The Government of India recently announced setting up a specialized Centre of Excellence (CoE) focused on testing and surveillance of nutritional supplements and nutraceuticals. Headquartered in National Capital Region, the state-of-the-art centre will function as an autonomous scientific body to implement stringent quality regulations and compliance monitoring for the rapidly growing nutraceutical industry in India.
Overview of Nutraceuticals Market in India
The nutraceuticals sector comprising functional foods and dietary supplements is currently valued at over $4 billion in India with an annual growth rate of 17%-18%. This exponential expansion has raised concerns around quality standards and safety of nutraceutical products lacking scientific substantiation of health claims.
Regulation Challenges
While the Food Safety Standards Authority of India (FSSAI) has issued quality standards for health supplements, lack of enforcement and surveillance has led to proliferation of spurious products. The absence of mandatory testing protocols also allows exaggerated health benefit claims without accountability.
Key Objectives of Nutraceutical CoE
Stringent testing protocols
- Define quality standards for domestic & imported supplements
- Mandatory batch-wise quality testing
- Oversight on GMP through manufacturing facility audits
Surveillance of products
- Rigorous product audits through supply chain sampling
- Screen substandard products making false claims
- Prosecute violative manufacturers manipulating content
Enforce label claim regulations
- Verify health benefit and nutrient content claims
- Clinical substantiation mandatory for therapeutic indications
- Control exaggeration and manipulation of label information
Capacity building and R&D
- Train quality managers on regulatory protocols
- Guidance to innovators to validate product efficacy
- Original research to develop testing methodologies
- Knowledge sharing through public databases and publications
Infrastructure and Testing Facilities
- 40,000 sq ft state-of-the-art testing complex
High-end control labs
- Microbiology labs (BSL-2 grade) for pathogen testing
- Analytical labs with advanced chromatography (HPLC, GC, ICPMS) and spectrometry platforms (LC-MS/MS, NMR, FTIR)
Genomic and bioanalytical platforms
- Next generation genomic sequencing
- High-throughput bioassays for screening
- Cell culture laboratories
- Animal research facility for pre-clinical studies
Databases and software
- LIMS, ELN and MDC software
- Data analytics and statistical applications
- AI-based platforms for predictive modeling
R&D Laboratories
- Method development and validation
- Reference standards generation
- Emerging technologies research including omics
Additional Facilities
- GLP-certified facilities
- Stability testing chambers
- Logistics for nation-wide sample transport
- Air-tight contaminated sample disposal
The advanced testing and research infrastructure will enable comprehensive, evidence-based quality assurance and innovation support for nutraceuticals regulation in India.
Coverage of Supplement Categories
In the initial phase, the nutraceutical CoE will focus testing on the following major product segments:
- Vitamins, minerals and nutraceutical commodities
- Amino acids, proteins, plant extracts
- Probiotics, prebiotics and omega fatty acids
- Herbal preparations like turmeric, ashwagandha etc
- Other popular supplements like glucosamine, melatonin etc
Surveillance Across Distribution Channels
Sampling protocols
- Import consignments
- Random batch sampling at all ports
- Test each category supplements annually
- Domestic manufacturers
- Annual testing from all licensed manufacturers
- Additional sampling if non-compliant history
- Retail outlets and e-commerce
- Round-the-year nationwide sampling plan
- Test suspect products flagged by consumers
Screening details
- Microbiological hygiene and shelf-life
- Chemical – authenticity of ingredients
- Genomic – species validation
- Efficacy – claims substantiation
Violation follow-up
- Notice to manufacturer with test reports
- Mandatory quality improvement if deviations
- Financial penalty and prosecution for fraud
- Product recall from markets
- Blacklisting repeat offenders
The extensive surveillance mechanisms will deter manufacturers from quality violations in contents and label claims across distribution channels for nutraceuticals.
Partnerships for Shared Regulations
As a national body, the CoE will collaborate with other government institutes, industry and international organizations in areas such as:
- Joint research on emerging ingredients and test methods
- Database of validated claims and clinical studies
- Technical capacity building of supplement manufacturers
- Exchange of surveillance data with global regulatory partners
The public-private partnerships will foster innovation in product development aligned to global quality compliance for “Make in India” nutraceuticals.