Hyderabad:At least one person involved in a clinical trial for various drugs, formulations, and medicines, either as a participant, or a volunteer, has died every day in India in the last four and a half years.
Four persons every day during the same period – the precise figure is 4.2 persons – have experienced what are referred to as Serious Adverse Events (SAEs) that can precede related deaths in the country.
Just this year alone, in the first seven months till the end of July, 232 persons, whether participants seeking a cure for a health problem, or ‘volunteers’ in clinical trials, have lost their lives.
This data was received in response to an RTI inquiry filed with the Central Drugs Standard Control Organisation (CDSCO) by this correspondent. While the RTI inquiry specifically sought information with respect to SAEs and SAE-related deaths in Hyderabad and Telangana for the last five years, the CDSCO instead provided total country data on such cases.
The trend of at least one death a day of participants in a clinical trial is not just limited to the first seven months of this year, according to the CDSCO provided data.
From 2021 till the end of this year’s July, the CDSCO revealed that 1,705 were the “number of SAE (deaths) all over India.” During the same period, the total SAE (injury) cases in the country stood at 7,189, according to the RTI response from the Central government agency.
Only a few of all those who lose their lives end up receiving any compensation as this provision is not implemented unless it is proved that such a death is a result of participation in a clinical trial. According to the CDSCO’s response to the RTI inquiry, of all the 1,705 SAE deaths in the country from 2021 till the end of July 2025, “compensation was provided to 68 ‘subjects’ as per law.”
In March, the Supreme Court, hearing a PIL filed by Swasthya Adhikar Manch that said unethical clinical trials were being conducted in Madhya Pradesh and the rest of the country, had said that this was a “critical matter” and it would “monitor” the issue.
Amidst the daily clinical trial related deaths in the country, there are fears that Hyderabad — home to several clinical trials with more than 100 companies, hospitals among others registered for conducting such trials — too may not be a stranger either to SAEs, or SAE related deaths.
The CDSCO said that some information sought in the RTI inquiry with respect SAEs or related deaths linking them to the CROs, hospitals, or the drugs or pharmaceutical preparations that occurred in Hyderabad or rest of Telangana, replied that this information was exempted under Section 8(1)E of RTI Act 2005. This Section of the Act states “information available to a person in his fiduciary relationship, unless the competent authority is satisfied that the larger public interest warrants the disclosure of such information.”
The CDSCO, in response to a specific query in the RTI inquiry if it has noted any violations by companies/hospitals/CROs involved in such trials for the past five years in Hyderabad and Telangana, replied that “no such information available in this office.”
