How to Apply for Ayush Manufacturing License in India?
Ayush License registration process in India step-by-step :
Step-1 : Documentation
The AYUSH Registration process in India is completely online and application-based. The concerned AYUSH License application form is filed along with certain supporting documents submitted in their prescribed formats and containing up to date information. Any error in filing these documents may lead to the complete rejection of your application. Therefore, we strongly recommend that you begin the process of application filing only after ensuring that you are in possession of all the necessary documents.
Step-2 : Apply for GMP Certificate
The World Health Organisation has issued guidelines for Good Manufacturing Practices to regulate the drug/cosmetics manufacturing process and the quality of manufactured drugs/cosmetics products. These guidelines have been adopted by several nations, including India. So, even the drugs/cosmetics manufactured in India must comply with these guidelines and obtain a GMP Certificate validating its compliance, from the Drug Controller General of India. However, the application for it can be made to the Drug Control Department of the concerned state. The GMP Certificate is an important document to be submitted while applying for the AYUSH license.
Step-3 : Apply for COPP Certificate, if applicable
Certificate of Pharmaceutical Products is a certificate designed by the WHO to ascertain the quality of the drugs exported from one country to another. This Certificate is usually sought by the National Health Authorities of the importing country, and is required to be obtained by the exporter from its country of origin. For manufacturers of AYUSH drugs and cosmetics planning to sell their products outside India, this certificate will have to be necessarily submitted while applying for the AYUSH license. Like GMP Certificate, even COPP is issued by the Drug Controller General of India. However, the application for it can be made to the Drug Control Department of the concerned state.
Step-4 : Download the form for Ayush License Certificate
Once you are sure that you are in possession of all the necessary documents, you can begin the process of AYUSH License apply online. Rule 153 of the Drugs and Cosmetics Rules, 1945, prescribes form 24D to be filed for the grant of AYUSH manufacturing license and Form 25E for the grant of AYUSH loan license. Since these licenses are state-specific, the concerned application can be downloaded from the e-aushadhi portal.
Step-5 : Fill out & Submit the Application
Once the application form is downloaded, you are required to fill in the necessary details manually. These include the details of the place of business or location of the manufacturing facility, the details of the product to be manufactured and/or sold, and the details of the staff employed. After having filled out the application, obtain its scanned copy, and submit it on the Department’s website along with the scanned copy of the prescribed documents and prescribed application fees.
Step-6 : Verification by AYUSH Department’s Commissioner
Upon receiving the application, the Department will examine it thoroughly and verify every bit of information it contains. Also, the AYUSH Department’s commissioner would visit your office/place of business/manufacturing facility to conduct a physical examination and prepare a report for the same. Based on the report of the Commissioner, the Department will ultimately decide whether to approve your application or not.
Step-7 : AYUSH license granted
If the Department has approved the application based on its examination of the form and the main office/manufacturing facility of the business, it will grant the AYUSH license to the applicant in Form 25D. Usually, it takes around 60 days for the Department to process the form used for the AYUSH Certificate application online.