Thirty-five-year-old Ritu Bhalla was twice diagnosed with blood cancer, at the ages of four and 11. She developed chronic hepatitis B as a long-term side-effect after cancer treatment.

Three years ago, while waiting for a follow up consultation in a hospital in Delhi, a woman who was not part of the hospital staff approached Bhalla – she asked her to provide a blood sample and sign a consent sheet to take part in a gastrointestinal clinical trial. But she did not explain why.

Bhalla asked for the information sheet or details of the study, but that only annoyed the woman, who she assumed was a trial coordinator, she said. Since no one came forward to explain the study, she refused to participate.

Experts say Bhalla’s experience isn’t a one-off occurrence. This is even as India’s regulatory framework covering clinical trials was significantly strengthened after the Supreme Court’s intervention in 2013, and subsequent amendments were made to the Drugs & Cosmetics Rules.

New rules include provisions for compensation to trial participants, and recording consent on video, especially among vulnerable populations. These, and mandatory registration of ethics committees with the central licensing authority, CDSCO, have improved safeguards for participants, said Poonam Bagai, founder and chairman, CanKids…KidsCan, which also hosts the Pediatric Cancer Research Institute (pCRI),...

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