In recent years, immunotherapy has expanded the limits of cancer treatment. Therapies that harness the body’s immune system to fight malignant cells have improved survival rates in cancers once considered terminal. Yet, some of these breakthroughs, such as Merck & Co’s Keytruda, have also become a source of ethical unease. An investigation by this newspaper, in collaboration with the International Consortium of Investigative Journalists, reveals that the drug is priced beyond the reach of most patients.
A 100 mg vial costs Rs 1.5 lakh and for most patients, therapy extends over months or years, taking the total cost into tens of lakhs. The medicine has become mired in a shadow economy. Across cities, networks involving hospital staff, pharmacists, and middlemen allegedly diverted used vials, refilled them with other substances and sold them as genuine doses at discounted rates. Patients, driven by desperation, have become easy targets of such illicit activity.
The investigation points to gaps in hospital waste disposal, weak tracking systems, and an absence of accountability in the drug supply chain. More fundamentally, it exposes how large pharmaceutical firms game the patent system. Merck holds the primary patent on pembrolizumab — the generic name for Keytruda — till 2028 and has built a dense “patent thicket” around it that includes protections over formulations, delivery mechanisms and incremental innovations. Such strategies are designed to delay the entry of cheaper alternatives even after the core patent expires. India has historically used its patent laws to curb such “evergreening”.
Indian firms are now working on biosimilars of Keytruda that could reduce costs by as much as 70 per cent. But unlike conventional generics, biosimilars are derived from living cells rather than chemical synthesis. They demand advanced manufacturing capabilities, face stricter regulatory scrutiny, and can take four to eight times longer to develop. Courts have, by and large, prioritised patient access when cheaper substitutes are challenged by Big Pharma. Yet, legal battles can be protracted and critically ill patients do not have time.
In the short term, India must strengthen regulatory oversight and fast-track biosimilars. The country must also move beyond being a manufacturer of affordable medicines to becoming a centre for innovation. India’s early success with CAR-T therapy shows that homegrown therapies can lower costs while expanding access.
Scaling the model that produced the CAR-T breakthrough will require sustained investment in R&D, stronger academia-industry collaboration, speedier regulation that doesn’t compromise on safety, and financing that can absorb risks associated with biotech. This shift will not happen overnight. But the country with the world’s third-largest cancer burden cannot treat drug discovery as a distant goal. It needs to begin conversations on this imperative urgently.
