137 Cancer Drugs Including Pembrolizumab, Osimertinib to Get Cheaper, Prices May Drop Up to 70%

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has capped trade margins on 137 identified non-scheduled anti-cancer drugs at 30%, with revised maximum retail prices (MRPs) set to take effect from November 9,2026.

The intervention is expected to reduce prices by up to 70%, depending on existing price structures, offering relief to cancer patients and their families.

The authority, functioning under the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, issued the order through Gazette notification S.O. 5690(E), dated October 17, 2026, invoking its extraordinary powers under Paragraph 19 of the Drugs (Prices Control) Order (DPCO), 2013.

The order covers non-scheduled formulations containing any of the 137 listed drugs, whether individually or in combination, irrespective of strength, dosage form or route of administration. It also applies when these formulations are used for other therapeutic purposes.

According to the Ministry release cited in the accompanying report, the medicines include immunotherapy drugs used across more than 20 types of cancer, Denosumab used by breast and prostate cancer patients, Pegfilgrastim used to prevent neutropenia in cancer patients, and Bevacizumab used to treat colon, ovarian and cervical cancers. Widely used medicines such as Pembrolizumab, Durvalumab and Osimertinib are among those covered.

Concerns over excessive margins and treatment costs

Explaining the intervention, NPPA noted that cancer treatment in India places a severe financial burden on patients and their families, often resulting in catastrophic health expenditure.

State authorities, patients, civil society and public platforms had raised concerns over excessive anti-cancer drug prices, particularly the substantial difference between procurement costs and the MRPs charged to consumers.

Market data also showed significantly high average trade mark-ups for certain non-scheduled anti-cancer drugs. Differences between retail and hospital prices, including varying discounts on MRP, indicated that actual transaction prices could differ considerably from the printed MRP.

For this order, trade margin means the difference between the manufacturer’s selling price to the stockist or distributor and the MRP charged to the patient, excluding Goods and Services Tax (GST).

The notification notes that the National List of Essential Medicines, 2022, contains 388 drugs, including 63 anti-cancer drugs subject to price control under DPCO, 2013. Scheduled formulations are regulated through ceiling prices, while non-scheduled formulations are ordinarily monitored for compliance with the annual MRP increase limit under Paragraph 20.

Expansion of the 2019 exercise

The latest measure builds on the government’s 2019 pilot Trade Margin Rationalisation (TMR) exercise covering 42 non-scheduled anti-cancer drugs under Paragraph 19.

While the Gazette records that the pilot generated substantial savings, the accompanying Ministry release states that the earlier 30% trade-margin cap led to MRP reductions of up to 90% across 526 brands of non-scheduled anti-cancer medicines.

At its 283rd overall meeting and 151st meeting under DPCO, 2013, held on October 8, 2026, NPPA considered the need to address excessive trade mark-ups. It concluded that extraordinary circumstances justified intervention in the public interest to correct market distortions, curb profiteering and ensure fair and affordable prices.

The Department of Pharmaceuticals subsequently sought the constitution of an Expert Committee under the Directorate General of Health Services (DGHS) through the Ministry of Health and Family Welfare to identify medicines for inclusion.

According to the accompanying release, the committee comprised leading oncologists, medical specialists, experts from hospitals across the country and government officers. After examining available information, data, viewpoints and options for improving affordability, it recommended 137 non-scheduled anti-cancer drugs.

NPPA considered the recommendations at its 284th overall meeting and 152nd meeting under DPCO, 2013, held on October 16 and 17, 2026, and decided to notify the list. The list will be updated periodically in response to market developments and public-health considerations.

The authority also clarified that patented drugs can be covered by price fixation under DPCO, 2013, except where an exemption has been approved under Paragraph 32. It therefore decided to include patented drugs within the order’s coverage, subject to that qualification.

How manufacturers must calculate revised prices

Manufacturers must calculate MRPs using the price at the first point of sale, described as the Price to Stockist or Price to Distributor (PTS/PTD), under the following formula:

MRP = PTS/PTD × {1 + [TM ÷ (100 − TM)]} + applicable GST

Here, TM is the trade margin, which cannot exceed 30. The formula therefore caps the margin at 30% of the MRP excluding GST.

The notification illustrates this with a formulation having an existing MRP of ₹300 plus applicable GST and a PTS/PTD of ₹70. Its maximum permissible revised MRP would be:

₹70 × {1 + [30 ÷ (100 − 30)]} = ₹100 plus applicable GST.

The following calculation requirements apply:

• March 2026 sales: PTS/PTD must be calculated by dividing the manufacturer’s total net sales realisation for the product during March 2026 by the total quantity sold that month.

• No sales in March 2026: Manufacturers must instead divide total net sales realisation during April 2025–March 2026 by the total quantity sold during that period.

• Categories of sales: All sales categories must be considered, except government sales.

• Products launched after March 31, 2026: MRPs must be calculated using the current PTS/PTD.

• Direct hospital supplies: Where manufacturers supply directly to hospitals or medical institutions, those establishments will be treated as stockists or distributors, and the manufacturer’s invoice data will form the basis of the calculation.

• GST: Manufacturers may add GST only where it has actually been paid or is payable to the government.

Manufacturers selling branded formulations, generic formulations or both above the calculated permissible MRP must reduce their prices accordingly. Products already priced below the calculated amount must retain their existing MRPs.

Conditions for excluding free patient-assistance supplies

Quantities supplied under manufacturer-run Patient Assistance Programmes (PAPs) may be excluded from the PTS/PTD and MRP calculations, subject to specified safeguards.

The medicines must be supplied free of cost to patients. Manufacturers must give NPPA an undertaking, in line with applicable Customs notifications issued by the Department of Revenue, that they will maintain records covering:

• The patient’s name, age, gender, residence and contact details;

• Valid identity and residence proofs of the patient and caregiver, where applicable;

• The diagnosed disease and prescribed drug dosage; and

• The drugs imported or received and consumed.

Manufacturers must also undertake that the medicines will be used only for the specified purpose.

A further declaration must confirm that the PAP information is true and correct to the manufacturer’s knowledge and belief. The company will be liable for consequences arising from false, misleading or incorrect declarations under DPCO, 2013, and the Essential Commodities Act, 1955.

NPPA reserves the right to seek further information, conduct audits or inspections, and verify PAP implementation through third-party agencies or other appropriate means. Failure to meet the conditions can result in the relevant PAP quantities losing the exemption.

Seven-day reporting and price-list requirements

Under Paragraph 9(2) of DPCO, 2013, manufacturers must submit information in Annexure I within seven days of publication of the order in the Official Gazette, irrespective of whether their MRPs change.

Revised price information must be submitted to both NPPA and the concerned State Drug Controller. Failure to submit it will be treated as non-reduction of MRP and can trigger proceedings to recover overcharged amounts.

Annexure I requires the names and addresses of the manufacturer or importer and the marketing company, where applicable. Product-level details include the drug, strength, dosage form, brand name, approved composition, pack size, March 2026 PTS/PTD excluding GST, applicable GST rate, calculated revised MRP including GST, and the previous MRP including GST.

The submission must contain a declaration of correctness, the authorised person’s signature and stamp, name, designation and organisation, along with the place and date.

Manufacturers must also issue and submit the applicable Form V price list through IPDMS, in accordance with Paragraph 25 of DPCO, 2013, and furnish copies to the concerned State Drug Controller, dealers and other required entities within seven days of Gazette publication.

Reporting PTS/PTD and MRP details for the covered formulations on NPPA’s IPDMS portal will be compulsory.

Public disclosure and hospital responsibilities

Manufacturers must, when asked by NPPA, produce documentary evidence showing adequate dissemination of revised prices. The notification specifies:

• Circulation of revised MRP lists to dealers and retailers within seven days of Gazette publication for consumer display;

• Advertisements in leading newspapers within the same period to inform dealers, retailers and consumers of price reductions;

• A dedicated “Drugs (Prices Control) Order Matters” section on the company homepage containing the notification details and MRPs; and

• Submission of batch-wise production details and the stock position held by the company and distributors when the order was published.

Under Paragraph 25(3), every retailer, dealer, hospital and institution must display manufacturers’ price lists and supplementary price lists prominently at their business premises, where anyone wishing to consult them can easily do so.

As a substantial share of anti-cancer medicines is supplied directly to hospitals and medical institutions, these establishments must monitor the notified MRPs and ensure compliance. They must also prominently display revised prices on their websites and report violations to NPPA.

The accompanying Ministry release states that retailers and hospitals must charge the reduced prices from November 9, 2026. Consumers can check revised prices through the Pharma Sahi Daam app and NPPA website.

Production safeguards and action against overcharging

Manufacturers must maintain existing production levels. Any proposed reduction in average monthly production requires prior permission from NPPA.

A manufacturer intending to discontinue production or import of a covered formulation must submit information in Form IV of Schedule II of DPCO, 2013, at least six months before the proposed discontinuation date.

State Drug Controllers must monitor compliance by manufacturers, dealers, hospitals and medical institutions, which are required to assist in verification. Violations must be reported to NPPA for action, including recovery of overcharged amounts.

Non-compliant manufacturers will be liable to deposit the overcharged amount along with interest under DPCO, 2013, read with the Essential Commodities Act, 1955. The order defines the overcharged amount as the difference between the MRP excluding GST and the permissible MRP calculated under the notified formula, also excluding GST.

The notified prices will remain in force until further orders. Manufacturers may avail annual price increases under Paragraph 20(1), subject to continued compliance with the maximum permissible trade margin, from the date of Gazette publication.

The notification also supersedes earlier orders fixing ceiling prices under Paragraph 4 or retail prices under Paragraphs 5 and 15, if any, for drugs specified in the list.

According to the accompanying Ministry release, the measure seeks to curb excessive distribution and retail margins while safeguarding legitimate manufacturer revenues and ensuring uninterrupted medicine supplies.