Overview of AYUSH License Registration
AYUSH License in India is provided to the companies or businesses that want to venture into the field of Ayurveda, Unani, or Siddha drugs. Chapter four of the Drug and Cosmetic Act, of 1940 talks about the concept of Ayurveda, Unani, or Siddha drugs. The provisions relating to Ayurveda, Unani or Siddha drugs start from Section 33B. AYUSH License is provided by the Central Government under the Ministry of AYUSH. The Ministry of AYUSH was established in the year 2014, before the establishment of the Ministry of AYUSH, AYUSH License used to be provided by the Department of Indian System of Medicine and Homeopathy (ISM&H), which was established in the year 1995.
What is the AYUSH License?
In India, if a person wants to start any business related to import and export, or sale or making of any drugs or cosmetics, then this person needs to abide by the rules written under the Drugs and Cosmetics Act which came in 1940 and the Drugs and Cosmetics Rules which were made in 1945. Any business that engages in any manufacturing, retail business, export, import, or sale of any drugs related to herbal, Unani, or homeopathic or ayurvedic products shall get AYUSH License registered.
India is known for yoga and Ayurveda in the world. In ancient India, doctors used to treat their patients with ayurvedic medicines and Unani methods, the best thing about these methods was that patients do not face any side effects after going through these treatments. Because of their no side effects, Ayurveda and Unani drugs are getting famous worldwide, people are choosing Ayurveda over other allopathic or homeopathic medicines.
Individuals who Require to get AYUSH License
There are three groups of individuals who need to get an AYUSH License in India which are given below-
- Manufacturers of products mentioned under chapter four, Section 33B of the Drugs and Cosmetics Act, 1940 like Self-Manufacturing, Loan Manufacturing, and Third-party manufacturing.
Points to be Remember before Applying for AYUSH License in India
- A person or an entity cannot start any business which indulges in the manufacturing or sale of cosmetics or drugs without a license provided by the appropriate authority.
- If a person wants to start any business in the domain of Ayurveda, Unani drugs or cosmetic, allopathic or homeopathy then he or she needs to abide by the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.
- If a person deals in the business mentioned under Section 33 B of the Drugs and Cosmetics Act, 1940, then he needs to get AYUSH License from the Ministry of AYUSH before starting the business.
Types of AYUSH License
There are various types of AYUSH Licenses that an applicant can avail of, some of them are given below-
1. AYUSH Manufacturing License
AYUSH Manufacturing License is required when the applicant wants to manufacture and market the Ayurvedic, Unani, or Siddha products. In this event, the applicant needs to establish his manufacturing unit for the business. This is one of the most common licenses that people try to get. The procedure and compliances to get the AYUSH Manufacturing License and manufacturing units to vary from state to state. Therefore, the applicant needs to abide by the state laws, in which he wants to open the manufacturing unit. Steps that a person needs to follow to get the AYUSH Manufacturing License-
- The place for establishing the manufacturing unit must be an industrial area.
- The manufacturing unit must be at least 1200 sqft in size.
- If the manufacturer is manufacturing more than one drug or product then he needs to have some more places in the manufacturing unit.
- The manufacturing unit must be Good Manufacturing Practice GMP certified.
- The working team in the manufacturing unit must consist of at least 2 pharmacists and 2 ayurvedic experts.
- The manufacturing unit must have all the machines related to manufacturing and packaging.
- The regular inspection should be done regularly by the inspector.
2. AYUSH Loan License
AYUSH Loan License is obtained if the applicant wants to get the license but does not own a manufacturing unit. In simple terms here the applicant uses the premises, machinery, and experts of another person who has an AYUSH Manufacturing License. Here, the products and drugs are manufactured by a third party. For getting this type of license, first of all, the applicant needs to approach the GMP-certified manufacturer then the license will be issued to the applicant. Later, the applicant needs to take approval for drugs and products from the respective authorities. Steps that a person needs to follow to get the AYUSH Manufacturing License-
- The place for establishing the manufacturing unit must be an industrial area.
- The manufacturing unit must have at least three rooms.
- One room should be used for the storage of raw materials.
- One room should be used for the storage of the final products.
- One room should be used for official purposes.
- The AYUSH Loan License should be renewed on time.
- The inspector should visit the manufacturing regularly for inspection.
- It is not compulsory to have pharmacists and ayurvedic experts.
- The company's registration and the manufacturing set-up should be done on the same footings.
3. AYUSH Contract License or Third-Party Manufacturing License
This type of license is obtained in the situation where the person does not have the license and his own manufacturing unit both. In that case, the third-party manufacturer does only the marketing part and the remaining compliances and liaison work is done by the manufacturer itself. The third part manufacturer does not have any obligation to meet the compliance part.
Here, the license of the manufacturer shall be utilized, and he also needs to take the approval of the third-party manufacturer for all the drugs and products from the respective authorities. But the party manufacturer is free to provide raw material if he wants to avail otherwise that is the duty of the manufacturer himself to avail of the raw material. This type of license is also known as white-level manufacturing or product-to-product manufacturing. The benefits of getting an AYUSH Contract License or Third-party Manufacturing License are given below-
- The applicant needs to take care of marketing only; every other compliance will be dealt with by the manufacturer itself.
- The applicant operates his marketing company in any state irrespective of the location of the manufacturing company.
- The applicant can follow his own method of doing business.
- The display of the product will mention the name of both manufacturer and the third-party manufacturer or the applicant. For example, this product is made by XYZ Company and marketed by the ABC Company.
4. Unani Manufacturing License
Unani is a type of medicine which is regarded as the science and craft of healing. This type of medicine is famous among the people because of its unique kind of healing procedure. People prefer this because it doesn’t have any side effects. It is a very respectful profession with regard to the enduring humanity. In the last few years, this type of medicine becomes preferable among people. Now people start believing in such systems of medicine. It is one of the best corresponding medical systems.
5. Siddha Manufacturing License
This kind of treatment is for the connection between the body, mind, and spirit. It has been believed that some diseases can be cured through willpower as well. Siddha treatment gives equal importance to the body, mind, and spirit. It focuses on the complete harmony between all three of them. They believe that our body, mind, and spirit are somewhat connected with each other. It is the balance between the psychological and physiological functions of the body.
Good Manufacturing Practice or GMP Certification
Good Manufacturing Practice (GMP) is a practice or standard that is maintained to ensure that the products are regularly produced and maintained as per the quality standards prescribed by WHO. This practice is followed to reduce the risk and dilution of pharmaceutical products and drugs.
a good manufacturing practice certificate indicates that the drug manufacturing company has fulfilled the criteria fixed by the pharmaceutical regulatory authorities. It also indicates that the products are meeting the standard of good manufacturing practices set by WHO and they are safe to export and sell in the market.
Certificate of a Pharmaceutical Product (COPP)
The document that is Certificate of a Pharmaceutical Product is a legal instrument that proves that the manufacturing company has got permission from the authorities to sell their products legally in the country where they are selling them. If an individual wants to expand his pharmaceutical business in other countries or overseas then for approval, the governing authority will ask him for the Certificate of a Pharmaceutical Product and without this document, the governing authority will not allow selling the products overseas.
List of Required Documents for AYUSH License
Following are the required documents which are necessary for the AYUSH License-
- The personal details of the applicant, such as the applicant's name, permanent address proof, contact details, etc.
- A copy of the manufacturing license is required.
- The list of the products for which the applicant wants to get COOP along with the composition of all drugs.
- The process for making the products or drugs along with the formula of the process.
- The analysis of the products along with the specification of the final product.
- The list of the products that already got the COOP approval
- Record of stability study evaluation for every batch along with other details of the product such as date of manufacturing and expiry of the drug, name of the said product, etc.
- Report of process validity of three batches if the application is made for the herbal product.
- The detailed list of the working staff along with their qualifications, experience, and approval status.
- List of the instruments and machines that are used or will be used.
- The layout of the manufacturing unit.
- Diagram of the water system.
- Diagram of HVAC system.
- Events of export of last year where the re-validation of the COOP is required.
- Detailed summary sheet of the products.
- Original labels of the products that are required to be applied for WHO-COOP.
- Report for safety and effectiveness of the drug as provided in Rule 158B of the Drug and Cosmetic Rule, 1945.
- Report and undertaking for the compliances given under the Drug and Cosmetic Act, 1940, Drugs and Magic Remedies (Objectionable Advertisements), Act, 1954, and Drug and Cosmetic Rule, 1945.
Note: However, these documents may vary from state to state. Therefore, for getting the updated and correct list of documents you need to visit the website of that respective state.
Procedure to obtain AYUSH License
To obtain the AYUSH License follow the steps given below carefully-
- Visit the Official Website
- Submission of Form
- Approval by the Concern Authority
- Grant of License
One who wants to take AYUSH License, the very first thing which he or she needs to do is visiting the official website of the AYUSH and download the form which is required for the purpose of getting registration. With the application form one needs to provide GMP AND COPP affidavits. Fill the downloaded form very carefully.
After filling the form next step is to submit the form to the concerned authority which is AYUSH Department’s Commissioner. With this form, one also needs to attach all the required documents as per the need for AYUSH License Registration. Now this application will be reviewed by the concerned authorities.
Once the application is submitted to the AYUSH Department’s Commissioner for approval, everything like the future of the license depends on him. He will review or verify the application and if satisfied then approve the application within 15-days.
After the valid verification by the AYUSH Department’s Commissioner, one will get the AYUSH License.
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Apart from food and culture, India is famous for Ayurveda, yoga, and Siddha. In ancient India, doctors used to treat their patients by giving Ayurvedic medications or they used to provide them with Unani therapy that cures and prevents further infections. Apart from this, doctors used to practice Shuddhi of mind, and soul with the body for curing diseases. India is known for yoga and Ayurveda in the world. In ancient India, doctors used to treat their patients with ayurvedic medicines and Unani methods, the best thing about these methods was that patients do not face any side effects after going through these treatments. Because of their no side effects, Ayurveda and Unani drugs are getting famous worldwide, people are choosing Ayurveda over other allopathic or homeopathic medicines.
The most important and best part of these practices was that they do not leave any kind of side effects on people. In India, many people have their own recipes for herbs to cure diseases. These people used to fraud and dilution the medications. And to stop all these
practices the Ministry of AYUSH was established in 2014. Now if you want to indulge in any business that indulges any type of ayurvedic or Siddha Products, you need to get AYUSH License and meet different compliances given by the authorities. These medications, drugs, and cosmetics can be sold overseas as well after meeting some basic compliances such as GMP Certification and COOP. This is why it is advised to get the AYUSH License. You can hire some professionals to file for your AYUSH License.
FAQs Regarding AYUSH License Registration
AYUSH License can be given to the drugs mentioned under Section 33 B of the Drug and Cosmetic Act, 1940. Those drugs are Ayurvedic, Unani, and Siddha products. Ayurvedic products, herbal products, drug products, and cosmetics can get AYUSH License.
Ministry of AYUSH provides AYUSH License. It also regulates the products that come under the purview of AYUSH products. Before the establishment of the Ministry of AYUSH, an AYUSH license used to be provided by the Department of Indian System of Medicine and Homeopathy (IS&H), which was established in the year 1995.
Here, the license of the manufacturer shall be utilized, and he also needs to take the approval of the third-party manufacturer for all the drugs and products from the respective authorities. But the party manufacturer is free to provide raw material if he wants to avail otherwise that is the duty of the manufacturer himself to avail of the raw material.