AYUSH License
License from the Ministry of AYUSH for manufacturing, selling, or distributing Ayurveda, Yoga, Unani, Siddha, and Homeopathy (AYUSH) products and medicines.
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What is an AYUSH License?
The AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, Homeopathy) license is issued by the respective State Drug Control Authority or the Ministry of AYUSH for businesses engaged in manufacturing, distribution, or retail sale of traditional medicine products. It is governed under the Drugs and Cosmetics Act, 1940 (for Ayurvedic, Siddha, and Unani drugs) and the Homoeopathy Central Council Act, 1973. The license ensures product safety, quality standards, and proper manufacturing practices.
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Types of AYUSH Licenses
Manufacturing License
For businesses manufacturing Ayurveda, Unani, Siddha, or Homeopathy products.
Wholesale License
For wholesale distributors of licensed AYUSH products.
Retail License
For retail pharmacies and stores selling AYUSH medicines.
Export License
For businesses exporting AYUSH products to international markets.
Eligibility & Requirements
How to Obtain AYUSH License
AYUSH license applications are submitted to the respective State Drug Controller / State AYUSH Department.
1Step 1: Identify License Type and Authority
Determine whether you need State AYUSH Drug Control license or Central license (for national distribution).
2Step 2: Premises Preparation
Ensure manufacturing premises comply with GMP standards — layout, equipment, and quality control lab.
3Step 3: Appoint Technical Staff
Appoint qualified BAMS/BUMS doctor or Pharmacy graduate as technical director.
4Step 4: Submit Application
File Form 24D (for ASU drugs) with complete documentation to the State Drug Authority.
5Step 5: Premises Inspection
Drug Inspector visits and inspects the manufacturing facility. Issues report to licensing authority.
6Step 6: AYUSH License Issued
State Drug Authority issues the manufacturing / wholesale / retail license after satisfactory inspection.
AYUSH license takes 30–60 days. Premises inspection is the key milestone — ensure GMP compliance before inspection.
Documents Required
Applicant Documents
- PAN Card
- Address proof
- Photograph
- Qualification certificates
Premises Documents
- Ownership/rental deed
- Layout plan of premises
- Equipment list
- GMP compliance certificate
Technical Staff
- Qualification certificates of technical staff
- Appointment letter
- Experience certificates
Post-Registration Compliance
GMP Compliance
Maintain Good Manufacturing Practices (GMP) at all times — premises, equipment, and staff standards.
License Renewal
AYUSH manufacturing licenses must be renewed every 5 years. Retail/wholesale typically annually.
Product Quality Testing
All batches must be tested in an approved laboratory before dispatch.
Label Compliance
All AYUSH product labels must comply with Drugs and Cosmetics Act rules — ingredients, dosage, batch number, expiry.
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