Government News

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.

India's pharmaceutical sector has undergone a significant transformation over the past decade, driven by a combination of affordable healthcare initiatives, domestic manufacturing incentives, and innovation-focused policies. According to the Ministry of Chemicals and Fertilizers, the country has expanded access to low-cost medicines while simultaneously strengthening its position as a global pharmaceutical manufacturing hub.

India’s drug regulator has issued a fresh reminder to pharmaceutical manufacturers and other stakeholders regarding the mandatory implementation of pharmacovigilance (PV) systems under the provisions of the Drugs and Cosmetics Act, 1940 and related rules.

Wockhardt has received marketing authorization from India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), for its breakthrough antibiotic ZAYNICH® (Zidebactam/Cefepime). The approval marks a significant milestone for India’s fight against antimicrobial resistance, especially in difficult-to-treat Gram-negative bacterial infections.