Guest column : India’s new regulatory environment hostile to clinical trials

Since January 2013, Indian regulatory authorities have announced a spate of laws and guidelines that will make a huge impact on the clinical trial sector in India.

These changes are the need of hour. If made in a pro-active manner over a period of several years, various stakeholders such as the industry, investigators and ethics committees that these rules impact, will have had adequate time to adapt to them. Instead, these changes have been reactive – in point, a reaction to the Supreme Court’s orders.

Besides, the manner in which they have been made will only serve to make clinical trials in India slow and expensive, compelling sponsors to look at alternatives.

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India and clinical trials : no denoument in sight

There are murmurs among clinical research industry executives that India’s health ministry will reexamine some of the clauses in the rules on compensation in case of clinical trial injury that it had notified in the Gazette of India in February and that had caused grave concern among trial sponsors.

This follows discussions between the industry and high-level ministry officials including the Director General of Health Services, clinical research industry sources said.

India & clinical trials: PhRMA weighs in

In a guest column, Jay Taylor, vice-president (international affairs) at US-headquartered Pharmaceutical Research and Manufacturers of America (PhRMA), a vocal representative of Big Pharma interests, argues that “much of the characterization of the clinical trial environment has been sensationalized.. (is) overstated or simply wrong.” Among other things, he states that the death rate for patients enrolled in clinical trials in India is approximately half of the death rate for the country’s general population.  Read on for his views.