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Read MoreWhat is an AYUSH License?
AYUSH stands for Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy, representing ancient medicinal practices in India. These practices gained regulatory oversight in 2014 with the establishment of the Ministry of AYUSH under Central and State Governments.
The AYUSH license is a mandatory requirement for businesses involved in manufacturing, selling, marketing, or exporting AYUSH products such as herbal medicines, cosmetics, or treatments. It ensures compliance with the Drugs and Cosmetics Rules, 1945, and aims to maintain product safety, efficacy, and quality.
Types of AYUSH Licenses
AYUSH Manufacturing License
For businesses owning a manufacturing facility to produce their ASU products or treatments.
AYUSH Loan License
For businesses using another manufacturing unit to produce their AYUSH products.
Who Needs an AYUSH License?
All businesses engaged in Ayurvedic, Unani, Siddha, or herbal product manufacturing or treatments must apply for an AYUSH license. Below are the minimum requirements for each license type:
| License Type | Minimum Requirements |
|---|---|
| AYUSH Manufacturing License | Own a GMP-certified manufacturing unit, 1200 sq. ft. industrial land, equipment, and Ayurvedic experts. |
| AYUSH Loan License | Use a certified unit for production and ensure separate spaces for storage and office operations. |
Documents Required for AYUSH License
| S. No. | Document Name | Remarks |
|---|---|---|
| 1 | Copy of Manufacturing License | Applicable if the applicant is manufacturing AYUSH products |
| 2 | Site layout of the manufacturing facility | |
| 3 | Details of Manufacturing formula and manufacturing process | |
| 4 | Finished product specification report | |
| 5 | List of applied and approved products for COPP certification | |
| 6 | Process Validation Report for 3 batches | |
| 7 | Details of the technical staff, their names, experience, and qualifications | |
| 8 | List of equipment to be used for manufacturing | |
| 9 | Water & HVAC system diagrams | |
| 10 | Proof of Safety & Effectiveness as per Rule 158B of Drugs & Cosmetics Rules, 1945 | |
| 11 | Undertaking regarding the absence of non-herbal ingredients | Applicable for herbal products |
| 12 | Undertaking regarding compliance with applicable acts and rules | Relevant for herbal products |
| 13 | KYC details of the applicant | |
| 14 | Address Proof of the Premises | Rent Agreement |
| 15 | Constitution Document of the business |
