A high-level interministerial panel has proposed regulating health supplements like vitamins, minerals, and prebiotic and probiotic formulations as pharmaceutical products.
The measure aims to enhance due diligence before approval and maintain stricter control over production quality and pricing.
Dual Regulatory Roles Suggested
The panel suggests dividing regulatory responsibilities between two authorities.
While the Food Safety and Standards Authority of India (FSSAI) should oversee nutritional and health claims made by nutraceuticals, the Central Drugs Standard Control Organisation (CDSCO) should regulate claims related to curing or mitigating specific diseases, disorders, or conditions.
Report Submitted by Expert Committee
Constituted in January 2023 and led by former Union health secretary Apurva Chandra, the
eight-member committee submitted its findings to the government earlier this month. The report was formulated to address overlapping regulatory issues between drugs and nutraceuticals.
Addressing Regulatory Challenges
The report highlights the need for clarity due to challenges such as inconsistent enforcement and the interchangeable use of nutrients or ingredients in different doses for pharmaceutical and nutraceutical purposes.
It also points to overlaps in the prophylactic and therapeutic use of these products and disease risk reduction claims.
Defining Nutraceuticals
Health supplements as defined in the report, include products containing bioactive substances, , herbs, minerals, or dietary supplements with therapeutic properties.
Common examples are probiotics, health drinks, antioxidants, vitamins, minerals, and amino acids.
Global Aspirations
India’s nutraceuticals market, valued at $4-5 billion in 2020, is projected to grow significantly to over $18 billion by 2025.
The report notes that in 2017, India held only 2% of the global nutraceutical market share, which rose substantially by 2019.
By the end of 2023, estimates suggest the country could account for at least 3.5% of the global market.
Way Forward
As reported by theprint.in, the panel’s recommendations aim to streamline regulatory frameworks and position India as a leader in the rapidly expanding nutraceutical sector, ensuring consumer safety and fostering market growth.
