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CDA IN MAKING
P A Francis | Wednesday, December 19, 2007, 08:00 Hrs  [IST]

The move to set up the Central Drug Authority of India in a bid to streamline the entire drug administration in the country is in an advanced stage. The whole exercise should be completed in a few weeks from now and the Authority should be functional by early next year. As per a cabinet note, the CDA will upgrade the national regulatory system for drugs and cosmetics to provide a technical vision and policy direction in respect of quality of drugs marketed in the country. It is proposed that the Authority will have ten main divisions to discharge functions under the Drugs & Cosmetics Act, 1940. The most controversial move of centralization of issue of manufacturing licenses is going to be done in a phased manner. This clarification should calm down a section of drug control officials who are opposing the formation of CDA. The grant of licences for sale of drugs, inspection of sale premises, monitoring the movement of spurious and sub standard drugs and investigations of such cases for taking action under the D&C Act would be looked after by the state licensing authorities. The states would also oversee operations of the state drug laboratories. The cabinet has taken a clear stand in its note with regard to the role of state drug authorities. Enforcement of all rules and regulations on a national level is critical to the drug reform process and that can be attained only by strengthening state drug control machinery. The capacity building project for food and drugs, already under implementation in the country, should therefore be augmented for the purpose. One of the main constraints of the slow progress or ineffectiveness in implementation of drug laws in the country is insufficient funds available to the system. As the Union finance ministry and the Planning Commission had already made clear that there would not be any budgetary or Plan support for the new authority, health ministry has proposed a new fee structure under CDA. The entire cost burden to run CDA including creation and maintenance of new posts, is thus going to be directly passed on to the pharmaceutical industry. It is proposed to add a new fees for GMP certification inspection and to increase the rates of present fees for import registration of drugs, new drug registration, licence for manufacturing/inspection/products and clinical trials. Barring fee for new drug registrations and manufacturing licences, there would be an yearly fee hike of 5 per cent in all other categories of services. Autonomous nature of CDA should make the body financially independent to carry out its goals objectively in the years to come. Formation of CDA was contemplated by the Central government considering the pace of growth of Indian pharmaceutical industry and its allied sectors over the years. Need for centralizing the drug control administration was felt on account of the urgency in bringing uniformity in enforcement of numerous new drug rules. Various parts of the D&C Act such as Schedule K, Schedule M, Schedule Y, etc. have been already amended and elaborated over the years considering the growth needs of this industry but their implementation has been faulty in many states. An empowered CDA should be able to address these issues effectively.

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