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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
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
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 Licenses | Application on Form | License on Form | License Fee Rs. | Renewal / Retention fee (after 5 years) | Late fee Per month | Fee for duplicate copy of license | Additional Item (per item) |
|---|---|---|---|---|---|---|---|
| Drug sale licenses | |||||||
| Whole Sale | 19 | 20-B & 21-B | 3000/ (1500/- each) | Retention fee after 5 years Rs. 3000/- | 2% of license fee (Rs 60/-) | 300/- | - |
| Retail sale | 19 | 20 & 21 | -do- | -do- | -do- | -do- | - |
| Homeopathic (WSDL) | 19-B | 20-D | 250/- | 20-E | 50/- | 150/- | - |
| Homeopathic (RSDL) | 19-B | 20-C | 250/- | 20-E | 50/- | 150/- | - |
| Sch. X (WSDL) | 19-C | 20-G | 500/- | Retention fee after 5 years Rs. 500/- | 2% of license fee (Rs 10/-) | 150/- | - |
| Sch. X (RSDL) | 19-C | 20-F | 500/- | Retention fee after 5 years Rs. 500/- | 2% of license fee (Rs 10/-) | 150/- | - |
| Drug manufacturing licenses | |||||||
| Manufacturing (Non-Biological) | 24 | 25 | 7500/- | Retention | 2% of license fee (Rs 150/-) | 1000/- | 300/- |
| Manufacturing (Biological) | 27 | 28 | 7500/- | Retention | 2% of license fee (Rs 150/-) | 1000/- | - |
| License for Test / Analysis | 29 | 30 | 250/- | Valid for 3 years and further renewal for 1 year | - | - | - |
| Loan License (Biological) | 27-A | 28-B | 7500/- | Retention | 2% of license fee (Rs 150/-) | NO | 300/- |
| Loan License (Non-Biological) | 24-A | 25-B | 7500/- | Retention | 2% of license fee (Rs 150/-) | NO | 300/- |
| LVP | 27-D | 28-D | 7500/- | Retention | 2% of license fee (Rs 150/-) | NO | 300/- |
| Blood Centre | 27-C | 28-C | 7500/- | 26-G | 1000/- | NO | 300/- |
| Homeopathic Mfg License | 24-C | 25-C | 300/- | 26-C | 100/- | 50/- | 50/- |
| Cosmetic Mfg License | 31 | 32 | 3500/- | Retention | 2% of license fee (Rs 70/-) | 250/- | 100/- |
| Cosmetic Mfg Loan License | 31-A | 32-A | 3500/- | Retention | 2% of license fee (Rs 70/-) | 250/- | 100/- |
| Approval of Commercial testing Lab | 36 | 37 | 7500/- | Retention | 2% of license fee (Rs 150/-) | - | - |
| Repacking (Non-Biological) | 24-B | 25-B | 700/- | Retention | 2% of license fee (Rs 14/-) | 1000/- | 100/- |
| Medical Devices (Cat A& B) | MD-3 | MD-5 | 5000/- | Retention | 2% of license fee (Rs 100/-) | - | 500/- |
| Medical Devices Loan License) (Cat A& B) | MD-4 | MD-6 | 5000/- | Retention | 2% of license fee (Rs 100/-) | - | 500/- |
| Medical Devices (Cat C& D) | MD-7 | MD-8 | 50,000/- | Retention | 2% of license fee (Rs 1000/-) | - | 1,000/- |
| Medical Devices Loan License (Cat C& D) | MD-9 | MD-10 | 50,000/- | Retention | 2% 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
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
Licensing procedure for Medical devices
Licensing procedure for manufacturing of Drugs
