Law Updates

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Summary: The price of cancer medicines can make treatment difficult for many patients in India. Some medicines cost thousands of rupees, and patients may need them for months. When the price paid by a patient is much higher than the price at which the manufacturer originally sold the medicine, the additional cost can become a serious concern. This problem was solved by the issuance of a new drug pricing notification by the National Pharmaceutical Pricing Authority (NPPA) dated 17th October 2026. The government has fixed the maximum trade margin of 30% for formulations containing 137 listed non-scheduled anti-cancer drugs. This implies that the drug manufacturing companies will need to check the prices of the medicines and then calculate the MRP using the formula laid down by NPPA. In cases where the prices are more than what is allowed, they are to be reduced. The new prices will take effect from 9 November 2026. But prior to that, there are a number of tasks that the manufacturers have to complete in seven days. The order affects more than medicine pricing. It also includes requirements related to manufacturer reporting, price-list publication, stock records, hospital monitoring and production continuity. For pharmaceutical manufacturers, importers and businesses dealing with these medicines, understanding the new requirements is necessary to avoid pricing errors and possible recovery action under the Drugs (Prices Control) Order, 2013. NPPA Anti-Cancer Drug Price Control Order 2026 at a Glance The notification introduces specific pricing and reporting requirements for the medicines included in its official list. Particular Details Issuing Authority National Pharmaceutical Pricing Authority (NPPA) Ministry Ministry of Chemicals and Fertilizers Department Department of Pharmaceuticals Notification Number S.O. 5690(E) Notification Date 17 October 2026 Applicable Law Drugs (Prices Control) Order, 2013 Relevant Provision Paragraph 19 of DPCO 2013 Medicines Covered 137 specified non-scheduled anti-cancer drugs Maximum Trade Margin 30% Price Calculation Basis Price to Stockist / Price to Distributor Revised Price Effective Date 9 November 2026 Reporting Deadline Within seven days of Gazette publication Main Regulatory Authority NPPA Key Affected Stakeholders Pharmaceutical manufacturers, distributors, stockists, hospitals and other covered entities The order has already been issued and is binding according to its terms. Manufacturers should distinguish between obligations triggered by Gazette publication and the later date on which revised prices become effective. Understanding Drug Price Regulation Under DPCO 2013 What Does NPPA Do? The National Pharmaceutical Pricing Authority is responsible for fixing, revising and monitoring the prices of medicines covered by India's drug price-control framework. Its work is governed mainly by the Drugs (Prices Control) Order, 2013, issued under the Essential Commodities Act, 1955. NPPA helps ensure that applicable medicine prices remain within permitted limits. It can also take action when a manufacturer charges more than the legally allowed price. It is imperative that pharmaceutical firms understand the differences between NPPA compliance and CDSCO compliance because although CDSCO takes care of drug approval and other related licensing procedures, it is the NPPA that takes care of drug pricing according to DPCO 2013. What Is the Difference Between Scheduled and Non-Scheduled Medicines? Under DPCO 2013, scheduled formulations are generally subject to government-fixed ceiling prices. Non-scheduled formulations are not ordinarily covered by the same ceiling-price mechanism. However, their price increases remain regulated under Paragraph 20 of DPCO 2013. The October 2026 order provides a particular pricing constraint in respect of formulations comprising 137 drugs listed under the notification. Hence, if a drug is considered to be non-scheduled, it does not imply that its manufacturer will be free from all constraints to determine its MRP. Why Has NPPA Used Paragraph 19? Paragraph 19 allows the government to intervene in medicine prices under extraordinary circumstances in the public interest. NPPA has used this provision because of concerns about excessive trade mark-ups on certain cancer medicines. The objective is to reduce unusually high margins between the manufacturer's first selling price and the price charged to patients. Why Has the Government Introduced a 30% Trade Margin Cap? The cost of cancer treatment is one of the reasons behind this decision. The Gazette explains that significant differences have been observed between the prices at which certain medicines are first sold and the MRPs charged to consumers. For expensive medicines, even a large margin on a single product can increase the amount a patient must pay. High Margins Between Manufacturer Prices and MRPs When a pharmaceutical manufacturer supplies a medicine to a stockist or distributor, the selling price may be much lower than the printed MRP. The difference between these prices is described as the trade margin for the purpose of this order. NPPA identified cases where the mark-up on non-scheduled anti-cancer medicines was considerably high. The new pricing method limits this margin to 30% of the MRP, excluding GST. Different Prices Across Hospitals and Pharmacies The notification also discusses differences between medicine prices in hospitals and retail pharmacies. Some medicines may be supplied at discounted rates, while other sales may take place closer to the printed MRP. As a result, two patients purchasing the same medicine through different channels may face different prices. The NPPA order addresses the maximum permissible price rather than requiring every seller to charge the same actual transaction price. Earlier Price Intervention in 2019 NPPA had already introduced a trade-margin rationalisation exercise in 2019 for 42 non-scheduled anti-cancer drugs. The October 2026 Gazette states that the earlier intervention resulted in substantial savings. The latest order expands the approach to a list of 137 medicines recommended following an expert review. The government has also indicated that the list may be updated later if market conditions or public-health considerations require it. What Has Changed Under the NPPA Drug Pricing Order 2026? The main change is the introduction of a maximum 30% trade margin for the listed non-scheduled anti-cancer medicines. However, the order contains several related requirements that manufacturers must also follow. 1. Maximum Trade Margin Is Limited to 30% The permissible MRP should be calculated by the manufacturers through the initial point of sale and the notified formula. In the event that the current MRP is greater than the permissible MRP, the manufacturers will have to lower it. 2. The Order Covers Different Formulations The pricing constraint is for those drug formulations that include any of the drugs mentioned in Table B, whether single-agent or combination formulations. This is irrespective of the dose, route of administration, or form of formulation. 3. Revised Pricing Information Must Be Submitted Manufacturers must submit the information prescribed in Annexure I. The requirement applies even where a covered product does not require an MRP change. 4. Price Lists Must Be Communicated Manufacturers should issue and disseminate revised price lists and make all the necessary disclosures. 5. Production Should Not Be Reduced Manufacturers cannot just reduce their average monthly production without first getting the approval of NPPA. The order also provides requirements for companies intending to discontinue the production or import of affected formulations. Which 137 Anti-Cancer Drugs Are Covered Under the NPPA Order? The notification identifies 137 medicines in Table B. The list covers different types of cancer treatments, including certain chemotherapy medicines, targeted therapies, immunotherapies and other oncology-related drugs. Some of the listed medicines include: Drug Name Covered Under Table B Abemaciclib Yes Abiraterone Acetate Yes Acalabrutinib Yes Afatinib Yes Alectinib Yes Bevacizumab Yes Cabazitaxel Yes Daratumumab Yes Durvalumab Yes Ibrutinib Yes Lenvatinib Yes Nivolumab Yes Olaparib Yes Osimertinib Yes Palbociclib Yes Pembrolizumab Yes Ribociclib Yes Venetoclax Yes This table shows selected medicines, not the complete 137-drug list. Manufacturers should use Table B of the official Gazette to confirm product coverage. Are Patented Medicines Also Covered? Yes. The notification expressly addresses patented medicines and includes them within the pricing intervention, subject to any approved exemption under Paragraph 32 of DPCO 2013. A pharmaceutical company should therefore not assume that a patented medicine is automatically outside the new pricing requirements. What About Generic and Branded Medicines? The order applies to covered formulations regardless of whether they are marketed under a brand name or as generic products. The important question is whether the formulation contains a drug identified in Table B. Does the Order Apply to Different Strengths? Yes. The notification covers applicable formulations across different strengths, dosage forms and routes of administration. It also extends to covered formulations used for therapeutic purposes other than cancer treatment. This means manufacturers must review the full product range rather than checking only one brand or pack. How Will the New MRP of Anti-Cancer Drugs Be Calculated? The NPPA order does not set one common price for every medicine on the list. Instead, manufacturers must calculate the maximum permissible MRP using the relevant Price to Stockist (PTS) or Price to Distributor (PTD). What Are PTS and PTD? PTS is the price at which a manufacturer sells a medicine to a stockist. PTD is the corresponding price charged to a distributor. These prices provide the starting point for determining the MRP under the notification. NPPA Formula for Revised MRP The official formula is: MRP = PTS/PTD × [1 + {TM / (100 − TM)}] + Applicable GST Where: MRP: Maximum Retail Price PTS/PTD: Price to Stockist or Price to Distributor TM: Trade Margin, which cannot exceed 30 GST: Applicable Goods and Services Tax At the maximum 30% trade margin, the pre-GST MRP is calculated by dividing the relevant PTS/PTD by 0.70. The margin is calculated as a share of the MRP excluding GST. It should not be confused with simply adding 30% to the distributor price. Official Example of the Revised MRP Calculation The Gazette provides the following calculation. Particular Amount Existing MRP 300 rupees + Applicable GST PTS/PTD 70 rupees Maximum Trade Margin 30% Permissible Revised MRP 100 rupees  + Applicable GST Calculation: 70 rupees × [1 + {30 ÷ (100 − 30)}] = 100 rupees  In this official example, the pre-GST MRP falls from 300 rupees to 100 rupees. This represents a reduction of approximately 66.7% before GST. The calculation is illustrative. The actual price reduction for any covered medicine depends on its existing MRP and the PTS/PTD determined under the notification. What If the Existing MRP Is Already Lower? Manufacturers whose existing MRP is lower than the amount calculated under the formula must maintain the existing lower price. The notification does not allow them to increase that price merely because the new calculated ceiling is higher. Can Manufacturers Add GST? GST can be added only where it has actually been paid or is payable to the Government. Manufacturers must apply the correct tax treatment to each formulation rather than assuming one GST rate applies to all products. How Should Manufacturers Calculate PTS/PTD If March 2026 Sales Data Is Missing? March 2026 is the general reference period for calculating the first-point-of-sale price under the order. However, the Gazette provides separate rules for products without sales during that month. When March 2026 Sales Data Is Available Manufacturers must calculate the average PTS/PTD using: Total net sales realisation during March 2026 ÷ Total quantity sold during March 2026 This calculation must follow the exclusions and conditions prescribed by the notification. When There Were No Sales in March 2026 If a product was not sold during March 2026, the calculation must use net sales realisation and quantities sold during April 2025 to March 2026. Government Sales Are Excluded The notification states that Government sales must be excluded when determining PTS/PTD. Manufacturers should therefore identify these transactions separately. Medicines Launched After 31 March 2026 For covered medicines launched after 31 March 2026, the current PTS/PTD must be used to calculate the MRP. Medicines Supplied Directly to Hospitals Where a manufacturer supplies a covered formulation directly to a hospital or medical institution, the hospital or institution is treated as the stockist or distributor for the calculation. The relevant manufacturer invoice data must be used. NPPA Compliance Deadlines: What Must Pharmaceutical Companies Complete? Manufacturers must pay attention to two different timelines: the reporting requirements triggered by Gazette publication and the date revised prices take effect. Compliance Requirement Deadline Gazette Order Issued 17 October 2026 Submission of Annexure I Information Within 7 days of publication Form V Price-List Submission Within 7 days of publication Circulation of Revised MRP Lists Within 7 days of publication Newspaper Communication of Price Reductions Within 7 days of publication Revised MRP Becomes Effective 9 November 2026 Intimation for Discontinuation of Production/Import At least 6 months before the intended discontinuation The order uses seven days from Gazette publication for the specified reporting and communication obligations. Companies should verify the applicable deadline calculation rather than waiting until 9 November. Manufacturers should begin by identifying the affected products, calculating permissible MRPs and preparing the required information for submission. Mandatory NPPA Reporting Through the IPDMS Portal The Integrated Pharmaceutical Database Management System (IPDMS) is used for pharmaceutical pricing information under the NPPA framework. Under the October 2026 notification, manufacturers must report the relevant PTS/PTD and MRP information for their formulations. Form V Price-List Submission Manufacturers must issue and submit applicable price lists in Form V in accordance with Paragraph 25 of DPCO 2013. Copies must also be provided to the concerned State Drug Controller, dealers and other entities where required. Reporting the Correct MRP Manufacturers should confirm that the price being reported has been calculated using the correct PTS/PTD data. This includes checking sales quantities, excluded transactions, applicable GST and any existing lower MRP. Maintaining Reporting Records Companies should retain the supporting documents used for their calculations and filings. Clear records can help explain how the MRP was determined if NPPA or another competent authority requests verification. Annexure I: Information Pharmaceutical Manufacturers Must Submit Annexure I, provided in the Gazette, contains the format for submitting MRP details. Manufacturers must submit this information within the prescribed period even when there is no change in the existing MRP. Details Required Under Annexure I Particular Information Required Manufacturer/Importer Name and address Marketing Company Name and address, if applicable Formulation Drug name Product Strength Approved strength Dosage Form Form of medicine Brand Name Product's brand name Composition Composition approved by drug-control authorities Pack Size Relevant package size PTS/PTD Applicable reference price excluding GST GST Rate Applicable rate Calculated MRP MRP determined using the notification's formula Previous MRP Pre-revised MRP including GST Authentication Authorised person's signature, name, designation and organisation Manufacturers must use the official format and provide accurate information. The Gazette, in its terms, clearly says that the non-filing of the necessary price details will also constitute failure to reduce the MRP, and an action will be taken under the provisions of DPCO. Special Rules for Patient Assistance Programmes Some pharmaceutical manufacturers provide medicines free of cost to patients through Patient Assistance Programmes (PAPs). The NPPA order allows qualifying quantities supplied under such programmes to be excluded from PTS/PTD and MRP calculations, provided the prescribed conditions are satisfied. When Can PAP Medicines Be Excluded? The exclusion is available where medicines are supplied free of cost under the manufacturer's qualifying programme. The manufacturer must also provide the required undertakings and maintain the prescribed records. Records Manufacturers Must Maintain The notification requires relevant information, including: Patient identification and contact details Identity and residence documents Details of the diagnosed disease Prescribed medicine and dosage Medicines imported or received and consumed Records supporting their use for the specified purpose What Happens If PAP Conditions Are Not Followed? NPPA can request further information, inspect records, conduct audits and verify how the programme is operated. If the required conditions are not met, the relevant quantities may become ineligible for exclusion from the calculation. Manufacturers should therefore review PAP records carefully before claiming this treatment. How Will the NPPA Order Affect Pharmaceutical Businesses? Different stakeholders have different responsibilities under the notification. Pharmaceutical Manufacturers Manufacturers have the most direct pricing and reporting responsibilities. They must identify covered medicines, determine the correct PTS/PTD, calculate permissible MRPs and complete the required submissions. They must also communicate price revisions, maintain production levels and follow applicable requirements before reducing or discontinuing supply. Pharmaceutical Importers Importers of affected formulations should review how the order applies to their products and commercial arrangements. Import-related decisions, particularly discontinuation of affected formulations, may involve specific obligations. The applicable reporting responsibility should be determined according to the relevant legal provisions rather than assuming every importer has identical duties. Pharmaceutical Marketing Companies Marketing companies should coordinate pricing information with manufacturers and distribution partners. Where products are marketed under different brand names, the applicable MRP information should remain consistent with the order. Distributors and Stockists Distributors and stockists must pay attention to revised price information circulated by manufacturers. Relevant dealers and retailers must display applicable price lists as required by DPCO 2013. Hospitals and Medical Institutions Hospitals and medical institutions must monitor the MRPs of covered medicines and ensure compliance with the applicable order. The revised prices should also be displayed prominently on their websites as specified in the notification. Requirements for Communicating Revised Medicine Prices Manufacturers must do more than update their internal pricing records. The order requires the communicating of reduced prices to relevant enterprises and consumers. Revised Price Lists The manufacturers need to distribute the revised MRP list to their dealers and retailers within seven days. These lists help make the prices available for consumer display. Newspaper Advertisements The order requires advertisements in leading newspapers within seven days of Gazette publication to inform dealers, retailers and consumers about price reductions. Manufacturer Website Disclosure Manufacturers must create a dedicated section on their company homepage for Drugs (Prices Control) Order matters. The relevant price notification and MRP information must be uploaded. Batch-Wise Stock Details The notification also mandates the production data and stocks of the formulations that come under the purview of the notification at the time of Gazette notification. Manufacturers may be required to produce documentary evidence showing that they made sufficient efforts to communicate the revised prices. Can Manufacturers Reduce or Discontinue Production of Anti-Cancer Drugs? The notification includes provisions intended to support the continued availability of affected medicines. Maintaining Production Levels Manufacturers are required to maintain their present production levels. A manufacturer wishing to reduce average monthly production must seek prior NPPA permission. Discontinuing Production or Import Where a manufacturer intends to discontinue production and/or import of a covered formulation, it must provide information in Form IV of Schedule II of DPCO 2013. The information must be submitted at least six months before the proposed discontinuation date. Manufacturers should consider these requirements before making decisions about production capacity, product withdrawal or import discontinuation. What Happens to Existing Lower MRPs and Earlier Price Orders? The notification specifically protects existing prices that are already lower than the newly calculated permissible MRP. A manufacturer must retain its existing lower MRP rather than increasing it to the calculated ceiling. The order also provides for the supersession of relevant earlier price orders under specified provisions of DPCO 2013 where they concern the identified drugs. The new prices remain in force until further orders. Although the notification refers to the possibility of annual price increases under Paragraph 20(1), manufacturers must continue to comply with the maximum permissible trade margin and other applicable conditions. Role of State Drug Controllers in Monitoring Compliance State Drug Controllers are responsible for monitoring compliance with the order by relevant manufacturers, dealers, hospitals and medical institutions. These stakeholders must assist the authorities in verifying compliance. Where a violation is identified, it must be brought to NPPA's notice. NPPA may then initiate recovery action under the applicable drug-pricing provisions. Accurate records, price lists and communication documents can help businesses demonstrate the steps they have taken to implement the order. What Happens If a Manufacturer Does Not Follow the NPPA Order? Failure to comply with the notification can result in recovery of amounts charged above the permissible price. Recovery of Overcharged Amounts Manufacturers that charge more than the applicable permitted MRP may be required to deposit the overcharged amount. The notification explains that the amount is determined by comparing the actual MRP excluding GST with the MRP calculated under Table A, also excluding GST. Interest on Overcharging The order also refers to recovery of overcharged amounts together with interest under DPCO 2013 read with the Essential Commodities Act, 1955. Failure to Submit Required Information Not submitting the prescribed Annexure I details may be treated as non-reduction of MRP. This can result in action for recovery of overcharged amounts. Business Risks Incorrect pricing data, delayed reporting or inconsistent price communication can create additional operational difficulties. Pharmaceutical companies should therefore check their calculations and coordinate the implementation process across the relevant teams. NPPA Compliance Checklist for Pharmaceutical Manufacturers Businesses dealing with the listed medicines should review the following actions. Compliance Activity What Businesses Should Check Product Applicability Identify formulations containing Table B drugs Formulation Review Check brands, strengths, combinations and dosage forms Sales Data Verify March 2026 or applicable alternative PTS/PTD data MRP Calculation Apply the official Table A formula Existing Lower Prices Retain lower MRPs where required Annexure I Prepare and submit prescribed pricing information Form V and IPDMS Complete applicable price reporting Dealer Communication Circulate revised price lists Website and Newspaper Disclosure Complete applicable publication requirements Stock Records Maintain relevant batch-wise information PAP Records Verify eligibility and supporting records Production Planning Review NPPA permission and discontinuation requirements Some of these steps are mandatory under the order, while others are practical checks that help businesses meet the prescribed requirements. Manufacturers should assign responsibility for each applicable activity and confirm the relevant deadlines. How Corpseed Can Help With Pharmaceutical Regulatory Compliance The NPPA anti-cancer drug price control order 2026 requires affected manufacturers to pay close attention to drug pricing, reporting and documentation. For pharmaceutical businesses, the challenge is not only understanding the new margin limit. It is also identifying the affected formulations, using the correct pricing information and completing the relevant compliance activities on time. Professional pharmaceutical regulatory compliance services may help businesses assess their regulatory requirements and organise the information needed for applicable submissions. Corpseed provides a platform for businesses seeking support with regulatory and compliance requirements. Companies can enquire about relevant assistance for pharmaceutical regulatory matters, including applicable documentation and compliance assessments. If you are looking for compliance consultancy in respect of NPPA or drug price compliance, it is best to first clarify the scope of support that we can provide for the same. CDSCO approvals and drug licenses are two different things and hence need to be considered on an independent basis. Looking for help in pharmaceutical regulatory compliance? Talk to Corpseed about the regulatory compliances for your pharmaceutical business. Key Takeaways The NPPA order dated 17 October 2026 has a provision that sets a maximum trade margin of 30% for the formulations of 137 non-scheduled anti-cancer medicines. The manufacturer will have to apply the prescribed PTS/PTD formula for calculating the MRP. If their current MRP is higher than the allowed amount, it has to be decreased. The revised prices will apply from 9 November 2026, while several reporting and communication requirements must be completed within seven days of Gazette publication. The order also addresses hospital pricing, patient assistance programmes, production continuity, stock records and regulatory monitoring. Drug manufacturers facing problems with their affected products need to examine their pricing information and reporting requirements right away. Proper calculation, submission, and communication with the sales chain are key elements in meeting the revised requirements.