News Feature | December 5, 2014

Indian Government Mandates Quality Accreditation For New Clinical Trials

By Suzanne Hodsden

The Government of India has introduced a new statute that requires all new clinical trials conducted in India to receive accreditation from a third-party Quality Council of India (QCI), reports the Economic Times (ET) of India.

ET cites a government official who explains, “Pharma companies or sponsors keen to conduct new clinical trials in India would have to seek accreditation from the QCI for their sites, ethics committee, and investigators before they apply for the drug regulator’s clearance.”

The expert specified that these new rules would not be applied to ongoing clinical trials but that the new rules would be enforced eventually.

India is an attractive location for clinical trials for a number of reasons. India possesses a highly technically trained workforce, low costs, and a large population from which to recruit clinical trial participants.

While drug makers and developers flocked to India to perform clinical trials, many expressed concerns that India was not equal to the task of accommodating the new influx of business and adequately monitoring quality and safety issues.

Chandra Gulhati, editor of the Monthly Index of Medical Specialties, told the WHO in 2008 that, “Fewer than 40 ethics committees in India are properly constituted and functioning, which means that the safety of the subjects of clinical trials is on the back burner.”

In response, the Indian government has implemented a number of new regulations in recent years to step up quality control issues in its domestic pharmaceutical industry across the board.

Last year, the CDSCO drafted a new protocol which required all Indian clinical trial participants to provide video-recorded consent, which included an explanation of all potential adverse health risks.

In July, India introduced a mandatory, new online registration system for clinical trials which would allow for greater transparency and easier monitoring.

The Central Drugs Standard Control Organization (CDSCO) committed to monitoring and tightening quality control in drugs being exported to other countries.

This new accreditation requirement is the latest move by the Indian government to restore faith in the Indian clinical trial industry.