The major obstacles in testing of new drugs, especially for those diseases whose is not yet available in India, have been cleared by the recent amendment to the compensation guidelines for carrying out clinical trials in the country.
"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 been either not participating in or withdrawing from trials," said Suneela Thatte, President of Indian Society for Clinical Research (ISCR).
AdvertisementShe added that to make sure the trials are carried out in the safest way, the new regulations seek to streamline the 'institutional ethical committee'.
"The guidelines earlier provided a blanket for any injury suffered by the patient, which the medical management had to provide 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," said Thatte.
YK 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 corrective measures. All institutional ethical committees for the trials have to be accredited and no trial can be conducted without the informed consent of a patient." He said that the amendment has added the provision of "recording and archiving" the interaction with the patient for future references.
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."
"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.
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