National drug agency to be set up this year

The National Drug Authority, the centralised drug licensing agency proposed by the Task Force for Drug Standardisation and Quality Control under R A Mashelkar, is expected to come into effect this year.

The new agency for drug licensing and quality control, which is mooted in line with the US Food and Drug Administration, would replace the existing Central Drugs Standard Control Organisation (CDSCO) and the state level drug control agencies by merging the functions and responsibilities of the central-state departments.

Currently the CDSCO is responsible for approval of new drugs, in addition to issuing licenses for marketing and imports of new drugs.

Manufacturing licenses and production facility inspections along with trade licensing are currently handled by the state drug authorities.

"Once a central body of the proposed National Drug Authority is in place as anticipated within this year, the CDSCO will get transformed into the new structure immediately and the entire process of centre-state departmental integration and restructuring of responsibilities and functionalities would take place over a period of five years," said a senior health ministry official.

The draft proposal for setting up the central agency has already been sent to the Cabinet for approval and the clearance is awaited, he added.

The authority would deal with issues of safety of drugs, licensing, medical devices and alternate systems of medicine would also be brought under its purview.

According to the draft proposal, the new agency would have an advisory board, which would comprise representatives from Health ministry,

Ministry of Chemicals, Department of Biotechnology and also representation from consumer action groups and NGOs. The executive head of NDA will be a technical official in the rank of Drug Controller General, the sources said.