Guidelines for mfg & marketing of dietary supplements, nutraceuticals to be issued soon

Task force constituted by the food safety authority to regulate category of special food items like nutraceuticals and dietary supplements submitted their recommendations to the Food Safety and Standards Authority of India (FSSAI) last week.  The recommendations basically comprises of guidelines for the approval of dietary supplements and nutraceutical products that are manufactured and marketed throughout the country. It is understood that the seventeen-member team had submitted the recommendations based on a detailed study conducted on the market in consultation with all the stakeholders. It basically highlights the key regulatory requirements that need to be implemented to regulate this huge market. Once these recommendations gets the nod from the FSSAI, all the manufacturers in the country falling under this category will have to get a no objection certificate (NOC) and approval from the centre prior to manufacturing and marketing the products. Dr Koshia commissioner of Gujarat FDCA who was the part of this task force informed that the aim behind coming out with these recommendations was to bring in a regulatory semblance to this highly unregulated segment, especially considering the adverse health implications it may have on people if left unchecked. At present, India does not have any kind of regulatory guidelines for the approval or monitoring of the products under this segment. Interestingly, a lot of ayurvedic products in the country, are sold as nutraceuticals or dietary supplements. Experts state though there is currently no fixed statistics to show the size of the market, the scope of the same is huge as it is basically a direct to consumer segment. “Implementing these guidelines will not only help in effectively regulating the market but also maintain a proper data on the same, which is not the case today.  In the recent past, there has been an increase in the incidents of misuse or improper manufacturing conditions. Considering the huge health risks it can pose to the consumers it is high time to concentrate on having an ideal approval policy that will ensure proper compliance of manufacturing of all the products that are available in the market,” informed Dr Koshia.  It was in this light that the Centre has constituted the task force over two and a half month back. Highly placed sources from the Centre informed that this move will help in checking a lot of activities that go unaccounted in the country as of now. It has been observed by experts that a lot of Ayush products are currently sold under this segment directly to the consumers.  Some cite that certain products especially those that claim to aid health benefits to the consumers, having ingredients which usually need to undergo stringent approval process under the drugs and cosmetics act gets easily available in the market as a dietary or nutraceutical product.

Source:Pharmabiz