Picture: Pixabay

Allopathic Drugs - Repacking: Procedure for obtaining a license

Must read articles

Click below links:

Marketers responsibility as per latest D&C Rules

FAQs – on Notification: Marketer of drugs

FAQs on Pollution in Drug, Cosmetics & Homeopathic Industries

FAQs – on Drug Permission in Brand or Generic Name

FAQs on Medical Oxygen

FAQs – on Disinfectants (Series-2)

FAQs – on Disinfectants (Series-1)

FAQs – on Ranitidine tablets and injections in India

FAQs – on Ranitidine tablets and injections in India

FAQs – On Narcotic Drugs, Brand Names of drug (G.S.R. no. 828 (E) dated 06-11-2019) etc

Understanding Quality Risk Management

Importance of patent regime in pharma industry

How to obtain repacking license for drugs

List of 86 items for repacking

List of 86 items permitted for Repacking during the 30th Drug Consultative Committee (DCC) on 07-05-1994, click the below link to download the list.

List-of-86-items-permitted-for-Repacking-during-30th-DCC-on-07-05-1994

Documents required

For obtaining a repacking license for drugs, the list of documents required is provided below. Download the pdf file and prepare the documents accordingly.

Documents-required-for-obtaining-license-for-repacking-of-drugs

Procedure

Procedure for obtaining a repacking license for drugs. Download the pdf file for more detail and prepare the documents accordingly.

Procedure-for-obtaining-repacking-license-for-drugs

Forms

A list of forms for obtaining the said license is provided below. Download the pdf file, prepare the form accordingly, and submit the required fee.

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

Form-24B

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

License-conditions-for-Repacking

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/allopathic-drugs-repacking/