The Union Ayush ministry will soon set up a structured regulatory framework for Ayush drugs. As per the proposal, a vertical structure will be developed for Ayush drugs in the Central Drugs Standard Control Organization (CDSCO).
Accordingly, amendments required in the Drugs & Cosmetics Act, 1940 pertaining to regulation of Ayurvedic, Siddha, Unani, Sowa-rigpa and Homoeopathy drugs have already been conceptualized and have been submitted to the Department of Health & Family Welfare under whose jurisdiction the proposal of amending Drugs & Cosmetics Act, 1940 and strengthening of CDSCO are being processed.
The Ministry of Ayush has already notified creation of 12 posts of Deputy Drugs Controllers, Assistant Drugs Controllers and Inspectors of Ayurvedic, Siddha, Unani and Homoeopathy and the nitty gritties of the matter of vertical structure for Ayush drugs in CDSCO are being discussed with the Department of Health & Family Welfare. For this purpose, certain changes relating to Ayush have been included in draft Bill for amending the Drugs & Cosmetics Act 1940 and the Bill has been considered by a Group of Ministers.
Ayush drugs are regulated in the country in accordance with the provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder. Good Manufacturing Practices and Standards of Ayush drugs as prescribed in the Drugs & Cosmetics Rules and Pharmacopoeias are mandatory for the manufacturers to follow. Voluntary certification scheme for Ayurvedic, Siddha and Unani as per WHO guidelines is also in place, under which eight manufacturers have obtained WHO Certification of Pharmaceutical Products (CoPP) for their Ayush products.
For further strengthening the Ayush system of drugs in the country, the government has set up Pharmacopoeia Commission of Indian Medicine & Homoeopathy and Pharmacopoeia Committees to develop quality standards and Standard Operating Procedures for the manufacturing of Ayurvedic, Siddha, Unani and Homoeopathic drugs. Two central Pharmacopoieal Laboratories of Indian Medicine and Homoeopathy are being set up as appellate laboratories and 41 laboratories have been approved under the provisions of Drugs & Cosmetics Rules, 1945 for carrying out analysis of drugs and raw materials.