Before an Ayurvedic product can carry your brand name, the right licences and paperwork need to be in place, both at the manufacturer’s end and at yours. Knowing the documents required for Ayurvedic third party manufacturing up front saves weeks of back-and-forth and keeps your first batch on schedule.

This guide explains the two common routes (third party manufacturing and loan licence), what the manufacturer handles, what you as the brand owner need to arrange, and a checklist you can use before you place your first order.

This is general guidance for brand owners, not legal advice. Requirements and forms vary by state, so always confirm with your State Licensing Authority.

Two routes: third party manufacturing or loan licence

Ayurvedic medicines are regulated under the Drugs and Cosmetics Act, 1940, and its rules, with licences issued by each state’s Licensing Authority for Ayurveda, Siddha and Unani (ASU) drugs under the Ministry of AYUSH framework. Brand owners usually choose one of two routes:

Most brands, including PCD companies, direct-selling businesses and D2C Ayurvedic brands, start with third party manufacturing because it is faster and simpler. If you want to understand how this compares with contract manufacturing, read our explainer on the differences between Ayurvedic third party and contract manufacturing.

What the manufacturer is responsible for

In third party manufacturing, the manufacturer carries the manufacturing compliance. A reliable partner should have:

• A valid manufacturing licence for ASU drugs from the State Licensing Authority, covering the products and dosage forms you want
• Product permissions for each formulation it manufactures, where required by the state
• GMP certification for the facility, and ideally WHO-GMP for buyers who need a higher quality standard
• Records for raw material, in-process and finished-product testing
• Batch documentation it can share with you for each order

Always ask to see copies of these before you sign. A manufacturer that hesitates to share its licence or GMP certificate is a warning sign. Learn more in our guide to choosing GMP-certified Ayurvedic manufacturers.

Documents you need as the brand owner

1. Business registration

Proof of your business constitution: a certificate of incorporation for a company, a partnership deed or an LLP agreement. Keep the identity and address proof of your directors or partners ready as well.

2. GST registration

You will need GST registration to buy from the manufacturer and invoice your distributors, retailers or customers.

3. Trademark application for your brand

File for your brand name and logo through Intellectual Property India before you print labels. A trademark application protects the name you are investing in and avoids costly reprints if a conflict appears later.

4. Licence to sell or distribute

If you will stock and sell the medicines yourself, for example as a PCD company or distributor, you will usually need a licence for the sale of Ayurvedic drugs from your State Licensing Authority. The exact requirement differs by state and by business model, so check before your first stock arrives.

5. Manufacturing agreement

A written agreement with the manufacturer covering products, specifications, prices, quality responsibilities, timelines, confidentiality and who owns the formula and artwork.

6. Product list and formulations

The list of products you want, with their composition. For classical Ayurvedic formulations, the reference text is usually required. Proprietary formulations may need additional supporting information. Your manufacturer will tell you exactly what its State Licensing Authority asks for.

7. Label artwork

Final label and carton artwork for each product, showing the details required for Ayurvedic medicines, such as composition, dosage, batch number, manufacturing and expiry dates, manufacturer and marketer details and the licence number. Labels must not make prohibited claims about curing diseases.

If you choose a loan licence

A loan licence lets you hold the manufacturing licence for a product made at another company’s licensed unit. Applications for ASU loan licences are typically made in Form 24-E, with the licence issued in Form 25-E by the State Licensing Authority, often through the e-Aushadhi portal. Expect to provide:

• A consent letter from the principal manufacturer whose facility will be used
• Proof of your premises and business registration
• The list of products with composition, method of manufacture and references
• Proposed labels and the applicable fees

Requirements differ between states, so get your state’s current checklist before you apply.

Your pre-order checklist

Common paperwork mistakes that delay launches

1. Printing labels before the artwork is checked. One missing detail can mean reprinting every carton.
2. Not checking the manufacturer’s licence covers your dosage form. A licence for tablets does not automatically cover oils or ointments.
3. Skipping the written agreement. Unclear terms on formula ownership and quality lead to disputes later.
4. Leaving the sale licence to the end. Stock that arrives before your licence cannot be sold.
5. Making cure claims on labels or marketing. These are not allowed and can put the product at risk.

How MAC Biosciences supports brand owners

MAC Biosciences has been manufacturing Ayurvedic products for brands since 2013 in its GMP and WHO-GMP certified, ISO certified facility in Panchkula, Haryana, and our founder brings more than 25 years of industry experience. We manufacture tablets, capsules, liquids, oils, ointments and personal care products, offer 300+ formulations and have worked with 100+ companies in Ayurvedic third party manufacturing, including PCD and pharma companies, direct-selling businesses and D2C brands. We share the documents you need, review your label artwork, and typically deliver within 30 to 40 days of formula and artwork approval. Explore our Ayurvedic third party manufacturing services.

Frequently asked questions

Do I need my own manufacturing licence for Ayurvedic third party manufacturing?

No. In third party manufacturing, the manufacturer produces under its own licence and you market the product under your brand. You only need a licence in your name if you choose the loan licence route.

What is the difference between a third party arrangement and a loan licence?

In a third party arrangement, the manufacturer’s licence covers production and you act as the marketer. With a loan licence, you hold a licence in your own name for products made at the manufacturer’s licensed facility, which means more paperwork and a longer wait.

Do I need a drug licence to sell Ayurvedic products I get manufactured?

If you stock and sell Ayurvedic medicines yourself, most states require a licence for sale from the State Licensing Authority. Requirements depend on your state and business model, so confirm before stock arrives.

How long does the paperwork take before production can start?

For third party manufacturing with a ready formulation, the main steps are your agreement, product list and approved artwork. These can often be completed in a few weeks. Loan licences and new product permissions take longer, depending on the state.

Who owns the formula in third party manufacturing?

It depends on your agreement. Ready formulations usually remain the manufacturer’s, while custom formulations developed for you can belong to your brand. Put formula ownership in writing.

Need help with your documents?

Share your product list and business model with us, and our team will tell you exactly which documents you need and help you get your first batch moving. Contact MAC Biosciences for a quote and product list.