Documents required for Ayush license

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 Ministry of Ayush, 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. Undertaking regarding the absence of non-herbal ingredients (applicable in the case of herbal products)
12. Undertaking regarding compliance with the Drugs and Cosmetics Act, Drugs and Cosmetic Rules, Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, and its corresponding rules (applicable in case of herbal products only)
13. KYC details of the applicant
14. Address Proof of the Premises
15. Constitution Document of the business

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

1. 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.

2. Site Layout Of The Manufacturing Facility

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

3. Manufacturing Formula And Process

This document provides the details of the manufacturing formula and manufacturing process. It includes:

• List of the ingredients
• Quantity of each ingredient
• Steps involved in manufacturing process
• Quality control measures
• Information on the production capacity per batch

4. Finished Product Specification Report

This is the document detailing the quality standards of the final product. Details of the finished products includes:

• Physical & chemical properties
• Microbial contamination limit
• Stability test result

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. Proof Of Safety & Effectiveness

According to the Drugs and Cosmetics Rules, 1945 (Rule 158B), it is mandatory to provide pieces of evidence proving product safety and efficacy.

11. 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.

12. Self-Declaration Regarding Compliance With Regulatory

This document ensures that the business & products comply with the Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rules, and the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.

13. 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

14. Address Proof of the Premises

If the manufacturing unit or office is rented, the rent agreement is needed. If owned, documents such as electricity bills, property tax receipts, or land ownership papers are required.

15. Constitution Document of the business

This document depends on the business structure such as:

• Proprietorship: GST registration, Udyam certificate (if applicable)
• Partnership: Partnership deed, PAN card of the firm
• Private Limited or LLP: Certificate of Incorporation, MOA, AOA

How To Apply For Ayush Certification?

To apply for Ayush license you need to follow the given steps:

Step 1: Documentation

The first step to applying for Ayush certification is to gather all the documents required for Ayush license.

Step 2: Apply for a GMP Certificate

The next step after gathering documents is to apply for a GMP certificate if you are a manufacturer.

Step 3: Apply for a COPP Certificate (if applicable)

Obtain a COPP Certificate to export Ayush products.

Step 4: Download the form for the Ayush License Certificate

After getting the necessary certificate download the form from the Ayush portal to apply online.

Step 5: Fill out & Submit the Application

After downloading the form, fill it out & apply.

Step 6: Verification by AYUSH Department’s Commissioner

Ayush license document verification will take place after submission. Authorities may also visit your office or manufacturing unit.

Step 7: AYUSH license granted

After ensuring compliance, the authorized department grants the AYUSH license.

What Are The Types Of Ayush Licenses Available?

1. Ayush manufacturing license – Required for businesses that manufacture 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 vary. 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.

Frequently Asked Question

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.

What is the validity of an AYUSH License?

An AYUSH License is generally valid for 5 years and must be renewed before expiry.

Is A Drug License Required For Ayurvedic Medicine?

Yes, a drug license is required to manufacture, distribute, or sell Ayurvedic medicines. The Ministry of Ayush regulates the production and sale of Ayurveda, Siddha, Unani, and Homeopathy under the Drugs & Cosmetics Rules, 1945.

What Is The Law For Ayurvedic Medicine?

1. Drugs and Cosmetics Rules, 1945
2. Rule 158B of the Drugs & Cosmetics Rules, 1945
3. Good Manufacturing Practices (GMP) under Schedule T
4. Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
5. Food Safety and Standards Authority of India

Can I Manufacture Ayush Products Without An Ayush License?

No, it is illegal to manufacture, sell, or distribute Ayush products without a valid license. It can result in serious legal actions such as fines & product bans.