Drugs Panel to weigh bringing all sterile drug products under central licensing amid contamination concerns

New Delhi: The Drugs Consultative Committee (DCC) will soon consider a proposal to bring all sterile drug products, including small volume parenterals (SVPs), under the central licensing oversight to tighten regulation of these medicines prone to microbial contamination, people aware of the development said.

The proposal comes amid a renewed debate over the division of regulatory powers between the Centre and states. The Supreme Court this week declined to interfere with a Himachal Pradesh High Court ruling that held that enforcement powers relating to manufacture, sale and distribution under Chapter IV of the Drugs and Cosmetics Act essentially rest with state authorities.

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The proposal to expand the Central Licensing Approving Authority (CLAA) framework was referred to DCC by the drugs technical advisory board (DTAB) at a meeting in August, the people said.

At present, only specified categories of sterile medicines, including large-volume parenterals, sera and vaccines, recombinant DNA-derived products, cell or stem-cell-derived products, gene therapeutic products and xenografts, are covered under the CLAA scheme. Other sterile products are licensed by state authorities.

The proposal argues that sterile products, including injectables and ophthalmic preparations are particularly vulnerable to microbial contamination and, therefore, require stringent adherence to good manufacturing practices.

It notes that around 240 injection samples were found to be not of standard quality (NSQ) during 2025-26, excluding other sterile dosage forms. It also cites recent international contamination incidents involving injectable medicines, including a metoprolol injection contaminated with Burkholderia cepacia and a batch of adenosine injection reported to have Gram-negative bacterial contamination.

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According to the proposal, the existing licensing framework is fragmented, with some sterile products under CLAA plan and others under state licensing authorities. It also flags variations in application scrutiny and inspection practices among states, particularly when additional products are approved after a manufacturing licence has been granted.

The proposal therefore seeks to bring all sterile drug products, irrespective of category, under the CLAA scheme, with the objective of creating a more uniform regulatory framework.