Clinical research: Regulatory uncertainty hits drug trials in India

A. Nair | The Pharmaceutical Journal | 12 March 2015

An avalanche of reforms to rules governing the conduct of clinical trials in India has led to an exodus of drug companies and research organisations.

Shirin Abdul Khan was 16 years old when in 2009 she was enrolled as a volunteer in a clinical trial to study the effects of adding vitamin D to conventional treatment for patients newly diagnosed with pulmonary tuberculosis. Along with many of her school friends, she was lured by the easy money.

“It was harmless,” Khan says. “We just had to sign a blank form every time the money was given. Whenever I had to go for a check-up, once a month, they would pay us 150 rupees (US$2.50). It was good money for a school student.”

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