The Hindu Business Line : Clarity eludes sale of nutraceuticals in Maharashtra from July

LACK of clarity and nutraceuticals seem to go hand-in-hand. First, there is ambiguity on whether nutraceuticals is a food or drug. And, now, there is confusion on whether nutraceutical products can sell in Maharashtra without a drug licence, come July.

With just two days to go, the State Government is believed to have "stayed" a directive from the Maharashtra Food and Drug Administration (FDA) asking manufacturers to get a drug licence if they wanted to make curative claims on nutraceutical products.

A Ministry official handling the issue confirmed the development and said that the order staying the FDA directive was to be issued later on Tuesday. However, a top FDA official told Business Line that he was not aware of the development.

These conflicting signals emerged after a meeting between the State Food and Drugs Minister, Mr Manohar Naik, FDA authorities and representatives of the Health foods And Dietary Supplements Association (HADSA).

Representatives of nutraceutical and drug companies, including Herbalife, Banner, Amway, USV, Ranbaxy, Nicholas Piramal and Wockhardt, met the Minister, said an industry representative who attended the meeting.

The State FDA's directive had been issued some months ago when Ranbaxy was asked to get a drug licence for its Revital, a nutritional supplement for mental and physical health.

The developments are being closely watched by authorities at the Centre, as nutraceuticals gets tossed around between the Ministries of Health and Food. At last count, nutraceuticals were to be brought under the purview of the proposed Integrated Food Bill.

A representative with a domestic drug said that "functional foods" or nutraceuticals should be classified as a food and not a drug. If the July directive were to be implemented an estimated Rs 500 crore of nutraceuticals business would have come to a halt, the representative claimed. However, the industry official admitted that there should be regulations governing the labelling and advertising of the product.

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