The Mashelkar committee which is preparing a comprehensive road map for revamping Indian drug regulatory system will suggest a three phase switch over from the current state licensing system to a central licensing regime for drug manufacturing facilities across the country.

If the committee's recommendations are to have its way, the Central Drugs Standard Control Organisation (CDSCO) rechristened, as Central Drug Administration (CDA) will take over the responsibilities of issuing licenses to drug manufacturing facilities of 19 states where pharma industry has least presence (5 per cent) during 2004-05. States like Maharashtra, Gujarat, Tamil Nadu, Andhra Pradesh, Karnataka, West Bengal and Goa, where 75 per cent of the drug manufacturing units are located, will be the last to be under CDC control as the authority needs to substantially strengthen its infrastructure and expert manpower in these states for effective discharge of its responsibilities. Centralised licensing in these states will happen from 2006 onwards.

The committee is to suggest that the licensing functions of Category II states, where 20 per cent of manufacturing activity is concentrated can be taken over by proposed CDA from 2005 onwards. The states that come under this category include Delhi, Bihar, Haryana, Kerala, Madhya Pradesh, Orissa, Punjab, Rajasthan and Uttar Pradesh.

The expert committee has observed that about 100 additional posts would have to be created in CDA if it has to take up the Phase 1 challenges. This includes additional recruitment of 50 drug inspectors, 11 senior level officials, technical experts, administrative, accounts personnel, computer operators etc. Deputing experienced and willing regulatory officers from the state departments for the purpose of inspection and licensing has been one of the suggestions put forth by the committee to meet the manpower requirement.

Expansion of zonal and sub-zonal offices, creation of additional infrastructure or new offices in states, creation of considerable number of senior level and supporting posts, additional funds the requirements for creating a world class CDA are many.

According to highly placed sources, the committee has felt that the changes can position Indian drug regulatory systems at par with that of developed countries and bring in uniformity in interpretation and enforcement of laws. If the suggested changes are to be in place, the present state level drug enforcement system will be asked to focus on areas like inspection of sales premises, inspection of manufacturing units, surveillance/investigation concerning movement of spurious/counterfeit/adulterated drugs etc. The Mashelkar panel feels that the state authorities are competent enough to take up these activities in a uniform manner across the country.