Ayush License

Overview

Overview

What is Ayush License ?

AYUSH stands for Ayurvedic, Yoga & Naturopathy, Unani, Siddha, and Homeopathy. These are all ancient forms of medicine and treatments which have been quite popular in India since decades. Prior to 2014, these products and treatments were in extensive use but remained completely unregulated. However, since the establishment of a dedicated AYUSH Ministry under the Central and State governments, in the year 2014, AYUSH businesses have received a robust regulatory framework for manufacturing, sale, marketing, and export of products within and outside India.

AYUSH licenses are a significant part of this regulatory framework, whereby the Government prohibits unlicensed AYUSH businesses from operating in India. The AYUSH license is granted by the AYUSH Ministry of the state government, under the jurisdiction of which the AYUSH business operates. The license must be obtained by all businesses dealing in Ayurvedic, Unani, Siddha, herbal, and homeopathy, drugs / cosmetics, and other related treatments. As far as the application for the grant of license is concerned, the provisions for the same are mentioned in the Drugs and Cosmetics Rules, 1945.

License Is Important

Legal Authorization
Without the license you cannot legally manufacture or brand AYUSH products in India.

Quality & Safety Compliance
It ensures your products meet Good Manufacturing Practices (GMP) and other safety standards under Schedule T or applicable rules of the Drugs & Cosmetics Act.

Business Credibility
Having this license boosts consumer trust and helps companies expand into retail, distribution, and export markets (e.g., via Certificate of Pharmaceutical Product — COPP).

Export & Growth Options
The license also allows access to international markets with additional certifications (like COPP) if you want to export AYUSH products.

Documents Required

1.     Copy of Manufacturing License, if the applicant is manufacturing AYUSH products

2.     Site layout of the manufacturing facility

3.     Details of Manufacturing formula and manufacturing process

4.     Finished product specification report

5.     List of applied and approved products for COPP certification

6.     Process Validation Report for 3 batches

7.     Details of the technical staff, their names, experience, and qualifications

8.     List of equipment to be used for manufacturing

9.     Water & HVAC system diagrams

10.    Proof of Safety & Effectiveness according to Rule 158B of Drugs & Cosmetics Rules, 1945

11.    Undertaking regarding the absence of non-herbal ingredients, applicable in case of herbal products

12.    Undertaking regarding compliance with the Drugs and Cosmetics Act, Drugs and Cosmetic Rules, Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954, and its corresponding rules (applicable in case of herbal products only)

13.    KYC details of the applicant

14.    Address Proof of the Premises (Rent Agreement)

15.    Constitution Document of the business

Apply to AYUSH License

1  Decide the License Type

Choose whether you need a Manufacturing, Loan, or Third-Party license.

2  Prepare Required Documents

 Collect business, technical, and premises documentation. https://www.bajajfinserv.in

3  Apply Online

Submit the application through the official AYUSH portal (often via state AYUSH/DCA portal or e-Aushadhi).

4  Pay Fees

Pay the prescribed government application fee (varies based on product count/type).

5  Inspection

State Drug Licensing Authority inspects the premises for GMP compliance (premises, personnel, hygiene, quality control).

6  Grant of License

Upon successful verification and inspection, the license is issued (often in Form-25D for manufacturing).

Benefits

Legal Recognition   -   Obtaining an AYUSH license grants you legal recognition to practice traditional medicine in India. It provides a regulatory framework for traditional medicinal practices, ensuring that the public receives safe and effective treatments.

Wide Acceptance   -   The AYUSH system of medicine is recognized and widely accepted in India. It has been practiced for thousands of years and is still popular among people today. Obtaining an AYUSH license allows you to tap into this endless market very easily.

Increased Credibility   -   An AYUSH license adds credibility to your practice. It demonstrates that you have undergone the necessary training and have met the standards required to practice traditional medicine in India. This can enhance the trustworthiness of your brand.

Diversification   -   Obtaining an AYUSH license allows you to diversify your practice. You can offer a wider range of treatments to your patients, combining modern medicine with traditional practices. This can help attract more patients and increase your revenue.

Health Benefits   -   The AYUSH system of medicine is known for its holistic approach to health and wellness. It focuses on the prevention of diseases, rather than just treating the symptoms. The health benefits offered by a licensed AYUSH practitioner are immense.

Job Opportunities   -   There is a growing demand for AYUSH practitioners in India, both in the public and private sectors. Obtaining an AYUSH license can open up job opportunities of service and self employment in government and private hospitals alike.

Risks Without License

Operating without the required AYUSH license can lead to:

❌  Product seizure or confiscation
❌  Heavy fines
❌  Imprisonment for serious offenses
❌  Forced shutdown of business

Summary

   Aspect                                          Details

    What                                       Legal license to manufacture/distribute AYUSH products

    Why                                         Ensures safety, quality and legal compliance

    Law                                         Drugs & Cosmetics Act and AYUSH rules

   Types                                       Manufacturing, Loan, Third-party, Homoeopathy

  Who Needs It                            Manufacturers, brand owners, distributors exporting

   Process                                   Online application → inspection → license issuance

    Validity                                     Perpetual (license) + 5-year GMP renewals

FAQs