Procedure to obtain license for Blood Centre (Blood Bank)

How to obtain license for Blood Centre (Blood Bank)

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Blood Bank Centre Donation Unit
Picture: Pixabay
SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
Rakesh Dahiya

Last Updated on January 14, 2024 by The Health Master

Blood Centre / Bank – How to obtain license


Click below links:

DCGI-Notice-dt-03-06-2022-Advisory-for-registration-of-Blood-Centres-on-E-rakhtkosh

Blood Centre (Bank) – requirements at a glance

FAQs – on Blood Bank / Centre (Part-1)

FAQs – on Blood Bank / Centre (Part-2)

FAQs – on Blood Bank / Centre (Part-3)

FAQs on Legal Metrology & Blood Bags

FAQs – on Blood Bags and its Testing

Pharmacopoeial status of Blood and its components

Your Guide to Preventing and Treating Blood Clots

Adequate and safe blood transfusion for all: Article

Mandatory requirements for Blood donation camps

Bombay Blood Group

Why India needs more blood donors: Article

Operation of Blood Storage Centres

Blood Centre: Precautions and safety to be observed during blood transfusion

Blood Bank / Centre: Difference Between SDP and RDP

Blood Storage Centre

Operation of Blood Storage Centres

Blood Bank / Centre: Difference Between SDP and RDP

Blood Centre: Precautions and safety to be observed during blood transfusion


How to obtain manufacturing license for Blood Centre / Bank

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

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

Fee

Download the pdf file for the license fee structure for all licenses under the Drugs and Cosmetics Act 1940 and the Rule framed thereunder. Click below link


Fees for various kinds of drugs Licenses under Drugs and Cosmetics Act 1940 & Rules 1945

Types of LicensesApplication Form License on Form FeeRenewal / Retention fee Late fee Duplicate licenseFee per item
Drug Sale Licenses
Whole Sale1920-B & 21-B3000/-  3000/-2%  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/-500/-2%  150/-
Sch. X (RSDL)19-C20-F500/-500/-2%150/-
Drug Manufacturing Licenses
Manufacturing (Non- Biological)24257500/-7500/-2%  1000/-300/-
Manufacturing (Biological)27287500/-7500/-2%  1000/-300/-
Manufacturing Schedule X24 F25 F7500/-7500/-2%1000/-300/-
License for Test / Analysis2930250/-Valid for 3 years. Renewal for 1 year
Loan License (Biological)27-A28-B7500/-7500/-2%  No300/-
Loan License (Non- Biological)24-A25-B7500/-7500/-2%  No300/-
LVP27-D28-D7500/-7500/-2%  No300/-
Cosmetics Manufacturing Licenses
ManufacturingCOS 5COS 810,000/10,000/-  2%500/-
Loan LicenseCOS 6COS 910,000/10,0002% 500/-
LaboratoryCOS 22COS 231,000/-1,000/-2%100/-
Additional Section10,000/
Free SaleNo fee
Medical Devices Manufacturing Licenses
Medical Devices (A& B)MD-3MD-55000/-5000/-2%500/-
Medical Devices (Loan License) (A& B)MD-4MD-65000/-5000/-2%500/-
Medical Devices (C& D)MD-7MD-850,000/-50,000/-2%1,000/-
Medical Devices Loan License (C& D)MD-9MD-1050,000/-50,000/-2%  1,000/-
Registration of Medical Devices LaboratoryMD-39MD-4020,000/-20,000/-2%
Sale LicenseMD-41MD-423,000/-3,000/-2%
Free Sale certificate  1,000/- for each category    
Other Licenses
Blood Centre27-C28-C7500/-26-G1000/-No300/-
Homeopathic Mfg License24-C25-C300/-26-C100/-50/-50/-
Approval of Commercial testing Lab36377500/-7500/-2%
Repacking Non-Biological24-B25-B700/-700/-2%1000/-100/-

Area required

Area required for manufacturing of Drugs, Cosmetics, Homoeopathic and Blood Centre

Manufacturing area / sectionArea prescribed for basic installations (Square Metre)Ancillary Area prescribed (Square Metre)Total Area required (Square Metre)
Allopathic drugs   
External Preparations301040
Oral Liquid Preparations301040
Tablets (uncoated) Non-Beta Lactum (Granulation + compression + packaging etc)602080
Coating (Non-Beta Lactum)30 1040
Tablets (uncoated) Beta Lactum (Granulation + compression + packaging etc)602080
Coating (Beta Lactum)30 1040
Powders (oral)3030
Hard Gelatin Capsules (Beta-lactam)251035
Hard Gelatin Capsules (Non Beta-lactam)251035
Ophthalmic Preparation251035
Eye ointment, Eye lotion2525
Pessaries2020
Inhalers & Vitrallae2020
Re-packing of drugs3030
Parenteral (Small Volume Parenteral)150100250
Parenteral (Large Volume Parenteral)150150300
Plastic (LVP) by Form-Fill-Seal / Blow, Fill –Seal technology250150400
Homoeopathic   
Mother tincture and
mother solutions
5555
Potentization section2020
Trituration, Tableting,
Pills and Globules section
5555
Syrups & other oral liquids2020
Ointments & lotions section2020
Ophthalmic Preparations2020
Packing & labelling5050
Cosmetics   
A. Powders1515
B. Skin powder for infants1515
C. Creams, Lotions, Shampoo, Shaving Creams, Hair Oils, Emulsions, Pastes, Cleansing Milk, Pomade2525
D. Nail Polish and Nail Lacquers1515
E. Lipsticks and Lipgloss1515
F. Depilatories used for eyes1010
G.
1. Eyebrows, Eyelashes, Eyeliners
2. Kajal and Surma

10 10



5 For base sterilization

10 15
H. Aerosols1515
I. Alcoholic Fragrance Solutions1515
J. Hair Dyes1515
K. Tooth powders general1515
L. Toilet Soaps100100
Blood Bank / Centre   
Blood Bank / Centre
(only for Whole Human Blood)
100100
Blood Component5050
Blood Bank / Centre
including Blood Components
150150
Apheresis1010
Medical Devices
Area not prescribed in MDR 2017 for manufacturing of Medical Devices
Medicinal Gas
Area not prescribed for manufacturing of Medicinal gases
Disinfectant
Area not prescribed for manufacturing of Disinfectants
API (Bulk drug)
Area not prescribed for manufacturing of API (Bulk drugs)
Empty Capsule Shell
Area not prescribed for manufacturing of Empty gelatin Shell
Soft Gelatin Capsules
Area not prescribed for manufacturing of Soft Gelatin Capsules
Cytotoxic substances / Sex hormones
Same area required as defined for tablet section
Laboratory
Area for Commercial Laboratory or Laboratory for manufacturing units not prescribed

Note: Requirement of ancillary area shall not apply to the units registered before 30-06-2005


Compiled by:

Lalit Kr. Goel, DSDC, FDA Haryana

Rakesh Dahiya, SDCO, FDA Haryana


Download area requirement

Click below link to download the requirement for the manufacturing of Drugs, Cosmetics, Homoeopathic and Blood Centre


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:

Bulk transfer of Blood and Blood Components

According to the notification GSR No. 328 (E) dt 03-04-2017, bulk transfers of whole human blood and blood components are permitted to other blood centers.

National Blood Transfusion Council in its meeting of 05.08.2015 has also issued some guidelines and conditions for the Bulk transfer of blood and its components from one blood centre to another blood centre.

Procedure

The formats for the request and issue of a bulk transfer of blood and its components are as follows:

Request Form for Recipient Blood Centre: Click the below link to download the Form

Request-Form-for-Recipient-Blood-centre

Issue Form for Supplier Blood Centre: Click the below link to download the Form

Issue-Form-for-Supplier-Blood-centre

Conditions

Bulk transfer of blood and blood components amongst licensed blood centres in the country would henceforth be allowed under the following conditions:

  • Bulk transfers of whole human blood and blood components can be done between licensed blood centres.
  • Bulk transfers of whole human blood and blood components can be done among Blood centres in the state or across the state borders.
  • All transfers shall be done at the recommended temperature and as per prescribed storage conditions for whole human blood and blood components.
  • The recipient blood banks shall not further transfer units obtained from another blood bank except to another blood storage centre or a patient
  • The supplier blood centre shall be responsible for compliance thereof.
  • The recipient blood centre should have the capacity to hold the units requested, at an appropriate temperature until the time of utilization.
  • Broad-based donor consent should be incorporated in the standard donor form to ensure that the donor agrees to his blood unit being utilized beyond the blood centre where it is donated.
  • The supplier blood centre can levy the prescribed processing charges on the patient or recipient, or the recipient blood centre as per NBTC norms.
  • The recipient blood centre can levy only processing charging for compatibility testing (cross-matching), in addition to charges levied by the supplier blood centre, from the patient/recipient for such transferred units.
  • Records of traceability shall be retained throughout the process.
  • The supplier blood centre would be responsible for all the complications except those related to compatibility testing, which will be the responsibility of the recipient blood bank.
  • The recipient blood bank shall report and evaluate all the adverse transfusion reactions, including those happening due to blood that has been transferred from the supplier blood bank.
  • The documents accompanying the transfer shall include a TTI testing report and a record of transport at the appropriate temperature.
  • Blood centres would be informed regarding bulk transfers to SBTC and, in the case of interstate bulk transfers, to NBTC.

Note: Also follow the guidelines or instructions issued by the concerned State Authorities where the Supplier or Recipient Blood centre is situated.

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.
(vi) Aspirin.

List of SOPs used in Blood Centres

List of SOPs used in Blood Centres, click the link below to download:

List of SOPs used in Blood Centres

Deferment of blood donation

Blood donation cannot be done in the conditions mentioned below for the period mentioned in the table below:

CONDITIONSPERIOD OF DEFERMENT
Abortions6 months
History of Blood6 months
Surgery12 months 
Typhoid12 months after recovery
History of Malaria and duly treated 2 months (endemic) 3 years (nonendemic area)
Tattoo6 months
Breastfeeding12 months after delivery
Immunization (Cholera, Typhoid, Diphtheria, Tetanus, Plague, Gammaglobulin)15 days  
Rabies vaccination1 year after vaccination
History of Hepatitis in the family or close contact12 months
Immunoglobulin12 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:

(a) Cancer
(b) Heart disease
(c) Abnormal bleeding tendencies
(d) Unexplained weight loss
(e) Diabetes-controlled insulin
(f) Hepatitis infection
(g) Chronic nephritis
(h) Signs and symptoms, suggestive of AIDS
(i ) Liver diseases
(j) Tuberculosis
(k) Polycythemia Vera.
(l) Asthma
(m) Epilepsy
(n) Leprosy
(o) Schizophrenia
(p) Endocrine disorders

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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Cord Blood Banking

FAQs on Cord Blood Banking

ICMR – FAQs on Cord Blood Banking, clccik below link

ICMR-FAQs-on-Cord-Blood-Banking

ICMR Guidelines for Umbilical Cord Blood Banking 2023

ICMR – Guidelines for Umbilical Cord Blood Banking 2023, click the link below

ICMR-Guidelines-for-Umbilical-Cord-Blood-Banking-2023

List of Blood Centres / Banks in India

List of Licensed Blood Centres / Banks in India as on Feb 2015

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:

2022

National Standards for Blood Centres 2nd Edition 2022

National Standards for Blood Centres 2nd Edition 2022

2018

2017

2015

2014

NACO Guidelines

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 the below links:

National Plasma Policy 2014

Standards-for-Blood-Banks-and-Blood-Transfusion-Services-2007


Notifications – Blood Bank / Centre

Bombay Blood Group

Your Guide to Preventing and Treating Blood Clots

Adequate and safe blood transfusion for all: Article

Why India needs more blood donors: Article

Blood Centre: Precautions and safety to be observed during blood transfusion

Blood Bank / Centre: Difference Between SDP and RDP

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