Exploring Regulatory Shifts: Nutraceuticals and the Role of CDSCO

Nutraceuticals, derived from food sources, are believed to offer additional health benefits beyond basic nutritional value

The Health Master

February 20, 2024

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Last Updated on March 2, 2024 by The Health Master

Nutraceuticals

In recent developments, the Indian government has initiated discussions regarding the potential transfer of regulatory authority for nutraceuticals from the Food Safety and Standards Authority of India (FSSAI) to the Central Drugs Standard Control Organisation (CDSCO).

This move aims to address regulatory challenges and enhance consumer safety in the rapidly growing nutraceutical market.

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Understanding the Current Regulatory Landscape

Under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022, FSSAI currently oversees the regulation of health supplements and nutraceuticals.

These regulations encompass specially processed or formulated food items designed for specific nutritional or dietary purposes.

Defining Nutraceuticals

Nutraceuticals, derived from food sources, are believed to offer additional health benefits beyond basic nutritional value.

As the market for these products in India is projected to reach USD 18 billion by 2025, the government is taking proactive measures to ensure effective regulation.

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Challenges in the Current Regulatory Framework

During a recent meeting with CDSCO officials, challenges in the uniform implementation and enforcement of regulations were discussed.

Issues such as interchangeable usage of the same nutrient/ingredient at different doses for pharmaceutical and nutraceutical purposes, overlap in prophylactic and therapeutic usage, and claims related to disease risk reduction were identified as key concerns.

Formation of a High-Level Committee

To address these challenges, a high-level committee has been constituted under the chairmanship of the Secretary, Ministry of Health.

The committee comprises members from various departments, including:

Ministry of Ayush,
Ministry of Food Processing Industries,
Department of Pharmaceuticals,
CEO of FSSAI,
Drugs Controller General of India,
Director General of the Indian Council of Medical Research, and
Director General of Health Services.

Rising Concerns in the Nutraceutical Market

Officials noted instances where health supplements with therapeutic applications, such as probiotics, vitamins, minerals, and botanicals, faced unclear demarcation between CDSCO and FSSAI approval.

This ambiguity led several companies to shift from CDSCO to FSSAI for the approval of ingredients akin to drugs, like melatonin and zinc carnosine.

Safety Implications and Consumer Awareness

The lack of mandatory medical supervision for products covered under nutraceutical regulations raised concerns about potential harm due to prolonged or excessive consumption.

Unsupervised usage could lead to simultaneous intake of supplements and medications, resulting in possible adverse effects on consumer health.

Committee’s Mandate and Focus Areas

The newly formed committee aims to identify the feasibility of regulating probiotic/prebiotic in both food and drug formats.

Additionally, it will assess the need and potential for bringing nutraceuticals and health supplements under the ambit of CDSCO.

Exploring the feasibility of price control, GMP provisions, and certification for nutraceuticals aligning with schedule M of drugs are also on the committee’s agenda.

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