Clinical trial for ayurveda medicine

Kochi: In a bid to widen the acceptability of Ayurvedic medicine across the globe and to halt spurious drugs flooding the market, the State government will launch the clinical trial and safety study of proprietary and patented Ayurvedic medicines.

“The first clinical trial and safety study of Ayurvedic medicines will kick off in two weeks,” Drugs Controller for Ayurveda Dr N Vimala told Deccan Chronicle.

“We will start the process with one product at Vaidyaratnam P S Varier Ayurveda College, Kottakkal, to be followed by three in Government Ayurveda College, Thiruvanmanthapuram and one in Government Ayurveda College, Thripunithura.”    

The government received five applications for the study, which has been made mandatory for granting the license to manufacture and sell patented and proprietary medicines. 

Care Keralam, the special purpose vehicle of the State government promoting research in Ayurveda, will conduct the toxicity study.

The State-level monitoring committee with the additional secretary (health) as the head had cleared all the five applications and asked the companies to manufacture the medicines and submit them for trials.

“One manufacturer has already completed the process and we shall start the trial as soon as they submit the drug,” Dr Vimala said. The study is expected to start in November itself.

The trial will follow the WHO guidelines for research in traditional medicines, she said. “We selected the three colleges as they have ethical committees, which will supervise the trials,” she said.

“We shall test only those formulation which use ingredients mentioned in the approved list of 56 classical tests. We will give licenses only to those formulations which clear the tests.”

“The government has authorised us to take up the study and we are fully equipped to do it,” Dr Joy Varghese, chief executive officer of CARe Keralam, said.

“We will conduct the studies as per the protocol which includes effective dose study, lethal dose study, and animal efficacy study,” he said.

At present, Ayurvedic medicines are exported as food supplements as they do not qualify for medicine for lack of proper certification and documentation.

A certification based on toxicity study and clinical trial will help Ayurveda get better recognition in overseas markets.

Experts in the field who welcomed the study, however, voiced certain reservations. “It’s a welcome move as it can stop spurious products hitting the market.

At the same time, this would be used as an advertisement tool as well,” an academic said.