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Regulatory Requirements for Ayurvedic, Siddha and Unani Drugs - An Overview

Vijay Kumar Garg, Nitin Rai and Rajeev Kr. Sharma

Hippocratic Journal of Unani Medicine
Hippocratic Journal of Unani Medicine April - June 2014, Vol. 9 No. 2, Pages 129-140


The drug legislation in India is governed by Drugs & Cosmetics Act 1940 and Rules 1945. During the British rule the drugs were imported in the country and Government regulated the drugs under the provisions of Poisons Act, 1919 and Dangerous Drug Act, 1930. To strengthen the regulation then Government appointed Drug Enquiry Committee under

the chairmanship of Lt. Col. R.N. Chopra in 1931 to enquire into the extent to which drugs and chemicals of impure quality or of defective strength, particularly those recognized by the British Pharmacopoeia, are imported, manufactured and sold in British India and the necessity of controlling such import, manufacture and sale in the public interest and to make recommendations thereof. The committee categorically recommended; (i) Regulate the standards of drugs and medicines including patent and proprietary medicines; (ii) Compilation of a National Pharmacopoeia; (iii) Development of the Pharmacy profession; (iv) Standardization of indigenous drugs and; (v) Development of drug industry.

These recommendations prompted the Government of India to pass the Drugs & Cosmetics Act in 1940, partly implementing the Chopra Committee’s recommendations to regulate, manufacture, distribute and sale of drugs in India. The drugs of Ayurvedic, Siddha and Unani are also under regulatory requirements laid in the Act and its compliance is mandatory. This communication provides genesis of the Drugs and Cosmetics Act and a synoptic account of regulatory requirements of ASU drugs in the country to educate and help manufacturers of ISM drugs.

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