New FSSAI rules on nutraceuticals may leave companies like Sun Pharma, GSK ailing

MUMBAI: Drug companies, still reeling from a recent health ministry ban on some of India's most popular antibiotics and cough syrups, may be facing another stiff challenge with a regulatory notice threatening the Rs 20,000-crore nutraceuticals industry, the leading lights of which include Sun Pharma, Abbott Nutrition and GlaxoSmithKline.

The Food Safety and Standards Authority of India has ordered companies to follow strict norms in manufacturing and testing of health supplements launched after 2011, based on a draft report. Apart from the firms mentioned above, Amway Nutrition, Mankind Pharma and Herbalife are among manufacturers of health supplements in India.

"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.

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, when FSSAI's product approval advisory committee was scrapped after a Supreme Court judgement. Products explicitly covered under the draft notification on nutraceuticals, food supplements and health supplements will also be allowed.

The industry's fear is that the notification could effectively mean a ban on all products launched after 2011. The notice was "too high-handed", said Ramesh Juneja, managing director of New Delhi-based Mankind Pharma, which sells popular brands such as Health OK and Nurokind.

Issue brewing for some time

The issue has been brewing for some time, starting with the Patna food and drug regulator banning all health supplements in 2014. The matter went to the Supreme Court. In 2011, FSSAI had set up the product approval committee, which was supposed to approve such products using the same parameters as those for drugs. But last year, the Supreme Court ruled against the establishment of the committee, which FSSAI had to abandon.

There was no immediate response to emails sent to the other companies cited above.

A drug company executive suggested the notification may not be in line with the apex court's decision. "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," the person said. "How can the regulator approve products by a body that does not exist?"

Drugmakers said the move was similar to the ban on fixed-dose drug combinations (FDCs) that has led to sales of top-selling medicines such as Corex, Saridon and D Cold being halted. That ban imposed by the health ministry has been challenged in court.

"The regulations for health and food supplements are not in place," said RK Sanghvi, who heads the nutraceuticals committee of the Indian Drugs Manufacturers' Association, a lobby group of more than 300 companies. "If there are no regulations, we cannot rely on drafts for enforcement. This is like the ban on fixed dose combinations all over again."

The ban on FDCs that lack "therapeutic justification" threatens to put an end to sales of drugs worth about Rs 3,000 crore annually if it's upheld.