Parliament Question: Promotion of animal-free drug testing methods in the country

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE RAJYASABHA UNSTARREDQUESTION NO. 2843 TOBE ANSWERED ON17TH MARCH, 2026 PROMOTION OFANIMAL-FREE DRUG TESTING METHODS IN THE COUNTRY 2843.SHRISNIRANJAN REDDY: Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate: (a)whether Government hasexaminedthe needtopromote animal-free drug testing methods, including non-animal methods (NAMs) such as organ-on-chip, AI-based models and human- cell-basedassays; (b) whether India proposes to align its regulatory framework with global developments in phasing out animaltesting for drug development; (c) the steps taken to strengthen infrastructure, validation mechanisms and funding support for adoptionof NAMs inthe country; and (d) whether any dedicated centres of excellence or national platformsare beingestablished to promote research, industry collaboration and faster adoption of human-relevant testing technologies? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SMT.ANUPRIYAPATEL) (a)to(d): Central Drugs Standard Control Organization (CDSCO) regulates safety, efficacy and quality of the drugs for Human and Animals use under the provisions of Drugs & Cosmetics Act, 1940& Rules, 1945 made there under. A provision has been incorporated in Indian Pharmacopoeia (IP) - General Monograph, Addendum 2024 (to IP 2022) under General requirement of Veterinary Vaccine wherein the batch safety test using target animals may be omitted if conditions prescribed thereinare complied. Ministry of Health and Family Welfare has published G.S.R. No. 175 (E) dated 09.03.2023, wherein non-clinical testing methods has included cell-based assay, organ chips and microphysiological systems, sophisticated computer modellingand otherhuman biology -based test methodsunderthe New Drugs andClinical Trials(NDCT) Rules, 2019. NDCT Rules, 2019 contains provisions that the animal toxicology studies may be planned, designed and conducted as per the International Council for Harmonization (ICH)guidelines to promote safe, ethical development and availability of new drugs with reduced use of animalsinaccordance with 3R (Reduce/Refine/Replace)principles. Department of Biotechnology under Ministry of Science & Technology has informed about its support to research & innovation for developing processes or technologies for application of non-animal methods in areas of cell therapy, pre-clinical models for drug discovery for screening drugs/lead molecules/ new chemical entities/ vaccines, and in-vitro based modelsfor disease biology. Biotechnology Research and Innovation Council-inStem (Institute for Stem Cell Science and Regenerative Medicine (BRIC-inStem) under Department of Biotechnology is involved in 3D tissue and organoid models to test and quantify the developmental toxicology of new chemical entities for drug discovery programs by eliminating the use of animal models. Through Biotechnology Industry Research Assistance Council (BIRAC), several projects have been supported for developing 3D organoid models, organ-on-chip, in-vitro modelsystems andplatformsfor non- animal methods. Under the Precision Biotherapeutics-monoclonal antibodies vertical, of the Biomanufacturing initiative recently, the Department of Biotechnology has supported a project on "Validation of a Human-Relevant Lung-on-Chip Platform” as an alternative to Animal Models for PreclinicalToxicity Assessment of Monoclonal Antibodies" at Institute of ChemicalTechnology, Mumbai. **********