Patients suffer as new norms impede clinical trials in India

Doctors have said the decline in the number of clinical trials is a loss to patients, who are being deprived of cutting edge drugs that clinical trials can offer.

In the last two years, just 25 Global Clinical Trials (GCT) were approved to be conducted in India.

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Doctors have said the decline in the number of clinical trials is a loss to patients, who are being deprived of cutting edge drugs that clinical trials can offer.

Indian Society for Clinical Research (ICSR) and academic researchers have said India has now fallen behind smaller countries like Korea, Taiwan and Japan because of the new regulations were framed following a public interest litigation (PIL) in the Supreme Court.

The re gulations were enforced based on the recommendations of the Professor Ranjit Roy Choudhury expert committee appointed by the ministry of health and family welfare.

They have made it difficult for clinical trials to be carried out in the country. Some of the contentious regulations range from providing ancillary care to the clinical trial participant to compensation for injury or death even at a later stage of life.

“The new guidelines have brought clinical research in India to a grinding halt. While the intention of the new guidelines may be well meaning, but at the same time, they are so irrational that all the stakeholders in a clinical research are wary of applying for clinical trials,” said Suneela Thatte, president ICSR.

Data provided by I ACR revealed that less than 1.5% of global clinical trials are conducted in India. Of 1,80,649 clinical trials in 178 countries, just 2,563 studies or 1.4% are being done in India.

“After the new regulations were introduced, the National Institute of Health, USA, which was going to collaborate for as many as 40 clinical trials in India, decided to pull out,” said Dr CS Pramesh, surgical oncologist at Tata Memorial Hospital and lead investigator of many national and international trials.