New ayurvedic drugs to face tough clinical trials
New ayurvedic drugs will be sold in the market only after they go through rigorous clinical trials, and will soon be notified by the government, said people familiar with the development.
While the Modi government is on a major drive to promote yoga and ayurveda globally as key wellness initiatives, it has also decided to clamp down on mushrooming ayurvedic drugs hitting the market without any proven efficacy. This has prompted the Department of Ayush to enforce a stricter regime by mandating clinical trials for every new ayurvedic drug.
While the move could open up bigger export markets for ayurveda, it has already raised an alarm in the industry. At present, manufacturers require a licence from state authorities before new drugs are marketed, but there's no need for clinical trials, leading to ambiguity in the regulatory system.
The Indian ayurvedic drug market is about Rs 8000 to 9000 crores, which is much less than the Rs 120,000-crore allopathic market.
"With ayurvedic drugs, the problem is that the regulatory structure is very weak. While there are many classical formulation drugs that derive from ancient texts that are listed in the Drugs Act, there are several other patented and propriety drugs that may completely pass through without any safety or efficacy tests. We are now going to ensure that every new drug undergoes a clinical trial, and only based on the results, will the state authorities give a licence to such drugs. We will notify the mandatory clinical trials within the next three months ," a senior official from the Department of Ayush confirmed to ET.
"The idea is to check flooding the market with drugs that make all kinds of tall claims, from obesity to height," the official said.
Starting April, the department will also begin a major drive to check spurious ayurvedic drugs with random sample testing across the country.
"The ayurvedic drug sector comprises about 9000 units, most of which fall in the small scale and micro scale levels. They just don't have the wherewithal to go through all these legal requirements…," PM Varier, president of the Ayurveda Drugs Manufacturing Association, told ET.
Currently, regulatory provisions are available under the Drugs and Cosmetics Act, 1940, and Drugs and Cosmetics Rules, 1945, that are applied for regulating and monitoring the quality, safety and efficacy of ayurveda, siddha, unani and homoeopathy medicines in the country.
The Ayurveda Drugs Manufacturing Association has warned such a move will adversely affect the industry.
"There are lots of new patented and propriety drugs. The Centre has been talking of bringing in a new clinical trial-backed regime. We have also shared our concerns and are quite certain the impact of such a move will be huge, and will lead to quite a diminution of the industry and will discourage manufacturers. Clinical trials take as long as 4 years and require major investments. Our contention is that since even these new drugs are derived from the same classical medicines that are exempt from the clinical trial regime, the new ones should also be spared too," Varier said.
The department's move is in keeping with the recommendations by the Ayush Task Force report in 2015. This report had said the regulations should explicitly "place onus on manufacturers to demonstrate compliance and the accepted means of demonstrating compliance, especially using third party audits should be prescribed".