Ayush License Registration In Ujjain

All such manufacturer who is dealing with the Ayurvedic or Herbal products in India is required to obtain the license from AYUSH regulated by the Ministry of AYUSH. The Ministry of AYUSH was formed on 9th November 2014, earlier it was known as the Department of Indian System of Medicine and Homeopathy (ISM&H) which was created in March 1995.

Ayurveda is an ancient therapy for healing that improves longevity, it is also known as "Life Science." Ayurveda is one of the world's old surviving medical systems which started nearly 5000 years ago. The Ayurveda theory describes a set of mental structures marked by balance and chaos, well-being, and illness. It explains that the mental, emotional, and spiritual being of a person is all interconnected and that even a slight difference between them contributes to health disorders and disease.

There are four types of Ayush Licenses:

1. AYUSH Manufacturing License

2. Unani Manufacturing License

3. Siddha Manufacturing License

4. AYUSH Loan License

1. Applicant’s details such as Name, Address, E-mail, Contact Number

2. A copy of Manufacturing License

3. Complete product list applied for issuance of COPP and their composition

4. Site Master file/ Manufacturing Plant Layout

5. Submit the manufacturing formula along with the manufacturing process

6. Method of analysis and finished product specification Report

7. Approved products list

8. Stability study analysis based on batch, along with the Date of manufacturing, Date of Expiry, stability study condition, the name of Drug

9. Process validation report for three batches

10. Technical staff list along with the information like experience, qualification, and approval status

11. List of equipment and instruments used or to be used

12. Water System Diagram

13. HVAC System Diagram

14. Export data for the last 2 years, wherever re-validation of COPP is applicable

15. A proof of safety and effectiveness as mentioned in Rule 158B of Drugs & Cosmetic Rules, 1945.

16. Undertaking related to the absence of any non-herbal such as metals/ or minerals etc in the products applied for WHO-CoPPs (Applicable in case of herbal products)

17. Undertaking related to compliance with the provisions of domestic regulations inter-alia Drug and Cosmetics Act, 1940 and Rules thereunder, Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and rules there under, (Applicable in case of herbal products)