Even as the Union Ministry of Health and Family Welfare is getting ready to set up the proposed autonomous central drug authority, the states are not enthusiastic to the idea of changing the current structure of state drug control administrations. The centralization of licensing, as proposed in the cabinet note that details the blue print for the Central Drugs Authority of India (CDA-I), is unlikely to pass the final scrutiny, ministry officials fear.

According to them, there is an urgent need for uniform implementation of drug laws across the country. While a central drug administration would be the ideal answer to the problem, it cannot happen without the approval of the states. While some states have welcomed the move, majority are against it, they feel. The cabinet note however, talks about the centralization plans and the outcome will depend upon the cabinet approval.

CDA (I) is envisaged as an autonomous body on the lines of United States Food and Drugs Administration (US FDA) that will report to the Health Ministry.

As reported earlier, the proposal is to see Central Drugs Standard Control Organisation (CDSCO) taken out of the ministry and converted into an autonomous institution reporting to the ministry. The change will not only give the new organization autonomy in decision-making, it would also convert CDA (I) into a self-sustaining body. The central authority would be allowed to charge for its various services and retain the fee it collects and utilize for improving the efficiency of drug regulatory activities in the country. The CDA (I) would also gradually become the sole authority for the issue of drug manufacturing licenses. As per the current plan, the shift towards centralization of manufacturing licenses would be carried out in a phased manner.

The structure of CDA (I) would be more or less similar to what has been recommended by the Mashelkar Committee in its report on drug regulatory issues. Centralisation of drug licensing was one of the major recommendations made by the Committee in 2003. The committee had noted that grant of manufacturing licenses should only be given by CDA and had charted out time bound programmes for the transition from state level licensing practice towards central licensing. The report had also called for 10 main divisions for CDA to independently handle issues like regulatory affairs and enforcement, new drugs and clinical trials, biological and biotechnology products, pharmacovigilance, medical devices and diagnostics, imports, organizational services, training and employment, quality control affairs and legal and consumer affairs.

The ministry is hoping to have CDA in place by 2006 end in order to turn it fully operational from January 2007.