Regulatory Updates

The Drug Regulatory Authority of Pakistan has revised and updated the requirements for Establishment of pharmaceutical unit and also developed new guidance annexure VI (A) for requirements for grant of Drug manufacturing license by way of Basic and semi basic manufacturing for Blood and plasma Establishments in line with DRAP Act 2012, Drug Act 1976 and rules framed there under.
These requirements serve a reference document for the applicants intended to apply for grant of Drug Manufacturing Licenses for Blood/Plasma Establishments by way of basic/semi-basic manufacturing. The requirements aim to facilitate harmonization with international regulatory requirements, enabling Pakistani plasma establishments to meet the stringent standards required by international fractionators and foreign regulatory authorities.
These requirements are applicable to a broad range of entities and activities within the plasma supply chain. All Plasma Establishments that hold Drug Manufacturing Licenses and engage in the collection, testing, processing, storage, or distribution of plasma intended for fractionation must comply with these requirements. This also includes blood establishments that collect whole blood from which plasma is recovered, and plasma warehouses and distribution facilities that handle plasma after collection.
Accordingly, the 3rd version of guidance document titled “ESTABLISHMENT OF PHARMACEUTICAL UNIT AND POST LICENSE CHANGES “along with newly drafted Annexure VI ( A) REQUIREMENTS FOR GRANT OF DRUG MANUFACTURING LICENSE BY THE WAY OF BASIC & SEMI-BASIC MANUFACTURING FOR BLOOD/ PLASMA ESTABLISHMENTs are uploaded on the official website of DRAP on the 29th of December , 2025 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 akbar.ali∂dra.pk and drapakbar∂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.