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.
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.
- New drug and clinical trial approval
- Biosimilar guidelines
- Local trial waivers for reference-regulator approvals
- CAR-T and cell therapy approvals
Pages like this
not linked directly; found by shared links- IdeaTie WHO essential-medicines listing to a published tiered price and supply pledge
Shares Imatinib, Trastuzumab, Prices and value, Most of the world has almost no cancer care.
- IdeaPooled procurement and voluntary licensing for essential cancer medicines in low-income countries
Shares Imatinib, Trastuzumab, Prices and value, Most of the world has almost no cancer care.
- IdeaPooled international procurement of essential adult cancer medicines
Shares Imatinib, Trastuzumab, 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 Trastuzumab, Monoclonal antibodies, Prices and value, Most of the world has almost no cancer care.
- IdeaBiosimilar-first defaults and payment parity in every cancer day unit
Shares Trastuzumab, Monoclonal antibodies, Prices and value.
- 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.
- IdeaPublic-sector CAR-T manufacturing in India, Brazil and South Africa under $50,000
Shares Tata Memorial Centre, Most of the world has almost no cancer care, CAR-T cell therapy.
- IdeaApprove cancer biosimilars on analytics and pharmacokinetics, no efficacy trials
Shares Trastuzumab, Monoclonal antibodies, Prices and value.