Policy Matter

Government following international quality control to boost export of Ayurveda products

Central Government issued directions in September, 2007 to the State Governments under Section 33-P of the Drugs & Cosmetics Act, 1940 to streamline the system for licensing of patent & proprietary Ayurveda, Siddha and Unani Products under Rule 154 and 154-A of the Drugs & Cosmetics Rules, 1945 by constituting an Expert Committee under the chairmanship of Commissioner/Director (Indian Systems of Medicine) of the State as per the provisions of the Rule 154(2) for advising the State Licensing Authority before any patent & proprietary Ayurvedic, Siddha or Unani Medicine is licensed for production by any manufacturing unit.ayurveda-products

There is no grading system for AYUSH products except categorization as classical formulations and patent & proprietary medicines as defined in Section 3(a) and (h) of the Drugs & Cosmetics Act, 1940. Homeopathic medicines have different potencies depending upon the extent of dilution of mother tincture.

Quality standards of Ayurvedic, Siddha, Unani and Homeopathic drugs are prescribed in respective pharmacopoeias published by the Government. Ayurvedic pharmacopoeia contains 645 monographs of single drugs and 202 monographs of compound formulations; Unani Pharmacopoeia contains 298 monographs of single drugs and 150 monographs of compound formulations; Siddha pharmacopoeia contains 139 monographs of single drugs and Homeopathic Pharmacopoeia has 1117 monographs. Provisions for quality control of Ayurvedic, Siddha, Unani and Homeopathic drugs are provided in Drugs & Cosmetics Act, 1940 and Rules there under.

For enhancing export of the Ayurvedic products, compliance to Good Manufacturing Practices has been made mandatory for the manufacturers and quality certification system as per WHO guidelines is administered by Central Drugs Standard Control Organization and similarly AYUSH Standard Mark and AYUSH Premium Mark certification system is implemented by Quality Council of India. Through the Central Scheme of International Cooperation implemented by the Ministry of AYUSH, financial support is provided for preparation of product dossier, registration of products in foreign countries and for participation of AYUSH drugs manufacturers in the International Trade Fairs, Exhibitions and Road shows.

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