Authored by Ammu Brigit
Patanjali Ayurveda Limited (Patanjali) along with Divya Pharmacy Limited in its recent press conference launched ayurvedic medicines claiming to be the first ayurvedic cure medicines with 100% recovery within seven days for Covid-19. Taking notice of this announcement, Ministry of Ayurveda, Yoga, Neuropathy, Unani, Siddha and Homeopathy (Ministry of AYUSH) instructed Patanjali to stop advertisements, and sought from it the name and composition of the medicines, site/hospital where the research study was conducted, protocol, sample size, Institutional Ethics Committee (IEC) clearance, Clinical Trial Registry-India (CTRI) registration, result data of the study. In the context, in this article we look into the legal position with regard to the research, manufacturing and advertising of Ayurvedic medicines in India.
Manufacturing of Ayurvedic Medicines
Under section 33EEC of Drugs and Cosmetics Act,1940 (DCA) read together with Part XVI of Drugs and Cosmetics Rules 1945 (DCR), a person intending to manufacture any ayurvedic medicine should obtain appropriate license after fulfilling the conditions of license under DCA and DCR.
The AYUSH ministry taking note of the gap in DCR as it does not contain specific regulatory provision requiring conduct of clinical trials for Ayurveda, Siddha, Unani and Homeopathic drugs (AYUSH Drugs), and recognising the need for scientifically generated clinical data for validation and credibility of drugs for Covid-19, came up with a notification dated 21st April 2020.
Under this notification, the AYUSH Ministry required scientists, researchers, clinicians of any recognised systems of medicine under Indian Medicine Central Council Act 1970 (IMCC Act), National Medical Commission Act, 2019 (NMC Act), and Homeopathy Central Council Act 1973 (HCC Act) undertaking research on cure or prevention of Covid-19 through Ayurveda, Siddha, Unani and Homeopathy systems (
