India’s drug regulator ramps up plan to tackle antibiotic resistance crisis

Summary: CDSCO proposes tougher antibiotic rules, new R&D push and monitoring to fight rising AMR deaths.

India’s top drug regulator is planning a major shake-up in how antibiotics are regulated, sold and monitored as antimicrobial resistance (AMR) climbs toward crisis levels. The issue — where bacteria evolve to shrug off medicines once used to treat infections — is already linked to hundreds of thousands of deaths annually in India and threatens to make even basic illnesses harder and more expensive to treat.

A high-level panel formed under the Drugs Consultative Committee (DCC) has just delivered a report to the Central Drugs Standard Control Organisation (CDSCO) with more than a dozen urgent recommendations aimed at slowing resistance and encouraging the development of new antibiotics.

Among the proposed changes are moves such as:

• Banning over-the-counter sales of antibiotics so they can only be dispensed with valid prescriptions.

• Stamping and tracking prescriptions to prevent reuse or improper sharing.

• State-level software systems to monitor antibiotic sales and use in real time.

• Extending producer responsibility for safe disposal of expired or unused drugs.

• Tighter inspections of manufacturers and stricter biomedical waste compliance.

Officials say the goal is to intervene at every step of a drug’s journey — from lab to local pharmacy — because misuse along the way, including self-medication and premature stoppage of treatment doses, drives resistance. Studies have shown that many of the infections doctors once treated easily now require stronger drugs, and in some cases, even those are losing their effectiveness.

The panel also pressed for strengthening India’s ecosystem for antibiotic research and innovation, including streamlining clinical trial approvals and making regulatory processes faster for promising new molecules targeted at resistant “superbugs.” Experts warn that without fresh tools in the antibiotic pipeline, healthcare systems could face rising costs and limited treatment options.

Other parts of the plan focus on awareness and enforcement, such as mandatory legal warnings at pharmacies about prescription-only medicines and appointing state nodal officers to oversee compliance. The report also stresses that antibiotics used in animals and livestock — a known contributor to AMR — must be tightly controlled.

Policymakers are now expected to share the recommendations with states for implementation and to weave them into the National Action Plan on AMR, which has been in place since 2017 and was refreshed last year for 2025–29.

Doctors and public health experts say this sort of multi-layered strategy — blending regulation, surveillance, awareness and innovation — is critical if India is to slow the march of drug-resistant infections that are already outpacing the development of new treatments.