This policy announcement from the Ministry of Chemicals and Fertilizers, dated August 5, 2025, addresses rumors of a ban on paracetamol and other common medicines. The Ministry of Health and Family Welfare clarifies that the Central Drugs Standard Control Organisation (CDSCO) has no information supporting these rumors and confirms that paracetamol is not banned in India. While paracetamol itself is not banned, various Fixed Dose Combinations (FDCs) including those containing paracetamol, have been banned. A list of these banned combinations is available on the CDSCO website (www.cdsco.gov.in).
The National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals regulates drug prices under the Drugs Prices Control Order, 2013 (DPCO, 2013). The NPPA uses the following procedures:
1. **Essential Medicines:** For formulations listed in the National List of Essential Medicines (NLEM) and the First Schedule to DPCO, 2013 (including OTC formulations), NPPA fixes and revises ceiling prices annually based on the Wholesale Price Index. Manufacturers must sell within this ceiling price plus local taxes.
2. **New Drugs:** For new drugs launched by existing manufacturers listed in NLEM (through combining with another drug, or changing strength/dosage, including OTC drugs), NPPA fixes the retail price applicable to the applicant manufacturer.
3. **Non-Scheduled Formulations:** Manufacturers cannot increase the Maximum Retail Price (MRP) of non-scheduled formulations (including OTC formulations) by more than 10% of the preceding 12 months' MRP. NPPA monitors these MRPs.
To ensure essential drug availability and reduce patient costs, the Government supports the Free Drugs Service Initiative under the National Health Mission, providing financial support to States and Union Territories for free essential medicines in public health facilities. This includes funding for procurement, quality assurance, supply chain management, warehousing, prescription audits, grievance redressal, and the Drugs and Vaccine Distribution Management System (DVDMS). A central dashboard monitors supply chain management, with some states implementing the DVDMS portal to Sub Health Centres.
The Ministry of Health and Family Welfare recommends facility-wise Essential Medicines Lists for public healthcare facilities. The recommended Essential Medicines List for Sub Health Centres, Primary Health Centres, Community Health Centres, Sub-District Hospitals, and District Hospitals consist of 106, 172, 300, 318 and 381 drugs respectively, with flexibility to States to add more medicines.
The Medical Stores Organisation (MSO) Government Medical Store Depots (GMSDs) have active rate contracts for 697 drug formulations to ensure an uninterrupted supply chain of essential drugs. 1,152 registered indenters across India, including government hospitals and rural primary health centers, can demand drug supplies from MSO-GMSDs through the MSO-DVDMS application software four times annually.
This information was provided by the Union Minister of State for Chemicals and Fertilizers, Smt. Anupriya Patel, in Rajya Sabha.
Key Entities Referenced
Ministry of Chemicals and Fertilizers: The ministry responsible for chemicals and fertilizers related policies.
Ministry of Health and Family Welfare: The ministry responsible for health and family welfare policies.
Paracetamol: A common over-the-counter drug.
Central Drugs Standard Control Organisation: The national regulatory body for pharmaceuticals and medical devices in India.
National Pharmaceutical Pricing Authority: An organization that fixes and monitors the prices of drugs in India.
Drugs Prices Control Order, 2013: An order regulating the prices of drugs in India.
National Health Mission: A government initiative to address health needs.
Anupriya Patel: The Union Minister of State for Chemicals and Fertilizers.
Ministry of Chemicals and Fertilizers
Ban on paracetamol and other common medicines
The Ministry of Health and Family Welfare has
informed that the Central Drugs Standard Control
Organisation is not in receipt of information about
rumours regarding drug paracetamol ban
The National Pharmaceutical Pricing Authority
(NPPA) under the Department of Pharmaceuticals
fixes and monitors the prices of drugs, including OTC
drugs, under the Drugs (Prices Control) Order, 2013
(“DPCO, 2013”)
Posted On: 05 AUG 2025 5:01PM by PIB Delhi
The Ministry of Health and Family Welfare has informed that the Central Drugs Standard Control
Organisation is not in receipt of information about such rumours. It has further informed that the drug
Paracetamol is not banned in the country, although in the recent past various Fixed Dose Combinations,
including such combinations of Paracetamol with other drugs, have been banned in the country, and the list of
all such banned combinations is available on the website of the Central Drugs Standard Control Organisation
(www.cdsco.gov.in ).
The National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals
fixes and monitors the prices of drugs, including OTC drugs, under the Drugs (Prices Control)
Order, 2013 (“DPCO, 2013”), in the following manner:
i. For formulations that are listed in the National List of Essential Medicines issued by the Department of
Health and Family Welfare and incorporated in the First Schedule to DPCO, 2013, including OTC
formulations, NPPA fixes the ceiling price and revises them annually based on the Wholesale Price
Index (all commodities). All manufactures, importers and marketers of scheduled medicines are required
to sell their products within the ceiling price (plus applicable local taxes) fixed.
ii. For new drugs (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),
including OTC drugs, NPPA fixes the retail price. Such retail price is applicable to the applicant
manufacturer and marketer, who are required to sell these drugs within the retail price fixed.
iii. For other non-scheduled formulations, including non-scheduled OTC formulations, manufacturers are
required not to increase the maximum retail price (MRP) of such formulations launched by them bymore than 10% of MRP during the preceding 12 months, and NPPA monitors their MRP with a view to
ensure the same.
The Ministry of Health and Family Welfare has informed that to ensure availability of essential drugs and
reduce out-of-pocket expenditure of patients visiting the public health facilities, including government
hospitals and rural primary health centres, Government has rolled out the Free Drugs Service Initiative under
the National Health Mission. Under this, financial support is provided to States and Union territories for
provision of free essential medicines in public health facilities based on the requirements posed by them in
their Programme Implementation Plans within their overall resource envelope for the said Mission. Support
under the said initiative is available for procurement of drugs and strengthening or setting up of robust
systems of procurement, quality assurance, supply chain management and warehousing, prescription audit and
grievance redressal, and for the dissemination of standard treatment guidelines and establishment of the
information-technology enabled platform named Drugs and Vaccine Distribution Management System
(DVDMS), which is used for monitoring the actual status of procurement and availability of essential
medicines. To facilitate monitoring of supply chain management activity at the national level, a central
dashboard has been developed. Some States have also implemented the roll-out of the DVDMS portal till Sub
Health Centres for monitoring the status of procurement and availability of essential medicines.
The Ministry of Health and Family Welfare has recommended facility-wise Essential Medicines List
to be made available at public healthcare facilities, including government hospitals and rural primary
health centres. The recommended Essential Medicines List for Sub Health Centres, Primary Health
Centres, Community Health Centres, Sub-District Hospitals and District Hospitals consist of 106,
172, 300, 318 and 381 drugs respectively, with flexibility to States to add more medicines.
To ensure uninterrupted supply chain of essential drugs in government hospitals and rural health
facilities, the Medical Stores Organisation (MSO) / Government Medical Store Depots (GMSDs) has
active rate contracts for 697 drug formulations. MSO has 1,152 registered indenters across India,
including government hospitals and rural primary health centres, who may place demands for
supply of drugs to MSO/GMSDs through MSO-DVDMS application software four times in a financial
year.
This information was given by the Union Minister of State for Chemicals and Fertilizers Smt
Anupriya Patel in Rajya Sabha in reply to a question today.
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MV/GS
(Release ID: 2152591)