Mumbai: The Maharashtra FDA has now taken Ranbaxy Laboratories to task over its product Revital. The regulatory body says the drug company''s claims of Revital being a food supplement are suspect.

According to the Maharashtra FDA, if the product is a food supplement, it need not have a dosage prescribed for it as food does not need to be taken in doses.

Going a step further the state FDA has stopped the sale of all nutraceutical products and products making therapeutic or curative claims in the state of Maharashtra unless the products have a drug licence.

Industry representatives are scheduled to meet the ministry of consumer protection and FDA authorities in this regard.

Earlier this year, the state FDA asked Ranbaxy to obtain a drug license for its Revital, which the company claimed was a nutritional supplement for mental and physical health. The FDA claimed that Revital was a medicinal product, attracting an excise duty of 16 per cent. The FDA said classification of the product under the food category was done to avoid paying the excise duty as food supplements attract zero excise.

Ranbaxy had moved its Revital product to the over-the-counter segment in early 2004 to increase its sales. Revital was initially launched as a prescription drug.

Revital is a combination of ginseng extract as a primary ingredient along with vitamins. It is promoted as a nutritional supplement for enhancing mental and physical health.

The FDA points out, that nutraceutical products contain vitamins and minerals in dosage levels similar to drugs and so should be classified as drugs.

The conflict has arisen as the Centre continues to lack clarity on whether to bring nutraceuticals as part of the constantly-under-review Drugs and Cosmetics Act or put it under the purview of the proposed Integrated Food Bill.