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Pharma Companies are not in Favour of Bringing Nutraceuticals under Drug Regulator

Pharma Companies are not in favour of bringing nutraceuticals under drug regulator

The government is planning to shift nutraceuticals to the drug regulatory authority from the oversight of the Food Safety and Standards Authority of India ( FSSAI) come under the pharma lobby groups, Industry experts raised concern over this and asked to temporary disuse this proposal until it is discussed in detail.

Nutraceuticals are food products with additional health benefits, including supplements, functional food and beverages. According to industry data, the segment will grow to $18 billion in India by the end of 2025 from $ 4 billion in 2020. 

Experts stated that regulations for nutraceuticals in the company are aligned with Codex Alimentarius ( It is a global body functioning under the auspices of the World Health Organization to ensure the safety of consumers).

Regulations from FSSAIs are similarly synced with the other global regulations. It can be comparable with those in other countries such as the US, UK, Australia, China and Japan.

Dr, R K Sanghavi, Chairman of the Nutraceutical Committee of the Indian Manufacturers Association (IDMA) said that all these countries’ regulations include the very same categories under the FSSAI in the regulation, including Vitamins, Minerals, Pro and Prebiotics and FSSAI aligned India’s nutraceutical with global practices to ensure safety.

To review the guidelines related to these products, a high-level committee was formed earlier this year and suggested a new framework. Senior officials from the Ministries of Health and Family Welfare, Department of Pharmaceuticals, FSSAI, Drug Controller General of India, Director General of Indian Council of Medical Research and Director General of Health Services are actively trying to resolve this issue and will soon come up with measures to regulate the nutraceutical industry. 

Another expert who denied being identified said that A meeting was held with industry experts in April, thereafter government officials are discussing within themselves. There is not enough discussion happening with them that’s why they don’t have any update regarding this issue. 

Sanghvi said that even if only minerals and nutraceuticals are excluded from FSSAI, market of nutraceuticals will shrink by 70%. 
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