Ayush License

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 –

Retail license – You need to obtain retail license in case you want to sell the ayurvedic or herbal products as a retailer.

Wholesale license –You need to obtain wholesale license in case you want to sell the ayurvedic or herbal products as a wholesaler.

Manufacturing license - In case you are planning to manufacture ayurvedic drugs and medicines, you need to set up your own manufacturing unit and obtain an ayush license for the same. Any person who wants to apply for Ayush manufacturing license needs to comply with all the state requirements issued by the Ayush state authority.

In order to take Ayush manufacturing license, these requirements must be fulfilled by the applicant under Ayush act –

The manufacturing unit set up should be an industrial area.
The manufacturing unit should have an area of minimum 1200 sq. ft for one category of drug only.
You need to add more space in case more than one drug is required.
The manufacturing unit is mandatorily required to be GMP certified.
You team must consist of 2 ayurvedic experts and 2 pharmacists.  All the manufacturing & packaging machinery should be available with you

Regular inspection of the premises should be done by drug inspectors.

Ayush loan license –Ayush loan license is issued in case the products are manufactured by the third party manufacturers. In such cases, manufacturing unit is not owned by the applicant. This loan license should apply with a GMP certified manufacturer and later issued to the
applicant company.
In order to take Ayush loan license, these requirements should be fulfilled by the applicant under Ayush act –
The manufacturing unit set up should be an industrial area.
The premises should have minimum three rooms –
One room for raw material storage
One room for finished material storage
One for office
Regular inspection of the premises should be done by drug inspectors.
Loan license should be renewed regularly.
No ayurvedic experts & pharmacists are required.
The manufacturing set up and company registration should be the same.

Ayush contract/ third party manufacturing licenses: In this case, neither the manufacturer has his own manufacturing set up or nor the license. This contract only consists of marketing part which is to be done by the contract/ third party manufacturing. Manufacturer takes care of all the compliance & liaison work. The manufacturer license is used and the manufacturer will get approval from the concerned authorities
for your product. However, you have the right to provide raw material & packaging material to the manufacturer or else manufacturer can arrange the same from his own sources. For ex - ABC ltd. is the manufacturer but the goods are marketed by you as a third party manufacturer.

Documents Required To Obtain Ayush License (For Retailers Or Wholesalers)

The documents required to apply for ayush license are as follows –

1 Memorandum of association (MOA) (https://www.finacbooks.com/memorandum-of-association-moa-amendment) & articles of association
(AOA) of the company
2 Photo ID proof of the proprietor/ director/ partner of the company
3 Address proof
4 Qualification proof
5 Registration of Delhi ayush council (In case you are applying for the license in Delhi state)
6 Affidavit regarding the compliance of MPD 2021
7 Biodata and appointment letter of the director of the company.

Documents Required For License Of Manufacturing Of Ayurvedic Or Herbal Products

Attested copies of documents related to ownership/rent/lease
Plan or layout of the premises showing the installation of machinery & equipment.
Declaration 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

Name of the product
Detailed method of preparation
Formula shall contain shastric/tibbi name, part used & quantity.
Indications
Purifications of drugs wherever required
Detail dosage schedule
Side-effects
Anti-dotes
Diet restrictions (If any)

Process Of Obtaining Ayush License

The process of obtaining Ayush license is as follows –

STEP 1 – Every state has a different website for Ayush. Visit your own state website of Ayush.

STEP 2 – In the second step, download the application form, attachment, list of documents including affidavits & other certifications such as
GMP and COPP (Apply for GMP & COPP, if applicable)

STEP 3 - In the third step, fill your application form and send the same for review along with the documents to the commissioner of Ayush
department.

STEP 4 - In the fourth step, commissioner will review your application along with the required documents. If commissioner of Ayush department feel satisfied after checking your application. The application will be processed within 15 days.

STEP 5 - In the fifth step, after processing of the application, ayush license is granted to the company