Procedure to obtain License to Manufacture drugs for testing and analysis purposes

Procedure to obtain License to Manufacture drugs for testing and analysis purposes

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Laboratory
Picture: Pixabay

Last Updated on July 5, 2021 by The Health Master

Manufacturing of drugs for testing and analysis

How to obtain License to manufacture drugs for purposes of examination, test or analysis

Medicine Factory
Picture: Pixabay

Documents required

For obtaining License to manufacture drugs for purposes of examination, test or analysis, the list of documents required is provided below. Download the pdf file and prepare the documents accordingly.

Procedure

Procedure for obtaining License to manufacture drugs for purposes of examination, test or analysis. Download the pdf file for more detail and prepare the documents accordingly.

Forms & Fee

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.

Forms-and-fees-for-Manufacturing-of-Allopathic-Drugs

Download the below pdf file for obtaining the said license

Form-30

Submit your application (Online and / or hard copy) to State Drugs Controller / Licensing Authority of your area after completing all the required documents.

Types of LicensesApplication on FormLicense on FormLicense Fee Rs.Renewal / Retention fee (after 5 years)Late fee Per monthFee for duplicate copy of licenseAdditional Item (per item)
Drug sale licenses
Whole Sale1920-B & 21-B3000/ (1500/- each)Retention fee after 5 years Rs. 3000/-2% of license fee (Rs 60/-)300/--
Retail sale1920 & 21-do--do--do--do--
Homeopathic (WSDL)19-B20-D250/-20-E50/-150/--
Homeopathic (RSDL)19-B20-C250/-20-E50/-150/--
Sch. X
(WSDL)
19-C20-G500/-Retention fee after 5 years Rs. 500/-2% of license fee (Rs 10/-)150/--
Sch. X
(RSDL)
19-C20-F500/-Retention fee after 5 years Rs. 500/-2% of license fee (Rs 10/-)150/--
Drug manufacturing licenses
Manufacturing (Non-Biological)24257500/-Retention2% of license fee (Rs 150/-)1000/-300/-
Manufacturing (Biological)27287500/-Retention2% of license fee (Rs 150/-)1000/--
License for Test / Analysis2930250/-Valid for 3 years and further renewal for 1 year---
Loan License (Biological)27-A28-B7500/-Retention2% of license fee (Rs 150/-)NO300/-
Loan License (Non-Biological)24-A25-B7500/-Retention2% of license fee (Rs 150/-)NO300/-
LVP27-D28-D7500/-Retention2% of license fee (Rs 150/-)NO300/-
Blood Centre27-C28-C7500/-26-G1000/-NO300/-
Homeopathic Mfg License24-C25-C300/-26-C100/-50/-50/-
Cosmetic
Mfg License
31323500/-Retention2% of license fee (Rs 70/-)250/-100/-
Cosmetic
Mfg Loan License
31-A32-A3500/-Retention2% of license fee (Rs 70/-)250/-100/-
Approval of Commercial testing Lab36377500/-Retention2% of license fee (Rs 150/-)--
Repacking (Non-Biological)24-B25-B700/-Retention2% of license fee (Rs 14/-)1000/-100/-
Medical Devices (Cat A& B)MD-3MD-55000/-Retention2% of license fee (Rs 100/-)-500/-
Medical Devices Loan License)
(Cat A& B)
MD-4MD-65000/-Retention2% of license fee (Rs 100/-)-500/-
Medical Devices
(Cat C& D)
MD-7MD-850,000/-Retention2% of license fee (Rs 1000/-)-1,000/-
Medical Devices Loan License
(Cat C& D)
MD-9MD-1050,000/-Retention2% of license fee (Rs 1000/-)-1,000/-

Note: Requirements of some of documents and procedure for submission of application may vary from State to State

Permission from CDSCO for new drug

For applying for grant of permission to manufacture new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis. Click below links:

As per New Drugs and Clinical Trials Rules 2019 we have provided Application Forms relevant to the above said topic, Click below links for more information:

Form CT-1: Application for registration / renewal of ethics committee relating to clinical trial or bioavailability and bioequivalence study or biomedical health research
Form-CT-1

Form CT-4: Application for grant of permission to conduct clinical trial of new drug or investigational new drug
Form-CT-4

Form CT-5: Application for grant of permission to conduct bioavailability or bioequivalence study
Form-CT-5

Form CT-8: Application for registration / renewal of bioavailability or bioequivalence study centre
Form-CT-8

Form CT-10: Application for grant of permission to manufacture new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis
Form-CT-10

Form CT-12: Application for grant of permission to manufacture formulation of unapproved active pharmaceutical ingredient for test or analysis or clinical trial or bioavailability or bioequivalence study
Form-CT-12

Form CT-13: Application for grant of permission to manufacture unapproved active pharmaceutical ingredient for development of formulation for test or analysis or clinical trial or bioavailability or bioequivalence study
Form-CT-13

Form CT-16: Application for grant of licence to import new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis
Form-CT-16

Form CT-18: Application for grant of permission to import new drug for sale or for distribution
Form-CT-18

Form CT-21: Application for grant of permission to manufacture new drug formulation for sale or for distribution
Form-CT-21

Form CT-24: Application for licence to import of unapproved new drug for treatment of patients of life threatening disease in a government hospital or government medical institution
Form-CT-24

Form CT-26: Application for grant of permission to manufacture unapproved new drug but under clinical trial for treatment of patients of life threatening disease in a government hospital or medical institution
Form-CT-26

Forms: Drugs

Forms: Cosmetics

Forms: Medical Devices

Forms: Clinical Trial

FDAs of India

Here is the link for FDAs of India.

FDA (Food and Drugs Administration)

Notifications

For notifications of Drugs Act and Drugs Rule and New Drugs, FDC, Clinical Trial click below links:

Notification New Drugs, FDC, Clinical Trial

Notifications – Drugs Act

Notifications – Drugs Rule

Licensing procedure for Medical devices

Licensing procedure for manufacturing of Drugs

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