Govt revives plan to set up federal drug authority

NEW DELHI: After keeping in abeyance the ’86 drug policy proposal, the government is now lending some serious thought to forming the National Drug Authority (NDA), as a centralised establishment with inclusive powers of drug regulation. The idea, virtually deserted for lack of financial resources, has re-surfaced at the first meeting of the R A Mashelkar panel, set up by the health ministry, for drug regulatory revamp.
The Mashelkar panel will have three sub-groups to dwell into various issues of drug regulation. One of the sub-groups will look into the feasibility of a centralised structure with most of the powers of licensing, monitoring and new drug approvals vested with it. Constitutional issues that might emanate due to setting up of NDA would be considered by the sub-group. Considering the federal nature of the drug regulatory structure — licensing powers are currently vested with the state governments and new drug validations and approvals are the prerogative of the central government — legal issues required to be weighed in earnest, government sources said.
It is to be known whether the proposal would go down well with sufficient number of state governments. Alternatively, the Mashelkar panel would also weigh other options such as upgrading the existing regulatory set-up itself. The proposal is to infuse more knowledge and professionalism in the sector.
At present, central drug regulation is under the Drugs Controller-General of India who is part and parcel of the Central Drug Standard Control Organisation attached to the Directorate-General of Health Services (DGHS) which is an outfit of the health ministry.