Blood Bank / Centre

Last Updated on June 13, 2021 by The Health Master

Blood Bank / Centre – How to obtain license


Must read articles

Click below links:

Blood Centre (Bank) – requirements at a glance

FAQs – on Blood Centre (Series-3)

FAQs – on Blood Centre (Series-2)

FAQs – on Blood Centre (Series-1)

FAQs on Legal Metrology & Blood Bags

Pharmacopoeial status of Blood and its components

Your Guide to Preventing and Treating Blood Clots

Adequate and safe blood transfusion for all: Article


How to obtain manufacturing license for Blood Bank / Centre

Documents required for obtaining Blood Centre

For obtaining manufacturing license for Blood Centre, the list of documents required is provided below. Download the pdf file and prepare the documents accordingly.

Procedure for obtaining license

Procedure for obtaining manufacturing license for Blood Centre. Download the pdf file for more detail and prepare the documents accordingly.

Form and fee

List of Forms & Fee for obtaining the said license is provided below. Download the pdf file and prepare the Form accordingly and submit the required fee.

Form-27C

Download the below pdf files for various Forms which suits your requirement

Submit your application (Online and / or hard copy) to DCGI and State Drugs Controller / Licensing Authority of your area after completing all the required documents.

Note: Requirements of some of documents and procedure for submission of application may vary from State to State


License conditions

Conditions of licenses is to be maintained after obtaining the required Blood Centre. Download the pdf file for ready reference.

License renewal fee: Procedure

Procedure for submission of license renewal fee. Download the pdf file for more detail and prepare the documents accordingly.

Requirements for running a Blood Centre

Part X-B

Requirements for the collection, storage, processing and distribution of Whole Human Blood, Human Blood Components by Blood Banks / centres and manufcature of blood products are mentioned in “part X B of drugs and cosmetics act 1940 and rules framed thereunder. For more details click below:

Part XII-B

Requirements for the functioning and operation of a blood Centre and / or for preparation of blood components are mentioned in “part XII B of drugs and cosmetics act 1940 and rules framed thereunder. For more details click below:

Important notifications

2020

GSR-166 (E) dated 11-03-20 regarding – Blood Bank / Blood Centre, Qualification of Doctor and technical staff etc.

Central Govt. has issued notification dated 03-04-2017 regarding Blood Transfer to another Blood Bank and Blood donation Camps. Click below for the said notification:

2017

GSR 733 (E) dt 21-12-2005 Blood bank run by Govt, Red Cross, Hospitals, Charitable trust or Voluntary Organization approved by Blood Transfusion Council

2005

GSR-733-E-dt-21-12-2005-Blood-bank-run-by-Govt-Red-Cross-Hospitals-Cheritable-trust-or-Voluntary-Organization-approved-by-Blood-Transfusion-Council

2002

GSR 600 (E) dt 27-08-2002 regarding In-Vitro Blood grouping Sera and In-Vitro Diagnostic Devices for HIV, HbsAg and HCV

GSR-600-E-dt-27-08-2002-regarding-In-Vitro-Blood-grouping-Sera-and-In-Vitro-Diagnostic-DEvices-for-HIV-HbsAg-and-HCV

2001

GSR 40 (E) Dt 29-01-2001 Regarding Blood Bank – Blood donation, Testing, Records labels, Plasma etc.

GSR-40-E-Dt-29-01-2001-Regarding-Blood-Bank-Blood-donation-Testing-Records-labels-Plasma-etc.

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FAQs on Cord Blood Banking

ICMR – FAQs on Cord Blood Banking, clccik below link

ICMR-FAQs-on-Cord-Blood-Banking

NBTC Guidelines

National Blood Transfusion Council (NBTC) has issued some guidelines regarding Blood banks / centres. (These guideline shave been taken from NBTC website) Click below links to read or download:

2018

2017

2015

2014

National Blood Policy

National Blood Policy, Click below link

Must read article: Bombay Blood Group

Must read article: Why India needs more blood donors: Article

For notifications of Blood Bank / Centre, click below link:

Notifications – Blood Bank / Centre


Types of LicensesApplication on FormLicense on FormLicense Fee Rs.Renewal / Retention fee (after 5 years)Late fee Per monthFee for duplicate copy of licenseAdditional Item (per item)
Drug sale licenses
Whole Sale1920-B & 21-B3000/ (1500/- each)Retention fee after 5 years Rs. 3000/-2% of license fee (Rs 60/-)300/--
Retail sale1920 & 21-do--do--do--do--
Homeopathic (WSDL)19-B20-D250/-20-E50/-150/--
Homeopathic (RSDL)19-B20-C250/-20-E50/-150/--
Sch. X
(WSDL)
19-C20-G500/-Retention fee after 5 years Rs. 500/-2% of license fee (Rs 10/-)150/--
Sch. X
(RSDL)
19-C20-F500/-Retention fee after 5 years Rs. 500/-2% of license fee (Rs 10/-)150/--
Drug manufacturing licenses
Manufacturing (Non-Biological)24257500/-Retention2% of license fee (Rs 150/-)1000/-300/-
Manufacturing (Biological)27287500/-Retention2% of license fee (Rs 150/-)1000/--
License for Test / Analysis2930250/-Valid for 3 years and further renewal for 1 year---
Loan License (Biological)27-A28-B7500/-Retention2% of license fee (Rs 150/-)NO300/-
Loan License (Non-Biological)24-A25-B7500/-Retention2% of license fee (Rs 150/-)NO300/-
LVP27-D28-D7500/-Retention2% of license fee (Rs 150/-)NO300/-
Blood Centre27-C28-C7500/-26-G1000/-NO300/-
Homeopathic Mfg License24-C25-C300/-26-C100/-50/-50/-
Cosmetic
Mfg License
31323500/-Retention2% of license fee (Rs 70/-)250/-100/-
Cosmetic
Mfg Loan License
31-A32-A3500/-Retention2% of license fee (Rs 70/-)250/-100/-
Approval of Commercial testing Lab36377500/-Retention2% of license fee (Rs 150/-)--
Repacking (Non-Biological)24-B25-B700/-Retention2% of license fee (Rs 14/-)1000/-100/-
Medical Devices (Cat A& B)MD-3MD-55000/-Retention2% of license fee (Rs 100/-)-500/-
Medical Devices Loan License)
(Cat A& B)
MD-4MD-65000/-Retention2% of license fee (Rs 100/-)-500/-
Medical Devices
(Cat C& D)
MD-7MD-850,000/-Retention2% of license fee (Rs 1000/-)-1,000/-
Medical Devices Loan License
(Cat C& D)
MD-9MD-1050,000/-Retention2% of license fee (Rs 1000/-)-1,000/-

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