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 Instrument Microscope
Picture: Pixabay
SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
Rakesh Dahiya

Last Updated on June 19, 2024 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

Laboratory Research Testing Flask Chemistry
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.

Form

Download the pdf file and prepare the Form accordingly and submit the required fee.

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


Fees for various kinds of drugs Licenses under Drugs and Cosmetics Act 1940 & Rules 1945

Types of LicensesApplication Form License on Form FeeRenewal / Retention fee Late fee Duplicate licenseFee per item
Drug Sale Licenses
Whole Sale1920-B & 21-B3000/-  3000/-2%  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/-500/-2%  150/-
Sch. X (RSDL)19-C20-F500/-500/-2%150/-
Drug Manufacturing Licenses
Manufacturing (Non- Biological)24257500/-7500/-2%  1000/-300/-
Manufacturing (Biological)27287500/-7500/-2%  1000/-300/-
Manufacturing Schedule X24 F25 F7500/-7500/-2%1000/-300/-
License for Test / Analysis2930250/-Valid for 3 years. Renewal for 1 year
Loan License (Biological)27-A28-B7500/-7500/-2%  No300/-
Loan License (Non- Biological)24-A25-B7500/-7500/-2%  No300/-
LVP27-D28-D7500/-7500/-2%  No300/-
Cosmetics Manufacturing Licenses
ManufacturingCOS 5COS 810,000/10,000/-  2%500/-
Loan LicenseCOS 6COS 910,000/10,0002% 500/-
LaboratoryCOS 22COS 231,000/-1,000/-2%100/-
Additional Section10,000/
Free SaleNo fee
Medical Devices Manufacturing Licenses
Medical Devices (A& B)MD-3MD-55000/-5000/-2%500/-
Medical Devices (Loan License) (A& B)MD-4MD-65000/-5000/-2%500/-
Medical Devices (C& D)MD-7MD-850,000/-50,000/-2%1,000/-
Medical Devices Loan License (C& D)MD-9MD-1050,000/-50,000/-2%  1,000/-
Registration of Medical Devices LaboratoryMD-39MD-4020,000/-20,000/-2%
Sale LicenseMD-41MD-423,000/-3,000/-2%
Free Sale certificate  1,000/- for each category    
Other Licenses
Blood Centre27-C28-C7500/-26-G1000/-No300/-
Homeopathic Mfg License24-C25-C300/-26-C100/-50/-50/-
Approval of Commercial testing Lab36377500/-7500/-2%
Repacking Non-Biological24-B25-B700/-700/-2%1000/-100/-

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

Area required

Area required for manufacturing of Drugs, Cosmetics, Homoeopathic and Blood Centre

Manufacturing area / sectionArea prescribed for basic installations (Square Metre)Ancillary Area prescribed (Square Metre)Total Area required (Square Metre)
Allopathic drugs   
External Preparations301040
Oral Liquid Preparations301040
Tablets (uncoated) Non-Beta Lactum (Granulation + compression + packaging etc)602080
Coating (Non-Beta Lactum)30 1040
Tablets (uncoated) Beta Lactum (Granulation + compression + packaging etc)602080
Coating (Beta Lactum)30 1040
Powders (oral)3030
Hard Gelatin Capsules (Beta-lactam)251035
Hard Gelatin Capsules (Non Beta-lactam)251035
Ophthalmic Preparation251035
Eye ointment, Eye lotion2525
Pessaries2020
Inhalers & Vitrallae2020
Re-packing of drugs3030
Parenteral (Small Volume Parenteral)150100250
Parenteral (Large Volume Parenteral)150150300
Plastic (LVP) by Form-Fill-Seal / Blow, Fill –Seal technology250150400
Homoeopathic   
Mother tincture and
mother solutions
5555
Potentization section2020
Trituration, Tableting,
Pills and Globules section
5555
Syrups & other oral liquids2020
Ointments & lotions section2020
Ophthalmic Preparations2020
Packing & labelling5050
Cosmetics   
A. Powders1515
B. Skin powder for infants1515
C. Creams, Lotions, Shampoo, Shaving Creams, Hair Oils, Emulsions, Pastes, Cleansing Milk, Pomade2525
D. Nail Polish and Nail Lacquers1515
E. Lipsticks and Lipgloss1515
F. Depilatories used for eyes1010
G.
1. Eyebrows, Eyelashes, Eyeliners
2. Kajal and Surma

10 10



5 For base sterilization

10 15
H. Aerosols1515
I. Alcoholic Fragrance Solutions1515
J. Hair Dyes1515
K. Tooth powders general1515
L. Toilet Soaps100100
Blood Bank / Centre   
Blood Bank / Centre
(only for Whole Human Blood)
100100
Blood Component5050
Blood Bank / Centre
including Blood Components
150150
Apheresis1010
Medical Devices
Area not prescribed in MDR 2017 for manufacturing of Medical Devices
Medicinal Gas
Area not prescribed for manufacturing of Medicinal gases
Disinfectant
Area not prescribed for manufacturing of Disinfectants
API (Bulk drug)
Area not prescribed for manufacturing of API (Bulk drugs)
Empty Capsule Shell
Area not prescribed for manufacturing of Empty gelatin Shell
Soft Gelatin Capsules
Area not prescribed for manufacturing of Soft Gelatin Capsules
Cytotoxic substances / Sex hormones
Same area required as defined for tablet section
Laboratory
Area for Commercial Laboratory or Laboratory for manufacturing units not prescribed

Note: Requirement of ancillary area shall not apply to the units registered before 30-06-2005


Compiled by:

Lalit Kr. Goel, DSDC, FDA Haryana

Rakesh Dahiya, SDCO, FDA Haryana


Download area requirement

Click below link to download the requirement for the manufacturing of Drugs, Cosmetics, Homoeopathic and Blood Centre


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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