A new guideline on clinical trials of Ayurvedic drugs is soon to be released by the Ayush Ministry appointed subcommittee by the end of this month.
The Subcommittee has come into existence under the chairmanship of VK Joshi, Chairman ,Ayurveda Pharmacopeia Commission (APC) along with the representatives from the DCGI office, Ayurvedic Drug Manufacturers Association (ADMA), Central Council for Research in Ayurvedic Sciences (CCRAS), Central Council of Indian Medicine (CCIM) and Ministry of Ayush. Two subcommittee meetings that have already taken place have discussed the mandatory requirement s for clinical trials.
According to an official from ADMA, the subcommittee has to frame rules for clinical trials and approvals of new products. The draft, he said would be ready after the next subcommittee meeting and sent to the Ayush Ministry.
The central government has of late mandated clinical trials for all Ayurvedic drugs, to ensure efficacy and safety of the products. This was not the case earlier, as drug manufacturers could launch a product, once they had the product licence from the state licensing authority. No clinical or pre clinical trials were called for. Today, the situation is different as the state licensing authority will have to forward the application of Ayurvedic drug manufacturers for clinical trials of new drugs to the central authority. The central authority further will have to appoint a committee, to grant approval for the clinical trials.
Ayush’s move to allow marketing of Ayurveda products only after the completion of clinical trials is a way to ensure safety and efficacy of the drugs being marketed. Clinical trials would also ensure controlling the entry of irrational and harmful combination of medicines from entering the market.
Worth about Rs. 8000 crore, the ayurvedic drug market comprises of small, medium, and a few large companies.With aurvedic products much in demand, and on an ever increasing high globally , consumption is likely to reach new heights in the coming years according to Pharmabiz.