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 Ear Drops FAQs on Pollution in Drug, Cosmetics & Homeopathic Industries FAQs – on Drug Permission in Brand or Generic Name FAQs on Medical Oxygen 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. Documents-required-for-obtaining-DML Procedure Procedure for obtaining manufacturing license for drugs. Download the pdf file for more detail and prepare the documents accordingly. Procedure-for-obtaining-DML 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. Forms-and-fees-for-Manufacturing-of-Allopathic-Drugs Download the below pdf files for various Forms which suits your requirement Form-24 Form-24A Form-24F Form-27 Form-27A Form-27B Form-30 Click for all other application forms Schedule M 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. 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. License-conditions-for-manufacturing-of-Allopathic-drugs 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 FORM-51 Retention Fee Procedure for submission of license retention fee. Download the pdf file for more detail and prepare the documents accordingly. Procedure-for-License-retention-fee List of colors permitted List of Colours Permitted in manufacturing of drug, click below link: List-of-colours-permitted-to-be-used-in-drugs 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: Life-period-of-Drugs Pack size of Drugs Click below link for Pack size of drugs: 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: List-of-Drugs-approved-since-2006-to-2021 Guidelines for Pharma Manufacturers for uploading data on Sugam Portal Guidelines for Pharma Manufacturers for uploading data on Sugam Portal: Click below link Guidelines-for-Pharma-Manufacturers-for-uploading-data-on-Sugam-Portal 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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