DTAB Recommends All Antimicrobials Be Treated as New Drugs to Tackle AMR

In a major regulatory move aimed at curbing antimicrobial resistance (AMR), the Drugs Technical Advisory Board (DTAB) has recommended that all antimicrobials should be permanently classified as "New Drugs" under the New Drugs and Clinical Trials (NDCT) Rules, 2019. This step is intended to strengthen regulatory oversight in the public interest.

This recommendation follows a prior proposal reviewed by the Drugs Consultative Committee (DCC), which supported redefining antibiotics as new drugs to address the growing AMR threat. The DTAB adopted this stance after considering the DCC's input during its 92nd meeting held on April 24, 2025. The Board also advised that relevant amendments be made to the NDCT Rules to reflect this change.

The DCC had earlier, in 2024, recommended rule amendments empowering the Central Drugs Standard Control Organisation (CDSCO) with greater authority over antimicrobial approvals nationwide. Both DTAB and DCC have been actively engaged in formulating strategies to combat AMR, a serious and escalating global health concern that has received attention at high-level forums such as the UN General Assembly, G7, and G20.

In addition to redefining antimicrobials, the DTAB had, in its August 2024 meeting, proposed changes to the Drugs Rules, 1945, to introduce a distinct blue strip or box on antimicrobial product labels. This visual cue is intended to raise awareness and curb inappropriate use.

The Board also backed the DCC's proposal to ban the sale of antimicrobials to non-pharmaceutical industries lacking appropriate licenses. This follows concerns over the use of these substances in sectors like food and beverages, which could contribute to AMR.