HOW INDIA BUILT
ITS OWN CAR-T
The origin of NexCAR19 โ from Prof. Rahul Purwar's IIT Bombay laboratory to CDSCO approval โ is the most important story in global oncology access of the last decade.
analyticsAt a Glance
- check_circleImmunoACT founded 2018 as IIT Bombay spin-off with TMC collaboration
- check_circleProf. Rahul Purwar lab led CAR-T construct development from 2016
- check_circleGovernment-funded via DBT and DST โ not reliant on private pharma
- check_circleNature Medicine 2024 publication sealed the evidence base
The Origin: Prof. Rahul Purwar's IIT Bombay Laboratory
The story of Indian CAR-T begins in the Department of Biosciences and Bioengineering at IIT Bombay, where Prof. Rahul Purwar began investigating T-cell engineering around 2016 โ years before CAR-T was commercially available anywhere in Asia.
โThe decision to build from scratch โ not licence from Novartis or Kite โ is what made a $30,000 price point possible.โ
Prof. Rahul Purwar โ IIT Bombay
Prof. Purwar's lab focused on T-cell immunology and cancer immunotherapy. Recognising that global CAR-T prices would be prohibitive for Indian patients, his team set out to develop a domestically manufacturable CD19 CAR construct from first principles โ not licenced from any foreign IP.
Dr. Navin Khattry โ Tata Memorial Centre BMT Unit
The clinical translation was led by Dr. Navin Khattry and the Bone Marrow Transplant unit at Tata Memorial Centre Mumbai โ India's premier cancer institute. TMC provided the patient population, clinical expertise, and the regulatory credibility needed for a CDSCO application.
From Laboratory to Marketing Approval: The Development Timeline
The journey from academic concept to CDSCO-approved product took approximately 7 years โ fast by any standard, remarkable for an academic institution in an emerging market.
- 1
2016 โ IIT Bombay CAR-T Programme Initiated
Prof. Purwar's lab begins CD19 CAR construct design and preclinical T-cell engineering work.
- 2
2018 โ ImmunoACT Founded
ImmunoACT is incorporated as an IIT Bombay spinoff to commercialise the CAR-T platform. DBT and DST provide early-stage government funding.
- 3
2019โ2020 โ IND Application and Regulatory Filing
Investigational New Drug (IND) application filed with CDSCO. Pre-clinical safety and efficacy data packages submitted.
- 4
2021โ2022 โ Academic Clinical Trial
33-patient first-in-human trial enrolling B-ALL and DLBCL patients at Tata Memorial Centre. Manufacturing at the ImmunoACT GMP facility.
- 5
July 2024 โ Nature Medicine Publication
Full trial results published: 73% overall CR, 81% B-ALL CR, 58% DLBCL CR. Safety profile better than Western comparators.
- 6
October 2023 โ CDSCO Marketing Approval
NexCAR19 receives full marketing approval from CDSCO โ the first Indian-developed CAR-T product ever approved anywhere in the world.
Government Funding: Why India's Model Is Different
Unlike Western CAR-T products that required hundreds of millions in private venture capital, NexCAR19 was substantially funded by the Indian government โ a model that allowed pricing decisions unconstrained by VC return requirements.
Department of Biotechnology (DBT)
DBT provided direct grants to IIT Bombay and ImmunoACT under its biotechnology development programmes, funding GMP facility build-out, manufacturing process development, and early clinical trial costs.
Department of Science and Technology (DST)
DST supported the basic science and technology transfer aspects of the programme, including the IIT Bombay incubation infrastructure through which ImmunoACT was supported in its earliest years.
How Public Funding Enabled Affordable Pricing
Because the foundational R&D and manufacturing scale-up was government-funded rather than VC-backed, ImmunoACT was not obligated to price NexCAR19 to recoup $500M+ investment rounds. This structural difference โ not manufacturing efficiency alone โ explains the $30โ40K price point.
A Replicable Model for Other Countries
The ImmunoACT model is now studied by Brazil, South Africa, Egypt, and other countries as a blueprint for domestic CAR-T development. WHO and Wellcome Trust have cited the programme in discussions about global health equity in advanced oncology.
The Programme by the Numbers
- 33Trial PatientsFirst-in-human academic trial at Tata Memorial Centre, B-ALL and DLBCL combined.
- >95%Mfg Success RateManufacturing success rate โ product successfully released for infusion in >95% of attempts.
- ~7 yrsLab to ApprovalFrom Prof. Purwar's initial programme (~2016) to CDSCO marketing approval (October 2023).
- 1stIn India + WorldFirst Indian-developed CAR-T; first approved CAR-T from any LMIC country.
Global Significance: Why the LMIC World Was Watching
Before NexCAR19, CAR-T therapy was effectively a treatment that existed only for patients in the USA, Europe, Japan, and wealthy segments of China. The 85% of the world's cancer burden living in LMICs had no access pathway.
From 'Theoretically Available' to 'Actually Accessible'
Kymriah was approved in the USA in 2017. For most patients in Africa, South Asia, Southeast Asia, and Latin America, it remained out of reach โ not because of lack of facilities but purely because of cost. NexCAR19 changes that calculus for the first time.
Comparable Efficacy โ Not a Compromise
NexCAR19's 81% CR in B-ALL matches Kymriah's ELIANA trial result exactly. The lower CRS rate (6% grade 3+ vs ~22% for Kymriah in ELIANA) suggests the NexCAR19 safety profile may actually be advantageous in lower-resource settings where ICU capacity is more limited.
More from the CAR-T India Resource Library
Explore the full context โ from NexCAR19's clinical data to how to access treatment as an international patient.
- CAR-T Cell Therapy in India โ Complete Guide
- What Is NexCAR19 and Why Is It the World's Most Affordable CAR-T?
- NexCAR19 Clinical Trial Results: What the Pivotal Data Shows
- CAR-T Trials at AIIMS and CMC Vellore
- CAR-T for B-Cell ALL in India: Paediatric and Adult Programmes
- How to Access CAR-T Cell Therapy in India via CancerFax
Frequently Asked Questions
Is ImmunoACT a private company or government organisation?
ImmunoACT is a private company โ a spin-off from IIT Bombay incorporated in 2018. However, it received substantial early-stage public funding from India's Department of Biotechnology (DBT) and Department of Science and Technology (DST). IIT Bombay holds IP rights, and ImmunoACT holds the commercialisation licence. It is not a government entity, but it is closely linked to the academic and public research ecosystem.
Where is NexCAR19 manufactured?
NexCAR19 is manufactured at ImmunoACT's GMP facility located within IIT Bombay's campus in Mumbai. Leukapheresis (T-cell collection) is performed at the treating hospital. The T-cells are transported to the ImmunoACT facility, engineered and quality-tested, then returned to the hospital for infusion. The whole process takes 3โ4 weeks.
How many patients have received NexCAR19 since approval?
As of the information available to CancerFax, NexCAR19 has been administered to over 50 patients since commercial approval in October 2023, with the programme expanding across additional licensed centres. The exact commercial-use numbers are not publicly disclosed by ImmunoACT, but Tata Memorial Centre and other approved hospitals report growing caseloads.
Are there other Indian institutions developing CAR-T therapies?
Yes. AIIMS New Delhi and CMC Vellore both have investigational CAR-T programmes underway, though none have reached marketing approval status as of 2024. These are academic trials rather than approved commercial products. ImmunoACT and NexCAR19 remain the only CDSCO-approved Indian-origin CAR-T product currently available commercially.
How CancerFax Helps
CancerFax is a specialist cancer access and patient-navigation platform. We help patients and families understand their options, organise medical records, coordinate hospital communication, and support cross-border treatment planning where appropriate.
We help collect and organise reports, scans, pathology, biomarker results, and treatment history for structured case review.
We communicate with hospitals or trial teams to assess whether a case may be suitable for further screening.
We support appointment coordination, document submission, translation, and direct communication with international departments.
For international patients, we help with practical coordination โ travel planning, hospital admission guidance, and local support.
If this option is not suitable, we help explore other relevant treatments, clinical trials, or advanced care pathways.
From inquiry through to follow-up, our coordinators provide a single point of contact for the family.
CancerFax does not guarantee treatment access, eligibility, or clinical outcome. Our role is to help patients access accurate information, structured review, and appropriate specialist pathways.
Interested in NexCAR19 at Tata Memorial or Another Indian Centre?
CancerFax coordinates access to ImmunoACT-licensed centres across India, including eligibility assessment, records review, and end-to-end travel logistics for international patients.
This content is for informational purposes only and does not constitute medical advice. Always consult a qualified oncologist before making treatment decisions.