Regulation Against Excessive And Irrational Use Of Antibiotics

The Indian government has decided to take a stricter stance against the misuse of antibiotics. The Drugs Technical Advisory Board (DTAB) Sub-Committee has sought information on antibiotics from drug controllers across the country. This request was made by a notice dated May 16, 2024.

It may be recalled that an expert group meeting in April 25, 2023 at ICMR, HQ recommended banning inappropriate antibiotic combinations.

A subsequent meeting in October 16, 2023 by DGHS and focused on regulating antibiotic overuse and irrational use.

Based on the discussions at this meeting, Central Drugs Standard Control Organization (CDSCO) was to conduct a bi-annual review of all fixed-dose antibiotic combinations marketed across India.

Subsequently, in the DTAB meeting dated January 25, 2024, it was decided that a sub-committee would be formed to examine the matter in detail.

In light of this, the first sub-committee meeting was held on May 5, 2024 and the following recommendations were advanced:

  • State Licensing Authorities (SLAs) are required to:
    • Submit a list of all licensed antibiotic combinations within two weeks.
    • Monitor their jurisdiction for the presence of unapproved antibiotic combinations.
    • Report any unapproved combinations to the CDSCO on a priority basis.

These actions aim to eliminate inappropriate antibiotic combinations from the market. They also seek to improve the monitoring of antibiotic use in India and promote responsible antibiotic prescribing practices.