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.² 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.³

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.¹

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.³

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.

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.⁴

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.⁵ Organise your inspection evidence under those headings so that a staff member can retrieve each item without searching several cupboards or computers.

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.

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.⁶

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.

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.

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

• 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 and Form 27-C cdsco.gov.in
2. Drugs and Cosmetics Rules, 1945, Rule 122H, duration of licence, and Form 28-C cdsco.gov.in
3. Drugs and Cosmetics Rules, 1945, Rules 122-I and 122J, inspection before renewal and the inspector report cdsco.gov.in
4. Drugs and Cosmetics Rules, 1945, Rule 122G cdsco.gov.in
5. Drugs and Cosmetics Rules, 1945, Schedule F Part XIIB cdsco.gov.in
6. CDSCO blood bank licensing guidance and official inspection forms no public URL