What happened: Ministry of AYUSH connects regulation, standardization, and export promotion for AYUSH medicines

The Ministry of AYUSH describes a quality governance system for AYUSH medicines that covers licensing obligations, GMP compliance, pharmacopoeial standards, routine sampling and laboratory testing, enforcement against sub-standard products, and export-linked credentials. The Ministry also highlights institutional roles of PCIM&H and Drug Testing Laboratories and names schemes and quality marks aimed at raising manufacturing and testing standards for international acceptance.

Background and earlier position: legal regulation anchored in Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945

The Drugs & Cosmetics Act, 1940 and the Drugs Rules, 1945 provide exclusive regulatory provisions for AYUSH drugs. Manufacturers are required to follow licensing requirements that include proof of safety and effectiveness, compliance with Good Manufacturing Practices (GMP) as specified under Schedule T and Schedule M-I of the Drugs Rules, 1945 (as applicable to different AYUSH systems), and compliance with quality standards prescribed in the respective pharmacopoeia.

What changed now: quality assurance is actively linked to export credentials and international standards

Along with domestic enforcement, the Ministry emphasizes export readiness by using internationally recognized certification pathways (WHO-CoPP), supporting higher manufacturing and testing standards through the Central Sector Scheme AOGUSY, and using quality marks for market verification. The Ministry also states that AYUSH systems receive attention in international standardization work through ISO/TC249 Sectional Committee 2.

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