What Are The Documents Required For Ayush License?

For Ayush registration, it is mandatory to submit all the documents required for Ayush license. As per the Ayush department, if any document is omitted or the application is incomplete then it may lead to rejection or revocation of the application for an Ayush license. In this article, we will provide you with a list of all the documents required for Ayush registration.

What Is an AYUSH License?

Ayush license is a mandatory legal document for all manufacturers & distributors of Ayurvedic, Yoga, Unani, Siddha, & Herbal products. This license is issued by the Ministry of Ayush upon meeting the necessary safety, efficacy, and quality standards. Ayush licenses are categorized based on business activities they are involved in, Such as Ayush manufacturing license & Ayush loan license.

List Of The Documents Required For Ayush License

Here is the list of all the documents required for Ayush registration. These documents can vary depending on the license you are applying for:

1. Copy of Manufacturing license
2. Site Layout of the manufacturing facility
3. Manufacturing formula and process.
4. Finished product specification report.
5. List of approved products for COPP certification.
6. Process Validation Report for 3 batches.
7. Details of the technical staff.
8. List of equipment used for manufacturing.
9. Water & HVAC system diagrams.
10. Proof of Safety & Effectiveness.
11. Self-Declaration For The Absence Of Non-Herbal Ingredients.
12. Self-Declaration Regarding Compliance With Regulatory
13. KYC details of the applicant.
14. Address Proof of the Premises.
15. Constitution Document of the business.

Brief Of Documents Required For Ayush License Application

For your better understanding, we have explained each document below:

Copy Of Manufacturing License:

If the applicant is a manufacturer, he must submit a copy of the manufacturing license to ensure compliance with the legal regulations. A manufacturing license gives the authority to manufacture products as it is issued after meeting certain standards.

Site Layout Of The Manufacturing Facility:

The site layout of the manufacturing facility is one of the important documents required for the Ayush license. It provides details of the manufacturing plan and ensures compliance with regulatory standards.

Manufacturing Formula And Process.

This document provides the details of the manufacturing formula and manufacturing process. It includes list of the ingredients, the quantity of each ingredient, steps involved in the manufacturing process, quality control measures & information on the production capacity per batch.

Finished Product Specification Report.

This is the document detailing the quality standards of the final product. Details of the finished products include the physical & chemical properties, and microbial contamination limit to ensure the safety & stability to test result.

List Of Approved Products For Copp Certification.

The certificate of pharmaceutical products is the legal document required to export Ayush products. This includes a list of products for which the company has applied for COPP certification and the approval status from the regulatory authority.

Process Validation Report For 3 Batches.

One of the mandatory documents required for Ayush license to demonstrate that the manufacturing process consistently produces the quality products. This document must include the data from 3 consecutive batches to confirm consistency & test result for each batch.

Details Of The Technical Staff.

Details of the technical staff need to be submitted along with the documents to ensure that personnel involved in the manufacturing process have the necessary qualifications. This list of the details about technical staff must include their name, 

List Of Equipment Used For Manufacturing.

This document must include the list of all the equipment that are going to be used to manufacture Ayurvedic or herbal products.

Water & HVAC System Diagrams.

Water & HVAC system diagrams are the crucial documents required for Ayush registration as they describe the purification and distribution system for water used in production. HVAC( Heating, Ventilation, & Air conditioning) ensures air purification, temperature control, and humidity management to preserve product quality.

Proof Of Safety & Effectiveness. 

According to the Rule 158B Drugs & Cosmetics Rule, 1945, It is mandatory to provide pieces of evidence proving product safety and efficacy. 

Self-Declaration For The Absence Of Non-Herbal Ingredients.

If offering herbal products then it is mandatory to submit an undertaking for the absence of non- herbal ingredients. It ensures that the product does not contain any synthetic products.

Self-Declaration Regarding Compliance With Regulatory

This document ensures that the business & products comply with the Drugs and Cosmetics Act, Drugs and Cosmetics Rule, and Drugs and Magic Remedies Act, of 1954. (applicable in the case of herbal products only)

KYC details of the applicant.

KYC details of the applicant should be submitted, such as: PAN card, Aadhar card, passport, or other government-issued ID & Business registration details.

Address Proof of the Premises.

If the manufacturing unit or office is rented the rented agreement is needed. If they owned the property then documents such as electricity bills, property tax receipts, or land ownership papers are required to be submitted along with the application.

Constitution Document of the business.

This document depends on the business structure such as 

For Proprietorship: GST registration, Udyam certificate (if applicable).

For Partnership: Partnership deed, PAN card of the firm.

For Private Limited or LLP: Certificate of Incorporation, MOA (Memorandum of Association), AOA (Articles of Association).

How To Apply For Ayush Certification?

What Are The Types Of Ayush Licenses Available?

The Ayush department offers various types of licenses according to the business activities:

1. Ayush manufacturing license- required for businesses that manufacturer AYush products.
2. Ayush loan license- Mandatory for companies that manufacture Ayush products using manufacturing facilities of other companies.
3. Ayush wholesale license- Necessary for businesses involved in the manufacturing or distribution of Ayush medicines.
4. Ayush GMP & COPP Certificate- Compulsory to export Ayush products.

Note: Depending on the type of license documents required for Ayush license can varies, omission of any document can lead to serious legal consequences. So it is recommended to consult with legal provider to avoid penalties and fines. Elt Corporate Pvt Ltd makes your application process easy and gives you consultation to establish a strong presence in the diverse market.

What If Any Document Is Omitted For Ayush License?

If any document is omitted or found to be false then the application for Ayush license can be revoked or products can be banned permanently. So, it is recommended to consult with the agency to avoid risks and for the smooth application process. Elt Corporate Pvt Ltd is one of the leading service providers and consultants, we help you in the documentation and make your application process easy.

How Long Does It Take To Get An Ayush License?

It generally takes 30 to 90 days to process the application and to grant Ayush license, depending on the compliance check and verification.