·PIB

NPPA releases Revised MRP for 543 brands of Anti-Cancer Medicines; List to be updated on continual basis; New Prices Effective from November 9, 2026

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In this note
  1. At a Glance
  2. Why in the News
  3. Background & Evolution
  4. Core Static Facts
  5. Multi-Dimensional Analysis
  6. Recent Developments (last 12–18 months)
  7. Prelims Hooks
  8. TMR Cuts the Middlemen's Share, Not the Factory Price
  9. Why the Price Falls on Paper Before It Falls at the Chemist
  10. NPPA Measures Margins Using Data From the Drug Trade Itself
  11. Why the Real Savings May Be Smaller Than the Headline
  12. The Best Case Against Capping Margins, and Where It Fails
  13. What a Permanent TMR Rule Should Fix
  14. Anchors for Answers
  15. Mains Relevance
  16. Related Topics to Study Next
  17. NCERT Concepts to Revise
  18. Common Errors / Trap Areas

1. At a Glance

  • NPPA has published revised Maximum Retail Prices (MRPs) for 543 brands of anti-cancer medicines. The new prices take effect on 9 November 2026 [1].
  • These prices follow from the Trade Margin Rationalisation (TMR) of 137 non-scheduled anti-cancer drugs, announced on 17 October 2026 [1].
  • TMR caps the margin earned between the manufacturer and the retailer. Normally, non-scheduled drugs have no price ceiling and are only watched under a 10% yearly limit on price increases [1][3].
  • UPSC relevance: this sits where GS-II (health, access to medicines) meets GS-III (pricing regulation, the pharma industry). It is also a direct follow-up to the 2019 TMR pilot.

2. Why in the News

  • 17 Oct 2026: NPPA announced TMR for 137 non-scheduled anti-cancer drugs "in public interest" to curb excessive trade margins. Manufacturers were told to submit revised price lists [1].
  • Late Oct 2026: NPPA released revised MRPs for 543 brands, based on company submissions received up to 27 Oct 2026. The list will be updated continually as more submissions come in [1].
  • Example: Bevacizumab 100 mg/4 ml injection (Abbott) falls from ₹21,767.70 to ₹5,930.13 [1]. That is a cut of about 72.8% (worked out from these two figures).
  • Aug 2026: the Lok Sabha Standing Committee on Chemicals & Fertilizers (33rd Report) criticised the "inordinate delay" in building TMR permanently into DPCO 2013 [3].

3. Background & Evolution

  • 1970: the Bureau of Industrial Costs and Prices (BICP) was set up. Along with the Tariff Commission and its predecessors, it advised on drug costing and pricing [3].
  • 29 Aug 1997: NPPA was constituted by a Government Resolution published in Gazette No. 159. Drug price-fixing work moved from BICP to NPPA [3].
  • 2008: the Department of Pharmaceuticals (DoP) was created under the Ministry of Chemicals & Fertilizers, and NPPA was placed under it [3].
  • 7 Dec 2012: the National Pharmaceutical Pricing Policy (NPPP), 2012 was notified. Its principles are essentiality (based on NLEM), control of formulation prices only, and market-based pricing [3].
  • DPCO 2013: moved drug pricing from cost-based to market-based [3].
  • 2014: Para 19 was used to cap the MRPs of 106 non-scheduled formulations (22 for diabetes, 84 cardiovascular) [3].
  • 13 Feb 2017: ceiling prices were fixed for coronary stents. 16 Aug 2017: ceiling prices were fixed for knee implants [3].
  • 27 Feb 2019 (S.O. 1041(E)): the TMR pilot capped the trade margin at 30% on 42 non-scheduled anti-cancer drugs [3]. At the time, PIB put coverage at 72 formulations and 355 brands [2]. NPPA later reported that 526 brands fell by about 50% on average, saving patients about ₹984 crore a year [3].
  • 1 Apr 2020: all medical devices were brought under DPCO 2013 (NPPA S.O. 1232(E)) [3].
  • June–July 2021: TMR was applied to 6 COVID-related devices: oxygen concentrators, pulse oximeters, BP monitors, nebulisers, digital thermometers and glucometers. Margins were capped at 70% of Price to Distributor [3].
  • Oct 2026: TMR was extended to 137 anti-cancer drugs, and revised MRPs were issued for 543 brands [1].

4. Core Static Facts

Item Fact
Regulator NPPA, an attached office of the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers [1][3]
Constituted Resolution dated 29.8.1997 (Gazette No. 159) [3]
Governing order Drugs (Prices Control) Order, 2013, issued under Section 3 of the Essential Commodities Act, 1955 [3]
Policy NPPP 2012, notified 7.12.2012 [3]
Scheduled drugs NLEM medicines placed in Schedule-I of DPCO 2013. NPPA fixes their ceiling prices under Paras 4 & 6 [3]
NLEM 2022 388 medicines, about 900+ formulations. Issued by MoHFW on the recommendation of the Standing National Committee on Medicines (SNCM) [3]
Ceiling prices in force 933 formulations (as of 23.10.2025) [3]
Annual revision Para 16: ceiling prices are revised each year in line with the WPI, on or before 1 April [3]
New drug pricing Para 5, with "new drug" defined in Para 2(1)(u). About 3,570 retail prices fixed up to 23.10.2025 [3]
Non-scheduled drugs Manufacturers set the price. The MRP may rise by at most 10% in 12 months [3]
Actual non-scheduled price rise Average of 5.6% a year (Apr 2020–Mar 2025), compared with WPI at 5.4% [3]
Extraordinary power Para 19: prices can be fixed in public interest in extraordinary circumstances. TMR is carried out under this power [3]
Market split (FY25) Scheduled drugs are about 18% of market value and non-scheduled about 82% [3]
State-level arm Price Monitoring and Resource Units (PMRUs) in 32 States/UTs, working under the State Drugs Controllers [3]
2026 TMR 137 drugs and 543 brands, effective 9 Nov 2026 [1]
Drugs covered (examples) Immunotherapy drugs (used in 20+ cancer types), Denosumab (breast and prostate cancer), Pegfilgrastim (prevents neutropenia), Bevacizumab (colon, ovarian and cervical cancers) [1]

5. Multi-Dimensional Analysis

Economic

  • Non-scheduled drugs make up about 82% of market value, so ceiling prices alone leave most of the market uncontrolled. TMR targets margins in this segment without full price control [3].
  • About 87% of the non-scheduled market has weighted average markups of up to 45%. Only about 4% has markups above 100% of the Price to Distributor. Excessive margins are therefore concentrated in a few segments, such as high-priced cancer drugs, which is why TMR is applied selectively [3].
  • The 2019 pilot saved about ₹984 crore a year, which shows the scale of the potential fiscal benefit [3].

Social / Health equity

  • Cancer treatment costs patients heavily out of pocket. Cuts of about 70% on biologics like Bevacizumab improve access for poor and middle-income patients [1].
  • The drugs covered include supportive-care medicines such as Pegfilgrastim, not just cancer-killing drugs [1].

Legal / Regulatory

  • TMR rests on Para 19, an extraordinary, time-limited power. DPCO 2013 has no permanent enabling provision for TMR [3].
  • The Standing Committee recommended a permanent TMR framework within a defined timeframe. The Department said it has no set time frame [3].

Governance / Administrative

  • Enforcement is staggered. Prices depend on manufacturers' submissions, and the list is "updated on a continual basis" [1].
  • One known violation is selling old stock at pre-revised MRPs, which the Committee has flagged [3].
  • Total overcharging demands against violators reached ₹10,013.30 crore [3], which shows how weak recovery has been.

Industry / Stakeholder

  • MSME pharma associations have objected to TMR being applied to non-scheduled formulations. Stakeholders have also raised concerns about the "span and extent" of TMR [3].
  • The Department warns that price cuts must not make products unviable to the point where life-saving drugs disappear from the market [3].

6. Recent Developments (last 12–18 months)

  • 23 Oct 2025: ceiling prices were in force for 933 formulations. NPPA had fixed about 3,570 new-drug prices [3].
  • Dec 2022 – Nov 2025: the Authority held 36 meetings. It fixed ceiling prices for 776 scheduled formulations and 1,425 new-drug retail prices [3].
  • Aug 2026: the 33rd Report of the Standing Committee on Chemicals & Fertilizers (18th Lok Sabha) reviewed NPPA and pushed for permanent TMR [3].
  • 17 Oct 2026: TMR was announced for 137 non-scheduled anti-cancer drugs [1].
  • 27 Oct 2026: this was the cut-off date for the first batch of company price submissions [1].
  • 9 Nov 2026: revised MRPs for 543 brands take effect [1].

7. Prelims Hooks

  • NPPA is an attached office of the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers. It is not under MoHFW [3].
  • NPPA was constituted by a Government Resolution on 29 Aug 1997. It is not a statutory body [3].
  • DPCO 2013 is issued under Section 3 of the Essential Commodities Act, 1955, not the Drugs & Cosmetics Act, 1940 [3].
  • The NLEM is prepared by MoHFW through the SNCM. NLEM drugs form Schedule-I of DPCO 2013 [3].
  • NLEM 2022 lists 388 medicines [3].
  • Para 19 of DPCO 2013 allows price fixation in extraordinary circumstances in public interest. It is the legal basis for TMR [3].
  • Para 16 of DPCO 2013 requires annual WPI-linked revision of ceiling prices [3].
  • Non-scheduled drug MRPs may rise by at most 10% in 12 months [3].
  • The first TMR pilot (27 Feb 2019) capped trade margins at 30% on 42 anti-cancer drugs [3].
  • The 2026 TMR covers 137 drugs, with revised MRPs for 543 brands, effective 9 Nov 2026 [1].
  • Pegfilgrastim prevents neutropenia in cancer patients [1].
  • Denosumab is used for breast and prostate cancer patients [1].
  • Bevacizumab 100 mg/4 ml falls from ₹21,767.70 to ₹5,930.13 [1].
  • Coronary stents were first price-capped on 13 Feb 2017 under Para 19 [3].
  • PMRUs operate in 32 States/UTs [3].

8. TMR Cuts the Middlemen's Share, Not the Factory Price

  • What TMR touches and what it leaves alone
  • A drug's price passes through three points: the price the company charges the distributor (PTD, Price to Distributor), the price the retailer pays (PTR, Price to Retailer), and the MRP the patient pays.
  • TMR limits only the gap between the first point and the last. This gap is the trade margin, the money earned by distributors and chemists.
  • The company's own selling price is not examined at all.

  • NPPA has no legal power to check what a drug costs to make

  • DPCO 2013 fixes prices only from market data, meaning the prices already charged in the market. It has 'no provision' for using cost-audit data, which shows the actual cost of making a drug [3].
  • The NPPA representative told the Committee: 'I have no power to do cost audit' [3].
  • So if a company sets a high price at the factory gate, TMR leaves it alone. TMR removes the extra markup added on top of that price, and nothing more.

  • The Committee wants a way to look behind the price

  • It says depending only on market data may fail to catch distortions caused by 'market monopolies' [3].
  • It recommended that the Ministry consider bringing back cost-based pricing, through changes in the law, where markups are abnormally high [3].
  • This matters for patented biologics, where one company may be the only seller.

9. Why the Price Falls on Paper Before It Falls at the Chemist

  • Old stock is the most common way the new price is avoided
  • When a price is cut, companies do not have to take back stock already in shops. They only have to make sure it is sold at the new, lower price [3].
  • 'Ceiling price violation (including pre-manufactured stock)' was the biggest category of violation. Between April 2020 and March 2025 it had 366 cases and ₹177.14 crore detected, but only ₹21.89 crore was recovered [3].
  • A revised MRP that starts on 9 November 2026 can still be beaten by boxes printed with the old MRP.

  • Fines are demanded but rarely collected

  • Of ₹10,013.30 crore in overcharging demands, ₹8,526.10 crore (about 85%) was still unpaid on 30.9.2025 [3].
  • ₹5,944.16 crore is stuck in High Court or Supreme Court cases. 280 of those 345 cases have been pending for between 6 and more than 20 years [3].
  • So a company gains more by overcharging and fighting the demand in court than by obeying.

  • The dispute is about the margin itself

  • Companies challenge demands on several grounds. One is how the 'trade margin' should be deducted from the overcharged amount [3].
  • Until a permanent TMR rule defines this clearly, every new TMR order can lead to the same arguments.

  • There are few people to enforce it

  • 15 of NPPA's 48 sanctioned posts are vacant. It depends on legal consultants hired on contract [3].
  • Few patients complain directly. The Pharma Jan Samadhan portal received only 66 of 1,316 complaints between 2022-23 and November 2025 [3].

10. NPPA Measures Margins Using Data From the Drug Trade Itself

  • NPPA does not collect its own price data
  • Para 9 of DPCO 2013 allows prices to be fixed using data from a private market-data company. NPPA uses Pharmarack Technologies [3].
  • Pharmarack grew out of AIOCD Pharma. AIOCD is the All India Organisation of Chemists and Druggists [3]. Chemists are the very traders whose margins TMR cuts.
  • This does not prove the data is biased. But the regulator depends on records from the trade it regulates.

  • The data misses the places where cancer drugs are often sold

  • Pharmarack covers about 70% of the Indian pharmaceutical market [3].
  • It does not cover hospitals, dispensing doctors, Jan Aushadhi, trade generics or e-commerce [3].
  • Cancer injections are often bought from hospital pharmacies. So the real margins on these sales cannot be seen.

  • Large discounts show that big margins exist

  • The Committee found hospitals and retailers giving discounts of 20% to 60% on MRP. This means large margins are built into the price [3].
  • The Department itself admitted that 'something needs to be done' about huge margins in some parts of the distribution chain [3].

  • The fix is already being worked on, slowly

  • IPDMS 2.0 is NPPA's own online system for collecting price data from companies. 2,344 companies were registered on it by November 2025 [3].
  • The Committee wants it built into an independent database, so NPPA no longer has to rely on outside data firms [3].

11. Why the Real Savings May Be Smaller Than the Headline

  • The headline example is the best case, not the usual one
  • In 2019, some MRPs fell by up to 90% [4]. But the average cut across 526 brands was about 50% [3].
  • Bevacizumab's fall of about 73% is a single example. It does not tell you the typical cut in 2026.

  • Savings are counted as if every patient paid the full MRP

  • The ₹984 crore estimate compares the old MRP with the new MRP [3].
  • Many patients did not pay the old MRP. Hospitals and chemists already gave discounts of 20% to 60% [3].
  • AMRIT pharmacies, which cover oncology, already sell at up to 50% below MRP [3].
  • For these patients, the real saving is the gap between the old discounted price and the new MRP. That gap is smaller.

  • Who gains the most

  • Patients who buy at full MRP from ordinary chemists gain the most. These are often patients far from big hospitals.
  • So the policy helps people outside the AMRIT and Jan Aushadhi network the most.

12. The Best Case Against Capping Margins, and Where It Fails

  • The objection, stated fairly
  • MSME drug makers say TMR will hurt small firms, cost jobs and reduce the supply of medicines to remote areas [3].
  • Their reasons: 'trade generics' (cheap generic medicines sold mainly through small distributors in rural and remote markets) make up about 8-9% of the market [3]. Distributors in this channel pay more for transport, for holding stock, for expired goods and for loans [3].
  • In this model the trade, not the manufacturer, pays for marketing. So a high percentage margin is partly a real cost [3].
  • The Department adds that strict price control discourages investment. The pharma sector grew 9.9% a year, slower than the 11.8% nominal GDP growth of the economy [3].
  • WHO also warns that products may disappear from the market if markups do not cover suppliers' costs [5].

  • What the objection gets right

  • Medicines can become too cheap to make. NPPA itself allowed 50% price rises for drugs that had become unviable, in 2019, 2021 and 2024 [3].
  • A flat, blanket margin cap on all non-scheduled drugs would hurt cheap rural generics the most.

  • Why it does not apply well to cancer drugs

  • The Department's own explanation says high percentage margins come from a low ex-factory price and low sales volume. A small cost looks large as a percentage of a cheap product [3].
  • A ₹21,767 cancer injection is the opposite case [1]. Even a modest percentage margin on it earns many rupees.
  • Only about 4% of the non-scheduled market has markups above 100% of PTD [3]. Choosing high-priced cancer drugs aims TMR at that small group, not at rural generics.

  • So the honest conclusion is

  • The MSME argument is a good reason to design TMR carefully. It is not a reason to drop TMR for expensive cancer drugs.

13. What a Permanent TMR Rule Should Fix

  • DoP should write TMR into DPCO with a deadline
  • Today TMR depends on Para 19, an emergency power used 'for a limited period' [3].
  • The Department has worked on this for 5-6 years and says it has 'no set time frame' [3].
  • The Committee asked for a permanent TMR framework 'within a clearly defined timeframe' [3].

  • Use a margin that gets smaller as the price gets bigger

  • WHO's 2020 pricing guideline suggests regressive markups. This means the allowed percentage margin falls as the drug's price rises [5].
  • This answers both sides. Cheap rural generics keep a higher percentage to cover real costs. Costly cancer drugs get a lower percentage, so traders cannot earn huge sums in rupees.
  • WHO also asks countries to publish the markup method and review it regularly [5].

  • Give NPPA a limited power to check costs

  • The Committee recommended cost-based pricing, through changes in the law, where markups are abnormally high [3].

  • Make recovery faster than court cases

  • The Committee wants three things [3]:

    • a time-bound, fast-track way to settle disputes outside court
    • a dedicated legal cell inside NPPA
    • clear rules on disputed points, such as how the trade margin is deducted from the overcharged amount
  • Staff and data

  • Fill the 15 vacant posts and approve the proposed 59 new posts in NPPA [3].
  • Bring hospital and e-commerce sales into the price data [3].

  • Let patients have a say

  • Over three years, draft prices for 'new drugs' got about 30 comments. 29 came from companies and 1 from an industry association. None came from patients or consumer groups [3].
  • The Committee asked DoP and NPPA to draw the public into price-setting [3]. A permanent TMR rule should be consulted on in the same open way.

14. Anchors for Answers

  • Data: About 82% of the drug market by value is non-scheduled, which ceiling prices do not reach. Only about 4% of it has markups above 100% of PTD [3]
  • Data: ₹8,526.10 crore of ₹10,013.30 crore in overcharging demands (about 85%) is unrecovered. 280 of 345 court cases are 6 to 20+ years old [3]
  • Data: 15 of NPPA's 48 sanctioned posts are vacant [3]
  • Report/Committee: Lok Sabha Standing Committee on Chemicals & Fertilizers, 33rd Report (August 2026). It called the delay in a permanent TMR 'inordinate' and recommended considering cost-based pricing where markups are abnormal [3]
  • Law/Case: Para 19 of DPCO 2013 (emergency public-interest power, the current basis of TMR). DPCO is issued under Section 3 of the Essential Commodities Act, 1955, and violations can be penalised under Section 7 of the same Act [3]
  • Comparison: WHO Guideline on Country Pharmaceutical Pricing Policies (2020) suggests regressive markups, where the percentage falls as the price rises, along with a published method and regular review [5]
  • Scheme: AMRIT pharmacies (255 outlets, covering oncology, up to 50% off MRP, about ₹8,691 crore saved) and PMBJP/Jan Aushadhi (about 80% cheaper than leading brands) work alongside TMR [3]

15. Mains Relevance

16. Related Topics to Study Next

  • NLEM 2022 and Schedule-I of DPCO: these decide which drugs are scheduled and which are not.
  • NPPP 2012: the policy that introduced market-based pricing.
  • Essential Commodities Act, 1955: the parent statute of DPCO.
  • Jan Aushadhi (PMBJP): a parallel route to affordable medicines through generics.
  • Medical devices under DPCO (2020): TMR on stents, knee implants and COVID-era devices.
  • CDSCO and the Drugs & Cosmetics Act, 1940: quality regulation, as distinct from price regulation.
  • Biosimilars: Bevacizumab, Denosumab and Pegfilgrastim are biologics, so link to biosimilar policy and pricing.
  • Out-of-pocket health expenditure and the cancer burden: the case for affordability.

17. NCERT Concepts to Revise

  • Price ceiling (Economy): Scheduled drugs get government-fixed ceiling prices; TMR extends a similar cap to margins on non-scheduled drugs.
  • Maximum Retail Price (Economy): The article is about NPPA revising MRPs, the highest price patients can be charged, for 543 brands.
  • Price control (Economy): DPCO 2013 and TMR are forms of price regulation, balancing affordability against industry viability.
  • Essential commodities (Economy): DPCO is issued under the Essential Commodities Act, 1955, the legal base for drug price control.
  • Wholesale Price Index (Economy): Ceiling prices are revised every year in line with WPI, and non-scheduled price rises are compared to it.
  • Standing committee (Polity): The Lok Sabha Standing Committee's 33rd Report criticised the delay in a permanent TMR framework.

18. Common Errors / Trap Areas

  • Wrong ministry: NPPA is under the Ministry of Chemicals & Fertilizers (DoP), while the NLEM comes from MoHFW. Students often mix these up [3].
  • 137 vs 543: 137 is the number of drugs under TMR, and 543 is the number of brands with revised MRPs [1].
  • 2019 vs 2026: 2019 covered 42 drugs and 2026 covers 137 [1][3]. The 2019 brand count differs by source: 355 at launch [2] and 526 in a later NPPA report [3].
  • Scheduled vs non-scheduled: TMR applies to non-scheduled drugs. Scheduled drugs already have ceiling prices [1][3].
  • Statutory basis: DPCO comes from the Essential Commodities Act, not the Drugs & Cosmetics Act. NPPA was created by resolution, not by statute [3].

Sources

  1. 1PIB – NPPA releases Revised MRP for 543 brands of Anti-Cancer Medicines (user-supplied digest)pib.gov.in · tier 1
  2. 2PIB – Ministry of Chemicals and Fertilizers, TMR on 42 anti-cancer drugs (2019); facts taken from the search-result summarypib.gov.in · tier 1
  3. 3Lok Sabha Standing Committee on Chemicals & Fertilizers (2025-26), 33rd Report: "Review of Role, Functions and Duties of NPPA…", Aug 2026sansad.in · tier 1
  4. 4PIB – NPPA has put a cap on Trade Margin of 42 select non-scheduled anti-cancer medicines under 'Trade Margin Rationalization (TMR)' Approach resulting in reduction up to 90% of MRP of 526 brandspib.gov.in · tier 1
  5. 5WHO publishes pricing policy guideline to improve affordable access to medicines (WHO Guideline on Country Pharmaceutical Pricing Policies, 2020)who.int · tier 2

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