Regulatory Perspectives of Ayurvedic, Siddha and Unani Formularies and Pharmacopoeias

Vijay Gupta; Archana Jain; Nitin Rai; M. B. Shankar; Rajeev Kr. Sharma

Abstract

The Ayurvedic Formulary of India, Ayurvedic Pharmacopoeia of India, Siddha Formulary of India, Siddha Pharmacopoeia of India, National Formulary of Unani Medicine, Unani Pharmacopoeia of India are included in the Schedule I of the Drugs and Cosmetic Act 1940 and rules made thereunder and serve as a tool for regulatory compliance and standardization tool for the Ayurvedic, Siddha and Unani system of medicines respectively. The Pharmacopoeias of Ayurvedic, Siddha and Unani system of medicines publishes the monographs i.e. quality standards describing the identity, purity and strength of selected drugs and these are officially applied on licensed Ayurvedic, Siddha and Unani drugs manufacturers in India. The Pharmacopoeias of Ayurveda, Siddha and Unani system of medicine are publishing in different volumes under two parts; the part I and part II, the part I which covers monographs on the single drug (Raw materials) while the later includes monographs of finished products/ formulations includes in the Formularies of respective system of medicines. Since the Pharmacopoeias and Formularies of Ayurveda, Siddha and Unani system of medicine are official publication for the quality standards of the raw materials and finished products and implemented on the Ayurvedic, Siddha and Unani system of medicine drug manufactures under different definition and rules of the Drugs and Cosmetic Act, 1940.

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