Ayush Licence in Bihar
The Ministry of Ayush issues the Ayush license for doing business in manufacturing products relating to Ayurveda, Yoga, Unani, Siddha and Homoeopathy. Nawcare Business Solutions in getting the Ayush License in Bihar.
Ayush License in Bihar
AYUSH stands for Ayurvedic, Yoga & Naturopathy, Unani, Siddha, and Homeopathy. These are all ancient forms of medicine and treatments which have been quite popular in India since decades. Prior to 2014, these products and treatments were in extensive use but remained completely unregulated. However, since the establishment of a dedicated AYUSH Ministry under the Central and State governments, in the year 2014, AYUSH businesses have received a robust regulatory framework for manufacturing, sale, marketing, and export of products within India.
AYUSH license in Bihar are a significant part of this regulatory framework, whereby the Government prohibits unlicensed AYUSH businesses from operating in India. The AYUSH license is granted by the AYUSH Ministry of the state government, under the jurisdiction of which the AYUSH business operates. The license must be obtained by all businesses dealing in Ayurvedic, Unani, Siddha, herbal, and homeopathy, drugs / cosmetics, and other related treatments. As far as the application for the grant of license is concerned, the provisions for the same are mentioned in the Drugs and Cosmetics Rules, 1945.
What Are the Different Types of AYUSH Licenses
1. AYUSH Manufacturing License
Required if the business wants to manufacture and market its own ASU products / treatments, for which it will use its own manufacturing facility. Nawcare assists in Ayush Manufacturing Licence at Bihar.
2. AYUSH Loan License
Required by a manufacturing business which does not own a manufacturing unit, and is renting it from some other manufacturer, along with the manufacturing equipment and staff.
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Who needs Ayush Licence?
All types of businesses dealing with Ayurvedic, Unanni, Siddha or herbal products / treatments are required to obtain the AYUSH Certificate online to carry out their business activities in India. However, there are some minimum requirements that these businesses need to fulfill based on the types of AYUSH license they have applied for. We have listed out all such minimum requirements below.
S.NO | NAME OF THE LICENSE | MINIMUM REQUIREMENTS TO OBTAIN THE LICENSE |
---|---|---|
1. | AYUSH Manufacturing license |
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2. | AYUSH Retail & Wholesale License | A retailer or wholesaler of Ayush products is not required to apply for AYUSH Retail or wholesale license. As provided in section 33A of Drugs and Cosmetics Act, 1940 (The Act ), Chapter IV A of the Act, which regulates the manufacture, sale, and distribution of drugs and cosmetics is not applicable to Ayush products. Further, Chapter Chapter IV A of the Act regulates only manufacturing of Ayush products. |
3. | AYUSH Loan License |
|
Documents Required to Apply for AYUSH License
S.NO | LIST OF DOCUMENTS REQUIRED FOR AYUSH LICENSE |
---|---|
1. | Copy of Manufacturing License, if the applicant is manufacturing AYUSH products |
2. | Site layout of the manufacturing facility |
3. | Details of Manufacturing formula and manufacturing 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 the technical staff, their names, experience, and qualifications |
8. | List of equipment to be used for manufacturing |
9. | Water & HVAC system diagrams |
10. | Proof of Safety & Effectiveness according to Rule 158B of Drugs & Cosmetics Rules, 1945 |
11. | Undertaking regarding the absence of non-herbal ingredients, applicable in case of herbal products |
12. | Undertaking regarding compliance with the Drugs and Cosmetics Act, Drugs and Cosmetic Rules, Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954, and its corresponding rules (applicable in case of herbal products only) |
13. | KYC details of the applicant |
14. | Address Proof of the Premises (Rent Agreement) |
15. | Constitution Document of the business |
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