PASARA License

What is the AYUSH License in India?

The AYUSH License is a mandatory requirement for manufacturers of Ayurvedic, Yoga and Naturopathy, Unani, Siddha, and Homeopathy products in India. This license ensures that the products meet the quality standards set by the Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy).

Key Features of AYUSH License

1. Mandatory for Security Agencies:   Required for all entities involved in the manufacturing and distribution of Ayurvedic, Unani, Siddha, and Homeopathic products.


2. Regulated by State and Central Authorities:   The license is issued by the State Licensing Authority (SLA) and regulated by the Ministry of AYUSH.


3. Quality and Safety:   That AYUSH products comply with the quality standards and are safe for consumption.

Types of AYUSH Licenses

1. Manufacturing License:   For businesses involved in the manufacturing of AYUSH products.


2. Loan License:   For businesses that do not have their own manufacturing facilities but use the facilities of another licensee.


3. Contract/Third-Party Manufacturing License:   For businesses outsourcing the manufacturing of AYUSH products to a third-party manufacturer.

Benefits of AYUSH License

1. Legal Authorization:   Legal authorization to manufacture and sell AYUSH products.


2. Consumer Trust:   Enhances credibility and builds trust among consumers.


3. Market Expansion:  Facilitates market expansion by ensuring compliance with legal standards.


4. Quality Assurance:   Ensures that products meet the required safety and quality standards.

Eligibility Criteria for AYUSH License

1. Qualified Personnel:   The business must employ qualified technical staff with expertise in Ayurveda, Unani, Siddha, or Homeopathy.


2. Proper Infrastructure:  The premises must have adequate facilities and equipment as per the norms.


3. Compliance with Standards:   The business must comply with the standards and guidelines set by the Ministry of AYUSH.

Steps for AYUSH License Registration

1. Determine the Type of License:   Identify whether you need a Manufacturing License, Loan License, or Contract/Third-Party Manufacturing License based on your business activities.


2. Application Submission:   Submit the application form along with the required documents to the respective State Licensing Authority.


3. Document Submission:  Provide necessary documents such as proof of premises, qualification certificates of the technical staff, layout plan of the premises, and other relevant documents.


4. Inspection:   The State Licensing Authority may inspect the premises to verify compliance with the prescribed norms and standards.


5. Fee Payment:   Pay the prescribed fee for the type of license being applied for.


6. Issuance of License:   Upon successful verification and inspection, the AYUSH license will be issued.

Required Documents for AYUSH License

1. Manufacturing License:
   
   
   • Application Form.
   
   
   • Covering Letter.
   
   
   • Proof of premises (ownership/tenancy agreement).
   
   
   • Layout plan of the premises.
   
   
   • List of equipment and machinery.
   
   
   • Details of technical staff (qualification, experience, etc.).
   
   
   • Manufacturing process and quality control process.
   
   
   • Proof of financial stability.
   
   


2. Loan License:
   
   
   • Application Form.
   
   
   • Covering Letter.
   
   
   • Proof of premises (ownership/tenancy agreement).
   
   
   • Consent letter from the manufacturing unit.
   
   
   • Manufacturing agreement between the applicant and the manufacturing unit.
   
   
   • Details of technical staff (qualification, experience, etc.).
   
   
   • List of products to be manufactured.
   
   


3. Contract/Third-Party Manufacturing License:
   
   
   • Application Form.
   
   
   • Covering Letter.
   
   
   • Proof of premises (ownership/tenancy agreement).
   
   
   • Agreement with the third-party manufacturer.
   
   
   • Details of technical staff (qualification, experience, etc.).
   
   
   • List of products to be manufactured.
   
   
   • Proof of financial stability.

Post-Registration Compliance

1. Quality Control:   Ensure continuous compliance with quality standards and guidelines set by the Ministry of AYUSH.


2. Record Maintenance:   Maintain detailed records of the manufacturing process, quality control tests, and distribution.


3. Periodic Inspections:   Prepare for periodic inspections by the State Licensing Authority to ensure ongoing compliance.


4. Renewal of License:  Apply for renewal of the AYUSH license before its expiry.

Conclusion

Obtaining an AYUSH license is crucial for businesses involved in the manufacturing and distribution of AYUSH products. It ensures legal compliance, enhances credibility, and maintains high standards of product quality and safety. By following the steps outlined above and maintaining the necessary documentation, businesses can successfully obtain and maintain their AYUSH licenses.For more detailed assistance with the AYUSH license registration process, feel free to contact us at ATHWISE Services Private Limited. Our expert consultancy team can guide you through the documentation and application process efficiently.

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