The once deferred Dietary Supplement (Nutraceuticals) Bill, which was proposed by the Union Ministry of Health, is likely to be presented in the next session of the Parliament with few important modifications. The ministry, which is reconsidering the proposal, has now asked the Central Drugs Standard Control Organisation (CDSCO) to update the recommendations with necessary alterations in the earlier draft before February 2005, said the sources from DCGI office.

Though the earlier draft had recommended categorizing dietary and health food supplements in a special group separate from food and drug for licensing and registration purpose, the new suggestion from the department is that once the CDSCO streamlined with additional manpower and infrastructure, the approval of nutraceuticals with functional claims on the label would be handled by a newly formed cell within the department. For this, it would follow all the required safety and efficacy procedures similar to that of a drug by the special cell in the CDSCO, the sources said.

The Bill was deferred earlier by the Ministry of Health due to concerns about the misuse of a liberalized licensing system for this category of products by the industry and trade as the competency of the regulatory system to control the same was doubtful.

Having prepared a draft Bill for this new set of regulations last year, the Centre had even decided to set up a tripartite Committee at the centre, which would represent the Ministry of Food and Agriculture, Department of Indian System of Medicine and also Drug Control General of India, as an apex body to license dietary supplements and nutraceuticals.

Under the tripartite Committee it was also planning to form separate regulatory machinery parallel to existing central/ state Drug Control Administration. This committee would deal with registration, approval and licensing of products classified under 'Health Food Supplements,' which includes dietary supplements, vitamin preparations and most herbal health products currently marketed in the country.