Mustafa Kamal says WHO Level-3 accreditation could boost pharmaceutical exports as Pakistan prepares for final regulatory assessment
Minister for National Health Services, Regulations and Coordination Syed Mustafa Kamal on Tuesday told the Senate that Pakistan is moving towards opening more than 100 additional international markets for its medicines as the country prepares to secure World Health Organization (WHO) Maturity Level-3 accreditation.
Responding to a Calling Attention Notice moved by Senator Zeeshan Khanzada, the minister said Pakistan, currently accredited at WHO Maturity Level-2, was exporting pharmaceutical products to 52 countries.
He said achieving WHO Maturity Level-3 would significantly expand access for Pakistani medicines in international markets and provide a major boost to the country’s pharmaceutical exports.
The regulatory assessment process is progressing, with another assessment scheduled for October, followed by a final inspection covering regulatory systems at both federal and provincial levels.
The government is working to secure WHO Maturity Level-3 accreditation by April 2027.
Kamal said more than 100 international markets could open for Pakistani medicines once the country achieves Level-3 accreditation, describing the development as a potential breakthrough for the pharmaceutical industry.
He said Pakistan’s pharmaceutical exports had recorded 38% growth, while exports during the current year had so far increased by around 8%.
The minister added that Pakistan already manufactures around 85% of the medicines required domestically, highlighting the strength and potential of the local pharmaceutical industry.
Chinese investment boosts pharmaceutical sector
Kamal also highlighted growing Chinese interest in Pakistan’s pharmaceutical industry.
He said around 180 Chinese pharmaceutical companies participated in Pakistan-China B2B engagement, where agreements and memorandums of understanding worth around $350 million were signed.
According to the minister, 11 companies are investing in active pharmaceutical ingredients (APIs) and pharmaceutical raw materials in Pakistan.
The investment is expected to strengthen domestic manufacturing capacity and reduce the country’s dependence on imported pharmaceutical inputs.
Kamal said export growth and such investments required government facilitation, adding that regulatory reforms and international accreditation depended on active state involvement.
Medical device registration reduced to 20 days
Highlighting regulatory reforms, Kamal said the registration process for medical devices had been significantly shortened through digitalisation.
He said registration previously took between one-and-a-half and two-and-a-half years in some cases but had now been reduced to just 20 days.
Previously, applicants seeking registration for products ranging from wheelchairs to MRI machines were required to physically submit files and interact with officials.
Under the new digital system, applicants no longer need to visit the Drug Regulatory Authority of Pakistan (DRAP) or meet officials in person.
“There is no human interaction,” Kamal said, adding that applicants could complete the required form online from home and receive their registration certificates by email within 20 days.
He said the reform had reduced processing times while also limiting opportunities for unnecessary human intervention in the regulatory process.
Government reviews medicine pricing
On medicine prices, the minister said drug pricing broadly involved two categories: hardship cases involving already registered and marketed medicines where manufacturers seek price revisions, and fixation cases involving new molecules entering the Pakistani market for the first time.
Kamal described medicine pricing as a highly sensitive issue requiring careful scrutiny to protect patients while ensuring pharmaceutical companies remain commercially viable.
He said the federal cabinet had formed a committee of federal ministers, headed by the Finance Minister, to examine medicine pricing cases rather than leaving such decisions to an individual minister or ministry.
The committee reviews pricing formulas for individual molecules before cases are submitted for approval.
Kamal also acknowledged that excessive delays in pricing decisions could create unintended consequences.
He said pharmaceutical companies faced rising business costs and that some medicines could disappear from pharmacy shelves when they became commercially unviable.
Such shortages could force patients to obtain medicines through unregulated channels or agents, posing a particular concern for people requiring critical medicines, including cancer drugs.
The minister stressed that the government must maintain a balance between keeping medicines affordable for the public and ensuring legitimate manufacturers can continue producing essential medicines.