Regulatory Guide to Nutraceuticals in India: FSSAI vs CDSCO

In 2022, a startup launched a plant-based supplement claiming to treat hormonal imbalances. Within months, it was pulled off shelves by FSSAI for misleading claims. The founders were shocked. “We thought it was just a wellness product,” they argued.

Welcome to the evolving world of nutraceutical regulation in India, where supplements often straddle the blurry line between food and medicine.

As demand grows, so does the need for a framework that ensures both consumer safety and product credibility. This article decodes how India regulates nutraceuticals, the role of FSSAI and CDSCO, and what the future may hold for this high-growth category.

The Regulatory Bodies: Who Governs What?

FSSAI (Food Safety and Standards Authority of India)

• Governs nutraceuticals under the Food Safety and Standards Act, 2006
• Defines categories: health supplements, nutraceuticals, functional foods, foods for special dietary use (FSDU), and medical purposes (FSMP)
• Key regulation: FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use) Regulations, 2022

FSSAI ensures that products:

• Contain approved ingredients
• Follow dosage limits
• Avoid therapeutic claims (e.g., "cures," "treats")
• Include accurate labeling and safety info

CDSCO (Central Drugs Standard Control Organization)

• India's national drug regulator
• Governs pharmaceuticals under the Drugs and Cosmetics Act, 1940
• Currently does not regulate most nutraceuticals, unless they resemble or cross into the territory of drugs

But that may change. High-potency or therapeutic-looking products may soon fall under CDSCO’s purview.

What Defines a Nutraceutical in India?

FSSAI classifies nutraceuticals as:

• Food-based products
• Intended to supplement the diet
• Not to treat or prevent diseases
• Can include vitamins, minerals, botanicals, amino acids, or bioactive substances

If a product includes high doses or makes medical claims, it risks being classified as a drug—thus triggering CDSCO involvement.

Table: FSSAI vs CDSCO - Key Differences

Criteria

FSSAI

CDSCO

Governing Law

Food Safety and Standards Act, 2006

Drugs & Cosmetics Act, 1940

Product Type

Food supplements

Medicines, biologics, APIs

Approval Required

No pre-market approval (self-regulated)

Yes, clinical trials & registration

Claims Allowed

Structure/function only ("supports")

Therapeutic ("treats," "prevents")

Facility Standards

Food-grade GMP

Pharma-grade GMP

Labeling

Nutrient content, disclaimers

Prescription info, side effects, etc.

Recent Developments in India

• 2024: A government task force recommended high-potency or borderline products (e.g., hormone support supplements, joint health blends) be reviewed under CDSCO guidelines
• e-Commerce scrutiny: Online platforms like Amazon and Flipkart are under pressure to remove unapproved Nutra products
• Rise in legal notices for misleading claims and non-compliance with ingredient limits

What Indian Brands Must Keep in Mind

• Follow FSSAI's approved list of ingredients and their dosage limits
• Avoid medical claims (words like "treats," "heals," or "cures")
• Conduct stability and shelf-life studies
• Use third-party labs for batch testing
• Maintain documentation for traceability

Many export-focused Indian nutraceutical brands are voluntarily aligning with US-FDA, EFSA, or TGA norms to ensure global market access.

When Does CDSCO Get Involved?

A product may attract CDSCO regulation if it:

• Has high-potency ingredients beyond FSSAI limits (e.g., Vitamin D3 > 1000 IU)
• Uses pharma-grade excipients or delivery systems (e.g., transdermal patches)
• Is sold through doctors or branded like a drug
• Makes explicit therapeutic claims

In such cases, the product may require:

• Clinical trials
• Drug license (Form 25 or 28)
• Labeling revisions

Future Outlook: Toward Harmonized Regulation

India’s Nutra space is poised for reform. We can expect:

• Stricter borderlines between food and drug categories
• New hybrid categories like "nutraceutical-drugs"
• Pre-market registration for high-risk formulations
• Unified digital portals for FSSAI/CDSCO coordination

This may raise entry barriers, but will also build consumer trust and enable medical adoption.

Conclusion: A Sector Growing Up Fast

The Indian nutraceutical industry is projected to cross $18 billion by 2030. But rapid growth needs responsible regulation.

FSSAI has laid a solid foundation. Now, CDSCO is stepping in to handle edge cases. For brands and consumers alike, this dual-regulation ecosystem offers both opportunity and responsibility.

Whether you’re formulating a probiotic capsule or launching a liver detox blend, one thing is clear: regulation is no longer a side note. It’s part of the brand promise.

SEO-Optimized FAQs

Q1. Who regulates nutraceuticals in India?

FSSAI regulates most nutraceuticals. CDSCO may intervene if the product resembles a drug in potency or claims.

Q2. What is the main difference between FSSAI and CDSCO?

FSSAI governs food and supplement safety; CDSCO regulates pharmaceutical drugs and requires clinical trials.

Q3. Can nutraceuticals make medical claims in India?

No. They can only make structure-function claims like "supports immunity" but not "treats flu."

Q4. Are nutraceuticals in India pre-approved before sale?

No. Most are self-regulated under FSSAI guidelines, but documentation and batch testing are required.

Q5. What happens if a supplement crosses dosage limits?

It may be reclassified as a drug and require CDSCO approval, trials, and licensing.