DRUG STANDARDIZATION OF AYURVEDA, UNANI AND SIDDHA DRUGS

Abstract

India is a mother hub for development of Ayurveda, Unani, Siddha, Homoeopathy and other natural herbs based health science (AYUSH). Ayush Pharmaceutical industry is having great potential and opportunities for development in future. Standardization of drug means confirmation of its identity, quality and purity throughout all phases of its cycle i.e. shelf-life, storage, distribution and use by various parameters. Different techniques involved in standardization of crude/finished compound drugs so far, e.g. macroscopic methods, -microscopic methods, physical methods, chemical methods, biological methods. As we all know in our Ayurvedic system of medicines drug standardisation of Ayurvedic formulation is a big challenge. Clear cut guidelines have not been developed so far. Pharmacopeia testing protocol may be adopted for drug profiling. Drug standardization is required for the development of Indian system of Medicines (viz. Ayurveda) for identification of drug, purity of drug, safety of drug, strength of drug, efficacy of drug and to follow GMP and GLP standards as per various regulatory authorities. The national health authorities (national drug regulatory authorities, DCC) should ensure that all ASU pharmaceutical product subject to their control are in conformity with quality, safety, efficacy and that all premises and practices employed the manufacturing and distribution of these product comply with GMP standards, So as to ensure the continued conformity of the product with these requirements until such time as they are delivered to the end user.