Procedure to obtain license for manufacturing of Homoeopathic Medicines

Also download the Forms, Schedules and notifications

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Homoeopathy Medicine
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Rakesh Dahiya

Homoeopathy – How to obtain manufacturing license

FAQs – on Alcohol (in Pharma Industry)

FAQs on Pollution in Drug, Cosmetics & Homeopathic Industries

FAQs – on Drug Permission in Brand or Generic Name

Understanding Quality Risk Management

Importance of patent regime in pharma industry


How to obtain manufacturing license for Homeopathic medicines

Documents required

For obtaining manufacturing license for Homeopathic medicines, the list of documents required is provided below. Download the pdf file and prepare the documents accordingly.

Procedure for grant

Procedure for obtaining manufacturing license for Homeopathic medicines. Download the pdf file for more detail and prepare the documents accordingly.

Application form

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

Form-24 C

Download the below pdf files for various Forms which suits your requirement

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/-

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


Schedule M-I

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 Homeopathic medicines. Download the pdf file for ready reference.

Procedure for renewal

Procedure for submission of license renewal fee. Download the pdf file for more detail and prepare the documents accordingly.

List of Laboratory Instruments

We have provided list of laboratory instruments, click below link to exploxe:

List of Laboratory Instruments for Pharma & Cosmetics Industry


Notifications – Drugs Act

Notifications – Drugs Rule

Notifications – Homeopathic

Licensing procedure for manufacturing of Drugs

Procedure to obtain license for manufacturing of Cosmetics

Procedure to obtain license for manufacturing of Homoeopathic Medicines

Procedure to obtain license for manufacturing of Medical Devices

Procedure to obtain License to Manufacture drugs for testing and analysis purposes

Procedure to obtain license for Blood Centre (Blood Bank)

Procedure to obtain license for Commercial Testing Laboratories

Procedure to obtain license for Medical Store / Pharmacy

How to start Jan Aushadhi Store: Procedure


Compiled by:
Rakesh Dahiya
SDCO cum Licensing Authority, FDA Haryana


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