AYUSH implies for Ayurveda, Yoga, Unani, Siddha and Homeopathy and anyone who is involved in the business of manufacturing and trade of them is required to obtain an AYUSH license issued by the Ministry of AYUSH.
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Overview of AYUSH License
AYUSH Licenses are given by the government of India to those who wish to start a business in Ayurvedic/Unani/Siddha or any similar products. Such license is granted by the Ministry of AYUSH. The Ministry of AYUSH was established on 9th November 2014; earlier, it was known as the Department of Indian System of Medicine and Homeopathy (ISM&H), which was established in March 1995.
Ayurveda is the oldest form of medication system in the world, and it has been in India for millions of years. It has no side effects, and thus, its popularity is rising worldwide, and many countries have become their importers.
Points to be Considered while Applying for AYUSH License in India
- Any individual or entity cannot start or continue a drug or cosmetic business without obtaining an applicable license for running such a business.
- To conduct a medicine business under the purview of the Drug & Cosmetic act 1940, all forms of drug business like allopathic, homoeopathic, ayurvedic, herbal, or Unani drugs are protected.
- An individual must obtain a license from the Ministry of AYUSH to start manufacturing Ayurvedic medicines.
Benefits of Obtaining the AYUSH License
There are various benefits a person can have if they obtain AYUSH License –
- The individual or entity, after obtaining the AYUSH License, can function in any state regardless of the location of the manufacturing company.
- The individual or entity who has applied for the AYUSH License only looks after the marketing part of the product; the rest of all the compliance necessary for the product is being taken care of by the manufacturing company.
- AYUSH License benefits under the Health Insurance Policy as Benefits cover.
- The use of Ayurvedic and herbal medicine is most preferred in Indian culture, and to regulate and restrict the improper use of Ayurvedic medicine, one must get the AYUSH License.
- The government, with its approach of “go local”, is also encouraging entities and consumers to rely on home production, i.e., Ayurvedic and herbal medicines.
- The medicines produced by natural herbs and ayurvedic resources have a low risk of side effects, and the AYUSH license helps in enhancing the trust of the users.
Types of AYUSH Licenses
The manufacturing Licenses that are issued by the Ministry of AYUSH are as follows:
Let Us Discuss the Types of AYUSH Licenses in Depth, Those Are as Follows: –
- AYUSH Manufacturing License
It is acquired in the situations when the candidate wishes of getting the license and has come out with a plan of manufacturing and marketing both of the products. In a situation like this, the producer needs to set up his manufacturing unit.
Every state has its own set of requirements for setting up such manufacturing units. One needs to agree to all the requirements expressed by the state authority of AYUSH.
Requirements under AYUSH Act to obtain AYUSH Manufacturing License:
- It is necessary for the manufacturing unit to be in an industrial area.
- The minimum size of the manufacturing land for producing one Drug only should be 1200sqft.
- In case you are planning to produce more than one Drug, then it will eventually add more categories because you will require more space.
- It is compulsory for the manufacturing unit to be certified by GMP.
- Make sure to have on board 2 Ayurvedic experts and two pharmacies.
- You have access to all the manufacturing and packaging machinery.
- The drug inspector will conduct regular inspections of your manufacturing unit.
- Unani Manufacturing License
Unani Medicine is regarded as the science and craft of healing. It is a respectable profession of healing the enduring of humanity. The Unani framework is popular amongst people because of its one-of-a-kind approach through which it prevents and cures diseases. It has received mass acknowledgement as one of the corresponding medical systems.
- Siddha Manufacturing License
The treatment is done to maintain a balance between the mind-body and spirit system. Siddha treatment gives equal importance to the body, mind, and spirit and endeavours to restore complete harmony to different psychological and physiological functions of the body. In the treatment of Ayurveda, yoga plays a crucial role along with meditation, diet, and lifestyle.
- AYUSH Loan License
In this sort of set-up, the manufacturing unit is not claimed by the candidate. The Third-party manufactures the product. Such Loan License is to apply with a GMP certified manufacturer, and from there on, it will be given to the applicant organization. Thereafter product approval is needed to be acquired from the authorities.
Documents required to obtain an AYUSH License
- Applicant’s details such as Name, Address, E-mail, Contact Number
- A copy of the Manufacturing License,
- Complete product list applied for issuance of COPP and their composition,
- Site Master file/ Manufacturing Plant Layout,
- Submit the manufacturing formula along with the manufacturing process,
- Method of analysis and finished product specification Report,
- Approved products list,
- Stability study analysis based on batch, along with the Date of manufacturing, Date of Expiry, stability study condition, the name of the Drug
- Process validation report for three batches,
- Technical staff list along with the information like experience, qualification, and approval status,
- List of equipment and instruments used or to be used,
- Water System Diagram,
- HVAC System Diagram,
- Export data for the last two years, wherever re-validation of COPP is applicable,
- A proof of safety and effectiveness as mentioned in Rule 158B of Drugs & Cosmetic Rules, 1945.
- Undertaking related to the absence of any non-herbal such as metals/ or minerals etc. in the products applied for WHO-COPPs (Applicable in case of herbal products)
- Undertaking related to compliance with the provisions of domestic regulations inter-alia Drug and Cosmetics Act, 1940 and Rules thereunder, Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and rules thereunder, (Applicable in case of herbal products).
Procedure to Obtain the AYUSH License
Every Manufacturer dealing with Ayurvedic or herbal articles has to obtain a license from the Ministry of AYUSH. Every state has its own AYUSH website. To obtain the AYUSH license, an applicant must visit the AYUSH website of their concerned state. Below mentioned steps are required to obtain the license-
- Visit The Website
Visit the individual state website of AYUSH and download the application form for an AYUSH license. Also, the applicant shall provide the requisite GMP and COPP affidavits.
- Submission Of Form
The next step is to fill out the application form, attach the supporting documents, and send it for review to the AYUSH Department’s commissioner.
- Approval By The Commissioner
Once the commissioner gets satisfied, he will grant their approval within 15 days.
- Obtaining The License
An applicant will receive the AYUSH license by post.
Loan License holder Involvement
The Loan License holder can give the crude materials and packaging material, or the producer can arrange it from their sources too. The Manufacturer works to convert such raw material into the finished product and hence gives the finished product. The license holder can apply for a Loan License again with a new GMP certified manufacturer.
Charges imposed by the Manufacturer on Loan License Holder
The Manufacturer may charge conversion charges, i.e., you may have to pay for manufacturing the desired item on the Manufacturer’s premise. The Manufacturer will also ask for the product approval fee.
For that aspect, a legal report is required to be drafted between the maker and your insights concerning the way that you own the item. The Legal record so drafted ought to be sufficiently able to safeguard your privileges if there should be an occurrence of any dispute. It must have a clause in it that says no matter what, your company remains the owner of the product.
ApkaTax assistance in Obtaining the AYUSH License
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- Filing of the application.
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- Collection of requisite documents.
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Frequently Asked Questions
Manufacturers who are involved in producing Ayurvedic or Herbal products in India need to acquire an AYUSH License controlled by the Ministry of AYUSH. The Ministry of AYUSH was framed on 9th November 2014.
The Unani framework is popular amongst people because of its one-of-a-kind approach through which it prevents and cures diseases. It has got mass acknowledgment as one of the corresponding medical systems.
Manufacturing licenses that are issued by AYUSH are as follows:
- AYUSH Manufacturing License
- Unani Manufacturing License
- Siddha Manufacturing License
- AYUSH Loan License
- Contract Manufacturing/ White label Manufacturing/ Third Party/ Product to Product Manufacturing
Siddha treatment gives equal importance to the body, mind, and spirit and endeavors to restore complete harmony to different psychological and physiological functions of the body.
As per the protocols of HWC in AYUSH License, there is nearly 5,000 population in plain area and 3,000 population in hilly area covered under each Sub Health Centre.
It is compulsory to have AYUSH Retail license if you want to sell Ayurvedic /Unani / siddha medicines or any product related to ayurvedic in India. Without AYUSH License, you may have to pay penalties for dealing in the business of selling Ayurvedic/Unani products.
- Retail License
- Wholesale License
- Manufacturing License
- Loan License
- Contract or third-party license
- In such courses of action, one uses the manufacturing license of a third-party manufacturer to manufacture the said product. The applicant needs to market the product only. Further, in the applicant part, it is not needed that they should own a manufacturing unit.
- Certificate of Good Manufacturing Practices (GMP) demonstrates that the pharmaceutical manufacturing organization has gone through the examination and passed it by the regulatory body of that country. It guarantees that the item fulfills the guidelines of good manufacturing practices as expressed by the WHO.
- The COPP is the authoritative document that confirms the manufacturing organization having this certificate is legitimately permitted to sell their pharmaceutical item in the nation they are creating. In case of abroad, the administrative body responsible for approving the application will request COPP to guarantee that the item is being sold as a commercial finished product in the nation that is producing it.