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Manufacture, sale and distribution of drugs used by ASU&H are regulated by the Drugs and Cosmetics Act, 1940 (D&C)and Rules thereunder. Under this act, the Ayurvedic Formulary of India (AFI), Siddha Formulary of India (SFI), National Formulary of Unani Medicine (NFUM), Ayurvedic Pharmacopoeia of India (API), Siddha Pharmacopoeia of India (SPI), Unani Pharmacopoeia of India (UPI) and Homoeopathic Pharmacopoeia of India (HPI) represented by their Parts and Volumes are the books of standards for substances included therein and such standards are official.
The Pharmacopoeias are official compendia of quality standards of the drugs imported, manufactured for sale, stocked or exhibited for sale or distributed in India. The pharmacopoeial monographs prescribe standards to ensure the Identity, Purity and Strength of the given drugs through botanical identification, various physico-chemical parameters, assays for various elements/functional groups/marker compounds as well as sophisticated analytical techniques like High Performance Thin-Layer Chromatography (HPTLC), High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), UV-Visible Spectrophotometry etc. for detailed profiling.
The Formularies are official compendia identifying details of the formulations in practice.They decipher the selected formulations with description of composition of the drugs, method of preparation (general to the dosage form as well as specific to the formulation), therapeutic indications, contraindications, dosage, etc.
The work involved in the development of Pharmacopoeias and Formularies is accomplished by Pharmacopoeia Committees of respective system of medicine namely Ayurvedic Pharmacopoeia Committee (APC), Siddha Pharmacopoeia Committee (SPC), Unani Pharmacopoeia Committee (UPC) and Homeopathic Pharmacopoeia Committee (HPC). These Pharmacopoeia Committees work under the Guidance of Scientific Body of the PCIM&H.
Each of these pharmacopoeia committees comprises of 15-20 eminent experts from various fields related to development of pharmacopoeial standards and is constituted by PCIM&H generally for a period of three years. Secretary, AYUSH in the capacity of Ex-Officio Chairman of Commission in consultation with the Chairman of Scientific Body nominates the non-official members for these committees. Concerned Adviser from M/o AYUSH, Director, PCIM&H and Director of concerned pharmacopoeial laboratory (PLIM/HPL) hold Ex-Officio membership in each committee while Director General of respective Research Council (CCRAS/CCRS/CCRUM/CCRH as the case may be) holds Ex-Officio position of Member Secretary of the committee.