The Maharashtra Food and Drugs Administration which took up the quality and safety concerns relating to nutraceutical preparations in the country for the first time, once again raised the issue so as to bring some safety regulations for vitamins and other health supplements sold in the country with functional and medical claims.
The FDA has requested the central government to enact the nutraceuticals and dietary supplements regulation as early as possible to curtail the practice of marketing nutraceuticals with exaggerated claims of preventing and curing diseases.
"There are vitamins and mineral products in the form of tablets available in the market. Most of these products having some medicinal characteristics are promoted like rational drugs," said Dhanraj Khamatkar, commissioner, FDA, Maharashtra in a recent Pharma summit. The concerned departments have to take steps to enforce the nutraceuticals and dietary supplements regulation passed in 2006.
The Maharashtra FDA is the first state regulatory body to take action against nutraceuticals and dietary supplements supplied through fast moving consumer goods (FMCG) and pharmacy outlets, in 2005. The administration pointed out, at that time, these products contain vitamins and minerals like many other medicinal products and several dietary supplements have adverse effects but are not mentioned on the labels.
The administration also clarified that overdose of vitamins and minerals may cause health problems. Therefore the products are drugs and require valid drug licenses under Drugs and Cosmetics Act. However, the Mumbai High Court has issued an interim stay on a petition filed by Amway India blocking any further action from the FDA to seize the nutraceutical products. Later, the state government also issued a stay against the proposed ban on nutraceuticals, providing a breathing space to the nutraceuticals industry.
With the nutraceuticals and dietary supplements regulations passed through the food safety bill two years back, the administration is seeking earlier implementation of the rules to ensure safety and quality of the products sold as nutraceuticals. "We are ready to extend any kind of support to the implementation of the regulations, and we will submit our opinion on this to the central government, if it is sought," said Khamatkar.
He also raised concerns over the quality of products manufactured by surgical materials in the country. Many of the manufacturers are not complying with manufacturing standards as per the Schedule F of the Drugs and Cosmetics Act. The producers are not maintaining manufacturing quality, which may lead to serious complications in a later stage.