Fees For GMP Certification, Hike Of all Other Fees Likely Once CDAI Starts Operations

Setting up of the Central Drug Authority of India may prove 'too heavy' for the pharmaceutical industry in the country with the proposal to have a flat increase in the present fee structure and introduction of a new fee for GMP certification inspection. These are the two key proposals to raise funds for running the Authority.

With no grant-in-aid being proposed to run the new CDAI and to meet the additional expenses including those required for creation and maintenance of new posts, the additional cost burden of CDAI is thus going to be directly passed on to the industry, it is learnt.

"The CDSCO earns revenues through import registration fees, new drug registration, licence fees etc. But it has the grant-in-aid funds too. Once the CDAI becomes functional, it is proposed to add new fees for GMP certification inspection and to increase the rate of present fees for import registration (started in 2002), new drug registration, licence for manufacturing / inspection / products (last revised in 2001) and clinical trials," sources said.

Except for new drug registration and licence fees, there would be a yearly increase of 5 percent of fees in all other categories. In the first two categories, increase would not be on yearly basis. And the rate of increase proposed in all the categories would be clear only when the CDAI comes into force.

Interestingly, the Finance Ministry and the Planning Commission had already made clear to the Health Ministry that there would not be any budgetary or Plan support for the new authority. The Health Ministry is planning to mobilize the resources for operational and administrative costs and additional burdens of the CDAI fully through fees and other charges.

(Ref: The Chronicle Pharmabiz dated 20, December 2008)