"The government brought in amendment to the clinical trials guidelines in December 2014 and it has come into effect from June this year.
"And, the revised regulations are balanced and have addressed various issues, because of which sponsors have earlier been either not participating in or withdrawing from trials," President, Indian Society for Clinical Research (ISCR), Suneela Thatte said.
"The guidelines earlier were as blanket that for any injury suffered by the patient (trial subject) the medical management had to be provided to him or her, irrespective of its causality. This was one of the factors that was keeping sponsors away. Now with the amendment, the compensation would be awarded commensurate with the severity of the injury," Thatte said.
She was speaking at a press conference called at the AIIMS here, where few doctors and a patient, who have been associated with conduct of clinical trials, also participated.
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"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.
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.