{"entity":{"id":"cdsco","kind":"institution","name":"Central Drugs Standard Control Organization","aka":["CDSCO","Drugs Controller General of India","DCGI"],"tldr":"India's national drug regulator, headed by the Drugs Controller General of India, which approves new cancer drugs and oversees the generics and biosimilars industry that supplies much of the world.","summary":"CDSCO, under the Ministry of Health and Family Welfare, approves new drugs and clinical trials, licenses vaccine and biologic manufacturing and sets standards, while state authorities license most manufacturing and sale. India's generic and biosimilar manufacturers supply low-cost versions of trastuzumab, bevacizumab, rituximab and imatinib domestically and to many countries, and CDSCO's New Drugs and Clinical Trials Rules 2019 shortened trial approval timelines and introduced waivers of local trials for drugs approved by reference regulators. Price regulation of essential cancer medicines is handled by the National Pharmaceutical Pricing Authority. India's first domestically developed CAR-T (NexCAR19) was approved by CDSCO in 2023.","asOf":"2026-09-09","links":[{"label":"CDSCO","url":"https://cdsco.gov.in"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["car-t","monoclonal-antibody"],"targets":[],"drugs":["trastuzumab","imatinib"],"companies":[],"institutions":["tata-memorial","fda-oce","who"],"pathways":[],"terms":[],"trials":[],"people":["rajeev-singh-raghuvanshi"],"bottlenecks":["b-global-access","b-drug-pricing"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"city":"New Delhi","country":"IN","lat":28.614,"lng":77.209,"institutionType":"government","website":"https://cdsco.gov.in","programs":["New drug and clinical trial approval","Biosimilar guidelines","Local trial waivers for reference-regulator approvals","CAR-T and cell therapy approvals"]},"route":"/institutions/cdsco/","neighbours":{"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"drug":[{"id":"imatinib","kind":"drug","name":"Imatinib","route":"/drugs/imatinib/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"}],"institution":[{"id":"fda-oce","kind":"institution","name":"FDA Oncology Center of Excellence","route":"/institutions/fda-oce/"},{"id":"icmr","kind":"institution","name":"Indian Council of Medical Research","route":"/institutions/icmr/"},{"id":"tata-memorial","kind":"institution","name":"Tata Memorial Centre","route":"/institutions/tata-memorial/"},{"id":"who","kind":"institution","name":"World Health Organization Cancer Programme","route":"/institutions/who/"}],"person":[{"id":"rajeev-singh-raghuvanshi","kind":"person","name":"Rajeev Singh Raghuvanshi","route":"/people/rajeev-singh-raghuvanshi/"}],"bottleneck":[{"id":"b-global-access","kind":"bottleneck","name":"Most of the world has almost no cancer care","route":"/bottlenecks/b-global-access/"},{"id":"b-drug-pricing","kind":"bottleneck","name":"Prices and value","route":"/bottlenecks/b-drug-pricing/"}],"idea":[{"id":"idea-cost-voluntary-licensing-oncology","kind":"idea","name":"Voluntary licences and price caps for patented cancer drugs in low-income countries","route":"/ideas/idea-cost-voluntary-licensing-oncology/"}],"term":[{"id":"india-new-drugs-rules-2019","kind":"term","name":"India New Drugs and Clinical Trials Rules 2019","route":"/terms/india-new-drugs-rules-2019/"}]}}