The power to prohibit
Section 26A of the Drugs and Cosmetics Act, 1940 lets the Central Government, by notification in the Official Gazette, prohibit the manufacture, sale or distribution of a drug if it is satisfied that the drug is likely to involve risk to human beings or animals, or that it does not have the therapeutic value claimed, or that it contains ingredients in a quantity for which there is no therapeutic justification. Each ban appears as an S.O. (Statutory Order) or G.S.R. number in the Gazette, and it is that number that this register records.
Why fixed-dose combinations dominate
A fixed-dose combination, or FDC, packs two or more active ingredients into one formulation. Some are rational, amoxicillin with clavulanic acid, for example. Many marketed in India before 2012 were licensed by state authorities without the central approval required for a new drug, and were never assessed for safety or benefit as a combination. A 2012 Parliamentary Standing Committee report flagged the problem, and the Kokate committee examined thousands of such licences.
2016 to 2018: the long loop
On 10 March 2016 the government banned 344 FDCs in a single wave (S.O. 705(E) to 1048(E)). Manufacturers challenged the orders and on 1 December 2016 the Delhi High Court quashed them, holding that the Drugs Technical Advisory Board had not been consulted. In December 2017 the Supreme Court sent the list to the DTAB for fresh examination, excluding fifteen combinations licensed before 1988. The DTAB's sub-committee recommended prohibition for almost all of them, and on 7 September 2018 the government re-banned 328 FDCs (S.O. 4379(E) to 4706(E)), with a handful restricted rather than banned. A number of those orders were themselves stayed or quashed in later litigation; CDSCO's consolidated list records the court status of each entry, and so does this register.
Later waves
The fifteen pre-1988 combinations excluded in 2017 were re-examined and fourteen of them, including nimesulide + paracetamol dispersible tablets and chlorpheniramine + codeine syrup, were banned on 2 June 2023 (S.O. 2394(E) to 2407(E)). A further 156 FDCs were banned on 2 August 2024 (S.O. 3285(E) to 3440(E)), among them the paediatric aceclofenac + paracetamol combination and many cold-and-cough formulas. In April 2025 CDSCO directed state authorities to halt 35 combinations it described as unapproved, a direction, not a Section 26A notification, and on 11 June 2026 sixteen more FDCs were banned (S.O. 3068(E) to 3083(E)), including amoxicillin + serratiopeptidase. Single-molecule actions continue alongside: nimesulide above 100 mg was prohibited for adults on 29 December 2025 (S.O. 6091(E)).
What a ban means for stock on shelves
A Section 26A notification takes effect on publication unless it says otherwise. Manufacturing must stop, and distributors and retailers must withdraw remaining stock; there is normally no consumer-side grace period. If you hold a banned combination, ask your doctor or pharmacist for the equivalent single-ingredient products, the individual molecules are almost always still legal on their own.
How to read the status column
Banned means the prohibition is in force. Stayed means a court has suspended the order and the product may legally be sold pending the case. Quashed means a court struck the order down. Under examination marked the pre-1988 combinations between 2017 and 2023. Halted refers to the April 2025 CDSCO direction. Restricted means the drug may be sold subject to conditions such as a dose ceiling or an age warning. Every status on this site carries the notification number and date it rests on.