Union Ayush ministry to come up with guideline on clinical trials for new ayurvedic drugs soon

May 23, 2016

The Union Ayush ministry will soon come up with the guideline on clinical trials for the new ayurvedic drugs. The sub-committee formed to draft the guideline for the industry will submit the draft by this month end to the Union Ayush ministry.

The sub-committee was formed 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. The subcommittee has already held two meetings to discuss the mandatory requirements for clinical trials.

The draft will be finalized soon at the next subcommittee meeting and will be sent to the Union Ayush ministry for the approval. The subcommittee has to frame the rules for the clinical trials along with the approval of new products, informed an official from ADMA.

Recently, the central government has mandated clinical trials for all the new Ayurveda drugs launched in the market to maintain safety and efficacy of drugs. The state licensing authority will forward the application of Ayurvedic drug manufacturers for clinical trials of new drug to the central authority. The central authority will have a committee to grant approval for the clinical trials.

Earlier, any Ayurvedic drug manufacturer could launch a product throughout the country once a product license was obtained from any state licensing authority. No pre-clinical or clinical trials was needed to be conducted for ensuring the safety and efficacy of the product.

Indian ayurvedic drug market is estimated to be about Rs.8,000 crores comprising of products manufactured and marketed by thousands of small, medium scale units and a dozen large companies. With the demand for Ayurveda and herbal products increasing steadily in the domestic and overseas markets, consumption of these products is expected to go up substantially in the coming years.

The move by the Union ministry of Ayush to allow marketing of any new Ayurveda drug only after successful completion of clinical trials will ensure its safety and efficacy. Enforcement of such a rule can ensure controlling the entry of irrational and harmful combinations also into the market.


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