Bridging the Gap between Nutraceutical Regulations and Enforcement



by admin

Bridging the Gap between Nutraceutical Regulations and Enforcement



by admin

by admin

India, well-known as World’s Pharma hub, finds its root of Traditional medicines in Ayurveda! This legacy of curative knowledge is far older than the modern medicines. With Covid-19, world has accepted the role of preventive measures, thus “alternative” medicine becomes “mainstream”.

As per research, there is surge in global demand for nutraceutical products. The European consumption is influenced by innovation and research, the USA demand is driven by growing health awareness, whereas, Asian preference is due to the trust in conventional medicines.

India, having an inherent advantage in this space, is poised to benefit. Hence, to tap this potential, multipronged approach is needed, such as increasing grants for R&D, Ensuring end-to-end supply chain and redefining the regulatory system.

Efforts are being put by regulators to give the industry the required boost and allow it to contribute substantially for the public healthcare. So, let us have a look at some of the reforms done in regulations in Corona times.


11th June 2020: FSS Act, 2006 permits use of nutrients in products such as health supplements, nutraceuticals, etc. in amount not exceeding Recommended dietary allowance (RDA) prescribed by ICMR. – all the central and state licencing authorities are advised to strictly implement the limitation of ‘Not more than one RDA’ for nutrients as per section-22 of FSS Act, 2006 while granting licenses to FBO except for Food for Special Medical Purposes and Food for Special Dietary Uses where use of more than one RDA is permitted (as per schedule III of Nutraceuticals Regulations).

16th July 2020: Surveillance and enforcement to prohibit the sell of health supplements and nutraceutical products contains PABA- a banned ingredient-re. FSSAI has banned the use of PABA in the products covered under Nutraceutical regulations due to safety concern with immediate effect. No further manufacturing is allowed and products already manufactured and imported shall be withdrawn from the market.

 11th Aug 2020: Products covered under FSS (food or health supplements, nutraceuticals, food for special dietary use, food for special medicinal purpose, functional food and novel food) are required to comply with the general labelling requirements under the FSS (Packaging and Labelling) Regulations, 2011.

1 Oct 2020: The ministry of health and family welfare has framed Food Safety and Standards (Amendment) Bill 2020 and introduced 70 amendments in the 2006 Act to revamp FSSAI functioning and its jurisdiction.                                With the amendments, the government has proposed to bring regulation of animal feed industry under FSSAI.Government has also decided to specify standards for “food contact material”, which would mean specifying standards for food packaging material.
The government has also proposed to make the Act more stringent prescribing enhanced penalties for violations, including manufacture and sale of unsafe food, adulteration of food causing death, carrying out business without licence and repeat offences. The amendments propose enhancing maximum fine for manufacturing and sale of unsafe food from Rs 1 lakh to Rs 3 lakh.

8 Oct 2020: FSSAI invites EOIs (Expression of interest) for selection of Training Partners empanelled under FoSTaC for training of Food Handlers- working with MDM, Aanganwadi, Govt. Canteens and Place of Worship for FSSAI. Organization invites EOIs from experienced and well-established agencies with valid empanelment as Training Partners under FoSTaC launched by FSSAI and who are ready to provide their services with due care and guidance to the users so as to get maximum utilization of resources.

FSSAI will reimburse the amount with due verification, as deemed fit, considering the number of trainees per class. (EOI_TP_ FoSTaC pdf)

12 Oct 2020: The order on “Requirement of Non GM cum GM free certificate to accompany imported food consignments-reg” is presently applicable only to food crops mentioned in annexure I of the order and not to processed products in general. Comments received from different countries will be studied before order comes into effect. (Clarification_GM_Food pdf)


Leave a Reply

Your email address will not be published. Required fields are marked *

Quick Enquiry Top

Your Name

Your Email

Your Phone Number

Your City

Name of the Organization

Select Category

Select Services

Select Services

Select Services

Additional Comments