At the centre of this revolution was an unassuming but determined thirty-five-year-old scientist: Alka Dwivedi.
Dwivedi and her team had achieved what many thought impossible -- they had indigenously redesigned the most cutting-edge, patented cancer therapy of the West, capable of curing advanced blood and lymph cancers, and slashed its price by nearly 90 per cent without compromising on efficacy or safety.
It was the kind of medical breakthrough that might have made Dwivedi a household name anywhere else. But lost among the 1.4 billion people of India, she was barely recognized outside her circles, save some mentions in the Hindu and India Today. The Indian media was busy covering political turmoil and parliamentary elections when the news broke, while social media was captivated by the Ambani wedding, celebrity airport looks and influencer feuds. Dwivedi's achievement -- one that could save countless lives around the world for decades, if not centuries -- was drowned out by clickbait content and election drama.
Dwivedi's journey to this milestone was as remarkable as this cancer vaccine itself. Raised in the narrow lanes of dusty Mirzapur in rural Uttar Pradesh, she completed her schooling and early university in Mirzapur. She then pursed biotechnology for her master's at a little-known university in Nagpur. A brief internship at IISc, Bangalore during her master's opened her eyes to the world of serious scientific research.
She gained some industrial exposure at Japanese life sciences firm Daiichi Sankyo in Gurgaon, followed by a year-long stint at the Indian Agricultural Research Institute (IARI), New Delhi. There, she worked on plant-nematode interactions using RNA interference -- her first real brush with genetic engineering. After a year at IARI's iconic Pusa campus, she joined IIT Bombay's Biosciences and Bioengineering Department.
That's where she met Dr Rahul Purwar, an immunologist trained at Harvard Medical School and Hannover Medical School. Together, they set their sights on cancer immunotherapy -- often referred to as 'cancer vaccine' because it helps the body to generate its own immunity against cancer cells. Their objective: bring the Western designed CAR-T cell therapy to India and make it accessible to Indian patients. They got medical support from Dr Gaurav Narula and Dr Hasmukh Jain, two expert oncologists at the nearby Tata Memorial cancer hospital.
CAR-T cell therapy, hailed as a breakthrough in oncology, involves extracting a patient's T-cells, genetically engineering them with synthetic receptors (CARs) and reinfusing them into the body to hunt and destroy cancer cells. This 'living drug' has achieved astonishing success in treating blood cancers like leukemia and lymphoma since its advent, especially in children.1 But the cost was prohibitive -- up to ₹30-40 million (roughly $500,000) per patient even as cancer has been emerging as one of the worst killers in the modern world....
According to the National Cancer Registry Programme, the official source for India's cancer data, approximately 1.46 million new cancer cases are diagnosed each year in the country.... Besides this alarming data, a large number of cases go unreported beyond the coverage of cancer hospitals and in rural areas.
The incidence of cancer has been on the rise due to growing environmental pollution, over-use of plastics and chemicals and increasing dependence on processed and packaged food. The affected patients have been desperately seeking a cure. One of the reliable solutions that emerged in the West in the new millennium was CAR-T.
The concept of CAR-T originated in Israel in the late 1980s and was brought to clinical fruition by renowned oncologist Carl June's team in the US, with the launch of the first human trial in 2011. CAR-T cell therapy took immunotherapy to a highly personalized level -- a patient's own T-cells are extracted and genetically altered to recognize cancer. When infused back into the patient, these tailored cells seek out and destroy malignant cells with heightened precision.
In 2017, US FDA approved two CAR-T therapies -- Kymriah (Novartis) and Yescarta (Gilead) -- that made headlines for their remarkable success in treating certain leukemias and lymphomas, especially in children. The therapy marked a new era of 'living drugs' that are custom-made to each patient's cancer. Despite its promise, high costs and complex logistics made CAR-T therapy inaccessible for most of the world.
When Dwivedi arrived at IIT Bombay in 2015, CAR-T trials in the US were gaining momentum. But in India -- where nearly 1.5 million new cancer cases were being reported annually -- the therapy was out of reach for most. When she witnessed cancer patients lining up daily at the nearby Tata Memorial Hospital, the mission became a personal one for Dwivedi, setting her on track to develop a safe, effective and affordable version of CAR-T therapy in India, by India, for India.
Dwivedi led the technical process -- designing the CAR and producing the viral vector that delivers cancer-fighting genes into a patient's T-cells. But resources were scarce. A better equipped bioengineering lab was still under construction at IIT Bombay, and a variety of equipment had to be imported. Every step was a struggle. More significantly, researchers with know-how and hands on experience were hard to come by. The silver lining was that the project had received key support from Tata Trust in the beginning with ₹1.76 million and later from National Biopharma Mission through BIRAC, which sanctioned ₹191.5 million to fund the Phase I/II clinical trials.
A breakthrough came in 2017 after Dwivedi spent time at the US National Cancer Institute, where she picked up critical know-how in CAR-T cell manufacturing and viral vector development.
Returning to Mumbai, she cracked key challenges in CAR and vector production and began generating CAR T-cells in the lab. Animal trials showed promising remission rates. The project soon received a regulatory green light for clinical trials on cancer patients.
By 2021, the team had built a GMP-grade facility at IIT Bombay -- one that met WHO standards for sterility and safety. Clinical trials began shortly after, enrolling informed patients from Tata Memorial battling advanced leukemia and lymphoma.
4 June 2021 marked a historic milestone in India's cancer care journey. At the Bone Marrow Transplant unit of Tata Memorial Centre (TMC) in Mumbai, the country's first CAR-T cell therapy was successfully administered to patients by Narula and team. The results were stunning. Nearly three of four patients responded to the therapy, and almost half of them went into complete remission. Even more encouraging was the reduced toxicity. By tweaking the therapy design, the team managed to minimize dangerous side effects, making treatment safer and more tolerable.
Just as important was how they did it. Every component -- from viral vectors to cell-processing systems -- was made in India. No costly imports. No reliance on foreign patents. The result: a world-class CAR-T therapy at one-tenth the cost of its Western counterparts. In October 2023, the therapy -- branded NexCAR19 -- received approval from India's Central Drugs Standard Control Organization, becoming the country's first sanctioned CAR T-cell product.
By mid-2024, more than 150 patients had received NexCAR19. The team expects that number to cross 500 by 2025. Construction is underway on a larger manufacturing facility on the outskirts of Mumbai, with the goal of producing 1,200 treatments annually. The new site will house high-efficiency labs for vector and CAR T-cell production, along with expanded quality control units to accelerate turnaround time. The team dreams of bringing down the cost of the therapy to as little as ₹10,000 one day.