Regulatory Focus™ > News Articles > New Rules Set to Overhaul Indian Clinical Trials Framework

New Rules Set to Overhaul Indian Clinical Trials Framework

Posted 07 February 2013 | By Louise Zornoza

Indian regulators are out with two new clinical trials regulations that promise to reform some of the ethical hurdles that had plagued the sector in the past, including lax approval standards and a lack of compensation for injured participants.

Compensation

On 30 January 2013, India's Ministry of Health issued final regulations governing compensation for clinical trial injury or death, roughly a year after the draft regulations were released for public comment. 

Clinical trial sponsors are now liable for injuries or deaths that occur during the course of a clinical trial, and will be required to compensate subjects or the subject's family. The final version no longer requires a specific amount of compensation for injury or death to be included in the informed consent form, and no longer refers to insurance coverage for potential liability. 

New provisions include the requirement that the trial sponsor provide the trial subject with free "medical management" for as long as it would be required and includes a more detailed "procedure for payment of financial compensation."

Final Rules Governing Clinical Trials

India's Ministry of Health also issued final regulations on 1 February 2013 clarifying the conditions under which clinical trials may be authorized by the local licensing authority and the Central Drugs Standard Control Organization's (CDSCO) inspection authority over clinical trial sites. 

The key difference between the final and draft versions of the regulation is a new provision that permits the local licensing authority to require changes to a trial protocol as a condition of approval of the trial. The local authority may, "if considered necessary," impose additional conditions regarding the "objective, design, subject population, subject eligibility, assessments, conduct and treatment of" a proposed clinical trial.


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