Indian clinical trials: 211 deaths in first half of 2012

Latest study by the The Times of India revealed 211 clinical trial deaths in India from January to June this year. However, authorities are still uncovering the true cause of fatalities- trials or the result of disease.

For study-related deaths, the Union health ministry necessitates study conductors to provide medical care and compensation to the patient's family. However, the amount of compensation is determined by the company holding the trial. For instance, families of the 22 people who died during clinical trials in 2010 were paid about Rs 50 lakh in all by pharmaceutical companies, including Wyeth, Quintiles, Lilly, Bayer, Bristol Mayer, Sanofi, and Pfizer. Most of the families received Rs 1.5 lakh and Rs 2.5 lakh as a one-time settlement. This, only after companies initially refused to pay compensation for majority of the deaths.

Hence, as reported in the Times, India’s Central Drugs Standard Control Organization (CDSCO) is looking to change just that. It has proposed compensation to be meted out “on the basis of age of the deceased, income, seriousness and severity of the disease the subject was suffering at the time of his/her participation in the trial and percentage of permanent disability.” Hence, based on the proposed, younger patients will be receiving higher compensation.

However, this problem with Indian trials would not be easily solved. Lack of clinical standards and proper regulations make it difficult to ensure safety and accountability. "This lack of oversight makes it impossible for regulators to make sure trials are safe", experts say.

To learn how to establish clinical trial success in Asia and navigating through this ever changing regulatory landscape, join us at Pharma Trials World Asia 2013, 19-20 March in Singapore.

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