The Central Government under Section 26A of Drugs and Cosmetics Act, 1940 is empowered to regulate, restrict or prohibit, manufacture, sale and distribution of drugs or cosmetics in public interest. If the Central Government is satisfied that use of any drug or cosmetic is likely to involve risk to human being or animals or it do not have therapeutic value or justification, Central Government, in the interest of public health, can regulate, restrict or prohibit manufacture, sale and distribution of such drug or cosmetic by notification in official Gazette.
Now, while exercising these powers, the Central Government has notified in the Gazette of India SO No. 5633(E) dated 30.12.2024 prohibition of manufacture, sale and distribution of Nimesulide and its formulation for animal use with immediate effect i.e. from 30.12.2024. The notification says that Central Government is satisfied that drug formulations containing Nimesulide are likely to involve risk to animal and safer alternatives to said drug are available. Therefore, in public interest, and after consultation with Drugs Technical Advisory Board, the statutory board constituted under Drugs and Cosmetics Act, 1940, Central Government has issued the said notification.
Now, the manufacturers are required to stop the manufacture, sale and distribution of Nimesulide Nimesulide containing formulations for animal use. The manufacturers and marketers are also expected to withdraw the same from the market. The supply chain entities i.e. distributors, wholesalers and retailers are also required to stop sale and distribution of such drugs intended for animal use and return the stock to those entities, from whom they are procured for the purpose of its disposal.