Is azithromycin banned in India?

Azithromycin, sold as Azithral and many generics, is not banned in India. No Section 26A notification names the antibiotic on its own. What are banned are combinations that pair it with another drug.

The best known is cefixime + azithromycin. It was in the 10 March 2016 ban on 344 FDCs; Medical Dialogues reported then that such products had been sold "without approval from the central government" and that the expert committee found the combinations "likely to involve risk to human beings". That wave was quashed, but on 7 September 2018 the Health Ministry prohibited azithromycin + cefixime again under S.O. 4422(E), along with azithromycin combinations with levofloxacin, ofloxacin, cefpodoxime, ambroxol and acebrophylline, and a fluconazole + azithromycin + ornidazole kit. CDSCO's list shows them as in force. Apollo Pharmacy's page on the combination also says it "has been banned in India".

Later actions added ornidazole + fluconazole + azithromycin (S.O. 246(E), 11 January 2019) and azithromycin + adapalene, a skin product (S.O. 3310(E), 2 August 2024). On 11 April 2025 the CDSCO told state licensing authorities to halt cefixime 200 mg + azithromycin 250 mg + lactic acid bacillus tablets, one of 35 combinations licensed without central approval; that direction is not a Section 26A ban.

One kit, azithromycin + secnidazole + fluconazole, had its 2018 ban quashed by the Delhi High Court on 18 February 2019; CDSCO's list records an appeal. For patients the rule is simple: azithromycin on its own is legal, and any pack that adds cefixime or another antibiotic should be checked against the lists.