If you are launching a herbal supplement brand in India, understanding the AYUSH licence is one of the first compliance milestones you will encounter. For products that make Ayurvedic, Unani, Siddha, or other traditional medicine claims, an AYUSH licence is not optional: it is the legal foundation that allows you to manufacture and sell those products in India.

This guide explains what the AYUSH licence covers, who needs one, the different licence types, and how the application process works.

What Is an AYUSH Licence?

An AYUSH licence is a manufacturing and marketing authorisation issued under the Drugs and Cosmetics Act, 1940, specifically for products in the Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homoeopathy categories. It is administered by the respective State Licensing Authority (SLA) in each state, with oversight from the Central Government’s AYUSH Ministry.

Unlike FSSAI licensing (which covers food and dietary supplements), an AYUSH licence is required when your product is classified as a drug under the Ayurvedic, Siddha, and Unani drug schedules: which includes most traditional formulations and proprietary Ayurvedic medicines.

Do You Need an AYUSH Licence?

You need an AYUSH licence if your product:

Is a classical Ayurvedic formulation referenced in texts like Charaka Samhita, Sushruta Samhita, or the Ayurvedic Formulary of India
Is a proprietary Ayurvedic medicine (a new or branded formulation using Ayurvedic ingredients with therapeutic claims)
Carries label claims referencing traditional benefits (e.g., “Balances Vata, Pitta, Kapha,” “Supports Ojas,” “Promotes Rasayana effects”)
Uses ingredients listed in Schedules E(1), H, or X of the Drugs and Cosmetics Rules

If your product is a general wellness supplement without traditional medicine claims, for example, a vitamin C capsule or a plant protein powder, it likely falls under FSSAI rather than AYUSH. The line between the two can be blurry when botanical ingredients are involved, so getting a regulatory opinion before filing is worthwhile.

Types of AYUSH Licences

Manufacturing Licence (Form 25D): Required for any facility that physically manufactures AYUSH products. This is what your contract manufacturer holds. If you are outsourcing production, you do not need this: your manufacturer’s licence covers the manufacturing activity.

Loan Licence (Form 25E): This is what most brand owners obtain when they use a contract manufacturer. A Loan Licence authorises you to manufacture products using another company’s licensed facility. It is the standard route for brand founders who are not building their own factory.

Repacking Licence: Required if you are purchasing bulk product from a manufacturer and repackaging it under your brand. Different requirements apply to repackers versus original manufacturers.

Eligibility Requirements for a Loan Licence

To apply for an AYUSH Loan Licence, you typically need:

A qualified Ayurvedic physician (BAMS degree or equivalent) as your technical staff, or a pharmacist with Ayurvedic training. Some states accept a Graduate in Pharmacy (B.Pharm) as the qualified person: requirements vary by state, so check with your State Licensing Authority.

A registered business entity (private limited company, LLP, or proprietorship) in India. The manufacturing facility you plan to use must hold a valid AYUSH manufacturing licence. You will need a formal agreement with that manufacturer.

The Application Process: Step by Step

The application is filed with your State Licensing Authority (SLA). The process generally works as follows:

Step 1: Determine product classification. Before anything else, confirm whether your product is an AYUSH drug or a food supplement under FSSAI. Get written clarity on this from a regulatory consultant or the SLA itself.

Step 2: Prepare your product dossier. For each product, you will need a complete formulation with ingredient names (both common and Latin), part used, quantity per unit, and references to classical texts (for classical formulations) or a rationale for proprietary formulations.

Step 3: Compile supporting documents. This includes business registration documents, qualified personnel details and certificates, manufacturing agreement with the contract manufacturer, premises documents (for a Loan Licence, this is typically your registered office), and label artwork for each product.

Step 4: File the application. Submit Form 25E along with supporting documents and the prescribed fee to your SLA. Many states now accept applications through the Sugam portal (the online drug licensing system).

Step 5: Inspection and approval. The SLA may conduct an inspection of the manufacturing facility (your contract manufacturer’s premises). Timeline from filing to approval varies by state: expect 3-6 months in most cases, longer if there are queries on the formulation or documentation.

Common Reasons for Rejection or Delay

Applications are often delayed or rejected because of incomplete product dossiers, label claims that exceed what the formulation can support, missing qualified person documentation, or discrepancies between the label and the filed formulation. Having an experienced regulatory consultant review your application before submission can significantly reduce turnaround time.

How Your Contract Manufacturer Can Help

A manufacturer who has been through the AYUSH licensing process many times is a valuable resource. They will have templates for manufacturing agreements, understand what documentation the SLA expects, and can advise on formulation presentation. When evaluating a contract manufacturer, ask to see their current AYUSH manufacturing licence and GMP certificate directly, and confirm they have supported other brands through the Loan Licence process before. Suncos Natural supports brand founders through this process as part of the manufacturing partnership.

Once your AYUSH licence is in place, you are authorised to market your products across India, and in most cases, the same licence supports export with appropriate destination-country compliance layered on top.

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