Last Updated on January 26, 2024 by The Health Master
The healthcare industry, mostly engaged in manufacturing & marketing of nutraceuticals, has expressed concern over the Food Safety and Standards Authority of India (FSSAI)’s notification designating marketeers as relabellers, akin to re-packers, whilst directing them to procure a central FSSAI license or migrate from their already possessed state license to central license.
FSSAI came out with a circular on June 16, 2021 and thereafter on September 16, 2021 making it mandatory for manufacturers of health supplements, nutraceuticals, food for special dietary use, food for special medical purposes, functional foods, and novel food covered under Food Safety and Standards (FSS) Regulations, 2016 to modify/migrate from state license to central license by December 31, 2021, which was on December 17, 2021 extended to March 31, 2022.
Those who do not get their license modified/migrated by then, shall not be able to apply for renewal of license, said the circular.
In May 2020, the FSSAI had issued the order for modification of the licenses due to migration of the existing Food License and Registration System (FLRS) to Food Safety and Compliance System (FoSCoS) and the last date for the modification was fixed for December 31, 2021 which was subsequently extended till March 31, 2022.
Under the FLRS, the manufacturer applicant types the name of the product to be manufactured in the text box provided while in the FoSCoS the manufacturers will have to select a standardized product only out of the list provided on the licensing platform.
The FSS Act, 2006 governs the manufacture and sale of health supplements, nutraceuticals, and food for special medical purposes.
Taking exception to the FSSAI’s order designating marketeers as relabellers, Dr R K Sanghavi, chairman, Nutraceutical Committee, Indian Drug Manufacturers’ Association (IDMA) said “Marketeers are actively involved in product development.
Hence, “Re-designating marketers as relabellers would tantamount to disregarding their contribution to the product’s availability in terms of conceptualization, facilitating identifying of critical raw materials and supervising development and processing of the product.”
Dr Sanghavi also expressed concern over linking products manufactured and marketed with procuring of licenses. He said since FSSAI has already listed a number of products including nutraceuticals, functional food and food for medical purpose along with their ingredients there is no need to provide a list of products by Food Business Operators (FBOs) whilst manufacturing and marketing licenses. Even in the drug industry the licensing of manufacturers and marketeers is not linked to products in the Company’s portfolio, opined Dr Sanghavi.
Ganesh Kamath of Vital Neutraceuticals also appealed to FSSAI to delink product listing with licensing. According to the concerns voiced by Kamath the product related Intellectual Property will be at stake in view of such an elaborate list of products along with excipients, etc.
If such a scenario does become prevalent then the onus of exact mimicking of products by competitors could be on FSSAI. Measures must be taken by it to plug data leakage strictly.
Clarification from FSSAI was sought on the requirement of a central license for distribution channels – depots, warehouses, etc.
With a growing health consciousness and the rising disposable income of the people in the country, there has been an ever-increasing demand for health supplements and nutraceuticals.
The credit for this also goes to the nutritionists and dieticians and even the doctors who are advising nutraceutical products especially after the Covid-19 pandemic hit a large section of the population. The country’s nutraceutical market is expected to touch USD 18 billion by the end of 2025.
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