Chakraborty, Pradip
Current regulatory landscape for nutraceuticals - Vol.53(3), March - Mumbai Indian Journal of Pharmaceutical Science 2021 - 21-26p.
Food Safety and Standards Authority of India regulates domestic and imported food products in India since 5 th August, 2011. In the
absence of any regulations on health supplements and nutraceuticals in India, FSSAI considered these products as Proprietary and
Novel food. FSSAI issued several guidelines inviting applications from the food business operators for approval / No Objection Certificate
for Proprietary and Novel Food. However, the FSSAI also received several queries and concerns from food business operators regarding
the complexity and timelines for product approval.
Finally, FSSAI notified Regulations for Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Foods for Special Medical
Purpose, Functional Foods and Novel Foods which is effective from 1 st January, 2018. The regulations specify the essential composition
of the product, additives, compliance of specific labelling requirements, in addition to the provision of the Packaging and Labelling
Regulations (2011), Compliance of the Contaminants, Toxins and Residue Regulations (2011) and Health Claims, if any. Eight categories
of products have been defined.
The regulations contain eight schedules consisting of a permitted list of vitamins, minerals, amino acids, botanicals, nutraceuticals,
prebiotics and probiotics along with the permitted list of additives. For novel foods and health claims, pre-approval is required from
the FSSAI. The quantity of nutrients added shall not exceed the recommended daily allowance as specified by the Indian Council of
Medical Research. However, the regulations are under review and likely to be amended by the FSSA
PHARMACEUTICS
Current regulatory landscape for nutraceuticals - Vol.53(3), March - Mumbai Indian Journal of Pharmaceutical Science 2021 - 21-26p.
Food Safety and Standards Authority of India regulates domestic and imported food products in India since 5 th August, 2011. In the
absence of any regulations on health supplements and nutraceuticals in India, FSSAI considered these products as Proprietary and
Novel food. FSSAI issued several guidelines inviting applications from the food business operators for approval / No Objection Certificate
for Proprietary and Novel Food. However, the FSSAI also received several queries and concerns from food business operators regarding
the complexity and timelines for product approval.
Finally, FSSAI notified Regulations for Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Foods for Special Medical
Purpose, Functional Foods and Novel Foods which is effective from 1 st January, 2018. The regulations specify the essential composition
of the product, additives, compliance of specific labelling requirements, in addition to the provision of the Packaging and Labelling
Regulations (2011), Compliance of the Contaminants, Toxins and Residue Regulations (2011) and Health Claims, if any. Eight categories
of products have been defined.
The regulations contain eight schedules consisting of a permitted list of vitamins, minerals, amino acids, botanicals, nutraceuticals,
prebiotics and probiotics along with the permitted list of additives. For novel foods and health claims, pre-approval is required from
the FSSAI. The quantity of nutrients added shall not exceed the recommended daily allowance as specified by the Indian Council of
Medical Research. However, the regulations are under review and likely to be amended by the FSSA
PHARMACEUTICS