Banned : Azithromycin and Ofloxacin combination

The central government prohibited drug combination of Azithromycin +ofloxacin noting that the said there is no therapeutic justification for the ingredients contained in this FDC and that it may involve risk to human beings.

New Delhi: The Central Government of India has prohibited the manufacture for sale, sale and distribution for human use of drug fixed-dose combination of Azithromycin +Ofloxacin after finding combination “there is no therapeutic justification for the ingredients contained in the said FDC.

Through a gazette notification, the Central government has recently banned the fixed dose combination of vide S.O. number 763 (E) published in the Gazette of India through combination dose of Azithromycin +ofloxacin is a risk for human use.

The decision was announced after the matter has been examined by the Drugs Advisory Committee constituted by the Central Government said Committee has recommended to the Drugs Technical Advisory Board (DTAB ) in public interest recommended that

“there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Therefore, the only prohibition under Section 26A is recommended”.

After examination of the recommendations of the said 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 Azithromycin +ofloxacin with immediate effect.