Read or download the official PDF of this gazette notification issued by the Ministry of Chemicals and Fertilizers :
Department of Pharmaceuticals on 7th August 2026. Classified under Press Release.
Executive Summary
This report outlines the regulatory framework for drug pricing and quality control in India as of August 2026, managed by the National Pharmaceutical Pricing Authority (NPPA) under the DPCO 2013. It details the mechanisms for fixing ceiling prices for 935 formulations and retail prices for 3,845 new drugs, alongside annual price revisions based on the Wholesale Price Index (WPI). The document also highlights government initiatives for affordable medicine access and provides statistical data on drug quality testing and prosecutions from 2023 to 2026.
Key Points / Main Content
Pricing Regulation and Mechanisms
Regulatory Authority: The NPPA regulates medicine prices according to the Drugs (Prices Control) Order, 2013 (DPCO 2013), based on the National List of Essential Medicines (NLEM).
Ceiling and Retail Prices: As of July 23, 2026, ceiling prices are effective for 935 formulations, with an average price reduction of approximately 17% under NLEM 2022. Retail prices for 3,845 new drugs have also been fixed.
Non-Scheduled Formulations: Manufacturers cannot increase the Maximum Retail Price (MRP) by more than 10% within a 12-month period. Market data from June 2026 shows a lower actual weighted average increase of 6.94%.
Annual Revisions: Prices for scheduled medicines are revised annually on April 1st based on the WPI of the preceding calendar year. Recent WPI increases were 0.00551% (2024), 1.74028% (2025), and 0.64956% (2026).
Affordability Initiatives
Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP): Quality medicines are provided through Jan Aushadhi Kendras at 50% to 80% less than branded prices.
AMRIT Initiative: Provides medicines for cancer, cardiovascular diseases, and implants at an average discount of up to 50% through dedicated pharmacy stores.
Free Drugs Service Initiative: Essential medicines are provided free of charge at public health facilities under the National Health Mission.
Quality Control and Enforcement
Legislative Framework: Manufacture and sale are regulated under the Drugs and Cosmetics Act, 1940, and Rules, 1945.
Monitoring and Sampling: State Licensing Authorities (SLAs) conduct periodic and risk-based inspections. In 2025-26, 1,41,322 drug samples were tested, resulting in 3,012 samples declared not of standard quality and 779 provisional prosecution cases.
Penalties: Erring firms face actions including suspension or cancellation of licenses and prosecution in court.
Impact Analysis
Pharmaceutical Manufacturers and MarketersImpact
Manufacturers are restricted by mandatory ceiling prices for scheduled drugs and a 10% annual cap on MRP increases for non-scheduled drugs. They are subject to strict quality oversight and licensing requirements.
Action Required
Must ensure the retail price of new drugs does not exceed NPPA-notified levels and maintain compliance with quality standards to avoid license suspension or prosecution.
General Public / ConsumersImpact
Consumers benefit from regulated, affordable prices for essential medicines and access to heavily discounted or free drugs through government-led schemes (PMBJP, AMRIT, and PHCs).
Action Required
No direct action is required, though consumers can access information on revised prices through the NPPA website.
State Licensing Authorities (SLAs)Impact
SLAs are empowered to grant licenses and are responsible for the verification of compliance through inspections and drug sampling.
Action Required
Must carry out periodic and risk-based inspections of licensed premises and take legal action against firms found selling spurious or substandard drugs.
Key Entities Referenced
National Pharmaceutical Pricing Authority (NPPA): The regulatory body responsible for fixing ceiling prices of essential medicines and monitoring price compliance for both scheduled and non-scheduled formulations.
Drugs (Prices Control) Order 2013 (DPCO, 2013): The primary regulatory framework used to control drug prices and ensure the availability of medicines at affordable rates in India.
National List of Essential Medicines (NLEM): A list of priority medicines published by the Ministry of Health and Family Welfare that serves as the basis for fixing price ceilings on drug formulations.
Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP): A government initiative that provides quality generic medicines at significantly reduced prices through a network of Jan Aushadhi Kendras.
Drugs and Cosmetics Act, 1940: The fundamental legislation governing the manufacture, sale, and distribution of drugs to ensure quality standards and regulatory compliance.
Ministry of Chemicals and Fertilizers :
Department of Pharmaceuticals
Life-saving Medicines
प्रव तथ: 07 AUG 2026 2:47PM by PIB Delhi
Prices of drugs are regulated as per the provisions of the Drugs (Prices Control) Order 2013 (DPCO,
2013). The National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals
regulates the prices of medicines as per extant provisions of DPCO, 2013. NPPA fixes the ceiling prices of
formulations specified in Schedule-I to DPCO, 2013 which is based on the National List of Essential
Medicines (NLEM) published by Ministry of Health and Family Welfare (MoHFW) from time-to-time. As
on 23.07.2026, Ceiling prices of 935 formulations are effective. The average price reduction due to
refixation of prices under NLEM, 2022 is about 17%. 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 the 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 has fixed
the prices of drugs under Para 19 to ensure the availability of drugs at affordable prices in public interest.
Details of prices fixed or revised by NPPA are available on NPPA’s website (www.nppa.gov.in).
The ceiling prices of scheduled medicines are revised annually on the basis of Wholesale Price Index
(WPI) (all commodities) for preceding calendar year on or before 1st April of every year, which is notified
by the Government on the 1st day of April every year. This notified increase is the maximum permissible
increase for schedule drug for that year, and a manufacturer may avail the same or a lower increase in the
price of such drugs. The WPI of the last 3 years are as follows:
Year WPI
1.04.2024 0.00551%
1.04.2025 1.74028%
1.04.2026 0.64956%
In case of non-scheduled formulations, manufacturers may avail an increase of up to 10 per cent in the
MRP of a formulation over the MRP of that formulation during the preceding 12 months. However, it is
observed from the market data (based on Pharmarack database for June, 2026) that the weighted averageannual price increase in the non-scheduled drugs over the last three years is 6.94% which is below the
permissible price increase of 10% p.a.
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.
Besides price regulation, Government has also enabled access to affordable essential medicines through
Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP), under which quality medicines are offered
through Jan Aushadhi Kendras (JAKs) at rates that are typically 50% to 80% lower than the prices of
branded medicines. In addition, 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. Also, 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.
As per the information provided by Ministry of Health and Family Welfare, the manufacture, sale and
distribution of drugs in the country is regulated under the provisions of Drugs and Cosmetics Act, 1940
and Rules, 1945 thereunder through a system of licensing and inspection. Licenses for manufacture, sale
and distribution of drugs are granted by the State Licensing Authorities (SLAs) appointed by respective
State Governments.
Further, as per information received from various States/ Union Territories Drugs Controllers (SDCs),
number of drug samples reported Not of Standard Quality/ spurious/ adulterated by the States/UTs Drugs
Controller during the last three years is as follows:
Year Drugs Drugs samples Drugs samples Prosecution cases For
samples declared not of declared Spurious / Manufacturing, Sale And
tested standard quality Adulterated Distribution Of Spurious/
Adulterated Drugs
2023-24 1,06,150 2,988 282 604
2024-25 1,16,323 3,104 245 961
2025-26 1,41,322 3,012 283 779*
* provisional figure
State Licensing Authorities carryout periodic inspections or as per risk-based approach from time to time
of the licensed premises for verification of compliance with the provisions of the Act and rules thereunder.
Actions such as suspension and cancellation of licences, prosecutions in the court of law are taken against
the erring firms by the State Licensing Authorities.
This information was given by Minister of State for Chemicals and Fertilizers, Smt. Anupriya Patel, in a
written reply in the Lok Sabha today.*****
PC/JL
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