1,104 people die during clinical trials in India in 3 years

A total of 1,104 people have died during clinical trials of various drugs and procedures in India in the last three years, according to the ministry of health and family welfare.

However, not everyone who died during clinical trials are found to have died from the procedure through subsequent examinations.

Only the patients who are proven to have died due to the effect of the trial are eligible to get compensation from the sponsor of the study.

Out of the 1,104 persons who died while undergoing clinical trial between 2015 and 2017 in India, only 49 persons were held to have died due to reasons related to the trial itself, according to the data with the ministry.

The relatives of these 49 people were paid a total compensation of around Rs 3.82 cr, which works out to about Rs 7.8 lakh per dead patient.

The rules for Clinical Trials in India used to be among the most liberal, but have been made more strict in recent years due to complaints of exploitation and misuse.

In February this year, the government also came out with a new set of draft rules for clinical trials in India, including a provision to pay 60% of the compensation on an interim basis.

Some of the draft rules were opposed by the industry and clinical trial organizations, including the World Health Organization, which also runs the International Clinical Trials Registry Platform.

The government said it received an email from the WHO expressing apprehension that there was a possibility that sponsors would not conduct clinical trials in India and go elsewhere due to such provisions.

The final rules are expected to be released later this month.

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