Blood Bank Licence Renewal Under Rule 122G

Start your internal renewal file six months before the expiry printed on Form 28-C, and plan to submit Form 27-C before that date. Six months is a practical planning lead time, not a national statutory deadline. Rule 122F requires renewal before expiry; it also permits an application within six months after expiry with an additional fee of Rs 1,000 for every month or part of a month, but you should treat that as a late-filing route, not planned extra time.¹

A Form 28-C licence is valid for five years from the date of grant or renewal unless it is suspended or cancelled earlier. Your State Licensing Authority receives the application. Inspection and approval involve both the state authority and the Central Licence Approving Authority under the national rules.²

For blood bank licence renewal, the form you submit is Form 27-C and the licence you are asking the authorities to renew is Form 28-C. The same Form 27-C is used when an applicant seeks a first grant. Form 28-C is issued by the licensing authority; it is not a second application for your centre to complete.

Begin with the Form 28-C expiry date

Take the date from the signed Form 28-C held by your centre. Count from the date of grant or renewal, not from the inspection date, fee-payment date or the day your previous application was submitted.

A workable internal schedule is:

• Six months before expiry: ask the State Licensing Authority for its current checklist, submission channel and payment instructions. Compare the approved premises and component scope on Form 28-C with your present operation.
• Four months before expiry: close gaps in staff files, equipment records, premises documents and controlled procedures.
• Two months before expiry: complete Form 27-C, assemble the indexed dossier and leave time for queries or inspection scheduling.
• Before expiry: submit the application and preserve the acknowledgement, payment proof and an exact copy of everything filed.

If the licence is already close to expiry, do not assume that submitting a form silently settles your operating status. Ask the State Licensing Authority for written directions and escalate the file internally the same day.

The national licence renewal route

Rule 122F prescribes Form 27-C for the grant or renewal application. The form identifies the applicant, licensed premises, technical staff and whether the requested scope covers whole human blood, blood components or both. Rule 122F prescribes a licence fee of Rs 6,000 and an inspection fee of Rs 1,500, which is Rs 7,500 in total.³

Submit Form 27-C to the State Licensing Authority. Rule 122-I provides for the inspection that precedes a grant or renewal, carried out for either the State Licensing Authority or the Central Licence Approving Authority, and Rule 122J requires the inspector to send that authority a detailed report with recommendations.⁴

Do not replace Form 27-C with a covering letter, an old state checklist or a hospital’s general licence-renewal form. Those documents may accompany the application, but the prescribed application remains Form 27-C.

Form 27-C is the application; Form 28-C is the licence

Your centre completes and submits Form 27-C. After the authorities have scrutinised the application and completed the applicable inspection and approval process, the licence is issued or renewed in Form 28-C.⁵

If you are applying for the first grant, there is no existing Form 28-C to submit as though it were a current licence. Follow the State Licensing Authority’s instructions for identifying the application as a first grant and support the proposed particulars with premises, staff and equipment evidence.

For renewal, begin with the signed Form 28-C and its endorsements. A covering letter can explain a disclosed change, but it cannot quietly replace the address, scope or other particulars recorded on the current licence.

Run the Rule 122G check before you submit Form 27-C

Read the completed Form 27-C as an inspector will read it: each material entry should lead to a person, place, equipment item or record that can be verified at your centre. Rule 122G makes the required premises, plant and equipment, competent technical staff, change reporting, licence display and Form 35 Inspection Book conditions of the licence.⁶

Do this comparison before anyone signs Form 27-C. Once you have submitted it, changing an entry in your office copy destroys the value of that copy as evidence of what the authority actually received.

Separate the application forms from the evidence file

For blood bank licence renewal, divide the file into three parts: the prescribed application, the current licence particulars and the records that support inspection. Form 27-C is the prescribed application under Rule 122F. Form 28-C records the licence held by your centre, while Rule 122G and Schedule F Part XIIB determine what the licensing authority can ask you to demonstrate.

This separation prevents a common preparation error. A technician may collect calibration records, staff certificates and floor plans while the signed Form 27-C still carries an old applicant name or address. A thick evidence file cannot correct an inaccurate prescribed application.

Reconcile the licence particulars before anyone signs

Prepare a one-page comparison using the exact wording found in the current licence, the proposed application and the supporting documents. Resolve each difference or record how it has been disclosed to the authority.

Rule 122G requires specified changes in technical staff and material alterations in premises, plant or equipment to be reported to the licensing authorities. If the comparison exposes an unreported change, do not make the documents appear consistent by copying the newest detail across every page. Assemble the change evidence, preserve the earlier record and ask the State Licensing Authority how it should be dealt with in the renewal file.

Keep the reporting letter, its enclosures and proof of receipt together. If an inspector asks when a room, staff member or equipment item changed, your staff should be able to produce the dated trail rather than explain it from memory.

What Rule 122G requires from your centre

Form 27-C starts the application. Rule 122G supplies the substantive test: your centre must have the premises, plant and equipment, competent technical staff and operating arrangements required under Schedule F Part XIIB.

For renewal, those are working conditions rather than promises about what you will install later. An inspector should be able to see that the approved areas are in use, responsible staff are available, listed equipment can be identified and the records reflect the procedures your centre says it follows.

Schedule F Part XIIB covers the operational requirements for accommodation, personnel, equipment, blood collection and processing, testing, storage, labelling and records. Organise your inspection evidence under those headings so that a staff member can retrieve each item without searching several cupboards or computers.⁷

What a blood bank licence inspection will check

A licence inspection checks the conditions supporting your Form 28-C on the floor, not only the papers submitted with Form 27-C. Read Rule 122G together with Schedule F Part XIIB: the inspector can examine your premises, equipment, personnel, testing arrangements, storage and records against the licensed scope.

Use the middle column below as the statutory self-inspection checklist. The last column contains sensible local preparation steps. Those steps help you find a gap before the inspection, but they do not become national application requirements merely because your centre includes them in its renewal file.

Keep the current licence displayed and have the Inspection Book in Form 35 available. Rule 122G treats these as licence conditions, so the person receiving the inspector should know where the original licence and inspection book are kept.

Against every statutory checklist line, write the exact source, such as Rule 122G or the relevant Schedule F Part XIIB heading. Keep your centre’s floor-walk notes, sample selection and document index in a separate “local preparation” column. This prevents a useful internal control from being misquoted later as a requirement imposed by the national Rules.

Build an inspection-ready renewal file

Keep the statutory core together

Your first section should contain the documents directly connected to the national application:

• completed and signed Form 27-C, clearly marked for renewal;
• the applicant’s legal name, premises address and requested scope exactly as they should appear on the renewed licence;
• the current Form 28-C and any renewal or amendment endorsements;
• proof of the prescribed licence and inspection fee payments; and
• the submission acknowledgement and correspondence with the licensing offices.

“Statutory core” does not mean that every item in this section is a separate prescribed form. Form 27-C is prescribed by Rule 122F, and the required fees accompany the application. Form 28-C supplies the existing licence particulars; payment proof, acknowledgements and correspondence preserve the filing trail.

Check the current official form before signing. CDSCO’s blood-bank licensing guidance and inspection material also provide a useful structure for indexing premises, technical staff, equipment and supporting records.⁸

Prepare evidence for the Rule 122G inspection

The following documents support inspection readiness. They should not be presented as a universal list of mandatory application enclosures, because your State Licensing Authority may specify how and when each document must be filed.

• Personnel: appointment letters, qualification and experience documents, registrations where applicable, duty rosters and current responsibility assignments.
• Premises: an approved layout or current floor plan that can be matched to the collection, testing, component, storage and issue areas seen during inspection.
• Equipment: an equipment master with identification numbers, location, status and the corresponding maintenance, calibration or qualification evidence used by your centre.
• Controlled procedures: a current SOP master list, approval history and evidence that staff are using the issued versions.
• Operational records: sample files that connect collection, testing, component preparation, storage, issue or disposal through the unit identifier.

Two short comparison sheets make premises and personnel gaps easier to see. On the premises sheet, record the licensed address, each room’s current function, the identifiers of the approved and current plans, and the reference for any alteration correspondence. On the personnel sheet, place each person’s name and role beside the appointment record, qualification and experience evidence, present duty assignment, Form 27-C entry and any change-reporting correspondence.

These sheets are local preparation tools, not new forms under the national Rules. Keep them at the front of the supporting-evidence section so that your staff can move directly from a Form 27-C or Form 28-C particular to the source document.

Test the file with real retrievals. Select a unit identifier and follow your donor-to-recipient traceability, including the associated TTI testing records. If the issue entry is available but the test worksheet or component trail is missing, the renewal file will not repair that underlying gap.

Check older records against your record-retention controls. Where your centre conducts outdoor collections, include the corresponding blood donation camp documentation trail in the retrieval test.

If your centre uses RAKT, run the same unit-identifier retrieval from the live system before submission. Software can produce and connect records, but your centre remains accountable for the licence application, the entries made by staff and the documents shown to the inspector.

What to have ready before the inspector arrives

Prepare evidence that the statutory conditions exist now. Keep the current Form 28-C, Form 35, the filed Form 27-C set, technical staff files, equipment records and access to operational registers ready for inspection. The inspector may need to compare the dossier with the premises and records rather than review it as a standalone file.

On the last working day before the visit, complete these local preparation steps:

• Confirm who will receive the inspector: identify the licence holder’s representative, responsible medical officer and staff members who can open each operational area and retrieve records.
• Check physical access: make sure the inspector can see equipment labels, storage displays and the areas shown on the floor plan without waiting for keys or permissions.
• Check electronic access: test the logins, report permissions and printer or export route needed to produce live records. Do not rely on one staff member’s personal credentials.
• Run sample retrievals: choose unit identifiers from different dates and outcomes, then retrieve the donor, testing, component, storage, issue or disposal trail that applies.
• List open gaps honestly: record the missing item, immediate containment, responsible person and target date. Do not recreate a contemporaneous entry or change its date to make the file appear complete.
• Keep the submitted set unchanged: preserve the exact signed application, enclosures, payment proof and acknowledgement. File later correspondence separately in date order.

These are inspection-day controls, not extra enclosures prescribed by Rule 122F. Their purpose is to help your staff produce genuine records promptly and to stop a known gap being hidden inside an otherwise tidy renewal dossier.

Separate national rules from state instructions

Rule 122F, Form 27-C, Form 28-C, Rule 122G and Schedule F Part XIIB apply through the national Drugs and Cosmetics Rules. Submission mechanics issued by a state office do not automatically become national requirements.

Ask for the state checklist in writing or save the dated version from its official portal. If an instruction requests an extra document, place it in a separate “state requirements” section rather than describing it in your SOP as a Rule 122G requirement.

The same distinction matters elsewhere in your Drugs and Cosmetics Act compliance: the statutory record, the licensing-office instruction and your centre’s internal control may all be valid, but they come from different authorities.

Check these points before submission

• Are you sending a completed and signed Form 27-C as the prescribed application, rather than treating Form 28-C as an application form?
• For renewal, have you compared the application with the signed current Form 28-C and all endorsements?
• For a first grant, have you supported the proposed premises, technical staff, equipment and scope without creating current-licence particulars that do not yet exist?
• Does the applicant name match the existing licence and legal documents?
• Does the premises address match Form 28-C without abbreviations that could create doubt?
• Does the requested whole-blood and component scope match what your centre actually operates?
• Are the named technical staff still appointed, available and supported by current documents?
• Can every listed equipment identifier be found in the stated location?
• Can staff retrieve a complete sample unit trail while the inspector waits?
• Have you preserved the signed application, payment proof and submission acknowledgement?

A renewal file succeeds when Form 27-C is correct, the Form 28-C scope matches the centre on the floor and the Rule 122G evidence can be produced promptly. Start early enough to correct the operation, not merely rearrange the papers.

Sources

1. Drugs and Cosmetics Rules, 1945, Rule 122F cdsco.gov.in
2. Drugs and Cosmetics Rules, 1945, Form 28-C cdsco.gov.in
3. Drugs and Cosmetics Rules, 1945, Form 27-C cdsco.gov.in
4. Drugs and Cosmetics Rules, 1945, Rules 122-I and 122J cdsco.gov.in
5. Drugs and Cosmetics Rules, 1945, Forms 27-C and 28-C cdsco.gov.in
6. Drugs and Cosmetics Rules, 1945, Rule 122G cdsco.gov.in
7. Drugs and Cosmetics Rules, 1945, Schedule F Part XIIB cdsco.gov.in
8. Central Drugs Standard Control Organisation, Blood Centre resources cdsco.gov.in