Suggestions on draft document sought: DRAP revises requirements for establishment of pharma unit

ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has revised and updated the requirements for the establishment of a pharmaceutical unit and sought the comments and suggestions from stakeholders on the draft document.

According to an official communique online updated on the official website of the pharma sector regulator here on Monday, the authority has also developed new guidance for requirements for the grant of a drug manufacturing license by way of basic and semi-basic manufacturing for blood and plasma establishments in line with the DRAP Act 2012, Drug Act 1976, and rules framed there under.

These requirements serve as a reference document for applicants intending to apply for a grant of Drug Manufacturing Licenses for Blood/Plasma Establish-ments 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 apply 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 third version of the guidance document titled “Establishment Of Pharmaceutical Unit And Post License Changes”, along with newly drafted requirements for the 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.

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 [email protected] and [email protected] 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.

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