June 21, 2025

India’s nutraceutical sector is experiencing a regulatory transformation as the Central Drugs Standard Control Organization (CDSCO) prepares to take on a greater role in overseeing product registration, safety, and claims. With the nutraceutical market projected to reach $18 billion by the end of 2025, these changes are set to impact manufacturers, importers, and marketers across the country.

Key Regulatory Updates (2024–2025)

1. Shift of Regulatory Oversight
A government-appointed panel has recommended that many nutraceuticals, especially those containing vitamins, minerals, amino acids, probiotics, and botanicals in higher doses or pharmaceutical-like formats, be regulated by CDSCO rather than the Food Safety and Standards Authority of India (FSSAI). This aims to address concerns about unclear demarcation, product safety, and misleading health claims.

2. Stricter Product Claims and Labeling
CDSCO will regulate claims related to disease risk reduction, cure, or mitigation, while FSSAI will continue to oversee general nutritional and health claims. All product labels and claims must be submitted for review, and stricter advertising rules will apply to prevent exaggerated or false claims.

3. Good Manufacturing Practices (GMP) and Surveillance
The proposed changes will introduce GMP requirements for nutraceuticals, aligning them with pharmaceutical standards for quality and safety. Ongoing post-market surveillance and stricter compliance checks are also expected.

4. Digital Registration and Documentation
Applicants will need to submit detailed dossiers, including ingredient lists, safety data, and claims substantiation, through CDSCO’s online portal. This digital-first approach is designed to streamline approvals and improve traceability.

Compliance Checklist for Nutraceutical Applicants

  • Prepare comprehensive documentation (ingredient details, safety data, claims evidence)
  • Ensure labels and promotional materials comply with updated CDSCO and FSSAI rules
  • Align manufacturing facilities with GMP requirements
  • Monitor post-market safety and be ready for regulatory audits

How Maven Can Support Your Nutraceutical Registration

Maven Regulatory Solutions offers end-to-end support for nutraceutical companies navigating these new requirements:

  • Regulatory Strategy: Guidance on whether your products fall under CDSCO or FSSAI, and how to structure your applications
  • Dossier Preparation: Compilation and review of all technical documents and claims evidence
  • Digital Submission: Management of online applications and communication with CDSCO
  • Labeling and Claims Review: Ensuring all marketing materials meet the latest standards
  • Post-Market Surveillance: Ongoing compliance monitoring and audit support

Conclusion

As India tightens its nutraceutical regulations and shifts oversight to CDSCO for many products, companies must adapt quickly to ensure compliance and maintain market access. Maven’s regulatory experts can help you navigate this evolving landscape with confidence, from strategy to successful product registration.