Nutraceuticals slams FSSAI 'Product Approval' scheme

The Food Safety & Standards Act of 2006 was implemented in August 2010 and the FSSAI had framed regulations covering food products in August, 2011.

In January 2012, FSSAI introduced the 'Product Approval' system directing all Food Business Operators (FBOs) to obtain a product approval before applying for the licenses under the new Act.

The new Act provided automatic transition of existing licenses under the earlier regime of Prevention of Food Adulteration Act, but the Regulations issued in 2011 provided for one year time limit.

According to the FBO associations, most of the FBOs, including those who were producing proprietary foods for a long period of time have applied for the product approval by paying Rs.25000 for each product applied, in order to transfer the licences of existing products under erstwhile licenses and regime to the new one.

However, due to lack of clarity in implementation and the criteria adopted for such approvals, many of the FBOs have been facing significant problems. The majority of them have not received Product Approval/NOC despite having applied for it over a year ago, thus making them unable to apply for licenses, the industry players noted.

The FBOs noted that the scheme since 2012 and its guidelines have been changed eight times, the last one being in May 2013.

Following this, a Writ Petition was filed in the Bombay High Court against the advisories of Product Approval issued by FSSAI, for which the proceeding is on.

So far, FSSAI has been unable to justify whether this power to release advisories has been passed before both the Houses of Parliament or not, the FBO associations informed.

They further noted that the stay order meant to provide interim relief while decision on the Product Approval scheme is pending, has failed to blow life in the fading businesses of importers and manufacturers alike.

The associations asserted that stay on product approval process remains till August 2014, yet port authorities have been demanding the product approval from importers of dietary supplements and nutraceuticals.

The authorities refuse to send the landed products for testing without the product approval; as a result, no clearance is being made for import of goods in India, they said.

Jayesh Mehta, Proprietor, Paradise Nutrition Inc., said, "We filed for the product approval application 2 years back, but there is no revert on it from the authorities. It has neither been processed, nor rejected or accepted. This has affected over 70% of our business."

Mehta added, "Our imports have completely stopped since September 2013 and we are struggling to stay afloat with the sale of old insufficient stock. We have the necessary licence required to import and do business, and as per the stay order, we should have been allowed to run the business during this while."

The industry leaders said that, Indian players are suffering huge losses with many forced to shut down business.

A large number of FBOs are also exporting Nutraceuticals and Dietary supplements to developed markets like US & Europe, where there is no such product approval system, however, are adversely affected by the uncertain regulatory regime in India, they said.

Leading industry associations after making several representations to FSSAI officials, intense discussions with its own members and open conferences with the stakeholders have found no direction or definite solution from the authorities on the issue of Product Approvals.

Food Business Operators (FBO), however, through their associations are determined to find an effective way to resolve the prevailing issues and demand an independent body to help the cause.