From The Economic Times · Teena Thacker · · 1m 10s
India moves to centralize sterile drug oversight
A proposal would bring all sterile medicines under central licensing to address contamination risks and regulatory fragmentation.
In brief
A proposal would bring all sterile medicines under central licensing to address contamination risks and regulatory fragmentation. India is considering centralizing oversight of all sterile drugs to prevent contamination and create uniform safety standards. Originally reported by The Economic Times.
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.
At a glance
India is considering centralizing oversight of all sterile drugs to prevent contamination and create uniform safety standards.
