What is AYUSH Loan License in India?

AYUSH Loan License

The AYUSH Loan License is the authorization given to those who don't have a manufacturing unit but want to avail of the manufacturing Facility of the holder of an AYUSH manufacturing license. Simply put, loan licensing allows an individual who doesn't have a manufacturing unit to get another AYUSH manufacturer's manufacturing Facility on a loan licensing basis.

After getting the AYUSH Loan License…

When granted the license, the Manufacturer opens access to the working area, office, relevant departments, and other manufacturing facilities to the Ayursh Loan Licensee. Every AYUSH Department in the respective state grants a new license to an eligible applicant.

Also, the AYUSH Loan License holder must pay out the following as per the agreement with the Licensor:

• Additional Charges
• Facilities Rent
• Net gained Profit
• Dealer's Commission

After getting the required license certification, the Licensee can initiate production operations per the agreed terms.

Benefits of AYUSH Loan License

Gaining an AYUSH Loan License offers plenty of benefits. It also has its downsides which have been discussed on this web page.

• The AYUSH License ensures minimal production costs for the Licensee's products.
• Licensees can eliminate overhead expenses, which are prominent in the in-house production units.
• The AYUSH Licensee need not worry about Labour Management.
• Licensees can skip maintenance and repair expenses, which is a significant issue in in-house production. The absence of in-house production causes no overhead costs as well as increased profit margins.
• But with the AYUSH License, your trade secret may get exposed. However, you can handle it with a Non-Disclosure Agreement with the Manufacturer.

Here, the Licensee cannot gain complete control over the production line as it entirely depends on the Manufacturer-Licensee contract terms. Also, the Licensee cannot upgrade the production line of the Manufacturer, either by augmenting the present system or adding new equipment. He has to make do with what is available at the Manufacturing Facility.

Eligibility Criteria for AYUSH Loan License in India

AYUSH Loan License can only be granted on the condition that the manufacturing facility whose services you want to get on a loan licensing basis has the following:

• Adequate Staff
• Equipment
• Manufacturing Capacity
• Manufacturing Facilities

Simply put, the Manufacturer should have adequate facilities to manufacture AYUSH products on your behalf. 

Qualifications of the Manufacturer

An AYUSH license can be granted to the applicant only if the Manufacturer has the following:

• Manufacturing facility must be in an Industrial Area
• The Size of the Manufacturing Facility must be 1200 square feet, atleast.
• The Manufacturing Plant must have ample space for handling the Licensee’s production volume.
• The Manufacturer must be GMP-certified.
• The testing facility must also be adjoint to the Manufacturing Plant.
• The Facility must maintain two Ayurvedic experts and two pharmacies at all times.
• The Manufacturer-Licensee agreement must contain provisions for access to all the Manufacturing Units and Packaging Machinery.
• The Facility must fulfill the necessary inspection norms.

Documents required for AYUSH Loan License in India

The AYUSH Loan Licensee must arrange the following documents beforehand while filing the AYUSH Loan license registration application:

• Manufacturing license of the Manufacturer
• Letter of Request addressed to the Manufacturer to operate the Facility for producing the medicine
• Consent letter from the Manufacturing Facility
• Demand draft for AYUSH loan license processing as well as the GMP fees in favor of the State Directorate of the AYUSH License
• Facility-related Documents such as:
  • Rental Agreement
  • Or Sales Agreement
  • Tax Paid Receipt
• Alternative Medicines details, such as the following:
  • Duplicate Master Formula
  • Clinical Trial reports
  • Book References for medicine
  • Testing Procedures
  • Report relating to SSS (Specifications Safety Study) for schedule E1 drugs
• Recent Photographs of the Manufacturing Unit Owner
• For Partnership Firm, Partnership Deed attested with two passport-size photographs of its member partners
• If the applicant is a Company, then the MOA & AOA of the applicant company, along with two passport-size photographs of all Directors
• If the applicant is a Trust, the copy of the Trust Agreement along with the two passport-size photographs of the Trustees
• If the applicant is a Proprietorship, then two passport-size photos, identity proof, notarized copy of the Proprietorship
• Blueprint and Site plan prepared as per the schedule T of Drugs & Cosmetics Act of 1940
• Consent letter from AYUSH-certified laboratory for product testing 
• The applicant must submit an Affidavit that declares the non-conviction of Directors, proprietors, or member partners of the respective Firms under the Drugs & Magic Remedies (Objectionable Advertisement) of 1954 and the Drugs & Cosmetics Act of 1940. The affidavit must be on a Rs 100/- stamp paper
• For P&P, the applicant must submit the SSR (Stability Study Reports) under the Ayurvedic Pharmacopeia of India and Drugs & Cosmetics Rules.
• Other documents that the AYUSH ministry might ask for during the follow-ups

Procedure for AYUSH Loan License in India

The process of obtaining the AYUSH Loan License is as follows:

• First, a file has to be created containing all the required documents.
• Then, an application for AYUSH Loan License will be filed.
• The application is then submitted to the state office of the AYUSH ministry, along with the application processing fees. 

Our Assistance for AYUSH Loan License in India

We provide end-to-end assistance when getting you an AYUSH license in India:

1. We help file the application
2. We draft the required documents
3. We conduct follow up with the AYUSH ministry

If you don't want the hassle of dealing with the Department, get the AYUSH loan license hassle-free. Call Registrationwala. 

Contact us today so that we can get started right away.