The Centre has finalised trade margin caps at 30% for 137 non-scheduled anti-cancer drugs, seeking to curb markups of up to 700% in some cases and reduce retail prices by as much as 70%. According to the latest gazette notification dated October 17, 2026, the National Pharmaceutical Pricing Authority (NPPA) notified the cap under Paragraph 19 of the Drugs (Prices Control) Order (DPCO), 2013, with revised prices to take effect on November 9, 2026. The 30% cap on trade margins, calculated on the maximum retail price (MRP) excluding GST, corresponds to a mark-up of 42.86% on the price to stockist or distributor. The government invoked extraordinary public-interest powers to bring the drugs under tighter price regulation, following mounting scrutiny of excessive charges for life-saving treatments. As per the NPPA minutes of the 284th NPPA meeting held on October 16, the authority considered it necessary to cap the trade margin at 30% of MRP to retain a reasonable trade margin while preventing excessive mark-ups.
The order was issued through a gazette notification dated October 17 under Paragraph 19 of the Drugs (Prices Control) Order (DPCO), 2013, following directions from the Department of Pharmaceuticals. The move comes amid Supreme Court scrutiny of high mark-ups on essential medicines, with a Bench comprising Justices Vikram Nath and Sandeep Mehta questioning the regulatory distinction between scheduled and non-scheduled medicines under the DPCO and whether medicines classified as non-essential should remain outside price control mechanisms. The court has described such instances as 'broad daylight dacoity' and 'carnage', with the Centre's intervention expected to bring significant relief to patients and families affected by cancer, who often face high financial burden due to high treatment costs.
The list of 137 drugs includes widely prescribed cancer treatments, among them the immunotherapies and targeted therapies pembrolizumab, nivolumab, palbociclib, osimertinib, ribociclib, bevacizumab, atezolizumab, daratumumab, olaparib, and enzalutamide. According to the gazette notification, the list includes Nivolumab, Olaparib, Denosumab and Topotecan among other key oncology therapies. The restrictions apply to formulations containing any of the listed drugs, whether used alone or in combination, across all strengths, dosage forms and routes of administration. The list has been recommended by an Expert Committee under the Directorate General of Health Services (DGHS), which included leading oncologists, medical specialists, hospital experts from across India, and government officials. The Committee recommended 137 drugs for inclusion under TMR, with the list subject to periodic updates and excluding drug quantities supplied under Patient Assistance Programmes (PAP) run by drug manufacturers for individual patients.
Manufacturers must submit revised MRP filings to the NPPA and state drug controllers within seven days of publication of the gazette notification, even if there is no change in the MRP. As reported by Business Standard, they must also issue the prescribed price lists through the Integrated Pharmaceutical Database Management System and provide copies to state drug controllers, dealers and other entities as required. According to the latest official statement, all manufacturers will be required to inform NPPA of their revised prices within 7 days of publication and display the price lists on their website and widely disseminate to all retailers and hospitals. Hospitals and medical institutions, which account for a substantial share of anti-cancer drug supplies, have been asked to monitor MRPs and report violations to the NPPA. State drug controllers will oversee compliance by manufacturers, dealers, hospitals and medical institutions, with manufacturers not complying with the provisions liable to deposit the overcharged amount along with interest thereon under the provisions of the DPCO 2013 read with Essential Commodities Act, 1955. The measure aims to control excessive trade margins in the distribution and retail channel while safeguarding legitimate manufacturer revenues and preventing artificial market shortages.
According to Business Standard, the domestic anti-cancer drug market comprises about 225 drugs and 500 formulations, with annual turnover of approximately ₹12,500 crore. Non-scheduled anti-cancer drugs carry an average trade markup of approximately 170%, with markups of up to 700% in some cases, as found by the Expert Committee. The NPPA's intervention is expected to bring down the maximum retail prices (MRPs) of the identified non-scheduled anti-cancer drugs by up to 70%, depending on their existing price structures, and generate estimated annual savings of ₹2,500 crore. In February 2019, the Centre had capped trade margins on 42 non-scheduled anti-cancer medicines across 526 brands, delivering price cuts of up to 91% on MRP and estimated recurring annual savings of ₹984 crore for patients. The current exercise extends this approach to a larger set of anti-cancer drugs, building upon the success of NPPA's 2019 pilot TMR exercise, under which trade margins for 42 anti-cancer drugs were capped at 30% and MRP of 526 brands was reduced by up to 90%. The decision marks a first step towards trade margin rationalisation (TMR), with margin capping potentially extended beyond cancer drugs to other non-scheduled formulations, medical consumables and devices such as intravenous kits and catheters.
