Technical and legal hurdles in obtaining product approval certificates, which are mandatory for getting the new FSSA licence, are forcing the newly formed Tamil Nadu Food Supplement Manufacturers and Traders Association (TFSMTA) to launch a legal battle over the issue, it is learnt.

According to Thomas Philip, the advisor of the Association and the managing director of Stamin Millennium Nutraceuticals, the stringent norms in the Food Safety and Standard Act (FSSA) 2006 obstructs the growth of the industry and creates problems to the manufacturers. He argues that there is no need of product approvals and the provision should be quashed.

“Our Association will approach the court seeking amendment to quash the provisions demanding product approvals. Government is now insisting product approvals (PA) for even ordinary products like milk protein, whey protein etc., which have been in the market for decades. Previously, Prevention of Food Adulteration (PFA) licence was enough for manufacturing food products. PFA licences were issued by the district health officials. Now for getting FSSA licence, we have to submit PA certificates for which we should approach the Delhi FFSA office,” he told Pharmabiz.

As per the Act, if a new ingredient is added in the product, the product has to be subjected to toxicology test, heavy metal test and microbial test before applying for product approval. For each test, an SSI unit has to spend more than Rs.8,000. Most of the small scale units bring out more than one hundred products also. “So, the provision of product approval certificate has to be withdrawn and it is unwanted,” he opined.

Fortius Mohan, the president of TFSMTA said all the manufacturers are in a quandary now in respect of the PA. He said ten members from his Association applied for the FSSA licence in last March because of the expiry of PFA on March 31. But nobody was given the licence so far despite several trips were made to New Delhi. From April this year onwards, the health department has stopped issuing PFA licence.

Currently the Association is confining in Chennai district only, but the activity will be expanded to all the states soon by increasing the membership. There are over 300 food supplements manufacturers in Tamil Nadu, some of them are members of CIPMMA. But after getting registration for the Association, TFSMTA will join the Tamil Nadu Pharmaceutical Manufacturers Association, he added.

Meanwhile, the implementation of FSSA has also created embarrassment for the medical retailers as the act mandates every trader who sells packed food items to obtain food licence from the State Food Commissionerate. Food items come under dietary supplements such as Bournvita, Farex, Amul, Complan, Boost etc. and are being sold through medical shops. Therefore, separate licence is required to sell these items.

The state chemists and druggists association (TNCDA) approached the Commissioner of FDA requesting him to exempt the drug traders from taking separate licence for selling dietary supplements.

When contacted, G Selvaraju, the drugs control director, said as per the act, every manufacturer or trader who has an annual turnover of Rs.12 lakh has to obtain PA or food licence from FSSA office and those whose turnover is less than Rs.12 lakh has to register with the Commissionerate. In Tamil Nadu the FSSA 2006 came into force on August 8, 2011.