The government of Kerala has accorded sanction to carry out clinical study and safety study for proprietary and patented Ayurveda products before grant of license in order to prove their efficacy and safety before hitting the market.
To conduct the human trials, government has identified and designated three Ayurveda colleges from government and semi government sectors. The colleges and the department of Ayurveda are now engaged in forming a state level monitoring committee in order to associate with the ethical committees of the concerned colleges for the smooth conduct of the trials.
It is learnt that Kerala is the first state in the country to identify three health institutions to officially carry out the clinical and safety studies for the new traditional medicines as insisted by the central Ayush department through a notification dated 10.08.2010. The notification was issued by the government after making certain amendments to the D&C Rules, 1945. Once the report of clinical trials is ready, like China, India can also export herbal products to foreign countries as medicines.
According to Dr N Vimala, the state drugs controller for Ayurveda, the drugs that will undergo human trials are only the proprietary and patented ones, and not the classical formulations referred in the 56 classical texts come under Schedule 1 of D&C Act. The classical formulations do not require any clinical trials or any toxicity study. The toxicity and safety study will be carried out at the Ayush cluster, Care-Keralam, at Koratty ina Trissur.
Speaking to Pharmabiz, the Ayurveda drugs controller said from now on fresh licences for proprietary and patented drugs will be issued on production of report of the clinical study and documents of safety study. Those products which are already in the market do not require any trials, but if any adverse effect is reported, the license will be cancelled and send the product for clinical study. She said there are more than 3000 proprietary drugs now available in the market claiming Ayurveda products.
The three colleges identified for conducting clinical trials are the Government Ayurveda College at Thiruvananthapuram, Government Ayurveda College at Thrippunithura and VPSV Ayurveda College at Kottakkal. The principals of these colleges will be notified as the nodal officers for the programme. Government will form a state monitoring committee (SMC) which in association with the ethical committees of the college will supervise the studies.
The order issued by the government says that “before the clinical study, the manufacturer has to submit the trial drug to the licensing authority for pre-approval of the formula. After the approval of the formula, the manufacturer should produce a trial batch of products for administering to the patients. An amount of Rs. 500 will be charged for the approval of the formula and Rs. 10,000 for clinical study. The expense for the clinical study will be borne by the manufacturer. If the product contains ingredients specified in Schedule E1 drugs, safety study and toxicity study also will be conducted. The manufacturer will submit the trial drug along with pre-approval certificate, test report and toxicity study report to the licensing authority (ASU)”.
The decision of the Kerala government to designate health institutions to carry out clinical trials has been welcomed by the Chennai based Centre for Traditional Medicines & Research (CTMR), an NGO engaged in the research of ISM drugs. Dr T Thirunarayanan, the Secretary of CTMR said the decision of the Kerala government will enhance the status of Ayurveda drugs to international level and it will get a status equal to allopathy medicines besides an acceptance by the world community. He said the clinical study will also help for export of Ayurveda drugs to foreign countries.
Whereas, Dr D Ramanathan, the general secretary of Ayurveda Medicine Manufacturers Organisation of India (AMMOI) said the clinical trials will not do any good for Ayurveda sector as no new innovation is occurred in conducting the trials.
Welcoming the move, Dr Rejith Anand, general secretary of Ayurveda Medical Association of India (AMAI), said the clinical study will help for eliminating fake drugs from the market and genuine medicines can be supplied to the patients. He said the trial will also put an end to adulteration or change of ingredients/ methods different from what is indicated in the classical texts.