Approval of dietary supplements on hold following Bombay HC’s judgment

The Food Safety and Standards Authority of India (FSSAI) has put product approval on hold following the recent Bombay High Court judgment in favour of dietary and health supplement manufacturers. 

The High Court quashed the advisory of the country’s apex food regulator, which was issued in May 2013 for prior product approvals of dietary food and healthsupplements.

Dr R K Sanghavi, chairman, nutraceutical sub-committee, Indian Drug Manufacturers’ Association (IDMA), informed, “The advisory by the FSSAI to get product approvals for all 80 nutraceutical products and pay Rs 25,000 per product was not justified.” 

“We moved the High Court against FSSAI, and now the court has cancelled the advisory, terming it unlawful. The nutraceutical manufacturers are very happy with the High Court’s decision,” he added. 

“FSSAI has laid down new rules and regulations, which are not even in the Food Safety and Standards Act (FSSA), 2006,” Sanghavi stated.

T R Gopalkrishnan, secretary-general, Indian Drug Manufacturers’ Association (IDMA) said, “The nutraceutical manufacturers are following the Act and the Food Safety and Standards Regulations (FSSR), 2011, but now FSSAI is going beyond by laying down new rules and regulations.” 

“For every product to get approved by FSSAI, the nutraceutical manufacturers have to pay Rs 25,000, which is a huge amount. Big companies can pay it but what about the small companies who want to come in the market with new product. The High Court’s judgment was in our favour, and we are happy with it,” he added. 

H G Koshia, food commissioner, Food and Drugs Control Administration (FDCA), Gujarat, said, “There is a misconception in the mind of food business operators (FBO) about product approval.” 

“The product approval by FSSAI is only for nutraceutical manufacturers, because nutraceutical products contain minerals, vitamins and zinc which are also food items. Hence, nutraceutical manufacturers have to go for product approvals,” he added.

He added, “According to sources, I have also come to know that due to the intervention of the High Court in the matter, FSSAI has kept the product approvals on hold, and that is the reason businesses are incurring losses.” 

“The nutraceuticals manufacturers association should have a meet the FSSAI officials and should come up with a solution which would be beneficial for everyone,” Koshia stated.

In a relief to dietary and health supplement manufacturers, the High Court quashed, by a majority judgment, as unlawful, an advisory issued last May by FSSAI for prior product approvals of dietary food and health supplements already licenced and existing in the market under the Prevention of Food Adulteration (PFA) Act, 1954 (which preceded FSSA, 2006).

Since 2006, a Food Safety and Standards Act has been governing manufactured food safety in India.

IDMA and a private nutraceutical firm moved the High Court last year to challenge the advisory as it said the authority had no powers to issue it.