Ayush License in India

Ayush License in India

Ayush License in India

Licenses Types:

  • AYUSH manufacturing license

  • AYUSH Loan License

  • AYUSH Retail License

  • AYUSH Wholesale License

 

AYUSH manufacturing license

A person who wishes to manufacture herbal or ayurvedic items in India must obtain this license. A licensee in this situation must be building a manufacturing plant in accordance with the laws of their individual states.

The establishment must be located in an industrial setting.

  • A minimum of 1200 square feet is required.

  • If more than one medicine is present, additional space is required.

  • GMP Certificate

  • The team should include two Ayurvedic experts and two pharmacies.

  • Need of Inspection.

AYUSH Loan License

Unlike the previous agreement, the licensee does not own the manufacturing unit. This type of loan license is used in conjunction with a GMP-certified manufacturer. As a result, product approval is also necessary for this type of licensing.

AYUSH Retail License

A person who wants to sell herbal or ayurvedic items in India must obtain this license. A licensee does not require to have their own production facilities; instead, they purchase from a wholesaler.

AYUSH Wholesale License

A person who wants to sell herbal or ayurvedic items in India must obtain this license. A licensee does not require to have their own production facilities; instead, they purchase from a wholesaler.

List of Documents Needed for Ayush License

  • Information about the application. (e.g., PAN, adhar, etc.)

  • Company information (MOA or AOA). If this is the case.

  • Copy of the state government's Manufacturing License.

  • The following is a list of the products that have been applied for.

  • Issuance of Certificate of a Pharmaceutical Product composition.

  • Site Map.

  • Master the manufacturing formula as well as the production procedure.

  • A list of Products that need to be get Approved

  • Stability study evaluation by batch, including manufacturing date, expiration date, stability study condition, drug name, and so on.

  • For three batches, generate a validation report. (Herbal Supplements)

  • The analytical method's validation report.

  • List of technical personnel.

  • List of necessary equipment.

  • The layout of a manufacturing plant.

  • Requires proof of safety and effectiveness.

Submission Process of Application

  • The license must be applied for on the AYUSH state website.

  • Fill out the form, affidavits, and additional certifications, such as GMP and CoPP, if needed.

  • If applicable, submit an application for Good Manufacturing Practices and a Certificate of a Pharmaceutical Product.

  • Submit the information to AYUSH's local directorate.

18 Apr

Jagriti  Mehndiratta
CS Jagriti Mehndiratta

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