The centralized system of drug licensing will be implemented in India only in phases over a time span of five years once the final decision is taken in this regard. The bill to bring about this major change in the drug administration of the country will be introduced in the parliament soon.
According to informed sources, the move is to centralize issuing manufacturing licences for products in some key therapeutic groups as first phase. Licensing of more and more therapeutic groups would be brought under the purview of centralized licensing subsequent years.
The objective behind this phased approach in centralization of drug licensing is to bring about a smooth transition from the practice of state licensing of pharmaceutical products existed for several decades.
Centralized issue of drug licenses for molecules in key therapeutic groups is considered a better option now than the earlier plan of taking over licensing responsibilities of some weak states first and that of other states later.
The massive process to put a centralised system fully in place will need at least 150 more personnel and the central system would be strengthened by recruiting more as the process moves forward.
Though the Government maintained that it would set up the CDA in six months, it is going to take longer time depending on the passage of legislation and related procedures, sources said.
The centralised regulatory framework is going to be almost in line with the recommendations of the Dr R A Mashelkar committee report, except its name being changed from National Drug Authority.
One of the significant modifications is the process of issuing centralised licensing based on the therapeutic category basis as part of the transition from the present system. The Mashelkar committee had recommended introducing the centralised licensing from state to state in phases.
The CDA will however, have a strong mechanism for appraisal of new drugs. The proposed bill will also work out on the expenditure on regulatory monitoring, which is likely to be increased considerably.
It is also leant that the CDA as a regulator will have little say on the marketing ethics and practices of the companies, leaving the onus on the industry to regulate itself in their promotions.
As reported, the CDA will have ten divisions including those dealing with new drugs and clinical trials, for biological and biotechnology products, for pharmacovigilence and drugs safety, for medical devices and diagnostics.