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Clarity for nutra as panel suggests amendment
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Tuesday, 26 November, 2024, 08 : 00 AM [IST]
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Dr Sanjay Agrawal
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The nutraceuticals industry in India is on the cusp of transformative regulatory changes. An Inter-Ministerial Committee formed under the Union Health Ministry has proposed amendments to the Food Safety and Standards Act, 2006 (FSS Act), and related regulations to address the growing complexities in the segment. With nutraceuticals bridging the gap between food and medicine, the committee’s recommendations aim to bring clarity, ensure consumer safety, and bolster the sector's compliance standards.
The Need for Regulatory Clarity
Nutraceuticals, which include dietary supplements, functional foods, and other health products, have grown significantly in popularity due to increased consumer awareness about health and wellness. However, this growth has exposed gaps in regulatory oversight.
In India, the FSSAI has been the primary authority overseeing health supplements and nutraceuticals since its establishment in 2008. However, overlaps with the Drugs and Cosmetics Act, 1940, have caused confusion. For instance, certain vitamin formulations fall under both the FSS Act and the Drugs and Cosmetics Act based on dosage and claims, allowing manufacturers to sidestep stricter drug regulations by marketing their products as food supplements.
To address these issues, the Union Health Ministry formed the Inter-Ministerial Committee under the chairmanship of former Health Secretary Apurva Chandra. The committee's objective was to examine the regulatory challenges in the segment and provide actionable recommendations.
Key Recommendations of the Committee
The committee’s proposals encompass various aspects of nutraceutical regulation, aiming to ensure a robust framework that protects consumers while fostering industry growth.
1. Dual Regulatory Oversight
One of the most significant recommendations is the clear demarcation of responsibilities between FSSAI and CDSCO:
FSSAI’s Role:
FSSAI will continue to regulate food-based products, such as vitamins, minerals and amino acids added to foods (e.g., protein bars or beverages). These products must meet the macronutrient requirements defined in the FSS Act.
CDSCO’s Role:
Formulations with therapeutic doses, dosage forms (e.g., tablets or capsules), or excipients will fall under CDSCO's jurisdiction.
This separation aims to reduce the overlap that currently exists between the two Acts, ensuring more consistent enforcement.
2. Regulation of Claims
Claims made by manufacturers have been a contentious issue, with many products making exaggerated or misleading statements. The committee has proposed:
Disease Risk Reduction (DRR) Claims:
These claims, which relate to curing or mitigating diseases, should be regulated exclusively by CDSCO. FSSAI will focus solely on nutritional and general health claims listed under the FSS (Claims and Advertisements) Regulations, 2018.
Label Submission:
Manufacturers must submit product labels, including claims, at the time of licensing to ensure transparency and accountability.
This measure aims to curb the misuse of DRR claims and enhance consumer trust in the products they purchase.
3. Introduction of Good Manufacturing Practices (GMP)
To ensure product safety and quality, the committee has recommended introducing GMP requirements specifically for health supplements and nutraceuticals under the FSS (Licensing and Registration of Food Businesses) Regulations, 2011. These standards will align with global best practices, fostering confidence among domestic and international stakeholders.
4. Specialised Regulation for Certain Categories
The committee has also provided detailed guidance on specific product categories:
- Food for Special Medical Purpose (FSMP): FSMP will continue to be regulated by FSSAI, addressing conditions such as diabetes, high blood pressure, and sleep management.
- Food for Special Dietary Uses (FSDU): FSDU will cater to weight management, geriatric populations, pregnant and lactating women, and sportspersons.
- Probiotics and Prebiotics: Food products containing added prebiotics and probiotics will remain under FSSAI. However, pure prebiotic cultures or probiotic formulations in dosage form will shift to CDSCO.
5. Botanicals and Ayush Products - The recommendations include a framework for products containing botanicals, plant extracts, or molecules:
- Products making DRR claims will fall under the purview of the Ministry of Ayush.
- Non-DRR botanical products will remain regulated by FSSAI.
This distinction ensures that traditional systems of medicine and nutraceuticals are regulated appropriately.
Consumer-Centric Measures
The recommendations emphasise consumer protection by:
- Mandating risk-based assessments of safety and efficacy for FSMP and FSDU products.
- Establishing a dedicated cell within FSSAI to monitor nutraceutical advertisements, preventing false or misleading claims.
These measures aim to empower consumers with accurate information and ensure that products meet high safety and quality standards.
Addressing the Regulatory Overlap
One of the critical challenges identified by the committee is the overlap between the FSS Act and the Drugs and Cosmetics Act. For example:
- Vitamin formulations defined for prophylactic doses (up to one Recommended Dietary Allowance or RDA) are currently regulated under the FSS Act.
- Preparations with therapeutic claims or higher doses fall under the Drugs and Cosmetics Act.
This overlap has led some manufacturers to market therapeutic products as food supplements to avoid the rigorous drug regulatory regime. By clearly distinguishing between food and drug categories, the proposed amendments aim to eliminate such loopholes.
Implications for the Industry
The recommendations have far-reaching implications for India’s nutraceutical industry, which is one of the fastest-growing segments in the wellness sector. Key benefits include:
- Clarity for Manufacturers: Clear demarcation of regulatory responsibilities will reduce compliance ambiguity, enabling businesses to operate more effectively.
- Enhanced Product Quality: The introduction of GMP and stricter oversight of claims will improve product quality, building trust among consumers and international markets.
- Encouragement of Innovation: A streamlined regulatory framework will encourage innovation, particularly in categories such as FSMP and FSDU, where specialised products are in high demand.
A Global Perspective
The committee also reviewed international regulations to ensure that India aligns with global best practices. For instance, many countries have distinct regulatory frameworks for dietary supplements and therapeutic products, which India is now striving to emulate.
Challenges Ahead
While the recommendations are a significant step forward, their implementation may pose challenges, including:
- Coordination between multiple regulatory authorities such as FSSAI, CDSCO, and the Ministry of Ayush.
- Ensuring compliance across a fragmented industry with many small- and medium-sized players.
- Educating manufacturers and consumers about the new regulations and their implications.
A Step Toward Clarity
As the industry evolves, these amendments aim to eliminate gray areas, paving the way for innovation and growth while protecting consumer interests. Whether it’s aligning dosage limits with therapeutic claims or defining regulatory oversight more distinctly, this move is set to transform how nutraceuticals are manufactured, marketed, and consumed in India.
The ball is now in the government’s court to implement these recommendations, which promise to elevate standards in one of the fastest-growing segments of the wellness industry.
(The author is a leading pharmaceutical consultant)
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