Ayush Manufacturing License
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Ayurveda, or "Science of Life," is one of the world's oldest healing sciences, dating back nearly 5000 years. Consequently, there has been a steady increase in the number of Ayurvedic medicine manufacturing units in India. Furthermore, since these medicines have no side effects, experts predict that demand for Ayurvedic medicine will continue to grow.
Manufacturers who are related to manufacturing Ayurvedic or Herbal products in India must obtain an AYUSH License regulated by the Ministry of AYUSH. The Ministry of AYUSH was founded in November 2014, before it was recognized as the Department of Indian System of Medicine and Homeopathy (ISM&H) which was established in March 1995.
What is the Procedure to get the AYUSH License ?
Every manufacturer trading with the Ayurvedic or herbal articles has to obtain a license from the Ministry of AYUSH. Every state has its website dedicated to AYUSH. To get the AYUSH license, an applicant must go to the AYUSH website of their respective state. Below mentioned steps are needed to get the License:
Visiting 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.
Review Of Documents
Fill out the application form, attach the supporting documents, and submit it to the commissioner of the AYUSH Department for review.
Approval By The Commissioner
Once the commissioner gets satisfied, he will grant his or her consent within 15 days.
Obtaining The License
The AYUSH license is sent by mail to the applicant.
Important Points for AYUSH License in India
An Applicant Who Wants To apply AYUSH Manufacturing License Needs To Meet all the Conditions Under AYUSH Act:
- The manufacturing unit must be located in an industrial area.
- The least size of the manufacturing area for producing one drug only must be 1200sqft.
- If you want to make more than one drug, you'll have to add more categories because you'll need more space.
- The manufacturing unit must be approved by GMP.
- Make sure you have two Ayurvedic experts and two pharmacies on board.
- You have complete access to all production and packaging equipment.
- Drug inspector will carry daily inspection of your manufacturing unit
What are the Types of AYUSH Licenses?
The following are the manufacturing licences granted by the Ministry of AYUSH:
AYUSH Manufacturing License
It is obtained in the circumstances when the applicant desires to get the license and has come out with the strategy for producing and selling both goods. In a condition like this, the manufacturer must set up his manufacturing unit.
Every state has its own set of regulations for establishing such manufacturing units. One must adhere to all of the conditions stated by the state authority of AYUSH.
Unani Manufacturing License
Unani Medicine is thought to be a science and art of healing. It is a noble career that heals mankind's enduring. People are drawn to the Unani system because of its one-of-a-kind approach to disease prevention and treatment. It has gained widespread acceptance as one of the relevant medical systems.
Siddha Manufacturing License
The therapy is used to keep a balance between the mind-body and spirit system. Siddha therapy gives equal weight to the body, mind, and spirit and endeavors to restore complete harmony to different mental and physiological functions of the body. In the practice of Ayurveda, yoga plays a vital role along with meditation, diet, and lifestyle.
AYUSH Loan License
In this kind of set up the manufacturing unit is not required by the applicant. The Third-party produces the goods. Such a Loan License must be applied for with a GMP accredited producer before being granted to the applicant entity. Thereafter product approval is required to be taken from the authorities.
Who Required Ayush License or Ayush Certification?
The following individuals are required to have an Ayush License or Ayush Certification to trade in Ayurvedic medicines or herbal medicine products; otherwise, the Ayush Authority will impose a penalty:
- Manufacturer of Ayurvedic medicines and goods.
- Manufacturer of herbal medicines or goods.
- A person associated with selling or advertising of Ayurvedic or Herbal Products needs to apply for Ayush Loan License or Ayush Contract Manufacturing License.
- A person who sells Ayurvedic or herbal products in a retail or wholesale environment.
Documents Required For AYUSH License
Here’s a glance at the documents you require to get an Ayurvedic medicine sale license, either as retail or wholesale from the Department of AYUSH.
- Details about the applicant like Name, address, telephone, fax, e-mail etc.
- Manufacturing License copy.
- Products list applied for issuance of COPP & their composition.
- Site Master file.
- Master manufacturing formula along with the manufacturing process.
- Method of Analysis and finished product specification.
- List of approved products.
- Products List for which the firm has already availed the COPP.
- Evaluation of stability study batch wise, along with the Date of manufacturing, Date of Expiry, stability study condition, the name of Drug etc
- Process validation report for 3 batches. (Applicable in case of herbal products)
- Validation report of the analytical method.
- List of technical staff along with their qualification, experience and approval status.
- List of equipment and instruments used or to be used.
- Manufacturing Plant layout.
- Water system diagram.
- HVAC system diagram.
- Export data for the last 2 years, wherever re-validation of COPP is applicable
- Product summary sheet.
- Actual labels of the products which are required to be applied for WHO-COPP.
- Safety and effectiveness proof as per Rule 158B of Drugs & Cosmetic Rules, 1945.
- Certificates of Analysis for three batches of each product. (Applicable in case of herbal products), (Applicable in case of herbal products).
Frequently Asked Questions ?
Manufacturers who are connected in manufacturing Ayurvedic or Herbal products in India need to take an AYUSH License regulated by the Ministry of AYUSH. The Ministry of AYUSH was founded on 9th November 2014.
The Unani framework is successful amongst people because of its one-of-a-kind way through which it prevents and heals diseases. It has gained widespread acceptance as one of the relevant medical systems.
Manufacturing licenses that are allotted 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 therapy gives equal attention to the body, mind, and spirit and endeavors to restore the whole harmony to different psychological and physiological functions of the body.
According to the HWC protocols in the AYUSH License, each Sub Health Centre serves nearly 5,000 people in the plains and 3,000 people in the hills.
If you want to sell Ayurvedic/Unani/Siddha medicines or any other ayurvedic product in India, you must have an AYUSH Retail license. If you don't have an AYUSH license, you could face penalties if you sell Ayurvedic or 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 requires to sell the product only. Further, in the applicant part, it is not required that they should own a producing unit.
Certificate of Good Manufacturing Practices (GMP) proves that the pharmaceutical manufacturing company has gone through the test and passed it by the governing body of that country. It ensures that the item meets the guidelines of good manufacturing practices as stated by the WHO.
The COPP is the legal document that validates the manufacturing company having this certificate is legitimately authorized to sell their pharmaceutical item in the nation they are producing. In the case of overseas, the governing body accountable for approving the application will request COPP to ensure that the item is being sold as a commercial finished product in the nation that is manufacturing it.