Nutraceutical & Ayurvedic Regulations in India, Explained
FSSAI licensing, WHO-GMP certification, Schedule M, and export compliance — the complete regulatory picture for brand owners and manufacturers.
In India, nutraceutical and Ayurvedic manufacturing is primarily governed by FSSAI under the Food Safety and Standards Act, with additional Ayush Ministry licensing required for classical Ayurvedic medicines. WHO-GMP certification, while not always legally mandatory, is the widely recognized quality benchmark that most export markets and serious B2B buyers require from their manufacturing partner.
The Three Bodies That Govern This Industry
FSSAI
Regulates nutraceuticals, health supplements, and functional foods. Any manufacturer, distributor, or importer needs a license appropriate to their scale.
Ministry of Ayush
Governs classical Ayurvedic medicines making therapeutic claims tied to Ayurvedic texts, licensed at the state drug control level.
Schedule M
Outlines Good Manufacturing Practice requirements — facility design, equipment, documentation, and quality control systems.
FSSAI License Types Explained
| License Type | Who It’s For |
|---|---|
| Basic Registration | Small businesses / very low turnover |
| State License | Mid-size manufacturers operating within one state |
| Central License | Higher turnover, multi-state, import/export operations |
What Changes When You Sell Internationally
DSHEA Framework
FDA facility registration and different permissible claim structures than FSSAI.
Novel Food / EFSA
Notably stricter approval requirements on certain botanical ingredients.
Country Registration
UAE’s MOHAP registration, Saudi SFDA, and other country-specific requirements.
How to Verify a Manufacturer’s Compliance
- Copy of current FSSAI license — verify the license number on FSSAI’s official portal.
- WHO-GMP certificate with validity dates.
- A sample batch-wise Certificate of Analysis from a recent production run.
- Details of third-party testing lab partnerships (Eurofins, SGS, NABL).
- Export track record and documentation experience, if relevant to your goals.
Is WHO-GMP certification legally required in India?
What’s the difference between FSSAI license and WHO-GMP?
Do Ayurvedic products need Ayush licensing too?
What documentation is needed to export?
Talk to Our Regulatory Team
WHO-GMP, FSSAI Central License & US FDA registered — full compliance support for domestic and export launches.
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