Department of Health and Family Welfare of Ministry of Health and Family Welfare, Government of India has banned fixed dose combinations Gemifloxacin + Ambroxol
Through a gazette notification, the Central government has recently banned the use of the drug fixed dose combination of Gemifloxacin + Ambroxol announcing that it is not rational and is likely involve risk to human beings;
The decision was announced after the matter has been examined by Subject Expert Committee constituted by the Central Government and the said Committee recommended to the Central Government that the said drug does not have sufficient therapeutic justification as the drug Ambroxol does not have any added advantage in antimicrobial activity;
After examination of the recommendations of the aforesaid Committee, the Central Government announced it is 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 Gemifloxacin + Ambroxol with immediate effect.