Government News

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.

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.

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.

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.

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.

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.

Ministry of Health and Family Welfare has prohibited the manufacture, sale and distribution of 16 Fixed Dose Combinations (FDCs) for human use across India with immediate effect.

The decision was taken under Section 26A of the Drugs and Cosmetics Act, 1940, following an extensive scientific review of drug combinations available in the Indian market. The move forms part of the government's ongoing efforts to ensure that only scientifically validated, safe and therapeutically justified medicines remain available to patients.