After drug ban, another regulation by FSSAI puts nutraceuticals industry in a tight spot

After the recent ban on around 300 $4 by the health ministry took a toll on drug makers, another regulation is likely to impact the nutraceuticals industry, such as $4, which is a Rs 20,000-crore sector.

Companies such as $4, Abbott Nutrition, Amway Nutrition, Mankind Pharma, Herbalife and GlaxoSmithKline are to be hit after the $4 that has ordered companies to follow strict norms in manufacturing and testing of health supplements launched after 2011.

"It has (been) decided that till the standards of nutraceuticals food supplements and health supplements are finally notified, the enforcement activities against such food business operators may be restricted to requirements given in the draft notification on such products," said FSSAI enforcement director Rakesh Chandra Sharma.

Companies will get an exemption if the supplements were available in the market before the Food Safety and Standards Act came into effect in 2011 or if product approval was pending on August 19, 2015.

The matter started after Patna food and drug regulator banned all health supplements in 2014.

In 2011, FSSAI had set up the product approval committee to give nod to such products using the same parameters as those for drugs. However, last year, the Supreme Court ruled against the establishment of the committee, which FSSAI had to abandon.

"The regulations for health and food supplements are not in place. If there are no regulations, we cannot rely on drafts for enforcement. This is like the ban on fixed dose combinations all over again," RK Sanghvi, head of the nutraceuticals committee of the Indian Drugs Manufacturers' Association, told ET.