Monitor Clinical Trials

System in Place to Monitor Clinical Trials (The New Indian Express)
By Dileep V Kumar  Published: 15th July 2015 03:08 AM    Last Updated: 15th July 2015 03:08 AM


KOCHI: Recent instances of shoddy clinical studies resulting in health issues, including casualties, have called for a mechanism to regulate the trials, which have always been a controversial subject in the country.

While such a mechanism is yet to be implemented at the national level, the decision by the State Government to entrust clinical trials and safety-related studies of ayurveda products to three ayurveda colleges has been widely welcomed.

“The decision to ensure proper clinical trials and safety-related studies of ayurveda products before granting licence is a welcome one as it will ensure that the public get quality products. The system will ensure that no compromise is made with regard to the safety/quality aspects of the products,” said Ayurveda Medical Association of India general secretary Rejith Anand. The State Government in an order dated July 2 stated that clinical studies would be conducted at VPSV Ayurveda College, Kottakkal; Government Ayurveda College, Tripunithura and Government Ayurveda College, Thiruvananthapuram. The safety-related aspects of trials will be monitored by Care Keralam at Koratty, Thrissur.

Ayurveda drug controller N Vimala told ‘Express’ that the government issued the directive based on the revelations in ‘Good Clinical Practice Guidelines for Clinical Trials in Ayurveda, Siddha and Unani Medicines’, published recently by the Department of AYUSH.

She said the order came with additional clauses pertaining to ‘appointment of a monitoring committee, stipulation of the licence fee to be collected from firms that submit samples, fixation of remuneration, and the maximum duration of studies, among others. Meanwhile, the Ayurveda Medical Association of India has warned that care should be taken to check ayurveda products coming from the other states. “At present, the clinical and safety aspects are applicable only to products manufactured indigenously. Our plea is that products coming from the other states also be checked. Also, the three ayurveda colleges should sanction licences,” added Rejith Anand.

“The government is giving priority to the quality of medicines, and is not concerned about fixing a time-frame for clinical studies. When the clinical trial scenario witnesses a rush, we will consider the possibility of extending the number of study centres, including the private sector. The new system will bring ayurveda closer to the people,” added Nirmala.