Pakistan Has Just Four WHO-Approved Medicines

NEW YORK: Despite having a large pharmaceutical manufacturing base, Pakistan has only four medicines or therapeutic products prequalified by the World Health Organization (WHO), reflecting a major gap in global quality recognition. None of its drugs have been approved by the US FDA or other Stringent Regulatory Authorities (SRAs), limiting access to global markets.

Experts and officials are now urging local pharmaceutical companies to pursue WHO prequalification. This stamp of approval ensures medicine quality, boosts international credibility, and opens doors to procurement by UN agencies such as UNICEF and the Global Fund.

Without it, Pakistani medicines cannot qualify for international tenders, particularly for HIV/AIDS and tuberculosis (TB) treatments.

A senior DRAP official said most local companies avoid the process due to high costs and strict requirements, fearing competition from Indian and Chinese manufacturers with lower production costs.

However, some progress has been made. PharmEvo became the first Pakistani firm to receive WHO prequalification for zinc sulfate products, while Remington Pharmaceuticals was approved for its anti-TB tablet.

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Still, only two companies in Pakistan have achieved this status. WHO and UNAIDS have repeatedly encouraged Pakistan to start local production of HIV and TB drugs and offered technical support. DRAP will soon invite expressions of interest from local firms for prequalification of these medicines.