Abstract

ANALYTICAL EVALUATION, LABEL CLAIM VERIFICATION, AND REGULATORY COMPLIANCE OF SELECTED NUTRACEUTICALS IN INDIA: A REVIEW

Reetapa Chandra*, Neeraj Shrivastava, Kirti Solanki, Swati Kumari Gupta, Prabha Chauhan, Pankaj Ladwal, Vinod Kumar Gupta

Abstract

Concerns about product quality, label accuracy, and regulatory compliance have been raised by the nutraceutical market’s explosive growth in India. Nutraceuticals with probiotics, calcium, omega-3 fatty acids, vitamins (A, B-complex, C, and D), and other nutrients are frequently taken for both therapeutic and preventive purposes. However, in both Indian and foreign markets, disparities between label claims and actual content have been widely documented. The regulatory frameworks governing nutraceutical regulations in India, specifically those under the Food Safety and Standards Authority of India (FSSAI), are critically assessed in this review and compared to international norms. HPLC, spectrophotometry, titrimetry, ICPMS, gas chromatography, and microbiological enumeration are among the analytical techniques used for active ingredient quantification and verification. Probiotic viability evaluation and omega-3 oxidative stability, two important quality factors frequently linked to product non-compliance, are given particular attention. The review identifies gaps in post- marketing surveillance, analytical standardization, and enforcement in India and suggests ways to improve laboratory validation and regulatory harmonization. Maintaining industry credibility and safeguarding consumer health depend on accurate label declarations and adherence to FSSAI limits.

Keywords: Regulatory compliance, label claim, nutraceutical regulation, FSSAI, Analytical methodologies.