Centre may seek legal view on licensing of sterile drugs
The government is actively exploring a proposal to expand central licensing authority over all sterile drug products following a recent Supreme Court decision that restricted the enforcement authority of central officials. A meeting of the drugs c...
New Delhi: The government is considering obtaining a legal opinion on a proposal to bring all sterile drug products under central licensing oversight, after the Supreme Court dismissed its challenge to a Himachal Pradesh High Court ruling that limited the enforcement powers of central regulatory officials over drug manufacturers.
The drugs consultative committee (DCC), which advises the central and state governments, at a recent meeting, discussed the proposal to bring all sterile drug products under the central licence approving authority (CLAA) scheme. It recommended constituting a sub-committee to examine the feasibility of the proposal and to obtain a considered legal opinion before any further action is taken.
The move assumes significance as the Supreme Court recently declined to interfere with the Himachal Pradesh High Court's finding that a drugs inspector of the Central Drugs Standard Control Organisation (CDSCO) did not have independent enforcement powers under Chapter IV of the Drugs and Cosmetics Act. Chapter IV of the Act governs the manufacture, sale and distribution of drugs.
The SC order has brought the Centre's enforcement jurisdiction under Chapter IV into the legal focus, even as the government considers expanding the central licensing framework to cover sterile products currently regulated by state drug authorities.
The proposal was referred to the DCC by the drugs technical advisory board of the CDSCO. It seeks to bring all sterile drug products, including small-volume parenterals, injectables and ophthalmic preparations under the CLAA scheme.
At present, only specified categories of sterile medicines fall under the CLAA framework. These include large-volume parenterals, sera and vaccines, recombinant DNA-derived products, cell or stem-cell-derived products, gene therapeutic products and xenografts. Other sterile products are licensed by state authorities.
The proposal argues that sterile products warrant specialised regulatory oversight because of their vulnerability to microbial contamination.
According to the proposal, the existing framework is fragmented, with different categories of sterile products falling under either central or state licensing. It also flags variations in scrutiny of applications and inspection practices among state regulators, particularly when additional products are approved after a manufacturing licence has already been granted. The proposal seeks to bring all sterile drug products, irrespective of category, under the CLAA framework to establish a more uniform regulatory regime.
