Parliament Question: Clinical trials conducted in the country

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE RAJYASABHA UNSTARREDQUESTION NO. 2016 TOBE ANSWERED ON10TH MARCH, 2026 CLINICALTRIALS CONDUCTED IN THE COUNTRY 2016.SMT.JEBI MATHER HISHAM: Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate: (a) the data on clinical trials registered and conducted in the country over the last five years, alongwith outcomes; (b) the details of compensation paid to participants in clinical trials over the last five years, necessitated underthe New Drugs andClinical TrialsRules, 2019; (c) the steps taken to increase awareness among patients, particularly with rare or chronic diseases, about ongoingclinical trials; (d) whether mechanisms exist to make clinical trial registry information accessible and understandable tothe public, the detailsthereof; and (e) the details of adverse events or side effects observed during clinical trials in the last five yearsandactionstaken,State/UT-wise? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SMT.ANUPRIYAPATEL) (a)to(e): Clinical trials of drugs are regulated as per the provisions of New Drugs and Clinical Trials Rules, 2019. As per the said rules, every clinical trial shall be registered with the clinical trial registry of India (CTRI), an online registry, maintained by the Indian council of Medical Research (ICMR), before enrolling the first subject for the trail. The details of clinical trials registered and conducted in the country over the last five years, along with outcomes is available on https://ctri.nic.in.An e-Module is available on the CTRI homepage to guide users and registrants. A comprehensive frequently asked question (FAQs) section is also available on CTRI website to assist both registrants and public in understanding the registration process andaccessclinicaltrial relatedinformation. 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.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 compensationandfree medical managementoncase-to-case basis. The number of clinical trial permissions granted, SAE reported and Compensation paidduring last five yearsisasunder: Year Number of Permissions SAEReported Compensation paid granted (Amount Rs. incr) 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 **********