Clinical trials claimed 1,631
The registry is available with the Indian Council of Medical Research
Kochi: Around 1,631 persons have died during clinical trials between January 2012 and May 2015 in the country, according to the Director of General of Health Services.
A Kochi-based RTI activist, S. Dhanraj of Kochi, a techie working at Kochi Special Economic Zone, got the information under the Right to Information Act.
According to Mr Jayant Kumar, public information officer, the DGHS had granted permission for 241 global clinical trials primarily on imported medicines or investigational new drugs for testing during the same period in the country.
The DGHS, however, refused to divulge any details of the hospitals and the deceased or the number of criminal cases registered with regard to the clinical trials.
Around 1,631 serious Adverse Events (SAEs) of death were reported during clinical trials between January 2012 to May 14 , 2015.
Death or injury in clinical trials may occur due to various reasons such as critically or terminally ill patients suffering from cancer, cardiovascular disease, AIDS etc or due to other unforeseen reasons in hospital/institutes where clinical trials are permitted for the medicines.
The registry is available with the Indian Council of Medical Research. The DGHS also refused to reveal the details of illegal clinical trials happening in India and their results.
“Certain reports regarding the conduct of alleged illegal clinical trials were received which are under investigation. Such information is exempt from disclosure as per the section 8 (1) of RTI Act 2015,” it said. As per an earlier data, 1,600 persons died between 2008 and 2010.