Tuesday, January 21, 2014

Govt. set to tighten clinical trial norms

NEW DELHI: The government is set to tighten regulation of clinical trials in India by mandating that ethics committees that clear clinical trials will not only have to be registered but also accredited. It has put together a three-member committee to identify experts who'll form            the       accreditation council. 
The three-member committee consists of Dr YK Gupta, head of the pharmacology department of AIIMS and national scientific co-ordinator, Pharmacovigilance of India; Dr Ranjit Roy Chaudhury who headed the committee which submitted the report on guidelines on clinical trials; and Dr AK Aggarwal, ENT professor of Maulana Azad Medical College.

"All the ethics committees have been registered. But that is not enough. Now they have to be accredited. We have a long way to go for that because we have to decide basic issues such as procedure and frequency of accreditation, criteria of accreditation, whether the council will be under the Central Drug Standards Control Organization (
 CDSCO) and so on," explained Dr.Gupta. 

Dr Gupta added that there was an urgent need to ensure that the members of the various registered ethics committee knew what their role was, knew how to maintain oversight, decide on compensation and so on. "For this, many of the members might need training. Capacity building for the training and centres have to be identified across the country for training."

According to Dr Roy Chaudhury, they would be advising on the whole process of implementing the 23 recommendations of his committee's report on approval of new drugs and clinical trials, which the government has accepted. "We have to decide whether we want to constitute the accreditation council from scratch or farm it out to the
 Federation of Ethics Committees of India. Many of the ethics committees, like those associated with well-respected medical colleges like CMC Vellore or AIIMS, can be given accreditation without much hassle. And independent ethics committees are totally out, as far as I know," said Dr Chaudhury. 

He explained only clinical trials involving drugs, pharma research and those sponsored by pharma companies or a government or non-government agency required to be cleared by an accredited ethics committee. "Clinical research which is about academics and generating knowledge should not require clearance by a registered ethics committee. But these are all things we will have to decide," added Dr Chaudhury.

Posted by: Gauri Shah

Faculty Biotechnology

Bioinformatics Institute of India