Overview of AYUSH License
The history of Indian Ayurveda is the oldest history in the world and the number of people who believe in it is in the millions. India still sees its popularity today. They have spread their popularity throughout the world. Scientists are also doing research on this today, these drugs have also seen popularity in other countries. Therefore, India is the largest importer of Ayurvedic products like Canada, the US, Russia and European, Union. Export licenses have enabled to start a business that sells Ayurvedic products in India in the world.
AYUSH license or AYUSH certificate is a law. The Government of India is Ayurvedic/Union/Principle Retail Trade or Ayurvedic Production anywhere in India or licensing/certificate to the professionals who want to run Ayurvedic company. According to the rules set up by the Ministry of AYUSH, in 2014, illegal businessmen have made a punishment.
What is AYUSH license for AYUSH certification in India?
- No person or organization shall start or carry on a pharmaceutical or cosmetic business without obtaining an applicable license to carry on such business.
- The Medicines and Cosmetics Act 1940 protects all types of medicinal business such as allopathic, homoeopathic, ayurvedic, herbal or unani medicines.
- A person needs to obtain a license from the Ministry of AYUSH to start the manufacture of Ayurvedic medicines.
What are the following types of AYUSH license?
Commercial There are 4 types of AYUSH licenses
- AYUSH Retail License – You are given to sell Ayurvedic products as a retailer.
- AYUSH Wholesale License – We give this certificate if you want to sell Ayurvedic products as a wholesaler.
- AYUSH Manufacturing License – Someone gives this license to manufacture Ayurvedic drugs and medicines, which is often referred to as AYUSH Drug Licensing.
- AYUSH Loan License – An individual is granted a loan license using the primary production license holder, their equipment and personnel.
Ayurvedic manufacturers fall into two more types
- Unani Manufacturing License – Unani medicine is considered both a science and an art of healing. It is a respectable profession for the lasting healing of humanity. The Unani framework is popular among people because of its one-of-a-kind approach to preventing and curing disease through it. It has been widely recognized as one of the most relevant medical systems.
- Siddha Manufacturing License – Treatments are done to maintain balance between mind, body and spirit. Siddha treatment gives equal importance to the body, mind and spirit and seeks to restore complete harmony in the various mental and physical functions of the body. Yoga plays an important role in Ayurveda treatment along with meditation, diet and lifestyle.
Documents required to obtain an AYUSH License
- Details of the applicant such as name, address, e-mail, contact no
- Copy of Production License,
- Complete list of products applied for issue of COPP and their structure,
- Site Master File/ Manufacturing Plant Layout,
- Submit manufacturing formula with manufacturing process,
- Method of analysis and finished product specification report,
LIST OF APPROVED PRODUCTS
- Batch Based Stability Study Analysis, Manufacturing Date, Expiry Date, Stability Study Status, Drug Name
- Process Validation Report for three batches,
- A list technical staff with information such as experience, qualifications and accreditation status,
- We use or will use a list of equipment and tools.
- Water System Diagram,
- HVAC System Diagram,
- Export data for last two years, where revalidation of COPP is applicable,
- Evidence of safety and efficacy as specified in Rule 158B of the Drugs and Cosmetic Rules, 1945.
- Initiatives related to absence of any non-herbal like metals/or minerals etc. in products applied for WHO-COPP (applicable in case of herbal products)
- Activities relating to compliance with the provisions of the Drugs and Cosmetics Act, 1940 and regulations thereunder, the Drugs and Magic Remedies (Offensive Advertisements) Act, 1954 and regulations thereunder (applicable to herbal products).
FAQs About AYUSH License?
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