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Home India Ministry of Chemicals and Fertilizers : Department of Pharmaceuticals Notifications Price regulation of essential medicines... (Official PDF)
Date: 28th July 2026 Category: Press Release Jurisdiction: India, Central Government

Price regulation of essential medicines - 28th July 2026 - Ministry of Chemicals and Fertilizers : Department of Pharmaceuticals - Gazette Notification PDF

Issued by Ministry of Chemicals and Fertilizers : Department of Pharmaceuticals

Read or download the official PDF of this gazette notification issued by the Ministry of Chemicals and Fertilizers : Department of Pharmaceuticals on 28th July 2026. Classified under Press Release.

Executive Summary & Key Takeaways

Executive Summary This report details the regulatory framework for drug pricing in India under the Drugs (Prices Control) Order (DPCO) 2013 to ensure the affordability of essential medicines. As of July 23, 2026, the National Pharmaceutical Pricing Authority (NPPA) has fixed ceiling prices for 935 scheduled formulations and retail prices for 3,845 new drugs. The document outlines compliance requirements for manufacturers and various government initiatives aimed at providing low-cost healthcare and generic medicines to the public.

Key Points / Main Content

Pricing Regulation Mechanisms

  • Ceiling Prices: The NPPA fixes ceiling prices for drugs in Schedule-I of DPCO 2013, based on the National List of Essential Medicines (NLEM) 2022, which includes 388 medicines across 29 categories.
  • Retail Prices for New Drugs: NPPA fixes retail prices for "new drugs" (specific combinations or dosage changes by existing manufacturers); manufacturers and marketers are prohibited from selling above these notified prices.
  • Non-Scheduled Formulations: Manufacturers are restricted from increasing the Maximum Retail Price (MRP) of non-scheduled formulations by more than 10% within any 12-month period.
  • Emergency Powers: Under Para 19 of DPCO 2013, the NPPA may fix the price of any drug in the public interest during extraordinary circumstances.

Compliance and Monitoring

  • Labeling Requirements: Manufacturers must print the MRP on the label of every formulation container.
  • Sales Restrictions: No person is permitted to sell a formulation to a consumer at a price exceeding the MRP on the label or the current price list, whichever is lower.
  • Enforcement: NPPA monitors prices through State Drugs Controllers, Price Monitoring and Resource Units, market samples, and consumer grievances to take action against overcharging.

Government Affordability Initiatives

  • Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP): Provides generic medicines through over 20,000 Kendras at 50% to 80% less than branded prices.
  • Ayushman Bharat (AB-PMJAY): Offers health insurance of ₹5 lakh per family per year for secondary and tertiary care.
  • Free Drugs Service Initiative: Provides essential medicines free of charge at public health facilities ranging from Primary Health Centres to district hospitals.
  • AMRIT Pharmacies: Provides medicines for cancer and cardiovascular diseases, as well as implants, at an average discount of up to 50%.
  • Financial Assistance: Poor patients (BPL) suffering from life-threatening diseases receive aid through Rashtriya Arogya Nidhi and the Health Minister’s Discretionary Grant.

Impact Analysis

Pharmaceutical Manufacturers Impact Manufacturers are subject to strict price caps on scheduled drugs and annual 10% increase limits on non-scheduled drugs. They are legally liable for any overcharging. Action Required Must print the MRP on all containers and ensure that retail prices for new drugs are notified by the NPPA before sale.

Consumers / Patients Impact Consumers benefit from regulated pricing, access to deeply discounted generic medicines, and insurance coverage for hospitalization. Action Required May report overcharging through grievance redress channels and utilize government schemes like PMBJP or AB-PMJAY for reduced healthcare costs.

Retailers and Sellers Impact Sellers are prohibited from charging more than the printed MRP or the current price list. Action Required Must verify that the sale price of any formulation does not exceed the lower of the label price or the official price list.

NPPA and State Drugs Controllers Impact These bodies are responsible for the continuous review of drug availability and the enforcement of DPCO 2013 provisions. Action Required Must monitor market prices, collect samples from the open market, and take action against companies found to be overcharging.

Key Entities Referenced

Drugs (Prices Control) Order 2013 (DPCO, 2013): The primary legal framework under which the government regulates the ceiling prices and retail prices of essential medicines in India. National Pharmaceutical Pricing Authority (NPPA): The regulatory body responsible for fixing ceiling prices for scheduled formulations and monitoring price compliance to prevent overcharging. National List of Essential Medicines (NLEM): The official list of medicines that forms the basis for Schedule-I of the DPCO, determining which drugs are subject to price ceilings. Pradhan Mantri Bhartiya Janaushadhi Pariyojana: A government scheme that provides quality generic medicines at 50% to 80% cheaper rates through a network of over 20,000 Janaushadhi Kendras. Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY): A health assurance scheme providing a cover of ₹5 lakh per family per year for secondary and tertiary care hospitalisation, including medicines.
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Ministry of Chemicals and Fertilizers : Department of Pharmaceuticals Price regulation of essential medicines प्रव तथ: 28 JUL 2026 3:30PM by PIB Delhi Prices of drugs are regulated as per the provisions of the Drugs (Prices Control) Order 2013 (DPCO, 2013). As per extant provisions of DPCO, 2013, the 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 (NLEM) published by Ministry of Health & Family Welfare (MoHFW). NLEM, 2022 contains 388 medicines, listed under 29 therapeutic categories. NPPA has fixed ceiling prices for 935 scheduled formulations as on 23.07.2026. NPPA also fixes retail prices of new drugs as defined in para 2(1)(u) of DPCO, 2013, i.e., formulations launched by existing manufacturers of a medicine listed in NLEM by combining it with another drug, or by changing the strength or dosage or both of such medicine. The retail prices of new drugs are applicable to the applicant manufacturer and marketer and they cannot sell the new drug above the price notified by NPPA. Retail prices of 3,845 new drugs have been fixed by the NPPA till 23.07.2026. Further, in case of non-scheduled formulations, manufacturers are required to not increase their maximum retail price (MRP) of a formulation by more than ten percent of the MRP of that formulation during the preceding 12 months. In addition, NPPA can also fix the prices of any drug under Para 19 of DPCO 2013 in public interest in extra-ordinary circumstances. Details of prices fixed or revised by NPPA are available on NPPA’s website (www.nppa.gov.in). NPPA continuously reviews the affordability and availability of medicines. As and when required, Government invokes the provisions of DPCO, 2013 and makes required interventions to ensure affordability and availability of essential medicines. To prevent overpricing, DPCO 2013 requires every manufacturer of a formulation to print the maximum retail price on the label of the container of such formulation. Further, no person is permitted to sell any formulation to any consumer at a price exceeding the price specified on the current price list or price indicated on the label of the container or the pack thereof, whichever is less. Moreover, NPPA monitors the prices of both scheduled and non-scheduled formulations on an ongoing basis and takes action in accordance with the provisions of DPCO, 2013 against companies that are found overcharging consumers, based on references received regarding overcharging from any source, including Price Monitoring and Resource Units set up in States, State Drugs Controllers, samples purchased from open market, reports from market database and complaints lodged through various grievance redress channels. Government has taken various measures to improve the access of essential medicines at affordable rates to the common man which include the following: i. The Government has launched the Pradhan Mantri Bhartiya Janaushadhi Pariyojana scheme under which quality generic medicines is provided through more than 20,000 Janaushadhi Kendras at rates that are typically 50% to 80% cheaper than branded medicines. ii. Under Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) of the Department of Health and Family Welfare, health assurance/insurance cover of ₹5 lakh per family peryear is provided for secondary or tertiary care hospitalisation, including for medicines. iii. Under the Free Drugs Service Initiative of the National Health Mission, essential medicines list recommended under the Indian Public Health Standards (IPHS) are made available free of any charge at public health facilities ranging from Primary Health Centres (PHCs) to district hospitals across the country. iv. Under the Amrit (Affordable Medicines and Reliable Implants for Treatment) initiative of the Department of Health and Family Welfare, affordable medicines are provided for the treatment of cancer, cardiovascular and other diseases, implants, surgical disposables and other consumables etc., at an average discount of up to 50% on market rates through AMRIT Pharmacy stores set up in number of hospitals and healthcare institutions. v. Financial assistance is provided to poor patients belonging to families living below the poverty line, who suffer from major life-threatening diseases including cancer, under the umbrella scheme of Rashtriya Arogya Nidhi and the Health Minister’s Discretionary Grant. This information was given by Minister of State for Chemicals and Fertilizers Smt. Anupriya Patel, in a written reply in the Rajya Sabha today. ***** PC/PM (रलीज़ आईडी: 2290387) आगंतुक पटल : 526 इस वज्ञ को इन भाषाओ ंम पढ़: Urdu , ही , Telugu

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