Food Business Operators (FBOs) can now introduce new products, including those with combinations of known ingredients, but these should adhere to horizontal standards as laid down under the FSS Act, according to Dr R K Sanghavi, chairman, nutraceuticals subcommittee, IDMA. He was addressing a press conference held recently by IDMA (Indian Drug Manufacturers’ Association) following the Supreme Court verdict against FSSAI advisories on Product Approval.
Sanghavi pointed out that the apex court had put an end to the Product Approval advisory dated May 11, 2013, issued by Food Safety & Standards Authority of India (FSSAI), according to which FBOs were required to take approval for a broad spectrum of food products. These included proprietary food, novel foods, functional foods, food supplements, irradiated foods, genetically-modified foods, and foods for special dietary uses or extracts or concentrates of botanicals, herbs or of animal sources. It also specified products that were already available and being consumed. The apex court had upheld the Bombay High Court verdict in this regard.
He stated, “The Supreme Court outcome is a win-win situation since the FSSAI, being entrusted with consumer safety as criteria of governance, now has a guided goal to focus on risk management rather than the herculean task of virtual risk assessment product-by-product.”
However, Sanghavi cautioned that following the Supreme Court ruling, FBOs should not overenthusiastically launch products outside the purview of the upcoming regulations for nutraceuticals, functional foods, organic foods, foods for special dietary uses and so on. Any product available must ensure its safe consumption and satisfy all the standards in terms of content of pesticides, heavy metals, other contaminants, labelling norms, permitted additives, flavours and so on.
With regard to concern expressed by FBOs for nutraceuticals, dietary supplements and functional foods, Sanghavi pointed out, “Earlier there was Prevention of Food Adulteration (PFA) Act, which was later replaced with Food Safety and Standards Act, 2006, wherein the implementation started only in the year 2011. The Act is in the best interest of food safety for the consumer today.”
“But it is FBOs who faced difficulty and later felt the regulations are arbitrary in nature. The products which were approved as per earlier Act and consumed for previous 10-20 years were not approved or later banned.”
According to Sanghavi, the current nutraceuticals market is worth Rs 6,000 crore and has the potential to garner 20% of pharma market in India.
Sandeep Gupta, VC, IDMA, who was also present at the conference, stated, “The process of approval had virtually locked the progress of the industry. There are 5,500 applications of product approval pending with authorities. There is a multi-layer product approval process.
Meanwhile, Ganesh Kamath, director, Vital Nutraceuticals Pvt. Ltd, said, “The process of approval is not practical. No scientific test of products and its ingredients is done. Sampling and testing should be done to check the safety aspect of the product. In the current scenario, only stamp on dossier is given after reading it. There are lots of products/companies that had suffered from this attitude. There is no fresh investment. SMEs too are suffering. The company Lindt chocolate has exited from India and even Ferrero Rocher has shifted base to China.”
