Drug Manufacturing License

Last Updated on June 8, 2022

Manufacturers of human and veterinary drugs in Pakistan required to hold an authorization from DRAP in the form of a Drug Manufacturing License (DML). Division of Drug Licensing, DRAP is responsible for the licensing of the drugs manufacturing facilities of pharmaceutical and biological drug products.

There are following five types of Drug Manufacturing License are provided under the Drugs (Licensing, Registering and Advertising) Rules 1976 :-  

Types of LicensePurpose
By way of Formulation For manufacturing of pharmaceutical and biological drugs in finished dosage form
By way of Basic Manufacturing  For basic manufacturing of Active Pharmaceutical Ingredients or biological drug substance
By way of  Semi-Basic Manufacturing For semi basic manufacturing of Active Pharmaceutical Ingredients or biological drug substance
By way of Re-packing For manufacture of drugs by way of repacking as specified in Schedule D of the Drugs (LRA) Rules, 1976.
For Experimental purpose. For  manufacturing activities concerned with investigational drug products for use in clinical trials.
Drug Manufacturing Licenses are valid for 05 years until revoked or suspended earlier.

Companies considering establishing a manufacturing units in Pakistan are encouraged to engage with the DRAP at an early stage in order to facilitate the selection of manufacturing site, developing a layout plan, and rolling out application process for Drug Manufacturing License..

Application Process for Drug Manufacturing Licensees

Application forms, templates and checklists of required documentation according to each type of Drug Manufacturing License is intended to assist applicants for making an application to DRAP for issuance of new licenses or making a changes to existing licenses. Pakistan Integrated Regulatory Information Management System (PIRIMS) provides an online platform to the applicants and regulators for application management of all aspects of Drug Manufacturing Licenses. A guidance documents for regulatory process related to the drug manufacturing licenses issuance, renewal and post license variation is also drafted to explain regulatory requirements and procedures to be followed.