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The cost of AYUSH Certification varies, depending on a range of factors.
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The Ayush License or AYUSH certificate is a government authorization required for conducting retail business of Ayurvedic, Unani, Siddha, or similar products in India. Failure to obtain this license can result in penalties imposed by the Ministry of AYUSH, established in 2014.
Ayurveda, the ‘science of long life’, is one of the world’s oldest forms of medicine, dating back thousands of years in India. Despite being criticized by some in scientific circles as pseudo-science, its popularity has spread globally. Canada, US, Russia and the European Union are among the top importers of Ayurvedic products from India. AYUSH License has facilitated the retail sale of Ayurvedic and related products in India and around the world.
What are the consequences if an applicant does not adhere to the conditions or undertakings of the AYUSH license?
Non-compliance with the conditions or undertakings specified by the Nodal agencies or other departments/agencies of the AYUSH license will result in conviction or punishment in accordance with legal provisions.
To engage in the manufacturing and marketing of herbal products, a manufacturer must obtain a Complete Manufacturing License, which requires the establishment of a manufacturing unit. The following requirements must be fulfilled under the AYUSH Act:
The AYUSH manufacturing license of a third-party manufacturer is utilized for product manufacturing, as the name implies. The applicant need not own the manufacturing unit as they are only responsible for marketing the product.
In contrast, the manufacturer is accountable for fulfilling all necessary requirements and formalities.
A third party must obtain the AYUSH loan license, and it is important to note that the applicant is not responsible for medicine manufacturing, as it is completed by a third party. Additionally, the manufacturer must be GMP certified, and the license will be issued to the candidate/applicant.
The following requirements must be fulfilled under the AYUSH Act:
Unani medicine is both a science and an art of healing that utilizes a unique approach to prevent and cure diseases. To offer such services, obtaining an AYUSH manufacturing license is necessary.
Siddha is a practice or treatment that focuses on maintaining a balance between the mind, body, and spirit system, and emphasizes equal importance to all three aspects in restoring psychological and physiological harmony of the body.
To provide such services, establishments must obtain a Siddha manufacturing license, which is issued with the goal of promoting equal importance to the mind, body, and spirit.
Establishments seeking an AYUSH license must meet certain requirements to ensure compliance with health and safety regulations. These requirements include:
The following information and documents are required to be submitted:
Name, address, email, and contact information.
A copy of the manufacturing license.
List of approved products.
List of products for which COPP (Certificate of Pharmaceutical Product) is being applied for, along with their composition.
Layout of the manufacturing unit or site master file.
Details of the manufacturing process and manufacturing formula.
Specification report of the finished product and the method of analysis.
Process validation report of three batches.
Stability study analysis based on a batch, including manufacturing date, expiry date, stability study condition, and drug name.
Diagram of the water system and HVAC (Heating, Ventilation, and Air Conditioning) system.
List of technical staff, including their experience, qualifications, and approval status.
Export data of two years, wherever re-validation of COPP is applicable.
Evidence of safety and effectiveness as prescribed in Rule 158B of Drugs and Cosmetic Rule,1945.
Undertaking regarding compliance with the provisions of the Domestic Regulation Drugs and Cosmetic Act,1940.
In the case of herbal products, an undertaking regarding the absence of non-herbal components (like metals, minerals, etc.) in the products for which WHO-CoPPs (World Health Organization Certificates of Pharmaceutical Products) are being applied for.
Note: The commissioner has the authority to grant clearance to large industries. In contrast, the District Collector is responsible for granting clearance to MSMEs.
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