Raising the demand that process of issuing manufacturing licences for neutraceutical products should be made transparent and rationalized, the Tamil Nadu Food Supplement Manufacturers and Traders Association (TFSMTA) may approach the central health ministry requesting it to consider launching of a single window system for giving permissions for manufacture and sale of food supplements under Food Safety and Standard Act (FSSA) 2006.
The association has decided to raise the issue before the government because there is a confusion among manufacturers with regard to FSSA and increasing unwanted expenses which the small scale units are unable to bear, said K Mohan Kumar, president of TFSMTA.. If the process of licensing is brought under a single window system, all the hurdles for getting the product approvals (PA) and manufacturing licenses can be solved, he said.
While speaking to Pharmabiz, Mohan Kumar said the current method of licensing is cumbersome and prolonged, and it only confuses the manufacturers. If all processes are done through a single window, much of paper work can be reduced and the small scale units avoid their weekly trips to FSSA office in New Delhi. Further, the state government will have major role in controlling the industry.
‘No proper guidance on FSSA is given to the industry by the department and the manufacturers are unaware of how to proceed. We need simple and transparent process for getting product approval certificates and manufacturing licence. The PA is issued by separate authorities under FSSA and the manufacturing licence is given by another department. Today’s process is very tedious and expensive which we cannot afford to,” said he.
Regarding levying tax, he said all food supplement products are now charged 14.5 per cent VAT. The association wants the government to bring it down to a rate of 5per cent as the consumers of these products are mainly patients. For test analysis of a product, the company needs to pay around Rs. 15000/- per product and a general fee of Rs. 25000/- for product approval for one product. For renewal of licences, FSSA is charging Rs. 7000/, whereas the drug department is charging only Rs. 1500/- to 2000/- for product endorsement.
Previously the manufacturers were approaching the state health authorities for their licence problems, but the process has been shifted to FSSA office in New Delhi now. This makes several hurdles to the manufacturers and the whole process will take more than six months.
For domestic marketing of products, the state government is issuing the licence, but for out of state sales, licence is required from FSSA. Several drug companies are manufacturing food supplements after taking licence from FSSA, he added.