Blood Bank License | Form 28 C / Form 28 E / Form 28 F

Procedure for Obtaining a Blood Bank License in India:

• Obtaining Login credentials: To obtain a Blood Bank License, the applicant must first register in an online portal and create a Login ID and Password
• Documentation: The applicant must produce documents and upload them online accordingly. All documents must meet the rules of The Drugs And Cosmetic Act, 1940
• 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.
• Inspection: Following the submission of documentation, the Drug Inspector visits the premises to authenticate the location and verify the documents.
• Issue of Blood Bank License: Post Inspection by the Drug Inspector, the licensing authority verifies the documents and inspection report submitted by the Drug Inspector and will grant the Blood Bank License in Form 28 C, Form 28 E or Form 28 F as the case may be.

Pre - Requisites / Documents required for Blood Bank License:

• Area: A blood bank must have 100 square metres for operations and an additional 50 square metres for blood component preparation.
• Competent Technical Staff: Every Blood Bank shall have whole time competent technical staff i.e. Medical Officer, Blood Bank Technician, Registered Nurse and Technical Supervisor as the case may be.
• Storage Facility: A Blood Bank should have adequate storage facility for storage of blood or blood components.
• 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
• Details of proprietor/partner/ Director/Trustee etc.: Details of proprietor/director/trustee etc. mentioning their Name, Qualification, DOB, Phone Number, and Email id.
• ID Proof: Pan card and Aadhar card of proprietor/partners/directors.
• Agreement: Sale Agreement or Registered Rent Agreement of 5 years
• Premises ownership documents: Electricity Bill and Property tax Receipt
• Plan Layout: Plan layout drawn as per FDA rules
• List of Equipment: The equipment used in the collection, processing, testing, storage, and sale/distribution of blood and its components must be kept in good working order.
• SBTC Approval: The applicant has to register the Blood Bank with the State Blood Transfusion Council

The organisation / trust applying for a Blood Bank License has to pay a fees of six thousand rupees and and inspection fee of one thousand five hundred rupees for inspection of the premises. If the original of a licence issued under this rule is defaced, damaged, or lost, a fee of one thousand rupees must be paid for a duplicate copy.

If the Licensing Authority is satisfied that the applicant can meet the requirements outlined in the rules, he must prepare a report and submit it to the Central Licensing Approving Authority for grant of license.

Obtaining a Blood Bank License 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 certificate. We reduce the likelihood of application rejection and ensure that licenses are issued quickly and without complications.

You can apply for a Fresh Blood Bank License in Form 28 C, Form 28 E or Form 28 F / Renewal of Blood Bank License / Amendment in Blood Bank License / Change in Constitution / Surrender of Blood Bank 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