REGULATORY REQUIREMENT OF SAFETY AND EFFICACY FOR AYURVEDIC, SIDDHA AND UNANI DRUGS

Anzar Alam* and Sanjay Kumar

ABSTRACT

Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy together called AYUSH are the traditional medicine. Now Sowa Rigpa is also the part of traditional system of medicine. In Ayurveda, Siddha and Unani, the drugs are of textual reference as well as there are patent or proprietary drugs. The drug products should exhibit the expected therapeutic efficacy and must be safe for use. The type of safety and efficacy documents needed depends upon the nature of drug products. The requirements depend upon ingredients, indication, as well as the type of products i.e. products are classical or proprietary.

Keywords: Drug & Cosmetic Acts, Drugs Rules, Schedule E(1).