Clinical trials are no longer mandatory to get licence for patented and proprietary Ayurvedic medicines in Kerala, the last State to have such a practice in vogue.
The State government recently withdrew its own order issued on September 6, 2013, which had made it compulsory for manufacturers to go through the long-drawn process of trials and studies before introducing new products in the market. According to the new order issued on January 16, pilot studies as per the Drugs and Cosmetics Act, 1940, will be enough for getting licences. The quality and efficiency of patented and proprietary drugs will also have to be examined by an expert committee chaired by the Deputy Drugs Controller (Ayurveda), who is also the State Licensing Authority (SLA). Later, the SLA can issue licences as per provisions under Section 158 (B) II (B) of the Drugs and Cosmetics Rules, 1945.
Exemptions
The Drugs and Cosmetics Act was amended by the Centre in 2010 making clinical trials compulsory for patented and proprietary medicines, especially those being manufactured for export. Medical formulations from the 56 classical texts and those products already in the market were exempted.
The Kerala government issued orders in 2013 and appointed an expert committee that suggested Government Ayurveda College, Thiruvananthapuram; Government Ayurveda College, Thripunithura; and Vaidyaratnam P.S. Varrier Ayurveda College, Kottakkal; as the nodal agencies for the purpose. The doctors and teachers in those institutions, however, were reluctant to take up the job citing ethical reasons. This delayed the licensing process of new products altogether.
No new products
D. Ramanathan, general secretary, Ayurvedic Medicine Manufacturers Organisation of India, said the manufacturers in Kerala were not able to introduce new products in the market in the past five years.
The insistence on clinical trials was also one of the reasons for the closure of over 400 Ayurveda medicine manufacturing units, at least some of them small companies, in the State, he added.
The manufacturers then approached the Union government with a request to do away with the practice of clinical trials.
Though the Union Ayush Ministry issued a revised order in July, 2018, directing all State departments of Indian Systems of Medicine, the State government took a while before scrapping the provision.
T.D. Sreekumar, Deputy Drugs Controller (Ayurveda), told The Hindu that the expert committee, which had postgraduates in Ayurvedic medicine and a senior drug inspector as its members, would soon chalk out the procedures for pilot studies.
