Nutraceuticals regulation by Maharashtra FDA
The main problem voiced by Mr Ramesh Kumar, Commissioner of the Maharashtra Food and Drug Administration (FDA) is that nutraceuticals are only food supplements, then why are they to be taken in small doses only. After all, food does not require any particular dosage right?
According to FDA regulations in Maharashtra, companies making therapeutic or curative claims on nutraceutical products were not allowed to sell in Maharashtra from July, unless they had a drug licence.
This initiative was taken up when Ranbaxy was asked to get a drug license for its product Revital, a nutritional supplement for mental and physical health.the FDA considered it a ruse developed by drug companies circumvent the rules and avoid excise by selling their drugs as food supplements.
The Central Government is constantly in turmoil and continues to lack clarity on whether to bring nutraceuticals as part of the constantly-under-review Drugs and Cosmetics Act.
The dilemma over nutraceuticals started some years ago when the Centre brought in the system of indicating vegetarian and non-vegetarian products through green and brown dots on the packaging respectively.
Some companies unilaterally decided to carry the non-vegetarian brown dot, even though the Centre was not clear.
The FDA Commissioner pointed out that the levels of vitamins and minerals in nutraceuticals are similar to that in drugs.
Many nutraceuticals claim to use ayurvedic formulations in their products. This has caused fear in manufacturers of ayurvedic products that manufacturers may not put nutraceutical products through the rigours of the ayurvedic science and yet reap benefits by using the ayurvedic label.
Muhammed Majeed, Managing Director, Sami Labs, said in an interview with The Hindu newspaper, “Herbal extracts are products derived from herbs, that is, plants. Nutraceuticals are derived from nutritional compounds having therapeutic value in contrast to straightforward "Pharmaceuticals.'' Nutraceutical need not only be derived only from plants. Even vitamins, minerals and some synthetic compounds are classified as Nutraceuticals. Ayurvedic drugs not only include plant-based products mentioned in Ayurveda, but also minerals in the form of "Bhasmas'' and the like.”