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Report: 211 die during drugs trials in India

Some 211 people died during clinical trials for new drugs in just six months in India, an official reportedly said.

The Times of India newspaper said investigations were underway to see how many of the deaths were caused by the drugs or by diseases affecting the trial subjects, such as cancer.

The Times said that in 2011 some 438 cases of serious adverse events were reported, with 16 later found to be due to clinical drugs trials.

India’s Central Drugs Standard Control Organization has now proposed ways to reduce the number of problems and a new formula for compensation, the paper reported.

Compensation is currently decided “according to the will” of the drug company, the Times added. Previous compensation payments of families of people who died during trials amounted to just a few dollars.

"When a 70-year-old patient who is terminally ill dies during a clinical trial due to an adverse reaction of the drug, the compensation should be less than that given to a 22-year-old man in the first stage of the same disease who dies of the same drug," a CDSCO official told the paper.

"The youth could be the sole bread-winner of the family and would have lived longer but for the adverse drug reaction. So, the guidelines quantify accordingly who should get how much compensation. At present, both could get the same amount and it could be abysmally low if decided by the pharmaceutical company,” the official added.

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