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.

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

A list of forms for obtaining the said license is provided below. Download the pdf file, prepare the form accordingly, and submit the required fee.

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

Fee structure

Download the pdf file for the license fee structure for all licenses under the Drugs and Cosmetics Act 1940 and the Rule framed thereunder. Click below link

Licenses-fee-structure-for-all-licenses

Fees for various kinds of drugs Licenses under Drugs and Cosmetics Act 1940 & Rules 1945

Types of LicensesApplication on FormLicense on FormLicense FeeRenewal / Retention fee (after 5 years)Late fee Per monthFee for duplicate licenseAdditional Item (per item)Sale licensesWhole Sale1920-B 21-B3000/- (1500/- each)Retention fee after 5 years Rs. 3000/-2% (Rs 60/-)300/--Retail sale1920 & 21-do--do--do--do--Homeopathic (Wholesale)19-B20-D250/-20-E50/-150/--Homeopathic (Retail sale)19-B20-C250/-20-E50/-150/--Sch. X (Wholesale)19-C20-G500/-Retention2%150/--Sch. X (Retail Sale)19-C20-F500/-Retention2%150/--Manufacturing licensesManufacturing (Non-Biological)24257500/-Retention2%1000/-300/-Manufacturing (Biological)27287500/-Retention2%1000/-300/-Loan License (B)27-A28-B7500/-Retention2%-300/-Loan License (NB)24-A25-B7500/-Retention2%-300/-LVP27-D28-D7500/-Retention2%-300/-Homeopathic24-C25-C300/-26-C100/-50/-50/-CosmeticCOS 5COS 810,000/-Retention2% 500/-Repacking (NB)24-B25-B700/-Retention2%1000/-100/-Testing licensesLicense for Test / Analysis2930250/-Valid for 3 years and further renewal for 1 year---Cosmetic Testing LaboratoryCOS 22COS 231000/-----Commercial testing Laboratory36377500/-Retention2%--Blood CentreBlood Centre27-C28-C7500/-28-c1000/--300/-Medical Devices manufacturing licensesMedical Devices (Cat A& B)MD-3MD-55000/-Retention2%-500/-Medical Devices (Loan License) (Cat A& B)MD-4MD-65000/-Retention2%-500/-Medical Devices (Cat C& D)MD-7MD-850,000/-Retention2%-1,000/-Medical Devices Loan License (Cat C& D)MD-9MD-1050,000/-Retention2%-1,000/-Medical Devices RegistrationMedical Devices RegistrationMD-41MD-423,000/-Retention2%--

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 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:

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
https://thehealthmaster.com/drugs/manufacturing-licenses/allopathic-drugs/