Centre Caps Trade Margins on 137 Cancer Drugs Amid Supreme Court Scrutiny

The Centre has capped trade margins at 30 per cent of the maximum retail price (MRP), excluding GST, for 137 non-scheduled anti-cancer drugs to make cancer treatment more affordable and curb excessive mark-ups. The move comes amid Supreme Court scrutiny of high mark-ups on essential medicines and questions over the distinction between scheduled and non-scheduled drugs. The list covers patented and non-patented medicines recommended by an expert committee under the Directorate General of Health Services (DGHS). It includes Nivolumab, Olaparib, Denosumab and Topotecan. Medicines supplied to individual patients under manufacturers' Patient Assistance Programmes (PAP) are excluded. The revised prices will come into effect on November 9, 2026, following a gazette notification dated October 17. The National Pharmaceutical Pricing Authority (NPPA) has invoked Paragraph 19 of the Drugs (Prices Control) Order (DPCO), 2013, which empowers it to fix or revise medicine prices in extraordinary circumstances and in the public interest. The list will be updated periodically. The intervention is expected to reduce MRPs of the identified cancer medicines by up to 70 per cent, depending on their existing price structures. Manufacturers must publish revised price lists on their websites, circulate them among retailers and hospitals, and inform the NPPA of revised prices within seven days of the notification. State drug controllers have been directed to ensure compliance by manufacturers, dealers, retailers, hospitals and medical institutions. Hospitals procuring substantial quantities directly from manufacturers must also monitor applicable MRPs. Manufacturers violating the order will be liable to deposit overcharged amounts with applicable interest under the DPCO, 2013, read with the Essential Commodities Act, 1955. Pharmaceutical companies must maintain existing production and supply levels to ensure uninterrupted availability. The decision follows the Centre's 2019 initiative to cap trade margins for 42 cancer drugs, which reportedly generated annual savings of Rs 984 crore across 526 brands. An expert committee had reportedly found trade margins ranging from 170 per cent to 700 per cent for certain non-scheduled cancer medicines. Unlike scheduled formulations, non-scheduled drugs are not subject to the same specific price ceilings under the DPCO, 2013. Their MRP increases are generally limited to 10 per cent over a rolling 12-month period. These drugs account for an estimated 82 per cent of India's domestic pharmaceutical market. The decision marks an initial step towards broader trade margin rationalisation (TMR), under which the difference between the price charged by a manufacturer to a distributor and the price paid by consumers can be regulated. The Department of Pharmaceuticals and the NPPA are consulting the industry on price mark-ups for essential medicines, with possible expansion of the policy to other non-scheduled medicines, medical consumables and devices. The move comes amid Supreme Court scrutiny of medicine mark-ups. A Bench comprising Justices Vikram Nath and Sandeep Mehta has questioned the regulatory distinction between scheduled and non-scheduled medicines and whether drugs classified as non-essential should remain outside price-control mechanisms.