New Delhi, May 16, 2024 – The Directorate General of Health Services (DGHS) and the Central Drugs Standard Control Organization (CDSCO) are taking steps to regulating antibiotic use in India. On April 25, 2023, an expert group at the Indian Council of Medical Research (ICMR) recommended banning Inappropriate antibiotic combinations currently on the market. In a follow-up meeting on October 16, 2023, chaired by Dr. Atul Goel, DGHS, it was decided that the CDSCO would review various fixed drug combinations (FDCs) of antibiotics every six months. This proposal was discussed at the 90th Drugs Technical Advisory Board (DTAB) meeting on January 25, 2024, leading to the formation of a sub- committee chaired by Dr. D.S. Arya.

At its first meeting on May 1, 2024, the sub-committee recommended that State Licensing Authorities (SLAs) submit lists of antibiotic combinations licensed for manufacturing and marketing in their states. SLAs must promptly monitor and report any unapproved combinations to the CDSCO. State and Union Territory Drugs Controllers must submit their lists within two weeks and take action against unapproved combinations under the Drugs and Cosmetics Act & Rules. These measures aim to ensure responsible antibiotic use and combat antibiotic by regulating antibiotic use in India.

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