Last Updated on January 14, 2024 by The Health Master
Area required at a glance
Table
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
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
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