Clinical trial rules to be relaxed for academic institutions

The central government plans to tweak the current clinical trial norms to exempt academic institutions from some these stringent conditions, including paying compensation in most of the cases, so that research activities are not stymied.

“We are not diluting the norms, but revising the guidelines to provide clarifications for projects undergoing in research institutions. Because of the stringent guidelines, evolved from Supreme Court judgment, many academic clinical trials are stalled,” said Soumya Swaminathan, director general at the Indian Council of Medical Research (ICMR).

ICMR along with the Drugs Controller General of India and the Health Ministry is reworking on the guidelines to clarify some of the issues related to conduct of trials that would not lead to the registration of a new medicine.

When scientists test new dosage or combination of existing medicines, those trials would not come under such strict regulations. “Many trials at the Tata Memorial Hospital have come to a halt because of the stringent clinical trial guidelines,” she said.

“If we have to tackle India’s unmet cancer burden, we need to make clinical research work for our country. Investigator initiated research is an imperative, not merely an option in India,” said C S Pramesh professor and head of thoracic surgery, at the department of surgical oncology at Tata Memorial Hospital.

There would be classification on paying compensation to clinical trial victims.
The research institutions may be asked to pay compensation only if there is death or disability, directly caused by the medicine under trial. Paying compensation would largely be related to regulatory trials.