How to start an ayurvedic or herbal products business in India: AYUSH licence and registrations

Is your product a medicine or a food?

This decides your regulator. Ayurvedic, siddha and unani drugs, whether classical formulations or proprietary medicines, need a drug manufacturing licence from the state AYUSH authority. Herbal teas, health foods and many supplements are foods under the Food Safety and Standards Act, regulated by FSSAI, including its regulations on Ayurveda Aahara and nutraceuticals.

Herbal cosmetics such as hair oils or face packs sold for cosmetic purposes come under the Cosmetics Rules. Many brands sell across categories and need more than one licence, so classify each product before you design packaging.

Licences and registrations

The usual structure for herbal brands is a private limited company or LLP. The licences below are product and premises specific, so a multi-category brand often holds several at once.

Manufacturing licence requirements

Applications in Form 24-D are made to the state licensing authority, often through state portals. Expect to show premises compliant with Schedule T good manufacturing practices, qualified technical staff as prescribed, equipment lists, a quality control arrangement with an in-house or approved testing laboratory, and the list of products with formulation references.

Classical formulations must follow the authoritative texts listed in the Act. Proprietary ASU medicines need supporting evidence of safety and effectiveness as the rules prescribe. The authority inspects the unit before granting the licence. Contract manufacturing under a loan licence avoids building a factory but still requires your own technical oversight.

Advertising and labelling limits

The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 prohibits advertisements claiming to cure listed diseases and conditions. AYUSH advertising rules under the Drugs Rules have also been in flux, with court proceedings over government notifications, so get claims reviewed before campaigns.

Labels must carry the licence number, ingredients with quantities, batch number, dates and the words required for ASU medicines. GST depends on whether the product is classified as a medicament, food or cosmetic, so confirm the HSN code with your adviser.

Ongoing compliance

Maintain batch manufacturing records, raw material testing and stability data. Keep Schedule T compliance current, since inspectors check premises and documentation. Update the licence when you add products, change technical staff or alter premises.

Factories with 20 or more workers using power, or 40 without, are factories under the OSH Code, which came into force on 21 November 2025, bringing licensing and safety duties. Pollution consent renewals, GST returns and ROC filings complete the calendar.

Pitfalls in the herbal sector

Regulators and online platforms increasingly act on misleading health claims, and product recalls are costly, so test every batch against specifications and review claims before launch.

• Selling herbal 'medicines' under an FSSAI licence to avoid drug licensing.
• Making disease-cure claims in ads or on social media.
• Assuming a contract manufacturer's licence covers new products you add.
• Ignoring heavy metal and microbial testing requirements.

Step by step

1. 1Classify each product

   Decide whether it is an ASU drug, food or cosmetic.

2. 2Choose manufacturing route

   Own unit under Form 24-D or loan licence under Form 24-E.

3. 3Prepare the unit

   Meet Schedule T standards and appoint qualified technical staff.

4. 4Apply and face inspection

   File with the state AYUSH authority and host the inspection.

5. 5Obtain FSSAI or cosmetics licences

   For products outside the drug category.

6. 6Register for GST and packaging

   GST, Legal Metrology and EPR where applicable.

7. 7Review claims

   Check labels and ads against advertising law before launch.