The Ministry of Ayush issues the Ayush license for doing business in manufacturing products relating to Ayurveda, Yoga, Unani, Siddha and Homoeopathy. We assist in getting the Ayush License in India.
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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.
Required if the business wants to manufacture and market its own ASU products / treatments, for which it will use its own manufacturing facility.
Required by a manufacturing business which does not own a manufacturing unit, and is renting it from some other manufacturer, along with the manufacturing equipment and staff.
All types of businesses dealing with Ayurvedic, Unanni, Siddha or herbal products / treatments are required to obtain the AYUSH Certificate online to carry out their business activities in India. However, there are some minimum requirements that these businesses need to fulfill based on the types of AYUSH license they have applied for. We have listed out all such minimum requirements below.
| S.No | Name of the License | Minimum Requirements to obtain the License |
|---|---|---|
| 1. | AYUSH Manufacturing license |
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| 2. | AYUSH Retail & Wholesale License | A retailer or wholesaler of Ayush products is not required to apply for AYUSH Retail or wholesale license. As provided in section 33A of Drugs and Cosmetics Act, 1940 (The Act ), Chapter IV A of the Act, which regulates the manufacture, sale, and distribution of drugs and cosmetics is not applicable to Ayush products. Further, Chapter Chapter IV A of the Act regulates only manufacturing of Ayush products. For detail plz click here |
| 3. | AYUSH Loan License |
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| S.No | List of Documents required for AYUSH License |
|---|---|
| 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 |
The AYUSH Registration process in India is completely online and application-based. The concerned AYUSH License application form is filed along with certain supporting documents submitted in their prescribed formats and containing up to date information. Any error in filing these documents may lead to the complete rejection of your application. Therefore, we strongly recommend that you begin the process of application filing only after ensuring that you are in possession of all the necessary documents.
The World Health Organisation has issued guidelines for Good Manufacturing Practices to regulate the drug/cosmetics manufacturing process and the quality of manufactured drugs/cosmetics products. These guidelines have been adopted by several nations, including India. So, even the drugs/cosmetics manufactured in India must comply with these guidelines and obtain a GMP Certificate validating its compliance, from the Drug Controller General of India. However, the application for it can be made to the Drug Control Department of the concerned state. The GMP Certificate is an important document to be submitted while applying for the AYUSH license.
Certificate of Pharmaceutical Products is a certificate designed by the WHO to ascertain the quality of the drugs exported from one country to another. This Certificate is usually sought by the National Health Authorities of the importing country, and is required to be obtained by the exporter from its country of origin. For manufacturers of AYUSH drugs and cosmetics planning to sell their products outside India, this certificate will have to be necessarily submitted while applying for the AYUSH license. Like GMP Certificate, even COPP is issued by the Drug Controller General of India. However, the application for it can be made to the Drug Control Department of the concerned state.
Once you are sure that you are in possession of all the necessary documents, you can begin the process of AYUSH License apply online. Rule 153 of the Drugs and Cosmetics Rules, 1945, prescribes form 24D to be filed for the grant of AYUSH manufacturing license and Form 25E for the grant of AYUSH loan license. Since these licenses are state-specific, the concerned application can be downloaded from the e-aushadhi portal.
Once the application form is downloaded, you are required to fill in the necessary details manually. These include the details of the place of business or location of the manufacturing facility, the details of the product to be manufactured and/or sold, and the details of the staff employed. After having filled out the application, obtain its scanned copy, and submit it on the Department’s website along with the scanned copy of the prescribed documents and prescribed application fees.
Upon receiving the application, the Department will examine it thoroughly and verify every bit of information it contains. Also, the AYUSH Department’s commissioner would visit your office/place of business/manufacturing facility to conduct a physical examination and prepare a report for the same. Based on the report of the Commissioner, the Department will ultimately decide whether to approve your application or not.
If the Department has approved the application based on its examination of the form and the main office/manufacturing facility of the business, it will grant the AYUSH license to the applicant in Form 25D. Usually, it takes around 60 days for the Department to process the form used for the AYUSH Certificate application online.
Prior to introduction of the Drugs (4th Amendment) Rules, 2021, the validity of the AYUSH License extended up to 5 years only. It was regularly needed to be renewed before the expiry of its term of validity. However, after the said rules were introduced and enforced on the 1st of October, 2021, the validity of the AYUSH license has been extended for lifetime, subject to online submission of self-compliance declaration every year or unless the license is suspended or cancelled. Other than that, the manufacturing facility will be inspected and the GMP Certificate will have to be validated every 5 years.
With the 4th Amendment to the Drug Rules, enforceable since October 1st, 2021, the application fees for AYUSH License has been revised to Rs.2,000 from the earlier fees of Rs1,000, for any number of Ayurvedic, Unani & Siddha drugs/cosmetics. Additionally, the fees for up to 10 proprietary ASU drugs have been increased to Rs.3,000.
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.
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.
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.
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.
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.
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.
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