One Death a Day: 1,705 Lives Lost in India's Clinical Trials Since 2021, RTI Reveals

This information was provided by CDSCO in response to an RTI query, which had sought SAE-related data for Hyderabad and Telangana. Instead, the regulator shared nationwide figures. The CDSCO’s reply, accessed through an RTI application, shows that between 2021 and July 2025, 1,705 participants died due to Serious Adverse Events (SAEs) during clinical trials across the country. In the same period, 7,189 cases of non-fatal SAEs were recorded—an average of 4.2 people every day experiencing life-threatening side effects. For this year alone, from January to July 2025, 232 clinical trial participants lost their lives, whether they had enrolled as patients seeking treatment or as volunteers. The Medical Dialogues Team had earlier reported that a 33-year-old man died at his brother's home in Jalahalli after taking under-trial medication. He had been involved in a clinical trial conducted by R and D company. As per a recent media report in the Deccan Chronicle, even with the high death toll, compensation is still uncommon. Merely a small percentage of all reported fatalities receive any compensation because this clause is not used unless it can be established that the death was caused by taking part in a research experiment. In relation to the above, the CDSCO replied to the RTI inquiry that, 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.” The CDSCO said that certain details sought in the RTI inquiry—particularly regarding SAEs or related deaths linked to CROs, hospitals, or specific drugs and formulations in Hyderabad and the rest of Telangana—could not be disclosed. The regulator cited Section 8(1)(e) of the RTI Act, 2005, which 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.” In response to another query on whether any violations were noted by companies, CROs, or hospitals in Hyderabad or Telangana over the past five years, the CDSCO replied, “No such information is available in this office.”