Department of Health and Family Welfare of Ministry of Health and Family Welfare, Government of India has banned fixed dose combinations Etodolac + Paracetamol announcing with an immediate effect.
Through a gazette notification, the Central government has recently banned the use of the drug fixed dose combination of Etodolac + Paracetamol announcing that is not rational.
The decision was announced after the matter has been examined by the New Drugs Advisory Committee constituted by the Central Government and the said Committee has recommended to the Central Government that the said fixed dose combination drug does not have therapeutic justification and the two drugs are best administered separately on as required basis;
After examination of the recommendations of the aforesaid Committee, the Central Government announced that it was satisfied that it is necessary and expedient in public interest to regulate by way of prohibition, the manufacture for sale, sale and distribution for human use of the said drug in the country;
Central Government while exercising the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940) has prohibited the manufacture for sale, sale and distribution for human use of the drug fixed dose combination of Etodolac + Paracetamol with immediate effect.