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- India's revised draft Drugs, Medical Devices and Cosmetics Bill, 2026, proposes replacing the Drugs and Cosmetics Act, 1940, with a comprehensive regulatory framework. - The Bill establishes a Drugs and Medical Devices Controller General, India as the National Regulatory Authority, with separate Controller Generals for drugs and medical devices. - New provisions mandate compliance with Good Distribution Practices, expand the definition of spurious drugs, and grant inspectors arrest powers for serious offences. - The framework introduces an independent regulatory structure for medical devices and a dedicated chapter covering Ayush drugs, medical devices, and cosmetics.
- A 22-month-old Tripura child with Spinal Muscular Atrophy Type 1 has received 12 vials of Risdiplam from a designated Centre of Excellence in Dibrugarh. - The supply, valued at about Rs 2.29 lakh, is expected to cover roughly eight months of treatment under India's Rare Disease Programme. - AIIMS New Delhi experts recommended Zolgensma gene therapy, but the assessment noted the drug was still awaiting Drug Controller General of India approval. - The case exposes the gap between the Rs 50 lakh NPRD assistance cap and gene therapies priced at Rs 16-18 crore, with no official crowdfunding listing yet verified.
- India's Ministry of Health and Family Welfare has expanded mandatory QR code requirements from the top 300 brands to all vaccines, antimicrobials, narcotics, psychotropic substances, and anti-cancer drugs. - The phased rollout requires compliance by July 1, 2027 for vaccines, narcotics, psychotropics, and anti-cancer drugs, and July 1, 2028 for antimicrobials. - QR codes must encode nine data elements including unique product ID, batch number, manufacturing license, and excipient details to enable supply chain authentication. - The initiative aims to combat counterfeit medicines, curb antimicrobial resistance, and address recurring quality control concerns from the U.S. FDA and European Medicines Agency.
- India's Union Health Ministry has proposed replacing the import license requirement (Form 11) with a simpler acknowledgement-based system for drugs imported in small quantities for analytical and non-clinical testing. - The simplified procedure will not apply to biologics, beta-lactam drugs, sex hormones, cytotoxic drugs, and narcotic substances, which will continue to require prior licensing. - The draft amendment follows a similar January 2026 relaxation for domestic test licenses and reduces the processing timeline for new drug manufacturing applications from 90 to 45 days. - The initiative aims to reduce regulatory burden, accelerate drug development, and support startups and industries in quickly initiating testing or analysis.
- The Indian Ministry of Health and Family Welfare has imposed an immediate nationwide ban on 16 Fixed Dose Combination (FDC) drugs under Section 26A of the Drugs and Cosmetics Act, 1940. - The ban follows a Supreme Court directive and a comprehensive review by an Expert Committee and the Drugs Technical Advisory Board (DTAB), which found the combinations lacked therapeutic justification. - Banned formulations include antibiotic combinations such as Amoxicillin + Serratiopeptidase and 10 Aloe Vera-based over-the-counter products deemed irrational and potentially harmful. - This action is part of an ongoing regulatory crackdown, with over 50 irrational FDCs banned in the past 12 months, reinforcing the government's commitment to evidence-based healthcare.
- The Union Government informed the Delhi High Court that a three-year-old child with LRBA Deficiency is ineligible for financial aid under the National Policy for Rare Diseases (NPRD), 2021. - LRBA Deficiency is not among the 63 notified rare diseases covered by the policy, which caps financial assistance at Rs 50 lakh per eligible patient. - The Centre argued that extending benefits beyond the notified list would constitute judicial modification of executive policy and is not constitutionally mandated. - The NPRD, 2021 framework operates through 15 designated Centres of Excellence that route treatment recommendations and funding requests for covered diseases.
- The Indian Pharmacopoeia Commission (IPC) will spearhead a National Sensitization and Capacity Building Programme on Materiovigilance on July 10, 2026, at NIMHANS Bengaluru. - The initiative aims to strengthen competencies in medical device adverse event reporting, with a focus on AI/ML integration for signal detection and proactive surveillance. - The programme brings together healthcare professionals, regulators, biomedical engineers, and industry stakeholders under the theme "Safeguarding Patients through Robust Medical Device Safety and Vigilance Systems." - Participants will gain hands-on exposure to the ADRMS digital reporting portal and real-world safety case studies, with registration open until June 30, 2026.
- India's Union Budget 2026-27 introduces Biopharma Shakti, a Rs. 10,000 crore initiative over five years aimed at establishing India as a global biopharmaceutical manufacturing hub. - The budget exempts 17 critical cancer drugs including ribociclib and abemaciclib from basic customs duty, bringing the total number of duty-exempt medicines to 129. - Seven additional rare diseases have been added to the duty exemption list for personal imports of medicines, expanding coverage under the National Policy for Rare Disease 2021. - The initiative includes establishing three new NIPERs, upgrading seven existing ones, and creating over 1,000 accredited clinical trial sites to strengthen India's biopharmaceutical ecosystem.
- The Supreme Court of India ruled that stem cell therapy for Autism Spectrum Disorder outside approved clinical trials is unethical and constitutes medical malpractice due to lack of scientific evidence. - Justices declared that every use of stem cells in patients outside approved clinical trials violates medical standards and fails to meet reasonable care requirements. - The court directed the Ministry of Health to provide solutions for patients currently receiving therapy while prohibiting commercial stem cell treatments for autism. - Regulatory authorities must take action against errant clinics under existing legislation, with the court highlighting fragmented legal frameworks governing stem cell research.
- The Indian Ministry of Health and Family Welfare has published draft amendments to the Drugs Rules, 1945, to formally include cell and stem cell derived products, gene therapeutic products, and xenografts under regulatory oversight. - The proposed changes will expand existing manufacturing license forms (27D, 27DA, 28D, 28DA) currently used for recombinant DNA products to encompass these advanced biological therapies. - The amendments received approval from the Drugs Consultative Committee in June 2025 and the Drugs Technical Advisory Board in August 2024, following stakeholder consultations where all parties agreed with the proposed changes. - The draft rules are open for public consultation for 30 days, with the regulatory update addressing the gap in licensing provisions for modern cell and gene therapies in India's pharmaceutical framework.
