Guidelines on Post License Variations (For Comments)

The Drug Regulatory Authority of Pakistan has revised and updated the requirements for grant of Drug manufacturing license and Post Licnese variations, in line with DRAP Act 2012, Drug Act 1976 and rules framed there under after adaptation of PIC/s Guidelines.
These requirements serve a reference document for the applicants intended to apply for grant of Drug Manufacturing Licenses and Post License variation .The requirements aim to facilitate harmonization with international regulatory requirements, enabling Pakistani manufacturers to meet the stringent standards required by international regulatory bodies and foreign regulatory authorities.
Accordingly, the 4th version of guidance document titled “ESTABLISHMENT OF PHARMACEUTICAL UNIT, GRANT AND RENEWAL OF DML-THEREOF, and 1st version of “POST LICENSE VARIATIONS “along with newly drafted ANNEXURES are uploaded on the official website of DRAP on the 30th of September , 2026 to seek comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using the prescribed format. For further guidelines on submitting comments, visit the DRAP website or click here. Comments and suggestions can be forwarded via email to abdullah.diyo∂dra.gov.pk and drapakbar∂gmail.com , zunairafaryad∂gmail.com or can be posted at the mailing address, Director, Division of Drug Licensing , Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Islamabad.