Manufacturing of drugs for testing and analysis

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

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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.

Documents-required-for-obtaining-License-to-manufacture-drugs-for-purposes-of-examination-test-or-analysis

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.

Procedure-for-obtaining-license-to-to-manufacture-drugs-for-purposes-of-examination-test-or-analysis

Forms

Download the below pdf file for obtaining the said license

Form-30

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%--

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

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 researchForm-CT-1

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

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

Form CT-8: Application for registration / renewal of bioavailability or bioequivalence study centreForm-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 analysisForm-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 studyForm-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 studyForm-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 analysisForm-CT-16

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

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

Procedure for registration of Medical Devices: CDSCO
https://thehealthmaster.com/manufacturing-of-drugs-for-testing-and-analysis/