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Regulation & Quality

WHO Maturity Level 3: why DRAP’s next step could open 100 new export markets

Pakistan is at WHO Maturity Level 2 and exports medicines to 52 countries. The health minister expects Level 3 by April 2027.

1 min read

WHO Maturity Level 3: why DRAP’s next step could open 100 new export markets
In this article
  1. Where Pakistan stands
  2. What is being done
  3. Why it matters
  4. What it means for manufacturers
  5. Sources

For a medicine exporter, the strength of the home regulator is part of the product. That is why WHO’s rating of the Drug Regulatory Authority of Pakistan (DRAP) has become an industry priority.

Where Pakistan stands

  • Pakistan is currently at WHO Maturity Level 2 and exports pharmaceutical products to 52 countries, Health Minister Syed Mustafa Kamal told the Senate in August 2026.
  • He said Level 3 accreditation would move Pakistan towards opening more than 100 additional markets.
  • In July 2026, he said he expected Level 3 by April 2027, and that 80% of DRAP’s services were now online.

What is being done

The minister has directed DRAP to speed up the reforms and prepare a roadmap with timelines, Profit reported. Upgrades to the Central Drugs Laboratory, the country’s main medicine testing facility, are part of the plan, with international accreditation intended to align testing with global practice. In June 2026, DRAP was also designated an Observer of the International Council for Harmonisation (ICH).

Why it matters

Benefit cited by the government
Greater credibility of Pakistani medicines abroad
Access to international markets and investor confidence
Joint ventures with global firms
Higher exports of locally made medicines

What it means for manufacturers

A stronger regulator raises the bar at home as well as opening doors abroad. Plants that expect to export will need GMP systems that stand up to closer scrutiny — see DRAP’s PIC/S plan — and the laboratories, documentation and equipment to match.

Regulatory readiness is a recurring theme of the International Pharma Convention at Pharma Asia.

Sources