Form 27-C for Blood Banks: Submission Check

Before you submit Form 27-C, reconcile six points across the form and your supporting file: applicant identity, premises address, proposed scope, technical staff, readiness status and payment details. Form 27-C covers these particulars and requires the relevant Treasury Challan to be enclosed.¹

One correction matters: Form 27-C is prescribed under Rule 122F, not Rule 122G.² Rule 122G governs the form and conditions of the licence that follows.³

What Form 27-C is used for

Form 27-C is the application for grant or renewal of a licence to operate a blood bank for processing whole human blood and/or its components for sale or distribution.¹ If your immediate problem is the renewal date or continuity after filing, use the separate blood bank licence renewal guide.

Rule 122F currently sets a licence fee of rupees six thousand and an inspection fee of rupees one thousand five hundred, making the total payment Rs 7,500.² Record the two amounts correctly in your working papers. Calling Rs 7,500 the licence fee creates an avoidable discrepancy.

Rule 122G requires the licensee to maintain adequate staff, plant and premises, along with the records and registers specified in Schedule F Parts XIIB and XIIC as applicable. Its testing-record condition requires those records to be maintained for five years from the date of manufacture.³ Your application pack should therefore support what you have entered about the premises, staff and intended operations.

Check every Form 27-C field against evidence

Form 27-C asks for the applicant and premises, the items applied for, the names, qualifications and experience of competent technical staff, the date on which the premises and plant are ready for inspection, payment particulars, and the signatory’s date and designation.¹ Use this field-by-field check before anybody signs.

For internal indexing, avoid switching between “Form 27C” and “Form 27-C”. Use the official form number on the controlled copy, file index and covering letter.

Separate the filing set from inspection evidence

Rule 122F requires the application to be accompanied by the prescribed fees, while Form 27-C specifically refers to the relevant Treasury Challan.²¹ Do not present every readiness document as a prescribed Form 27-C enclosure. Instead, divide the pack into a filing set and an indexed evidence file.

The filing set

• Completed and signed Form 27-C
• Fee payment record and relevant challan
• Covering letter with a numbered enclosure list
• Any checklist specifically issued to your centre by the licensing authority
• Copy of the current licence and amendments when the application is for renewal

Keep the covering letter factual. If it includes a declaration, apply the same signatory and evidence checks used before you sign a blood bank declaration.

The inspection-readiness file

Before grant or renewal, inspectors examine the premises, appliances and equipment, process and testing facilities, and the qualifications of expert and technical staff.⁴ A practical evidence file should let you retrieve each of those subjects without searching through unrelated folders. The blood centre licensing inspection checklist provides the wider inspection view without turning this Form 27-C check into another renewal guide.

• Applicant and authority: legal identity papers, constitution records and signatory authorisation
• Premises: address evidence, current floor plan, room-use list and controlled layout
• Technical staff: appointment records, qualifications, experience evidence and assigned responsibilities
• Plant and equipment: equipment inventory with installation, maintenance and calibration status where applicable
• Operational scope: a matrix connecting each applied item to rooms, equipment, staff, SOPs and records
• Document control: current SOP index, approval status and revision history

Schedule F Part XIIB sets requirements covering accommodation, personnel, equipment, collection, processing, testing, storage, labelling and records.⁵ Your readiness index should follow those headings. This makes a missing section visible before an inspector asks for it.

For an operating centre, map the registers and reports named in Section L, including donor records, master records, issue and component-supply records, reagent records, crossmatch reports and adverse-reaction records.⁵ The detailed Schedule F Part XIIB record list can be used to check that index.

Apply the same control to supporting procedures. An obsolete SOP beside a current equipment list weakens the pack even when both documents are present, so verify the approval and revision status through your quality manual and SOP control process.

Run four reconciliation checks

Identity

Write the applicant’s name once in a reference sheet, then compare every occurrence against it. Include the spelling, institutional suffix, address and signatory designation. Record an explained difference instead of silently carrying two versions into the submission.

Scope

List each item applied for in one column. Against it, record the room, equipment set, responsible staff, SOP and record format that support the activity. Remove an unsupported item from the proposed scope or close the evidence gap before signing.

People and premises

Confirm that every person named in Form 27-C is currently appointed and that the supporting qualification and experience records belong to that person. Walk through the premises address and room descriptions against the controlled plan rather than checking them from memory.

Payment and authorisation

Have a second person compare the challan particulars with the application and covering letter. That reviewer should also confirm that the person signing has documented authority for the applicant named on the form.

Control the final submission

1. Assign a pack identifier and prepare a numbered index.
2. Mark the application clearly as grant or renewal.
3. Freeze the final scope, names and premises details.
4. Complete a second-person comparison against the evidence file.
5. Sign and date only after the comparison is closed.
6. Scan the complete signed set before dispatch or upload.
7. Record the acknowledgement, queries, replies and any replacement pages against the same pack identifier.

Never overwrite the submitted copy when the authority asks for a correction. Preserve the original, mark the revised page with its date, and keep the request that caused the change. Your record-retention schedule should distinguish this controlled application file from the operational records maintained under Schedule F.

A complete pack lets you answer three questions quickly: what your centre applied for, what evidence supported it on the submission date, and who checked and authorised the application. Whether those records sit in paper files or software, your centre remains accountable for the accuracy of Form 27-C.

Sources

1. Drugs and Cosmetics Rules, 1945, Form 27-C cdsco.gov.in
2. Drugs and Cosmetics Rules, 1945, Rule 122F cdsco.gov.in
3. Drugs and Cosmetics Rules, 1945, Rule 122G cdsco.gov.in
4. Drugs and Cosmetics Rules, 1945, Rule 122-I cdsco.gov.in
5. Drugs and Cosmetics Rules, 1945, Schedule F Part XIIB cdsco.gov.in