Allopathic Drugs

Last Updated on January 26, 2023 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

Form-24

Form-24A

Form-24F

Form-27

Form-27A

Form-27B

Form-30

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

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 licenses
Whole 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 licenses
Manufacturing (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 licenses
License for Test / Analysis2930250/-Valid for 3 years and further renewal for 1 year
Cosmetic Testing LaboratoryCOS 22COS 231000/-
Commercial testing Laboratory36377500/-Retention2%
Blood Centre
Blood Centre27-C28-C7500/-28-c1000/-300/-
Medical Devices manufacturing licenses
Medical 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 Registration
Medical Devices RegistrationMD-41MD-423,000/-Retention2%

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, Pomade
2525
D. Nail Polish and Nail Lacquers1515
E. Lipsticks and Lipgloss1515
F. Depilatories used for eyes1010
G. Eyebrows, Eyelashes Eyeliners1010
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


Schedule M

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

[table id=2 /]

Note: Requirements of some of documents and procedure for submission of application may vary from State to State

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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

FORM-51

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:

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 Circular 04-03-2020 – Regarding – Disposal of the applications of “Written confirmation” for active substances exported to the EU

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:

Notifications – Drugs Act

Notifications – Drugs Rule


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