# India moves to centralize sterile drug oversight

> A proposal would bring all sterile medicines under central licensing to address contamination risks and regulatory fragmentation.
- Title: India moves to centralize sterile drug oversight | Shortify
- Summary: A proposal would bring all sterile medicines under central licensing to address contamination risks and regulatory fragmentation. India is considering…
- Keywords: drugs consultative committee, sterile drug products, central licensing approving authority, india, pharmaceutical regulation, microbial contamination, injectables, drugs and cosmetics act, state licensing authorities, drug safety, himachal pradesh high court, moves
- Source: The Economic Times — https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/drugs-panel-to-weigh-bringing-all-sterile-drug-products-under-central-licensing-amid-contamination-concerns/articleshow/134342264.cms
- Author: Teena Thacker
- Published: 2026-09-18T18:21:00+00:00
- Read time: 1 min
- Topics: drugs consultative committee, sterile drug products, central licensing approving authority, india, pharmaceutical regulation, microbial contamination, injectables, drugs and cosmetics act, state licensing authorities, drug safety, himachal pradesh high court
## Central control for sterile drugs
The Drugs Consultative Committee will consider bringing all sterile drug products, including small volume parenterals, under central licensing oversight.
## Court ruling sparks regulatory debate
The proposal comes after the Supreme Court upheld a ruling that enforcement powers for drug manufacture and sale rest with state authorities.
## Current system covers only some drugs
Only specified sterile medicines like large-volume parenterals, vaccines, and gene therapeutics are currently under central licensing. States handle the rest.
## Contamination risk drives the push
Sterile products like injectables are vulnerable to microbial contamination. Around 240 injection samples failed quality standards in 2025-26 alone.
## Recent contamination incidents cited
The proposal references international cases, including metoprolol injection contaminated with Burkholderia cepacia and adenosine injection with Gram-negative bacteria.
## Fragmented oversight creates gaps
The current system splits responsibility between central and state authorities, leading to inconsistent scrutiny and inspection practices across states.
## Key takeaway

India is considering centralizing oversight of all sterile drugs to prevent contamination and create uniform safety standards.