What happened
The Ministry of Ayush has set out the quality control framework for Ayurvedic medicines. The framework rests on the Drugs & Cosmetics Act, 1940, the Drugs Rules, 1945, manufacturing licensing requirements, Good Manufacturing Practices (GMP) under Schedule T, and standards in the Ayurvedic pharmacopoeia.
The Ministry of Ayush also said that Drug Inspectors collect samples from manufacturing firms and sale shops, send them to Drug Testing Laboratories for quality testing, and initiate action when a sample is found to be not of standard quality. The stated action includes stopping sale in the market and taking legal action under the Drugs and Cosmetics Act, 1940 and the rules made under it.
Background and earlier position
Ayurvedic drugs already fall under a specific statutory regime within India's drug-control system. The Ministry of Ayush statement reiterates that manufacturers must show proof of safety and effectiveness, follow GMP, and comply with pharmacopoeial standards for identity, purity, and strength.
The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), a subordinate organization under the Ministry of Ayush, develops pharmacopoeial standards and formulary specifications for Ayurvedic drugs. The commission also functions as the appellate drug testing laboratory for Ayurvedic drugs and conducts capacity-building programmes for regulators, analysts, and other stakeholders.
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