Allopathic Drugs

Allopathic Drugs – How to obtain manufacturing license

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How to obtain manufacturing license for drugs

For obtaining drug manufacturing license (DML), the list of documents required is provided below. Download the pdf file and prepare the documents accordingly.

Procedure for obtaining manufacturing 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.

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 manufacturing 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.

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 notifications of Drugs Act and Drugs Rule, click below links:

Notifications – Drugs Act

Notifications – Drugs Rule


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