NPPA Fixing a Maximum 30% Trade Margin for Specified Non-Scheduled Anti-Cancer Formulations

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Dated: 19.10.2026

NPPA Fixing a Maximum 30% Trade Margin for Specified Non-Scheduled Anti-Cancer Formulations

India’s National Pharmaceutical Pricing Authority (NPPA) has capped trade margins at 30% for 137 non-scheduled anti-cancer drugs, a measure designed to reduce excessive mark-ups and improve affordability for patients. The revised prices take effect on 9 November 2026.

Why the NPPA introduced the measure

Cancer treatment can create severe financial pressure for patients and families. The NPPA found that, for certain non-scheduled oncology medicines, the gap between the manufacturer’s selling price and the maximum retail price (MRP) was substantial. Differences between retail and hospital prices, as well as varying discounts on MRP, indicated that published MRPs could be significantly higher than transaction prices.

The intervention uses the NPPA’s powers under Paragraph 19 of the Drugs (Prices Control) Order, 2013 (DPCO). It follows a 2019 pilot trade-margin rationalisation initiative covering 42 non-scheduled anti-cancer medicines, which was reported to have generated substantial savings.

What the order covers

The order applies to formulations containing any of 137 specified non-scheduled anti-cancer drugs, whether sold alone or in combination. It applies across strengths, dosage forms and routes of administration, including when the formulation is used for a therapeutic purpose other than cancer.

The covered list includes widely used targeted therapies, immunotherapies, chemotherapy agents and supportive oncology medicines, such as:

Abemaciclib, abiraterone acetate, afatinib and alectinib
Bevacizumab, cetuximab, pembrolizumab and nivolumab
Osimertinib, palbociclib, ribociclib and olaparib
Trastuzumab combinations, pegfilgrastim and denosumab
Venetoclax, zanubrutinib, tucatinib and zolbetuximab

Patented medicines are also within scope unless they have an approved exemption under Paragraph 32 of the DPCO.

How the revised MRP is calculated

Manufacturers must calculate the maximum permitted MRP from the Price to Stockist/Price to Distributor (PTS/PTD), using a maximum trade margin of 30%:

Maximum MRP = PTS/PTD × [1 + 30 / (100 – 30)] + applicable GST

This means the pre-GST MRP can be no more than approximately 42.86% above the PTS/PTD.

For most existing products, the PTS/PTD is based on the manufacturer’s average net sales realisation in March 2026. If there were no sales in that month, the calculation uses the average for April 2025 to March 2026. Government sales are excluded from this calculation.

Example

If a medicine has a PTS/PTD of ₹70, its maximum permitted MRP before GST is:

₹70 × [1 + 30 / 70] = ₹100

If its earlier MRP was ₹300 plus GST, the manufacturer must reduce the price to no more than ₹100 plus applicable GST. Products already priced below the calculated cap may retain their existing MRP.

Key obligations for manufacturers

Manufacturers must submit revised price information to the NPPA and the relevant State Drug Controller within seven days of the order’s publication, even where the MRP does not change. They must also:

File applicable price lists in Form V through the Integrated Pharmaceutical Database Management System (IPDMS).
Report PTS/PTD and MRP data on the NPPA portal.
Circulate revised MRP lists to dealers and retailers within seven days.
Publish notices of price reductions in leading newspapers within seven days.
Create a dedicated DPCO section on the company homepage showing the notification and updated MRPs.
Provide batch-wise production and stock details held by the company and distributors at the time of publication.
Maintain current production levels; prior NPPA permission is required before reducing average monthly production, while planned discontinuation requires at least six months’ advance notice.

For medicines launched after 31 March 2026, the MRP must be determined using the same formula based on the current PTS/PTD.

Responsibilities of hospitals, retailers and regulators

Hospitals and medical institutions that buy directly from manufacturers are treated as stockists or distributors for MRP calculations. They must monitor compliance, display revised prices prominently on their websites and report violations to the NPPA.

Retailers, dealers, hospitals and institutions must display the manufacturer-supplied price lists in a conspicuous and accessible location. State Drug Controllers are responsible for monitoring manufacturers, dealers, hospitals and medical institutions and reporting any non-compliance.

Patient assistance programmes

Free medicines supplied through a manufacturer’s Patient Assistance Programme may be excluded from the PTS/PTD and MRP calculation, subject to strict conditions. Manufacturers must maintain patient, diagnosis, prescription and medicine-use records; provide formal undertakings; and permit NPPA verification, audits or inspections. Failure to meet these conditions can remove the exclusion.

Enforcement and implications

The revised prices remain in force until further orders. Manufacturers may take annual price increases allowed under the DPCO, but only while continuing to comply with the 30% maximum trade-margin rule.

Non-compliant manufacturers may be required to deposit the overcharged amount plus interest. The overcharge is calculated as the difference between the actual pre-GST MRP and the maximum MRP permitted under the order.

By linking MRP directly to the manufacturer’s first-point-of-sale price, the policy targets excessive distribution mark-ups while preserving the existing regulatory framework for annual price revisions. Its central aim is to make high-cost cancer medicines more affordable and transparent for patients in India.

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Source: Ministry of Chemicals and Fertilizers, NPPA

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