Structured Regulatory Framework for AYUSH drugs

Government has considered setting up a structured central regulatory framework for AYUSH drugs. In this regard, the current proposal is to develop a vertical structure for AYUSH in the Central Drugs Standard Control Organisation (CDSCO).

Accordingly, amendments required in the Drugs and Cosmetics Act, 1940 pertaining to regulation of Ayurvedic, Siddha, Unani, Sowa-rigpa and Homoeopathy drugs have been conceptualised and conveyed to the Department of Health and Family Welfare under whose jurisdiction the proposal of amending Drugs and Cosmetics Act, 1940 and strengthening of CDSCO are being processed.

New posts created:

Ministry of AYUSH has notified creation of 12 posts of Deputy Drugs Controllers, Assistant Drugs Controllers and Inspectors of Ayurvedic, Siddha, Unani and Homoeopathy and the matter of vertical structure for AYUSH drugs in CDSCO has been followed up regularly with the Department of Health and Family Welfare.

Changes in regulations:

Certain changes relating to AYUSH have been included in draft Bill for amending the Drugs and 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 and Cosmetics Act, 1940 and Rules thereunder. Good Manufacturing Practices and Standards of

AYUSH drugs as prescribed in the Drugs and 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 for their AYUSH products.

Regulatory provisions are amended time to time in consultation with the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board and standards of drugs are developed by the Pharmacopoeia Commission and respective Pharmacopoeia Committees.

Pharmacopoeia Commission of Indian Medicine:

The Government has set up Pharmacopoeia Commission of Indian Medicine and 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 set up as appellate laboratories and forty one laboratories are approved under the provisions of Drugs and Cosmetics Rules, 1945 for carrying out analysis of drugs and raw materials.

Central Government has supported twenty seven State Drugs Testing Laboratories and 46 Pharmacies to improve quality production and testing facilities for AYUSH drugs.

Through National AYUSH Mission, financial support is provided to the States for strengthening the infrastructural and functional capacity of the Drugs Testing Laboratories, Pharmacies, and Enforcement Framework and for testing of drugs and quality control activities.

Quality Council of India with support from Ministry of AYUSH has implemented a scheme of quality certification of Ayurvedic, Siddha and Unani drugs with brand of AYUSH Standard and AYUSH Premium marks.