Clinical trials in India to be more legal friendly: ISCR

The earlier guidelines had no cap for compensating the patient (trial subject); the medical management had to provide him or her irrespective of the causality suffered. To further encourage the sponsors, the guidelines have been eased and the patient will now be commensurate in line with the severity of the injury.

As reported by PTI,

Y K Gupta, professor and head of department of pharmacology at AIIMS and executive council member, ISCR, said, there were some trials in the past, which "went wrong" and since then the government has taken "correctional measures" in the regulations.

"Compensation guidelines are balanced and ensure safety of patients, and the compensation offered would be based on the severity of the injury if any sustained by the patient during the course of the trial.

"All institutional ethical committees for the trials have to be accredited and no trial can be conducted without the informed consent of a patient," Gupta said.

He said that the amendment has added the provision of "recording and archiving" the interaction with the patient for future references.

President, Indian Society for Clinical Research (ISCR), Suneela Thatte said, "some of the sponsors (individual, company etc) over the period have been unwilling to participate, because of unpredictability in review process of their application to begin trials."

"The process takes long time and now the amendment to the rules seek to bring in more predictable review timeline, steps which will encourage sponsors to participate in the trials," she said.

"We therefore have cleared major hurdles in making clinical trial in India more streamlined and there are only operational challenges now, like the right number of trials, etc," she added.