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How To Apply For AYUSH License In India_ (2)

This presentation covers the complete process of applying for an AYUSH license in India. It includes the types of licenses, eligibility criteria, document checklist, step-by-step application procedure, authority involved, and post-approval compliance requirements.

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How To Apply For AYUSH License In India_ (2)

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  1. How To Apply For AYUSH License In India? A Step-by-Step Guide for Manufacturers and Marketers of Ayurvedic, Unani, Siddha, and Homoeopathic Medicines

  2. Introduction To AYUSH License An AYUSH license is mandatory for anyone intending to manufacture, market, or sell Ayurvedic, Unani, Siddha, or Homoeopathic medicines in India. This license is issued by the Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homoeopathy) through the State Licensing Authorities (SLAs) under the Drugs and Cosmetics Act, 1940.

  3. Types Of AYUSH Licenses • Manufacturing License: For companies producing AYUSH medicines. • Loan License: For those using third-party manufacturers. • Contract Manufacturing (Third-Party License): For brand owners outsourcing production. • Retail/Wholesale License: For sale and distribution of AYUSH medicines.

  4. HOW TO APPLY FOR AYUSH LICENSE? Applying for an AYUSH license is a mandatory step for anyone looking to manufacture, sell, or market Ayurvedic, Unani, Siddha, or Homeopathic products in India. Here's a step-by-step guide to help you navigate the process smoothly.

  5. Step 1 - Choose License Type • Identify Your Business Model. • Determine Whether You Need: • Manufacturing License • Loan License • Contract/Third-Party License • Retail/Wholesale License

  6. Step 2 - Set Up Manufacturing Facility • Required only for Manufacturing License. • Must comply with Good Manufacturing Practices (GMP). • Minimum Area: Approximately 1200 sq. ft. for a single category. • Appoint qualified personnel (e.g., BAMS, BUMS).

  7. Step 3 - Documentation Required • Application Form (24-D/24-E/24-B depending on license type) • Premises layout or blueprint • Ownership proof or rent agreement • GMP compliance declaration • List of equipment and machinery • List and credentials of technical staff • Affidavit of non-conviction • Product list with formulations

  8. Step 4 - Submit Application • Apply through State Drug Licensing Authority (AYUSH Wing) • Submit physical or digital documents (based on state norms) • Pay the prescribed government fee • Upload documents on the online portal (if available in your state)

  9. Step 5 - Site Inspection A drug inspector or AYUSH official will visit your manufacturing site or shop to verify compliance with guidelines and infrastructure.

  10. Step 6 - License Issuance • If inspection is satisfactory, license is granted • Valid for 5 years • Renewal required before expiry

  11. Key AYUSH Forms • Form 24-D: Ayurvedic/Unani/Siddha manufacturing license • Form 24-E: Homoeopathy manufacturing license • Form 24-B: Loan license • Form 25/25-D: Retail or wholesale license

  12. Timeline For Approval Timeline to get approval for AYUSH License are as follows:

  13. Final Checklist Before Applying • Manufacturing unit ready and GMP-compliant • Qualified staff appointed • Complete and accurate documentation • Fee payment completed • Prepare for site inspection

  14. Importance of Compliance • Non-compliance may lead to: • Rejection of license • Cancellation of existing licenses • Legal actions and penalties • Regulatory compliance ensures product safety and market trust

  15. Consulting Support Navigating AYUSH or Form COS-1 licensing requirements can be complex and time-consuming. At ELT Corporate Pvt. Ltd., we specialize in regulatory consulting and compliance support for the cosmetics, herbal, and healthcare industries.Our expert team provides end-to-end assistance, including: • ✅ Document preparation and review • ✅ Online application filing through the respective portals • ✅ Coordination with licensing authorities • ✅ Follow-ups and query resolution • ✅ Technical staff and GMP setup guidance • ✅ Labeling and formulation compliance support Contact us today [+91 85859 19582] to schedule a consultation and take the next step with confidence. Visit our website [Cosmetic regulatory consultant]

  16. Conclusion • Applying for an AYUSH license is essential for legal manufacturing and sale of traditional medicines. • Follow all steps carefully to avoid delays. • Regularly check for updates from Ministry of AYUSH and State Licensing Authorities.

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