**Executive Summary**
This document details the regulation of essential cancer drug prices in India under the Drugs (Prices Control) Order (DPCO), 2013. The National Pharmaceutical Pricing Authority (NPPA) fixes ceiling prices for scheduled cancer drugs, leading to significant price reductions. Key deadlines include the ceiling price for Paclitaxel Injection effective from April 1, 2025. The document also outlines measures to ensure affordability and access to cancer treatment for patients.
**Key Points / Main Content**
* **Drug Price Regulation Framework**
* Drug prices are regulated as per the Drugs (Prices Control) Order (DPCO), 2013.
* The National Pharmaceutical Pricing Authority (NPPA) fixes ceiling prices for drugs listed in Schedule-I of DPCO 2013, based on the National List of Essential Medicines.
* Previously, ceiling prices were fixed based on market data, without considering the gap between cost and Maximum Retail Price (MRP).
* **Price Reductions and Savings**
* As of March 9, 2026, ceiling prices for 131 anti-cancer drugs are effective, resulting in an approximate 21% reduction from prices fixed under NLEM, 2015.
* This has led to annual savings of around ₹294 crore for patients.
* **Manufacturer Obligations**
* Manufacturers must sell their products within the ceiling price fixed by NPPA, plus applicable Goods and Service Tax.
* Overcharging is dealt with as per DPCO, 2013 provisions.
* **New Drug Pricing**
* NPPA also fixes the retail price for new drugs as defined in DPCO, 2013.
* As of March 9, 2026, NPPA has fixed 58 retail prices for anti-cancer drugs, including anti-neoplastic and immuno-suppressive categories.
* **Non-Scheduled Formulations**
* For non-scheduled anti-cancer formulations, manufacturers cannot increase the MRP by more than 10% of the MRP from the preceding 12 months.
* In 2019, NPPA capped the trade margin for 42 select non-scheduled anti-cancer medicines, reducing the prices of over 500 brands by an average of about 50%.
* **Affordability and Access Initiatives**
* Cancer treatment is extended through free or subsidized treatment in Government Hospitals.
* The Ayushman Bharat-Pradhan Mantri Jan Arogya Yojana (PMJAY) provides cancer treatment.
* Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) makes quality generic medicines, including for cancer, affordable.
* Affordable Medicines and Reliable Implants for Treatment (AMRIT) Pharmacy stores offer cancer drugs at substantial discounts.
* The government is regularly rationalizing duties on anti-cancer drugs to reduce prices.
**Impact Analysis**
**Patients**
* **Impact:** Benefit from reduced prices of essential cancer drugs, leading to significant cost savings. Access to treatment is improved through various government schemes and subsidized pharmacies.
* **Action Required:** Utilize available schemes and pharmacies for affordable cancer treatment.
**Manufacturers**
* **Impact:** Must adhere to fixed ceiling prices and retail prices set by NPPA. Limitations on MRP increases for non-scheduled formulations.
* **Action Required:** Comply with DPCO, 2013 pricing regulations for all scheduled and new anti-cancer drugs. Ensure sales are within the notified ceiling/retail prices. Report any price increases for non-scheduled formulations within the permitted limit.
**National Pharmaceutical Pricing Authority (NPPA)**
* **Impact:** Responsible for fixing ceiling prices, retail prices of new drugs, and implementing trade margin caps. Oversees compliance with DPCO, 2013.
* **Action Required:** Continue to monitor and regulate prices of essential cancer drugs. Implement necessary interventions to ensure affordability and availability. Deal with instances of overcharging.
**Government**
* **Impact:** Implements policies and schemes to ensure affordable cancer treatment. Rationalizes duties on anti-cancer drugs.
* **Action Required:** Continue to develop and implement policies aimed at reducing the cost of cancer drugs and improving patient access to treatment.
Key Entities Referenced
Drugs (Prices Control) Order (DPCO), 2013: The primary legal framework for regulating drug prices in India, specifically impacting ceiling prices and retail price fixation for essential cancer drugs.
National Pharmaceutical Pricing Authority (NPPA): The regulatory body responsible for fixing ceiling prices and retail prices of drugs under the DPCO, playing a central role in implementing the policy's price control measures.
Pradhan Mantri Jan Arogya Yojana (PMJAY): A government health insurance scheme that extends access to cancer treatment for the poor, contributing to the policy's impact on affordability.
Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP): A program focused on making quality generic medicines, including those for cancer, available at affordable prices, thereby increasing accessibility.
Smt. Anupriya Patel: The Minister of State for Chemicals and Fertilizers who provided information on the policy in the Lok Sabha, indicating her role in the policy's communication and oversight.
Ministry of Chemicals and Fertilizers :
Department of Pharmaceuticals
Cost of Essential Cancer Drugs
Posted On: 13 MAR 2026 3:46PM by PIB Delhi
The prices of drugs are regulated as per the provisions of Drugs (Prices Control) Order (DPCO), 2013.
National Pharmaceutical Pricing Authority (NPPA) fixes the ceiling prices of the drugs included in the
Schedule-I of DPCO 2013 which is based on the National List of Essential Medicines published by
Ministry of Health and Family Welfare. As per the extant provision of DPCO 2013, the ceiling prices of
scheduled drugs are fixed on the basis of the market data and cost of drugs and gap between cost and MRP
are not taken into consideration while fixing the ceiling prices. As on 9.3.2026, ceiling prices of 131 anti-
cancer drugs are effective resulting in reduction of around 21% in the ceiling prices from the ceiling prices
fixed under NLEM, 2015 and annual savings of around ₹294 crore to patients. All manufacturers have to
sell their products within the ceiling price (plus applicable Goods and Service Tax) fixed by NPPA.
Paclitaxel Injection 30mg/5ml and 100mg/16.7ml are scheduled formulations and accordingly, NPPA has
fixed its ceiling price. The present applicable ceiling price is ₹219.19 per ml effective from 01.04.2025. All
manufacturers have to sell their products within the ceiling price (plus applicable Goods and Service Tax)
fixed by NPPA. Instances of overcharging are dealt with as per the provisions of DPCO, 2013
In addition, NPPA also fixes the retail price of new drugs as defined in para 2 (1)(u) of DPCO, 2013. The
retail price of a new drug is applicable to the applicant manufacturer and marketer, who are required to sell
the new drug within the price notified by NPPA. As on 9.03.2026, NPPA has fixed 58 retail prices under the
therapeutic category of Anti-Cancer drugs which includes 31 anti-cancer drugs, 26 anti-neoplastic drugs,
and 01 immuno-suppressive drug. Further, in the case of non-scheduled anti-cancer formulations,
manufacturers are required to not increase the maximum retail price (MRP) of such formulation by more
than 10% of the MRP of that formulation during preceding 12 months. Also, in order to ensure the
availability of drugs at affordable prices, NPPA in public interest capped the trade margin of 42 select non-
scheduled anti-cancer medicines in 2019. This move reduced the prices of above 500 brands of anti-cancer
medicines by an average of about 50%.
Access to the cancer treatment medicines are also extended through either free or highly subsidized
treatment of Cancer for the poor in Government Hospitals; treatment of Cancers under Ayushman Bharat –
Pradhan Mantri Jan Arogya Yojana (PMJAY); making available quality generic medicines including those
for cancer at affordable prices to all under Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP); and
setting up of Affordable Medicines and Reliable Implants for Treatment (AMRIT) Pharmacy stores in some
hospitals/institutions, that make available cancer drugs at a substantial discount vis-à-vis the MRP. In
addition, government has also been regularly rationalizing the duty on anti-cancer drugs to help reduce
their prices.
This information was given by Minister of State for Chemicals and Fertilizers, Smt. Anupriya Patel, in a
written reply in the Lok Sabha today.
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