AYUSH License: Types, Process, Documentation & Requirements

AYUSH License: Types, Process, Documentation & Requirements – The AYUSH license is very essential for operating a business dealing with the production of Ayurveda, Yoga, Unani, Siddha, and Homeopathy products. As the demand for natural and traditional healthcare solutions is expanding, many business professionals are turning to this industry to earn high profits. If you are also interested in starting a business related to  Ayurveda, Yoga, Unani, Siddha, and Homeopathy products. You have reached the right destination. As we are going to discuss the Ayush Licence: Types, Process, Documentation & Requirements.

Traditional healthcare systems such as Ayurveda, yoga, Unani, Siddha, and Homeopathy originated in India and have a very vast history. Even after being an ancient healthcare system they still have the same importance and relevance among the general public as they have amazing healing properties with no side effects. 

If someone is interested in operating a business dealing with Ayurvedic, Yoga, Unani, Siddha, homeopathy, drugs/cosmetics, and other related treatments then is very crucial to get an AYUSH license. AYUSH License is issued by the Central Government under the Ministry of AYUSH. This  Ministry was established in the year 2014. Before its establishment, the AYUSH License was used to be issued by the Department of Indian System of Medicine and Homeopathy (ISM&H), established in 1995. 

Different Types of AYUSH Licenses Available in the Market

There are many different types of Ayush licenses mentioned as follows. 

1. AYUSH Manufacturing License –

This type of license is granted to someone who deals with the manufacturing and marketing of the AYUSH and related products. In this case, the applicant is supposed to establish a manufacturing unit for operation. 

2. AYUSH Wholesale and Retail License –

This type of license is granted to someone interested in wholesale or retail business or who wants to own a shop of its own related to AYUSH and related products. 

3. AYUSH Loan License –

This type of license is granted to someone who wants to get a manufacturing license but does not own a manufacturing unit. The applicant uses the premises, machinery, equipment, and experts of another person who has an AYUSH Manufacturing License. Here, the third party deals with the manufacturing of products. 

4. AYUSH Third-Party Manufacturing License –

In this arrangement, the applicant neither owns the license nor the manufacturing unit. So, they work on a contract basis with a third party for the manufacturing of their products. In this case, the applicant is only involved in marketing and selling of the products. 

5. Unani Manufacturing License –

Unani is regarded as the science and craft of healing. This type of medicine is famous among people because of its unique kind of healing procedure and is preferred among others as it does not have any side effects. 

6. Siddha Manufacturing License –

Siddha is a kind of treatment that creates a connection between the body, mind, and spirit. Siddha believes that our body, mind, and spirit are equally important for general well-being. This health care system works n achieving a complete balance between the psychological and physiological functions of the body.

How can we obtain the AYUSH License?

You can obtain the AYUSH license by simply following the steps mentioned below.

1. Documentation – In India, the AYUSH registration process is completely online and application-based. Before filling out the application, make sure to collect all the essential supporting documents in their prescribed format and with up-to-date information.  
2. Visit the Official Website – After ensuring that you own all the required documents the next step is to open the official website and download the form needed for registration purposes. The applicants also need to provide the GMP and COPP certification. Then, just fill out the form very carefully and double-check all the information filled in. 
3. Submitting the Application Form – After filling out the application form, the next step is to submit the form by attaching all the required documents as per the need for AYUSH License Registration.
4. Approval by the Concerned Department – On submitting the application form to the AYUSH Department’s Commissioner. The commissioner will review the form, and if satisfied he/she will grant their approval within 15 days. 
5. Obtaining the AYUSH License – On successful approval by the AYUSH Department’s Commissioner, the applicant will receive the AYUSH License by post. 

What is the list of Essential Documents Required to Obtain an AYUSH License? 

To obtain the AYUSH license, the applicant needs to collect the mentioned supporting documents in their prescribed formats with the latest information. Any error in obtaining and filing these documents may lead to the complete rejection of your application for the AYUSH License. The list of documents may vary depending on the state rules.

• A Copy of Manufacturing License (if the applicant is dealing with manufacturing)
• Blueprint and Site layout of the manufacturing facility
• Details of the manufacturing process
• Specification report of the finished product
• List of approved products for COPP certification along with product composition
• Process Validation Report ( for 3 Batches)
• Complete bio data of the technical staff, along with their experience, and qualifications
• List of equipment and machinery to be used
• Water & HVAC( Heating, Ventilation and Air conditioning) system diagrams
• Proof of safety & effectiveness according to Rule 158B under the  Drugs & Cosmetics Rules,1945
• Undertaking regarding the absence of non-herbal ingredients (in the case of herbal products)
• Undertaking regarding compliance with the Drugs and Cosmetics Act, Drugs and Cosmetic Rules, Drugs & Magic Remedies Act, 1954, and its corresponding rules ( only in the case of herbal products)
• Applicant’s KYC details 
• Address Proof of the Premises 
• Constitution Document of the business such as MOA/AOA or Partnership deed/LLP

Conclusion

To conclude, obtaining an AYUSH License is a very simple process once you understand the whole process. This license grants you legal recognition to practice traditional medicine such as Ayurveda, Yoga, Unani, Siddha, and Homeopathy in India. Moreover, the AYUSH license verifies the quality of the product and ensures the best quality and safety of the product for the customers. 

FAQS regarding AYUSH Licence: Types, Process, Documentation & Requirement

Question 1. What are the eligibility criteria that the applicant has to fill to obtain the AYUSH manufacturing license?

Answer 1. If someone is interested in obtaining an AYUSH manufacturing license, the following criteria need to be fulfilled. 

• Own a manufacturing facility, on land.
• Land must be at least 1200 square feet for the manufacture of a single product. The land area will increase according to the number of products manufactured. 
• Obtain a GMP(Good Manufacturing Practice) Certificate.
• The presence of  2 Ayurvedic experts and at least 2 Ayurvedic pharmacists in the manufacturing facility.
• Good quality machinery and equipment must be installed in the manufacturing facility for production and packaging processes.

Question 2. What is the application fee for obtaining the AYUSH license?

Answer 2.  With the 4th Amendment to the Drug Rules, enforced on October 1st, 2021, the application fee for AYUSH License has been revised to Rs.2,000 from Rs1,000, for any number of Ayurvedic, Unani & Siddha drugs/cosmetics. In addition to this, the fees for up to 10 proprietary Ayurvedic, Unani, and Siddha drugs have been increased to Rs.3,000. 

Question 3. What are the benefits of the AYUSH license?

Answer 3. The following are benefits associated with the AYUSH license. 

• AYUSH license adds credibility to your practice and indicates that you have undergone the necessary training and have met the standards required to practice traditional medicine. 
• The AYUSH system of medicine is widely accepted in India and all around the world. Obtaining this license helps you to tap into an endless market very easily with assured profits.
• AYUSH license helps enhance the trust of users in your manufactured products and services.
• AYUSH license helps you to diversify your practice. So that you can offer a wide range of products and services to your customers.  
• The products manufactured under the AYUSH license are known for their holistic approach to health and wellness. They provide many health benefits and focus on the prevention of diseases, rather than just treating the symptoms. 

Question 4. Till how many years is the AYUSH license valid?

Answer 4. Before the 4th amendment of the  Drugs Rules, 2021, the validity of the AYUSH License was extended up to 5 years only. However, after the new rules were introduced and enforced on the 1st of October, 2021, the validity of the AYUSH license has been extended for a lifetime, unless the license is suspended or canceled by the issuing authority. Additionally, the manufacturing facility has to be inspected and the GMP Certificate will have to be validated every 5 years.