Quality control framework for Ayurvedic medicines: regulatory provisions, testing labs and pharmacopoeial standards
Drugs & Cosmetics Act, 1940 provisions, Schedule T GMP, and pharmacopoeial standards form the regulatory base for Ayurvedic medicine quality control.
- The commission develops pharmacopoeial standards and formulary specifications for Ayurvedic drugs and functions as the appellate drug testing laboratory.
- Drug Inspectors collect samples from manufacturing firms and sale shops and send them to Drug Testing Laboratories for quality testing.
- If a sample is found not of standard quality, the stated enforcement response includes preventing sale and initiating legal action under the Drugs & Cosmetics Act, 1940 and the rules made under it.
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.
UPSC may ask about the statutory framework for Ayurvedic drug licensing, Good Manufacturing Practices under Schedule T of the Drugs Rules, 1945, the role of the Pharmacopoeia Commission for Indian Medicine & Homoeopathy, and enforcement against substandard drugs. The Mains angle is the balance between traditional medicine promotion, product quality, consumer safety, and institutional capacity.
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