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A Loan License is a license issued by the Drug Control Authority that permits a business to use the manufacturing site of licensed manufacturer.The Permiso team will provide comprehensive assistance, starting from the project’s paperwork through its successful completion.
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The term Loan License can be extremely important for someone who wishes to start a manufacturing or production unit. People with little experience or equipment can also start a business with all of the facilities required in the pharmaceutical production process.
A Loan License for drug manufacturing is a License granted by the State Drug Control Authority to an applicant who does not have his own production but intends to use the manufacturing facilities owned by a licensee in the already licensed premise viz. having a valid Manufacturing Drug License.
To obtain a Loan License for manufacturing, a company needs to have a valid wholesale license. The license premised where the applicant wants to manufacture the products needs to have the necessary facilities, equipment, and processes in place to manufacture drugs in a clean and controlled environment and in accordance with specified rules and regulations. Compliance with Good Manufacturing Practices is required to obtain approval from the government.
Procedure for Obtaining a Manufacturing Drug License in India:
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Obtaining Login credentials: To obtain a Drug License, a person must first register in an online portal and create a Login ID and Password, which will be sent to them through SMS on the mobile phone.
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Documentation: The applicant must produce documents and upload them online accordingly. All documents must meet the rules of The Drugs And Cosmetic Act, 1940
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Fees: The applicant must pay the required fees online by the requirements as per The Drugs And Cosmetics Act, 1940, The Drugs And Cosmetics Rules, 1945 or The Medical Devices Rules, 2017.
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Inspection: Following the submission of documentation, the Drug Inspector visits the premises where the drug license is to be obtained to authenticate the location and verify the documents.
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Issue of Drug License: Post Inspection by the Drug Inspector, the licensing authority verifies the documents and inspection report submitted by the Drug Inspector and will grant or reject the license
Pre - Requisites / Documents required for Loan License for Manufacturing:
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Manufacturing License: The licensor must have a valid manufacturing license
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Wholesale License: The Licensee must have a valid wholesale license
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Covering Letter: A Covering letter on the letterhead stating the purpose of the application.
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Competent Technical Staff/ Registered Pharmacist Person: The List of competent technical staff with their qualifications, registration, experience, previous FDA approvals, and so on.
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Firms Constitution Documents: Photo ID / Partnership Deed & ROF registration receipt / Certificate of Incorporation / Trust Registration / HUF Deed / Society Registration depending on the type of constitution
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Details of proprietor/partner/ Director/Trustee etc.: Details of proprietor/director/trustee etc. mentioning their Name, Qualification, DOB, Phone Number, and Email id.
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ID Proof: Pan card and Aadhar card of proprietor/partners/directors
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Agreement: Sale Agreement or Registered Rent Agreement
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Others: The FDA department may require additional documents depending on the place and nature of business.
Complete registration of OWN licensee is required for LOAN licensee registration. After completing OWN licensee registration and uploading the necessary information, LOAN licensees will be able to register by selecting the appropriate OWN licensee.
Obtaining a Loan License for Manufacturing can be time-consuming and the licensing procedure consists of steps that require a clear and thoughtful method. Any blunder during the registration procedure may result in the applicant being denied the license. We reduce the likelihood of application rejection and ensure that licenses are issued quickly and without complications.
You can apply for a Loan License / Renewal of License / Change in Constitution / Change in Premises / Product Addition / Duplicate License or Surrender of License through M/s. The Permiso and obtain the application reference number within 2 days. If you have any issues or facing any difficulty with the application, you can call +91 8104691667 or email us at info@thepermiso.com
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FDA Loan License Registration Procedure
