Sanjeev Jain, Joint Managing Director, Akums Drugs & Pharmaceuticals Ltd
India’s nutraceuticals market has been on an impressive growth trajectory, with an average annual growth rate of 21 per cent over the past five years. This market surge, fueled by a rising awareness of health and wellness, presents an opportune moment for the Food Safety and Standards Authority of India (FSSAI) to take the reins and steer the industry toward a more prosperous future. With the ambitious goal of reaching a market valuation of $18.2 billion by 2030, the FSSAI has formulated a robust 10-point agenda for the next decade.
Enhancing Awareness and Training for Food Business Operators (FBOs)
Marketers and Wholesalers:
All Food Business Operators, including marketers and wholesalers, must be well-informed about the latest regulations introduced by the FSSAI. To address the lack of awareness among these entities, specialised training and awareness initiatives tailored to their specific needs should be organised. This will ensure that they are up-to-date with the evolving guidelines and are equipped to maintain high food safety and hygiene standards.
Manufacturers:
FBOs that operate as manufacturers are a critical part of the nutraceuticals market. The FSSAI must expedite the formalisation of draft regulations related to the industry. By involving insights from manufacturers, the finalised regulations can be more comprehensive and aligned with industry needs, while still upholding safety and quality standards.
Resolving Animal Feed Supplement Regulations
The regulations concerning Animal Feed Supplements are currently in a provisional state. The FSSAI needs to work on finalising these regulations, assessing their feasibility within the framework of the Food Safety and Standards Act (FSS Act). This move will ensure that the regulations are well-defined and comprehensive, enhancing safety standards for animal feed products.
Transparency in Ingredient Exclusions
The FSSAI should enhance its transparency when excluding ingredients from its list of approved components. Circulars explaining the rationale behind these exclusions should be issued to provide clarity to FBOs. This practice will ensure that stakeholders are well-informed about changes, and it will promote better compliance with the regulations.
Inclusion of Silicon Dioxide in Manufacturing
Silicon Dioxide, Amorphous (INS 551 / E 551), plays a crucial role in tablet manufacturing. Despite its approval in the EU framework and its usage in various formats, including tablets, capsules, and solutions, it is not included in the list of approved additives for Health Supplements, Nutraceuticals, Prebiotics, and Probiotics in India.
Clarification on Permitted Ingredient Ranges
While the permitted range of ingredients specified in Schedule-II & III (A) of FSSAI Nutra Regulations 2022 is crucial, it poses challenges for formulations containing multiple components. Maintaining strict adherence to permitted ranges for each individual ingredient can be complex. FSSAI should consider a practical approach where strict adherence to permissible ranges is reserved for single-ingredient formulations, recognising the complexities of multi-ingredient products.
FOSCOS Portal Enhancement
The FOSCOS Portal, which manages product endorsement applications, should be revamped to enable simultaneous endorsement of multiple modifications. This will improve efficiency and reduce delays in the approval process. Additionally, the FSSAI should introduce a systematic serialisation process that maintains consistency in serial numbers throughout the modification process, ensuring better record-keeping and traceability.
Comprehensive Stakeholder Training
A significant number of Food Business Operators lack complete awareness of FSSAI regulations, leading to discrepancies between industry practices and regulatory expectations. FSSAI should prioritise educational initiatives to bridge this gap, encouraging stakeholders to fully embrace and adhere to the latest regulations. This commitment will contribute to the overall safety and standards of the nutraceuticals market.
Conclusion
The FSSAI’s proactive and strategic approach over the next decade can significantly contribute to the growth and development of India’s nutraceuticals market. By addressing challenges, enhancing transparency, and promoting education, FSSAI will create an environment conducive to the production of high-quality, safe, and effective nutraceutical products, benefiting both consumers and the industry alike.