What is Ayush Manufaturing Licence?
Every business engaged in the manufacture, Retail, Wholesale, or any other form of trade of Ayurvedic or Herbal Products should get an Ayush Licence. The Ayush Manufacturing Licence is issued by the Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homoeopathy). The Ministry of AYUSH is responsible for the development, education, research, and growth of the alternative medicine system in India.
Ayurveda which means “The Science of Life” is one of the oldest healing science to have ever existed dating back almost 5000 years or more. Ayurveda originated from the ancient Vedic culture and is the basis of the principles of many of the natural healing systems now familiar in the West have their roots in Ayurveda, including Homeopathy and Polarity Therapy.
What are the points to consider to get Ayush Manufacturing License in India?
1. No person in India may start or continue a drug or cosmetic business without obtaining an appropriate license for conducting such operation.
2. To conduct a drug or cosmetic business under the purview of the Drug & Cosmetic Act 1940 all forms of drug or cosmetic business like allopathic, homeopathic, ayurvedic, or Unani drugs are protected.
3. To manufacture Ayurvedic medicines, one must obtain a license from the Ministry of Ayush for the manufacture of drugs.
4. Ayurveda is an ancient therapy for healing that improves longevity, it is also known as "Life Science. 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.
Who requires Ayush license and Pre- requisite for Ayush Manufacturing Licence?
a. Manufacturer
Self Manufacturing
Loan Manufacturing
Third-party manufacturing
b. Retailer
c. Wholesaler
Following are the Mandatory Requirements for Ayurveda Manufacturing Licence
Unit Location: The manufacturing unit should be situated in an industrial area.
Minimum Size of Unit: Should have a minimum of three rooms (1 for Raw Material, 1 for Finished products and an Office Room)Certification:
GMP Certificate is Mandatory (Click to get GMP Certification).
Team Specifications: There is a professional required for the team.
Inspection: Inspection by Drug Inspectors is one of the requisites for approval of the license.
Loan Manufacturing Agreement should be signed between the two parties.
What are the documents required for Ayush Manufacturing Licence?
1. MOA and AOA of the company or partnership deed
2. Proof of Occupancy or proof of address (Copy of the rent agreement) of the Manufacturing Unit
3. Photo ID proof of the Owner/proprietor/ Director/partner of the company.
4. Details pertaining to the refrigeration system
5. An affidavit confirming the compliance of MPD 2021
6. Proof of Qualification of the respective personnel
7. Registration of the state Ayush Council/department
8. Appointment Letter and detailed profile of the director/partners of the company.
9. Site Plan of the Manufacturing Unit
10. Detailed List of Products for which licence is being applied
11. List comprising of details of technical staff.
12. List of machinery, equipment and instruments (Used and to be used).
13. Proof of Safety and effectiveness as per the Rule 158B of Drugs & Cosmetic Rules, 1945
14. Undertaking regarding the absence of any non-herbal such as metals/ or minerals, etc. in the products applied for WHO-COPPs is applicable in case of herbal products.
15. Detailed Information Dossier on the Product(s) for which the licence is being applied.
What are the documents required for ayush Third Party Manufacturing License?
Incorporation / Formation Documents
Minimum Area of the unit should be 1285 sq. ft.
Technical Person / Officer should be a qualified BMS doctor Technical Officer (BSC with Bio.)
Details of the Product to be manufactured
Details of the (actual) manufacturer
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