Drug manufacturers across the country will soon come under a single licensing umbrella. The proposed National Drug Regulation Authority moots a central regulator for issuing licences to all.
This, and many more measures will ensure sweeping changes in the office of the current Drug Controller General of India.
The measures were likely to bring uniformity and transparency, said a health and family welfare ministry official. At present, manufacturing licences are issued by states and if a company gets rejected by one state due to irregularities or inability to comply with regulations, there remains the option of trying out other states.
However, the official said the central licensing scheme, in spite of its merits, would require a lot of political will as the states may not be willing to part with the power to issue licences.
Under the new regulator, issue of sales licences and enforcement matters will, however, continue to be under the state authorities. The new authority will entail an expansion of the technical work force and departments. Separate units may be established to look into specific aspects of medical devices, clinical trials, drug regulatory and enforcement affairs.
This will make it three to four times the size of the current DCGI office. Legal modifications might have to be made to the Drugs and Cosmetics Act, 1940 to accommodate the new body, the ministry source added.
The Drug Technical Advisory Board has recommended that all sterile medical devices be regulated under the Drugs and Cosmetics Act. This too will require the sphere of the Act to be expanded.
The proposed regulator is also likely to differ from the framework laid out in the Mashelkar Committee report in a couple of ways.
While Mashelkar had advised that states be initiated in stages into the regime of centralised licensing, the health ministry is considering listing out the items first that will be centrally licensed and then gradually expanding the list.
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