Parliament Question: Clinical Trials for New Medicines

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE LOK SABHA UNSTARREDQUESTION NO. 3668 TOBE ANSWERED ON13TH MARCH, 2026 CLINICALTRIALS FORNEW MEDICINES †3668.SHRIANILFIROJIYA: Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate: (a) whether clinical trials for new medicines are being conducted in the country for such serious andincurable diseases for which no complete cure is currently availableand if so, the detailsthereof,disease-wise; (b) whether the Government is pleased to state the names of the diseases for which trials of medicines have currently been granted approval by the Central Drugs Standard Control Organization (CDSCO) andthe stages theyare in,if so, the detailsthereof; (c) whether the Government has an estimate as to by when the medicines of these ongoing clinicaltrialsare likelytobe made availablefor generaluseandthe expectedtimelinethereof, disease-wise; and (d) whether the Government proposes to implement any special policy to provide financial assistance, insurance coverage or accelerated approval mechanisms for patients suffering from incurable andrare diseases during the trials, if so, the detailsthereof? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SMT. ANUPRIYAPATEL) (a)to(d): Permissions for clinical trials are approvedand regulatedby the Central Drugs Standard Control Organisation (CDSCO) under the provisions of the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trials Rules, 2019. These trials cover diseases such as cancer, rare genetic disorders, neurodegenerative diseases, autoimmune disorders, infectiousdiseases, andotherserious medical conditions. The details of approved clinical trials, including disease indication and trial phase, are available on the Clinical Trials Registry of India (CTRI) on https://ctri.nic.in, an online registry, maintainedbythe IndianCouncil of Medical Research (ICMR).The approval andavailability of medicinesfor general use subsequent toclinical trials depends on the successful completion of required phases by manufacturer/importer and subsequent regulatory evaluation for safety, efficacy and quality by regulator. The timelines varydependinguponthe nature of the disease, trial outcomesandregulatoryreview. The Government has taken several measures to facilitate clinical research and protect patient interests. The New Drugs and Clinical Trial Rules, 2019 provides provisions for accelerated approval, waiver or relaxation of certain clinical trial requirements in specific cases such asdrugs for life-threateningdiseases, rare diseases andunmetmedicalneedsunder the said rules. 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. *******