Cancer Treatment: India’s National Pharmaceutical Pricing Authority (NPPA) has set a limit on the trade margin for 137 commonly used cancer medications at 30% of the Maximum Retail Price (MRP). These new prices will come into effect on November 9. The selection of these 137 drugs was advised by a specialized committee from the Union Health Ministry, encompassing popular medications like Atezolizumab, Bevacizumab, Daratumumab, Enzalutamide, Erlotinib, Ipilimumab, and Lapatanib.
The drug Keytruda, an immunotherapy medication, is not part of this list. The 30% cap on the trade margin is calculated based on the MRP, excluding GST, equating to a markup of 42.86% on the amount received by the stockist or distributor. The NPPA clarified that this limit is applicable irrespective of the drug’s potency, form, or method of administration (e.g., injection or tablet), including combination drugs.
Key points to note:
– Drug prices must be decreased.
– The revised MRP will be determined based on the price paid to the stockist or distributor by March 2026.
– For drugs with no sales in that month, the price will be calculated using sales data from April 2025 to March 2026, excluding government sales.
– Manufacturers selling medications above the new MRP will need to lower their prices accordingly.
– Manufacturers can increase prices annually as allowed under the DPCO, provided they adhere to the trade-margin restriction.
The regulations also extend to formulations introduced after March 31, 2026, containing any of the listed drugs. In cases where manufacturers supply drugs directly to hospitals or medical institutions, these entities will be considered as stockists or distributors for MRP calculation, utilizing the manufacturer’s invoice data. Manufacturers are instructed to maintain their current production levels to ensure ongoing availability of medicines. If a manufacturer intends to alter their average monthly production, approval from the NPPA must be obtained. Manufacturers planning to halt production or imports must notify the NPPA at least six months in advance.
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– Manufacturers are allowed some flexibility in the quantity of free medicines provided under their Patient Assistance Program but must maintain meticulous records.
– The NPPA can conduct audits, request additional information, and ensure compliance.
– Manufacturers must inform the NPPA and state drug controller of any changes in MRP within seven days of the order’s publication.
– Failure to comply may lead to actions under the DPCO to recover overcharged amounts.
Hospitals and medical institutions, significant suppliers of anti-cancer drugs, are responsible for monitoring MRPs and reporting any violations to the NPPA. State drug controllers will oversee compliance by manufacturers, dealers, hospitals, and medical institutions with these regulations.