Last Updated on November 4, 2021 by The Health Master
Blood Bank / Centre – How to obtain license
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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.
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
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
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:
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:
List of emergency Equipment / Items / Drugs to be kept in the Blood Centre / Bank:
(i) Oxygen cylinder with mask, gauge and pressure regulator.
(ii) 5 per cent Glucose or Normal Saline.
(iii) Disposable sterile syringes and needles of various sizes.
(iv) Disposable sterile I.V. infusion sets.
(v) Ampoules of Adrenaline, Noradrenaline, Mephentin, Betamethasone or Dexamethasone, Metoclorpropamide injections.
Deferment of blood donation
Blood donation cannot be done in the conditions mentioned below for the period mentioned in the table below:
|CONDITIONS||PERIOD OF DEFERMENT|
|History of Blood||6 months|
|Typhoid||12 months after recovery|
|History of Malaria and duly treated||2 months (endemic) 3 years (non endemic area)|
|Breast feeding||12 months after delivery|
|Immunization (Cholera, Typhoid, Diphtheria, Tetanus, Plague, Gammaglobulin)||15 days|
|Rabies vaccination||1 year after vaccination|
|History of Hepatitis in family or close contact||12 months|
These persons should not donate blood
No person shall donate blood and no blood bank shall draw blood from a person, suffering from any of the diseases mentioned below, namely:
(b) Heart disease
(c) Abnormal bleeding tendencies
(d) Unexplained weight loss
(e) Diabetes-controlled on insulin
(f) Hepatitis infection
(g) Chronic nephritis
(h) Signs and symptoms, suggestive of AIDS
(i ) Liver diseases
(k) Polycythemia Vera.
(p) Endocrine disorders
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:
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
GSR 600 (E) dt 27-08-2002 regarding In-Vitro Blood grouping Sera and In-Vitro Diagnostic Devices for HIV, HbsAg and HCV
GSR 40 (E) Dt 29-01-2001 Regarding Blood Bank – Blood donation, Testing, Records labels, Plasma etc.
FAQs on Cord Blood Banking
ICMR – FAQs on Cord Blood Banking, clccik below link
List of Blood Centres / Banks in India
List of Licensed Blood Centres / Banks in India as on Feb 2015
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:
National AIDS Control Organisation has issued Blood Bank / Centre Guidelines, Standards for Blood Banks / Centres and Blood Bank / Centre Policy. To read or download click below links:
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