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Laxmi Yadav, Mumbai June 21 , 2022
The Indian Drug Manufacturers’ Association (IDMA) has urged Food Safety and Standards Authority of India (FSSAI) to delink license granted from Food Safety Compliance System (FoSCoS) from product details submission.
 
It will fast-track FoSCoS license grant, thus facilitating ease of doing business for Food Business Operators (FBOs) manufacturing and selling health supplements, nutraceuticals, and food for special medical purposes, stated the industry body.
 
IDMA has recently submitted a representation to Arun Singhal, CEO, FSSAI as well as its chairperson Rajesh Bhushan appealing them to take steps to delink FoSCoS license grant from the submission of individual product-related details.
 
FSSAI launched FoSCo on June 1, 2020 replacing the Food Licensing & Registration System (FLRS), which was launched in 2012 for issuance of pan-India FSSAI licenses and registration. The prime objective of FoSCoS is to enhance the user performance of the application, and make the required data submission process effective and simple in an effort to promote ease of doing business amongst the FBOs.
 
On the basis of one particular objective listed by FoSCoS Guidance Document, March 2020: ‘Achieve and enable the application to have standardized product approach rather than text box approach for manufacturers’ the FSSAI has enabled collection of product details, including complete composition, even of excipients, of marketed products as a pre-condition for issuing a FoSCoS license.
 
As per the guidance document, the complete product information regarding composition, excipients and their quantities are needed to be specified.
 
This is not only an impractical requirement but proving to be a bottleneck in grant of FSSAI central license. FBOs have painstakingly developed their own ‘proprietary’ blend which has potential to become public and hence a potential breach of the Intellectual Property (IP) rights, said Dr RK Sanghavi, chairman – Nutraceutical Committee, IDMA.
 
The guidance document further says the product information being provided should be identically matching (mirrored) in applications done by the marketeer as well as the manufacturer.
 
Taking exception to this, Dr Sanghavi said “For applicants of FoSCoS licenses this has become a bottleneck and grant of licenses are being withheld for both manufacturers as well as marketeers for no fault of theirs and resulting in huge financial losses for these FBOs.
 
It says marketeers of products under FSS (Nutra) Regulations need to upload details such as licenses, etc. of the manufacturers. “This is becoming a huge exercise since many large sized companies outsource their products from various manufacturers and even change the latter at any point of time for the same product,” he added.
 
The FBOs have been receiving queries in piecemeal rather than a one-time query to resolve all conflicts in application done for grant of FoSCoS license. They are at their wits end with repeat communications from FSSAI regarding details appearing in the license applied. Also, most of the queries are related to deficiencies and clarifications being addressed regarding the listed products whilst applying for FoSCoS license, he stated.
 
When a license has been granted and the manufacturer FBO intends to launch a new product, the modification is required to update details for which fees are additionally charged each time.
 
The concerned FSSAI officials on receiving applications for license modification for product addition start examining even the previously listed products already featuring in the system and re-start a cumbersome series of queries for approving the modification – on matters of nil relevance for which the application has been made. The FBOs are being forced to employ a full-time team to keep on applying for license modification and solving even queries raised regarding previously submitted and accepted data, said chairman of Nutraceutical Committee, IDMA.
 
An averagely operational manufacturing FBO could be churning out 1-2 products per fortnight if not more often, or more frequent. This could entail endless and time-consuming license modifications – possibly – every month, mandated under the new regime of FoSCoS license grant and with all the accompanying hiccups as elaborated above, he stated.
 
“Grant of license need not be confused with developing or marketing of products’ appropriateness. There are already set regulations in place to ensure the same and the Enforcement Department within the FSSAI is suitably empowered to haul up the errant FBOs in this respect. The FoSCoS licensing should be de-linked from product details submission. Such a practice is not even prevalent within the drug industry wherein the licensing is separate and has no direct linking to products permitted for manufacturing and/or marketing. If it is the intent of FSSAI to collect and collate data on available products in the country, the same can be done via another mechanism or platform. For ensuring ease of business for FBOs, fast-tracking of FoSCoS license grant is one of the mantras and it requires FoSCoS licensing to be de-linked from the submission of individual product-related details,” said Dr Viranchi Shah, national president, IDMA.

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