Over 9,000 Serious Adverse Events Reported in India Clinical Trials in 5 Years: Govt Data
New Delhi: In a detailed disclosure before the Rajya Sabha, the Ministry of Health and Family Welfare reported that a total of 8821 Serious Adverse Events (SAEs) were recorded in clinical trials across India over the last five years, highlighting key concerns around participant safety.
The Ministry also provided comprehensive insights into clinical trial permissions, compensation paid, and regulatory measures to ensure transparency and oversight in the conduct of clinical research in the country.
The information was shared in response to a question raised by MP Jebi Mather Hisham regarding clinical trials conducted in the country.
The Ministry clarified that all clinical trials are regulated under the provisions of the New Drugs and Clinical Trials Rules, 2019, which mandate prior registration of every trial with the Clinical Trials Registry of India (CTRI), maintained by the Indian Council of Medical Research (ICMR), before enrollment of participants.
Providing an overview of trial activity, the government stated that clinical trial permissions are granted by the Central Drugs Standard Control Organisation (CDSCO), and details of such approvals are made publicly accessible through its official website. Additionally, comprehensive data on trials and their outcomes are available on the CTRI portal, which includes user-friendly tools such as e-modules and FAQs to improve accessibility and understanding for both researchers and the general public.
Further, the clinical trial permissions issued by Central Drugs Standard Control Organization (CDSCO) in Form CT-06 are regularly uploaded on CDSCO’s website for public accessibility.
In addition, the Ministry stated that Clinical trials conducted are multi-centric, conducted simultaneously across many centres/ states across the country. Serious Adverse Events (SAE) may occur during clinical trials due to multiple reasons depending upon the study drug, conditions of patient, concomitant drugs etc. Each case of SAE reported during conduct of CT/BA-BE study is examined as per the provisions of New Drugs and Clinical Trial Rules, 2019 for payment of compensation and free medical management on case-to-case basis.
Significantly, the data revealed that a total of 1,233 clinical trial permissions were granted between 2021 and 2025. During the same period, 9,821 Serious Adverse Events (SAEs) were reported, highlighting the inherent risks associated with clinical research. These adverse events may arise due to multiple factors, including the investigational drug, patient condition, or concurrent medications.
The number of clinical trial permissions granted, SAE reported and Compensation paid during last five years is as under:
| Year | Number of Permissions Granted | SAE Reported | Compensation Paid (Amount Rs. in cr) |
|---|---|---|---|
| 2021 | 268 | 1811 | 6.36 |
| 2022 | 219 | 2127 | 5.19 |
| 2023 | 249 | 2004 | 4.83 |
| 2024 | 213 | 1706 | 2.93 |
| 2025 | 284 | 2173 | 1.93 |
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