HURDLES IN CDA FORMATION

The move to establish a centralized system of drug administration in the country by forming Central Drug Authority is being revived by the Union health ministry now after the proposal got shelved a few years ago. The plan was strongly opposed by the state governments and industry bodies from the very beginning. The health ministry had been wanting to centralize licensing for manufacture, sale, export and distribution of drugs in pursuance of the recommendations of the Mashelkar Committee. And the Drugs & Cosmetics (Amendment) Bill 2007 was drafted to set up the CDA. The Bill was introduced in the Rajya Sabha on August 21, 2007 and was thereafter referred to the Parliamentary Standing Committee of ministry of health. The Standing Committee had then submitted its recommendations to the government dropping the proposal for CDA and instead recommended setting up of a 'central drug administration' as an independent body with headquarters in Delhi and its zonal and sub-zonal offices at state-levels and by strengthening, modernising and restructuring the CDSCO. The health ministry seems to have taken expert opinion on the matter once again and the move now to set up CDA is on the basis of this new thinking.

Formation of CDA was contemplated by the government considering the fast pace of growth of Indian pharmaceutical industry over the years. Need for centralizing the drug control administration was felt on account of the urgency in bringing some uniformity in enforcement of various drug rules. Some of the key provisions 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 sector. As per the current system of drug administration, enforcement of all amended rules under the D&C Act is with the state health departments. But, most of the states have not been successful in implementing these amended regulations so far. This, in effect, has been making a mockery of the Act and rules in the pharmaceutical sector. Licensing of products has been one area where there was a lot of confusion prevailed in the country until 2008. A new drug is approved for marketing by CDSCO but issuing licences for its manufacture used to be done by various state drug administrations. Although states and Union territories are having drug control departments, most of them do not have officials with sufficient competence to evaluate an application before a manufacturing license is issued. The issues like these were under discussion by the office of the DCGI for some time but not in a comprehensive manner. All the state governments are still not in support of formation of CDA as that could take away a lot of powers from them. Now, without the support of the state governments and industry, it will be difficult for the health ministry to implement CDA even if the bill gets passed. Therefore, the health ministry needs to take the concurrence of most state governments and the industry again considering the sensitive features of the new system.