NEW DELHI: The National Pharmaceutical Pricing Authority (NPPA) has given in-principle approval to a proposal to cap trade margins at 30% on identified non-scheduled anti-cancer medicines, seeking to reduce prices and ease the financial burden on patients undergoing cancer treatment.
The decision, taken at the authority’s 151st meeting on October 8, comes amid a rising cancer burden and concerns over the affordability of life-saving medicines.
The proposed intervention could reduce maximum retail prices by 20% to 70%, depending on existing mark-ups, and generate estimated annual savings of around Rs 2,500 crore for consumers.
The scale of the challenge is evident from official estimates. India recorded an estimated 15.33 lakh new cancer cases in 2024, up from 14.61 lakh in 2022. Cancer deaths were estimated at 8.28 lakh in 2023, according to data from the Indian Council of Medical Research’s National Cancer Registry Programme. The rising burden has intensified concerns about access to timely diagnosis and sustained treatment.
The NPPA said trade margins on some non-scheduled cancer medicines had reached as high as 700%, while the average mark-up was around 170%. The proposal seeks to address excessive margins and wide price differences across pharmacies and hospitals, which can make it difficult for patients to identify affordable options.
The Department of Pharmaceuticals has directed the NPPA to rationalise trade margins under Paragraph 19 of the Drugs (Prices Control) Order, 2013, in the public interest. An expert committee under the Directorate General of Health Services has been asked to recommend the medicines to be covered, with its report expected by October 14.
India’s anti-cancer medicines market comprises approximately 225 drugs and 500 formulations, with an estimated annual turnover of Rs12,500 crore. While medicines included in the scheduled category are subject to government-mandated ceiling prices, non-scheduled medicines do not fall under the same ceiling-price mechanism.
The latest proposal builds on the NPPA’s 2019 intervention, when trade margins were capped at 30% for 42 non-scheduled anti-cancer medicines. According to the authority, that exercise reduced maximum retail prices by up to 91% for 526 brands and generated estimated annual savings of around ₹984 crore.
However, patient advocates say controlling trade margins, though necessary, may not be sufficient to make expensive cancer treatment affordable, particularly when patented medicines remain beyond the reach of many households.
“The NPPA’s 30% cap on trade margins for non-scheduled cancer medicines will not make many of these drugs affordable, particularly patented ones,” said Jyotsna Singh and K.M. Gopakumar, co-convenors of the Working Group on Access to Medicines and Treatments.
They cited ribociclib, whose monthly cost, they said, rose from Rs 58,000 in 2022 to Rs 78,000 in 2025 despite the earlier intervention. They also pointed to pembrolizumab, marketed as Keytruda, which they said costs around Rs 1,95,000 per vial.
“A margin cap cannot bring prices like these within reach of ordinary patients,” they said.
The advocates have called for stronger use of public-health safeguards under the Patents Act, including government-use licensing under Section 100 and compulsory licensing, where legally justified, to facilitate access to lower-cost alternatives.
The financial consequences of cancer treatment extend beyond the price of medicines. Patients may require repeated consultations, diagnostic tests, surgery, chemotherapy, radiotherapy and prolonged drug therapy. Travel, accommodation, loss of wages and the need for family members to provide care add to the burden.
A 2023 study published in Frontiers in Public Health, based on 12,148 patients at seven cancer centres in India, estimated average annual direct out-of-pocket expenditure at Rs 3.31 lakh per patient. Medicines accounted for a substantial share of treatment-related spending. The study also found that catastrophic health expenditure and impoverishment were widespread, particularly among poorer households.
Such findings underline why high out-of-pocket expenditure remains a major barrier to cancer care. Even when a patient can initially afford treatment, the cumulative cost of repeated visits and medicines may force families to use savings, borrow money or sell assets. Some patients may also delay or interrupt treatment because of financial constraints.
The proposed trade-margin cap could provide relief by reducing excessive mark-ups on covered medicines. However, its actual impact will depend on the final list of drugs, implementation and the extent to which price reductions reach patients.
A broader affordability strategy would also require reliable access to essential medicines in public hospitals, stronger generic competition, transparent pricing and financial protection for outpatient diagnostics and treatment. Insurance coverage must account for the continuing costs of cancer care, rather than hospitalisation alone.
The NPPA proposal is yet to be finalised. The medicines to be covered, the implementation timeline and the price reductions for individual products remain to be announced.
