Ayush License

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.

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

1. Memorandum of association (MOA) & 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.

1. 1

   Attested copies of documents related to ownership/rent/lease

2. 2Plan or layout of the premises showing the installation of machinery & equipment.

3. 3Declaration of the proprietor/director/ partnership in affidavit – 1 enclosed with online form, attested partnership deed/MOA & AOA

4. 4

   List of detailed manufacturing & analytical equipment

5. 5

   Appointment letter to full time technical supervisor.

6. 6

   Attested copies of academic qualification certificates, experience certificates from Ayurveda/unani and declaration of technical staff in the prescribed format.

7. 7

   Passport size photos of proprietor & Fulltime technical supervisor.

8. 8

   List of shastric medicines as well as the Xerox copies of concerned pages duly signed by FTS with samples

9. 9

   Each drug sample with sales pack draft labels with different sizes.

10. 10

    Sales pack draft labels for each drug as per D&C rules with different sizes

11. 11

    Self-addressed envelope along with sufficient postal stamps.

12. 12

    Clinically trial reports on at least 30 patients for each drug used orally from institutionally qualified ayurvedic/unani practitioners as per performa guidelines.

13. 13

    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)