Just 10% of those harmed in clinical trials in India receive compensation

pharmafile | January 21, 2019 | News story | Sales and Marketing |  India, WHO, clinical trials, compensation, health 

Clinical trials have led to nearly 5,000 deaths in India since 2005, while just a fraction of those affected have received compensation.

Overall 4,967 people have lost their lives in clinical trials conducted in both government and private hospitals in India since 2005. Meanwhile hundreds of patients developed side effects resulting in some cases in cancer, paralysis, asthma, and skin conditions.

“Since 2005, nearly 17 thousands clinical drug trails were conducted in the country. However, 4967 people lost their lives in various trials. Whereas hundreds of patients were diagnosed with cancer, paralysis, asthma, skin related diseases among others,” according to the non-profit organisation Swasthya Adhikar Manch.

To date only 508 of those affected have received compensation, despite provisions made in 2013. Meanwhile, of the family’s whose relatives have died, just 187 have been compensated. The law mandates that sponsors of clinical trials must pay a 60% upfront compensation fee within 15 days, if a human participant was found to have suffered permanent disability or death as a result of a clinical trial.   

However the government is now considering scrapping the law after industry leaders and health experts warned that sponsors would no longer see India as an attractive location for clinical trials.

The proposal comes after the WHO raised concern that the quick turnover would not allow due process. Writing in a letter to Union health secretary Preeti Sudan, WHO deputy director general Soumya Swaminathan, wrote: “In this case, 60 per cent of the fee has to be paid upfront before the central licensing authority goes through its expert review process to adjudicate and this is not reimbursable regardless of the decision of the further steps of the process.”

She further warned that: “[the law] will also hamper WHO’s work with India where we consider that it is a public health priority to conduct trails on a particular condition in India, WHO ourselves may not wish to act as a sponsor, and other partners may be similarly discouraged.”

Louis Goss