What happened
The Ministry of Ayush has outlined a multi-layered framework for Ayush drug quality assurance and for medicines sold through digital commerce platforms. The framework combines manufacturing standards, laboratory testing, pharmacovigilance, and action against misleading advertisements.
The regulatory structure rests on the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945, which contain exclusive provisions for Ayurvedic, Siddha, Sowa-Rigpa, Unani, and Homoeopathy drugs.
Background and earlier position
Ayush drug regulation already requires manufacturers to obtain a licence and comply with prescribed quality and manufacturing norms. The Ministry of Ayush says manufacturers must provide proof of safety and effectiveness, follow Good Manufacturing Practices (GMP), and conform to the relevant pharmacopoeial standards.
State and Union Territory drug inspectors also sample medicines from manufacturing firms and retail shops and send them to drug-testing laboratories. If a sample is found to be Not of Standard Quality, authorities can stop sale and initiate legal action under the Drugs and Cosmetics Act, 1940 and the rules made under it.
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