What is AYUSH License?

Producers who are involved in the manufacturing  of Herbal, Ayurvedic, Unani, and Siddha medicines or products need to obtain AYUSH License in India. AYUSH License is issued to manufacturers by the Ministry of AYUSH.

Types of AYUSH License 

AYUSH Manufacturing License

AYUSH Manufacturing License is obtained in the situations when the applicant wants to get the license and has a plan of marketing and manufacturing of the products. In these circumstances, a manufacturer needs to set up a manufacturing plant. Every state in India has its own set of compliances that needs to be fulfilled before setting up a manufacturing unit.

Unani Manufacturing License

Unani Medicine is considered as the craft and science of curing. Unani medicines are popular amongst people because of their approach to curing and protecting from diseases.

 Siddha Manufacturing License

The main focus of Siddha treatment is to maintain a balance between body, mind, and spirit system. This treatment offers equal importance to the mind, body, and spirit and makes an effort to restore a complete synchronization to the human body's physiological and psychological functions. In Siddha treatment, yoga plays an essential part along with diet, meditation, and lifestyle. It gives more prominence to preventing diseases than curing them. Scientific research conducted on Siddha treatment has verified the remedies are helpful in preventing and curing diseases. Siddha treatment helps in preventing curing diseases such as:

AYUSH Loan License

In this type of setup, the candidate does not claim the manufacturing unit. A third party manufactures the product. AYUSH Loan License is applied to a Goods Manufacturing Practice (GMP) certified producer, and after that, it is offered to the applicant. Subsequently, product approval is required to be obtained from the concerned authorities.

AYUSH Contract/Third-Party Manufacturing License

In these arrangements, neither the individual has the license, nor does the manufacturer have the license of its own. A third party does the marketing, and in that case, the liaison and compliance work must be taken care of by the manufacturer.

Necessary Documents Required to Obtain AYUSH License

The applicant has to provide details like Name, Address, Contact number, E-Mail.

·         A certified copy of the Manufacturing License.

·         A list of all the products for issuance of Certificate of Pharmaceutical Products (COPP) and their composition.

·         Site Master file.

·         The applicant has to submit the manufacturing formula along with the process of manufacturing.

·         Finished product specification and Method of Analysis.

·         Approved products list.

·         A detailed list of products for which the COPP is already availed.

·         The applicant has to submit an analysis of stability study on the basis of the batch, along with the date of expiry, date of manufacturing, name of the drug, stability study condition.

·         Validation process report for three batches.

·         The applicant has to submit a report on analytical method validation in order to obtain the AYUSH License.

·         A list of technical staff in which details like qualification, experience, and approval status must be mentioned in order to obtain the AYUSH License.

·         A detailed list of instruments and types of equipment that are being used or will be used.

·         The layout of the Manufacturing Plant.

·         Diagram of Water system.

·         Diagram of Heating, Ventilation, and Air-Conditioner (HAVC) system.

·         The applicant has to provide export data of the last two years, wherever re-validation of Certificate of Pharmaceutical Products (COPP) is applicable.

·         The applicant has t to submit a product summary sheet.

·         Real labels of commodities that are required to be applied for WHO-COPP.

·         Proof of effectiveness and safety, as stated in Rule 158B of Drugs & Cosmetics Rules, 1945, in order to obtain AYUSH License.

·         An Analysis certificate for three batches of each commodity.

·         Applicable only for herbal products, undertaking related to the deficiency of any non-herbal such as minerals or metals in the commodity applied for WHO-COPPs.

·         Applicable only for herbal products, undertaking related to the compliance with the requirements of domestic regulations inter-alia Drug and Cosmetic Act, 1940, and rules as per the Drugs and Magic Remedies Act, 1954.

 

Procedure for Obtaining AYUSH License

The process for obtaining the AYUSH License is very simple and can be done online. Following are the steps to obtain AYUSH License:

 The applicant has to visit the concerned state official website of the Ministry of AYUSH.

·         Now the applicant has to download the essential form, attachment, list of documents, which also includes certification and other affidavits such as Goods Manufacturing Practice (GMP) and Certificate of Pharmaceutical Products (COPP) as the case may be.

·         If appropriate, apply for Goods Manufacturing Practice (GMP) and Certificate of Pharmaceutical Products (COPP).

·         Now the applicant has to submit all the documents required for obtaining AYUSH License to the Directorate of the AYUSH.

Goods Manufacturing Practice (GMP) Certification

Goods Manufacturing Practice (GMP) is a structure that guarantees that the products are reliably manufactured and controlled as per the quality norm prescribed by the World Health Organisation (WHO). The main objective behind the GMP certification is eliminating the dangers related to any pharmaceutical product.

Goods Manufacturing Practice (GMP) certificate exhibit that the pharmaceutical the manufacturing company has positively gone through the examination process conducted by the concerned regulating authorities of a country. It guarantees that the product is manufactured as per the guidelines of GMP, as stated by the World Health Organisation (WHO).

Certificate of Pharmaceutical Product (COPP)

The Certificate of Pharmaceutical Product (COPP) is the imposing document that substantiates the manufacturing company having its certificate is lawfully permitted to sell their pharmaceutical product in the country it is created. In-state of affairs where the pharmaceutical product is to be registered underneath the abroad, the administrative entity responsible for approving the application will request a Certificate of Pharmaceutical Product (COPP) to guarantee that the product is sold as a commercially finished product in the country that it was produced. 

Conclusion

Manufacturers who are involved in the manufacturing of Herbal, Ayurvedic, Unani, and Siddha medicines or products need to obtain AYUSH License in India. AYUSH License is issued to manufacturers by the Ministry of AYUSH. Most of the medical practices are old and can trace back to early civilizations and are verified by science study that shows they are still effective in today's world.