TFSMTA could approach health min for single window for supplement nods

Raising the demand that process of issuing manufacturing licences for nutraceutical products should be made transparent and rationalised, the Tamil Nadu Food Supplement Manufacturers’ and Traders’ Association (TFSMTA) may approach the Union health ministry, requesting it to consider launching a single-window system for giving permissions for the manufacture and sale of food supplements under the Food Safety and Standards 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, 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.

Kumar said the current method of licensing was cumbersome and prolonged, and it only confused the manufacturers. If all processes were done through a single window, much of the paper work could be reduced and the small-scale units avoid their weekly trips to the Food Safety and Standards Authority of India’s (FSSAI) office in New Delhi. Further, the state government would have a 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 licences. The PA are issued by separate authorities under FSSA and the manufacturing licences is given by another department. Today’s process is very tedious and expensive, which we cannot afford to,” added he.Regarding levying tax, Kumar said all food supplement products are now charged at 14.5 per cent value-added tax (VAT). The association wants the government to bring it down to a rate of five per cent as the consumers of these products are mainly patients.

For test analysis of a product, the company needs to pay around Rs 15,000 per product and a general fee of Rs 25,000 for product approval for one product. For renewal of licences, FSSA is charging Rs 7,000, whereas the drug department charges only Rs 1,500 to Rs 2,000 for product endorsement.Previously the manufacturers approached the state health authorities for their licence problems, but the process has been shifted to the FSSA office in New Delhi now. This makes several hurdles to the manufacturers, and the whole process would take more than six months.”For the domestic marketing of products, the state government would issue the licence, but for out of state sales, a licence is required from FSSA. Several drug companies are manufacturing food supplements after taking licence from FSSA,” Kumar added.