India’s National Pharmaceutical Pricing Authority (NPPA) has limited the trade margin of 137 drugs widely used in cancer treatment to 30 percent of the MRP. The new prices will be effective from November 9. This list of 137 drugs has been prescribed by an expert committee of the Union Health Ministry. These include widely used drugs such as atezolizumab, bevacizumab, daratumumab, enzalutamide, erlotinib, ipilimumab, and lapatanib.

Immunotherapy drug ‘Keytruda’ is not included in this list. This limit of 30% on trade margin, calculated on the basis of Maximum Retail Price (MRP) exclusive of GST, is equivalent to a mark-up of 42.86% on the price received by the stockist or distributor. The NPPA said the limit would apply regardless of the strength of the drug, its form or the way it is taken (such as an injection or pill). This also includes drugs that are mixed with other drugs.

Prices of medicines have to be reduced

Under the approved arrangement, the revised MRP will be calculated based on the price paid to the stockist or distributor for March 2026. Medicines for which there is no sale in that month will be priced based on the sales data from April 2025 to March 2026. Government sales will not be included in this calculation. Manufacturers who are selling drugs at prices higher than the newly fixed MRP will have to bring down the prices to the prescribed level. NPPA said that if the current MRP is already low, it has to be maintained. This order will remain in force till further notice. In addition, producers can avail the annual price increase provided under the DPCO, provided they comply with the trade-margin cap.

This system will also apply to them

The order also applies to formulations (drugs) launched after March 31, 2026, including any drugs included in the list. Where manufacturers supply drugs directly to hospitals or medical institutions, these institutions will be treated as stockists or distributors for the purpose of calculating MRP, using invoice data from the manufacturers. The authority has directed the manufacturers to maintain their current production levels to ensure continuous availability of the drugs. According to the minutes of the meeting, if a producer wants to reduce his average monthly production level, he must first seek permission from NPPA. Manufacturers who want to stop production or import must give the prescribed information at least six months in advance.

Detailed records should be kept

The NPPA has given some relaxation in the quantity of medicines given free to patients under the manufacturers’ ‘Patient Assistance Programme’. However, to get this exemption, manufacturers have to give an undertaking and keep detailed records of patients, prescriptions, supply of medicines and their consumption. The authority may ask for further information, conduct audits or inspections and check whether the order is being complied with.

This concession can be withdrawn if the rules are not followed. Within seven days of the publication of the order in the ‘Official Gazette’, the manufacturers have to inform the NPPA and concerned State Drug Controller of the revised MRP, even if there is no change in the MRP. They shall also issue the price list as determined by the ‘Integrated Pharmaceutical Database Management System’ and provide copies thereof to the State Drug Controller, dealers and other concerned parties as required.

Otherwise action will be taken

If the required information is not provided, the MRP will be deemed not to have been reduced. In such a situation, action can be taken to recover the overcharged amount under DPCO. Hospitals and medical institutions, which account for a major share in the supply of anti-cancer drugs, have been asked to monitor the MRP and report any violations to the NPPA. State drug regulators will ensure that manufacturers, dealers, hospitals and medical institutions comply with these regulations.