Regulatory Requirements for Quality Control of Unani Medicines.

Compliance with pharmacopeial standards is mandatory to ensure the quality, safety, and efficacy of medicines. In India, allopathy, Ayurveda, Siddha, Unani, and homeopathy are the recognized systems of medicine and come under the provisions of different regulations. Promulgation of the "Drugs and Cosmetics Act, 1940" and the rules thereunder provide a regulatory framework for medicines of all of these systems and also prescribe "Pharmacopoeia and Formularies" for regulatory quality standards. Unlike in many other countries, the Act prescribes independent pharmacopeias for each system of medicine. The Unani Pharmacopoeia of India (UPI) and the National Formulary of Unani Medicine are the regulatory compendia for quality standards and manufacturing of Unani medicines, respectively. The Pharmacopoeia consists of Part I (single drugs) and Part II (formulations). Unani medicines are presented as classical or patent and proprietary formulations prepared using single ingredients or multiple ingredients of plant, animal, mineral, and/or metal origin. UPI Part I is published in six volumes comprising 298 monographs on Unani drugs derived from plants (single drugs). Part II is published in three volumes encompassing formulations, standard operating procedures, and quality standards for 150 classical formulations of Unani medicines, which are chosen from the National Formularies of Unani Medicine. The National Formulary of Unani Medicine is published in six parts comprising 1229 formulations of Unani medicines. Each monograph of the Pharmacopoeia provides specific analytical parameters and limits (standards) to ensure the quality of drugs or medicines. This communication reviews the UPI, the National Formulary of Unani Medicine, regulatory quality standards (parameters), and analytical techniques adopted for pharmacopeial standards of Unani drugs and medicines.