Clinical trial under regulatory scanner

| Updated on May 11, 2018


Clinical trial day, on May 20, comes at a time in India when the segment is seeing a fresh incident involving Jaipur’s Malpani Hospital that was testing drugmaker Glenmark’s osteoarthritis drug candidate. The sponsor of the trial, Glenmark, and the hospital’s principal investigator have been told to respond to the drug regulator on allegations of data falsification, among other things.

Over the last five years, the local clinical trial industry went through a slow burn, with the government tightening norms on the segment. In 2013, allegations of malpractice led to a furore against the industry’s practices. Now, as the Glenmark-Malpani incident is investigated by the Indian drug regulator, much remains to be fixed in terms of improving the quality of trials done in the country by accrediting hospitals, their ethics committees and doctors.

Published on May 11, 2018

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