Last Updated on June 25, 2023 by The Health Master
Blood Centre / Bank – How to obtain license
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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.
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
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 Licenses||Application Form||License on Form||Fee||Renewal / Retention fee||Late fee||Duplicate license||Fee per item|
|Drug Sale Licenses|
|Whole Sale||19||20-B & 21-B||3000/-||3000/-||2%||300/-||–|
|Retail sale||19||20 & 21||-do-||-do-||-do-||-do-||–|
|Sch. X (WSDL)||19-C||20-G||500/-||500/-||2%||150/-||–|
|Sch. X (RSDL)||19-C||20-F||500/-||500/-||2%||150/-||–|
|Drug Manufacturing Licenses|
|Manufacturing (Non- Biological)||24||25||7500/-||7500/-||2%||1000/-||300/-|
|Manufacturing Schedule X||24 F||25 F||7500/-||7500/-||2%||1000/-||300/-|
|License for Test / Analysis||29||30||250/-||Valid for 3 years. Renewal for 1 year||–||–||–|
|Loan License (Biological)||27-A||28-B||7500/-||7500/-||2%||No||300/-|
|Loan License (Non- Biological)||24-A||25-B||7500/-||7500/-||2%||No||300/-|
|Cosmetics Manufacturing Licenses|
|Manufacturing||COS 5||COS 8||10,000/||10,000/-||2%||–||500/-|
|Loan License||COS 6||COS 9||10,000/||10,000||2%||500/-|
|Laboratory||COS 22||COS 23||1,000/-||1,000/-||2%||100/-||–|
|Free Sale||–||–||No fee||–||–||–||–|
|Medical Devices Manufacturing Licenses|
|Medical Devices (A& B)||MD-3||MD-5||5000/-||5000/-||2%||–||500/-|
|Medical Devices (Loan License) (A& B)||MD-4||MD-6||5000/-||5000/-||2%||–||500/-|
|Medical Devices (C& D)||MD-7||MD-8||50,000/-||50,000/-||2%||–||1,000/-|
|Medical Devices Loan License (C& D)||MD-9||MD-10||50,000/-||50,000/-||2%||–||1,000/-|
|Registration of Medical Devices Laboratory||MD-39||MD-40||20,000/-||20,000/-||2%||–||–|
|Free Sale certificate||1,000/- for each category|
|Homeopathic Mfg License||24-C||25-C||300/-||26-C||100/-||50/-||50/-|
|Approval of Commercial testing Lab||36||37||7500/-||7500/-||2%||–||–|
Area required for manufacturing of Drugs, Cosmetics, Homoeopathic and Blood Centre
|Manufacturing area / section||Area prescribed for basic installations (Square Metre)||Ancillary Area prescribed (Square Metre)||Total Area required (Square Metre)|
|Oral Liquid Preparations||30||10||40|
|Tablets (uncoated) Non-Beta Lactum (Granulation + compression + packaging etc)||60||20||80|
|Coating (Non-Beta Lactum)||30||10||40|
|Tablets (uncoated) Beta Lactum (Granulation + compression + packaging etc)||60||20||80|
|Coating (Beta Lactum)||30||10||40|
|Hard Gelatin Capsules (Beta-lactam)||25||10||35|
|Hard Gelatin Capsules (Non Beta-lactam)||25||10||35|
|Eye ointment, Eye lotion||25||–||25|
|Inhalers & Vitrallae||20||–||20|
|Re-packing of drugs||30||–||30|
|Parenteral (Small Volume Parenteral)||150||100||250|
|Parenteral (Large Volume Parenteral)||150||150||300|
|Plastic (LVP) by Form-Fill-Seal / Blow, Fill –Seal technology||250||150||400|
|Mother tincture and |
|Trituration, Tableting, |
Pills and Globules section
|Syrups & other oral liquids||20||–||20|
|Ointments & lotions section||20||–||20|
|Packing & labelling||50||–||50|
|B. Skin powder for infants||15||–||15|
|C. Creams, Lotions, Shampoo, Shaving Creams, Hair Oils, Emulsions, Pastes, Cleansing Milk, Pomade||25||–||25|
|D. Nail Polish and Nail Lacquers||15||–||15|
|E. Lipsticks and Lipgloss||15||–||15|
|F. Depilatories used for eyes||10||–||10|
1. Eyebrows, Eyelashes, Eyeliners
2. Kajal and Surma
5 For base sterilization
|I. Alcoholic Fragrance Solutions||15||–||15|
|J. Hair Dyes||15||–||15|
|K. Tooth powders general||15||–||15|
|L. Toilet Soaps||100||–||100|
|Blood Bank / Centre|
|Blood Bank / Centre |
(only for Whole Human Blood)
|Blood Bank / Centre |
including Blood Components
|Area not prescribed in MDR 2017 for manufacturing of Medical Devices|
|Area not prescribed for manufacturing of Medicinal gases|
|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|
|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
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
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:
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.
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
Issue Form for Supplier Blood Centre: Click the below link to download the Form
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.
List of SOPs used in Blood Centres
List of SOPs used in Blood Centres, click the link below to download:
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 (nonendemic area)|
|Breastfeeding||12 months after delivery|
|Immunization (Cholera, Typhoid, Diphtheria, Tetanus, Plague, Gammaglobulin)||15 days|
|Rabies vaccination||1 year after vaccination|
|History of Hepatitis in the 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 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.
Cord Blood Banking
FAQs on Cord Blood Banking
ICMR – FAQs on Cord Blood Banking, clccik below link
ICMR Guidelines for Umbilical Cord Blood Banking 2023
ICMR – Guidelines for Umbilical Cord Blood Banking 2023, click the link below
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 Standards for Blood Centres 2nd Edition 2022
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:
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