Telangana among locations as Centre plans central licensing for sterile drugs

The Centre plans to bring sterile drug products under a central licensing system following quality concerns involving injectable medicines. About 240 injection samples were found not of standard quality during 2025-26, prompting a proposed shift from State-level licensing to central oversight.

Hyderabad: In the coming months, high-risk injections will fall under the unified central licensing system instead of remaining under the jurisdiction of the state-level drug control administrations like the Telangana Drug Control Administration (TSDCA).

The move comes in the wake of frequent instances where routine quality checks at State testing laboratories keep finding hundreds of bad or contaminated injections.
It turns out that local DCAs in some States were very strict about checking facilities, where the life-saving injections are manufactured, while others weren’t, which means unsafe medicines were slipping through the cracks.

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The upcoming amendment to the Drugs Rules, 1945, also stems from mounting regulatory concern over a recent development wherein roughly about 240 injections and sterile formulation samples, which were tested across multiple locations including Hyderabad, failed standard quality benchmarks during the 2026 fiscal year.

Under the present framework of the Drugs and Cosmetics Act, manufacturing approvals for a vast majority of medicines are handled independently by individual State Licensing Authorities (SLAs) like TSDCA. However, public health reviews have revealed deep structural discrepancies in how different states enforced inspection rigor, technical audits, and laboratory testing capabilities.

Unlike oral medications, which pass through the body’s digestive filters, drugs administered through injections, vaccines, and intravenous solutions enter the bloodstream directly, leading to immediate, fatal clinical risks if the injections are contaminated or improperly formulated.

The recent discovery of nearly 240 substandard injection batches in circulation exposed critical vulnerabilities in regional oversight, prompting the regulatory authorities including Central Drug Standards Control Organisation (CDSCO) to move toward a single, centralised system.

The new reform is expected to transition the licensing of all sterile products entirely to the Central License Approving Authority (CLAA) system. By moving approvals to a central authority, drug manufacturing companies will no longer face loose checks in some Indian states and strict checks in others, as every manufacturing facility will have to follow the exact same safety rules, no matter where it is located.

Centralizing control will also enable stricter batch testing, uniform environmental sterility validations, and synchronized national audits before life-saving serums or antibiotics are released into the supply chain.

The transition mandates formal amendments to the Drugs Rules, 1945, ensuring that every facility producing needle-bound medications complies with identical, centralized Good Manufacturing Practices (GMP). The policy is designed to ensure that critical medications in intensive care units and rural health care facilities are verified properly in their quality.