Every manufacturer who is dealing with ayurvedic or herbal products in India is required to obtain Ayush License. This license is regulated by the ministry of Ayush. The application of Ayush is approved by the commissioner of Ayush department.
Previously, it was known as the department of Indian system of medicine & homeopathy (ISM & H) formed in 1995. Later it was changed to ministry of Ayush on 9th November 2014. You cannot manufacture ayurvedic medicines without taking the consent of the government. In order to get Ayush license, you need to file an application along with the required documents to the ministry of Ayush for the approval.
Types of Drug Licenses Issued By Ministry Of Ayush
There are 5 types of drug licenses issued by ministry of Ayush to manufacture ayurvedic or herbal products in India –
What Is Included In Our Package?
Documents Required To Obtain Ayush License (For Retailers Or Wholesalers)
The documents required to apply for ayush license are as follows –
- Memorandum of association (MOA) & articles of association (AOA) of the company
- Photo ID proof of the proprietor/ director/ partner of the company
- Address proof
- Qualification proof
- Registration of Delhi ayush council (In case you are applying for the license in Delhi state)
- Affidavit regarding the compliance of MPD 2021
- Biodata and appointment letter of the director of the company.
Documents Needed For License Of Manufacturing Of Ayurvedic Or Herbal Products
Attested copies of documents related to ownership/rent/lease
2Plan or layout of the premises showing the installation of machinery & equipment.
3Declaration of the proprietor/director/ partnership in affidavit – 1 enclosed with online form, attested partnership deed/MOA & AOA
List of detailed manufacturing & analytical equipment
Appointment letter to full time technical supervisor.
Attested copies of academic qualification certificates, experience certificates from Ayurveda/unani and declaration of technical staff in the prescribed format.
Passport size photos of proprietor & Fulltime technical supervisor.
List of shastric medicines as well as the Xerox copies of concerned pages duly signed by FTS with samples
Each drug sample with sales pack draft labels with different sizes.
Sales pack draft labels for each drug as per D&C rules with different sizes
Self-addressed envelope along with sufficient postal stamps.
Clinically trial reports on at least 30 patients for each drug used orally from institutionally qualified ayurvedic/unani practitioners as per performa guidelines.
Drug information in the following lines for anubhutha yogas (patent drugs) duly signed by the proprietor & FTS.
There are two types of certifications –
GMP certification is provided to ensure that the products are consistently produced and controlled as per the quality standards prescribed with WHO. This certification is given to minimize the risk involved in any pharmaceutical production.
GMP means good manufacturing practice certification which signify that the pharmaceutical manufacturing company has cleared the inspection of the pharmaceutical regulatory body of that country, meets the standards of good manufacturing practices as prescribed by WHO and it is safe to be exported in any part of India.
Any manufacturing company having this certificate is legally permissible to sell the pharmaceutical products in any part of the country whereas in case if pharmaceutical product is registered under overseas, the government authority incharge will ask COPP to ensure that the product is being sold as a commercial finished product in the country.
Process Of Obtaining Ayush License
The process of obtaining Ayush license is as follows –