New rules on compensation to make clinical trials in India ‘virtually impossible’: ISCR

The Indian Society for Clinical Research (ISCR) has strongly criticised certain rules in the Gazette Notification on Compensation released by the Ministry of Health & Family Welfare on January 30, 2013.

In a statement published on its website on February 6, the ISCR spokesperson says that while it is fully supportive of the need to create a more robust and regulated environment in India for the conduct of clinical research which ensures the practice of the highest standards of ethics and quality and where patient rights and safety are protected and therefore welcomes a policy on compensation, some of the rules in the compensation gazette notification will make the continuing conduct of high quality, scientifically valid clinical trials in India virtually impossible, negatively impacting the availability of scientific data to assess the benefits and risks of new medicines for the Indian population.

Commenting on the sequence of events leading upto this Gazette Notification, the ISCR release points out that it was actively involved, as were other stakeholders including not-for-profit- organisations, bio pharma companies and CROs, academia and healthcare institutions, in providing its feedback to the Draft Notification on ‘Compensation in case of study related injury or death in clinical trials,’ which was published in November 18, 2011 and subsequently participated in task force meetings (March 18 and April 29, 2012) set up by CDSCO to discuss the comments and finalise the guidelines.

However, while much of the text in the Gazette Notification is along anticipated lines, two of the listed criteria for determination of eligibility for compensation are contrary to the consensus reached in the stakeholder meetings, and some of the other listed criteria remain controversial.

These include no distinction being made between study-related injuries and non-study related injuries, the use of placebos in placebo-controlled trials, the lack of any arbitration mechanism in case of disagreement on causality/quantum of compensation and the lack of clarity on who constitutes the Expert Committee constituted by the Licensing Authority.

With particular reference to the clause on compensation to be paid in the case of an injury or death due to an investigational product not having its intended therapeutic effect or due to a placebo controlled trial, ISCR believes that this will have a far reaching impact on organisations and academic institutions, both Indian and multinational, in risking doing clinical trials in India as they go against the tenets of science.

Referring to current ongoing efforts by the US FDA to discuss with industry experts how a speedier pathway to approve drugs and biologics for serious and life-threatening conditions with unmet medical needs can be constructed (http://medcitynews.com/2013/02/fda-hearing-questions-how-to-develop- fast-lane-for-drug-development-for-unmet-medical-needs/#ixzz2K0yMeekn), the ISCR release points out that India has 16 per cent of the world’s population and 20 per cent of the global disease burden and yet, less than 2 per cent of global trials take place in India. It is only through clinical research that we will be able to find newer and better medicines to treat our population and reduce mortality rates for various diseases, including those unique to our part of the world, according to the release.

EP News Bureau – Mumbai