Table of Contents
Allopathic Drugs – Procedure to obtain manufacturing license
Must read articles
Click below links:
FAQs – on Alcohol (in Pharma Industry)
Expiry and shelf life of medicine: Must read
Marketers responsibility as per latest D&C Rules
FAQs – on Notification: Marketer of drugs
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 manufacturing license for drugs
Documents required
For obtaining drug manufacturing license (DML), the list of documents required is provided below. Download the pdf file and prepare the documents accordingly.
Procedure
Procedure for obtaining manufacturing license for drugs. Download the pdf file for more detail and prepare the documents accordingly.
Forms & Fee
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
Schedule M
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
License conditions
Conditions of licenses is to be maintained after obtaining the required manufacturing license for drugs. Download the pdf file for ready reference.
Retention Fee
Procedure for submission of license retention 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
Circulars
DCGI has issued circular on 04-03-2020 Regarding – Disposal of the applications of “Written confirmation” for active substances exported to the EU for medicinal products for human use in accordance with Article 46(2) (b) of Directive No. 2001/83/EC.
DCGI has issued circular on 03-03-2020 regarding disposal applications of WHO-GMP, Certificate of Pharmaceutical Products (CoPP)
DCGI-Circular-03-03-2020-Regarding-Disposal-of-applications-of-WHO-GMP-CoPP
For more circulars by Govt of India / DCGI / Department of Pharmaceuticals etc, click here
Notifications
For notifications of Drugs Act and Drugs Rule, click below links:
Latest updates
The Health Master is now on Telegram. For latest update on health and Pharmaceuticals, subscribe to The Health Master on Telegram.
Go to main website, click here
Follow and connect with us on Facebook and Linkedin
For daily free updates on WhatsApp, click here
