Must read articles, click below links:
FAQs on Pollution in Drug, Cosmetics & Homeopathic Industries
FAQs – on Drug Permission in Brand or Generic Name
FAQs – on Disinfectants (Series-2)
FAQs – on Disinfectants (Series-1)
FAQs – on Ranitidine tablets and injections in India
FAQs – on Ranitidine tablets and injections in India
FAQs – On Narcotic Drugs, Brand Names of drug (G.S.R. no. 828 (E) dated 06-11-2019) etc
Understanding Quality Risk Management
Importance of patent regime in pharma industry
How to obtain repacking license for drugs
List of 86 items permitted for Repacking during 30th Drug Consultative Committee (DCC) on 07-05-1994, click below link to download the list.
For obtaining repacking license for drugs, the list of documents required is provided below. Download the pdf file and prepare the documents accordingly.
Procedure for obtaining repacking license for drugs. Download the pdf file for more detail and prepare the documents accordingly.
List of Forms & Fee for obtaining the said license is provided below. Download the pdf file and prepare the Form accordingly and submit the required fee.
Download the below pdf files for various Forms which suits your requirement
Submit your application (Online and / or hard copy) to State Drugs Controller / Licensing Authority of your area after completing all the required documents.
| Types of Licenses | Application on Form | License on Form | License Fee Rs. | Renewal / Retention fee (after 5 years) | Late fee Per month | Fee for duplicate copy of license | Additional Item (per item) |
|---|---|---|---|---|---|---|---|
| Drug sale licenses | |||||||
| Whole Sale | 19 | 20-B & 21-B | 3000/ (1500/- each) | Retention fee after 5 years Rs. 3000/- | 2% of license fee (Rs 60/-) | 300/- | - |
| Retail sale | 19 | 20 & 21 | -do- | -do- | -do- | -do- | - |
| Homeopathic (WSDL) | 19-B | 20-D | 250/- | 20-E | 50/- | 150/- | - |
| Homeopathic (RSDL) | 19-B | 20-C | 250/- | 20-E | 50/- | 150/- | - |
| Sch. X (WSDL) | 19-C | 20-G | 500/- | Retention fee after 5 years Rs. 500/- | 2% of license fee (Rs 10/-) | 150/- | - |
| Sch. X (RSDL) | 19-C | 20-F | 500/- | Retention fee after 5 years Rs. 500/- | 2% of license fee (Rs 10/-) | 150/- | - |
| Drug manufacturing licenses | |||||||
| Manufacturing (Non-Biological) | 24 | 25 | 7500/- | Retention | 2% of license fee (Rs 150/-) | 1000/- | 300/- |
| Manufacturing (Biological) | 27 | 28 | 7500/- | Retention | 2% of license fee (Rs 150/-) | 1000/- | - |
| License for Test / Analysis | 29 | 30 | 250/- | Valid for 3 years and further renewal for 1 year | - | - | - |
| Loan License (Biological) | 27-A | 28-B | 7500/- | Retention | 2% of license fee (Rs 150/-) | NO | 300/- |
| Loan License (Non-Biological) | 24-A | 25-B | 7500/- | Retention | 2% of license fee (Rs 150/-) | NO | 300/- |
| LVP | 27-D | 28-D | 7500/- | Retention | 2% of license fee (Rs 150/-) | NO | 300/- |
| Blood Centre | 27-C | 28-C | 7500/- | 26-G | 1000/- | NO | 300/- |
| Homeopathic Mfg License | 24-C | 25-C | 300/- | 26-C | 100/- | 50/- | 50/- |
| Cosmetic Mfg License | 31 | 32 | 3500/- | Retention | 2% of license fee (Rs 70/-) | 250/- | 100/- |
| Cosmetic Mfg Loan License | 31-A | 32-A | 3500/- | Retention | 2% of license fee (Rs 70/-) | 250/- | 100/- |
| Approval of Commercial testing Lab | 36 | 37 | 7500/- | Retention | 2% of license fee (Rs 150/-) | - | - |
| Repacking (Non-Biological) | 24-B | 25-B | 700/- | Retention | 2% of license fee (Rs 14/-) | 1000/- | 100/- |
| Medical Devices (Cat A& B) | MD-3 | MD-5 | 5000/- | Retention | 2% of license fee (Rs 100/-) | - | 500/- |
| Medical Devices Loan License) (Cat A& B) | MD-4 | MD-6 | 5000/- | Retention | 2% of license fee (Rs 100/-) | - | 500/- |
| Medical Devices (Cat C& D) | MD-7 | MD-8 | 50,000/- | Retention | 2% of license fee (Rs 1000/-) | - | 1,000/- |
| Medical Devices Loan License (Cat C& D) | MD-9 | MD-10 | 50,000/- | Retention | 2% of license fee (Rs 1000/-) | - | 1,000/- |
Note: Requirements of some of documents and procedure for submission of application may vary from State to State
Conditions of licenses is to be maintained after obtaining the required repacking license for drugs. Download the pdf file for ready reference.
Procedure for submission of license retention fee. Download the pdf file for more detail and prepare the documents accordingly.
Today’s updates
The Health Master is now on Telegram. For latest update on health and Pharmaceuticals, subscribe to The Health Master on Telegram.
Follow and connect with us on Facebook and Linkedin
Go to main website, click here
Subscribe for daily free updates, click here
