FSSAI and D&C Act – Overlapping of provisions – hurdle for enforcement

Since there is overlapping of various provisions in the Drugs & Cosmetics Act (D&C Act) and Food Safety & Standards Act of India (FSSAI), the regulatory bodies of drugs and food products are often confused of enforcing the laws properly.

Consequently, many drugs are marketed as food products and circumvent the drug laws and price control, said Dr Subhash Mandal, chairman of the regulatory affairs division of the Indian Pharmaceutical Association (IPA).
In a letter sent to the union government seeking its intervention for an immediate solution to this burning issue, he said several drug companies are violating the laws by marketing domestically and internationally several of their products in big quantum as food products. This happens because, in both the Acts, there is overlapping between drugs and food products, which helps the manufacturers or the marketers to take advantage of the loopholes. So, there is an urgent need to resolve the issue to protect the health of the people.
The letter, written on behalf of the Indian Pharmaceutical Association, has wanted union health ministry to carry out more research on the herbal food products and neutraceuticals in order to develop evidences of safety of them.
Dr. Mandal, who is also a regulatory official in the government of West Bengal, has also urged the government of the state to go through such products marketed there. The market is flooded with neutraceuticals, food supplements and micronutrients which are all making lofty claims of quality. The common people, without knowing much about the products, buy and use the products either by producing prescriptions or without. Most of these products are prescribed by doctors to their patients.
He pointed out that in most of the cases, the physicians were prescribing these products without any proof of safety, quality and even not considering the drug –food interaction or drug-drug interaction. Possibility of drug-food interaction and drug-drug interaction is manifold in the case of herbal food products. So, government should conduct researches in the safety of these herbal food products.
According to Dr. Mandal, though the Food Safety & Standards Act, & Rules 2011, prescribes measures for ensuring quality, it is yet to be implemented seriously and uniformly because of weak infrastructure and insufficient manpower in major part of the country. This problem should also be resolved, he wrote in the letter.



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