The practice of traditional medicine in India has a rich history, encompassing various ancient systems such as Ayurveda, Yoga, Unani, Siddha, and Homeopathy (AYUSH). To ensure these practices are regulated and safe for public use, the Ministry of AYUSH issues licenses for businesses involved in manufacturing, marketing, and exporting these products. This blog post provides a detailed overview of AYUSH licenses, their types, the application process, and the benefits of obtaining one.
Understanding AYUSH License
AYUSH stands for Ayurvedic, Yoga & Naturopathy, Unani, Siddha, and Homeopathy. These ancient forms of medicine have been widely practiced in India for centuries. However, they remained unregulated until 2014 when a dedicated AYUSH Ministry was established. The ministry introduced a regulatory framework to ensure the quality and safety of AYUSH products and treatments.
Types of AYUSH Licenses
- AYUSH Manufacturing License:
- Required for businesses that manufacture and market their own ASU products/treatments using their own manufacturing facility.
- AYUSH Loan License:
- Required for businesses that rent manufacturing units from other manufacturers, along with the necessary equipment and staff.
Who Needs to Apply for an AYUSH License?
All businesses dealing with Ayurvedic, Unani, Siddha, herbal, and homeopathy products/treatments must obtain an AYUSH license. The requirements vary based on the type of license:
| License Type | Minimum Requirements |
| AYUSH Manufacturing License | 1. Own a manufacturing facility on industrial land. 2. Minimum area of 1200 square feet for one product (increases with more products). 3. GMP Certified manufacturing unit. 4. At least 2 Ayurvedic experts and 2 Ayurvedic pharmacists. 5. Installed machinery and equipment for production and packaging. |
| AYUSH Retail & Wholesale License | Retailers or wholesalers do not need an AYUSH license under the Drugs and Cosmetics Act, of 1940. |
| AYUSH Loan License | 1. The rented manufacturing unit must hold an AYUSH manufacturing license. 2. The manufacturing unit must be located on industrial land. 3. Separate rooms for raw materials, finished products, and offices. 4. No need for pharmacies or Ayurvedic experts. 5. The loan license is subject to regular renewal. |
Documents Required for AYUSH License Application
| 1. Copy of Manufacturing License, if manufacturing AYUSH products |
| 2. Site layout of the manufacturing facility |
| 3. Details of Manufacturing formula and process |
| 4. Finished product specification report |
| 5. List of applied and approved products for COPP certification |
| 6. Process Validation Report for 3 batches |
| 7. Details of technical staff (names, experience, qualifications) |
| 8. List of manufacturing equipment |
| 9. Water & HVAC system diagrams |
| 10. Proof of Safety & Effectiveness (Rule 158B, Drugs & Cosmetics Rules, 1945) |
| 11. Undertaking regarding absence of non-herbal ingredients |
| 12. Compliance with relevant Acts and Rules |
| 13. KYC details of the applicant |
| 14. Address Proof of the Premises (Rent Agreement) |
| 15. Constitution Document of the business |
How to Apply for an AYUSH License in India
- Documentation:
- Ensure possession of all necessary documents before starting the application process.
- Apply for GMP Certificate:
- Obtain Good Manufacturing Practices certification from the Drug Controller General of India.
- Apply for COPP Certificate (if applicable):
- Obtain the Certificate of Pharmaceutical Products for exporting AYUSH products.
- Download the Application Form:
- Download Form 24D (for manufacturing license) or Form 25E (for loan license) from the e-aushadhi portal.
- Fill out & Submit the Application:
- Complete the application form with the necessary details and submit it along with the required documents and fees.
- Verification by the AYUSH Department:
- The department will verify the application and conduct a physical examination of the facility.
- AYUSH License Granted:
- If approved, the AYUSH license will be issued in Form 25D. Processing typically takes around 60 days.
Validity and Fees
- Validity:
- AYUSH licenses are now valid for a lifetime, subject to annual self-compliance declarations. GMP certificates must be renewed every 5 years.
- Government Fees:
- Application fees have been revised to Rs.2,000 for any number of Ayurvedic, Unani & Siddha drugs/cosmetics, and Rs.3,000 for up to 10 proprietary ASU drugs.
Benefits of Obtaining an AYUSH License
- Legal Recognition:
- Grants legal recognition to practice traditional medicine in India.
- Wide Acceptance:
- Allows tapping into the widely accepted and practiced AYUSH market.
- Increased Credibility:
- Demonstrates compliance with required standards, enhancing trustworthiness.
- Diversification:
- Enables offering a wider range of treatments, combining modern and traditional practices.
- Health Benefits:
- Focuses on prevention and holistic health, providing immense benefits.
- Job Opportunities:
- Opens up opportunities in both public and private sectors for AYUSH practitioners.
Conclusion
Obtaining an AYUSH license is essential for businesses involved in traditional medicine practices in India. It ensures compliance with regulatory standards, enhances credibility, and provides legal recognition. By following the outlined steps and fulfilling the requirements, businesses can successfully obtain their AYUSH license and contribute to the growing field of traditional medicine.
For more information and assistance in obtaining an AYUSH license, contact us today. Let’s work together to promote safe and effective traditional medicine practices in India.
To register for our next masterclass please click here https://linktr.ee/docpreneur
