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 June 2026. This newsletter aims to cover local, regional, and global news as well as regulatory updates, new government initiatives, and technological advancements etc.
- CDSCO constitutes consultancy committee for advice on suo motu disclosure
The Central Drugs Standard Control Organisation (CDSCO) has constituted a seven-member consultancy committee to advise on proactive disclosure of information under the Right to Information (RTI) Act, 2005, in line with the Department of Personnel and Training (DoPT) guidelines. Chaired by the Joint Drugs Controller (India), the committee will identify information suitable for suo motu disclosure, review compliance with Section 4(1)(b) of the RTI Act and recommend measures to improve transparency and accessibility. It will also oversee periodic updates of RTI disclosures across CDSCO offices, promote digitisation and public dissemination of information, and submit recommendations to the competent authority to strengthen proactive disclosure practices and regulatory transparency.
- CDSCO revises guideline for sampling of drugs, cosmetics and medical devices
The Central Drugs Standard Control Organization (CDSCO) has revised its guidelines for the sampling of drugs, cosmetics, and medical devices by Central and State Drugs Inspectors. The updated guidelines introduce expanded reporting formats for Not of Standard Quality (NSQ) and spurious drugs, requiring additional details such as product type, brand name, dosage form, manufacturing information, reporting source, and reasons for failure. The revised framework also updates the reporting format for spurious drugs and clarifies the criteria for classifying products as spurious under the applicable regulations. The changes aim to strengthen regulatory surveillance, improve reporting consistency, enhance public awareness through monthly alerts, and support more effective monitoring of product quality across the supply chain.
- Health ministry to rationalise residual shelf-life requirement for imported drugs
The Ministry of Health and Family Welfare has issued a draft notification proposing amendments to Rule 31 of the Drugs Rules, 1945, to revise the residual shelf-life requirement for imported drugs. The proposal replaces the existing requirement of more than 60% residual shelf life with a minimum residual shelf life of 12 months at the time of import. However, biological products and radiopharmaceuticals will continue to require a minimum residual life of more than 60% due to their specialised nature. The amendment aims to improve pharmaceutical supply chain efficiency, reduce medicine wastage, and enhance the availability of essential medicines while maintaining existing standards for the quality, safety, and efficacy of imported drugs.
- NPPA integrates Pharma Jan Samadhan with Pharma Sahi Daam portal
The National Pharmaceutical Pricing Authority (NPPA) has integrated its Pharma Jan Samadhan and Pharma Sahi Daam platforms into a single unified digital interface under the Pharma Sahi Daam portal. The integrated platform enables citizens to access government-approved medicine price information and submit complaints related to medicine pricing through one portal. The initiative aims to improve transparency, accountability, and public participation while enhancing access to affordable medicines. The integration also aligns with the Government of India’s vision of integrated digital governance by simplifying service delivery, reducing duplication, and providing a more user-friendly experience. The unified platform is operational with immediate effect for both medicine price verification and grievance redressal services.
- Centre Notifies Jan Vishwas Reforms under Clinical Establishments Act
The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945 to expand Schedule H2, bringing vaccines, antimicrobials, anti-cancer medicines, and narcotic and psychotropic drugs under a Quick Response (QR) Code-based track and trace framework. Manufacturers will be required to print or affix QR codes containing key product details, including batch number, manufacturing and expiry dates, manufacturer information, and licence details, to enable product authentication throughout the supply chain. The requirement will take effect from 1 July 2027 for vaccines, anti-cancer, narcotic, and psychotropic drugs, and from 1 July 2028 for antimicrobials. The initiative aims to improve traceability, strengthen regulatory oversight, and curb counterfeit and substandard medicines.
2) Approvals
- Alembic Pharma Receives US FDA Approval for Oseltamivir Phosphate Oral Suspension
Alembic Pharmaceuticals Limited has received final approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Oseltamivir Phosphate for oral suspension, 6 mg/mL. The approved product is therapeutically equivalent to Tamiflu oral suspension, the reference listed drug of Hoffmann-La Roche, Inc. Oseltamivir phosphate is indicated for the treatment of acute, uncomplicated influenza A and B in patients aged two weeks and older, and for the prophylaxis of influenza A and B in patients aged one year and above. According to IQVIA, the product has an estimated annual market size of US$ 27 million for the 12 months ending March 2026.
3) International Pharma News
- Zydus Lifesciences signs agreement to acquire Assertio Holdings
Zydus Lifesciences Limited has signed a definitive agreement, through its subsidiary, to acquire Assertio Holdings, Inc., a United States-based specialty pharmaceutical company. As part of the transaction, Zara Merger Sub Inc., a wholly owned acquisition subsidiary of Zydus, will merge with Assertio Holdings, with Assertio continuing as the surviving entity. The acquisition strengthens Zydus’ presence in the oncology segment through Assertio’s established commercial capabilities in the marketing and distribution of differentiated oncology products. Assertio’s key product, ROLVEDON, is administered once per chemotherapy cycle in the oncology supportive care market.
- Glenmark Launches Methylene Blue Injection in the US Market
Glenmark 2Pharmaceuticals Inc., USA has launched Methylene Blue Injection USP, 50 mg/10 mL (5 mg/mL) in a single-dose vial for the United States market. The product is bioequivalent and therapeutically equivalent to the reference listed drug, ProvayBlue Injection, manufactured by Provepharm SAS, and is approved for the indications specified in Glenmark’s approved label. The launch expands Glenmark’s institutional product portfolio and reinforces its focus on providing affordable treatment options to healthcare institutions and patients in the United States.
- Lilly Reports Positive Phase 3 Results for Oral GLP-1 Therapy Orforglipron
Eli Lilly and Company has announced positive results from three Phase 3 ACHIEVE trials evaluating Orforglipron, an oral Glucagon-Like Peptide-1 (GLP-1) receptor agonist, in adults with type 2 diabetes. In the head-to-head ACHIEVE-3 study, Orforglipron demonstrated superior glycated haemoglobin (A1C) reduction and weight loss compared with oral semaglutide. The ACHIEVE-2 and ACHIEVE-5 trials also met their primary and key secondary endpoints, showing greater improvements in blood glucose control and body weight than dapagliflozin and placebo, respectively. Across all studies, orforglipron showed clinically meaningful improvements in cardiovascular risk factors and a safety profile consistent with previous clinical studies.
- Simcere Pharma and Stanford Medicine Collaborate on Idiopathic Pulmonary Fibrosis Research
Simcere Pharmaceutical Group Limited has entered into a research collaboration agreement with Stanford Medicine to develop innovative therapies for Idiopathic Pulmonary Fibrosis (IPF), a progressive lung disease with significant unmet medical need. Under the agreement, Simcere will fund exploratory research on a first-in-class novel molecule and, upon successful completion, will obtain an exclusive global licence to the resulting product. The research will be conducted with Stanford Medicine’s chemical biology laboratories under Professors Chaitan Khosla and Cui Bianxiao. The collaboration aims to translate early scientific discoveries into potential new treatment options for IPF and represents Simcere’s continued focus on advancing innovative therapies through global research partnerships.
4) Domestic Pharma News
- AiMeD Welcomes Haryana’s Pharma and Medical Devices Manufacturing Policy 2026
The Association of Indian Medical Device Industry (AiMeD) has welcomed the Haryana Pharmaceutical and Medical Devices Manufacturing Policy 2026. The policy aims to attract over ₹10,000 crore in investments and strengthen pharmaceutical and medical device manufacturing through capital expenditure and operational expenditure incentives, export-linked benefits, patent commercialisation support, and green manufacturing initiatives. AiMeD stated that the policy would promote indigenous manufacturing, research and development, and industry competitiveness. The association also urged state and central governments to simplify compliance requirements and approval processes to maximise investment, accelerate project implementation, and further improve ease of doing business.
- Sun Pharma to Acquire Innovcare Lifesciences for ₹271.2 Crore
Sun Pharmaceutical Industries Limited has signed a definitive agreement to acquire a 100% stake in Innovcare Lifesciences Private Limited for ₹271.2 crore through an all-cash transaction. The acquisition is aimed at strengthening Sun Pharma’s portfolio in the preventive healthcare, nutraceutical, and wellness segments. The transaction is expected to be completed by July 31, 2026, and does not require any prior regulatory approvals. Innovcare is engaged in the marketing, distribution, and sale of pharmaceutical, nutraceutical, and cosmeceutical products, and has reported steady revenue growth over the past three financial years.
- Online Chikitsa Mitra expands medical store-led e-clinic network to improve healthcare access across rural India
Online Chikitsa Mitra (OCM), the flagship healthcare platform of Salubrious Technologies, has expanded its network of medical store-led e-Clinics to improve healthcare access in rural and semi-urban India. The platform has facilitated over 1.5 lakh doctor consultations through more than 600 e-Clinic partners across 15 states and is now extending its presence in southern and northeastern regions. The model enables local medical stores to provide assisted video consultations with qualified doctors, digital health records, and follow-up care. Supported by a dedicated patient assistance team and the 120by80 digital platform for healthcare professionals, the initiative aims to improve continuity of care, treatment adherence, and healthcare accessibility for underserved communities.
- Philips and Bajaj Integrated Health System collaborate for connected healthcare delivery in India
Philips and Bajaj Integrated Health System (BIHS) have entered into a strategic collaboration to establish a digitally connected healthcare network across India. The partnership will deploy Philips’ IntelliBridge Enterprise (IBE) platform to integrate patient data across home, clinic, ambulatory, and hospital settings, enabling seamless information flow and supporting coordinated care. The initiative marks the first global implementation of IntelliBridge Enterprise 3.0 Enterprise Cloud and aims to improve clinical decision-making, workflow efficiency, and continuity of patient care. Philips will also provide advanced imaging technologies, including its BlueSeal helium-free Magnetic Resonance Imaging (MRI) system, to support BIHS’ expanding healthcare network, with the first facility scheduled to open in 2026.
- Fortis Gurugram Launches India’s First Centre of Excellence for Myeloma and Lymphoma
Fortis Memorial Research Institute, Gurugram has launched India’s first Centre of Excellence for Myeloma and Lymphoma, dedicated to the management of blood cancers through an integrated, patient-centric approach. Built on the philosophy of “One Disease. One Doctor. One Focus.”, the centre brings together expertise in haematology, genomics, pathology, precision medicine, stem cell transplantation, cellular therapies, and clinical research under one platform. It aims to deliver personalised treatment pathways, improve clinical outcomes, expand access to advanced diagnostics and innovative therapies, and strengthen translational research. The initiative is also expected to serve as a national referral centre while supporting physician education and advancing standards of care in haematologic oncology.
5) Innovations
- Shilpa Biologicals Launches PartnerPower for Real-Time Biologics Development Monitoring
Shilpa Biologicals Pvt. Ltd. has launched PartnerPower, a proprietary digital platform that provides global sponsors with real-time visibility into biologics development and manufacturing programmes. Designed as a unified digital data platform, PartnerPower enables continuous monitoring of process development, analytical development, and Good Manufacturing Practice (GMP) manufacturing operations, replacing conventional periodic reporting with live project insights. The platform is intended to improve collaboration, accelerate decision-making, and facilitate efficient technology transfer. Built with a focus on data integrity, sponsor confidentiality, and audit readiness, PartnerPower aligns with the expectations of major regulatory authorities, including the United States Food and Drug Administration (US FDA), European Medicines Agency (EMA), and Pharmaceuticals and Medical Devices Agency (PMDA).
- Medtronic Launches PulseSelect Pulsed Field Ablation System in India
Medtronic has launched the PulseSelect Pulsed Field Ablation (PFA) system in India to treat Atrial Fibrillation (AF), a common heart rhythm disorder associated with an increased risk of stroke and heart failure. The technology uses short electrical pulses instead of heat or extreme cold to ablate targeted cardiac tissue, aiming to minimise damage to surrounding structures and support safer, more efficient procedures. The PulseSelect system complements Medtronic’s existing cryoablation portfolio, providing physicians with additional treatment options for managing atrial fibrillation. Supported by Investigational Device Exemption (IDE) clinical trial data, the launch is intended to strengthen atrial fibrillation care and improve treatment outcomes for patients in India.
- Novartis India launches Pluvicto for advanced prostate cancer
Novartis India has launched Pluvicto (lutetium (177Lu) vipivotide tetraxetan), the country’s first regulatory authority-approved radioligand therapy for eligible patients with Prostate-Specific Membrane Antigen (PSMA)-positive metastatic castration-resistant prostate cancer. The intravenous therapy delivers targeted radiation to prostate cancer cells while minimising exposure to healthy tissue. Pluvicto will be available through selected hospitals and nuclear medicine centres across India, supported by collaborations with healthcare institutions to strengthen treatment readiness and access. The launch is backed by Phase III clinical data demonstrating significant improvements in radiographic progression-free survival, reduced risk of disease progression or death, and a manageable safety profile in eligible patients with advanced prostate cancer.
- Medidata introduces next-gen AI imaging solution for delivering unprecedented speed and precision for clinical trials
Medidata, a Dassault Systèmes brand, has introduced an enhanced Artificial Intelligence (AI)-powered imaging solution within its Medidata Data Experience platform to improve the speed and accuracy of image-based clinical trials. The solution incorporates AI algorithms to automate health information redaction, verify anatomical images, and accelerate quality control, helping reduce manual effort and imaging-related delays. Future enhancements will include intelligent patient similarity checks, advanced tumour detection, and one-click image transfers through Medidata’s hospital network. Designed particularly for oncology and other image-dependent studies, the platform aims to improve clinical trial efficiency by delivering faster, more reliable imaging data and supporting quicker decision-making throughout the clinical research process.
6) Trends
- WHO Releases First Paediatric Drug Optimization Guidance for Dengue Treatments
The World Health Organization (WHO) has released its first Paediatric Drug Optimization (PADO) guidance for dengue, establishing research and development priorities to accelerate the availability of child-appropriate dengue treatments. Developed following a WHO-convened meeting in October 2025, the report identifies a priority list and watch list of therapeutic candidates, including a monoclonal antibody for children, to guide researchers, developers, regulators, and funders. The guidance also outlines paediatric-specific considerations for developing target product profiles and recommends early inclusion of children in clinical development once sufficient adult data are available. The report aims to promote the development of safe, effective, and age-appropriate dengue therapeutics, addressing a significant unmet need in paediatric care.
7) Law and Order Briefs
- Jabalpur HC denies bail to Paediatrician Dr S S Thakur in Coldrif cough syrup case
The Jabalpur Bench of the Madhya Pradesh High Court has denied bail to paediatrician Dr. S. S. Thakur in connection with the Coldrif cough syrup contamination case, which resulted in the deaths of several children due to acute kidney injuries linked to diethylene glycol-contaminated medicine. The court cited the seriousness of the public health crisis and allegations that the doctor continued prescribing the cough syrup despite regulatory warnings and emerging reports of adverse effects. The case forms part of a broader investigation that has also led to action against the manufacturer, distributors, and regulatory officials, with the court directing that the trial proceeds under relevant provisions of the Bharatiya Nyaya Sanhita and the Drugs and Cosmetics Act.
- TGA issues infringement notices for alleged unlawful importation of cosmetic injectables
The Therapeutic Goods Administration (TGA) of Australia has issued five infringement notices totalling AUD 19,800 against a registered nurse and an individual for the alleged unlawful importation of unapproved cosmetic injectables in violation of the Therapeutic Goods Act 1989. The imported products included pre-filled syringes containing hyaluronic acid, poly-L-lactic acid, lidocaine, and prescription-only tranexamic acid without the required exemption. The infringement notices, which were paid in May 2026, highlight the TGA’s enforcement efforts against illegal imports of unapproved therapeutic goods. The regulator reiterated that such products may pose health risks and warned that non-compliance may result in regulatory actions, including civil or criminal proceedings. Click to read more
- RDCA urges Delhi drug controller to issue advisory against deceptive discount boards, cites Kerala HC order
The Retail Distribution Chemists Alliance (RDCA) has urged the Delhi Drug Controller to issue an advisory directing retail pharmacies to remove misleading discount display boards, following a recent High Court of Kerala judgment on deceptive advertisements. The court upheld enforcement action against pharmacies using unsubstantiated promotional discount claims, while clarifying that medicines may be sold below the Maximum Retail Price (MRP) provided advertisements are truthful and not misleading. RDCA stated that the proposed advisory aims to promote ethical pharmacy practices, ensure compliance with the Drugs and Cosmetics Act, 1940, and protect consumers from deceptive promotional claims. The association also pledged to support regulatory authorities in strengthening transparency and responsible trade practices.
- HP HC quashes CDSCO complaints against pharma firms over jurisdictional and procedural lapses
The High Court of Himachal Pradesh has quashed three criminal complaints filed by the Central Drugs Standard Control Organization (CDSCO) against pharmaceutical manufacturers, partners, and directors, citing jurisdictional and procedural deficiencies. The Court held that Central Drugs Inspectors lacked the authority to initiate prosecutions under Chapter IV of the Drugs and Cosmetics Act, 1940, as such powers are vested with State Drugs Inspectors. It also ruled that the complaints failed to establish specific roles and responsibilities of the accused for invoking vicarious liability. Additionally, the Court observed that delays in testing drug samples beyond the prescribed timelines under the Drugs and Cosmetics Rules, 1945 prejudiced the accused, warranting dismissal of the proceedings.
- Kerala High Court Upholds Action Against Misleading Pharmacy Discount Boards
The High Court of Kerala has upheld the Drugs Control Department’s action against misleading discount boards displayed by retail pharmacies, dismissing petitions filed by chemists challenging the regulatory circular. The Court ruled that while pharmacies may sell medicines below the Maximum Retail Price (MRP), regulators have the authority to prevent deceptive promotional practices that mislead consumers. It also upheld the requirement for licence applicants and renewal applicants to undertake that they will not display misleading or vague discount claims. The judgment affirmed that reasonable licensing conditions can be imposed to promote transparent and ethical trade practices, while allowing genuine discounts and verified price information to continue in compliance with applicable regulations.
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