What is an AYUSH License?
An AYUSH License is a mandatory certification issued by the Ministry of AYUSH, Government of India, for businesses involved in the manufacturing, marketing, and sale of Ayurvedic, Yoga, Unani, Siddha, and Homeopathy products. It ensures that the products meet the safety and quality standards defined under the Drugs and Cosmetics Act, 1940.
Whether you are a manufacturer, retailer, or wholesaler of traditional medicines, obtaining this license is crucial for legal operations and building consumer trust.
Benefits of Obtaining an AYUSH License
- Legal Compliance: Operates your business legally without fear of penalties or closure.
- Consumer Trust: Proves that your products are safe, effective, and quality-tested.
- Market Expansion: Essential for selling products online and in retail stores across India.
- Export Opportunities: A prerequisite for obtaining a COPP (Certificate of Pharmaceutical Product) for exports.
- Government Support: Access to various schemes and subsidies offered by the Ministry of AYUSH.
Types of AYUSH Licenses
Depending on your business model, you can apply for one of the following licenses:
- Manufacturing License: For businesses that manufacture AYUSH products in their own facility.
- Loan License: For businesses that do not own a manufacturing unit but wish to manufacture products using a third-party's licensed facility.
- Contract Manufacturing License: For marketing companies that outsource production to a licensed manufacturer (White Labeling).
- Retail/Wholesale License: For selling AYUSH products in a shop or distributing them. (Issued by State Licensing Authorities).
Prerequisites for AYUSH Manufacturing License
- Premises: A manufacturing unit in an industrial area with a minimum size of 1200 sq. ft.
- GMP Certification: The facility must be GMP (Good Manufacturing Practices) certified.
- Technical Staff: Must employ at least 2 technical staff:
- One Ayurvedic/Unani/Siddha expert (BAMS/BUMS/BSMS).
- One Pharmacist (B.Pharm/D.Pharm).
- Machinery & Equipment: Adequate machinery and laboratory equipment for production and testing.
Documents Required
- Business Registration: COI, MOA/AOA, or Partnership Deed.
- Identity Proof: PAN and Aadhaar of Directors/Partners.
- Premises Proof: Rent Agreement/Ownership Deed and Electricity Bill.
- Site Plan: Blueprint of the manufacturing unit layout.
- Technical Staff Details: Degree certificates, appointment letters, and ID proofs of technical staff.
- Product Details: List of products, formulation details, and textual references.
- GMP Certificate: Copy of GMP certification.
- Pollution NOC: No Objection Certificate from the State Pollution Control Board.
Registration Process
- Document Preparation: Gather all necessary documents and ensure the manufacturing unit meets GMP standards.
- Online Application: Apply through the e-Aushadhi portal or the respective state's AYUSH department website.
- Fee Payment: Pay the requisite government fees online.
- Inspection: A Drug Inspector will visit the premises to verify compliance with GMP and other regulations.
- License Grant: Upon successful verification and inspection, the AYUSH License is issued.
AYUSH License Fees
Government Fees (Revised):
- For Generic (Classical) Products: ₹2,000 per product.
- For Proprietary Products: ₹3,000 per product (up to 10 products).
Professional Fees: Easyfilings charges a nominal fee for expert consultation and end-to-end application management.
Validity and Renewal
Perpetual Validity: As per the new rules (effective Oct 2021), AYUSH Manufacturing Licenses now have lifetime validity, provided the licensee submits an annual self-compliance declaration.
GMP Renewal: The GMP certificate must be renewed every 5 years.
Penalties: Operating without a license can lead to imprisonment (up to 3 years), heavy fines, and seizure of stock.
