Last Updated on January 14, 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
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
Download the below pdf file for obtaining the said license
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 Licenses | Application Form | License on Form | Fee | Renewal / Retention fee | Late fee | Duplicate license | Fee per item |
| Drug Sale Licenses | |||||||
| Whole Sale | 19 | 20-B & 21-B | 3000/- | 3000/- | 2% | 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/- | 500/- | 2% | 150/- | – |
| Sch. X (RSDL) | 19-C | 20-F | 500/- | 500/- | 2% | 150/- | – |
| Drug Manufacturing Licenses | |||||||
| Manufacturing (Non- Biological) | 24 | 25 | 7500/- | 7500/- | 2% | 1000/- | 300/- |
| Manufacturing (Biological) | 27 | 28 | 7500/- | 7500/- | 2% | 1000/- | 300/- |
| Manufacturing Schedule X | 24 F | 25 F | 7500/- | 7500/- | 2% | 1000/- | 300/- |
| License for Test / Analysis | 29 | 30 | 250/- | Valid for 3 years. Renewal for 1 year | – | – | – |
| Loan License (Biological) | 27-A | 28-B | 7500/- | 7500/- | 2% | No | 300/- |
| Loan License (Non- Biological) | 24-A | 25-B | 7500/- | 7500/- | 2% | No | 300/- |
| LVP | 27-D | 28-D | 7500/- | 7500/- | 2% | No | 300/- |
| Cosmetics Manufacturing Licenses | |||||||
| Manufacturing | COS 5 | COS 8 | 10,000/ | 10,000/- | 2% | – | 500/- |
| Loan License | COS 6 | COS 9 | 10,000/ | 10,000 | 2% | 500/- | |
| Laboratory | COS 22 | COS 23 | 1,000/- | 1,000/- | 2% | 100/- | – |
| Additional Section | – | – | 10,000/ | – | – | – | – |
| Free Sale | – | – | No fee | – | – | – | – |
| Medical Devices Manufacturing Licenses | |||||||
| Medical Devices (A& B) | MD-3 | MD-5 | 5000/- | 5000/- | 2% | – | 500/- |
| Medical Devices (Loan License) (A& B) | MD-4 | MD-6 | 5000/- | 5000/- | 2% | – | 500/- |
| Medical Devices (C& D) | MD-7 | MD-8 | 50,000/- | 50,000/- | 2% | – | 1,000/- |
| Medical Devices Loan License (C& D) | MD-9 | MD-10 | 50,000/- | 50,000/- | 2% | – | 1,000/- |
| Registration of Medical Devices Laboratory | MD-39 | MD-40 | 20,000/- | 20,000/- | 2% | – | – |
| Sale License | MD-41 | MD-42 | 3,000/- | 3,000/- | 2% | – | – |
| Free Sale certificate | 1,000/- for each category | ||||||
| Other Licenses | |||||||
| 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/- |
| Approval of Commercial testing Lab | 36 | 37 | 7500/- | 7500/- | 2% | – | – |
| Repacking Non-Biological | 24-B | 25-B | 700/- | 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 / section | Area prescribed for basic installations (Square Metre) | Ancillary Area prescribed (Square Metre) | Total Area required (Square Metre) |
| Allopathic drugs | |||
| External Preparations | 30 | 10 | 40 |
| Oral Liquid Preparations | 30 | 10 | 40 |
| Tablets (uncoated) Non-Beta Lactum (Granulation + compression + packaging etc) | 60 | 20 | 80 |
| Coating (Non-Beta Lactum) | 30 | 10 | 40 |
| Tablets (uncoated) Beta Lactum (Granulation + compression + packaging etc) | 60 | 20 | 80 |
| Coating (Beta Lactum) | 30 | 10 | 40 |
| Powders (oral) | 30 | – | 30 |
| Hard Gelatin Capsules (Beta-lactam) | 25 | 10 | 35 |
| Hard Gelatin Capsules (Non Beta-lactam) | 25 | 10 | 35 |
| Ophthalmic Preparation | 25 | 10 | 35 |
| Eye ointment, Eye lotion | 25 | – | 25 |
| Pessaries | 20 | – | 20 |
| Inhalers & Vitrallae | 20 | – | 20 |
| Re-packing of drugs | 30 | – | 30 |
| Parenteral (Small Volume Parenteral) | 150 | 100 | 250 |
| Parenteral (Large Volume Parenteral) | 150 | 150 | 300 |
| Plastic (LVP) by Form-Fill-Seal / Blow, Fill –Seal technology | 250 | 150 | 400 |
| Homoeopathic | |||
| Mother tincture and mother solutions | 55 | – | 55 |
| Potentization section | 20 | – | 20 |
| Trituration, Tableting, Pills and Globules section | 55 | – | 55 |
| Syrups & other oral liquids | 20 | – | 20 |
| Ointments & lotions section | 20 | – | 20 |
| Ophthalmic Preparations | 20 | – | 20 |
| Packing & labelling | 50 | – | 50 |
| Cosmetics | |||
| A. Powders | 15 | – | 15 |
| B. Skin powder for infants | 15 | – | 15 |
| C. Creams, Lotions, Shampoo, Shaving Creams, Hair Oils, Emulsions, Pastes, Cleansing Milk, Pomade | 25 | – | 25 |
| D. Nail Polish and Nail Lacquers | 15 | – | 15 |
| E. Lipsticks and Lipgloss | 15 | – | 15 |
| F. Depilatories used for eyes | 10 | – | 10 |
| G. 1. Eyebrows, Eyelashes, Eyeliners 2. Kajal and Surma | 10 10 | – 5 For base sterilization | 10 15 |
| H. Aerosols | 15 | – | 15 |
| I. Alcoholic Fragrance Solutions | 15 | – | 15 |
| J. Hair Dyes | 15 | – | 15 |
| K. Tooth powders general | 15 | – | 15 |
| L. Toilet Soaps | 100 | – | 100 |
| Blood Bank / Centre | |||
| Blood Bank / Centre (only for Whole Human Blood) | 100 | – | 100 |
| Blood Component | 50 | – | 50 |
| Blood Bank / Centre including Blood Components | 150 | – | 150 |
| Apheresis | 10 | – | 10 |
| 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
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
Procedure for registration of Medical Devices: CDSCO
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