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institutionsInstitution
Central Drugs Standard Control Organization
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.
Also called: CDSCODrugs Controller General of IndiaDCGI
Overview
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.
Location
New Delhi, IN
Type
government
Website
Newsweek 2026 oncology rank
Not in top 300 listing used
OnCo score
#371 · 16 points (0 Newsweek + 0 NCI + 16 from 8 linked objects) · ranking
- New drug and clinical trial approval
- Biosimilar guidelines
- Local trial waivers for reference-regulator approvals
- CAR-T and cell therapy approvals
Similar pages
- IdeaPooled procurement and voluntary licensing for essential cancer medicines in low-income countries
Shares Imatinib, Prices and value, Trastuzumab, Most of the world has almost no cancer care.
- IdeaTie WHO essential-medicines listing to a published tiered price and supply pledge
Shares Imatinib, Prices and value, Trastuzumab, Most of the world has almost no cancer care.
- IdeaPooled international procurement of essential adult cancer medicines
Shares Imatinib, Prices and value, Trastuzumab, Most of the world has almost no cancer care.
- IdeaPool purchasing of essential cancer medicines across countries
Shares World Health Organization Cancer Programme, Imatinib, Prices and value, Most of the world has almost no cancer care.
- IdeaWHO prequalification plus pooled demand to push biosimilar prices below 10% of the originator
Shares Prices and value, Trastuzumab, Most of the world has almost no cancer care, Monoclonal antibodies.
- TermNovartis v. Union of India (Glivec, 2013)
Shares India New Drugs and Clinical Trials Rules 2019, Imatinib, Prices and value, Most of the world has almost no cancer care.
- IdeaMedicines Patent Pool licences for every patented cancer drug on the WHO list
Shares Imatinib, Prices and value, Most of the world has almost no cancer care.
- IdeaBiosimilar-first defaults and payment parity in every cancer day unit
Shares Prices and value, Trastuzumab, Monoclonal antibodies.
technologies
drugs
ApprovedSmall-molecule kinase inhibitor (BCR-ABL, KIT, PDGFRA)
Imatinib · Gleevec
ApprovedMonoclonal antibody (anti-HER2)
Trastuzumab · Herceptin (and biosimilars, Phesgo with pertuzumab)