Allopathic Drugs

Last Updated on July 8, 2021 by The Health Master

Allopathic Drugs – Procedure to obtain manufacturing license

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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 LicensesApplication on FormLicense on FormLicense Fee Rs.Renewal / Retention fee (after 5 years)Late fee Per monthFee for duplicate copy of licenseAdditional Item (per item)
Drug sale licenses
Whole Sale1920-B & 21-B3000/ (1500/- each)Retention fee after 5 years Rs. 3000/-2% of license fee (Rs 60/-)300/--
Retail sale1920 & 21-do--do--do--do--
Homeopathic (WSDL)19-B20-D250/-20-E50/-150/--
Homeopathic (RSDL)19-B20-C250/-20-E50/-150/--
Sch. X
(WSDL)
19-C20-G500/-Retention fee after 5 years Rs. 500/-2% of license fee (Rs 10/-)150/--
Sch. X
(RSDL)
19-C20-F500/-Retention fee after 5 years Rs. 500/-2% of license fee (Rs 10/-)150/--
Drug manufacturing licenses
Manufacturing (Non-Biological)24257500/-Retention2% of license fee (Rs 150/-)1000/-300/-
Manufacturing (Biological)27287500/-Retention2% of license fee (Rs 150/-)1000/--
License for Test / Analysis2930250/-Valid for 3 years and further renewal for 1 year---
Loan License (Biological)27-A28-B7500/-Retention2% of license fee (Rs 150/-)NO300/-
Loan License (Non-Biological)24-A25-B7500/-Retention2% of license fee (Rs 150/-)NO300/-
LVP27-D28-D7500/-Retention2% of license fee (Rs 150/-)NO300/-
Blood Centre27-C28-C7500/-26-G1000/-NO300/-
Homeopathic Mfg License24-C25-C300/-26-C100/-50/-50/-
Cosmetic
Mfg License
31323500/-Retention2% of license fee (Rs 70/-)250/-100/-
Cosmetic
Mfg Loan License
31-A32-A3500/-Retention2% of license fee (Rs 70/-)250/-100/-
Approval of Commercial testing Lab36377500/-Retention2% of license fee (Rs 150/-)--
Repacking (Non-Biological)24-B25-B700/-Retention2% of license fee (Rs 14/-)1000/-100/-
Medical Devices (Cat A& B)MD-3MD-55000/-Retention2% of license fee (Rs 100/-)-500/-
Medical Devices Loan License)
(Cat A& B)
MD-4MD-65000/-Retention2% of license fee (Rs 100/-)-500/-
Medical Devices
(Cat C& D)
MD-7MD-850,000/-Retention2% of license fee (Rs 1000/-)-1,000/-
Medical Devices Loan License
(Cat C& D)
MD-9MD-1050,000/-Retention2% 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

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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 colors permitted

List of Colours Permitted in manufacturing of 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


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 Circular 04-03-2020 – Regarding – Disposal of the applications of “Written confirmation” for active substances exported to the EU

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:

Notifications – Drugs Act

Notifications – Drugs Rule


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