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“If you're looking to start a business dealing with Ayurvedic, Unani, Siddha, or other similar products in India, you'll need an AYUSH License. This certificate is granted by the Ministry of AYUSH, and it's mandatory for anyone who wants to operate in this industry. It ensures that your business is legally compliant and meets all the necessary guidelines set by the government. With an AYUSH License, you can start your business with confidence and offer your customers the assurance that they are getting authentic and safe products. Get your AYUSH License today and take the first step towards a successful venture in the traditional medicine industry.”
A person/company who obtains an AYUSH License can benefit through:
Regardless of where the manufacturing company is located, the person or organisation can work in any state after receiving an AYUSH License.
The person or organisation that applied for the AYUSH License is only responsible for the marketing of the product; the manufacturing firm is in charge of all other compliance requirements; and
The health insurance policy covers the AYUSH License as a benefit.
Ayurveda and herbal medicine are most frequently used in Indian culture, and obtaining an AYUSH License is necessary to control and prevent the inappropriate use of these treatments.
To produce Ayurvedic medications, an individual must secure a License from the Ministry of AYUSH. This License is required under the Drug & Cosmetic Act of 1940 for all medical businesses, such as those selling allopathic, homeopathic, Ayurveda, herbal, or Unani medicines. The Ministry of AYUSH holds power to punish the perpetrators who conduct business without acquiring a License.
In order to produce and manufacture Ayurveda items in India, following types of AYUSH licenses are granted.
• AYUSH Manufacturing License
Under this License, the individuals/companies are registered to work as drug and medicine manufacturers for Ayurveda. Often, this License is referred to as the AYUSH drug License.
• AYUSH Loan License
Under this License, the acquirer (individual/company) uses the manufacturing License of other individuals/companies but manufactures drugs and medicine using its own tools and manufacturing location. Such Licenses should be issued with GMP-accredited manufacturer
• AYUSH Contract
These Licenses are also called Third-Party Manufacturing License/ White label Manufacturing License/ Product-to-Product Manufacturing License. In such arrangements, neither the party has a License nor owns a manufacturing unit; a contract manufacturer or third-party manufacturer carries out only the marketing.
The manufacturer is responsible for all compliance and liaison work in such a case. The manufacturer will have to get approval for the acquirer’s product. The contract acquirer can supply the packaging materials and raw materials.
• AYUSH Wholesale License
This Premium Certificate is given to those seeking to start a wholesale business of ayurvedic items.
• AYUSH Retail License
This certificate is offered to those who wish to sell ayurvedic products as a retailer.
To apply for a retail or a wholesale AYUSH License
• The property area should be at least 10 square meters.
• The height of the property shall be in accordance with the 2005 National Building Code.
To applying for a retail and wholesale AYUSH License
• The property should have a minimum area of 15 square meters.
• The building's height should be in accordance with the 2005 National Building Code.
Document of Manufacturing Plant-
• Site master file/ manufacturing plant layout,
• Submit the manufacturing formula and process
• Process of analysing and finished product specification report
• Water system diagram
• HVAC system diagram
Document of Applicant/ Staff-
• Applicant’s details (name, address, e-mail, contact number)
• Manufacturing license
• List of technical staff with information of their experience, qualification, and approval status
Document Related To Products-
• Complete product list applied for issuance of COPP along with their composition
• List of products which are approved
• Stability study analysis based on batch, along with their name, date of manufacturing and expiry and their stability study condition
• Validation report of process of three batches
• List of equipment and instruments that are or will be used
• Export data for the last two years, wherever re-validation of COPP is applicable,
• A proof of safety and effectiveness as mentioned in rule 158b of drugs & cosmetic rules, 1945.
• Undertaking related to the absence of any non-herbal such as metals/ or minerals etc. In the products applied for who-COPP (only for herbal products)
• 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 thereunder, (only for herbal products).
An Ayush License is important for ASU & H companies in India as it allows them to legally manufacture, trade, or distribute ASU & H drugs in India. It also ensures that the drugs being manufactured, traded, or distributed are safe and of good quality.
The process of obtaining an Ayush License can take several week, depending on the completeness of the company's application and the specific state AYUSH department.
Yes, an Ayush License can be renewed. The process of renewal requires the company to submit a renewal application and pay the renewal fee.
Ayush license holders are typically inspected annually. If non-compliance is found during an inspection, the Ministry of AYUSH may impose penalties or revoke the Ayush license.