Sunday, January 8, 2023

Blood Products - How to obtain license

Must read articles, Click below links:

FAQs – on Blood Centre (Series-3)

FAQs – on Blood Centre (Series-2)

FAQs – on Blood Centre (Series-1)

FAQs on Legal Metrology & Blood Bags

Pharmacopoeial status of Blood and its components

Your Guide to Preventing and Treating Blood Clots

Adequate and safe blood transfusion for all: Article

How to obtain a manufacturing license for manufacturing of Blood Products

Documents required

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

Documents-required-for-obtaining-Blood-Products

Procedure

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

Procedure-for-obtaining-Blood-Products

Form

Download the below pdf files for various Forms which suit your requirement

Form-27E

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

Licenses-fee-structure-for-all-licenses

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

Types of LicensesApplication on FormLicense on FormLicense FeeRenewal / Retention fee (after 5 years)Late fee Per monthFee for a duplicate licenseAdditional Item (per item)Sale licensesWhole Sale1920-B 21-B3000/- (1500/- each)Retention fee after 5 years Rs. 3000/-2% (Rs 60/-)300/--Retail sale1920 & 21-do--do--do--do--Homeopathic (Wholesale)19-B20-D250/-20-E50/-150/--Homeopathic (Retail sale)19-B20-C250/-20-E50/-150/--Sch. X (Wholesale)19-C20-G500/-Retention2%150/--Sch. X (Retail Sale)19-C20-F500/-Retention2%150/--Manufacturing licensesManufacturing (Non-Biological)24257500/-Retention2%1000/-300/-Manufacturing (Biological)27287500/-Retention2%1000/-300/-Loan License (B)27-A28-B7500/-Retention2%-300/-Loan License (NB)24-A25-B7500/-Retention2%-300/-LVP27-D28-D7500/-Retention2%-300/-Homeopathic24-C25-C300/-26-C100/-50/-50/-CosmeticCOS 5COS 810,000/-Retention2% 500/-Repacking (NB)24-B25-B700/-Retention2%1000/-100/-Testing licensesLicense for Test / Analysis2930250/-Valid for 3 years and further renewal for 1 year---Cosmetic Testing LaboratoryCOS 22COS 231000/-----Commercial testing Laboratory36377500/-Retention2%--Blood CentreBlood Centre27-C28-C7500/-28-c1000/--300/-Medical Devices manufacturing licensesMedical Devices (Cat A& B)MD-3MD-55000/-Retention2%-500/-Medical Devices (Loan License) (Cat A& B)MD-4MD-65000/-Retention2%-500/-Medical Devices (Cat C& D)MD-7MD-850,000/-Retention2%-1,000/-Medical Devices Loan License (Cat C& D)MD-9MD-1050,000/-Retention2%-1,000/-Medical Devices RegistrationMedical Devices RegistrationMD-41MD-423,000/-Retention2%--

Click for all other application forms

Submit your
application (Online and / or hard copy) to 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 license. Download the
pdf file for ready reference.

License-conditions-for-Blood-Products

Retention Fee

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

Procedure-for-License-retention-fee

List of Laboratory Instruments

We have provided list of laboratory instruments, click below link to exploxe:

List of Laboratory Instruments for Pharma & Cosmetics Industry

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:

Notifications – Blood Bank / Centre
https://thehealthmaster.com/drugs/manufacturing-licenses/blood-products/

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