Pharma companies against plan to bring nutraceuticals under drug regulator

The government's plan to shift nutraceuticals to the drug regulatory authority from the oversight of the Food Safety and Standards Authority of India (FSSAI) has come under fire from pharma lobby groups and industry experts, who have raised apprehensions over the move and said the proposal should be kept in abeyance until it is discussed in detail.

Nutraceuticals refers to food products with extra health benefits and includes supplements, functional foods and beverages. According to industry data, the segment is projected to grow to $18 billion in India by the end of 2025 from $4 billion in 2020.

Experts said the regulations for nutraceuticals in the country are aligned with Codex Alimentarius, a global body functioning under the auspices of the World Health Organisation (WHO) to ensure safety of consumers.


The FSSAI regulations are similarly in sync with global practices and comparable with those prevailing in other countries such as the US, UK, Australia, China, Japan and those in the EU, they said.

"All these countries' regulations include the very same categories as under the FSSAI in their regulations, including, vitamins, minerals, pre- and probiotics," said Dr RK Sanghavi, chairman, Nutraceutical Committee of Indian Drug Manufacturers' Association (IDMA). He said the FSSAI has aligned India's nutraceuticals with global practices, thus ensuring safety of these products.

A high-level committee was formed earlier this year to review the guidelines related to these products and suggest a new framework. Senior officials from the ministries of health and family welfare, and food processing industries, Department of Pharmaceuticals, FSSAI, Drug Controller General of India, director general of the Indian Council of Medical Research and director general of health services are actively discussing the issue and will soon come out with measures to regulate the nutraceutical industry.

"A meeting was held with industry experts in April, and thereafter government officials have been having discussions among themselves. Not enough discussions have been held with us and hence we don't know what's happening on the issue," said another expert, who did not wish to be identified.

Sanghvi said even if only vitamins and minerals are to be shunted out from under the FSSAI, the nutraceutical market will shrink by 70%.

The government is also considering bringing nutraceuticals under price control, to make them more affordable for consumers.