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

Documents-required-for-obtaining-Blood-Centre

Procedure for obtaining license

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

Procedure-for-obtaining-Blood-Centre

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

Form-27C

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

License fee structure for all licenses

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-	–
Homeopathic (WSDL)	19-B	20-D	250/-	20-E	50/-	150/-	–
Homeopathic (RSDL)	19-B	20-C	250/-	20-E	50/-	150/-	–
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 (Biological)	27	28	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/-
LVP	27-D	28-D	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/-	–
Additional Section	–	–	10,000/	–	–	–	–
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%	–	–
Sale License	MD-41	MD-42	3,000/-	3,000/-	2%	–	–
Free Sale certificate			1,000/- for each category
Other Licenses
Blood Centre	27-C	28-C	7500/-	26-G	1000/-	No	300/-
Homeopathic Mfg License	24-C	25-C	300/-	26-C	100/-	50/-	50/-
Approval of Commercial testing Lab	36	37	7500/-	7500/-	2%	–	–
Repacking Non-Biological	24-B	25-B	700/-	700/-	2%	1000/-	100/-

Click for all other application forms

Area required

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)
Allopathic drugs
External Preparations	30	10	40
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
Powders (oral)	30	–	30
Hard Gelatin Capsules (Beta-lactam)	25	10	35
Hard Gelatin Capsules (Non Beta-lactam)	25	10	35
Ophthalmic Preparation	25	10	35
Eye ointment, Eye lotion	25	–	25
Pessaries	20	–	20
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

Click for Licensing procedure for manufacturing of Drugs

Homoeopathic
Mother tincture and mother solutions	55	–	55
Potentization section	20	–	20
Trituration, Tableting, Pills and Globules section	55	–	55
Syrups & other oral liquids	20	–	20
Ointments & lotions section	20	–	20
Ophthalmic Preparations	20	–	20
Packing & labelling	50	–	50

Click for Procedure to obtain license for manufacturing of Homoeopathic Medicines

Cosmetics
A. Powders	15	–	15
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
G. 1. Eyebrows, Eyelashes, Eyeliners 2. Kajal and Surma	10 10	– 5 For base sterilization	10 15
H. Aerosols	15	–	15
I. Alcoholic Fragrance Solutions	15	–	15
J. Hair Dyes	15	–	15
K. Tooth powders general	15	–	15
L. Toilet Soaps	100	–	100

Click for Procedure to obtain license for manufacturing of Cosmetics

Blood Bank / Centre
Blood Bank / Centre (only for Whole Human Blood)	100	–	100
Blood Component	50	–	50
Blood Bank / Centre including Blood Components	150	–	150
Apheresis	10	–	10

Click for Procedure to obtain license for Blood Centre (Blood Bank)

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

Click for Procedure to obtain license for Commercial Testing Laboratories

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

Area requirement for manufacturing

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-conditions-for-Blood-Centre

License renewal fee: Procedure

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

Procedure-for-License-renewal-fee

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:

Requirements-for-running-a-Blood-Bank-Part-X-B

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:

Requirements-for-running-a-Blood-Centre – Part XII B

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.

Download notification No. GSR No. 328 (E) dt 03-04-2017

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:

CONDITIONS	PERIOD OF DEFERMENT
Abortions	6 months
History of Blood	6 months
Surgery	12 months
Typhoid	12 months after recovery
History of Malaria and duly treated	2 months (endemic) 3 years (nonendemic area)
Tattoo	6 months
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
Immunoglobulin	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:

(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.

GSR-166-E-11-03-20-Blood-Bank-Blood-Centre

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-No.-328-E-dt-03-04-2017-Blood-Transfer-to-another-Blood-Bank-and-Blood-donation-Camps

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

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

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:

Blood-Bank-guidelines-BY-NACO-12-02-2014

National Plasma Policy 2014

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

National-Blood-Policy-2007

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

Also read

Notifications – Blood Bank / Centre

Also read

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