What is AYUSH License in India?

It is mandatory to get AYUSH License in India from the Ministry of Ayush for those manufacturers who involved in the manufacturing of the Ayurvedic or Herbal products in India. The Ministry of AYUSH was founded on 9^th Nov 2014, before this it was called "The Department of Indian Systems of Medicine and Homeopathy" which was introduced in 1995. Scroll down to check more information regarding AYUSH License in India.

Below are the types of licenses that are issued by AYUSH:

• AYUSH Manufacturing License:

If any individual wants to set up his manufacturing unit or he/she has come out with the proper plan of manufacturing and marketing can get this license.

To obtain the AYUSH Manufacturing License, you have to fulfill all the requirements as mentioned below:

• The minimum size of the manufacturing land for one drug should be 1200 sq. ft.
• The manufacturing unit must be in an industrial area.
• GMP should certify manufacturing unit.
• Make sure to have on board two pharmacies and two Ayurvedic experts.
• You have access to all the packaging machinery and all the manufacturing.
• The drug inspector will regularly inspect your manufacturing unit.
• Unani Manufacturing License:

This license is very popular amongst people because of its kind of approach through which it prevents and cures diseases. Unani medicine is for the science and craft of healing.

• Siddha Manufacturing License:

Siddha treatment more focuses on preventing diseases than curing them. It helps in treating diseases like Skin, Liver, Prostate, etc.

• Ayush Loan License:

This loan license applies to a GMP certified manufacturer, and from there, it will give to the applicant organization after that product approval is required from the authorities.

If you want to obtain Ayush Loan License, make sure you fulfill all the following requirements under AYUSH Act:

• The flat or building should have a minimum of three rooms' one room for office, one for storing the raw material and one for storing the finished product.
• Must renew the loan license.
• No need for any pharmacist and Ayurvedic expert.
• Inspection of a premise by drug inspector.
• The company registration and manufacturing structure should be the same.
• The manufacturing unit must be in an industrial area.

Following are all the necessary documents at the time of applying for AYUSH License in India:

• Details of the applicant such as Name, E-mail, address, contact number, etc.
• Copy of Manufacturing License.
• Manufacturing Plant Layout.
• Site Master File.
• Submit the manufacturing process along with the manufacturing formula.
• Approved product lists.
• List of used equipment and instruments.
• Water System diagram.
• HVAC system diagram.
• Product summary sheet.
• List of all technical staff with the details like qualification, experience, and approval status.
• Proof of effectiveness and safety, as mentioned under the Rule 158D of Drugs and Cosmetic Rules, 1945.
• Analysis certificate of each product.
• Last two years of Export data.
• Undertaking in related to the absence of any non-herbal such as minerals or metals in the products applied for WHO-COPPs.
• Method of analysis and specification of the finished product.
• Complete list of products applied for issuance of COPP and their composition.
• Stability study analysis along with the Date of Expiry, Date of Manufacturing, the name of Drug, etc.
• Actual labels of the products which are required to be applied for WHO-COPP.
• Compliance with the provisions of domestic regulations under the Drug and Cosmetics Act, 1940 and the Rules under Drugs and Magic Remedies Act, 1954.

Note: An individual has to visit the sites of the required state because the list of documents may vary from state to state.

Below is the step by step procedure to obtain AYUSH License in India:

• Go to the official sites of the individual state for AYUSH registration.
• Download the application form, attach all the documents which may include affidavits and other certificates like CoPP and GMP as in the case.
• Apply for GMP and CoPP if applicable.
• Submit the form along with all the important documents to the Directorate of the AYUSH.

In this certification, it is ensured that the products are consistently produced and controlled the quality standards as prescribed in the WHO. This certification aims to minimize the risks involved in any pharmaceutical production. A GMP certificate tells that the pharmaceutical company has cleared the inspection of the pharmaceutical regulatory body of that country, and it is safe to be exported. It also ensures that the product meets all the standards stated by the World Health Organization (WHO).

Any manufacturing company having Certificate of Pharmaceutical Product (CoPP) is allowed to sell their pharmaceutical product in the country. In the case where the pharmaceutical item is to be registered abroad, then the Government body is responsible for approving the application will request Certificate of Pharmaceutical Product (CoPP) to guarantee that the product can be sold as a finished product in the country.

Manufacturers who are indulged in the manufacturing of Herbal, Ayurvedic, Unani, and Siddha medicines or products need to obtain AYUSH License in India. AYUSH License in India is issued to manufacturers by the Ministry of AYUSH. Most of the medical practices are old and can trace back to early civilizations and are verified by science study that shows they are still effective in today's world.

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