FSSAI, Nutraceutical Cos lock horns over Enforcement Draft

The Food Safety and Standards Authority of India has ordered Manufacturers of health supplements to follow strict norms in manufacturing and testing of health supplements launched after 2011 based on a draft report.The announcement comes on the heels of a recent ban imposed on antibiotics by the government. The 20,000 crore pharma industry faces severe confrontation from the government, through this recent FSSAI notice.

According to ET, the most affected groups due to the current FSSAI supplement regulation would be Sun Pharma, Abbott Nutrition and GlaxoSmithKline. Besides these Amway Nutrition, Mankind Pharma and Herbalife are among manufacturers of health supplements in India who are also likely to be grieved by it."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 the FSSAI notification issued by Rakesh Chandra Sharma, its director of enforcement, on Thursday.

The FSSAI has given exemption to companies whose supplements were available for sale prior to the Food Safety and Standards Act implementation in 2011 or in the case of pending approvals on August 19,2015, when the advisory committee was dissolved after a Supreme Court Judgement.The pharma industry defined the notice as being high handed and feared that the notification could mean the end of all products launched after 2011.

The conflict between the FSSAI and the drug industry dates back to Patna food and drug regulator banning all health supplements in 2014. In 2011, FSSAI had set up the product approval committee, after the matter was taken up by the Supreme Court. The Committee was supposed to approve such products using the same parameters as those for drugs. However, the body did not last long for the supreme court ruled against it, forcing the FSSAI to disregard it. A drug company stated "A Supreme Court order last year had dismantled the advisory board that FSSAI had set up and now we are told that the products under that committee will be considered for approval," "How can the regulator approve products by a body that does not exist?"

Drugmakers compared this being similar to the fix dose ban imposition.

The drug industry expressed apprehensions about the regulations for health and food supplements not being in place. RK Sanghvi, Head, nutraceuticals committee, Indian Drugs Manufacturers' Association, was of the opinion that one could not rely on drafts for enforcement in the absence of regulations.