ABOUT DRUG CONTROL CELL

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ABOUT DRUG CONTROL CELL, MINISTRY OF AYUSH

Ministry of AYUSH has a Drug Control Cell (DCC) to administer regulatory and quality control provisions for Ayurveda, Siddha, Unani & Homoeopathy (ASU&H) drugs. The Drug Control Cell has been made AYUSH- Vertical of the CDSCO since February, 2018 to deal with the provisions of Drugs and Cosmetics Act, 1940 and Rules thereunder and the associated matter pertaining to ASU&H Drugs. In this regard, the Cell coordinates with the State Licensing Authorities and Drug Controllers to achieve uniform administration of the Act and for providing regulatory guidance and clarifications. Cell also manages the implementation of the Quality Control of ASU&H drugs related part of the National AYUSH Mission (NAM) through which grant in aid is provided for improving infrastructural and functional capacity of Drug Testing Laboratories & Pharmacies in the states for production, testing and quality enforcement of ASU&H drugs. The Secretariat for two statutory bodies- Ayurveda, Siddha, Unani Drug Technical Advisory Board (ASUDTAB) and Ayurveda, Siddha, Unani Drugs Consultative Committee (ASUDCC) is housed in the Drug Control Cell for planning, coordination and follow up action of their meetings.

The Drug Control Cell interacts with Central Drug Standard Control Organization (CDSCO), Directorate General Foreign Trade (DGFT), Ministry of Environment, Forests & Climate Change (MoEF&CC) and other regulatory agencies for WHO-GMP/CoPP certification scheme, export/import and clinical trials related matters, availability issues of raw materials and quality certification in respect of ASU&H Drugs, & industry related issues. In order to oversee effective implementation of the Drugs & Cosmetics Rules regarding approval of ASU drug testing institutions by the State Licensing Authorities, Technical Officers of the Ministry have been notified as Central Drug Inspectors to undertake joint inspection of the ASU drug testing laboratories and report to the designated authority.