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Introduction

AYUSH License is a mandatory license for any business engaged in Ayurvedic, Yoga & Naturopathy, Unani, Siddha and Homeopathy activity. There are three types of AYUSH License issued with AYUSH Ministry specifically for Manufacturers, Retailers and Loan License. In this article, you’ll get complete details related to AYUSH License including Eligibility Criteria, Documents Required, Procedure and Validity of AYUSH Registration.

What is the AYUSH License?

The term AYUSH stands for Ayurvedic, Yoga & Naturopathy, Unani, Siddha and Homeopathy. These all are the ancient types of medical treatment used in India for years. The launch of AYUSH Ministry created a big impact on these medical treatments again. However, The Ministry of AYUSH was framed on 9th November 2014 but before it was known as the Department of Indian System of Medicine and Homeopathy (ISM&H) which was made in March 1995.

In order to run a business related to medicines including manufacturing, marketing, sale or export/import of products require this Ayush License. The Ayush License is granted by the AYUSH Ministry of the State Government. This license is required for any business dealing in Ayurveda, Yoga & Naturopathy, Unani, Siddha or Homeopathy. However, there are some provisions mentioned in Drugs and Cosmetics Rules, 1945, these provisions must be followed in order to get AYUSH License.

Types of Ayush License

There are different types of AYUSH License. Depending on the type of business needed, one can select their more needed license. Following are the types of AYUSH License includes the following:

  1. AYUSH Manufacturing License: The Ayush Manufacturing License is required in the businesses engaged in the manufacturing and marketing of their own ASU products and treatment as well.
  2. AYUSH Retail License: AYUSH Retail License is used by individuals or companies to sell the AYUSH Product to consumers directly.
  3. AYUSH Loan License: While, AYUSH Loan License is required in the businesses who are not manufacturing the products but renting it from some other manufacturer.

Eligibility Criteria to Get Ayush Registration

In order to get AYUSH License, businesses need to fulfil some basic requirements depending on the type of AYUSH License. Following is eligibility criteria for each license:

AYUSH Manufacturing License:

  • To obtain AYUSH Manufacturing License, applicants must have a manufacturing unit on industrial land.
  • The Manufacturing unit must be GMP Certified.
  • There should be at least 2 ayurvedic experts and 2 Ayurvedic Pharmacists in the business.
  • For one single product, the manufacturing unit must be of 1200 sq. feet and in case of more products, the area will also increase.
  • All Machinery and equipment must have been installed in the Manufacturing unit for production and packaging.

AYUSH Retail License:

  • Any retailer or wholesaler of AYUSH Product is not required to apply for AYUSH Retail License as per the Chapter IV A, Section 33A of Drugs and Cosmetics Act, 1940.

AYUSH Loan License:

  • Any Loaned Manufacturing unit must be situated in an industrial land.
  • No Ayurvedic or Pharmacies Expert is required for AYUSH Loan License.
  • Manufacturing unit being loaned must have a spare room for storage of raw material and final product.
  • Loan Licensed is subject to regular renewal.

Documents Required for Ayush Registration

Following is the detailed list of the documents required for AYUSH Registration:

  • Finished Products Specification Report
  • Copy of Manufacturing License for those who manufacturing AYUSH products
  • Manufacturing Unit Site Layout
  • Process Validation Report for 3 batches
  • Water & HVAC system diagrams
  • KYC details of the applicant
  • Address Proof of the Premises (Rent Agreement)
  • Constitution Document of the business
  • List of equipment to be used for manufacturing

How to Apply for Ayush License?

In order to apply for Ayush License one need to follow these steps:

  • Step 01: Documentation: In order to obtain the AYUSH License, the first step is to gather all the required documents for the filing process. Make sure all the documents are correct and accurate. The documentation process of AYUSH License is completely online.
  • Step 02: Obtain GMP Certificate: The GMP Certificate is a crucial document that must be submitted while applying for AYUSH Certificate. The Drug/cosmetics manufactured in India must comply with the guidelines issued by Good Manufacturing Practices. The GMP Certificate can be obtained from the Drug Controller General of India.
  • Step 03: Get COPP Certificate, if needed: In order to ascertain the quality of drugs exported through countries, WHO has designed this COPP Certificate. This certificate is mandatory for manufacturers if they are supplying their products outside India.
  • Step 04: File the Application: Fill Form 24D for AYUSH Manufacturing License & for Form 25E for AYUSH Loan License. However, these licenses vary from state to state. It is advised to take consultant advice for choosing the right form. Fill the required details, obtain its scanned copy and then submit the application.
  • Step 05: Verification: After submitting the application, the AYUSH Department’s Commissioner will visit your office or manufacturing unit to conduct a physical examination. On the basis of the report submitted by the Commissioner, your application will be approved.
  • Step 06: AYUSH License: On the approval of the commissioner your AYUSH License will be approved. Usually it takes 60 days for the Department to process the application for final processing of AYUSH Certificate.

Validity or Renewal of Ayush Registration

The AYUSH License is valid for up to 5 years only before 4th Amendment Rules, 2021. It was used to renew regularly before the expiry of its term of validity but after the introduction of the rules, the validity of AYUSH License has been extended for lifetime. However, applicants are needed to submit a self-compliance declaration every year otherwise the license will be cancelled or suspended.

Why Bizfoc?

Bizfoc offers easy handling of documents required for AYUSH License to their clients. They can help you in getting you your AYUSH License. They guide their clients throughout the process of getting the certificate. Bizfoc has a team of experienced professionals who deal with AYUSH License.

Conclusion

AYUSH License is a mandatory license for the individual involved in Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy products. AYUSH registration to get the certificate or license is a critical process and any error in documents can lead to direct rejection. There are three major types of AYUSH License including Manufacturing License, Retailer License and Loan Licensed. It is important for an individual to fill the correct form: Form 24D or Form 25E, depending on their need.

Frequently Asked Questions

Legal recognition, wider acceptance among the public, increased credibility, diversification of practice, health benefits for patients, etc are some benefits of AYUSH License.

Yes, the Ayush license is mandatory for those dealing in Ayurved, Yoga & Naturopathy, Unani, Siddha or Homeopathy.

AYUSH Manufacturing License, AYUSH Retail License, AYUSH Loan License, etc are the different types of AYUSH License.

After 1st of October, 2021, AYUSH License validity has been extended for lifetime. However, it was 5 years before the 4th Amendment, 2021.

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