Last Updated on January 26, 2023 by The Health Master
Homoeopathy – How to obtain manufacturing license
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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
Procedures for obtaining manufacturing license for Homeopathic medicines. Download the pdf file for more detail and prepare the documents accordingly.
Application form
Form-24 C
Download the below pdf files for various Forms which suit 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
Licenses-fee-structure-for-all-licenses
Fees for various kinds of drugs Licenses under Drugs and Cosmetics Act 1940 & Rules 1945
| Types of Licenses | Application on Form | License on Form | License Fee | Renewal / Retention fee (after 5 years) | Late fee Per month | Fee for duplicate license | Additional Item (per item) |
| Sale licenses | |||||||
| Whole Sale | 19 | 20-B 21-B | 3000/- (1500/- each) | Retention fee after 5 years Rs. 3000/- | 2% (Rs 60/-) | 300/- | – |
| Retail sale | 19 | 20 & 21 | -do- | -do- | -do- | -do- | – |
| Homeopathic (Wholesale) | 19-B | 20-D | 250/- | 20-E | 50/- | 150/- | – |
| Homeopathic (Retail sale) | 19-B | 20-C | 250/- | 20-E | 50/- | 150/- | – |
| Sch. X (Wholesale) | 19-C | 20-G | 500/- | Retention | 2% | 150/- | – |
| Sch. X (Retail Sale) | 19-C | 20-F | 500/- | Retention | 2% | 150/- | – |
| Manufacturing licenses | |||||||
| Manufacturing (Non-Biological) | 24 | 25 | 7500/- | Retention | 2% | 1000/- | 300/- |
| Manufacturing (Biological) | 27 | 28 | 7500/- | Retention | 2% | 1000/- | 300/- |
| Loan License (B) | 27-A | 28-B | 7500/- | Retention | 2% | – | 300/- |
| Loan License (NB) | 24-A | 25-B | 7500/- | Retention | 2% | – | 300/- |
| LVP | 27-D | 28-D | 7500/- | Retention | 2% | – | 300/- |
| Homeopathic | 24-C | 25-C | 300/- | 26-C | 100/- | 50/- | 50/- |
| Cosmetic | COS 5 | COS 8 | 10,000/- | Retention | 2% | 500/- | |
| Repacking (NB) | 24-B | 25-B | 700/- | Retention | 2% | 1000/- | 100/- |
| Testing licenses | |||||||
| License for Test / Analysis | 29 | 30 | 250/- | Valid for 3 years and further renewal for 1 year | – | – | – |
| Cosmetic Testing Laboratory | COS 22 | COS 23 | 1000/- | – | – | – | – |
| Commercial testing Laboratory | 36 | 37 | 7500/- | Retention | 2% | – | – |
| Blood Centre | |||||||
| Blood Centre | 27-C | 28-C | 7500/- | 28-c | 1000/- | – | 300/- |
| Medical Devices manufacturing licenses | |||||||
| Medical Devices (Cat A& B) | MD-3 | MD-5 | 5000/- | Retention | 2% | – | 500/- |
| Medical Devices (Loan License) (Cat A& B) | MD-4 | MD-6 | 5000/- | Retention | 2% | – | 500/- |
| Medical Devices (Cat C& D) | MD-7 | MD-8 | 50,000/- | Retention | 2% | – | 1,000/- |
| Medical Devices Loan License (Cat C& D) | MD-9 | MD-10 | 50,000/- | Retention | 2% | – | 1,000/- |
| Medical Devices Registration | |||||||
| Medical Devices Registration | MD-41 | MD-42 | 3,000/- | Retention | 2% | – | – |
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. Eyebrows, Eyelashes Eyeliners | 10 | – | 10 |
| 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
Schedule M-I
Submit your application (Online and/or hard copy) to the 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 the license renewal fee. Download the pdf file for more detail and prepare the documents accordingly.
List of Laboratory Instruments
We have provided a list of laboratory instruments, click below link to explore:
List of Laboratory Instruments for Pharma & Cosmetics Industry
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
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