Special Offer - Flat 18% off on annual payments! 
Selling Ayurvedic products on Amazon India requires proper licensing. Unlike regular supplements that need FSSAI, Ayurvedic, Siddha, Unani, and Homeopathic medicines fall under AYUSH regulations — and Amazon strictly enforces this.
This guide covers everything you need to know about AYUSH licensing for selling traditional medicine products on Amazon and other ecommerce platforms.
What is AYUSH License?
AYUSH license is a manufacturing and sales permit issued by State Licensing Authorities under the Drugs and Cosmetics Act, 1940 for traditional medicine systems. AYUSH stands for:
AYUSH license is NOT the same as FSSAI. FSSAI covers food and dietary supplements. AYUSH covers medicines that make therapeutic claims (treats, cures, prevents disease). Selling AYUSH products without proper license is a criminal offense under the Drugs Act.
Who Needs AYUSH License?
You need AYUSH license if you’re:
- Manufacturing: Producing Ayurvedic/Siddha/Unani/Homeopathic medicines
- Selling products with therapeutic claims: “Treats diabetes”, “Cures joint pain”, etc.
- Using scheduled ingredients: Ingredients listed in Ayurvedic Pharmacopoeia
- Selling classical formulations: Triphala, Chyawanprash (medicinal version), Ashwagandha churna (drug claim)
FSSAI vs AYUSH: Which Do You Need?
Product Classification Examples
| Factor | FSSAI | AYUSH |
|---|---|---|
| Regulates | Food & dietary supplements | Traditional medicines (drugs) |
| Claims Allowed | General wellness, support, boost | Treat, cure, prevent disease |
| Governing Act | Food Safety Act, 2006 | Drugs & Cosmetics Act, 1940 |
| Approval Time | 15-90 days | 3-6 months |
| Facility Requirement | Basic hygiene standards | GMP (Schedule T) compliance |
| Penalty for Violation | Up to ₹10 Lakh fine | Up to ₹1 Lakh + 3 years imprisonment |
Many supplement brands position their Ayurvedic products as FSSAI health supplements (no drug claims) to avoid the longer AYUSH process. This is legal if you don’t make therapeutic claims. However, if you want to differentiate with “treats/cures” claims, AYUSH is mandatory.
AYUSH License Requirements
Facility Requirements (Schedule T GMP)
- Dedicated manufacturing premises (not home-based)
- Separate areas for raw material storage, production, packaging, finished goods
- Adequate ventilation, lighting, and drainage
- RO/treated water supply with testing records
- Pest control measures
- Quality control laboratory (in-house or tie-up)
- Qualified technical staff (BAMS/BHMS/equivalent for supervision)
Documents Required
Application Form 24
Prescribed format for license application
Site/Layout Plan
Detailed factory layout with dimensions
Product List
All products to be manufactured
Master Formulas
Product formulations as per pharmacopoeia
Technical Staff Credentials
Degree certificates of BAMS/BHMS/qualified person
Lab Tie-Up Agreement
If no in-house QC lab
Business Registration
Company incorporation, partnership deed
Fee Challan
License fee payment proof
Application Process
Prepare Manufacturing Facility
Set up facility as per Schedule T GMP requirements. This is often the longest step — budget 2-6 months and ₹5-25 Lakh depending on scale.
Appoint Technical Staff
Hire a qualified person with BAMS (Ayurveda), BHMS (Homeopathy), or equivalent degree as per the medicine system. They’ll be responsible for quality and compliance.
Prepare Documentation
- Application Form 24
- Product master formulas with references
- Site plan and equipment list
- SOPs for manufacturing and quality
Submit to State Drug Authority
Submit application to your State Drug Control Department (AYUSH Wing). Pay prescribed fees. Application is reviewed for completeness.
Facility Inspection
Drug Inspector visits your facility to verify GMP compliance. They check equipment, hygiene, documentation, and staff qualifications. Prepare for 2-3 hour inspection.
Address Observations (if any)
If inspection reveals gaps, you’ll receive observation report. Address issues and request re-inspection. Most first-time applications have some observations.
Receive Manufacturing License
After successful inspection, license is issued listing approved products. Validity is typically 5 years. Display at factory premises and include license number on all products.
Amazon Listing Requirements for AYUSH Products
Amazon India has specific requirements for AYUSH product listings:
✅ Amazon AYUSH Seller Checklist
Valid AYUSH Manufacturing License copy
Product-wise approval list from license
Product images showing license number
Batch number and manufacturing date visible
Complete ingredient list on label
Dosage and contraindication information
Manufacturer name and address
GST registration certificate
Amazon rejects AYUSH listings for: Missing or expired license, products not listed in license, improper label information, therapeutic claims without license, and poor image quality where license number isn’t readable. Ensure compliance before submitting.
Timeline: AYUSH License to Amazon Live
| Stage | Duration | Notes |
|---|---|---|
| Facility Setup | 2-6 months | Depends on scale and current state |
| Documentation Prep | 2-4 weeks | Formulas, SOPs, application |
| Application Review | 4-8 weeks | State authority processing |
| Inspection + Approval | 4-8 weeks | May need re-inspection |
| Amazon Category Approval | 1-2 weeks | After license received |
| Total | 4-9 months | Plan accordingly |
Need Help with AYUSH Compliance?
Brand Chanakya helps Ayurvedic brands navigate licensing, compliance, and Amazon setup. From license application to first sale — we handle the complexity.
Frequently Asked Questions