Table of Contents
Last Updated on August 20, 2022 by The Health Master
Allopathic Drugs – Procedure to obtain manufacturing license
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FAQs – on Disinfectants (Series-2)
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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.
Form-51
Form-51: Form of undertaking to the licensing authority for marketing a drug under a brand name or trade name — to be submitted by the manufacturer or on behalf of the manufacturer
Retention Fee
Procedure for submission of license retention fee. Download the pdf file for more detail and prepare the documents accordingly.
List of colors permitted
List of colours permitted in manufacturing of disinfectants, click below link
GSR-623E-dt-10-08-2022-To-include-colour-of-disinfectants-in-rule-127-of-Drugs-Rules-1945
List of Colours Permitted in manufacturing of the drug, click below link:
Also read the following notification regarding the use of color in Gelatin capsule:
GSR-1186-E-dt-07-12-2018-Rule-1272-Approved-or-permitted-color-in-Gelatin-capsule
Life period of Drugs
Click below link for Life period of drugs:
Pack size of Drugs
Click below link for Pack size of drugs:
List of Laboratory Instruments
We have provided list of laboratory instruments, click below link to exploxe:
List of Laboratory Instruments for Pharma & Cosmetics Industry
List of Drugs approved since 2006 to 2021
List of Drugs approved since 2006 to 2021: Click below link:
Guidelines for Pharma Manufacturers for uploading data on Sugam Portal
Guidelines for Pharma Manufacturers for uploading data on Sugam Portal: Click below link
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:
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