Overview
An AYUSH License is the statutory approval required to manufacture, and in many cases to sell, market or export, traditional Indian medicines and health products. AYUSH stands for Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy – the systems regulated by the Ministry of AYUSH, Government of India.
The license is granted by the State Licensing Authority (State Drug Controller / Directorate of AYUSH) under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. Manufacturing of Ayurvedic, Siddha and Unani (ASU) and Homeopathic drugs cannot legally be carried out without it.
It is required by any business that wants to produce Ayurvedic, Unani, Siddha, Homeopathic or herbal medicines and products – whether a new manufacturing unit, a contract manufacturer, or a brand getting products made on a third-party (loan license) basis. The most common type is the Manufacturing License (Form 25-D); a Loan License (Form 25-E) is available to companies that manufacture their products at an existing licensed facility instead of owning a unit.
License Is Important
Manufacturing AYUSH products in India is a regulated activity. Under Section 33A of the Drugs and Cosmetics Act, 1940, the law governing Ayurvedic, Siddha, Unani (ASU) and Homeopathic medicines makes a valid license compulsory before any such product can be manufactured.
- It is a legal requirement – producing AYUSH medicines without a license is an offence and can lead to seizure of products, penalties and closure of the business.
- It confirms the unit follows Good Manufacturing Practices (GMP) under Schedule T, assuring quality, safety and consistency of the medicines.
- It builds credibility and consumer trust, and is generally needed to supply to distributors, retailers, hospitals and e-commerce platforms.
- It is the basis for obtaining a COPP certificate for exports, allowing AYUSH products to be sold in foreign markets.
In short, the license is what legally permits a business to manufacture and commercialise AYUSH products in India.
Documents Required
Only PAN Card and Aadhaar Card are mandatory; the rest are optional.
- PAN Card
- Aadhaar Card
- Passport-size Photograph
- Address Proof (Utility / Electricity Bill)
- Bank Statement
- Business Registration Proof (Memorandum & Articles of Association, partnership deed, or proprietorship documents)
- Premises Proof (ownership documents, rent agreement, or lease agreement)
- Site Layout (GMP-compliant blueprint of the manufacturing unit)
- GMP Certificate
- COPP Certificate (if applicable, for export)
- Technical Staff Documents (appointment letters, biodata, academic qualifications, experience certificates, photos)
- Product Details (list of medicines, formulations, ingredients, clinical trial reports, draft labels)
- Affidavit of Non-Resemblance
- Compliance Undertakings (Drugs & Cosmetics Act and Drugs & Magic Remedies Act)
- Equipment List
- Process Validation Report (at least three batches)
- No Objection Certificate (NOC) from local authorities (if required)
- Self-addressed Envelope with postal stamps
How to Apply
Getting your AYUSH License through TaxoSure is simple and fully online. Just follow these steps:
- Visit TaxoSure. Go to taxosure.com and open this AYUSH License service page.
- Login or Register. Create your free TaxoSure account, or log in if you already have one.
- Upload your documents. Your KYC documents (PAN & Aadhaar) are auto-filled from your account; upload the remaining documents as per the checklist on this page.
- Submit your application. Send us your AYUSH License application in one click.
- Talk to our consultant. Our consultant connects with you on WhatsApp / Call to confirm the details, share the pricing and begin the work.
- Get your AYUSH License. Our experts handle the entire process end to end and deliver your AYUSH manufacturing license to you.
Benefits
- Legal authority to manufacture Ayurvedic, Unani, Siddha and Homeopathic products across India.
- Long-term validity – following the Drugs (4th Amendment) Rules, 2021, the manufacturing license carries lifetime validity, subject to filing an annual self-compliance declaration (GMP and COPP certificates are renewed periodically).
- Quality assurance – GMP and Schedule T compliance ensures consistent, safe and standardised products.
- Market access & trust – licensed products are accepted by distributors, retailers, hospitals and online marketplaces, strengthening brand credibility.
- Export opportunity – with the COPP certificate, products can be exported to international markets.
- Eligibility for support – a recognised, compliant unit is better placed to access institutional buyers, tenders and government schemes for the AYUSH sector.
Risks Without License
Manufacturing or selling AYUSH products without the required license is an offence under the Drugs and Cosmetics Act, 1940, and exposes a business to serious consequences:
- Legal action and penalties – fines and prosecution for manufacturing in contravention of the Act.
- Seizure and ban of products – unlicensed, substandard, adulterated or spurious products can be seized and prohibited from sale.
- Closure of the unit – authorities can shut down operations and cancel or refuse licenses.
- Loss of market access – distributors, retailers and e-commerce platforms will not stock unlicensed products, and exports are not possible without proper certification.
- Reputational damage – loss of consumer trust and brand value that is difficult to recover.
Summary
An AYUSH License is the mandatory approval for manufacturing Ayurvedic, Yoga & Naturopathy, Unani, Siddha and Homeopathic products in India, granted by the State Licensing Authority under the Drugs and Cosmetics Act, 1940 and Rules, 1945.
The main forms are the Manufacturing License (Form 25-D) for own units and the Loan License (Form 25-E) for third-party manufacturing, both requiring GMP compliance under Schedule T. For exports, a COPP certificate is needed.
The license offers long-term validity (subject to annual self-compliance declaration), quality assurance, market credibility and export eligibility – while operating without it risks penalties, product seizure and closure. Obtaining and maintaining the license is essential for running a compliant AYUSH business.