Legal Compliance
Manufacture AYUSH products as per the Drugs & Cosmetics Act, 1940 and Rules, 1945.
DRUG LICENSE SERVICES
Start Your AYUSH Manufacturing Business with the Right License
AYUSH Manufacturing License
Get professional assistance for AYUSH manufacturing licensing, documentation, premises requirements, technical staff, product formulation, application filing and regulatory compliance.
Starting at
₹9,000*
+ Government Fees
*Professional fee. Government fees, statutory charges and other
applicable expenses are additional.
AYUSH MANUFACTURING LICENSE
Ayurvedic Products
Siddha Products
Unani Products
GMP Compliance
Wide Product Range
Build Your Brand
Expert Support
Herbal
manufacturing
manufacturing
Build Your Own Brand
Launch and expand your Ayurvedic, Siddha or Unani product range legally.
Market Opportunities
Supply to retail, e-commerce, distributors and export markets.
Business Credibility
Increase trust with customers, investors and business partners.
Wide Product Range
Manufacture a variety of AYUSH products under a compliant framework.
Regulatory Support
End-to-end support from documentation to license approval.
UNDERSTANDING AYUSH LICENSING
What is an AYUSH Manufacturing License?
An AYUSH Manufacturing License is required for eligible businesses manufacturing Ayurvedic, Siddha or Unani drugs/products for sale under the Drugs & Cosmetics Act, 1940 and Rules, 1945.
COMPLYO provides end-to-end assistance with regulatory assessment, documentation, premises requirements, technical staff, product documentation, application filing and licensing coordination.
Manufacturing with a considered compliance pathway
The applicable route depends on your product, manufacturing setup and the requirements of the relevant Licensing Authority.
CHECK YOUR BUSINESS NEED
Who Needs an AYUSH Manufacturing License?
Ayurvedic medicine manufacturers
Siddha medicine manufacturers
Unani medicine manufacturers
Herbal product manufacturers under the AYUSH framework
Contract / loan manufacturers
Startups entering the AYUSH sector
Businesses planning to manufacture and sell AYUSH products
Existing manufacturers adding new products
PRODUCT CATEGORIES
Products That May Fall Under AYUSH Manufacturing
Product classification and applicable rules should be assessed for each product.
AYURVEDIC PRODUCTS
- Classical formulations
- Patent & proprietary products
- Herbal health products
- Certain skin, hair and body-care formulations
- As per applicable rules
SIDDHA PRODUCTS
- Siddha formulations
- Patent & proprietary products
- Other eligible Siddha products
UNANI PRODUCTS
- Classical formulations
- Patent & proprietary products
- Other eligible Unani products
CHOOSE THE LICENSING ROUTE
Own Manufacturing or Loan License?
Manufacturing License
For businesses acquiring/operating their own manufacturing facility.
Loan License
For businesses using the manufacturing facilities of an existing licensed manufacturer.
Licensing route and applicable forms should be checked against the proposed products and current requirements.
A CLEARER APPLICATION JOURNEY
AYUSH Manufacturing License Process
Requirements and review may depend on the product, manufacturing facility and relevant Licensing Authority.
-
01
Consultation
Understand your business model, proposed products and manufacturing setup.
-
02
Regulatory Assessment
Determine the applicable AYUSH category and licensing route.
-
03
Document Preparation
Collect and prepare all required documents.
-
04
Application Filing
File the application with the relevant Licensing Authority.
-
05
Department Review
Application scrutiny, inspection or queries if applicable.
-
06
License Approval
Once requirements are satisfied, the license is issued by the competent authority.
Review and issuance are subject to applicable requirements. No fixed approval timeline is promised.
PLAN YOUR FACILITY
Key Requirements
Suitable premises
Manufacturing premises as per Schedule T.
Facilities & equipment
Manufacturing facilities and equipment for the proposed activity.
Qualified technical staff
As per applicable rules and manufacturing activity.
Quality control
Quality control and testing arrangements.
Product documentation
Product formulation and supporting documentation.
Labelling & packaging
Proper product labelling and packaging.
GMP & Schedule T
Compliance with GMP and Schedule T requirements.
GET READY TO APPLY
Documents Required
Prepare the information and records relevant to your proposed products, premises and manufacturing setup.
- PAN Card
- Aadhaar / Identity Proof
- Business Constitution Documents
- Premises Proof (Ownership / Rent Agreement + NOC)
- Site / Factory Layout Plan
- Manufacturing Equipment Details
- Technical Staff Documents
- Product List and Formulation Details
- Labelling and Packaging Details
- Other documents as required by the Licensing Authority
Requirements may vary depending on the nature of products and applicable rules.
TECHNICAL SUPERVISION
QUALIFIED TECHNICAL OVERSIGHT
Technical Staff Requirement
The manufacturing activity must be conducted under the supervision of qualified technical staff as per applicable rules.
- Requirements depend on the nature of products and manufacturing activities.
- COMPLYO can help assess the exact technical staff requirement for your proposed products.
Specific qualifications and experience requirements may vary based on the manufacturing activity and applicable rules.
ANSWERS TO COMMON QUESTIONS
Frequently Asked Questions
READY TO START?
Ready to Start Your AYUSH Manufacturing Business?
Get professional assistance with documentation, technical requirements, application filing and regulatory coordination.
Expert Guidance
100% Compliance
Secure Process
Timely Support
End-to-End Assistance