Department of Health and Family Welfare of Ministry of Health and Family Welfare, Government of India has banned fixed dose combinations of Ofloxacin + Ornidazole injections after finding that the said combination is not rational
Through a gazette notification, the Central government has recently banned the fixed dose combination of Ofloxacin + Ornidazole injection announcing that the drug fixed dose combination of Ofloxacin + Ornidazole injection 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 is not rational and there is no specific advantage an administering both drugs together in parental form and as such there is no therapeutic justification for the continued marketing of this drug;
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 Ofloxacin + Ornidazole injection with immediate effect.