Manufacturing Drug License Registration

A Manufacturing Drug Licence is a license issued by the Drug Control Authority that permits a business to manufacture medicinal products. The Permiso team will provide comprehensive assistance, starting from the project’s paperwork through its successful completion.

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Manufacturing includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up, or otherwise treating or adopting any drug [or cosmetic] with a view to its [sale or distribution], but does not include the compounding or dispensing [of any drug, or the packing of any drug or cosmetic] in the ordinary course of retail business.

A manufacturing drug license is required for the manufacture of Ayurvedic, Allopathic, and Cosmetic drugs/products, according to the Drugs and Cosmetics Act of 1940. It is an official license or permit granted by the State Drug Control Authority or by the Central Drug Standard Control Organisation. This license is needed to ensure that the organization’s drugs are safe, effective, and satisfy quality requirements. In simple terms, a manufacturing drug license is like a permission slip that allows a company to make medicines/cosmetics. The manufacturing license is valid for 5 years.

To obtain a manufacturing drug license, a company needs to demonstrate that it has the necessary facilities, equipment, and processes in place to manufacture drugs in a clean and controlled environment. It also has to prove that its products are manufactured in accordance with specified rules and regulations. Compliance with Good Manufacturing Practices is required to obtain approval from the government.

A Manufacturing Drug License can be obtained for different products as per the Drugs and Cosmetics Rules and Act. The table below will explain the many sorts of manufacturing medicine licenses that are required for your company

Types of Manufacturing Drug License Application Form Grant Of License Form
For Allopathy Medicine FORM 24 & 27 FORM 25 & 28
For License to Repack FORM 24B FORM 25B
For Homoeopathic Medicines FORM 24C FORM 25C
For Ayurvedic/ Siddha or Unani drugs FORM 24D FORM 25D
For Cosmetics FORM 31 FORM 32

Procedure for Obtaining a Manufacturing Drug License in India:

  • check icon Plan Layout Approval: Preparing the plan layout is the first step for obtaining the license. The client has to get approval from the FDA department on the plan layout prepared by the architect as per the FDA norms.
  • check icon Obtaining Login credentials: To obtain a Drug License, a person must first register in an online portal and create a Login ID and Password, which will be sent to them through SMS on the mobile phone.
  • check icon Documentation: The applicant must produce documents and upload them online accordingly. All documents must meet the rules of The Drugs And Cosmetic Act, 1940.
  • check icon Fees: The applicant must pay the required fees online by the requirements as per The Drugs And Cosmetics Act, 1940, The Drugs And Cosmetics Rules, 1945 or The Medical Devices Rules, 2017.
  • check icon Inspection: Following the submission of documentation, the Drug Inspector visits the premises where the drug license is to be obtained to authenticate the location and verify the documents.
  • check icon Issue of Drug License: Post Inspection by the Drug Inspector, the licensing authority verifies the documents and inspection report submitted by the Drug Inspector and will grant or reject the license

Pre - Requisites / Documents required for Manufacturing Drug License:

  • check icon Area: The minimum area recommended is 1500 Sq. Ft.
  • check icon Competent Technical Staff/ Registered Pharmacist Person: The List of competent technical staff with their qualifications, registration, experience, previous FDA approvals, and so on.
  • check icon List of Plant and Machineries: Details of all the plant and machineries used for production including their specifications, photos, etc.
  • check icon Approved Layout: Plan layout of the premises approved by the licensing authority.
  • check icon MPCB: Consent to establish and Consent to operate from the Pollution Control Board
  • check icon DISH: NOC from the Department Of Industrial Safety & Health
  • check icon Firms Constitution Documents: Photo ID / Partnership Deed & ROF registration receipt / Certificate of Incorporation / Trust Registration / HUF Deed / Society Registration depending on the type of constitution
  • check icon Details of proprietor/partner/ Director/Trustee etc.: Details of proprietor/director/trustee etc. mentioning their Name, Qualification, DOB, Phone Number, and Email id.
  • check icon ID Proof: Pan card and Aadhar card of proprietor/partners/directors.
  • check icon Agreement: Sale Agreement or Registered Rent Agreement
  • check icon Others: Details Of Manufacturing Process, Process Flow Chart, AHU Installation and Water System Installation

Obtaining a Manufacturing Drug License can be time-consuming and the licensing procedure consists of steps that require a clear and thoughtful method. Any blunder during the registration procedure may result in the applicant being denied the license. We reduce the likelihood of application rejection and ensure that licenses are issued quickly and without complications.

You can apply for a Manufacturing Drug License / Renewal of a Manufacturing Drug License / Change in Constitution / Change in Premises / Product Addition / Technical Person Name Addition / Duplicate License or Surrender of License through M/s. The Permiso and obtain the application reference number within 2 days. If you have any issues or facing any difficulty with the application, you can call +91 8104691667 or email us at info@thepermiso.com

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Manufacturing Drug License Registration Procedure

Registration Procedure