No Ban on Paracetamol, Says Govt; 156 Drug Combos Axed Over Safety Concerns
New Delhi: While 156 fixed-dose combinations (FDCs), including some involving Paracetamol, have been banned in public interest, the standalone drug Paracetamol remains approved and widely available, the Central Government has clarified.
This clarification came in response to widespread rumours circulating about a Paracetamol ban, prompting the Ministry of Health and Family Welfare to issue a statement.
“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,” stated the Ministry in a PIB release dated 05 August 2025.
However, the government acknowledged that “in the recent past, various Fixed Dose Combinations, including such combinations of Paracetamol with other drugs, have been banned in the country,” and that the full list of such banned combinations is available on the CDSCO website (www.cdsco.gov.in).
FDC Ban Confirmed in Parliament Reply
The development also found mention in Lok Sabha, where Dr Thirumaavalavan Tholkappiyan had raised a question on 01 August 2025 regarding the government’s action against irrational FDCs over the last three years.
Responding on behalf of the Ministry, Minister of State for Health and Family Welfare, Anupriya Patel stated:
“The Central Government has prohibited number of drugs including FDCs for manufacture, sale or distribution.”
She gave a year-wise breakdown of recent FDC bans:
07.09.2018: 328 FDCs prohibited
11.01.2019: 80 FDCs prohibited (via notifications S.O. 180 (E) to S.O. 259 (E))
02.06.2023: 14 FDCs prohibited (via notifications S.O. 2394 (E) to S.O. 2407 (E))
02.08.2024: 156 FDCs prohibited (via notifications S.O. 3285 (E) to S.O. 3440 (E))
12.08.2024: Specific ban on S(+) Etodolac + Paracetamol combination (S.O. 3284(E))
These actions were taken under Section 26A of the Drugs and Cosmetics Act, 1940, which empowers the government to ban drugs in the public interest if they pose risk or lack therapeutic justification.
“Whenever any such concerns on any drug including FDCs are reported, the matter is examined in consultation with expert committee/ Drugs Technical Advisory Board (DTAB), and appropriate action is taken,” the Minister clarified.
Paracetamol Rumour Triggered the Clarification
The PIB clarification, posted on 05 August 2025, was issued specifically to quash “rumours regarding drug paracetamol ban.” It reiterated that Paracetamol is included in the National List of Essential Medicines (NLEM) and is regulated by the National Pharmaceutical Pricing Authority (NPPA) under the Drugs (Prices Control) Order, 2013.
Government’s Measures for Essential Drug Access
The clarification was accompanied by details on how the government is actively working to ensure affordable access to essential medicines and reduce out-of-pocket expenditure for patients at public health facilities, including government hospitals and rural primary health centres.
As part of these efforts, the Ministry has rolled out the Free Drugs Service Initiative under the National Health Mission (NHM). Under this initiative, financial support is provided to States and Union Territories for the provision of free essential medicines at public health facilities. This support is based on requirements proposed in their Programme Implementation Plans, within the overall resource envelope allotted to them.
Further, the government is also strengthening systems for procurement, quality assurance, warehousing, supply chain management, and prescription audit, along with the establishment of a grievance redressal mechanism. The initiative also promotes the use of standard treatment guidelines and leverages the Drugs and Vaccine Distribution Management System (DVDMS) — an IT-enabled platform that monitors real-time availability and distribution of essential medicines across the supply chain. Some States have expanded DVDMS implementation up to the Sub Health Centre level.
In addition, the Ministry has recommended a facility-wise Essential Medicines List (EML) to be made available at all public healthcare facilities. The EMLs are tailored by facility type and include:
106 drugs for Sub Health Centres
172 drugs for Primary Health Centres
300 drugs for Community Health Centres
318 drugs for Sub-District Hospitals
381 drugs for District Hospitals
States have the flexibility to add more medicines as needed.
To ensure uninterrupted drug supply, the Medical Stores Organisation (MSO) and Government Medical Store Depots (GMSDs) maintain active rate contracts for 697 drug formulations. The MSO has 1,152 registered indenters across India, including government hospitals and rural primary health centres, who can place supply requests via the MSO-DVDMS application software, up to four times per financial year.
