Introduction
The Indian government has initiated a significant review to determine whether nutraceuticals should be regulated under the Central Drugs Standard Control Organisation (CDSCO) instead of the Food Safety and Standards Authority of India (FSSAI). This move addresses various regulatory challenges and enhances consumer safety in the rapidly growing nutraceutical market.
Current Regulatory Framework
The FSSAI regulates health supplements and nutraceuticals under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Foods) Regulations, 2022. These regulations cover food items specifically processed or formulated for particular nutritional or dietary purposes.
Nutraceuticals, derived from food sources, are believed to offer additional health benefits beyond basic nutrition. However, the current framework has faced challenges in implementation and enforcement, leading to the establishment of a high-level committee to review the situation.
Challenges in Regulation
Several issues have been identified in the current regulatory environment:
- Uniform Implementation and Enforcement: There are difficulties in uniformly implementing and enforcing regulations across the board.
- Interchangeable Usage: The same nutrients or ingredients are used in different doses for both pharmaceutical and nutraceutical purposes, leading to overlaps in prophylactic and therapeutic usage, as well as disease risk reduction claims.
- Unclear Demarcation: Due to unclear boundaries between drugs and nutraceuticals, many companies have shifted from CDSCO to FSSAI for ingredient approval, especially for items like melatonin and zinc carnosine.
- Lack of Mandatory Medical Supervision: Products covered under nutraceutical regulations do not require mandatory medical supervision, which can lead to prolonged and potentially harmful consumption.
- Interaction with Drugs: Unsupervised use of supplements alongside drugs can cause adverse health effects due to potential interactions.
- Over-the-Counter Availability: The easy availability of health supplements raises the risk of consuming multiple nutrients that might counteract each other, such as calcium affecting iron absorption.
Formation of the Review Committee
To address these challenges, a high-level committee has been formed under the chairmanship of the Secretary, the Ministry of Health. The committee includes:
- Secretary, Ministry of Ayush
- Secretary, Ministry of Food Processing Industries
- Secretary, Department of Pharmaceuticals
- Chief Executive Officer (CEO), FSSAI
- Drugs Controller General of India
- Director General, Indian Council of Medical Research
- Director General of Health Services (DGHS)
Objectives of the Committee
The committee will explore several key areas to enhance the regulation of nutraceuticals:
- Feasibility of Regulation: Assess the feasibility of regulating probiotics and prebiotics in both food and drug formats.
- Integration with CDSCO: Examine the need and possibility of bringing nutraceuticals and health supplements under the ambit of CDSCO.
- Price Control: Explore the feasibility of implementing price controls for nutraceutical products.
- Good Manufacturing Practices (GMP): Consider aligning GMP provisions and certification for nutraceuticals with Schedule M of drug regulations.
The Growing Nutraceutical Market
The nutraceutical market in India is projected to grow significantly, reaching an estimated USD 18 billion by 2025, up from USD 4 billion in 2020. This rapid growth underscores the need for a robust regulatory framework to ensure consumer safety and product efficacy.
Conclusion
The formation of a high-level committee to review the regulatory oversight of nutraceuticals marks a critical step toward addressing existing challenges and promoting consumer safety. By potentially bringing nutraceuticals under the CDSCO, the government aims to ensure more stringent regulation, better enforcement, and enhanced safety for consumers. As the nutraceutical market continues to expand, these regulatory measures will be vital in maintaining the integrity and trustworthiness of health supplements and nutraceutical products in India.
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