The Union Ministry of Health and Family Welfare is ready with the blue print for the Central Drugs Authority of India (CDA-I). A cabinet note on the proposal is ready and the ministry is hoping to finalise the CDA (I) structure soon after the cabinet approval. The CDA (I) is envisaged as an autonomous body on the lines of the US Food and Drugs Administration that will report to the Health Ministry.

As per the Health Ministry proposal, the Central Drugs Standard Control Organisation (CDSCO) will no longer be a part of the ministry and will be converted into an autonomous institution reporting to the ministry. The change will not only give the new organisation 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 utilise it 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 centralisation 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 ten 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, organisational services, training and employment, quality control affairs and legal and consumer affairs.

The Health Ministry sources informed that the government was very serious in brining about the change in drugs regulatory sector and to ascertain that CDA is in place by the end of 2006 so that it would be fully operational from January 2007.