LVP, Sera & Vaccines - procedure for obtaining License

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How to obtain License

How to obtain manufacturing license for drugs (LVP, Sera & Vaccines)

Documents required

For obtaining manufacturing
license for drugs (LVP, Sera & Vaccines), the list of documents required is
provided below. Download the pdf file and prepare the documents accordingly.

Documents-required-for-obtaining-LVP-Sera-Vaccines

Procedure

Procedure for
obtaining manufacturing license for drugs (LVP, Sera & Vaccines). Download
the pdf file for more detail and prepare the documents accordingly.

Procedure-for-obtaining-LVP-Sera-Vaccines

Form

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

Form 27 D

Form-27D

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 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

Schedule M

Schedule-M

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 manufacturing license
for drugs. Download the pdf file for ready reference.

License-conditions-for-manufacturing-of-Allopathic-drugs

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

Notifications

For notifications of Drugs Act and Drugs Rule, click below links:

Notifications – Drugs Act

Notifications – Drugs Rule
https://thehealthmaster.com/drugs/manufacturing-licenses/lvp-sera-vaccines/