Parliament Question: Transparency and public trust in the vaccine approval process

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE RAJYASABHA UNSTARREDQUESTION NO. 3614 TOBE ANSWERED ON24TH MARCH, 2026 TRANSPARENCYAND PUBLIC TRUSTIN THE VACCINEAPPROVALPROCESS 3614.SHRIA. D. SINGH: Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate: (a) the criteria and process followed for the approval of COVID-19 vaccines used in the country; (b) whether the approvalinvolved emergencyuse authorization and; (c)whether the scientific evidencewere considered inthisregard; (d) if so, whether the post-approval safety and efficacy monitoring mechanisms are in place; and (e)how Government ensures transparency andpublic trust inthe vaccineapprovalprocess? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SMT.ANUPRIYAPATEL) (a)to(e): Central Drugs Standard Control Organization (CDSCO) regulates quality, safety and efficacy of vaccines as per the provisions of New Drugs and Clinical Trials (NDCT) Rules, 2019 under Drugs and Cosmetics Act, 1940. As per the said rule, vaccines includingCOVID-19 vaccineare considered as“newdrugs”. All applications for manufacturing/import of vaccines for sale and distribution in the country are required to be submitted along with pre-clinical and clinical data, Chemistry, Manufacturing, Control (CMC) data asperprovisions of NDCT Rules, 2019. These applications are reviewed by CDSCO in consultation with Subject Expert Committees (SECs) for clinical trial dossier and Central Drugs Laboratory (CDL), Kasauli Himachal Pradesh for quality dossier. Based on review of submitted data and recommendations of Subject Expert Committee (SEC) and CDL, Kasauli, permissions are granted to manufacture or import vaccines in the country. All the manufacturers & importers of human vaccines are required to send the samples along with protocol of manufacturing & testing of each batchto CDL, Kasauli for the purpose of lot-release before the final release of vaccines for sale and distribution in the country. Further, all manufacturers & importers have tocomplywith Post Marketing requirementsasprescribed underthe NDCTRules, 2019.As perthe provisions of NDCTRules, 2019 andinlight of urgent needdue toCOVID pandemic in the country and based on the recommendations of Subject Expert Committee (SEC COVID-19), COVID vaccines were granted permissions by CDSCO for prevention of COVID-19. For ensuring transparency and public trust, details of approved vaccine such as recommendations of Subject Expert Committee (SEC COVID-19) and summary of product characteristics (SmPC) containing quality, safety, immunogenicity and/or efficacy details are publicallyavailable onCDSCO website www.cdsco.gov.in. **********