Blood Bank / Centre – How to obtain license
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How to obtain manufacturing license for Blood Bank / 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 manufacturing license for Blood Centre. Download the pdf file for more detail and prepare the documents accordingly.
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.
Procedure for submission of license renewal fee. Download the pdf file for more detail and prepare the documents accordingly.
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:
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.
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:
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:
|Types of Licenses||Application on Form||License on Form||License Fee Rs.||Renewal / Retention fee (after 5 years)||Late fee Per month||Fee for duplicate copy of license||Additional Item (per item)|
|Drug sale licenses|
|Whole Sale||19||20-B & 21-B||3000/ (1500/- each)||Retention fee after 5 years Rs. 3000/-||2% of license fee (Rs 60/-)||300/-||-|
|Retail sale||19||20 & 21||-do-||-do-||-do-||-do-||-|
|Sch. X |
|19-C||20-G||500/-||Retention fee after 5 years Rs. 500/-||2% of license fee (Rs 10/-)||150/-||-|
|Sch. X |
|19-C||20-F||500/-||Retention fee after 5 years Rs. 500/-||2% of license fee (Rs 10/-)||150/-||-|
|Drug manufacturing licenses|
|Manufacturing (Non-Biological)||24||25||7500/-||Retention||2% of license fee (Rs 150/-)||1000/-||300/-|
|Manufacturing (Biological)||27||28||7500/-||Retention||2% of license fee (Rs 150/-)||1000/-||-|
|License for Test / Analysis||29||30||250/-||Valid for 3 years and further renewal for 1 year||-||-||-|
|Loan License (Biological)||27-A||28-B||7500/-||Retention||2% of license fee (Rs 150/-)||NO||300/-|
|Loan License (Non-Biological)||24-A||25-B||7500/-||Retention||2% of license fee (Rs 150/-)||NO||300/-|
|LVP||27-D||28-D||7500/-||Retention||2% of license fee (Rs 150/-)||NO||300/-|
|Homeopathic Mfg License||24-C||25-C||300/-||26-C||100/-||50/-||50/-|
|31||32||3500/-||Retention||2% of license fee (Rs 70/-)||250/-||100/-|
Mfg Loan License
|31-A||32-A||3500/-||Retention||2% of license fee (Rs 70/-)||250/-||100/-|
|Approval of Commercial testing Lab||36||37||7500/-||Retention||2% of license fee (Rs 150/-)||-||-|
|Repacking (Non-Biological)||24-B||25-B||700/-||Retention||2% of license fee (Rs 14/-)||1000/-||100/-|
|Medical Devices (Cat A& B)||MD-3||MD-5||5000/-||Retention||2% of license fee (Rs 100/-)||-||500/-|
|Medical Devices Loan License) |
(Cat A& B)
|MD-4||MD-6||5000/-||Retention||2% of license fee (Rs 100/-)||-||500/-|
|Medical Devices |
(Cat C& D)
|MD-7||MD-8||50,000/-||Retention||2% of license fee (Rs 1000/-)||-||1,000/-|
|Medical Devices Loan License |
(Cat C& D)
|MD-9||MD-10||50,000/-||Retention||2% of license fee (Rs 1000/-)||-||1,000/-|
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