Last Updated on November 29, 2024 by The Health Master
Various types of fees have been described under the Drugs and Cosmetics Act 1940 and Rules framed thereunder for obtaining licenses for the sale and manufacturing of drugs, cosmetics, Homoeopathy, Medical Devices, etc.
License fee structure for all licenses
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 | 3,000/- | 3,000/- | 2% | 300/- | – |
Retail sale | 19 | 20 & 21 | 3,000/- | 3,000/- | 2% | 300/- | – |
Homeopathic (WSDL) | 19-B | 20-D | 2,000/- | – | – | – | – |
Homeopathic (RSDL) | 19-B | 20-C | 2,000/- | – | – | – | – |
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 | 7,500/- | 7,500/- | 2% | 1,000/- | 300/- |
Manufacturing (Biological) | 27 | 28 | 7,500/- | 7,500/- | 2% | 1,000/- | 300/- |
Manufacturing Schedule X | 24 F | 25 F | 7,500/- | 7,500/- | 2% | 1,000/- | 300/- |
License for Test / Analysis | 29 | 30 | 250/- | Valid for 3 years. Renewal for 1 year | – | – | – |
Loan License (Biological) | 27-A | 28-B | 7,500/- | 7,500/- | 2% | No | 300/- |
Loan License (Non- Biological) | 24-A | 25-B | 7,500/- | 7,500/- | 2% | No | 300/- |
LVP | 27-D | 28-D | 7,500/- | 7,500/- | 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 | 5,000/- | 5,000/- | 2% | – | 500/- |
Medical Devices (Loan License) (A& B) | MD-4 | MD-6 | 5,000/- | 5,000/- | 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 | 7,500/- | 26-G | 1,000/- | No | 300/- |
Homeopathic Mfg License | 24-C | 25-C | 2,000/- For any no. of single ingredient | – | – | – | 200/- Per product of combination |
Approval of Commercial testing Lab | 36 | 37 | 7,500/- | 7500/- | 2% | – | – |
Repacking Non-Biological | 24-B | 25-B | 700/- | 700/- | 2% | 1,000/- | 100/- |
Compiled by:
Lalit Kr. Goel, DSDC, FDA Haryana
Rakesh Dahiya, SDCO, FDA Haryana
Download fee structure
Click below link to download the fee structure of all types of drug licenses
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
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