What Licenses Are Required to Manufacture and Sell Nutraceuticals in India?

The nutraceutical industry in India is growing rapidly. More people are using supplements for immunity, digestion, energy, heart health, and overall wellness. Because nutraceuticals are consumed daily and often without prescriptions, the government has created clear rules to ensure product safety, quality, and truthful labeling.

If you are planning to manufacture, market, or sell nutraceutical products in India, understanding the required licenses is very important. Without proper approval, products can be banned, recalled, or penalized. This blog explains all the key licenses and registrations needed for nutraceuticals in simple language.

What Are Nutraceuticals as Per Indian Regulations?

Nutraceuticals are products derived from food sources that provide health benefits beyond basic nutrition. These may include vitamins, minerals, amino acids, probiotics, herbal extracts, and functional ingredients.

In India, nutraceuticals are regulated as food products, not as drugs. They fall under the Food Safety and Standards Authority of India (FSSAI), which operates under the Food Safety and Standards Act, 2006 [1].

This classification is important because the licensing process, claims, and compliance requirements differ from pharmaceutical medicines.

FSSAI License: The Primary Requirement

The most important license for nutraceuticals in India is the FSSAI license. Any company involved in manufacturing, importing, marketing, or selling nutraceuticals must have a valid FSSAI registration or licensing.

Types of FSSAI Licenses

• Basic FSSAI Registration
  For small businesses with limited turnover.

• State FSSAI License
  For manufacturers or marketers operating within one state.

• Central FSSAI License
  Required for large manufacturers, importers, exporters, or businesses operating in multiple states.

The license type depends on production capacity, annual turnover, and business scale.

Manufacturing License for Nutraceutical Production Units

If you are manufacturing nutraceuticals, your production unit must be approved by FSSAI. This includes inspection of:

• Manufacturing premises
• Hygiene and sanitation practices
• Equipment and processing systems
• Storage and packaging areas

The unit must follow Good Manufacturing Practices (GMP) as prescribed by FSSAI to ensure product safety and consistency [2].

Many brands prefer working with a reputable nutraceutical manufacturer that already holds these approvals to avoid compliance challenges.

Product Approval and Ingredient Compliance

Each nutraceutical product must comply with FSSAI’s approved ingredient list. Only permitted vitamins, minerals, botanicals, and additives can be used within specified limits.

Key points include:

• Ingredients must be listed under the FSSAI nutraceutical regulations
• Dosage limits must not exceed prescribed values
• No medicinal or curative claims are allowed

Products with unapproved ingredients or misleading claims may face rejection or recall.

Labeling and Packaging Requirements

FSSAI has strict labeling rules for nutraceuticals to protect consumers and ensure transparency.

Mandatory label details include:

• Product name and category
• Ingredient list with quantities
• Nutritional information
• Recommended usage and warnings
• “NOT FOR MEDICINAL USE” statement
• FSSAI logo and license number

Incorrect labeling is one of the most common reasons for regulatory action against nutraceutical brands [3].

Import License for Nutraceutical Products

If you plan to import nutraceuticals or raw materials from outside India, a Central FSSAI License is mandatory. Additionally, imported products must go through:

• Customs clearance
• Product testing (if required)
• Compliance with Indian labeling standards

Imported products must meet the same safety and quality standards as domestically manufactured ones.

Additional Registrations That May Be Required

Depending on your business model, the following registrations may also be needed:

• GST Registration for tax compliance
• Trade License from local authorities
• Trademark Registration for brand protection
• Import Export Code (IEC) for exports

While these are not nutraceutical-specific, they are essential for smooth business operations.

Role of Third-Party Manufacturing in Compliance

Many nutraceutical brands choose third-party manufacturing to simplify licensing and regulatory compliance. In this model, the manufacturing partner already holds the required FSSAI license, GMP certification, and facility approvals.

This approach offers:

• Faster market entry
• Lower regulatory risk
• Reduced infrastructure costs
• Better focus on marketing and distribution

Choosing an experienced manufacturing partner helps brands stay compliant without handling complex approval processes.

Common Licensing Mistakes to Avoid

Businesses often face issues due to a lack of regulatory awareness. Common mistakes include:

• Using ingredients not approved by FSSAI
• Making disease-related or therapeutic claims
• Selling products without a proper license renewal
• Incorrect or incomplete labeling

Avoiding these errors protects your brand reputation and prevents legal complications.

Final Thoughts

Licensing is the foundation of a safe and successful nutraceutical business in India. FSSAI approval, compliant manufacturing, proper labeling, and ethical marketing are not optional; they are mandatory. Whether you are a startup or an expanding brand, working with a trusted and experienced partner ensures long-term growth and regulatory peace of mind. To ensure quality, safety, and compliance from day one, contact the best nutraceutical manufacturer in India for expert manufacturing and regulatory support.

To explore more, you can also check our group websites: Zoicayurveda for 3rd party Ayurvedic and herbal cosmetic manufacturing, Biozoc for allopathic and drug PCD franchise opportunities, and Zocveda for Ayurvedic and herbal PCD franchise solutions.

FAQs

Q1. Is a drug license required for nutraceuticals in India?
No. Nutraceuticals are regulated as food products and require FSSAI licensing, not a drug license.

Q2. Can herbal ingredients be used in nutraceuticals?
Yes, but only approved botanicals and extracts listed by FSSAI can be used within permitted limits.

Q3. How long does it take to get an FSSAI license?
It usually takes 15–60 days, depending on license type and documentation.

Q4. Are nutraceutical claims regulated?
Yes. Claims must be general wellness or nutrition-related and must not mention disease treatment or cure.

Medical Disclaimer

This content is for informational purposes only and does not constitute legal, medical, or regulatory advice. Nutraceutical products should be manufactured, marketed, and consumed in accordance with FSSAI, AYUSH, and WHO guidelines. Always consult qualified regulatory and healthcare professionals before product formulation or use.

References

[1] Food Safety and Standards Authority of India (FSSAI) – Nutraceutical Regulations
[2] WHO Guidelines on Good Manufacturing Practices for Food Supplements
[3] FSSAI Labelling and Display Regulations