Last Updated on January 6, 2024 by The Health Master
Allopathic Drugs – Procedure to obtain manufacturing license
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How to obtain manufacturing license for drugs
Documents required
For obtaining drug manufacturing license (DML), the list of documents required is provided below. Download the pdf file and prepare the documents accordingly.
Procedure
Procedure for obtaining manufacturing license for drugs. Download the pdf file for more detail and prepare the documents accordingly.
Forms
A list of forms for obtaining the said license is provided below. Download the pdf file, prepare the form accordingly, and submit the required fee.
Download the below pdf files for various Forms which suits your requirement
Fee structure
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/- |
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
Download Schedule M
Download Schedule M dated 28-12-2023
Schedule M
Gist of 31 Chapters on Schedule M. Click the link below:
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
License conditions
Conditions of licenses is to be maintained after obtaining the required manufacturing license for drugs. Download the pdf file for ready reference.
Form-51
Form-51: Form of undertaking to the licensing authority for marketing a drug under a brand name or trade name — to be submitted by the manufacturer or on behalf of the manufacturer
Retention Fee
Procedure for submission of license retention fee. Download the pdf file for more detail and prepare the documents accordingly.
List of colors permitted
List of colours permitted in manufacturing of disinfectants, click below link
GSR-623E-dt-10-08-2022-To-include-colour-of-disinfectants-in-rule-127-of-Drugs-Rules-1945
List of Colours Permitted in manufacturing of the drug, click below link:
Also read the following notification regarding the use of color in Gelatin capsule:
GSR-1186-E-dt-07-12-2018-Rule-1272-Approved-or-permitted-color-in-Gelatin-capsule
Life period of Drugs
Click below link for Life period of drugs:
Pack size of Drugs
Click below link for Pack size of drugs:
List of Laboratory Instruments
We have provided list of laboratory instruments, click below link to exploxe:
List of Laboratory Instruments for Pharma & Cosmetics Industry
List of Drugs approved since 2006 to 2021
List of Drugs approved since 2006 to 2021: Click below link:
List of SOPs used in Pharma Industry
List of SOPs used in Pharma Industry, click below link to download:
Guidelines for Pharma Manufacturers for uploading data on Sugam Portal
Guidelines for Pharma Manufacturers for uploading data on Sugam Portal: Click below link
Circulars
DCGI has issued circular on 04-03-2020 Regarding – Disposal of the applications of “Written confirmation” for active substances exported to the EU for medicinal products for human use in accordance with Article 46(2) (b) of Directive No. 2001/83/EC.
DCGI has issued circular on 03-03-2020 regarding disposal applications of WHO-GMP, Certificate of Pharmaceutical Products (CoPP)
DCGI-Circular-03-03-2020-Regarding-Disposal-of-applications-of-WHO-GMP-CoPP
For more circulars by Govt of India / DCGI / Department of Pharmaceuticals etc, click here
Notifications
For notifications of Drugs Act and Drugs Rule, click below links:
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For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
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