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Standardization and quality control of Ayush products

Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), subordinate office under Ministry of Ayush lays down the formulary specifications and pharmacopoeial standards for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs which serves as official compendia for ascertaining the quality (identity, purity and strength) of the ASU&H drugs.

As per Drugs and Cosmetics Act, 1940 and Drugs Rules 1945, compliance to these quality standards are mandatory for the manufacturing of ASU&H drugs.  PCIM&H also acts as the Central Drugs Laboratory for Indian Medicine and Homoeopathy for the purpose of testing or analysis of ASU&H Drugs.

Further, PCIM & H impart training to the Drug Regulatory Authorities, State Drug Analyst etc on laboratory techniques and methods used to maintain quality of ASU & H drugs.

The Drugs & Cosmetics Act, 1940 and Rules made there under have exclusive regulatory provisions for Ayurveda, Siddha, Sowa-Rigpa, Unani, and Homoeopathy drugs.

Provisions relating to Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs are contained in Chapter IVA and Schedule- I of the Drugs and Cosmetics Act, 1940 and in Rules 151 to 169, Schedules E(I), T & TA of the Drugs Rules, 1945.

Further, Rules 2dd, 30AA, 67 (C-H), 85 (A to I), 106-A, Schedule K, Schedule M-I of the Drugs Rules, 1945 pertain to Homoeopathic drugs.


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