Clinical Trial Norms to be more stringent in India

New Delhi January 10, 2014:

The Indian government plans to tighten clinical trials regulation in India by focusing on the ethics committees, which are responsible for clearing the clinical trials. It aims at making it mandatory for the ethics committees to not only be registered but also be necessarily accredited by the given council.

Presently, although all the ethics committees are registered, it does not seem to be enough and accreditation is binding on all. The details of accreditation, like the procedure, frequency and criteria of accreditation need to be evaluated. Also, additional research would be required on which type of companies and agencies require accreditation, whether it is only pharmaceutical drugs related companies or also those related to academics is yet to be decided.

The government has appointed a committee of three-members who are in charge of identifying experts that can be a part of the accreditation council. The committee includes, Dr YK Gupta, who is the head of pharmacology department at AIIMS and national scientific co-ordinator for Pharmacovigilance of India, Dr Ranjit Roy, who was the head of the committee that submitted the report on guidelines for clinical trials and an ENT professor Dr AK Aggarwal, who previously was the dean of Maulana Azad Medical College.IGMPI