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 months of March and April 2026. This newsletter aims to cover local, regional, and global news as well as regulatory updates, new government initiatives, and technological advancements etc.
1) Regulatory Update
- DTAB recommends certain exemptions to specific categories from revised Schedule M norms
The Drugs Technical Advisory Board (DTAB) has recommended continuing exemptions under the revised Schedule M norms for certain drug categories, including medical gases, empty gelatin capsules, and disinfectant fluids, as specific plant and equipment requirements are not applicable to them. This recommendation was made during its 93rd meeting held on February 16, 2026, following stakeholder requests. The revised Schedule M, notified in December 2023 to align with global manufacturing standards, mandates compliance with timelines based on turnover. While enforcement actions have begun post-deadline, MSMEs continue to seek further extensions to ensure compliance without disrupting operations.
- CDSCO Streamlines Drug Testing with Immediate NOC Issuance
The Central Drugs Standard Control Organisation (CDSCO) has introduced reforms to speed up approvals for importing and manufacturing new drugs in India, effective June 1, 2026. No Objection Certificates (NOCs) for mandatory drug testing will now be issued immediately upon application instead of after detailed review. This fast-tracks process will rely on Pharmacopoeia standards and product-specific Quality Management Systems, with companies required to submit finalized regulatory specifications. These changes follow earlier 2026 reforms reducing approval timelines to 45 days and simplifying licensing for limited production for testing purposes.
- Draft rules issued for post-approval manufacturing changes
The Government of India issued draft rules to regulate post-approval changes in drug manufacturing under the Drugs Rules, 1945. The proposal aims to ensure better quality control and transparency by requiring pharmaceutical companies to inform licensing authorities about any significant changes in manufacturing processes, composition, packaging, shelf life, testing methods, or documentation. The rules introduce a risk-based classification system where major and moderate changes require prior approval, while minor changes only need reporting. These reforms aim to close regulatory gaps, standardize compliance practices, and strengthen patient safety by ensuring that any changes made after drug approval do not affect quality or efficacy.
- DTAB recommends amendment of Rule 64 on qualification of competent person
The Drugs Technical Advisory Board (DTAB) has recommended amending Rule 64 of the Drugs Rules, 1945 to expand the qualification criteria for a competent person supervising drug sales premises. Along with registered pharmacists, science graduates with two years’ experience in drug handling and a six-month online certificate course recognised by bodies such as the Pharmacy Council of India and National Institute of Pharmaceutical Education and Research may become eligible. This marks a shift from earlier proposals restricting eligibility to pharmacy-qualified professionals. The amendment aims to balance accessibility with quality assurance in wholesale drug licensing. The Central Drugs Standard Control Organisation has also formed a committee to revisit the rule considering current industry needs, while the Drugs Consultative Committee will review the report to ensure uniform national implementation.
- DTAB recommends amendment of Schedule K to allow only unflavored nicotine gums sold under exemption
The Drugs Technical Advisory Board (DTAB) has recommended amending Schedule K of the Drugs Rules, 1945 to restrict over the counter (OTC) sale of nicotine replacement therapies (NRTs). It proposed allowing only unflavoured nicotine gums (2 mg) under exemption, while removing nicotine lozenges (2 mg) from the exemption list, thereby requiring a sale license. The Board also suggested safeguards such as prohibiting sales to minors, monitoring online access, and conducting post-marketing surveillance. Additionally, concerns over conflict of interest led to recommendations to restrict NRT marketing by tobacco companies. The move aligns with expert inputs, including from the Indian Council of Medical Research (ICMR), highlighting risks of misuse and advocating regulated access.
- India tightens import norms for Glufosinate for six months for effective regulatory oversight
The Government of India has amended the import policy for Glufosinate and its salts under ITC (HS) 2022, introducing stricter conditions for six months. While the overall import status remains “Free,” imports will be treated as “Restricted” if the CIF value, including anti-dumping duty, falls below ₹1,154 per kg—effectively setting a minimum import price. This measure aims to curb low-cost imports that may distort market competition or raise quality concerns. The amendment applies across multiple ITC (HS) codes, ensuring uniform enforcement. Existing safety and regulatory requirements remain unchanged. Issued by the Directorate General of Foreign Trade, the move reflects a calibrated approach to balance trade flexibility with protection of domestic industry and fair pricing.
- CDSCO implements prior intimation system for certain drugs under amended NDCT Rules
The Central Drugs Standard Control Organisation (CDSCO) has implemented a prior intimation system under amended New Drugs and Clinical Trials Rules, 2019 effective April 21, 2026. The amendment allows companies, especially generic manufacturers, to conduct bioavailability/bioequivalence (BA/BE) studies for certain low-risk drugs after submitting an online Form CT-05 on the Sugam portal and receiving acknowledgment, instead of prior approval. It applies to specific oral drugs (excluding high-risk categories) approved in India or select global markets, for export purposes. Ethics Committee approval is mandatory, with a minimum sample size of 18. The system simplifies procedures, though prior approval remains necessary for categories not covered under the amendment.
2) Approvals
- Zydus receives US FDA final approval for Ivermectin tablets
Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration (FDA) to market Ivermectin Tablets USP 3 mg (reference: Stromectol) and Dapsone Tablets USP 25 mg and 100 mg in the United States. Ivermectin is used to treat parasitic infections such as strongyloidiasis and onchocerciasis, while Dapsone is indicated for leprosy and dermatitis herpetiformis. Both products will be manufactured at Zydus facilities in Ahmedabad and marketed by Viona Pharmaceuticals Inc.
- Lupin receives US FDA tentative approval for Pitolisant tablets
Lupin Limited has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Pitolisant Tablets in strengths of 4.45 mg and 17.8 mg. The approval confirms that Lupin’s Pitolisant tablets are bioequivalent to Wakix for the approved indications as per the reference listed drug labelling. This development strengthens Lupin’s US generics portfolio and demonstrates its continued focus on expanding its presence in the regulated US pharmaceutical market through compliant and cost-effective generic alternatives.
- UK MHRA approves Sun Pharma’s Deuruxolitinib to treat severe alopecia areata in adults
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Deuruxolitinib (Leqselvi), developed by Sun Pharmaceutical Industries’s UK arm, for treating severe alopecia areata in adults. Alopecia areata is an autoimmune condition causing hair loss due to inflammation of hair follicles. Approved on March 11, 2026, through the International Recognition Procedure, the drug works by inhibiting JAK enzymes that cause inflammation, helping promote hair regrowth. Clinical trials involving 1,223 patients showed significant improvement, with about 30% achieving at least 80% scalp hair regrowth after 24 weeks. The medicine requires a prescription, with a recommended dose of 8 mg twice daily. Common side effects include headache and acne, and safety monitoring will continue.
- Lupin receives US FDA approval for dapagliflozin tablets
Lupin Limited has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for dapagliflozin tablets in 5 mg and 10 mg strengths. These tablets are approved as bioequivalent to Farxiga for all labeled indications. Headquarters in Mumbai, Lupin is a global pharmaceutical company with a presence in over 100 markets. It focuses on branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients, strengthening its position in the global pharmaceutical industry through this approval.
- EU grants marketing approval to ALK’s EURneffy 1 mg, a needle-free adrenaline treatment for young children at risk of anaphylaxis
A large bulk drugs park, “MILES City,” is planned in Raigad district near Dighi Port to strengthen India’s pharmaceutical self-reliance in APIs and KSMs. The project, led by Ramky Infrastructure Ltd in partnership with Maharashtra Industrial Development Corporation, will span 1,000 hectares and may cost up to Rs. 5,000 crore over five years. It is expected to attract Rs. 80,000 crore–1 lakh crore in investments over time. The park will integrate manufacturing, R&D, incubation, and skill development facilities, alongside strong environmental safeguards. Overall, it aims to boost exports, innovation, and domestic supply chains while creating a comprehensive life sciences ecosystem.
- AstraZeneca Wins U.S. Food and Drug Administration Approval for First Triple-Therapy Asthma Inhaler in the US
AstraZeneca has received approval from the U.S. Food and Drug Administration for its inhaler Breztri Aerosphere as a maintenance treatment for asthma in patients aged 12 and older. It is the first single-inhaler triple therapy (ICS/LABA/LAMA) approved for asthma in the US. The decision is based on Phase III KALOS and LOGOS trials involving about 4,300 patients, which showed significant improvements in lung function compared to dual therapy, with rapid effects seen within five minutes of the first dose. No new safety concerns were identified. The approval targets unmet needs among millions of uncontrolled asthma patients. Breztri is already approved for COPD and is under regulatory review for asthma in other major markets.
- Dr Reddy’s receives Health Canada approval for generic Semaglutide Injection
Dr. Reddy’s Laboratories has received a Notice of Compliance from Health Canada for its generic semaglutide injection, becoming the first to gain market authorisation in Canada ahead of schedule. The approval covers 2 mg/pen and 4 mg/pen formulations, with launch preparations underway. Semaglutide, a GLP-1 receptor agonist, improves glycaemic control in adults with Type 2 Diabetes when combined with diet and exercise. Canada, the second-largest semaglutide market, has about 3.9 million diabetes patients. The approval highlights Dr. Reddy’s strength in complex generics and peptide therapeutics, supported by in-house API production. The therapy is intended for weekly use and not for type 1 diabetes or diabetic ketoacidosis.
3) International Pharma News
- UK sets out world-leading pathway for space-manufactured drugs
The United Kingdom Space Agency, along with the Medicines and Healthcare Products Regulatory Agency (MHRA) and other partners, has announced new measures to support the development of pharmaceuticals manufactured in space. Microgravity conditions can improve the quality and stability of biologic drugs, potentially benefiting cancer and rare disease treatments. The initiative includes regulatory guidance, case studies, a regulatory sandbox, and supply-chain support to help companies move from space research to patient access. Backed by the UK’s £2 billion Life Sciences Sector Plan, the program aims to accelerate innovation and investment. Demonstration missions and projects like BioOrbit highlight the UK’s leadership ambitions. The MHRA will also provide regulatory pathways and early scientific advice to ensure space-manufactured medicines meet safety, quality, and efficacy standards before reaching patients.
- US-Israel-Iran conflict creates severe impact on pharma supply chains
The escalating conflict involving the US, Israel and Iran is emerging as a global health concern due to disruptions in pharmaceutical supply chains. Instability around key trade routes such as the Strait of Hormuz has caused shipping delays, airspace closures and rising logistics costs, affecting the supply of critical medicines like cancer drugs and insulin. The World Health Organisation has warned of delivery delays, increased transport costs and humanitarian supply bottlenecks. Regions most at risk include the Middle East, South Asia and Africa, particularly countries dependent on imports. While current stockpiles may prevent immediate shortages, prolonged conflict could strain global medicine access. The crisis highlights the vulnerability of globalised pharma supply chains and the urgent need for diversified and resilient drug supply systems. Click to read more
- WHO releases new target product profiles for urgently needed antibiotics
The World Health Organisation has released three new Target Product Profiles (TPPs) to guide the development of antibiotics against drug-resistant bacteria causing serious infections such as bloodstream infections, pneumonia, urinary tract infections and meningitis. The TPPs focus on multidrug-resistant Gram-negative infections, Gram-positive infections in immunocompromised patients, and bacterial meningitis. Despite about 90 antibiotics in development, few target priority resistant pathogens. The TPPs outline minimum and prefer standards for safety, efficacy and quality to align research with urgent global health needs. The initiative also aims to promote innovation, affordability and access while strengthening collaboration among researchers, regulators and funders. This effort is part of WHO’s partnership with Health Emergency Preparedness and Response Authority to combat antimicrobial resistance.
- Denmark becomes first country in EU to eliminate mother-to-child transmission of HIV and syphilis
The World Health Organisation (WHO) has certified Denmark for eliminating mother-to-child transmission of HIV and syphilis, making it the first EU country to achieve this milestone. The validation followed assessments confirming that Denmark met targets between 2021–2024, including testing and treating over 95% of pregnant women and maintaining very low infant infection rates. WHO Director-General Tedros Adhanom Ghebreyesus praised Denmark’s strong healthcare system, political commitment, and maternal care programmes. Denmark’s success is attributed to universal healthcare, routine prenatal screening, strong data systems, and rights-based policies. The country now aims to achieve triple elimination by adding hepatitis B. Denmark joins 22 other countries recognized for progress in preventing mother-to-child transmission of these infections through effective public health measures.
- Strait of Hormuz Standoff Puts the U.S.’s Generic Drug Supply at Risk
Tensions disrupting the Strait of Hormuz threaten the pharmaceutical supply chain between India and the United States, where India supplies nearly half of generic drugs. Heavy reliance on this route for key inputs creates a “petroleum-to-pill” bottleneck, risking shortages of antibiotics, diabetes, and cardiovascular medicines within 4–6 weeks. Air freight costs have surged by 400%, raising logistics expenses, especially for cold-chain biologics. Cyberattacks on firms like Stryker add further strain. Public sentiment is largely negative, driven by fears of rising drug prices, supply disruptions, and reduced healthcare access.
- Eli Lilly introduces oral GLP-1 pill, Foundayo for weight loss in US markets
Eli Lilly and Company has launched Foundayo (orforglipron) in the US following approval by the U.S. Food and Drug Administration for adults with obesity or overweight with related conditions. This once-daily oral GLP-1 receptor agonist supports weight loss alongside diet and exercise, showing up to 27-pound average reduction in trials. Available via LillyDirect, telehealth, and retail pharmacies, it offers flexible access and pricing options, starting at $149 per month. Backed by the ATTAIN phase 3 programme, Foundayo also improved cardiovascular risk markers. While generally well tolerated, it carries potential side effects and safety warnings. The launch aims to expand access to obesity treatment amid limited insurance coverage in the US.
4) Domestic Pharma News
- Central drug regulator tightens regulatory surveillance overweight loss drug GLP-1 supply chain
India’s central drug regulator has stepped up action to prevent misuse and unauthorized sales of GLP-1 weight-loss drugs such as semaglutide after the launch of multiple generic versions. Increased availability through pharmacies, online platforms, and wellness clinics raised concerns about unsupervised use and health risks. Authorities, along with state regulators, have conducted inspections at 49 entities and issued notices for violations like improper prescriptions and misleading promotions.A March 10, 2026, advisory banned indirect advertisements and surrogate marketing. Regulators warned of strict action including license cancellation and penalties for non-compliance. Patients were advised to use these drugs only under specialist supervision to ensure safety and proper medical oversight.
- KPRDO demands pan-India implementation of COA on drug purchases by wholesalers from pharma manufacturers
The Karnataka Pharma Retailers & Distributors Organisation (KPRDO) has urged the government to implement the requirement for Certificates of Analysis (COA) for medicine purchases on a pan-India basis rather than only in Karnataka. KPRDO leaders C. Jayaram and V.V. Kappar shettar said collecting batch-wise COAs for thousands of transactions would create a heavy operational and documentation burden for wholesalers. They also highlighted challenges related to storage, digital management, and increased compliance costs, especially for small traders. Since many medicines are sourced from other states, state-level implementation could disrupt supply chains and cause shortages. KPRDO suggested a centralized digital portal, similar to the Goods and Services Tax Network system, where manufacturers could upload COAs for access by wholesalers and regulators, ensuring uniform compliance and transparency nationwide.
- Lupin and Zydus ink licensing agreement to co-market innovative semaglutide injection in India
Lupin Limited has entered into a licensing and supply agreement with Zydus Lifesciences to co-market semaglutide injection (15 mg/3 ml) with a reusable pen device in India to improve access to advanced treatments for metabolic disorders. Under the agreement, Lupin will have semi-exclusive rights to market the drug under the brands Semanext and Livarise, while Zydus will continue selling it as Semaglyn, Mashema, and Alterme. Lupin will also pay upfront licensing fees and milestone payments. Semaglutide, a GLP-1 therapy, is used to treat type 2 diabetes and support chronic weight management alongside diet and exercise. The partnership combines Lupin’s market reach with Zydus’ development capabilities to expand access to innovative cardio-metabolic therapies across India.
- Sun Pharma introduces semaglutide injection under the brand names, Noveltreat and Sematrinity in India
Sun Pharmaceutical Industries Limited has launched semaglutide injections in India under the brand names Noveltreat and Sematrinity for chronic weight management and type 2 diabetes treatment. The products are available in multiple dose strengths and are priced significantly lower than innovator brands, improving patient affordability. Noveltreat features a prefilled pen with a concealed needle, while Sematrinity offers a multi-dose pen for flexible dosing. The launch aims to expand access to GLP-1 therapies amid rising obesity and diabetes prevalence in India, while also offering patient support programmes to enhance treatment adherence and outcomes.
- India’s healthcare & pharma sector to witness a 30–35% hiring uptick by 2030: Adecco India Adecco India highlights that India’s healthcare, and pharmaceutical sector is shifting toward a capability-led growth model, emphasizing specialization, regulatory expertise, and technology integration over volume hiring. The sector is expected to generate 2–2.5 million jobs by 2030, with 30–35% of the workforce requiring reskilling. Healthcare spending may rise from 3.3% of GDP in 2022 to nearly 5% by 2030, driven by digital health, diagnostics, and outsourcing. Demand for remote care roles could grow 20–25%, while R&D and regulatory hiring may increase 25–30%. Expansion in CDMO/CRDMO, GCCs, and MedTech is boosting hiring, alongside rising global demand for Indian healthcare professionals.
- Lupin completes acquisition of European specialty pharma company, VISUfarma
Lupin Limited has completed the acquisition of VISUfarma B.V. from GHO Capital Partners LLP, strengthening its specialty care presence in Europe. The deal expands Lupin’s ophthalmology portfolio to over 60 branded products across areas such as dry eye, glaucoma, and retinal health. VISUfarma brings a strong commercial footprint in key markets including Italy, the UK, Spain, Germany, and France, along with deep domain expertise. The acquisition supports Lupin’s strategy to address rising demand for eye care solutions and enhances its global specialty franchise.
- Trump’s 100% tariff on patented drugs and ingredients may have limited impact immediately, say reports
The tariff proposal by Donald J. Trump imposing 100% duties on patented pharmaceuticals is expected to have limited immediate impact on India’s pharma sector, as nearly 90% of exports to the US are generics, which remain exempt for now. However, long-term risks exist for raw material suppliers and contract manufacturers if policies expand. Tariffs vary by agreement, with possible exemptions or reduced rates under MFN pricing or onshoring deals. Some firms like Sun Pharmaceutical Industries Ltd may face short-term impact due to exposure to patented drugs. The move, based on national security concerns, has already driven significant investment commitments in US pharmaceutical manufacturing.
- Emcure Pharma reduces Poviztra starting dose price by 55% to expand patient access
Emcure Pharmaceuticals Ltd has reduced the price of its weight management drug Poviztra to Rs. 3,999 per month, improving affordability across India. Poviztra, a once-weekly semaglutide injection available in multiple strengths, is distributed by Emcure as a second brand of Novo Nordisk’s therapy. Effective April 2026, the move aims to expand access to clinically proven treatment amid rising obesity levels. Backed by extensive global usage and clinical evidence, semaglutide supports weight management and related conditions. The price revision reflects Emcure’s focus on enhancing patient access, improving health outcomes, and addressing India’s growing obesity burden.
- Sun Pharma–Organon Deal Buzz Sparks Investor Caution Amid $12 Billion Acquisition Speculation
Sun Pharmaceutical Industries is reportedly in advanced talks to acquire Organon in a deal valued at around $12 billion, potentially its largest acquisition. However, Sun Pharma clarified that the reports are speculative and no disclosure is required. The deal has drawn attention due to Sun’s strong cash position and prior interest in disciplined acquisitions. Organon’s focus on women’s health, biosimilars portfolio, and US market presence make it an attractive target. However, its $8 billion debt raises concerns. Following the news, Sun Pharma’s shares fell nearly 4%, reflecting investor caution over the potential financial and strategic implications of the acquisition.
- India extends export RELIEF Scheme to Egypt and Jordan to cushion pharma trade amid West Asia disruptions
India’s Resilience & Logistics Intervention for Export Facilitation (RELIEF) scheme has been expanded by the Directorate General of Foreign Trade to include Egypt and Jordan, supporting pharma exporters amid West Asia supply disruptions. Backed by ₹497 crore under the Export Promotion Mission, the scheme offers enhanced insurance via Export Credit Guarantee Corporation of India, including up to 100% risk cover for past shipments and 95% for upcoming consignments. MSMEs can claim up to 50% reimbursement of increased logistics costs. Triggered by geopolitical tensions affecting routes like the Strait of Hormuz, the initiative includes waivers, real-time monitoring, and policy coordination through an inter-ministerial group, ensuring continuity of exports and supply chain resilience.
5) Innovations
- AI and Advanced Human Models in Drug Discovery
Roche is advancing pharmaceutical innovation through its Institute of Human Biology, which uses artificial intelligence and advanced human model systems such as organoids and organ-on-chip technologies to improve drug discovery. These models replicate human tissues and organs, helping researchers better predict drug safety and effectiveness while reducing dependence on animal testing. By combining AI, data science and human biology, the institute aims to reduce clinical trial failures and accelerate the development of safer, more effective medicines. The initiative also promotes collaboration between academia and industry to improve research outcomes. This innovation reflects a broader industry shift toward technology-driven drug development, enabling faster identification of promising therapies and improving success rates in bringing new treatments to patients.
- Zydus launches AI-powered Continuous Glucose Monitor devices, Diasens and GlucoLive
Zydus Lifesciences has launched Diasens and GlucoLive, next-generation Continuous Glucose Monitoring (CGM) devices that use artificial intelligence to provide real-time glucose insights and remote care integration. The devices automatically transmit glucose readings to smartphones every three minutes without manual scanning, improving monitoring continuity and early clinical intervention. Zydus has partnered with Digicare Health Solutions (TatvaCare) to integrate the devices with the GoodFlip mobile app, which offers AI-based report analysis, personalised diet and exercise plans, doctor consultations, and medical record management. The launch aims to address India’s growing diabetes burden, where over 101 million adults are affected. The solution is expected to enhance chronic disease management through data-driven insights, improved patient monitoring, and better treatment outcomes.
- Trivitron launches Kiran Smart Track, a first-of-its-kind app in India for radiation protection apparel monitoring
Trivitron Healthcare has launched Kiran Smart Track, India’s first intelligent tracking app for radiation protection and X-ray apparel. The app uses QR codes on each product to provide detailed information such as manufacturing details, specifications, protection levels, and shelf life. It helps healthcare providers ensure safety compliance, verify product authenticity, and manage inventory efficiently. Key features include real-time shelf-life monitoring, instant quality checks, warranty tracking, and access to safety reports. By digitizing product tracking and improving transparency, the app enhances operational efficiency in hospitals and diagnostic centres. This initiative reflects Trivitron’s focus on innovation, safety, and smarter management of medical safety equipment.
- Median Technologies partners with Tempus to broaden US access to Eyonis LCS lung cancer screening software
Median Technologies has signed a non-exclusive distribution agreement with Tempus AI to enhance the availability of its AI-powered lung cancer screening software, Eyonis LCS, in the United States. The partnership follows the US FDA’s 510(k) clearance and focuses on integrating the software into clinical practice through the Tempus Pixel platform. Eyonis LCS, a software as a medical device (SaMD), leverages artificial intelligence to analyse low-dose CT scans to help detect and assess lung cancer, enabling earlier diagnosis and more efficient screening. Under the arrangement, Tempus AI will market the solution to imaging centres nationwide and assist with deployment, with potential plans to expand distribution into European markets in the future.
- U.K. Drug Manufacturing in Space
The UK Space Agency, along with the Medicines and Healthcare Products Regulatory Agency, Civil Aviation Authority, and the Regulatory Innovation Office, has announced collaboration to support space, biopharma and pharmaceutical companies through regulatory guidance and innovation programs. The initiative aims to strengthen the UK’s leadership in in-orbit manufacturing (IOM). Funding includes a £250,000 feasibility study for BioOrbit to develop systems for manufacturing biologic cancer drugs in space. Microgravity conditions can improve drug purity, stability, and crystallisation, especially for biologics like monoclonal antibodies, vaccines, and insulin, potentially improving drug effectiveness while reducing manufacturing risks and costs.
- Akums launch first-of-its-kind Lasmiditan dispersible tablets for rapid migraine care
Akums Drugs & Pharmaceuticals has launched the world’s first Lasmiditan dispersible tablets for the acute treatment of migraine, approved by the Drugs Controller General of India (DCGI). Designed for faster relief, the patient-friendly formulation dissolves in water, making it easier to take during migraine attacks often accompanied by nausea, vomiting, and difficulty swallowing. The tablet uses a dual disintegration mechanism for rapid action and includes taste-masking technology to improve patient compliance. Lasmiditan, a selective 5-HT1F receptor agonist, targets migraine-related neural pathways and is indicated for acute treatment in adults. This innovation highlights Akums’ focus on patient-centric drug delivery, advanced R&D, and improving treatment accessibility and outcomes in migraine management.
- AI-designed drugs could replace decades-long process
Google DeepMind CEO Demis Hassabis said artificial intelligence could transform drug discovery by replacing much of the traditional, decades-long process. Through his company Isomorphic Labs, AI systems are being developed to design drugs and predict their effects before physical testing begins. This could significantly reduce time, cost, and high failure rates in medicine development. The work builds on advanced tools like AlphaFold, which can model protein structures, and newer systems that simulate how drugs interact in the body. Hassabis expects the first clinical trials of fully AI-designed drugs by 2026. The broader goal is to create a scalable system capable of producing many new medicines faster, potentially revolutionising how treatments are discovered and delivered globally.
- Scientists discover drug for type 1 diabetes to reduce insulin use
A recent study reported by ScienceDaily reveals that metformin, a cheap and widely used drug for type 2 diabetes, may also help people with type 1 diabetes. In a clinical trial, researchers found that although metformin did not improve insulin resistance as expected, it allowed patients to use about 12% less insulin while maintaining stable blood sugar levels. This is significant because managing type 1 diabetes requires constant insulin use, which can be physically and mentally demanding. Scientists believe the unexpected benefit may be linked to changes in the gut microbiome, though more research is needed. Overall, the findings suggest metformin could become a simple, cost-effective way to improve diabetes management in the future.
- India Pharmaceutical Sector Aims to Make India a Global Innovation Hub In 2026
India’s pharmaceutical sector is set to shift from volume-driven growth to an innovation-led global model through India Pharma 2026, organised by the Department of Pharmaceuticals with Federation of Indian Chambers of Commerce and Industry and Indian Pharmaceutical Alliance. Held on April 13–14 in New Delhi, the event will unite policymakers, industry leaders, and researchers to promote value-based growth, innovation, and global collaboration. The theme, “Discover in India: Leapfrogging Life-Sciences Innovation,” highlights ambitions to make India a hub for advanced research. Discussions will cover drug discovery, biosimilars, and complex generics, while showcase India’s strong manufacturing base and expanding R&D ecosystem. The initiative aligns with the vision of Viksit Bharat 2047, focusing on healthcare access, innovation, and global health security.
- Raay Neo Pharma launches to transform India’s healthcare landscape with quality-driven, patient-centric pharmaceutical solutions
Raay Neo Pharma is a newly launched pharmaceutical company focused on delivering affordable, high-quality healthcare solutions across India. Founded by Amit Patni, it builds on decades of entrepreneurial experience across multiple sectors. The company offers over 90 formulations spanning acute and specialized therapies, including antibiotics, anti-diabetics, cardiac, dermatology, and gastrointestinal treatments, with more products in development. Operating across major Indian
states, it reaches nearly 55–60% of the population. Its model combines branded generics with strategic manufacturing partnerships to ensure quality and scalability. Emphasizing ethics, innovation, and patient-centricity, Raay Neo Pharma aims to strengthen healthcare access while fostering trust, transparency, and sustainable growth in India’s evolving pharmaceutical landscape.
6) Trends
- IFPMA paper on AI in pharmaceutical manufacturing
The International Federation of Pharmaceutical Manufacturers and Associations published a March 2026 paper on the role of artificial intelligence in pharmaceutical manufacturing, highlighting its potential to improve efficiency, accuracy, innovation, and quality assurance. The paper calls for global regulatory harmonisation by building on existing International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines. It emphasizes the opportunity to align regulations early as AI adoption grows. The report also welcomes joint AI guidance from the European Medicines Agency and the U.S. Food and Drug Administration. Additionally, it highlights the use of machine learning and “digital twins” to predict manufacturing outcomes and optimize production planning.
- Apollo AyurVAID marks World Sleep Day with digital film on India’s growing sleep crisis
Apollo AyurVAID Hospitals marked World Sleep Day with a film highlighting declining sleep quality as a health challenge of modern lifestyles. The campaign shows how long work hours, late-night screen use and constant connectivity are normalising fatigue and poor sleep. It emphasises that disturbed sleep, night awakenings and persistent tiredness may signal deeper biological imbalance. The film explains sleep’s role in brain function, metabolism, hormones, immunity and emotional health. Founder Rajiv Vasudevan said restorative sleep is essential for performance and long-term wellbeing. From an Ayurvedic perspective, improving sleep requires balanced routines (dinacharya), proper diet, stress management and personalised care to restore natural rhythms and health.
- Heartfulness survey finds heavy AI users with high screen exposure reporting later bedtimes and rising daytime fatigue
A Heartfulness Institute survey conducted across major Indian cities among over 550 participants highlights a link between rising AI usage, increased screen time and declining sleep quality. The findings show that individuals with over six hours of daily screen exposure report nearly 80% higher sleep problems, greater disturbances and increased daytime sleepiness. High screen-time users form 22.7% of respondents but account for 34.6% of sleep complaints. Kamlesh D. Patel of Shri Ram Chandra Mission emphasised the need to balance technology use with mental well-being, noting that quality sleep is essential for productivity and inner balance. The study suggests limiting screen exposure to under six hours may improve sleep, while also calling for further research on AI’s impact on sleep patterns.
- Indian pharma to benefit from GLP-1 market growth
India’s metabolic therapy market is changing rapidly after the patent expiry of semaglutide, shifting from a high-cost, innovator-driven segment to a competitive, volume-based market. Prices have dropped by nearly 85–90%, improving affordability and driving demand. With 75–80 million obese individuals and rising comorbidities, the market could reach ₹34–67 billion in 3–5 years. Adoption is expanding beyond endocrinologists to other specialists, boosting prescriptions. However, the entry of multiple players has intensified competition, causing price pressure and limited revenue gains for individual companies. Physicians also tend to prescribe only a few brands, increasing marketing competition. While tiered pricing improves access, it pressures margins. Meanwhile, next-generation metabolic therapies may gradually shift market leadership due to better efficacy and physician preference.
- Lupin earns Great Place to Work certification for 2026-27
Lupin Limited has received the prestigious Great Place to Work certification, marking a significant milestone as one of the few pharma companies to earn it through a global assessment across all subsidiaries. The recognition reflects strong employee engagement, with an 85% participation rate in the evaluation process. Lupin’s leadership highlighted its inclusive, values driven culture and commitment to enhancing employee experience. The company employs over 24,000 professionals worldwide and, in FY25, invested Rs. 40 billion in employee benefits and logged over 1.25 million hours of training, reinforcing its focus on workforce development.
- Zydus, Lupin gets FDA final nod for Dapagliflozin generic
Indian pharma companies Zydus Lifesciences and Lupin have received final approval from the U.S. Food and Drug Administration to market generic versions of dapagliflozin, a widely used anti-diabetic drug. The medicine belongs to the SGLT2 inhibitor class and is prescribed to improve blood sugar control in adults with type 2 diabetes.Zydus will manufacture the drug at its Ahmedabad facility and is eligible for 180 days of shared exclusivity, providing an early market advantage. The drug has a significant U.S. market size of over $1 billion annually, making this approval commercially important. Overall, the approval strengthens both companies’ presence in the competitive U.S. generics market and expands their diabetes treatment portfolios.
- India’s Pharma Shift from Generics to Global Innovation Leadership
India’s pharmaceutical sector is entering a critical transition phase, moving beyond its traditional strength in generics and cost efficiency toward innovation-led growth. A key driver of this shift is the Telangana Life Sciences Policy 2026 – 30, which aims to attract $25 billion in investments and position the state as a global biopharma hub. The India Pharma Expo 2026 at HITEX Exhibition Center is emerging as a pivotal platform where policymakers, industry leaders, and investors will align strategies and execution. Discussions will focus on AI-driven drug development, digital infrastructure, and regulatory acceleration. The event is expected to shape investment flows, partnerships, and technological adoption, marking a coordinated push toward making India a global innovation engine in pharmaceuticals.
- AI will play a pivotal role in accelerating drug discovery
Experts at the India Pharma 2026 event highlighted that artificial intelligence (AI) will play a crucial role in transforming and accelerating drug discovery. AI is expected to enable precision medicine, improve clinical efficiency, and drive an innovative-led healthcare ecosystem. Industry leaders emphasized that companies must go beyond simple digitisation and reimagine processes using strong data and technology foundations for effective AI adoption. Automation powered by AI can streamline research and development, reduce timelines, and enhance decision-making in clinical trials. The discussions also stressed the need to bridge the gap between policy and implementation to fully realise AI’s potential. Overall, AI is emerging as a key driver of faster, smarter, and more efficient pharmaceutical innovation.
- LegitScript Healthcare Merchant Certification now recognized by Google for pharmacies in India and telemedicine providers in New Zealand
LegitScript has expanded its partnership with Google to certify pharmacies in India and telemedicine providers in New Zealand for advertising on Google Ads. The update allows certified providers to demonstrate compliance in licensure, prescribing, privacy, and transparency before advertising. The move aligns with rising adoption of online pharmacies in India and telehealth in New Zealand, supported by regulatory changes like the Medicines Amendment Act 2025. LegitScript’s certification helps ensure patient safety while enabling providers to expand digital reach. The partnership reflects growing demand for trusted healthcare verification as digital health services scale globally.
7) Law and Order Briefs
- Supreme Court upholds interim relief in pharma dossier dispute
The Supreme Court upheld the Allahabad High Court’s decision granting interim protection to Jubilant Generics Ltd. in a dispute concerning the alleged misuse of its pharmaceutical product dossiers. Jubilant claimed that its proprietary scientific and regulatory data, licensed to Jamp Pharma Corporation for use in Canada, was unlawfully transferred to Indian entities for manufacturing purposes, amounting to copyright infringement, breach of confidentiality, and trade secret misappropriation. The Court found no error in the High Court’s finding of a prima facie case and confirmed the interim injunction. It also clarified that the trial court should decide the matter independently and that parties may pursue appropriate remedies regarding related FIRs.
- KSRPO flags sale of spurious drugs by fake doctors in Karnataka
The Karnataka State Registered Pharmacists’ Organisation has alerted state authorities about the growing menace of fake doctors operating illegal clinics and selling spurious and expired drugs. The organisation highlighted that such unqualified practitioners are dispensing physician samples and medicines without valid Licenses, posing serious risks to public health. It has urged the state Food and Drug Administration (FDA) and health authorities to intensify inspections, surveillance, and enforcement actions, including coordination with law enforcement agencies. The issue persists despite ongoing crackdowns, with calls for stricter legal action and continuous monitoring to curb illegal medical practices and safeguard patients.
- Supreme Court directs Centre to frame no-fault compensation policy for Covid-19 vaccine SAEs
The Supreme Court of India has directed the Central government to develop a no-fault compensation framework for serious adverse events (SAEs) linked to Covid-19 vaccination. The Court clarified that such a policy would not imply admission of liability by the government. It also advised the continuation of the existing adverse events following immunisation (AEFI) monitoring system and recommended periodic public disclosure of relevant data. The directive arose from petitions concerning alleged vaccine-related deaths. Additionally, the Court reiterated earlier directions on transparency in clinical trial data and adverse event reporting, reinforcing the need for accountability, patient safety, and public trust in vaccination programmes.
- DGHS Directs Strict Compliance with Ethical and Regulatory Norms for Drug Manufacturers
The Directorate General of Health Services (DGHS) has instructed drug manufacturers and importers to strictly comply with ethical and regulatory requirements governing the manufacture, sale, distribution, and promotion of medicines. The advisory warns that promotional activities, including awareness campaigns that indirectly advertise prescription-only drugs, may be treated as misleading or irrational marketing practices. Companies have been directed to adhere strictly to approved indications, licensing conditions, labelling requirements, and other statutory provisions. DGHS also clarified that prescription drugs, including GLP-1 receptor agonists, must only be prescribed by Registered Medical Practitioners in accordance with approved indications and marketing authorization conditions to ensure patient safety and regulatory compliance.
- DCC recommends amendment of rules to mandate installation of CCTV cameras at medical stores
The Drugs Consultative Committee has recommended amending drug rules to mandate installation of CCTV cameras in medical stores to ensure better monitoring of drug sales. The proposal, backed by the National Commission for Protection of Child Rights, aims to curb the misuse of prescription and psychotropic drugs, especially among children. The DCC also suggested developing a centralized MIS or drug portal for real-time tracking of drug sales data. The recommendation builds on earlier initiatives under a joint action plan with the Narcotics Control Bureau. Several states, including Maharashtra and Delhi, have already implemented similar measures, with over 3.6 lakh CCTV cameras installed in pharmacies nationwide.
- High Court relief to Sun Pharma, Ahd Co barred from using ‘Esiraft’
The Bombay High Court granted relief to Sun Pharmaceutical Industries Ltd. by restraining an Ahmedabad-based company, Meghmani Lifesciences Ltd., from using the trademark “Esiraft” in a pharmaceutical dispute. The court held that “Esiraft” was deceptively similar to Sun Pharma’s registered trademark “Raciraft,” particularly in phonetic terms, which could lead to confusion among consumers. The court emphasized that in medicines, even a slight chance of confusion can have serious health consequences, warranting stricter scrutiny. As a result, an interim injunction was granted, preventing Meghmani from using the mark until further orders. The case highlights the importance of trademark protection in pharmaceuticals and the higher standard applied to avoid consumer harm.
- Government Push for CDSCO Strengthening
In April 2026, the Central Drugs Standard Control Organisation (CDSCO) came under focus as the Indian government announced plans to strengthen and restructure the regulator. The proposal includes hiring a large number of subject experts and improving institutional capacity to enhance drug regulation. The aim is to make CDSCO more efficient in handling approvals, monitoring compliance, and supporting pharmaceutical innovation. The move also emphasizes better coordination between government bodies and private stakeholders. Legally, this development signals stronger regulatory oversight, improved enforcement of drug laws, and a more robust framework for ensuring drug safety and quality. Overall, it reflects the government’s intent to modernize India’s pharmaceutical regulatory system while promoting research and development in the sector.
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