Rule reference

Blood Bank / Blood Centre Licence — Schedule F

RULE_DRUGS_BLOOD_LICENSE

Plain-language overview for organisations checking what may apply to them. This is a reference guide — not a substitute for the official gazette or legal advice.

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Blood Bank / Blood Centre Licence — Schedule F (RULE_DRUGS_BLOOD_LICENSE)

Reference only — not legal advice. This page is EarthReheal WasteLedger's plain-language interpretation of the rule, written to help organisations understand what may apply to them. It can be incomplete or inaccurate. Always read the official gazette notification or statute, and confirm with your regulator or a qualified adviser, before relying on it for compliance decisions.

Quick Summary

Operating a blood bank / blood centre in India requires a manufacturing-style licence under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945, Part X-B (Rules 122F–122P), subject to the special conditions in Schedule F Part XII-B (blood bank / components) and Part XII-C (blood products), as applicable. CDSCO guidance specifies a minimum operational area of 100 square metres, plus additional 50 square metres if preparing blood components (and further area for apheresis where applicable). Licence validity is five years from grant or renewal (Rule 122-H). Technical and quality expectations align with NBTC / DGHS standards and State Blood Transfusion Council (SBTC) approvals where required (especially for charitable/voluntary organisations).

What This Rule Is

Full name (EarthReheal WasteLedger label): Blood Bank / Blood Centre Drugs Licence (RULE_DRUGS_BLOOD_LICENSE).

Issuing authority: State Licensing Authority under the Drugs Rules, with Central oversight frameworks via CDSCO; National Blood Transfusion Council (NBTC) / DGHS policy standards; SBTC approvals for specified categories.

Part X-B architecture (CDSCO blood-bank guidelines / Drugs Rules mirrors):

  • Rule 122F — application for licence for operation of Blood Bank / processing of whole human blood for components / manufacture of blood products (and related activities as amended) in Form 27-C or Form 27-E as applicable, with prescribed fees (CDSCO FAQ: licence fee ₹6,000 + inspection fee ₹1,500 = ₹7,500 total commonly cited — confirm current fee schedule before remitting).
  • Rule 122G — form of licence and conditions; space, plant and equipment per Schedule F Part XII-B and/or XII-C.
  • Rule 122-H — Duration of licence: original licence in Form 28-C / 28-E (or renewed Forms 26-G / 26-I as applicable) valid for five years from the date on which it is granted or renewed, unless sooner suspended or cancelled.
  • Rule 122-P — Conditions of licence: special conditions in Schedule F Parts XII-B / XII-C (and related parts as amended), plus general conditions (staff, premises, equipment, records).

Schedule F Part XII-B — area (CDSCO guideline / Schedule F text): A blood bank shall have an area of 100 square metres for its operations and an additional area of 50 square metres for preparation of blood components, with prescribed room segregation (donor, bleeding, store, laboratory, etc.). CDSCO Blood Centre FAQs add additional 10 sq. m for apheresis procedures where relevant.

Schedule F Part XII-C: requirements for manufacture of blood products (separate from whole-blood bank operations) — apply when manufacturing products, not merely collecting/processing components.

NBTC / DGHS / SBTC: CDSCO FAQs state blood centres run by charitable trusts/voluntary organisations need SBTC approval per NBTC procedure; government/IRCS/hospital categories have specified eligibility to organise camps and operate. Always confirm current NBTC guidelines for technical standards (donor selection, testing, storage temperatures, look-back, etc.).

Policy purpose: ensure blood and components are collected, tested, stored, and issued only from licensed, adequately staffed and equipped centres meeting national quality and safety standards.

Who This Applies To

Blood banks / blood centres run by government, hospitals, Indian Red Cross Society, charitable trusts, voluntary organisations, and other eligible entities under the Rules/FAQs. EarthReheal WasteLedger blood-bank org pack marks this rule mandatory.

Not covered by this rule alone: ordinary pharmacy drug sale (RULE_DRUGS_ACT); hospital END/narcotics (RULE_DRUGS_NDPS); BMW disposal of blood bags/tubing (RULE_BMW_2016).

State-Level Variations

Licence is State-granted under central Rules. Variation appears in portal UX, inspection calendars, SBTC approval SOPs, and any State FDA circulars supplementing NBTC standards. Multi-state networks need per-centre licences.

Compliance Requirements — What You Actually Have to Do

1. Secure SBTC / category approvals where required (charitable/voluntary).

2. Apply in Form 27-C / 27-E with premises plan, technical staff credentials, equipment list, SOPs, ownership/tenancy, fees.

3. Meet Schedule F XII-B/XII-C premises and equipment (100 + 50 sq.m as applicable; room-wise layout).

4. Obtain and display Form 28-C / equivalent licence; diary 5-year renewal.

5. Operate to NBTC/DGHS standards — testing panels, cold chain, donor records, haemovigilance, discard logs.

6. Maintain records/registers for the periods specified (Rules/Schedule often reference multi-year retention — CDSCO mirrors cite five years for certain manufacturing/test records; confirm for your activity).

7. Parallel BMW / HWM / Fire / CEA obligations for the facility (see Related Rules).

Penalties & Enforcement

Operating a blood bank without licence is an offence under the Drugs & Cosmetics Act (CDSCO FAQ). Licence suspension/cancellation and criminal prosecution for spurious/unsafe blood practices are live risks. Treat as critical compliance.

Frequently Asked Questions

Q: Is the licence the same as a retail pharmacy Form 20? A: No. Blood centres use Part X-B manufacturing/operation licences (27-C / 28-C family), not ordinary retail sale forms.

Q: We only store blood issued by another bank — still need a licence? A: Storage/processing/distribution of whole blood/components for sale or distribution is licence-regulated — confirm your exact activity with the State Licensing Authority; do not assume a hospital ward fridge is exempt without written FDA clarification.

Q: Validity really five years? A: Yes — Rule 122-H states five years from grant or renewal unless suspended/cancelled.

Government / Official Sources

Related Rules

  • RULE_BMW_2016 — blood bags, tubing, laboratory BMW.
  • RULE_DRUGS_ACT — if a separate retail pharmacy exists on campus.
  • RULE_DRUGS_NDPS — only if ENDs/controlled drugs are stocked in an attached pharmacy.
  • RULE_CEA_2010 / RULE_FIRE_SAFETY / SPCB consents — often parallel for hospital-linked centres.
  • RULE_MERCURY_PHASEOUT — if mercury devices remain in older setups.

Additional Reference Content

Secondary sources (law firm explainers, news, consultancy blogs, or official-body sites on a non-.gov.in/.nic.in domain) — useful context, not primary legal authority.

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