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  • Union Health Ministry Issues Advisory on Stem Cell Therapy; Use for Autism Restricted to Approved Clinical Trials
    23 September 2026

    Union Health Ministry Issues Advisory on Stem Cell Therapy; Use for Autism Restricted to Approved Clinical Trials

    The Ministry of Health and Family Welfare has issued an advisory to States and Union Territories regarding the regulation of stem cell therapy, reiterating that stem cell treatments can be offered as standard clinical care only for approved disease conditions and indications. The advisory was issued on September 16, 2026, in the context of the Supreme Court judgment dated January 30, 2026, in Yash Charitable Trust & Ors. v. Union of India & Ors.

  • CDSCO Cancels Cosmetic Import Registrations of Skintl Enterprises Over Multiple Violations
    3 September 2026
    CDSCO Cancels Cosmetic Import Registrations of Skintl Enterprises Over Multiple Violations

    The Central Drugs Standard Control Organization (CDSCO) has cancelled three registration certificates issued to M/s Skintl Enterprises Pvt. Ltd., citing multiple violations related to the import, labelling and handling of cosmetic products. The cancellation order was issued by the Central Licensing Authority on 24 August 2026.

  • ₹5,000 Crore PRIP Scheme Opens Second Funding Round for Pharma and MedTech Innovation
    1 September 2026
    ₹5,000 Crore PRIP Scheme Opens Second Funding Round for Pharma and MedTech Innovation
    Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, has announced the second call for applications under the Promotion of Research and Innovation in Pharma & MedTech (PRIP) Scheme, creating fresh funding opportunities for startups, MSMEs and pharmaceutical and MedTech companies working on high-impact innovations.
  • CDSCO Flags 239 Drug Samples as Not of Standard Quality in July 2026 Alert
    24 August 2026
    CDSCO Flags 239 Drug Samples as Not of Standard Quality in July 2026 Alert

    The Central Drugs Standard Control Organization (CDSCO) has released its July 2026 Not of Standard Quality (NSQ) drug alert, listing a large number of medicine samples that failed to meet specified quality standards during testing by state and CDSCO laboratories.

  • PCI Unveils Four Major Initiatives to Transform Pharmacy Education, Research and Career Opportunities
    22 August 2026
    PCI Unveils Four Major Initiatives to Transform Pharmacy Education, Research and Career Opportunities

    The Pharmacy Council of India (PCI) has introduced four major initiatives aimed at strengthening pharmacy education, research and professional development in India. The initiatives were unveiled at CAPSULE 4.0 and include the new M.Pharm (Medical Devices) programme, Research Promotion Scheme (RPS), Doctoral Fellowship Scheme (PDFS) and Pharmacy Awards.

  • CDSCO Directs IND Division to Process Applications for Unapproved New Drugs Under Review by Foreign Regulators
    15 August 2026
    CDSCO Directs IND Division to Process Applications for Unapproved New Drugs Under Review by Foreign Regulators

    The Central Drugs Standard Control Organisation (CDSCO) has clarified that applications seeking permission to import and market new drugs that are not approved anywhere in the world, where Phase III Global Clinical Trials (GCTs) are either ongoing or have been completed with the participation of Indian subjects, will be examined and processed by the Investigational New Drug (IND) Division.

  • CDSCO Panel Rejects Dexlansoprazole–Domperidone FDC Proposal
    17 July 2026
    CDSCO Panel Rejects Dexlansoprazole–Domperidone FDC Proposal

    The Subject Expert Committee (SEC) on Gastroenterology and Hepatology has declined to recommend approval of a Fixed Dose Combination (FDC) containing Dexlansoprazole (enteric coated pellets) 60 mg and Domperidone (sustained release pellets) 30 mg capsules proposed by MSN Laboratories Private Limited.

    The decision was taken during the 08th/26 SEC meeting held on 9 July 2026 at the CDSCO Headquarters, New Delhi, after the company presented its proposal before the committee.

  • Government Brings High-Alcohol Oral Medicines Under Schedule H1 with New Drugs Rules Amendment
    13 July 2026
    Government Brings High-Alcohol Oral Medicines Under Schedule H1 with New Drugs Rules Amendment

    In a significant move to strengthen the regulation of certain medicinal products, the Ministry of Health and Family Welfare has notified the Drugs (Tenth Amendment) Rules, 2026, bringing specific high-alcohol oral formulations under the stricter provisions of Schedule H1 of the Drugs Rules, 1945.

  • Government Adds Navi Mumbai Airport to India's Approved Drug Import Network Under Drugs Rules
    8 July 2026
    Government Adds Navi Mumbai Airport to India's Approved Drug Import Network Under Drugs Rules

    The Central Government has officially amended the Drugs Rules, 1945, allowing Navi Mumbai Airport to be used as an authorized entry point for the import of drugs into India. The amendment has been notified through the Drugs (Ninth Amendment) Rules, 2026, which came into force upon its publication in the Official Gazette.

  • Government Expands licensing Rules to Cover Cell & Gene Therapies, Stem Cell Products and Xenografts
    3 July 2026
    Government Expands licensing Rules to Cover Cell & Gene Therapies, Stem Cell Products and Xenografts

    In a significant move to strengthen the regulation of advanced biological therapies in India, the Ministry of Health and Family Welfare has notified the Drugs (Eighth Amendment) Rules, 2026, expanding the scope of the Central Licence Approving Authority (CLAA) under the Drugs Rules, 1945. Through this amendment, Cell or Stem Cell Derived Products, Gene Therapeutic Products, and Xenografts have been formally included alongside Recombinant DNA (r-DNA) derived drugs within the CLAA licensing framework.

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