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 –

  • 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.

What Is Included In Our Package?

Eligibility Consultation

Document Preparation

Application Drafting

Government Fees


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) & 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 Needed For License Of Manufacturing Of Ayurvedic Or Herbal Products

  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)

Certifications

There are two types of certifications –

GMP (Good manufacturing practice) certification

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.

COPP (Certificate of pharmaceutical product)

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 –

  • 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.

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