Pacific (Hyderabad, Beijing, Shanghai, Greater Tokyo), Canada (Toronto, Montreal), and Europe (Cambridge, Paris). Notably, Hyderabad has emerged as a major life sciences manufacturing center in India.
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• Senores Pharma acquires ANDA for enalapril maleate tablets 2.5mg, 5mg, 10mg and 20mg from Wockhardt.
Senores Pharmaceuticals, through its wholly owned US subsidiary Senores Pharmaceuticals, Inc., has signed an agreement to acquire the US FDA-approved Abbreviated New Drug Application (ANDA) for enalapril maleate tablets (2.5mg, 5mg, 10mg, and 20mg) from Wockhardt. Enalapril is used to treat hypertension, heart failure, and asymptomatic left ventricular dysfunction. The US market for enalapril tablets was valued at approximately US$ 28.6 million (MAT December 2024, IQVIA) and US$ 109.24 million (MAT March 2025, Symphony specialty data).
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• Centre reinstates RoDTEP for AAs, SEZs, and EOUs from June 1 to boost pharma export competitiveness.
In a major relief for pharma exporters, the Union Ministry of Commerce and Industry has restored RoDTEP (Remission of Duties and Taxes on Exported Products) benefits for holders of Advance Authorisations (AAs), Special Economic Zones (SEZs), and Export-Oriented Units (EOUs), effective June 1, 2025. This decision follows industry pressure after the government had withdrawn these benefits from February 6, 2025. Pharma exporters had strongly opposed the exclusion, highlighting that AA-manufactured goods involve significant domestic inputs and that removing RoDTEP benefits conflicted with the government’s Make in India initiatives.
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• CDSCO cancels registration of certain products from Spanish skincare brand Mesoestetic.
The Central Drugs Standard Control Organisation (CDSCO) has cancelled the registration of certain products from Spanish skincare brand Mesoestetic after finding salicylic acid levels exceeding prescribed limits. These products, imported into India by Mesoestetic’s official partner Spectra Medical India, based in Tamil Nadu, will be voluntarily surrendered by the importer, according to CDSCO. The original registration certificate, issued in 2023, was valid for imports until May 31, 2027.
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• Parliamentary Panel recommends setting up of institutional mechanism for integration of systems of medicine.
The Parliamentary Panel on Health and Family Welfare has recommended an institutional mechanism to bring modern medicine and traditional medicine systems on a common platform and adapt a cooperative and collaborative approach for an integrated system for treatment of various diseases.
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• Indian pharma researchers are now focusing on monoclonal antibodies to treat malaria.
Indian pharmaceutical researchers are increasingly focusing on monoclonal antibodies as a promising approach to treat and prevent malaria. Current studies include exploring new antimalarial drugs and strategies, with institutions like the Indian Institute of Science (IISc), Bengaluru, investigating innovative treatments such as combining garlic oil with artemether. This combination has shown encouraging results in mice, highlighting its potential in malaria therapy.
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• CCI approves merger between Aster DM Healthcare and Quality Care India.
Competition Commission of India (CCI) has approved the proposed merger between Aster DM Healthcare and Quality Care India under Section 31(1) of the Competition Act, 2002.
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• Gujarat FDCA to equip drug inspectors with high-tech spectrophotometers for onsite drug testing.
In a significant step towards strengthening drug regulation and ensuring public safety, the Gujarat Food and Drug Control Administration (FDCA) will be equipping its drug inspectors with advanced handheld spectrophotometers for onsite drug testing. This initiative aims to enhance the efficiency and accuracy of drug quality assessments, reducing the reliance on laboratory testing and expediting the detection of substandard or counterfeit drugs in the market. Dr Hemant Koshia, Commissioner of Gujarat FDCA, informed that the state government has sanctioned an amount of Rs. 10 crore for procuring these cutting-edge devices. The spectrophotometers, which use advanced light absorption techniques to analyse drug composition, will enable inspectors to conduct real-time quality checks, thereby improving regulatory oversight and protecting consumer health.
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• Indian pharma working to strengthen PMS & supply chain transparency for OTC drugs.
Indian pharma is working to enhance post-marketing surveillance (PMS) and supply chain transparency for over the counter (OTC) drugs to ensure patient safety and improve medicine quality. Raghuram Nidavanda, in his thesis, compares the regulatory frameworks for OTCs in India and the US. He highlights India’s need for clearer regulations, unlike the US, which has a well-established FDA system. While OTCs offer significant growth and cost-saving potential, regulatory challenges persist. Raghuram emphasizes the importance of adopting global best practices and leveraging emerging technologies to improve regulatory standards and ensure OTC product safety and efficacy.
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• Punjab FDA directs zonal officers to track manufacture and sale of seven H and H1 drugs.
The Punjab Food and Drugs Administration (FDA) has directed zonal officers to track the manufacture and sale of seven Schedule H and H1 drugs—Pregabalin-300 mg, Gabapentin-400 mg, Dicyclomine, Tapentadol, Zopiclone, Flupentixol, and Carisoprodol—due to concerns about their misuse for intoxication. Manufacturers, Carrying and Forwarding Agents (C&FAs), Wholesalers, and Retailers must report sales and stock movement to the Drugs Control Office. Large transactions require additional reporting, and monthly data submission is mandated. The move aims to curb drug abuse while ensuring availability for genuine patients. A meeting with stakeholders has been held to address the issue.
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• Bharat Biotech launches $75 million cell and gene therapy facility in Hyderabad.
Bharat Biotech on Thursday launched vertically integrated cell and gene therapy, viral production facility at Genome Valley in Hyderabad. The company has invested around $75 million US dollars, which it says first of its kind in the country. The 50,000-square-foot dedicated state-of-the-art cell and gene therapy facility is designed to produce high-titer viral vectors (AAV, Lentivirus, Adenovirus), which are essential for gene therapy applications – the crucial material for anti-cancer and genetic disorders and robust clinical development abilities for quality control (QC) releases.
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• Apollo Hospitals in Hyderabad becomes India’s first AHA-certified comprehensive stroke centre:
Apollo Hospitals in Hyderabad has become India’s first AHA-certified Comprehensive Stroke Centre, meeting the highest standards for emergency response, specialized stroke teams, advanced imaging, and critical care. The hospital’s multidisciplinary team, available 24/7, includes experts in neurosurgery, emergency medicine, critical care, neuro-radiology, and neurology. The certification highlights the hospital’s commitment to world-class healthcare, with a focus on timely, accurate care. The integrated stroke-alert system and advanced imaging ensure quick diagnosis and treatment, significantly improving patient outcomes. This achievement marks a major milestone in stroke care, addressing India’s growing health crisis and enhancing emergency response.
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• Allo Health Raises ₹16 Crore to Expand India’s Largest Sexual Health Ecosystem.
Allo Health, India’s leading sexual health platform, has secured Rs. 16 crores only in a Pre-Series A funding round led by Rainmatter and existing investors. With 35+ clinics in major cities, Allo has treated over 200,000 patients, achieving an 85% improvement in patient outcomes. Unlike digital-only health tech startups, Allo employs a hybrid model combining physical clinics, AI-powered treatment protocols, and structured medical training. The funds will be used for clinic expansion, technology development, and deeper patient engagement. The company is also exploring mental health as a new category, aiming to build a comprehensive, structured healthcare ecosystem in India.
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• Mankind Pharma Launches Affordable Generic Empagliflozin:
Mankind Pharma has introduced a generic variant of the diabetes drug Empagliflozin in India. Mankind Pharma has launched a generic version of Empagliflozin in India under the brands Empaglyde, Empagreat, and Dynaduo. The launch breaks cost barriers, offering the medication at competitive prices. According to Mankind Pharma Vice Chairman and Managing Director Rajeev Juneja, the launch aims to make high-quality diabetes treatment affordable. Prices for Empagliflozin start at Rs 5.49 for 10 mg and Rs 9.90 for 25 mg tablets. Click to read more.
• Expert Panel Reaffirms Beta-Blockers as First-Line Therapy for Hypertension in India
An expert panel in India came together to develop a consensus on the role of beta-blockers in managing hypertension. Hypertension, a condition affecting millions worldwide, remains a significant health challenge, especially in India, where early cardiovascular disease (CVD) is a growing concern. Despite advances in treatment, the management of essential hypertension continues to be difficult, with control achieved in fewer than 1 in 10 cases, particularly when aligned with updated guidelines from the American College of Cardiology (ACC) and the International Society of Hypertension (ISH).
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• Exporters raise alarm over new Export NOC Guidelines, seek Urgent Resolution.
According to the pharma exporters, the recently implemented Export NOC system, effective from March 7, 2025, introduces stringent documentation and compliance requirements that create unnecessary bottlenecks for exporters. Expressing its dissatisfaction, an expert stated, “These new requirements pose a severe threat to the ease of doing business for pharma exporters and could severely impact the industry’s contribution to India’s export economy.” Key concerns raised include mandatory undertaking from active pharmaceutical ingredient (API) manufacturers. The new rule mandates a legal undertaking from the API manufacturer, a requirement that is difficult to fulfil as APIs are often procured through traders. Since manufacturers typically source APIs from multiple approved vendors, obtaining such undertakings on legal stamp paper is practically unfeasible. Exporters assert that this requirement, which was not mandatory earlier, serves no effective purpose and will disrupt the supply chain.
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Innovations
• Akums’ patented ‘Tablet-in-Tablet’ Technology brings relief to expectant mothers.
Akums Drugs & Pharmaceuticals, a CDMO, has received a patent for its innovative extended-release formulation of doxylamine and pyridoxine, targeting nausea and vomiting in pregnancy (NVP). This advanced “tablet-in-tablet” technology features a unique dosage form with an outer layer that delivers immediate relief and an inner core that provides sustained drug release for prolonged therapeutic effect.
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• India joins global ranks with Enliva’s accelerator-free nitrile gloves from Wadi Surgicals.
Wadi Surgicals, India’s leading nitrile glove manufacturer has achieved a significant innovation milestone with the launch of accelerator-free nitrile gloves under its flagship brand Enliva. Developed through extensive R&D and global collaboration, these are India’s first accelerator-free nitrile gloves, offering enhanced skin safety and allergy-free protection. With a commitment to research, regulatory compliance, and export excellence, Wadi Surgicals is setting new benchmarks in Indian glove manufacturing.
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• A non-invasive breast cancer screening test, Revealia Breast offers a glimpse of the future of early cancer detection.
Enterprises, Inc., a biotech firm specializing in mRNA diagnostics and AI-driven health solutions, has announced the upcoming launch of its flagship product, Revealia Breast—a non-invasive breast cancer screening test in advanced development. Using a simple cheek swab, the test detects cancer-related inflammation, aiming to identify breast cancer even before symptoms emerge. Revealia Breast offers a more affordable, accessible, and comfortable alternative to traditional mammograms, supporting earlier and less invasive diagnosis. Click to read more.
• Researchers get breakthroughs in non-invasive methods to decode speech directly from brain signals.
Jihwan Lee, a leading researcher at the University of Southern California’s Ming Hsieh Department of Electrical and Computer Engineering and USC’s Signal Analysis and Interpretation Laboratory (SAIL), is pioneering non-invasive techniques to decode speech directly from brain signals. His work aims to benefit individuals with speech and communication disorders. Traditionally, this required invasive methods like electrocorticography (EcoG), involving implanted electrodes. Instead, a non-invasive electroencephalography (EEG) to achieve similar outcomes is being leveraged, potentially revolutionizing brain-computer interfaces.
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• Abbott’s Libre technology is first CGM associated with reduced hospitalizations for heart complications in people with diabetes.
Abbott has announced new findings from its REFLECT real-world studies showing that its FreeStyle Libre continuous glucose monitoring (CGM) system significantly reduces the risk of heart-related hospitalizations in people with diabetes. For the first time, data indicates that CGM use can lessen cardiovascular complications in individuals with Type 1 diabetes, regardless of prior low blood sugar episodes or heart disease history. Similar benefits were also observed in people with Type 2 diabetes on insulin using the Libre bio wearable technology.
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• Oxford Brain Diagnostics launches groundbreaking dementia diagnosis technology.
Oxford Brain Diagnostics (OBD) is aiming to transform early dementia detection with its patented Cortical Disarray Measurement (CDM®) technology. This software analyzes standard MRI scans to objectively assess neurodegeneration, providing a more precise evaluation of brain health. With FDA 510(k) clearance and UKCA self-certification secured, OBD is set to commercially launch its technology in the UK and US. The company’s goal is to improve global diagnostics for conditions like Alzheimer’s by enabling earlier and more accurate detection.
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• NICE recommends sparsentan for IgA nephropathy.
The National Institute for Health and Care Excellence (NICE) has recommended FILSPARI (sparsentan) for NHS use in England to treat primary IgA nephropathy. It is the first non-immunosuppressive, dual-action therapy approved for eligible patients. This follows UK regulatory approval and is backed by data from the Phase 3 PROTECT trial. NICE advises its use in adults with urine protein excretion 1.0 g/day or a protein-to-creatinine ratio 0.75 g/g and recommends continuing treatment only in those who show a positive response.
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• Medkart introduces India’s first room-temperature stable Nicorandil tablets for cardiac care.
Ahmedabad-based Medkart has launched India’s first room-temperature stable generic Nicorandil tablets, a breakthrough that enhances accessibility and affordability of heart medication. Nicorandil, used to treat chronic stable angina, traditionally requires cold-chain storage due to its sensitivity to heat and humidity. Medkart’s innovation eliminates this need, easing distribution challenges, especially in rural and semi-urban areas and ensuring wider, more cost-effective patient access.
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• Autonomix Medical’s innovative catheter-based platform technology receives US patent.
Autonomix Medical, Inc., a medical device company focused on precision nerve-targeted therapies, announced that the U.S. Patent and Trademark Office has granted Patent No. 12,257,071 titled “Controlled sympathectomy and micro-ablation systems and methods.” This patent covers advanced catheter-based systems that integrate nerve mapping with radiofrequency (RF) ablation, enabling precise, minimally invasive treatment of overactive peripheral nerves.
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• Breakthrough in bowel cancer research will speed up diagnosis.
British company Xgenera, in collaboration with the University of Southampton, has developed technology that could enable earlier and more accurate detection of bowel cancer. This innovation promises faster, cheaper diagnosis, reducing the need for invasive procedures like colonoscopies and biopsies. Announced by the government on April 23, technology could save valuable time and resources for patients and the NHS.
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• ISRO and SCTIMST sign MoU in space medicine.
ISRO has signed a Framework Memorandum of Understanding with Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST) to collaborate on space medicine. This partnership is a key step forward in advancing space medicine and its applications in India. ISRO highlighted that the Gaganyaan human space program presents a unique opportunity for national agencies, academia, and industry to engage in human health research, microgravity studies, space medicine, and space biology.
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• Personalized Medicine and Genomic Advancements.
As of April 2025, personalized medicine is advancing rapidly, fueled by breakthroughs in AI, molecular biology, and genomics. Pharma companies are increasingly developing treatments tailored to individual genetic profiles and lifestyles, especially for complex diseases like cancer. Targeted therapies—such as HER2 inhibitors for breast cancer and PARP inhibitors for ovarian cancer—are boosting treatment effectiveness and patient outcomes. Additionally, the use of real-world data (RWD) and real-world evidence (RWE) is enhancing personalization by providing valuable insights into how patients respond to therapies.
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• Tech Mahindra and NVIDIA to advance drug safety with AI-powered pharmacovigilance solution.
Tech Mahindra, in collaboration with NVIDIA, has developed an AI-powered pharmacovigilance (PV) solution to enhance drug safety management. Using agentic AI and automation, the system optimizes PV workflows, reducing manual delays, human errors, and data overload. Built on Tech Mahindra’s TENO framework and powered by NVIDIA AI Enterprise, the solution automates case intake, classification, quality control, and compliance management. It reduces turnaround times by 40%, enhances data accuracy by 30%, and lowers operational costs by 25%. The AI-driven approach transforms pharmacovigilance from a reactive to a predictive model, ensuring faster, more reliable drug safety monitoring.
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• Smart Labels in Pharma: A New Era of Patient Safety.
Smart labels are revolutionizing the pharmaceutical industry by enhancing patient safety, improving drug authentication, and streamlining logistics. Technologies like QR codes, Near-Field Communication (NFC) tags, and Radio-Frequency Identification (RFID) tracking allow real-time monitoring of medications, ensuring drug integrity and reducing counterfeit risks. These labels provide instant access to drug details, dosage instructions, and expiry dates, fostering better patient compliance. Additionally, smart labels can track medication usage, assist in clinical research, and improve emergency medical responses. As digital health advances, smart labels are set to bridge the gap between technology and patient care, creating a more transparent and efficient healthcare system.
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• Gastrointestinal cancer diagnosis with AI: Faster, more accurate abdominal CT scan analysis.
Gastrointestinal cancers pose a significant global health challenge, with over 1.2 million cases diagnosed annually, nearly 40% in China. Abdominal body composition plays a crucial role in prognosis, influencing treatment outcomes. By automating the segmentation of abdominal CT images, this AI tool offers a faster and more accurate method for body composition analysis. Clinicians can use it to identify high-risk patients early, develop more personalized treatment strategies, and monitor treatment progress over time.
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• NURA Launches Mobile Health Screening Facility ‘NURA Express’ in Kozhikode.
NURA, a joint venture between Fujifilm Healthcare and Dr. Kutty’s Healthcare, has launched its mobile health screening service, ‘NURA Express,’ in Kozhikode, Kerala. This mobile unit offers cancer screenings and tests for lifestyle diseases via on-site CT scans, catering to employees and residents. The results are analyzed remotely and shared through a dedicated app. NURA plans to expand by partnering with local governments for municipal health screenings, aiding in early disease detection. This initiative utilizes Fujifilm’s advanced imaging and AI-driven medical IT systems to enhance health outcomes.
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• Harbour BioMed Inks Global Strategic Collaboration with AstraZeneca to discover and develop Next-Generation Therapeutic Antibodies.
Harbour BioMed, a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics in immunology and oncology, announced a global strategic collaboration with AstraZeneca to discover and develop next-generation multi-specific antibodies for immunology, oncology and beyond. Under the terms of the agreements, AstraZeneca will obtain the option to license two preclinical immunology programs and will nominate further targets for Harbour BioMed to discover the next-generation multi-specific antibodies. AstraZeneca will have the option to license these programs for advancement into clinical development.
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• Lupin Digital Health introduces comprehensive post-procedure home-based care guide with American College of Cardiology.
Lupin Digital Health, in partnership with the American College of Cardiology, has introduced a home-based care guide for heart patients. The guide covers recovery, medication management, lifestyle changes, and cardiac rehabilitation. It aims to support patients post-procedure and reduce hospital readmissions. Leading cardiologists contributed to developing the guide, ensuring its medical accuracy. This initiative enhances patient care and promotes better health outcomes.
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• Monash University and Peninsula Health develop AI methods to improve dementia diagnosis.
The National Centre for Healthy Ageing (NCHA), a joint initiative between Monash University and Peninsula Health, has introduced an advanced approach to enhance dementia detection in hospitals by integrating traditional screening techniques with artificial intelligence (AI). Researchers from NCHA’s Healthy Ageing Data Platform, along with clinicians from Australia and the USA, used a specific AI technique—natural language processing (NLP)—to analyze written medical records, significantly improving the accuracy of dementia identification.
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Trends
• Vaccine preventable diseases rising.
Vaccine-preventable diseases like measles, meningitis, and yellow fever are making a comeback due to disrupted immunisation programs and funding cuts, global health leaders have warned. In a joint statement, the WHO, UNICEF, and Gavi highlighted that misinformation, population growth, and ongoing humanitarian crises are further undermining vaccination efforts. They called on world leaders to prioritise and reinforce immunisation programmes with urgent and sustained political commitment.’
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• Neurocrine Biosciences announces new survey revealing need for routine screening and earlier diagnosis for people living with tardive dyskinesia.
Neurocrine Biosciences, Inc., a leading neuroscience-focused biopharmaceutical company, announced the release of findings from a new survey conducted by The Harris Poll highlighting the profound negative impact of tardive dyskinesia on patients and reinforcing the need for routine screening, earlier diagnosis and treatment. The findings revealed that 80% of people living with tardive dyskinesia surveyed wished they had been screened for the condition earlier, and 86% wished their provider had discussed available treatment options for their uncontrolled movements sooner.
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• India-UK FTA will be a game-changer for ceramic & pharmaceutical exports: Gujarat industry players.
Upbeat about the free trade agreement (FTA) between India and the United Kingdom, ceramic and pharmaceutical players in Gujarat have described the deal as a “game-changer.” Pharmaceutical players in Gujarat also felt that the deal with the UK will ease regulatory approvals for generic drugs, improve market access and thus boost pharmaceutical exports from India.
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• Oracle, Cleveland Clinic & G42 enter into a strategic partnership to launch an AI-based global healthcare delivery platform.
Oracle Health, Cleveland Clinic, and G42 announced a strategic partnership to develop a groundbreaking AI-based healthcare delivery platform. This initiative aims to improve patient care and public health management by leveraging AI, nation-scale data analytics, and intelligent clinical applications to create secure, scalable, and accessible care models that positively impact people’s health and longevity. The platform will serve as the foundation for an AI-driven healthcare hub, combining Oracle Cloud Infrastructure, Oracle AI Data Platform, and Oracle Health applications, Cleveland Clinic’s world-class clinical expertise, and G42’s capabilities in sovereign AI infrastructure, health data integration, and advanced clinical AI models.
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• VITU and Gleneagles Hospital Chennai sign MoU to collaborate on AI-driven neuroscience innovation.
Vellore Institute of Technology University (VITU) has signed a Memorandum of Understanding (MoU) with Gleneagles Hospital Chennai to foster collaboration in research and innovation in artificial intelligence (AI) and neurosciences. The MoU was formalised by Dr. Nageshwar Rao, CEO of Gleneagles Hospital Chennai, and Dr. T. Thyagarajan, Pro Vice-Chancellor of VIT University.
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• Global Pharma Investment and Power Shifts: Roche and Eli Lilly Take the Lead.
In April, Roche announced a $50 billion investment to expand its U.S. R&D and manufacturing, creating 12,000 jobs across eight states. Although the company didn’t comment on political motives, the move followed a Swiss-U.S. diplomatic call, sparking speculation about tariff-related factors. Meanwhile, Eli Lilly is gaining market share over Novo Nordisk in diabetes and obesity treatments, with its drugs Mounjaro and Zepbound outperforming Novo’s Ozempic and Wegovy. Supported by a strong pipeline including orforglipron and retatrutide, Lilly’s 32% annual growth has analysts optimistic, prompting BMO to downgrade Novo’s outlook amid intensifying competition.
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• Biotech Boom and EU Pressure: Investment Trends and Geopolitical Tensions.
Venture capital investment in biotech remains strong in early 2025, with median funding rounds reaching $93 million US dollars. Investors are focusing on late-stage, clinic-ready startups, particularly in China, aiming for faster regulatory approvals and quicker returns. However, experts warn that IPO delays and regulatory uncertainties may pose valuation risks. Meanwhile, 32 pharma CEOs from companies like Roche, Novartis, and Pfizer have urged the EU to enact policy reforms to avoid losing up to €103 billion Euros in investments. Facing U.S. drug import tariffs, pharma leaders are pushing for faster drug approvals, stronger IP protections, and eased environmental penalties to maintain Europe’s competitiveness in global life sciences innovation.
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• Startoon Labs signs MoU with Medplus to initiate Pheezee assessment.
Startoon Labs Private Limited, a Hyderabad-based medical device R&D and manufacturing company specializing in joint and muscle health, has signed an MoU with Medplus to introduce the Pheezee assessment at Medplus diagnostic centres. Medplus Diagnostics, part of the well-known Medplus pharmacy retail chain, offers pathology and radiology services and will now provide muscle and joint health diagnostics using the Pheezee device.
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Law and Order Briefs
• Delhi High Court sets aside patent office’s order rejecting Taiho Pharma’s application.
The Delhi High Court has set aside a Patent Office order refusing patent to an anticancer compound from Japanese pharma firm Taiho Pharmaceutical, part of Otsuka Group, remanding back the matter for fresh consideration of the Patent Authority. The High Court observed that while the patent application was rejected on various grounds including Section 3(d) of the Patents Act, 1970, the Patent Office did not identify any particular ‘known substance’ in the hearing notice, providing a fair opportunity to the applicant to respond to the same. By not sharing the information the applicant could not have defended his case.
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• The Supreme Court Criticizes Pharmacy Council of India for Arbitrary Rejection of Pharma College Approvals.
The Supreme Court has recently expressed serious concern over the Pharmacy Council of India (PCI) for acting irresponsibly in rejecting approvals for pharma colleges. The court highlighted that PCI, an expert body in pharmacy education, should be more diligent and avoid arbitrary actions that affect students’ futures. The Court set aside PCI’s rejection orders and directed the Registrar to forward a copy of the judgment to the Secretary, Ministry of Health and Family Welfare. The intent is to ensure that such unnecessary litigations do not happen again. Click to read more.
• The Supreme Court says doctors must prescribe only generic drugs, not branded medicines.
The Supreme Court on Thursday stated that doctors nationwide should be required to prescribe only generic medicines instead of branded ones. The top court was hearing a Public Interest Litigation (PIL) seeking the stringent regulation of the marketing and promotion of drugs by pharmaceutical firms. This observation came during the hearing of a petition filed by the Federation of Medical & Sales Representatives Associations of India (FMSRAI) and others. The plea emphasised that large sums of money are spent on sales and promotional activities aimed at influencing doctors to increase prescription volumes.
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• The Supreme Court Challenges Health Insurance Policy on Epilepsy Exclusion.
The Supreme Court has requested the government’s response to a petition challenging the omission of epilepsy from health insurance coverage. The plea, filed by Sanvedana Foundation, argues that excluding epilepsy violates constitutional rights and restricts healthcare access for affected individuals. The existing policy, as stated by IRDA, deems epilepsy a permanent exclusion.
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• Bombay HC Notice to CDSCO on Denial of Phase I Trial for Indigenous Cancer Drug.
The Bombay High Court has issued a notice to the Central Drugs Standard Control Organisation (CDSCO) and the Union government following a petition by Nashik-based Datar Cancer Genetics. The company challenges the CDSCO’s rejection of its application to conduct Phase I human trials for its indigenous cancer immunotherapy drug, Per-C-Vax, intended for patients recently diagnosed with solid organ cancers. A division bench comprising Chief Justice Alok Aradhe and Justice M.S. Karnik is reviewing the case, where Datar alleges that the CDSCO’s April 22, 2025, rejection was “arbitrary,” “unscientific,” and a “fraud on the statute.”
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• Delhi High Court quashes Indian Patent Office’s decision to hear pre-grant opposition after signing patent approval.
The Delhi High Court invalidated the Indian Patent Office’s (IPO) decision to entertain a pre-grant opposition against Vertex Pharmaceuticals’ patent for a cystic fibrosis drug, ruling that the opposition was filed after the patent was already granted by the controller. Although the patent grant order had not yet been uploaded online, the Court found this delay was due to technical issues on the IPO’s side, not Vertex’s fault. Consequently, the absence of the patent certificate or delay in its publication did not affect the validity of the patent grant, rendering the pre-grant opposition invalid.
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• Relatives of rare disease requests CJI to help them access life-saving medicines at affordable cost.
Mothers and caregivers of children with rare diseases like spinal muscular atrophy (SMA) and cystic fibrosis have appealed to the Chief Justice of India, Justice Sanjiv Khanna, seeking access to life-saving medicines at affordable prices. In a letter signed by around 220 parents and caregivers, they urged the Supreme Court to take suo motu cognizance of the urgent situation and expedite the resolution of pending legal cases related to rare disease treatments.
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• The Supreme Court issues notice to Roche on risiplam matter.
The Supreme Court of India (SCI) has issued a notice to Swiss pharmaceutical company F Hoffmann-La Roche Ltd, maker of the spinal muscular atrophy (SMA) drug risdiplam, seeking clarity on whether the drug can be supplied in India at a lower price if offered at such rates in neighboring countries. This follows a Special Leave Appeal filed by the Union of India challenging a Kerala High Court order that directed the government to cover the cost of one month’s medicine for a patient, Seba PA, who sought help to continue treatment beyond the Rs. 50 lakhs only limit set by the National Rare Disease Policy (NRDP).
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• The Supreme Court pushes for expert recommendations on Food Labelling.
The Supreme Court has directed an expert committee to recommend amendments to food safety regulations requiring warning labels on packaged foods, focusing on sugar, salt, and unhealthy fats. This initiative aims to help consumers make healthier dietary choices amid rising non-communicable diseases. The Court acknowledged the efforts of the Centre and the Food Safety and Standards Authority of India (FSSAI), which received around 14,000 public objections and suggestions on the proposed changes. The expert committee will review these inputs and suggest appropriate amendments to the regulations.
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• The Supreme Court mandates immediate cancellation of hospital licenses in case of child trafficking.
The Supreme Court has issued strict guidelines to curb newborn trafficking, including the immediate suspension of hospital licenses where such cases occur. Justices JB Pardiwala and R Mahadevan warned that any violation of these directions would be treated as contempt of court. Highlighting the severity of child trafficking, the Court described its impact as worse than death and called for greater parental vigilance. Additionally, state governments were urged to implement recommendations from a human trafficking report by the Bharatiya Institute of Research and Development.
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• Kerela Doctor moves HC seeking Regulations for Home Births:
A medical officer from Malappuram, Dr Pratibha K, has approached the Kerela High Court seeking clear legal provisions and penalties to regulate childbirth outside medical facilities. She has urged for establishment of proper guidelines to ensure the safety of both mothers and newborns. The issue came in light after a woman gave birth at her rental home in November, but officials refused to issue the certificate as no formal records of the delivery existed.
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• Apollo Hospitals Bengaluru slammed, slapped Compensation by Consumer Court.
The Bengaluru Urban District Consumer Disputes Redressal Commission has ordered Apollo Hospitals in Seshadripuram to compensate a senior patient Rs 1 lakh only for the harassment and rude behaviour he endured during his treatment. The forum observed that “the complainant has suffered mental agony and discomfort at the hands of hospital staff. It is the responsibility of the doctor and medical staff to prove that due care was taken in discharge of their duties. The complainant is entitled to compensation for harassment and mental agony and financial loss suffered by him for the harassment given by the staff of the hospital”.
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• Patients and experts urge Court to ensure access to cystic fibrosis in India.
Patients with cystic fibrosis (CF), along with public health experts, are urging the Karnataka High Court to facilitate the availability of affordable treatment for CF patients in India. The petitioners seek the government’s approval for generic production of the CF drug, which would allow for compulsory licensing and lower prices. The drug, a combination of three CFTR modulators, is lifesaving for CF patients, improving lung function and reducing hospitalizations. However, despite the drug being available in high-income countries, its cost in India exceeds Rs. 2.5 crores annually, and it is not marketed or approved in India by Vertex Pharmaceuticals, which holds the patents. The petitioners argue that the drug’s monopoly prevents access and call for remedies to introduce generic competition, making the drug affordable. The case could have significant implications for rare disease patients in India.
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• False Advertising, Misrepresentation- CCI Clears Hospital in Unregistered Surgeon Row.
The Competition Commission of India (CCI) has dismissed a complaint filed against Victor Hospital, Margao, Goa, regarding allegations of misleading consumers by employing an unregistered surgeon and engaging in anti-competitive practices. The commission stated that misleading consumers by misrepresenting a surgeon’s qualifications and engaging in false advertising, while serious, do not amount to anti-competitive behavior under the Competition Act, 2002. It was noted that such issues should be dealt with by medical regulatory bodies rather than CCI. Click to read more.
• Big pharma faces heat as India records 307 drug pricing violations.
Pharmaceutical companies have repeatedly violated drug pricing regulations by exceeding permitted price hikes, according to a report by the Parliamentary Standing Committee on Chemicals and Fertilizers. As of 6 March 2025, the National Pharmaceutical Pricing Authority (NPPA) recorded 307 cases of violations under Paragraph 20 of the Drugs (Prices Control) Order (DPCO), 2013, which governs price increases for non-scheduled drugs. These violations highlight growing concerns over the unchecked rise in medicine prices and their impact on affordability.
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• Karnataka Government. proposes to establish Special Court to hear cases related to Supply of fake and spurious drugs.
A special court to hear cases related to the supply of fake and spurious drugs would be specifically designated to deal with cases involving counterfeit, adulterated, or substandard drugs that pose a significant risk to public health. This type of court would help address the growing problem of drug-related fraud, ensuring swift trials and harsher penalties for those involved in such activities. The department is making sure the company which supplies fake medicines are imposed huge fines and taken to task. We are also bringing the Drug Recall Policy so that fake medicine suppliers and manufacturers are taken to task. According to the data furnished to the House, a total of 20 cases have been registered in the last three years against the companies which supplied fake medicines.
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• BIS Cracks Down on E-Commerce Platforms Selling Non-Certified Products.
The Bureau of Indian Standards (BIS) has conducted search and seizure operations at multiple Amazon and Flipkart warehouses in Lucknow, Gurugram, and Delhi, confiscating thousands of non-certified consumer products such as toys, hand blenders, electric heaters, and gas stoves. The raids also uncovered large-scale violations by Tech vision International Pvt Ltd, leading to legal action under the BIS Act, 2016. BIS has filed cases and warned e-commerce platforms to ensure only BIS-certified products are sold. Consumers are urged to use the BIS Care app to verify certification and report violations. The crackdown aims to enhance product safety and protect public interest.
Click to read more.In this issue of Noverra Partners Pharma and Healthcare Insight we have made an effort to include all the pertinent developments in the pharmaceuticals and healthcare sector during the month of March, April, and May 2025. This newsletter aims to cover local, regional, and global news as well as regulatory updates, new government initiatives, and technological advancements etc.
Regulatory Update
• DTAB recommends all antimicrobials to be considered as new drug under NDCT Rules.
The Drugs Technical Advisory Board (DTAB) has recommended that, in the public interest, all antimicrobials should be classified as new drugs under the New Drugs and Clinical Trials (NDCT) Rules, 2019. This recommendation follows the Board’s earlier proposal to the Drugs Consultative Committee (DCC), urging the inclusion of all antibiotics within the definition of new drugs as a measure to combat antimicrobial resistance (AMR). The latest decision was made after a thorough review of DCC’s observations and recommendations.
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• The Health Ministry notifies rules on compounding offences.
The Union Health Ministry has officially notified the rules for compounding minor offences under drug regulations. This long-anticipated move, following the draft issued nearly nine months ago, aligns with the Jan Vishwas (Amendment of Provisions) Act, 2023. The newly introduced Drugs and Cosmetics (Compounding of Offences) Rules, 2025, aim to ease legal burdens, enhance compliance, and promote ease of doing business. As per the final notification dated April 24, 2025, the rules will come into effect from the date of their publication in the Official Gazette.
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• DTAB agrees with the sub-committee report recommending prohibition of 16 FDCs.
The Drugs Technical Advisory Board (DTAB), in its 92nd meeting held on April 24, 2025, endorsed the findings of its sub-committee led by Dr. Nilima Kshirsagar, which identified 16 fixed dose combinations (FDCs) as irrational and recommended their prohibition due to potential risks to human health. Additionally, the Board has referred 29 FDCs—previously deemed irrational by the Prof. Kokate Committee—to the Kshirsagar sub-committee for further evaluation.
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• CDSCO revises guidelines for issuance of export NOC for unapproved, approved new drugs.
The Central Drugs Standard Control Organisation (CDSCO) has revised its procedure for issuing Export No Objection Certificates (NOCs) for the manufacture of unapproved and approved new drugs intended solely for export purposes. Key changes include the discontinuation of quantity-specific and purchase order-specific NOCs, except in the case of Narcotic Drugs, Psychotropic Substances (NDPS), and banned drugs. CDSCO has also released a revised guidance document outlining the updated process, which follows the centralisation of the NOC issuance system implemented last year.
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• DGFT eases pharma export rules for SCOMET items for testing and evaluation.
In a bid to promote technological advancement and streamline pharmaceutical export processes, the Government of India has proposed amendments to the Handbook of Procedures (HBP) 2023, allowing the export of SCOMET (Special Chemicals, Organisms, Materials, Equipment and Technologies) items for the purpose of testing and evaluation. The Directorate General of Foreign Trade (DGFT) has issued a draft public notice seeking feedback from stakeholders, including exporters, industry associations, and technical experts, on the proposed changes.
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• NPPA fixes retail prices of 84 drugs, including empagliflozin combos.
The National Pharmaceutical Pricing Authority (NPPA), in its 132nd meeting held on April 29, has fixed the retail prices for 84 drug combinations, including 36 generic versions of empagliflozin, a diabetes medication originally developed by Boehringer Ingelheim. The move follows the expiry of empagliflozin’s patent on March 11, which opened the market to multiple generic manufacturers, resulting in a significant price drop of 80–85%. In response to this surge in competition and to ensure price regulation, the NPPA intervened under the Drug Price Control Order (DPCO). Alongside empagliflozin-based formulations, the updated price list also covers several anti-hypertensive drug combinations.
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• DGFT amends import norms for Di-octyl phthalate to enhance export efficiency.
In a strategic effort to align export-import ratios with industry requirements and enhance trade efficiency, the Directorate General of Foreign Trade (DGFT) has amended the Standard Input Output Norms (SION). The revision specifically adjusts the permissible import quantity of a key raw material used in the production of Di-octyl phthalate (DOP), a crucial plasticizer. This move is aimed at streamlining trade practices and better supporting the operational needs of manufacturers.
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• Substandard Drugs Flagged Across Multiple States, over 130 Batches Fail Quality Tests in April.
The Central Drugs Standard Control Organisation (CDSCO), in its April 2025 alert, has flagged 136 drug batches as Not of Standard Quality (NSQ). The list includes widely used medications such as paracetamol, amoxicillin, cefixime, telmisartan, various dermatological products, and several veterinary formulations. Issued as part of CDSCO’s routine regulatory surveillance, the alert also draws attention to repeated quality violations by certain manufacturers, particularly involving albendazole and ivermectin-based products.
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• The Health Ministry restricts use of common cold medicine in children under four years.
The Union Health Ministry has restricted the use of the commonly used cold medication combination, Chlorpheniramine Maleate and Phenylephrine Hydrochloride, for children under four years of age. Manufacturers have been directed to include a warning on the drug’s label and package insert. The decision was made after the Central Government concluded that the fixed dose combination (FDC) poses potential risks to children in this age group and that safer alternatives are available.
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• NABL issues updated accreditation criteria for biobanks aligned with ISO 20387:2018.
The National Accreditation Board for Testing and Calibration Laboratories (NABL) has released an amended version of its Specific Criteria for Accreditation of Biobank, marking a significant step toward standardizing and enhancing biobanking practices across India. The revised criteria are specifically designed to align Indian biobanking systems with international standards, particularly ISO 20387:2018. This move reflects the growing global emphasis on quality, consistency, and ethical practices in the handling and storage of biological materials, which are foundational to scientific research and innovation.
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• CDSCO launches online registration for CROs.
The Central Drugs Standard Control Organization (CDSCO) has mandated online registration for Clinical Research Organizations (CROs) via the Sugam portal from April 1, 2025. Under the amended New Drugs and Clinical Trials Rules (NDCTR), 2019, CROs must register with the Central Licensing Authority (CLA) to conduct clinical trials, paying Rs. 5 lakhs only for a five-year license. Approvals take 45 working days, with appeal options available. Authorities can inspect and penalize non-compliance. The Ninth Schedule outlines staffing, quality control, and data retention norms. Finalized after public consultation, these rules enhance oversight and transparency in clinical research.
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• Centre Bans Chloramphenicol and Nitrofurans for Use in Food-Producing Animals:
The Union Health Ministry has banned the import, manufacture, sale, and distribution of chloramphenicol and nitrofurans (including furaltadone, furazolidone, nitrofurantoin, and nitrofurazone) for use in food-producing animals. The decision follows recommendations from the Drugs Consultative Committee (DCC) and the Drugs Technical Advisory Board (DTAB), citing misuse in poultry and livestock feed. The ban aligns with the Food Safety and Standards Authority of India (FSSAI) guidelines, which already prohibited these drugs in meat, poultry, and seafood processing. Chloramphenicol, an antibiotic used to treat bacterial infections, and nitrofurans, used for urinary tract infections, poses health risks such as bone marrow suppression and antibiotic residues in food.
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Approvals
• Glenmark’s cancer drug ISB 2001 gets fast track designation from US FDA.
Ichnos Glenmark Innovation (IGI) has received Fast Track designation from the US FDA for its investigational trispecific antibody, ISB 2001, intended for the treatment of relapsed or refractory multiple myeloma (RRMM) in adults who have received at least three prior lines of therapy. ISB 2001 is designed to simultaneously target BCMA and CD38 on myeloma cells and CD3 on T cells, enhancing immune-mediated tumor cell killing. The candidate is currently undergoing evaluation in a Phase 1 dose-expansion study.
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• Zydus gets USFDA nod for generic drug to treat multiple sclerosis.
Zydus Lifesciences has received approval from the US Food and Drug Administration (USFDA) to market its generic version of Glatiramer Acetate Injection, available in 20 mg/mL and 40 mg/mL single-dose prefilled syringes. This medication is the generic equivalent of Copaxone, a treatment indicated for relapsing forms of multiple sclerosis (MS). The approval marks a significant milestone for the company in expanding its presence in the central nervous system (CNS) therapeutic area within the US market.
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• AstraZeneca Pharma India gets CDSCO approval to import, sell cancer treatment medicine.
AstraZeneca Pharma India Ltd announced on Monday that it has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute the cancer treatment drug Durvalumab solution in India. According to a regulatory filing, the approval covers the import, sale, and distribution of Durvalumab infusion solutions in 120 mg/2.4 ml and 500 mg/10 ml (marketed as Imfinzi) for an additional indication. Durvalumab, when used in combination with Tremelimumab, is indicated for the treatment of patients with unresectable hepatocellular carcinoma.
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• The US FDA approves the first at-home test for cervical cancer screening.
The U.S. Food and Drug Administration (FDA) has approved the first-ever at-home test for cervical cancer screening, announced Teal Health on Friday. This new option provides an alternative to traditional Pap smears, which require an in-office visit. While Pap smears have played a crucial role in reducing cervical cancer incidence over the past 80 years, many women find the in-clinic procedure uncomfortable. The FDA’s approval was supported by a study involving over 600 women, demonstrating that self-collected samples using Teal Health’s test perform comparably to those collected by clinicians. Click to read more.
• US FDA approves Novavax’s BLA for Covid-19 vaccine, Nuvaxovid.
Novavax, Inc. has announced that the US Food and Drug Administration (FDA) has approved its Biologics License Application (BLA) for Nuvaxovid, a vaccine for active immunization against COVID-19 caused by SARS-CoV-2. The approval covers adults aged 65 and older, as well as individuals aged 12 to 64 with at least one underlying condition that increases their risk of severe COVID-19 outcomes, such as asthma, cancer, diabetes, obesity, or smoking. Following this US license approval, Sanofi has triggered a milestone payment of $175 million to Novavax.
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• UK MHRA approves Janssen-Cilag’s guselkumab for Crohn’s disease and ulcerative colitis.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved guselkumab (Tremfya) for the treatment of Crohn’s disease and ulcerative colitis (UC). Previously approved for plaque psoriasis and psoriatic arthritis, guselkumab has now demonstrated efficacy in clinical studies for adults with moderately to severely active Crohn’s disease and UC who have either not responded adequately to other therapies or have experienced intolerable side effects.
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• US FDA grants IDE approval to Innoblative’s SIRA RFA electrosurgical device for breast cancer treatment.
The US Food and Drug Administration has approved Innoblative Designs Inc.’s, Investigational Device Exemption application, paving the way for the company to initiate its US feasibility study. Through this safety and effectiveness of the company’s SIRA RFA electrosurgical device in patients undergoing breast-conservation surgery will be evaluated. Click to read more.
• UK MHRA approves eplontersen to treat adults with rare inherited nerve disease or polyneuropathy.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved eplontersen for the treatment of adults with polyneuropathy linked to hereditary transthyretin amyloidosis (ATTRv), a rare inherited and progressive disorder. The condition is caused by abnormal transthyretin (TTR) protein, which forms amyloid deposits that accumulate in nerves, the heart, and other organs, impairing their function. Click to read more.
• AstraZeneca’s Imfinzi receives US FDA approval for patients with muscle-invasive bladder cancer.
The U.S. Food and Drug administration has approved AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as a neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy, for adult patients with muscle-invasive bladder cancer (MIBC).
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• US FDA grants breakthrough device designation to Roche’s companion diagnostic, VENTANA TROP2 (EPR20043) RxDx Device for non-small cell lung cancer.
The US Food and Drug Administration (FDA) granted Breakthrough Device Designation to the VENTANA TROP2 (EPR20043) RxDx Device. It is the first Breakthrough Device Designation to be granted for a computational pathology companion diagnostic device.
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• US FDA approves celecoxib capsules of Strides.
Strides Pharma announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte., Singapore, has received U.S. FDA approval for celecoxib capsules in 100 mg, 200 mg, and 400 mg strengths. Celecoxib is a selective COX-2 inhibitor used to manage pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis, acute pain, and dysmenorrhea. Click to read more.
• US FDA grants Breakthrough Device Designation to Mursla Bio’s EvoLiver test.
Mursla Bio, a pioneer in Extracellular Vesicle (EV) science, has announced that the U.S. FDA has granted Breakthrough Device Designation to its lead product, EvoLiver. This Dynamic Biopsy-based blood test leverages organ-specific EVs to aid in the surveillance of hepatocellular carcinoma (HCC), the most common type of primary liver cancer, in high-risk cirrhotic patients. The designation highlights EvoLiver’s potential to significantly improve cancer outcomes through early detection.
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International Pharma News
• Minghui Pharma enters strategic partnership and licensing pact with Qilu Pharma to develop B7-H3 ADC in Greater China.
Minghui Pharmaceutical has signed an exclusive licensing and collaboration agreement with Qilu Pharmaceutical for the development, manufacturing, and commercialization of its B7-H3 ADC (MHB088C) in Greater China (Mainland China, Hong Kong, Macau, and Taiwan). Qilu will have exclusive rights in the region, while Minghui will receive up to 1.345 billion RMB, including 280 million RMB upfront, milestone payments, and royalties. Minghui retains global rights outside Greater China and will continue development there. MHB088C is an innovative antibody-drug conjugate developed using Minghui’s proprietary SuperTopoi ADC platform.
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• GSK to buy Boston Pharma’s efimosfermin, a phase III-ready potential best-in-class specialty medicine to treat and prevent progression of SLD.
GSK plc and Boston Pharmaceuticals have announced an agreement for GSK to acquire Boston’s lead asset, efimosfermin alfa phase III-ready, potential best-in-class investigational treatment for steatotic liver disease (SLD). Under the deal, GSK will pay $1.2 billion US dollars upfront, with up to $800 million US dollars in additional success-based milestone payments.
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• US President Trump announces ‘equalisation’ policy for medicines prices in the US.
US President Donald Trump announced that the United States will no longer subsidize healthcare costs for other countries, as part of his efforts to negotiate medicine price reductions ranging from 59% to as much as 80-90%. Describing his “equalization” policy, President Trump highlighted that while the US represents less than five percent of the global population, it accounts for nearly three-quarters of worldwide pharmaceutical profits. He clarified that the directive targets developed countries that set drug prices lower than those in the US, rather than pharmaceutical companies themselves. Additionally, Trump introduced the “Most Favoured Nation” policy, which aims to align US drug prices with the lowest prices available in any other country.
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• US FDA to expand use of unannounced inspections at foreign manufacturing facilities.
The US Food and Drug Administration (FDA) has announced plans to increase the use of unannounced inspections at foreign manufacturing facilities producing food, essential medicines, and other medical products for American consumers and patients. Expanding on its existing Foreign Unannounced Inspection Pilot program in India and China, the agency aims to ensure that foreign manufacturers are held to the same rigorous regulatory standards and oversight as domestic companies.
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• Ethiopian Food and Drug Authority revise GMP Rules, mandates re-inspection every 3 years.
The Ethiopian Food and Drug Authority (EFDA) has updated its pharmaceutical inspection directive to align with global standards, aiming to improve the safety, quality, and efficacy of health products in Ethiopia. The revised rules shorten the Good Manufacturing Practice (GMP) re-inspection interval for compliant facilities from five to three years, reflecting EFDA’s commitment to stricter oversight. Additionally, GMP inspection fees and waivers will now be valid for only three years. Manufacturers holding a five-year cGMP certificate must apply for re-inspection after three years under the new framework. Click to read more.
• Kaushik Desai has been appointed as a member of the WHO Expert Committee on ECSSP.
Kaushik Desai has been appointed as a member of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) for the 2025–2027 term. In this role, he will contribute to the development and revision of WHO pharmaceutical guidelines. The ECSPP is a high-level advisory body that provides expert guidance to the WHO Director-General and Member States on pharmaceutical quality assurance and is responsible for creating and updating international standards published in the WHO Technical Report Series.
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• India initiates anti-dumping investigation on imports of MIPA from China.
The Directorate General of Trade Remedies (DGTR) has initiated anti-dumping investigation concerning the import of monoisopropylamine (MIPA) originating in or exported from China PR. This move follows an application filed by Alkyl Amines Chemicals Limited, alleging material injury to the domestic industry due to unfair trade practices.
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• India initiates crucial oral hearing in anti-dumping probe on TDI imports from EU & Saudi Arabia.
In a move to safeguard India’s domestic industry, the Directorate General of Trade Remedies (DGTR) has scheduled an oral hearing in its ongoing sunset review anti-dumping investigation concerning the import of Toluene Di-Isocyanate (TDI) from the European Union (EU) and Saudi Arabia.
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• Bioxodes announces positive data from BIRCH phase 2a trial of BIOX-101 to treat patients with intracerebral hemorrhagic stroke.
Bioxodes SA, a clinical-stage biopharmaceutical company, reported promising interim results from the BIRCH phase 2a trial of its lead drug BIOX-101 for intracerebral hemorrhagic stroke (ICH). Analysis of the first 16 patients in this randomized, standard-of-care controlled study showed that both primary safety and secondary efficacy goals were achieved. The Data Monitoring Committee found no safety issues related to ICH volume changes, serious adverse events, neurological outcomes, or mortality.
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• Zealand Pharma begins patient enrolment in phase 2b ZUPREME-2 trial of petrelintide in people with overweight or obesity and type 2 diabetes.
Zealand Pharma A/S, specializing in peptide-based medicines, has enrolled the first participant in ZUPREME-2, a phase 2b trial testing petrelintide—a long-acting amylin analog—in people with overweight or obesity and type 2 diabetes. This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of three doses of once-weekly subcutaneous petrelintide versus placebo, alongside a reduced-calorie diet and increased physical activity.
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• Orion & Criceto signs agreement to develop and commercialize Aporon, an innovative apomorphine spray to treat OFF episodes in Parkinson’s disease.
Orion Corporation, a Nordic pharmaceutical company, and Criceto IKM B.V., an innovation-focused pharma firm, have signed an exclusive license agreement for the development and commercialization of Aporon. Aporon is a novel apomorphine oromucosal spray in phase 3 trials, aimed at treating OFF episodes in Parkinson’s disease patients. Designed as a rescue therapy, Aporon targets the difficult OFF episodes that greatly affect patients’ quality of life.
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• WHO issues its first-ever reports on tests and treatments for fungal infections.
The World Health Organization (WHO) released its first reports highlighting a critical shortage of medicines and diagnostic tools for invasive fungal diseases, underscoring the urgent need for innovative research and development to address these gaps. Fungal infections, such as candida causing oral and vaginal thrush, are becoming a growing public health concern due to increasing resistance to treatments. These infections particularly affect severely ill and immunocompromised individuals, including cancer patients, people living with HIV, and organ transplant recipients.
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Domestic Pharma News
• PETA writes to discontinue forced swimming test.
People for the Ethical Treatment of Animals (PETA) recently wrote to the Pharmacy Council of India (PCI), urging the discontinuation of the Forced Swim Test (FST) in thousands of pharmacy institutions nationwide. In response, the PCI has circulated PETA India’s request to all pharmacy institutions for appropriate action. The Forced Swim Test involves placing small animals, such as mice and rats, into tanks of water from which they cannot escape. Some researchers interpret the time animals spend floating rather than attempting to escape as an indicator of ‘depression,’ using the test to model human depression or evaluate antidepressant drugs. However, animal rights activists argue that the test lacks scientific credibility and is unnecessarily cruel.
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• Hyderabad emerges as one of the top global centres of life sciences manufacturing: CBRE report.
CBRE, a leading global real estate firm, released its ‘Global Life Sciences Atlas’ report highlighting key life sciences hubs and investment trends. The growing life sciences sector is driving significant real estate development, with over 35 million sq. ft. of lab and R&D space under construction last year. While the largest R&D centers remain in the US, major hubs also include cities in Asia-Pacific (Hyderabad, Beijing, Shanghai, Greater Tokyo), Canada (Toronto, Montreal), and Europe (Cambridge, Paris). Notably, Hyderabad has emerged as a major life sciences manufacturing center in India.
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• Senores Pharma acquires ANDA for enalapril maleate tablets 2.5mg, 5mg, 10mg and 20mg from Wockhardt.
Senores Pharmaceuticals, through its wholly owned US subsidiary Senores Pharmaceuticals, Inc., has signed an agreement to acquire the US FDA-approved Abbreviated New Drug Application (ANDA) for enalapril maleate tablets (2.5mg, 5mg, 10mg, and 20mg) from Wockhardt. Enalapril is used to treat hypertension, heart failure, and asymptomatic left ventricular dysfunction. The US market for enalapril tablets was valued at approximately US$ 28.6 million (MAT December 2024, IQVIA) and US$ 109.24 million (MAT March 2025, Symphony specialty data).
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• Centre reinstates RoDTEP for AAs, SEZs, and EOUs from June 1 to boost pharma export competitiveness.
In a major relief for pharma exporters, the Union Ministry of Commerce and Industry has restored RoDTEP (Remission of Duties and Taxes on Exported Products) benefits for holders of Advance Authorisations (AAs), Special Economic Zones (SEZs), and Export-Oriented Units (EOUs), effective June 1, 2025. This decision follows industry pressure after the government had withdrawn these benefits from February 6, 2025. Pharma exporters had strongly opposed the exclusion, highlighting that AA-manufactured goods involve significant domestic inputs and that removing RoDTEP benefits conflicted with the government’s Make in India initiatives.
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• CDSCO cancels registration of certain products from Spanish skincare brand Mesoestetic.
The Central Drugs Standard Control Organisation (CDSCO) has cancelled the registration of certain products from Spanish skincare brand Mesoestetic after finding salicylic acid levels exceeding prescribed limits. These products, imported into India by Mesoestetic’s official partner Spectra Medical India, based in Tamil Nadu, will be voluntarily surrendered by the importer, according to CDSCO. The original registration certificate, issued in 2023, was valid for imports until May 31, 2027.
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• Parliamentary Panel recommends setting up of institutional mechanism for integration of systems of medicine.
The Parliamentary Panel on Health and Family Welfare has recommended an institutional mechanism to bring modern medicine and traditional medicine systems on a common platform and adapt a cooperative and collaborative approach for an integrated system for treatment of various diseases.
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• Indian pharma researchers are now focusing on monoclonal antibodies to treat malaria.
Indian pharmaceutical researchers are increasingly focusing on monoclonal antibodies as a promising approach to treat and prevent malaria. Current studies include exploring new antimalarial drugs and strategies, with institutions like the Indian Institute of Science (IISc), Bengaluru, investigating innovative treatments such as combining garlic oil with artemether. This combination has shown encouraging results in mice, highlighting its potential in malaria therapy.
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• CCI approves merger between Aster DM Healthcare and Quality Care India.
Competition Commission of India (CCI) has approved the proposed merger between Aster DM Healthcare and Quality Care India under Section 31(1) of the Competition Act, 2002.
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• Gujarat FDCA to equip drug inspectors with high-tech spectrophotometers for onsite drug testing.
In a significant step towards strengthening drug regulation and ensuring public safety, the Gujarat Food and Drug Control Administration (FDCA) will be equipping its drug inspectors with advanced handheld spectrophotometers for onsite drug testing. This initiative aims to enhance the efficiency and accuracy of drug quality assessments, reducing the reliance on laboratory testing and expediting the detection of substandard or counterfeit drugs in the market. Dr Hemant Koshia, Commissioner of Gujarat FDCA, informed that the state government has sanctioned an amount of Rs. 10 crore for procuring these cutting-edge devices. The spectrophotometers, which use advanced light absorption techniques to analyse drug composition, will enable inspectors to conduct real-time quality checks, thereby improving regulatory oversight and protecting consumer health.
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• Indian pharma working to strengthen PMS & supply chain transparency for OTC drugs.
Indian pharma is working to enhance post-marketing surveillance (PMS) and supply chain transparency for over the counter (OTC) drugs to ensure patient safety and improve medicine quality. Raghuram Nidavanda, in his thesis, compares the regulatory frameworks for OTCs in India and the US. He highlights India’s need for clearer regulations, unlike the US, which has a well-established FDA system. While OTCs offer significant growth and cost-saving potential, regulatory challenges persist. Raghuram emphasizes the importance of adopting global best practices and leveraging emerging technologies to improve regulatory standards and ensure OTC product safety and efficacy.
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• Punjab FDA directs zonal officers to track manufacture and sale of seven H and H1 drugs.
The Punjab Food and Drugs Administration (FDA) has directed zonal officers to track the manufacture and sale of seven Schedule H and H1 drugs—Pregabalin-300 mg, Gabapentin-400 mg, Dicyclomine, Tapentadol, Zopiclone, Flupentixol, and Carisoprodol—due to concerns about their misuse for intoxication. Manufacturers, Carrying and Forwarding Agents (C&FAs), Wholesalers, and Retailers must report sales and stock movement to the Drugs Control Office. Large transactions require additional reporting, and monthly data submission is mandated. The move aims to curb drug abuse while ensuring availability for genuine patients. A meeting with stakeholders has been held to address the issue.
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• Bharat Biotech launches $75 million cell and gene therapy facility in Hyderabad.
Bharat Biotech on Thursday launched vertically integrated cell and gene therapy, viral production facility at Genome Valley in Hyderabad. The company has invested around $75 million US dollars, which it says first of its kind in the country. The 50,000-square-foot dedicated state-of-the-art cell and gene therapy facility is designed to produce high-titer viral vectors (AAV, Lentivirus, Adenovirus), which are essential for gene therapy applications – the crucial material for anti-cancer and genetic disorders and robust clinical development abilities for quality control (QC) releases.
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• Apollo Hospitals in Hyderabad becomes India’s first AHA-certified comprehensive stroke centre:
Apollo Hospitals in Hyderabad has become India’s first AHA-certified Comprehensive Stroke Centre, meeting the highest standards for emergency response, specialized stroke teams, advanced imaging, and critical care. The hospital’s multidisciplinary team, available 24/7, includes experts in neurosurgery, emergency medicine, critical care, neuro-radiology, and neurology. The certification highlights the hospital’s commitment to world-class healthcare, with a focus on timely, accurate care. The integrated stroke-alert system and advanced imaging ensure quick diagnosis and treatment, significantly improving patient outcomes. This achievement marks a major milestone in stroke care, addressing India’s growing health crisis and enhancing emergency response.
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• Allo Health Raises ₹16 Crore to Expand India’s Largest Sexual Health Ecosystem.
Allo Health, India’s leading sexual health platform, has secured Rs. 16 crores only in a Pre-Series A funding round led by Rainmatter and existing investors. With 35+ clinics in major cities, Allo has treated over 200,000 patients, achieving an 85% improvement in patient outcomes. Unlike digital-only health tech startups, Allo employs a hybrid model combining physical clinics, AI-powered treatment protocols, and structured medical training. The funds will be used for clinic expansion, technology development, and deeper patient engagement. The company is also exploring mental health as a new category, aiming to build a comprehensive, structured healthcare ecosystem in India.
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• Mankind Pharma Launches Affordable Generic Empagliflozin:
Mankind Pharma has introduced a generic variant of the diabetes drug Empagliflozin in India. Mankind Pharma has launched a generic version of Empagliflozin in India under the brands Empaglyde, Empagreat, and Dynaduo. The launch breaks cost barriers, offering the medication at competitive prices. According to Mankind Pharma Vice Chairman and Managing Director Rajeev Juneja, the launch aims to make high-quality diabetes treatment affordable. Prices for Empagliflozin start at Rs 5.49 for 10 mg and Rs 9.90 for 25 mg tablets. Click to read more.
• Expert Panel Reaffirms Beta-Blockers as First-Line Therapy for Hypertension in India
An expert panel in India came together to develop a consensus on the role of beta-blockers in managing hypertension. Hypertension, a condition affecting millions worldwide, remains a significant health challenge, especially in India, where early cardiovascular disease (CVD) is a growing concern. Despite advances in treatment, the management of essential hypertension continues to be difficult, with control achieved in fewer than 1 in 10 cases, particularly when aligned with updated guidelines from the American College of Cardiology (ACC) and the International Society of Hypertension (ISH).
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• Exporters raise alarm over new Export NOC Guidelines, seek Urgent Resolution.
According to the pharma exporters, the recently implemented Export NOC system, effective from March 7, 2025, introduces stringent documentation and compliance requirements that create unnecessary bottlenecks for exporters. Expressing its dissatisfaction, an expert stated, “These new requirements pose a severe threat to the ease of doing business for pharma exporters and could severely impact the industry’s contribution to India’s export economy.” Key concerns raised include mandatory undertaking from active pharmaceutical ingredient (API) manufacturers. The new rule mandates a legal undertaking from the API manufacturer, a requirement that is difficult to fulfil as APIs are often procured through traders. Since manufacturers typically source APIs from multiple approved vendors, obtaining such undertakings on legal stamp paper is practically unfeasible. Exporters assert that this requirement, which was not mandatory earlier, serves no effective purpose and will disrupt the supply chain.
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Innovations
• Akums’ patented ‘Tablet-in-Tablet’ Technology brings relief to expectant mothers.
Akums Drugs & Pharmaceuticals, a CDMO, has received a patent for its innovative extended-release formulation of doxylamine and pyridoxine, targeting nausea and vomiting in pregnancy (NVP). This advanced “tablet-in-tablet” technology features a unique dosage form with an outer layer that delivers immediate relief and an inner core that provides sustained drug release for prolonged therapeutic effect.
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• India joins global ranks with Enliva’s accelerator-free nitrile gloves from Wadi Surgicals.
Wadi Surgicals, India’s leading nitrile glove manufacturer has achieved a significant innovation milestone with the launch of accelerator-free nitrile gloves under its flagship brand Enliva. Developed through extensive R&D and global collaboration, these are India’s first accelerator-free nitrile gloves, offering enhanced skin safety and allergy-free protection. With a commitment to research, regulatory compliance, and export excellence, Wadi Surgicals is setting new benchmarks in Indian glove manufacturing.
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• A non-invasive breast cancer screening test, Revealia Breast offers a glimpse of the future of early cancer detection.
Enterprises, Inc., a biotech firm specializing in mRNA diagnostics and AI-driven health solutions, has announced the upcoming launch of its flagship product, Revealia Breast—a non-invasive breast cancer screening test in advanced development. Using a simple cheek swab, the test detects cancer-related inflammation, aiming to identify breast cancer even before symptoms emerge. Revealia Breast offers a more affordable, accessible, and comfortable alternative to traditional mammograms, supporting earlier and less invasive diagnosis. Click to read more.
• Researchers get breakthroughs in non-invasive methods to decode speech directly from brain signals.
Jihwan Lee, a leading researcher at the University of Southern California’s Ming Hsieh Department of Electrical and Computer Engineering and USC’s Signal Analysis and Interpretation Laboratory (SAIL), is pioneering non-invasive techniques to decode speech directly from brain signals. His work aims to benefit individuals with speech and communication disorders. Traditionally, this required invasive methods like electrocorticography (EcoG), involving implanted electrodes. Instead, a non-invasive electroencephalography (EEG) to achieve similar outcomes is being leveraged, potentially revolutionizing brain-computer interfaces.
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• Abbott’s Libre technology is first CGM associated with reduced hospitalizations for heart complications in people with diabetes.
Abbott has announced new findings from its REFLECT real-world studies showing that its FreeStyle Libre continuous glucose monitoring (CGM) system significantly reduces the risk of heart-related hospitalizations in people with diabetes. For the first time, data indicates that CGM use can lessen cardiovascular complications in individuals with Type 1 diabetes, regardless of prior low blood sugar episodes or heart disease history. Similar benefits were also observed in people with Type 2 diabetes on insulin using the Libre bio wearable technology.
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• Oxford Brain Diagnostics launches groundbreaking dementia diagnosis technology.
Oxford Brain Diagnostics (OBD) is aiming to transform early dementia detection with its patented Cortical Disarray Measurement (CDM®) technology. This software analyzes standard MRI scans to objectively assess neurodegeneration, providing a more precise evaluation of brain health. With FDA 510(k) clearance and UKCA self-certification secured, OBD is set to commercially launch its technology in the UK and US. The company’s goal is to improve global diagnostics for conditions like Alzheimer’s by enabling earlier and more accurate detection.
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• NICE recommends sparsentan for IgA nephropathy.
The National Institute for Health and Care Excellence (NICE) has recommended FILSPARI (sparsentan) for NHS use in England to treat primary IgA nephropathy. It is the first non-immunosuppressive, dual-action therapy approved for eligible patients. This follows UK regulatory approval and is backed by data from the Phase 3 PROTECT trial. NICE advises its use in adults with urine protein excretion 1.0 g/day or a protein-to-creatinine ratio 0.75 g/g and recommends continuing treatment only in those who show a positive response.
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• Medkart introduces India’s first room-temperature stable Nicorandil tablets for cardiac care.
Ahmedabad-based Medkart has launched India’s first room-temperature stable generic Nicorandil tablets, a breakthrough that enhances accessibility and affordability of heart medication. Nicorandil, used to treat chronic stable angina, traditionally requires cold-chain storage due to its sensitivity to heat and humidity. Medkart’s innovation eliminates this need, easing distribution challenges, especially in rural and semi-urban areas and ensuring wider, more cost-effective patient access.
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• Autonomix Medical’s innovative catheter-based platform technology receives US patent.
Autonomix Medical, Inc., a medical device company focused on precision nerve-targeted therapies, announced that the U.S. Patent and Trademark Office has granted Patent No. 12,257,071 titled “Controlled sympathectomy and micro-ablation systems and methods.” This patent covers advanced catheter-based systems that integrate nerve mapping with radiofrequency (RF) ablation, enabling precise, minimally invasive treatment of overactive peripheral nerves.
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• Breakthrough in bowel cancer research will speed up diagnosis.
British company Xgenera, in collaboration with the University of Southampton, has developed technology that could enable earlier and more accurate detection of bowel cancer. This innovation promises faster, cheaper diagnosis, reducing the need for invasive procedures like colonoscopies and biopsies. Announced by the government on April 23, technology could save valuable time and resources for patients and the NHS.
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• ISRO and SCTIMST sign MoU in space medicine.
ISRO has signed a Framework Memorandum of Understanding with Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST) to collaborate on space medicine. This partnership is a key step forward in advancing space medicine and its applications in India. ISRO highlighted that the Gaganyaan human space program presents a unique opportunity for national agencies, academia, and industry to engage in human health research, microgravity studies, space medicine, and space biology.
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• Personalized Medicine and Genomic Advancements.
As of April 2025, personalized medicine is advancing rapidly, fueled by breakthroughs in AI, molecular biology, and genomics. Pharma companies are increasingly developing treatments tailored to individual genetic profiles and lifestyles, especially for complex diseases like cancer. Targeted therapies—such as HER2 inhibitors for breast cancer and PARP inhibitors for ovarian cancer—are boosting treatment effectiveness and patient outcomes. Additionally, the use of real-world data (RWD) and real-world evidence (RWE) is enhancing personalization by providing valuable insights into how patients respond to therapies.
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• Tech Mahindra and NVIDIA to advance drug safety with AI-powered pharmacovigilance solution.
Tech Mahindra, in collaboration with NVIDIA, has developed an AI-powered pharmacovigilance (PV) solution to enhance drug safety management. Using agentic AI and automation, the system optimizes PV workflows, reducing manual delays, human errors, and data overload. Built on Tech Mahindra’s TENO framework and powered by NVIDIA AI Enterprise, the solution automates case intake, classification, quality control, and compliance management. It reduces turnaround times by 40%, enhances data accuracy by 30%, and lowers operational costs by 25%. The AI-driven approach transforms pharmacovigilance from a reactive to a predictive model, ensuring faster, more reliable drug safety monitoring.
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• Smart Labels in Pharma: A New Era of Patient Safety.
Smart labels are revolutionizing the pharmaceutical industry by enhancing patient safety, improving drug authentication, and streamlining logistics. Technologies like QR codes, Near-Field Communication (NFC) tags, and Radio-Frequency Identification (RFID) tracking allow real-time monitoring of medications, ensuring drug integrity and reducing counterfeit risks. These labels provide instant access to drug details, dosage instructions, and expiry dates, fostering better patient compliance. Additionally, smart labels can track medication usage, assist in clinical research, and improve emergency medical responses. As digital health advances, smart labels are set to bridge the gap between technology and patient care, creating a more transparent and efficient healthcare system.
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• Gastrointestinal cancer diagnosis with AI: Faster, more accurate abdominal CT scan analysis.
Gastrointestinal cancers pose a significant global health challenge, with over 1.2 million cases diagnosed annually, nearly 40% in China. Abdominal body composition plays a crucial role in prognosis, influencing treatment outcomes. By automating the segmentation of abdominal CT images, this AI tool offers a faster and more accurate method for body composition analysis. Clinicians can use it to identify high-risk patients early, develop more personalized treatment strategies, and monitor treatment progress over time.
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• NURA Launches Mobile Health Screening Facility ‘NURA Express’ in Kozhikode.
NURA, a joint venture between Fujifilm Healthcare and Dr. Kutty’s Healthcare, has launched its mobile health screening service, ‘NURA Express,’ in Kozhikode, Kerala. This mobile unit offers cancer screenings and tests for lifestyle diseases via on-site CT scans, catering to employees and residents. The results are analyzed remotely and shared through a dedicated app. NURA plans to expand by partnering with local governments for municipal health screenings, aiding in early disease detection. This initiative utilizes Fujifilm’s advanced imaging and AI-driven medical IT systems to enhance health outcomes.
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• Harbour BioMed Inks Global Strategic Collaboration with AstraZeneca to discover and develop Next-Generation Therapeutic Antibodies.
Harbour BioMed, a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics in immunology and oncology, announced a global strategic collaboration with AstraZeneca to discover and develop next-generation multi-specific antibodies for immunology, oncology and beyond. Under the terms of the agreements, AstraZeneca will obtain the option to license two preclinical immunology programs and will nominate further targets for Harbour BioMed to discover the next-generation multi-specific antibodies. AstraZeneca will have the option to license these programs for advancement into clinical development.
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• Lupin Digital Health introduces comprehensive post-procedure home-based care guide with American College of Cardiology.
Lupin Digital Health, in partnership with the American College of Cardiology, has introduced a home-based care guide for heart patients. The guide covers recovery, medication management, lifestyle changes, and cardiac rehabilitation. It aims to support patients post-procedure and reduce hospital readmissions. Leading cardiologists contributed to developing the guide, ensuring its medical accuracy. This initiative enhances patient care and promotes better health outcomes.
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• Monash University and Peninsula Health develop AI methods to improve dementia diagnosis.
The National Centre for Healthy Ageing (NCHA), a joint initiative between Monash University and Peninsula Health, has introduced an advanced approach to enhance dementia detection in hospitals by integrating traditional screening techniques with artificial intelligence (AI). Researchers from NCHA’s Healthy Ageing Data Platform, along with clinicians from Australia and the USA, used a specific AI technique—natural language processing (NLP)—to analyze written medical records, significantly improving the accuracy of dementia identification.
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Trends
• Vaccine preventable diseases rising.
Vaccine-preventable diseases like measles, meningitis, and yellow fever are making a comeback due to disrupted immunisation programs and funding cuts, global health leaders have warned. In a joint statement, the WHO, UNICEF, and Gavi highlighted that misinformation, population growth, and ongoing humanitarian crises are further undermining vaccination efforts. They called on world leaders to prioritise and reinforce immunisation programmes with urgent and sustained political commitment.’
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• Neurocrine Biosciences announces new survey revealing need for routine screening and earlier diagnosis for people living with tardive dyskinesia.
Neurocrine Biosciences, Inc., a leading neuroscience-focused biopharmaceutical company, announced the release of findings from a new survey conducted by The Harris Poll highlighting the profound negative impact of tardive dyskinesia on patients and reinforcing the need for routine screening, earlier diagnosis and treatment. The findings revealed that 80% of people living with tardive dyskinesia surveyed wished they had been screened for the condition earlier, and 86% wished their provider had discussed available treatment options for their uncontrolled movements sooner.
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• India-UK FTA will be a game-changer for ceramic & pharmaceutical exports: Gujarat industry players.
Upbeat about the free trade agreement (FTA) between India and the United Kingdom, ceramic and pharmaceutical players in Gujarat have described the deal as a “game-changer.” Pharmaceutical players in Gujarat also felt that the deal with the UK will ease regulatory approvals for generic drugs, improve market access and thus boost pharmaceutical exports from India.
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• Oracle, Cleveland Clinic & G42 enter into a strategic partnership to launch an AI-based global healthcare delivery platform.
Oracle Health, Cleveland Clinic, and G42 announced a strategic partnership to develop a groundbreaking AI-based healthcare delivery platform. This initiative aims to improve patient care and public health management by leveraging AI, nation-scale data analytics, and intelligent clinical applications to create secure, scalable, and accessible care models that positively impact people’s health and longevity. The platform will serve as the foundation for an AI-driven healthcare hub, combining Oracle Cloud Infrastructure, Oracle AI Data Platform, and Oracle Health applications, Cleveland Clinic’s world-class clinical expertise, and G42’s capabilities in sovereign AI infrastructure, health data integration, and advanced clinical AI models.
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• VITU and Gleneagles Hospital Chennai sign MoU to collaborate on AI-driven neuroscience innovation.
Vellore Institute of Technology University (VITU) has signed a Memorandum of Understanding (MoU) with Gleneagles Hospital Chennai to foster collaboration in research and innovation in artificial intelligence (AI) and neurosciences. The MoU was formalised by Dr. Nageshwar Rao, CEO of Gleneagles Hospital Chennai, and Dr. T. Thyagarajan, Pro Vice-Chancellor of VIT University.
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• Global Pharma Investment and Power Shifts: Roche and Eli Lilly Take the Lead.
In April, Roche announced a $50 billion investment to expand its U.S. R&D and manufacturing, creating 12,000 jobs across eight states. Although the company didn’t comment on political motives, the move followed a Swiss-U.S. diplomatic call, sparking speculation about tariff-related factors. Meanwhile, Eli Lilly is gaining market share over Novo Nordisk in diabetes and obesity treatments, with its drugs Mounjaro and Zepbound outperforming Novo’s Ozempic and Wegovy. Supported by a strong pipeline including orforglipron and retatrutide, Lilly’s 32% annual growth has analysts optimistic, prompting BMO to downgrade Novo’s outlook amid intensifying competition.
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• Biotech Boom and EU Pressure: Investment Trends and Geopolitical Tensions.
Venture capital investment in biotech remains strong in early 2025, with median funding rounds reaching $93 million US dollars. Investors are focusing on late-stage, clinic-ready startups, particularly in China, aiming for faster regulatory approvals and quicker returns. However, experts warn that IPO delays and regulatory uncertainties may pose valuation risks. Meanwhile, 32 pharma CEOs from companies like Roche, Novartis, and Pfizer have urged the EU to enact policy reforms to avoid losing up to €103 billion Euros in investments. Facing U.S. drug import tariffs, pharma leaders are pushing for faster drug approvals, stronger IP protections, and eased environmental penalties to maintain Europe’s competitiveness in global life sciences innovation.
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• Startoon Labs signs MoU with Medplus to initiate Pheezee assessment.
Startoon Labs Private Limited, a Hyderabad-based medical device R&D and manufacturing company specializing in joint and muscle health, has signed an MoU with Medplus to introduce the Pheezee assessment at Medplus diagnostic centres. Medplus Diagnostics, part of the well-known Medplus pharmacy retail chain, offers pathology and radiology services and will now provide muscle and joint health diagnostics using the Pheezee device.
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Law and Order Briefs
• Delhi High Court sets aside patent office’s order rejecting Taiho Pharma’s application.
The Delhi High Court has set aside a Patent Office order refusing patent to an anticancer compound from Japanese pharma firm Taiho Pharmaceutical, part of Otsuka Group, remanding back the matter for fresh consideration of the Patent Authority. The High Court observed that while the patent application was rejected on various grounds including Section 3(d) of the Patents Act, 1970, the Patent Office did not identify any particular ‘known substance’ in the hearing notice, providing a fair opportunity to the applicant to respond to the same. By not sharing the information the applicant could not have defended his case.
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• The Supreme Court Criticizes Pharmacy Council of India for Arbitrary Rejection of Pharma College Approvals.
The Supreme Court has recently expressed serious concern over the Pharmacy Council of India (PCI) for acting irresponsibly in rejecting approvals for pharma colleges. The court highlighted that PCI, an expert body in pharmacy education, should be more diligent and avoid arbitrary actions that affect students’ futures. The Court set aside PCI’s rejection orders and directed the Registrar to forward a copy of the judgment to the Secretary, Ministry of Health and Family Welfare. The intent is to ensure that such unnecessary litigations do not happen again. Click to read more.
• The Supreme Court says doctors must prescribe only generic drugs, not branded medicines.
The Supreme Court on Thursday stated that doctors nationwide should be required to prescribe only generic medicines instead of branded ones. The top court was hearing a Public Interest Litigation (PIL) seeking the stringent regulation of the marketing and promotion of drugs by pharmaceutical firms. This observation came during the hearing of a petition filed by the Federation of Medical & Sales Representatives Associations of India (FMSRAI) and others. The plea emphasised that large sums of money are spent on sales and promotional activities aimed at influencing doctors to increase prescription volumes.
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• The Supreme Court Challenges Health Insurance Policy on Epilepsy Exclusion.
The Supreme Court has requested the government’s response to a petition challenging the omission of epilepsy from health insurance coverage. The plea, filed by Sanvedana Foundation, argues that excluding epilepsy violates constitutional rights and restricts healthcare access for affected individuals. The existing policy, as stated by IRDA, deems epilepsy a permanent exclusion.
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• Bombay HC Notice to CDSCO on Denial of Phase I Trial for Indigenous Cancer Drug.
The Bombay High Court has issued a notice to the Central Drugs Standard Control Organisation (CDSCO) and the Union government following a petition by Nashik-based Datar Cancer Genetics. The company challenges the CDSCO’s rejection of its application to conduct Phase I human trials for its indigenous cancer immunotherapy drug, Per-C-Vax, intended for patients recently diagnosed with solid organ cancers. A division bench comprising Chief Justice Alok Aradhe and Justice M.S. Karnik is reviewing the case, where Datar alleges that the CDSCO’s April 22, 2025, rejection was “arbitrary,” “unscientific,” and a “fraud on the statute.”
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• Delhi High Court quashes Indian Patent Office’s decision to hear pre-grant opposition after signing patent approval.
The Delhi High Court invalidated the Indian Patent Office’s (IPO) decision to entertain a pre-grant opposition against Vertex Pharmaceuticals’ patent for a cystic fibrosis drug, ruling that the opposition was filed after the patent was already granted by the controller. Although the patent grant order had not yet been uploaded online, the Court found this delay was due to technical issues on the IPO’s side, not Vertex’s fault. Consequently, the absence of the patent certificate or delay in its publication did not affect the validity of the patent grant, rendering the pre-grant opposition invalid.
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• Relatives of rare disease requests CJI to help them access life-saving medicines at affordable cost.
Mothers and caregivers of children with rare diseases like spinal muscular atrophy (SMA) and cystic fibrosis have appealed to the Chief Justice of India, Justice Sanjiv Khanna, seeking access to life-saving medicines at affordable prices. In a letter signed by around 220 parents and caregivers, they urged the Supreme Court to take suo motu cognizance of the urgent situation and expedite the resolution of pending legal cases related to rare disease treatments.
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• The Supreme Court issues notice to Roche on risiplam matter.
The Supreme Court of India (SCI) has issued a notice to Swiss pharmaceutical company F Hoffmann-La Roche Ltd, maker of the spinal muscular atrophy (SMA) drug risdiplam, seeking clarity on whether the drug can be supplied in India at a lower price if offered at such rates in neighboring countries. This follows a Special Leave Appeal filed by the Union of India challenging a Kerala High Court order that directed the government to cover the cost of one month’s medicine for a patient, Seba PA, who sought help to continue treatment beyond the Rs. 50 lakhs only limit set by the National Rare Disease Policy (NRDP).
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• The Supreme Court pushes for expert recommendations on Food Labelling.
The Supreme Court has directed an expert committee to recommend amendments to food safety regulations requiring warning labels on packaged foods, focusing on sugar, salt, and unhealthy fats. This initiative aims to help consumers make healthier dietary choices amid rising non-communicable diseases. The Court acknowledged the efforts of the Centre and the Food Safety and Standards Authority of India (FSSAI), which received around 14,000 public objections and suggestions on the proposed changes. The expert committee will review these inputs and suggest appropriate amendments to the regulations.
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• The Supreme Court mandates immediate cancellation of hospital licenses in case of child trafficking.
The Supreme Court has issued strict guidelines to curb newborn trafficking, including the immediate suspension of hospital licenses where such cases occur. Justices JB Pardiwala and R Mahadevan warned that any violation of these directions would be treated as contempt of court. Highlighting the severity of child trafficking, the Court described its impact as worse than death and called for greater parental vigilance. Additionally, state governments were urged to implement recommendations from a human trafficking report by the Bharatiya Institute of Research and Development.
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• Kerela Doctor moves HC seeking Regulations for Home Births:
A medical officer from Malappuram, Dr Pratibha K, has approached the Kerela High Court seeking clear legal provisions and penalties to regulate childbirth outside medical facilities. She has urged for establishment of proper guidelines to ensure the safety of both mothers and newborns. The issue came in light after a woman gave birth at her rental home in November, but officials refused to issue the certificate as no formal records of the delivery existed.
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• Apollo Hospitals Bengaluru slammed, slapped Compensation by Consumer Court.
The Bengaluru Urban District Consumer Disputes Redressal Commission has ordered Apollo Hospitals in Seshadripuram to compensate a senior patient Rs 1 lakh only for the harassment and rude behaviour he endured during his treatment. The forum observed that “the complainant has suffered mental agony and discomfort at the hands of hospital staff. It is the responsibility of the doctor and medical staff to prove that due care was taken in discharge of their duties. The complainant is entitled to compensation for harassment and mental agony and financial loss suffered by him for the harassment given by the staff of the hospital”.
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• Patients and experts urge Court to ensure access to cystic fibrosis in India.
Patients with cystic fibrosis (CF), along with public health experts, are urging the Karnataka High Court to facilitate the availability of affordable treatment for CF patients in India. The petitioners seek the government’s approval for generic production of the CF drug, which would allow for compulsory licensing and lower prices. The drug, a combination of three CFTR modulators, is lifesaving for CF patients, improving lung function and reducing hospitalizations. However, despite the drug being available in high-income countries, its cost in India exceeds Rs. 2.5 crores annually, and it is not marketed or approved in India by Vertex Pharmaceuticals, which holds the patents. The petitioners argue that the drug’s monopoly prevents access and call for remedies to introduce generic competition, making the drug affordable. The case could have significant implications for rare disease patients in India.
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• False Advertising, Misrepresentation- CCI Clears Hospital in Unregistered Surgeon Row.
The Competition Commission of India (CCI) has dismissed a complaint filed against Victor Hospital, Margao, Goa, regarding allegations of misleading consumers by employing an unregistered surgeon and engaging in anti-competitive practices. The commission stated that misleading consumers by misrepresenting a surgeon’s qualifications and engaging in false advertising, while serious, do not amount to anti-competitive behavior under the Competition Act, 2002. It was noted that such issues should be dealt with by medical regulatory bodies rather than CCI. Click to read more.
• Big pharma faces heat as India records 307 drug pricing violations.
Pharmaceutical companies have repeatedly violated drug pricing regulations by exceeding permitted price hikes, according to a report by the Parliamentary Standing Committee on Chemicals and Fertilizers. As of 6 March 2025, the National Pharmaceutical Pricing Authority (NPPA) recorded 307 cases of violations under Paragraph 20 of the Drugs (Prices Control) Order (DPCO), 2013, which governs price increases for non-scheduled drugs. These violations highlight growing concerns over the unchecked rise in medicine prices and their impact on affordability.
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• Karnataka Government. proposes to establish Special Court to hear cases related to Supply of fake and spurious drugs.
A special court to hear cases related to the supply of fake and spurious drugs would be specifically designated to deal with cases involving counterfeit, adulterated, or substandard drugs that pose a significant risk to public health. This type of court would help address the growing problem of drug-related fraud, ensuring swift trials and harsher penalties for those involved in such activities. The department is making sure the company which supplies fake medicines are imposed huge fines and taken to task. We are also bringing the Drug Recall Policy so that fake medicine suppliers and manufacturers are taken to task. According to the data furnished to the House, a total of 20 cases have been registered in the last three years against the companies which supplied fake medicines.
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• BIS Cracks Down on E-Commerce Platforms Selling Non-Certified Products.
The Bureau of Indian Standards (BIS) has conducted search and seizure operations at multiple Amazon and Flipkart warehouses in Lucknow, Gurugram, and Delhi, confiscating thousands of non-certified consumer products such as toys, hand blenders, electric heaters, and gas stoves. The raids also uncovered large-scale violations by Tech vision International Pvt Ltd, leading to legal action under the BIS Act, 2016. BIS has filed cases and warned e-commerce platforms to ensure only BIS-certified products are sold. Consumers are urged to use the BIS Care app to verify certification and report violations. The crackdown aims to enhance product safety and protect public interest.
Click to read more.In this issue of Noverra Partners Pharma and Healthcare Insight we have made an effort to include all the pertinent developments in the pharmaceuticals and healthcare sector during the month of March, April, and May 2025. This newsletter aims to cover local, regional, and global news as well as regulatory updates, new government initiatives, and technological advancements etc.
Regulatory Update
- DTAB recommends all antimicrobials to be considered as new drug under NDCT Rules.
The Drugs Technical Advisory Board (DTAB) has recommended that, in the public interest, all antimicrobials should be classified as new drugs under the New Drugs and Clinical Trials (NDCT) Rules, 2019. This recommendation follows the Board’s earlier proposal to the Drugs Consultative Committee (DCC), urging the inclusion of all antibiotics within the definition of new drugs as a measure to combat antimicrobial resistance (AMR). The latest decision was made after a thorough review of DCC’s observations and recommendations.
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- The Health Ministry notifies rules on compounding offences.
The Union Health Ministry has officially notified the rules for compounding minor offences under drug regulations. This long-anticipated move, following the draft issued nearly nine months ago, aligns with the Jan Vishwas (Amendment of Provisions) Act, 2023. The newly introduced Drugs and Cosmetics (Compounding of Offences) Rules, 2025, aim to ease legal burdens, enhance compliance, and promote ease of doing business. As per the final notification dated April 24, 2025, the rules will come into effect from the date of their publication in the Official Gazette.
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- DTAB agrees with the sub-committee report recommending prohibition of 16 FDCs.
The Drugs Technical Advisory Board (DTAB), in its 92nd meeting held on April 24, 2025, endorsed the findings of its sub-committee led by Dr. Nilima Kshirsagar, which identified 16 fixed dose combinations (FDCs) as irrational and recommended their prohibition due to potential risks to human health. Additionally, the Board has referred 29 FDCs—previously deemed irrational by the Prof. Kokate Committee—to the Kshirsagar sub-committee for further evaluation. Click to read more.
- CDSCO revises guidelines for issuance of export NOC for unapproved, approved new drugs.
The Central Drugs Standard Control Organisation (CDSCO) has revised its procedure for issuing Export No Objection Certificates (NOCs) for the manufacture of unapproved and approved new drugs intended solely for export purposes. Key changes include the discontinuation of quantity-specific and purchase order-specific NOCs, except in the case of Narcotic Drugs, Psychotropic Substances (NDPS), and banned drugs. CDSCO has also released a revised guidance document outlining the updated process, which follows the centralisation of the NOC issuance system implemented last year.
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- DGFT eases pharma export rules for SCOMET items for testing and evaluation.
In a bid to promote technological advancement and streamline pharmaceutical export processes, the Government of India has proposed amendments to the Handbook of Procedures (HBP) 2023, allowing the export of SCOMET (Special Chemicals, Organisms, Materials, Equipment and Technologies) items for the purpose of testing and evaluation. The Directorate General of Foreign Trade (DGFT) has issued a draft public notice seeking feedback from stakeholders, including exporters, industry associations, and technical experts, on the proposed changes.
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- NPPA fixes retail prices of 84 drugs, including empagliflozin combos.
The National Pharmaceutical Pricing Authority (NPPA), in its 132nd meeting held on April 29, has fixed the retail prices for 84 drug combinations, including 36 generic versions of empagliflozin, a diabetes medication originally developed by Boehringer Ingelheim. The move follows the expiry of empagliflozin’s patent on March 11, which opened the market to multiple generic manufacturers, resulting in a significant price drop of 80–85%. In response to this surge in competition and to ensure price regulation, the NPPA intervened under the Drug Price Control Order (DPCO). Alongside empagliflozin-based formulations, the updated price list also covers several anti-hypertensive drug combinations.
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- DGFT amends import norms for Di-octyl phthalate to enhance export efficiency.
In a strategic effort to align export-import ratios with industry requirements and enhance trade efficiency, the Directorate General of Foreign Trade (DGFT) has amended the Standard Input Output Norms (SION). The revision specifically adjusts the permissible import quantity of a key raw material used in the production of Di-octyl phthalate (DOP), a crucial plasticizer. This move is aimed at streamlining trade practices and better supporting the operational needs of manufacturers.
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- Substandard Drugs Flagged Across Multiple States, over 130 Batches Fail Quality Tests in April.
The Central Drugs Standard Control Organisation (CDSCO), in its April 2025 alert, has flagged 136 drug batches as Not of Standard Quality (NSQ). The list includes widely used medications such as paracetamol, amoxicillin, cefixime, telmisartan, various dermatological products, and several veterinary formulations. Issued as part of CDSCO’s routine regulatory surveillance, the alert also draws attention to repeated quality violations by certain manufacturers, particularly involving albendazole and ivermectin-based products.
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- The Health Ministry restricts use of common cold medicine in children under four years. The Union Health Ministry has restricted the use of the commonly used cold medication combination, Chlorpheniramine Maleate and Phenylephrine Hydrochloride, for children under four years of age. Manufacturers have been directed to include a warning on the drug’s label and package insert. The decision was made after the Central Government concluded that the fixed dose combination (FDC) poses potential risks to children in this age group and that safer alternatives are available.
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- NABL issues updated accreditation criteria for biobanks aligned with ISO 20387:2018.
The National Accreditation Board for Testing and Calibration Laboratories (NABL) has released an amended version of its Specific Criteria for Accreditation of Biobank, marking a significant step toward standardizing and enhancing biobanking practices across India. The revised criteria are specifically designed to align Indian biobanking systems with international standards, particularly ISO 20387:2018. This move reflects the growing global emphasis on quality, consistency, and ethical practices in the handling and storage of biological materials, which are foundational to scientific research and innovation.
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- CDSCO launches online registration for CROs The Central Drugs Standard Control Organization (CDSCO) has mandated online registration for Clinical Research Organizations (CROs) via the Sugam portal from April 1, 2025. Under the amended New Drugs and Clinical Trials Rules (NDCTR), 2019, CROs must register with the Central Licensing Authority (CLA) to conduct clinical trials, paying Rs. 5 lakhs only for a five-year license. Approvals take 45 working days, with appeal options available. Authorities can inspect and penalize non-compliance. The Ninth Schedule outlines staffing, quality control, and data retention norms. Finalized after public consultation, these rules enhance oversight and transparency in clinical research.
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- Centre Bans Chloramphenicol and Nitrofurans for Use in Food-Producing Animals:
The Union Health Ministry has banned the import, manufacture, sale, and distribution of chloramphenicol and nitrofurans (including furaltadone, furazolidone, nitrofurantoin, and nitrofurazone) for use in food-producing animals. The decision follows recommendations from the Drugs Consultative Committee (DCC) and the Drugs Technical Advisory Board (DTAB), citing misuse in poultry and livestock feed. The ban aligns with the Food Safety and Standards Authority of India (FSSAI) guidelines, which already prohibited these drugs in meat, poultry, and seafood processing. Chloramphenicol, an antibiotic used to treat bacterial infections, and nitrofurans, used for urinary tract infections, poses health risks such as bone marrow suppression and antibiotic residues in food.
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Approvals
- Glenmark’s cancer drug ISB 2001 gets fast track designation from US FDA.
Ichnos Glenmark Innovation (IGI) has received Fast Track designation from the US FDA for its investigational trispecific antibody, ISB 2001, intended for the treatment of relapsed or refractory multiple myeloma (RRMM) in adults who have received at least three prior lines of therapy. ISB 2001 is designed to simultaneously target BCMA and CD38 on myeloma cells and CD3 on T cells, enhancing immune-mediated tumor cell killing. The candidate is currently undergoing evaluation in a Phase 1 dose-expansion study.
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- Zydus gets USFDA nod for generic drug to treat multiple sclerosis.
Zydus Lifesciences has received approval from the US Food and Drug Administration (USFDA) to market its generic version of Glatiramer Acetate Injection, available in 20 mg/mL and 40 mg/mL single-dose prefilled syringes. This medication is the generic equivalent of Copaxone, a treatment indicated for relapsing forms of multiple sclerosis (MS). The approval marks a significant milestone for the company in expanding its presence in the central nervous system (CNS) therapeutic area within the US market.
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- AstraZeneca Pharma India gets CDSCO approval to import, sell cancer treatment medicine.
AstraZeneca Pharma India Ltd announced on Monday that it has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute the cancer treatment drug Durvalumab solution in India. According to a regulatory filing, the approval covers the import, sale, and distribution of Durvalumab infusion solutions in 120 mg/2.4 ml and 500 mg/10 ml (marketed as Imfinzi) for an additional indication. Durvalumab, when used in combination with Tremelimumab, is indicated for the treatment of patients with unresectable hepatocellular carcinoma.
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- The US FDA approves the first at-home test for cervical cancer screening.
The U.S. Food and Drug Administration (FDA) has approved the first-ever at-home test for cervical cancer screening, announced Teal Health on Friday. This new option provides an alternative to traditional Pap smears, which require an in-office visit. While Pap smears have played a crucial role in reducing cervical cancer incidence over the past 80 years, many women find the in-clinic procedure uncomfortable. The FDA’s approval was supported by a study involving over 600 women, demonstrating that self-collected samples using Teal Health’s test perform comparably to those collected by clinicians.
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- US FDA approves Novavax’s BLA for Covid-19 vaccine, Nuvaxovid.
Novavax, Inc. has announced that the US Food and Drug Administration (FDA) has approved its Biologics License Application (BLA) for Nuvaxovid, a vaccine for active immunization against COVID-19 caused by SARS-CoV-2. The approval covers adults aged 65 and older, as well as individuals aged 12 to 64 with at least one underlying condition that increases their risk of severe COVID-19 outcomes, such as asthma, cancer, diabetes, obesity, or smoking. Following this US license approval, Sanofi has triggered a milestone payment of $175 million to Novavax.
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- UK MHRA approves Janssen-Cilag’s guselkumab for Crohn’s disease and ulcerative colitis.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved guselkumab (Tremfya) for the treatment of Crohn’s disease and ulcerative colitis (UC). Previously approved for plaque psoriasis and psoriatic arthritis, guselkumab has now demonstrated efficacy in clinical studies for adults with moderately to severely active Crohn’s disease and UC who have either not responded adequately to other therapies or have experienced intolerable side effects.
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- US FDA grants IDE approval to Innoblative’s SIRA RFA electrosurgical device for breast cancer treatment.
The US Food and Drug Administration has approved Innoblative Designs Inc.’s, Investigational Device Exemption application, paving the way for the company to initiate its US feasibility study. Through this safety and effectiveness of the company’s SIRA RFA electrosurgical device in patients undergoing breast-conservation surgery will be evaluated.
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- UK MHRA approves eplontersen to treat adults with rare inherited nerve disease or polyneuropathy.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved eplontersen for the treatment of adults with polyneuropathy linked to hereditary transthyretin amyloidosis (ATTRv), a rare inherited and progressive disorder. The condition is caused by abnormal transthyretin (TTR) protein, which forms amyloid deposits that accumulate in nerves, the heart, and other organs, impairing their function.
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- AstraZeneca’s Imfinzi receives US FDA approval for patients with muscle-invasive bladder cancer.
The U.S. Food and Drug administration has approved AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as a neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy, for adult patients with muscle-invasive bladder cancer (MIBC).
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- US FDA grants breakthrough device designation to Roche’s companion diagnostic, VENTANA TROP2 (EPR20043) RxDx Device for non-small cell lung cancer.
The US Food and Drug Administration (FDA) granted Breakthrough Device Designation to the VENTANA TROP2 (EPR20043) RxDx Device. It is the first Breakthrough Device Designation to be granted for a computational pathology companion diagnostic device.
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- US FDA approves celecoxib capsules of Strides.
Strides Pharma announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte., Singapore, has received U.S. FDA approval for celecoxib capsules in 100 mg, 200 mg, and 400 mg strengths. Celecoxib is a selective COX-2 inhibitor used to manage pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis, acute pain, and dysmenorrhea.
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- US FDA grants Breakthrough Device Designation to Mursla Bio’s EvoLiver test.
Mursla Bio, a pioneer in Extracellular Vesicle (EV) science, has announced that the U.S. FDA has granted Breakthrough Device Designation to its lead product, EvoLiver. This Dynamic Biopsy-based blood test leverages organ-specific EVs to aid in the surveillance of hepatocellular carcinoma (HCC), the most common type of primary liver cancer, in high-risk cirrhotic patients. The designation highlights EvoLiver’s potential to significantly improve cancer outcomes through early detection.
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International Pharma News
- Minghui Pharma enters strategic partnership and licensing pact with Qilu Pharma to develop B7-H3 ADC in Greater China.
Minghui Pharmaceutical has signed an exclusive licensing and collaboration agreement with Qilu Pharmaceutical for the development, manufacturing, and commercialization of its B7-H3 ADC (MHB088C) in Greater China (Mainland China, Hong Kong, Macau, and Taiwan). Qilu will have exclusive rights in the region, while Minghui will receive up to 1.345 billion RMB, including 280 million RMB upfront, milestone payments, and royalties. Minghui retains global rights outside Greater China and will continue development there. MHB088C is an innovative antibody-drug conjugate developed using Minghui’s proprietary SuperTopoi ADC platform.
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- GSK to buy Boston Pharma’s efimosfermin, a phase III-ready potential best-in-class specialty medicine to treat and prevent progression of SLD.
GSK plc and Boston Pharmaceuticals have announced an agreement for GSK to acquire Boston’s lead asset, efimosfermin alfa phase III-ready, potential best-in-class investigational treatment for steatotic liver disease (SLD). Under the deal, GSK will pay $1.2 billion US dollars upfront, with up to $800 million US dollars in additional success-based milestone payments.
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- US President Trump announces ‘equalisation’ policy for medicines prices in the US.
US President Donald Trump announced that the United States will no longer subsidize healthcare costs for other countries, as part of his efforts to negotiate medicine price reductions ranging from 59% to as much as 80-90%. Describing his “equalization” policy, President Trump highlighted that while the US represents less than five percent of the global population, it accounts for nearly three-quarters of worldwide pharmaceutical profits. He clarified that the directive targets developed countries that set drug prices lower than those in the US, rather than pharmaceutical companies themselves. Additionally, Trump introduced the “Most Favoured Nation” policy, which aims to align US drug prices with the lowest prices available in any other country.
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- US FDA to expand use of unannounced inspections at foreign manufacturing facilities.
The US Food and Drug Administration (FDA) has announced plans to increase the use of unannounced inspections at foreign manufacturing facilities producing food, essential medicines, and other medical products for American consumers and patients. Expanding on its existing Foreign Unannounced Inspection Pilot program in India and China, the agency aims to ensure that foreign manufacturers are held to the same rigorous regulatory standards and oversight as domestic companies.
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- Ethiopian Food and Drug Authority revise GMP Rules, mandates re-inspection every 3 years.
The Ethiopian Food and Drug Authority (EFDA) has updated its pharmaceutical inspection directive to align with global standards, aiming to improve the safety, quality, and efficacy of health products in Ethiopia. The revised rules shorten the Good Manufacturing Practice (GMP) re-inspection interval for compliant facilities from five to three years, reflecting EFDA’s commitment to stricter oversight. Additionally, GMP inspection fees and waivers will now be valid for only three years. Manufacturers holding a five-year cGMP certificate must apply for re-inspection after three years under the new framework.
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- Kaushik Desai has been appointed as a member of the WHO Expert Committee on ECSSP.
Kaushik Desai has been appointed as a member of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) for the 2025–2027 term. In this role, he will contribute to the development and revision of WHO pharmaceutical guidelines. The ECSPP is a high-level advisory body that provides expert guidance to the WHO Director-General and Member States on pharmaceutical quality assurance and is responsible for creating and updating international standards published in the WHO Technical Report Series.
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- India initiates anti-dumping investigation on imports of MIPA from China.
The Directorate General of Trade Remedies (DGTR) has initiated anti-dumping investigation concerning the import of monoisopropylamine (MIPA) originating in or exported from China PR. This move follows an application filed by Alkyl Amines Chemicals Limited, alleging material injury to the domestic industry due to unfair trade practices.
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- India initiates crucial oral hearing in anti-dumping probe on TDI imports from EU & Saudi Arabia.
In a move to safeguard India’s domestic industry, the Directorate General of Trade Remedies (DGTR) has scheduled an oral hearing in its ongoing sunset review anti-dumping investigation concerning the import of Toluene Di-Isocyanate (TDI) from the European Union (EU) and Saudi Arabia.
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- Bioxodes announces positive data from BIRCH phase 2a trial of BIOX-101 to treat patients with intracerebral hemorrhagic stroke.
Bioxodes SA, a clinical-stage biopharmaceutical company, reported promising interim results from the BIRCH phase 2a trial of its lead drug BIOX-101 for intracerebral hemorrhagic stroke (ICH). Analysis of the first 16 patients in this randomized, standard-of-care controlled study showed that both primary safety and secondary efficacy goals were achieved. The Data Monitoring Committee found no safety issues related to ICH volume changes, serious adverse events, neurological outcomes, or mortality.
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- Zealand Pharma begins patient enrolment in phase 2b ZUPREME-2 trial of petrelintide in people with overweight or obesity and type 2 diabetes.
Zealand Pharma A/S, specializing in peptide-based medicines, has enrolled the first participant in ZUPREME-2, a phase 2b trial testing petrelintide—a long-acting amylin analog—in people with overweight or obesity and type 2 diabetes. This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of three doses of once-weekly subcutaneous petrelintide versus placebo, alongside a reduced-calorie diet and increased physical activity.
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- Orion & Criceto signs agreement to develop and commercialize Aporon, an innovative apomorphine spray to treat OFF episodes in Parkinson’s disease.
Orion Corporation, a Nordic pharmaceutical company, and Criceto IKM B.V., an innovation-focused pharma firm, have signed an exclusive license agreement for the development and commercialization of Aporon. Aporon is a novel apomorphine oromucosal spray in phase 3 trials, aimed at treating OFF episodes in Parkinson’s disease patients. Designed as a rescue therapy, Aporon targets the difficult OFF episodes that greatly affect patients’ quality of life.
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- WHO issues its first-ever reports on tests and treatments for fungal infections.
The World Health Organization (WHO) released its first reports highlighting a critical shortage of medicines and diagnostic tools for invasive fungal diseases, underscoring the urgent need for innovative research and development to address these gaps. Fungal infections, such as candida causing oral and vaginal thrush, are becoming a growing public health concern due to increasing resistance to treatments. These infections particularly affect severely ill and immunocompromised individuals, including cancer patients, people living with HIV, and organ transplant recipients.
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Domestic Pharma News
- PETA writes to discontinue forced swimming test.
People for the Ethical Treatment of Animals (PETA) recently wrote to the Pharmacy Council of India (PCI), urging the discontinuation of the Forced Swim Test (FST) in thousands of pharmacy institutions nationwide. In response, the PCI has circulated PETA India’s request to all pharmacy institutions for appropriate action. The Forced Swim Test involves placing small animals, such as mice and rats, into tanks of water from which they cannot escape. Some researchers interpret the time animals spend floating rather than attempting to escape as an indicator of ‘depression,’ using the test to model human depression or evaluate antidepressant drugs. However, animal rights activists argue that the test lacks scientific credibility and is unnecessarily cruel.
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- Hyderabad emerges as one of the top global centres of life sciences manufacturing: CBRE report.
CBRE, a leading global real estate firm, released its ‘Global Life Sciences Atlas’ report highlighting key life sciences hubs and investment trends. The growing life sciences sector is driving significant real estate development, with over 35 million sq. ft. of lab and R&D space under construction last year. While the largest R&D centers remain in the US, major hubs also include cities in Asia-Pacific (Hyderabad, Beijing, Shanghai, Greater Tokyo), Canada (Toronto, Montreal), and Europe (Cambridge, Paris). Notably, Hyderabad has emerged as a major life sciences manufacturing center in India.
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- Senores Pharma acquires ANDA for enalapril maleate tablets 2.5mg, 5mg, 10mg and 20mg from Wockhardt.
Senores Pharmaceuticals, through its wholly owned US subsidiary Senores Pharmaceuticals, Inc., has signed an agreement to acquire the US FDA-approved Abbreviated New Drug Application (ANDA) for enalapril maleate tablets (2.5mg, 5mg, 10mg, and 20mg) from Wockhardt. Enalapril is used to treat hypertension, heart failure, and asymptomatic left ventricular dysfunction. The US market for enalapril tablets was valued at approximately US$ 28.6 million (MAT December 2024, IQVIA) and US$ 109.24 million (MAT March 2025, Symphony specialty data).
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- Centre reinstates RoDTEP for AAs, SEZs, and EOUs from June 1 to boost pharma export competitiveness.
In a major relief for pharma exporters, the Union Ministry of Commerce and Industry has restored RoDTEP (Remission of Duties and Taxes on Exported Products) benefits for holders of Advance Authorisations (AAs), Special Economic Zones (SEZs), and Export-Oriented Units (EOUs), effective June 1, 2025. This decision follows industry pressure after the government had withdrawn these benefits from February 6, 2025. Pharma exporters had strongly opposed the exclusion, highlighting that AA-manufactured goods involve significant domestic inputs and that removing RoDTEP benefits conflicted with the government’s Make in India initiatives.
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- CDSCO cancels registration of certain products from Spanish skincare brand Mesoestetic.
The Central Drugs Standard Control Organisation (CDSCO) has cancelled the registration of certain products from Spanish skincare brand Mesoestetic after finding salicylic acid levels exceeding prescribed limits. These products, imported into India by Mesoestetic’s official partner Spectra Medical India, based in Tamil Nadu, will be voluntarily surrendered by the importer, according to CDSCO. The original registration certificate, issued in 2023, was valid for imports until May 31, 2027.
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- Parliamentary Panel recommends setting up of institutional mechanism for integration of systems of medicine.
The Parliamentary Panel on Health and Family Welfare has recommended an institutional mechanism to bring modern medicine and traditional medicine systems on a common platform and adapt a cooperative and collaborative approach for an integrated system for treatment of various diseases.
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- Indian pharma researchers are now focusing on monoclonal antibodies to treat malaria.
Indian pharmaceutical researchers are increasingly focusing on monoclonal antibodies as a promising approach to treat and prevent malaria. Current studies include exploring new antimalarial drugs and strategies, with institutions like the Indian Institute of Science (IISc), Bengaluru, investigating innovative treatments such as combining garlic oil with artemether. This combination has shown encouraging results in mice, highlighting its potential in malaria therapy.
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- CCI approves merger between Aster DM Healthcare and Quality Care India.
Competition Commission of India (CCI) has approved the proposed merger between Aster DM Healthcare and Quality Care India under Section 31(1) of the Competition Act, 2002.
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- Gujarat FDCA to equip drug inspectors with high-tech spectrophotometers for onsite drug testing.
In a significant step towards strengthening drug regulation and ensuring public safety, the Gujarat Food and Drug Control Administration (FDCA) will be equipping its drug inspectors with advanced handheld spectrophotometers for onsite drug testing. This initiative aims to enhance the efficiency and accuracy of drug quality assessments, reducing the reliance on laboratory testing and expediting the detection of substandard or counterfeit drugs in the market. Dr Hemant Koshia, Commissioner of Gujarat FDCA, informed that the state government has sanctioned an amount of Rs. 10 crore for procuring these cutting-edge devices. The spectrophotometers, which use advanced light absorption techniques to analyse drug composition, will enable inspectors to conduct real-time quality checks, thereby improving regulatory oversight and protecting consumer health.
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- Indian pharma working to strengthen PMS & supply chain transparency for OTC drugs.
Indian pharma is working to enhance post-marketing surveillance (PMS) and supply chain transparency for over the counter (OTC) drugs to ensure patient safety and improve medicine quality. Raghuram Nidavanda, in his thesis, compares the regulatory frameworks for OTCs in India and the US. He highlights India’s need for clearer regulations, unlike the US, which has a well-established FDA system. While OTCs offer significant growth and cost-saving potential, regulatory challenges persist. Raghuram emphasizes the importance of adopting global best practices and leveraging emerging technologies to improve regulatory standards and ensure OTC product safety and efficacy.
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- Punjab FDA directs zonal officers to track manufacture and sale of seven H and H1 drugs.
The Punjab Food and Drugs Administration (FDA) has directed zonal officers to track the manufacture and sale of seven Schedule H and H1drugs—Pregabalin-300 mg, Gabapentin-400 mg, Dicyclomine, Tapentadol, Zopiclone, Flupentixol, and Carisoprodol—due to concerns about their misuse for intoxication. Manufacturers, Carrying and Forwarding Agents (C&FAs), Wholesalers, and Retailersmust report sales and stock movement to the Drugs Control Office. Large transactions require additional reporting, and monthly data submission is mandated. The move aims to curb drug abuse while ensuring availability for genuine patients. A meeting with stakeholders has been held to address the issue.
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- Bharat Biotech launches $75 million cell and gene therapy facility in Hyderabad –
Bharat Biotech on Thursday launched vertically integrated cell and gene therapy, viral production facility at Genome Valley in Hyderabad. The company has invested around $75 million US dollars, which it says first of its kind in the country. The 50,000-square-foot dedicated state-of-the-art cell and gene therapy facility is designed to produce high-titer viral vectors (AAV, Lentivirus, Adenovirus), which are essential for gene therapy applications – the crucial material for anti-cancer and genetic disorders and robust clinical development abilities for quality control (QC) releases.
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- Apollo Hospitals in Hyderabad becomes India’s first AHA-certified comprehensive stroke centre:
Apollo Hospitals in Hyderabad has become India’s first AHA-certified Comprehensive Stroke Centre, meeting the highest standards for emergency response, specialized stroke teams, advanced imaging, and critical care. The hospital’s multidisciplinary team, available 24/7, includes experts in neurosurgery, emergency medicine, critical care, neuro-radiology, and neurology. The certification highlights the hospital’s commitment to world-class healthcare, with a focus on timely, accurate care. The integrated stroke-alert system and advanced imaging ensure quick diagnosis and treatment, significantly improving patient outcomes. This achievement marks a major milestone in stroke care, addressing India’s growing health crisis and enhancing emergency response.
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Allo Health Raises ₹16 Crore to Expand India’s Largest Sexual Health Ecosystem
Allo Health, India’s leading sexual health platform, has secured Rs. 16 crores only in a Pre-Series A funding round led by Rainmatter and existing investors. With 35+ clinics in major cities, Allo has treated over 200,000 patients, achieving an 85% improvement in patient outcomes. Unlike digital-only health tech startups, Allo employs a hybrid model combining physical clinics, AI-powered treatment protocols, and structured medical training. The funds will be used for clinic expansion, technology development, and deeper patient engagement. The company is also exploring mental health as a new category, aiming to build a comprehensive, structured healthcare ecosystem in India.
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- Mankind Pharma Launches Affordable Generic Empagliflozin:
Mankind Pharma has introduced a generic variant of the diabetes drug Empagliflozin in India. Mankind Pharma has launched a generic version of Empagliflozin in India under the brands Empaglyde, Empagreat, and Dynaduo. The launch breaks cost barriers, offering the medication at competitive prices. According to Mankind Pharma Vice Chairman and Managing Director Rajeev Juneja, the launch aims to make high-quality diabetes treatment affordable. Prices for Empagliflozin start at Rs 5.49 for 10 mg and Rs 9.90 for 25 mg tablets.
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- Expert Panel Reaffirms Beta-Blockers as First-Line Therapy for Hypertension in India An expert panel in India came together to develop a consensus on the role of beta-blockers in managing hypertension. Hypertension, a condition affecting millions worldwide, remains a significant health challenge, especially in India, where early cardiovascular disease (CVD) is a growing concern. Despite advances in treatment, the management of essential hypertension continues to be difficult, with control achieved in fewer than 1 in 10 cases, particularly when aligned with updated guidelines from the American College of Cardiology (ACC) and the International Society of Hypertension (ISH).
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- Exporters raise alarm over new Export NOC Guidelines, seek Urgent Resolution
According to the pharma exporters, the recently implemented Export NOC system, effective from March 7, 2025, introduces stringent documentation and compliance requirements that create unnecessary bottlenecks for exporters. Expressing its dissatisfaction, an expert stated, “These new requirements pose a severe threat to the ease of doing business for pharma exporters and could severely impact the industry’s contribution to India’s export economy.” Key concerns raised include mandatory undertaking from active pharmaceutical ingredient (API) manufacturers. The new rule mandates a legal undertaking from the API manufacturer, a requirement that is difficult to fulfil as APIs are often procured through traders. Since manufacturers typically source APIs from multiple approved vendors, obtaining such undertakings on legal stamp paper is practically unfeasible. Exporters assert that this requirement, which was not mandatory earlier, serves no effective purpose and will disrupt the supply chain.
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Innovations
- Akums’ patented ‘Tablet-in-Tablet’ Technology brings relief to expectant mothers.
Akums Drugs & Pharmaceuticals, a CDMO, has received a patent for its innovative extended-release formulation of doxylamine and pyridoxine, targeting nausea and vomiting in pregnancy (NVP). This advanced “tablet-in-tablet” technology features a unique dosage form with an outer layer that delivers immediate relief and an inner core that provides sustained drug release for prolonged therapeutic effect.
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- India joins global ranks with Enliva’s accelerator-free nitrile gloves from Wadi Surgicals.
Wadi Surgicals, India’s leading nitrile glove manufacturer has achieved a significant innovation milestone with the launch of accelerator-free nitrile gloves under its flagship brand Enliva. Developed through extensive R&D and global collaboration, these are India’s first accelerator-free nitrile gloves, offering enhanced skin safety and allergy-free protection. With a commitment to research, regulatory compliance, and export excellence, Wadi Surgicals is setting new benchmarks in Indian glove manufacturing.
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- A non-invasive breast cancer screening test, Revealia Breast offers a glimpse of the future of early cancer detection.
Enterprises, Inc., a biotech firm specializing in mRNA diagnostics and AI-driven health solutions, has announced the upcoming launch of its flagship product, Revealia Breast—a non-invasive breast cancer screening test in advanced development. Using a simple cheek swab, the test detects cancer-related inflammation, aiming to identify breast cancer even before symptoms emerge. Revealia Breast offers a more affordable, accessible, and comfortable alternative to traditional mammograms, supporting earlier and less invasive diagnosis.
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- Researchers get breakthroughs in non-invasive methods to decode speech directly from brain signals.
Jihwan Lee, a leading researcher at the University of Southern California’s Ming Hsieh Department of Electrical and Computer Engineering and USC’s Signal Analysis and Interpretation Laboratory (SAIL), is pioneering non-invasive techniques to decode speech directly from brain signals. His work aims to benefit individuals with speech and communication disorders. Traditionally, this required invasive methods like electrocorticography (EcoG), involving implanted electrodes. Instead, a non-invasive electroencephalography (EEG) to achieve similar outcomes is being leveraged, potentially revolutionizing brain-computer interfaces.
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- Abbott’s Libre technology is first CGM associated with reduced hospitalizations for heart complications in people with diabetes.
Abbott has announced new findings from its REFLECT real-world studies showing that its FreeStyle Libre continuous glucose monitoring (CGM) system significantly reduces the risk of heart-related hospitalizations in people with diabetes. For the first time, data indicates that CGM use can lessen cardiovascular complications in individuals with Type 1 diabetes, regardless of prior low blood sugar episodes or heart disease history. Similar benefits were also observed in people with Type 2 diabetes on insulin using the Libre bio wearable technology.
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- Oxford Brain Diagnostics launches groundbreaking dementia diagnosis technology.
Oxford Brain Diagnostics (OBD) is aiming to transform early dementia detection with its patented Cortical Disarray Measurement (CDM®) technology. This software analyzes standard MRI scans to objectively assess neurodegeneration, providing a more precise evaluation of brain health. With FDA 510(k) clearance and UKCA self-certification secured, OBD is set to commercially launch its technology in the UK and US. The company’s goal is to improve global diagnostics for conditions like Alzheimer’s by enabling earlier and more accurate detection.
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- NICE recommends sparsentan for IgA nephropathy.
The National Institute for Health and Care Excellence (NICE) has recommended FILSPARI (sparsentan) for NHS use in England to treat primary IgA nephropathy. It is the first non-immunosuppressive, dual-action therapy approved for eligible patients. This follows UK regulatory approval and is backed by data from the Phase 3 PROTECT trial. NICE advises its use in adults with urine protein excretion 1.0 g/day or a protein-to-creatinine ratio 0.75 g/g and recommends continuing treatment only in those who show a positive response.
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- Medkart introduces India’s first room-temperature stable Nicorandil tablets for cardiac care.
Ahmedabad-based Medkart has launched India’s first room-temperature stable generic Nicorandil tablets, a breakthrough that enhances accessibility and affordability of heart medication. Nicorandil, used to treat chronic stable angina, traditionally requires cold-chain storage due to its sensitivity to heat and humidity. Medkart’s innovation eliminates this need, easing distribution challenges, especially in rural and semi-urban areas and ensuring wider, more cost-effective patient access.
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- Autonomix Medical’s innovative catheter-based platform technology receives US patent.
Autonomix Medical, Inc., a medical device company focused on precision nerve-targeted therapies, announced that the U.S. Patent and Trademark Office has granted Patent No. 12,257,071 titled “Controlled sympathectomy and micro-ablation systems and methods.” This patent covers advanced catheter-based systems that integrate nerve mapping with radiofrequency (RF) ablation, enabling precise, minimally invasive treatment of overactive peripheral nerves.
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- Breakthrough in bowel cancer research will speed up diagnosis.
British company Xgenera, in collaboration with the University of Southampton, has developed technology that could enable earlier and more accurate detection of bowel cancer. This innovation promises faster, cheaper diagnosis, reducing the need for invasive procedures like colonoscopies and biopsies. Announced by the government on April 23, technology could save valuable time and resources for patients and the NHS.
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- ISRO and SCTIMST sign MoU in space medicine.
ISRO has signed a Framework Memorandum of Understanding with Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST) to collaborate on space medicine. This partnership is a key step forward in advancing space medicine and its applications in India. ISRO highlighted that the Gaganyaan human space program presents a unique opportunity for national agencies, academia, and industry to engage in human health research, microgravity studies, space medicine, and space biology.
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- Personalized Medicine and Genomic Advancements.
As of April 2025, personalized medicine is advancing rapidly, fueled by breakthroughs in AI, molecular biology, and genomics. Pharma companies are increasingly developing treatments tailored to individual genetic profiles and lifestyles, especially for complex diseases like cancer. Targeted therapies—such as HER2 inhibitors for breast cancer and PARP inhibitors for ovarian cancer—are boosting treatment effectiveness and patient outcomes. Additionally, the use of real-world data (RWD) and real-world evidence (RWE) is enhancing personalization by providing valuable insights into how patients respond to therapies.
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- Tech Mahindra and NVIDIA to advance drug safety with AI-powered pharmacovigilance solution.
Tech Mahindra, in collaboration with NVIDIA, has developed an AI-powered pharmacovigilance (PV) solution to enhance drug safety management. Using agentic AI and automation, the system optimizes PV workflows, reducing manual delays, human errors, and data overload. Built on Tech Mahindra’s TENO framework and powered by NVIDIA AI Enterprise, the solution automates case intake, classification, quality control, and compliance management. It reduces turnaround times by 40%, enhances data accuracy by 30%, and lowers operational costs by 25%. The AI-driven approach transforms pharmacovigilance from a reactive to a predictive model, ensuring faster, more reliable drug safety monitoring.
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- Smart Labels in Pharma: A New Era of Patient Safety.
Smart labels are revolutionizing the pharmaceutical industry by enhancing patient safety, improving drug authentication, and streamlining logistics. Technologies like QR codes, Near-Field Communication (NFC) tags, and Radio-Frequency Identification (RFID) tracking allow real-time monitoring of medications, ensuring drug integrity and reducing counterfeit risks. These labels provide instant access to drug details, dosage instructions, and expiry dates, fostering better patient compliance. Additionally, smart labels can track medication usage, assist in clinical research, and improve emergency medical responses. As digital health advances, smart labels are set to bridge the gap between technology and patient care, creating a more transparent and efficient healthcare system.
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- Gastrointestinal cancer diagnosis with AI: Faster, more accurate abdominal CT scan analysis.
Gastrointestinal cancers pose a significant global health challenge, with over 1.2 million cases diagnosed annually, nearly 40% in China. Abdominal body composition plays a crucial role in prognosis, influencing treatment outcomes. By automating the segmentation of abdominal CT images, this AI tool offers a faster and more accurate method for body composition analysis. Clinicians can use it to identify high-risk patients early, develop more personalized treatment strategies, and monitor treatment progress over time.
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- NURA Launches Mobile Health Screening Facility ‘NURA Express’ in Kozhikode.
NURA, a joint venture between Fujifilm Healthcare and Dr. Kutty’s Healthcare, has launched its mobile health screening service, ‘NURA Express,’ in Kozhikode, Kerala. This mobile unit offers cancer screenings and tests for lifestyle diseases via on-site CT scans, catering to employees and residents. The results are analyzed remotely and shared through a dedicated app. NURA plans to expand by partnering with local governments for municipal health screenings, aiding in early disease detection. This initiative utilizes Fujifilm’s advanced imaging and AI-driven medical IT systems to enhance health outcomes.
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- Harbour BioMed Inks Global Strategic Collaboration with AstraZeneca to discover and develop Next-Generation Therapeutic Antibodies.
Harbour BioMed, a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics in immunology and oncology, announced a global strategic collaboration with AstraZeneca to discover and develop next-generation multi-specific antibodies for immunology, oncology and beyond. Under the terms of the agreements, AstraZeneca will obtain the option to license two preclinical immunology programs and will nominate further targets for Harbour BioMed to discover the next-generation multi-specific antibodies. AstraZeneca will have the option to license these programs for advancement into clinical development.
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- Lupin Digital Health introduces comprehensive post-procedure home-based care guide with American College of Cardiology.
Lupin Digital Health, in partnership with the American College of Cardiology, has introduced a home-based care guide for heart patients. The guide covers recovery, medication management, lifestyle changes, and cardiac rehabilitation. It aims to support patients post-procedure and reduce hospital readmissions. Leading cardiologists contributed to developing the guide, ensuring its medical accuracy. This initiative enhances patient care and promotes better health outcomes.
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- Monash University and Peninsula Health develop AI methods to improve dementia diagnosis.
The National Centre for Healthy Ageing (NCHA), a joint initiative between Monash University and Peninsula Health, has introduced an advanced approach to enhance dementia detection in hospitals by integrating traditional screening techniques with artificial intelligence (AI). Researchers from NCHA’s Healthy Ageing Data Platform, along with clinicians from Australia and the USA, used a specific AI technique—natural language processing (NLP)—to analyze written medical records, significantly improving the accuracy of dementia identification.
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Trends
- Vaccine preventable diseases rising.
Vaccine-preventable diseases like measles, meningitis, and yellow fever are making a comeback due to disrupted immunisation programs and funding cuts, global health leaders have warned. In a joint statement, the WHO, UNICEF, and Gavi highlighted that misinformation, population growth, and ongoing humanitarian crises are further undermining vaccination efforts. They called on world leaders to prioritise and reinforce immunisation programmes with urgent and sustained political commitment.’
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- Neurocrine Biosciences announces new survey revealing need for routine screening and earlier diagnosis for people living with tardive dyskinesia.
Neurocrine Biosciences, Inc., a leading neuroscience-focused biopharmaceutical company, announced the release of findings from a new survey conducted by The Harris Poll highlighting the profound negative impact of tardive dyskinesia on patients and reinforcing the need for routine screening, earlier diagnosis and treatment. The findings revealed that 80% of people living with tardive dyskinesia surveyed wished they had been screened for the condition earlier, and 86% wished their provider had discussed available treatment options for their uncontrolled movements sooner.
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- India-UK FTA will be a game-changer for ceramic & pharmaceutical exports: Gujarat industry players.
Upbeat about the free trade agreement (FTA) between India and the United Kingdom, ceramic and pharmaceutical players in Gujarat have described the deal as a “game-changer.” Pharmaceutical players in Gujarat also felt that the deal with the UK will ease regulatory approvals for generic drugs, improve market access and thus boost pharmaceutical exports from India.
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- Oracle, Cleveland Clinic & G42 enter into a strategic partnership to launch an AI-based global healthcare delivery platform.
Oracle Health, Cleveland Clinic, and G42 announced a strategic partnership to develop a groundbreaking AI-based healthcare delivery platform. This initiative aims to improve patient care and public health management by leveraging AI, nation-scale data analytics, and intelligent clinical applications to create secure, scalable, and accessible care models that positively impact people’s health and longevity. The platform will serve as the foundation for an AI-driven healthcare hub, combining Oracle Cloud Infrastructure, Oracle AI Data Platform, and Oracle Health applications, Cleveland Clinic’s world-class clinical expertise, and G42’s capabilities in sovereign AI infrastructure, health data integration, and advanced clinical AI models.
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- VITU and Gleneagles Hospital Chennai sign MoU to collaborate on AI-driven neuroscience innovation.
Vellore Institute of Technology University (VITU) has signed a Memorandum of Understanding (MoU) with Gleneagles Hospital Chennai to foster collaboration in research and innovation in artificial intelligence (AI) and neurosciences. The MoU was formalised by Dr. Nageshwar Rao, CEO of Gleneagles Hospital Chennai, and Dr. T. Thyagarajan, Pro Vice-Chancellor of VIT University.
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- Global Pharma Investment and Power Shifts: Roche and Eli Lilly Take the Lead.
In April, Roche announced a $50 billion investment to expand its U.S. R&D and manufacturing, creating 12,000 jobs across eight states. Although the company didn’t comment on political motives, the move followed a Swiss-U.S. diplomatic call, sparking speculation about tariff-related factors. Meanwhile, Eli Lilly is gaining market share over Novo Nordisk in diabetes and obesity treatments, with its drugs Mounjaro and Zepbound outperforming Novo’s Ozempic and Wegovy. Supported by a strong pipeline including orforglipron and retatrutide, Lilly’s 32% annual growth has analysts optimistic, prompting BMO to downgrade Novo’s outlook amid intensifying competition.
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- Biotech Boom and EU Pressure: Investment Trends and Geopolitical Tensions.
Venture capital investment in biotech remains strong in early 2025, with median funding rounds reaching $93 million US dollars. Investors are focusing on late-stage, clinic-ready startups, particularly in China, aiming for faster regulatory approvals and quicker returns. However, experts warn that IPO delays and regulatory uncertainties may pose valuation risks. Meanwhile, 32 pharma CEOs from companies like Roche, Novartis, and Pfizer have urged the EU to enact policy reforms to avoid losing up to €103 billion Euros in investments. Facing U.S. drug import tariffs, pharma leaders are pushing for faster drug approvals, stronger IP protections, and eased environmental penalties to maintain Europe’s competitiveness in global life sciences innovation.
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- Startoon Labs signs MoU with Medplus to initiate Pheezee assessment.
Startoon Labs Private Limited, a Hyderabad-based medical device R&D and manufacturing company specializing in joint and muscle health, has signed an MoU with Medplus to introduce the Pheezee assessment at Medplus diagnostic centres. Medplus Diagnostics, part of the well-known Medplus pharmacy retail chain, offers pathology and radiology services and will now provide muscle and joint health diagnostics using the Pheezee device.
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Law and Order Briefs
- Delhi High Court sets aside patent office’s order rejecting Taiho Pharma’s application.
The Delhi High Court has set aside a Patent Office order refusing patent to an anticancer compound from Japanese pharma firm Taiho Pharmaceutical, part of Otsuka Group, remanding back the matter for fresh consideration of the Patent Authority. The High Court observed that while the patent application was rejected on various grounds including Section 3(d) of the Patents Act, 1970, the Patent Office did not identify any particular ‘known substance’ in the hearing notice, providing a fair opportunity to the applicant to respond to the same. By not sharing the information the applicant could not have defended his case.
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- The Supreme Court Criticizes Pharmacy Council of India for Arbitrary Rejection of Pharma College Approvals.
The Supreme Court has recently expressed serious concern over the Pharmacy Council of India (PCI) for acting irresponsibly in rejecting approvals for pharma colleges. The court highlighted that PCI, an expert body in pharmacy education, should be more diligent and avoid arbitrary actions that affect students’ futures. The Court set aside PCI’s rejection orders and directed the Registrar to forward a copy of the judgment to the Secretary, Ministry of Health and Family Welfare. The intent is to ensure that such unnecessary litigations do not happen again. Click to read more.
- The Supreme Court says doctors must prescribe only generic drugs, not branded medicines.
The Supreme Court on Thursday stated that doctors nationwide should be required to prescribe only generic medicines instead of branded ones. The top court was hearing a Public Interest Litigation (PIL) seeking the stringent regulation of the marketing and promotion of drugs by pharmaceutical firms. This observation came during the hearing of a petition filed by the Federation of Medical & Sales Representatives Associations of India (FMSRAI) and others. The plea emphasised that large sums of money are spent on sales and promotional activities aimed at influencing doctors to increase prescription volumes.
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- The Supreme Court Challenges Health Insurance Policy on Epilepsy Exclusion.
The Supreme Court has requested the government’s response to a petition challenging the omission of epilepsy from health insurance coverage. The plea, filed by Sanvedana Foundation, argues that excluding epilepsy violates constitutional rights and restricts healthcare access for affected individuals. The existing policy, as stated by IRDA, deems epilepsy a permanent exclusion.
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- Bombay HC Notice to CDSCO on Denial of Phase I Trial for Indigenous Cancer Drug.
The Bombay High Court has issued a notice to the Central Drugs Standard Control Organisation (CDSCO) and the Union government following a petition by Nashik-based Datar Cancer Genetics. The company challenges the CDSCO’s rejection of its application to conduct Phase I human trials for its indigenous cancer immunotherapy drug, Per-C-Vax, intended for patients recently diagnosed with solid organ cancers. A division bench comprising Chief Justice Alok Aradhe and Justice M.S. Karnik is reviewing the case, where Datar alleges that the CDSCO’s April 22, 2025, rejection was “arbitrary,” “unscientific,” and a “fraud on the statute.”
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- Delhi High Court quashes Indian Patent Office’s decision to hear pre-grant opposition after signing patent approval.
The Delhi High Court invalidated the Indian Patent Office’s (IPO) decision to entertain a pre-grant opposition against Vertex Pharmaceuticals’ patent for a cystic fibrosis drug, ruling that the opposition was filed after the patent was already granted by the controller. Although the patent grant order had not yet been uploaded online, the Court found this delay was due to technical issues on the IPO’s side, not Vertex’s fault. Consequently, the absence of the patent certificate or delay in its publication did not affect the validity of the patent grant, rendering the pre-grant opposition invalid.
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- Relatives of rare disease requests CJI to help them access life-saving medicines at affordable cost.
Mothers and caregivers of children with rare diseases like spinal muscular atrophy (SMA) and cystic fibrosis have appealed to the Chief Justice of India, Justice Sanjiv Khanna, seeking access to life-saving medicines at affordable prices. In a letter signed by around 220 parents and caregivers, they urged the Supreme Court to take suo motu cognizance of the urgent situation and expedite the resolution of pending legal cases related to rare disease treatments.
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- The Supreme Court issues notice to Roche on risiplam matter.
The Supreme Court of India (SCI) has issued a notice to Swiss pharmaceutical company F Hoffmann-La Roche Ltd, maker of the spinal muscular atrophy (SMA) drug risdiplam, seeking clarity on whether the drug can be supplied in India at a lower price if offered at such rates in neighboring countries. This follows a Special Leave Appeal filed by the Union of India challenging a Kerala High Court order that directed the government to cover the cost of one month’s medicine for a patient, Seba PA, who sought help to continue treatment beyond the Rs. 50 lakhs only limit set by the National Rare Disease Policy (NRDP).
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- The Supreme Court pushes for expert recommendations on Food Labelling.
The Supreme Court has directed an expert committee to recommend amendments to food safety regulations requiring warning labels on packaged foods, focusing on sugar, salt, and unhealthy fats. This initiative aims to help consumers make healthier dietary choices amid rising non-communicable diseases. The Court acknowledged the efforts of the Centre and the Food Safety and Standards Authority of India (FSSAI), which received around 14,000 public objections and suggestions on the proposed changes. The expert committee will review these inputs and suggest appropriate amendments to the regulations.
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- The Supreme Court mandates immediate cancellation of hospital licenses in case of child trafficking.
The Supreme Court has issued strict guidelines to curb newborn trafficking, including the immediate suspension of hospital licenses where such cases occur. Justices JB Pardiwala and R Mahadevan warned that any violation of these directions would be treated as contempt of court. Highlighting the severity of child trafficking, the Court described its impact as worse than death and called for greater parental vigilance. Additionally, state governments were urged to implement recommendations from a human trafficking report by the Bharatiya Institute of Research and Development.
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- Kerela Doctor moves HC seeking Regulations for Home Births:
A medical officer from Malappuram, Dr Pratibha K, has approached the Kerela High Court seeking clear legal provisions and penalties to regulate childbirth outside medical facilities. She has urged for establishment of proper guidelines to ensure the safety of both mothers and newborns. The issue came in light after a woman gave birth at her rental home in November, but officials refused to issue the certificate as no formal records of the delivery existed.
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- Apollo Hospitals Bengaluru slammed, slapped Compensation by Consumer Court.
The Bengaluru Urban District Consumer Disputes Redressal Commission has ordered Apollo Hospitals in Seshadripuram to compensate a senior patient Rs 1 lakh only for the harassment and rude behaviour he endured during his treatment. The forum observed that “the complainant has suffered mental agony and discomfort at the hands of hospital staff. It is the responsibility of the doctor and medical staff to prove that due care was taken in discharge of their duties. The complainant is entitled to compensation for harassment and mental agony and financial loss suffered by him for the harassment given by the staff of the hospital”.
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- Patients and experts urge Court to ensure access to cystic fibrosis in India.
Patients with cystic fibrosis (CF), along with public health experts, are urging the Karnataka High Court to facilitate the availability of affordable treatment for CF patients in India. The petitioners seek the government’s approval for generic production of the CF drug, which would allow for compulsory licensing and lower prices. The drug, a combination of three CFTR modulators, is lifesaving for CF patients, improving lung function and reducing hospitalizations. However, despite the drug being available in high-income countries, its cost in India exceeds Rs. 2.5 crores annually, and it is not marketed or approved in India by Vertex Pharmaceuticals, which holds the patents. The petitioners argue that the drug’s monopoly prevents access and call for remedies to introduce generic competition, making the drug affordable. The case could have significant implications for rare disease patients in India.
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- False Advertising, Misrepresentation- CCI Clears Hospital in Unregistered Surgeon Row.
The Competition Commission of India (CCI) has dismissed a complaint filed against Victor Hospital, Margao, Goa, regarding allegations of misleading consumers by employing an unregistered surgeon and engaging in anti-competitive practices. The commission stated that misleading consumers by misrepresenting a surgeon’s qualifications and engaging in false advertising, while serious, do not amount to anti-competitive behavior under the Competition Act, 2002. It was noted that such issues should be dealt with by medical regulatory bodies rather than CCI.
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- Big pharma faces heat as India records 307 drug pricing violations.
Pharmaceutical companies have repeatedly violated drug pricing regulations by exceeding permitted price hikes, according to a report by the Parliamentary Standing Committee on Chemicals and Fertilizers. As of 6 March 2025, the National Pharmaceutical Pricing Authority (NPPA) recorded 307 cases of violations under Paragraph 20 of the Drugs (Prices Control) Order (DPCO), 2013, which governs price increases for non-scheduled drugs. These violations highlight growing concerns over the unchecked rise in medicine prices and their impact on affordability.
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- Karnataka Government. proposes to establish Special Court to hear cases related to Supply of fake and spurious drugs.
A special court to hear cases related to the supply of fake and spurious drugs would be specifically designated to deal with cases involving counterfeit, adulterated, or substandard drugs that pose a significant risk to public health. This type of court would help address the growing problem of drug-related fraud, ensuring swift trials and harsher penalties for those involved in such activities. The department is making sure the company which supplies fake medicines are imposed huge fines and taken to task. We are also bringing the Drug Recall Policy so that fake medicine suppliers and manufacturers are taken to task. According to the data furnished to the House, a total of 20 cases have been registered in the last three years against the companies which supplied fake medicines.
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- BIS Cracks Down on E-Commerce Platforms Selling Non-Certified Products.
The Bureau of Indian Standards (BIS) has conducted search and seizure operations at multiple Amazon and Flipkart warehouses in Lucknow, Gurugram, and Delhi, confiscating thousands of non-certified consumer products such as toys, hand blenders, electric heaters, and gas stoves. The raids also uncovered large-scale violations by Tech vision International Pvt Ltd, leading to legal action under the BIS Act, 2016. BIS has filed cases and warned e-commerce platforms to ensure only BIS-certified products are sold. Consumers are urged to use the BIS Care app to verify certification and report violations. The crackdown aims to enhance product safety and protect public interest.
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