No clinical trials equals no new drugs: ISCR prez

India is home to 16 percent of the global population, and carries 20 percent of the global disease burden. However, the country’s contribution towards clinical research is a mere 2 percent. Industry experts attribute this to India’s draconian regulations


Ms Suneela Thatte, president, Indian Society for Clinical Research (ISCR)

Q: What is the current status of clinical research in the country now?
Ms Suneela Thatte: Currently clinical research is hit by two primary reasons. Firstly, it is the clinical research review and approval timelines, which are very unpredictable.

The waiting period is making India a more unattractive destination for clinical research organizations (CROs), and as well as for academicians to carry out clinical trials in the country.

Secondly, the compensation guidelines have totally tilted the balance, and there is a massive misuse potential factor to it. This is driving a lot of organizations away.

This is not just affecting industrial research but also academics. Usually academic researches operate on tight budgets. The current guidelines require that an average compensation payment be between Rs 35-45 lakh. This amount could be the actual proposed budget for the entire clinical trials.

As a result, investigators are scared to do clinical trials, patients are doubtful about participating, and sponsors hesitate to conduct trials in India.


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