ISLAMABAD, Aug 25 (APP):Minister for National Health Services, Regulations and Coordination Syed Mustafa Kamal on Tuesday apprised 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 …
Pakistan eyes 100 new pharma export markets as WHO Level-3 accreditation nears: Senate told
ISLAMABAD, Aug 25 (APP):Minister for National Health Services, Regulations and Coordination Syed Mustafa Kamal on Tuesday apprised 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, while achieving Level-3 would further expand access for Pakistani medicines to global markets.
He said the regulatory assessment process was progressing, with another assessment scheduled for October, followed by the final inspection involving regulatory systems at the federal and provincial levels.
The government, he said, was working towards securing WHO Maturity Level-3 accreditation by April 2027.
The day Pakistan achieves WHO Level-3, more than 100 markets will open for Pakistani medicines, the minister said, describing the accreditation as a potential breakthrough for the country’s pharmaceutical exports.
Kamal said Pakistan’s pharmaceutical exports had recorded 38 per cent growth, while exports during the current year had so far increased by around eight per cent.
He said Pakistan already manufactured around 85 per cent of the medicines required domestically, demonstrating the strength and potential of its local pharmaceutical industry.
Highlighting growing Chinese interest in the sector, the minister said around 180 Chinese pharmaceutical companies participated in the Pakistan-China B2B engagement, where agreements and MoUs worth around $350 million were signed.
He said 11 companies were investing in Active Pharmaceutical Ingredients (APIs) and pharmaceutical raw materials in Pakistan, a development aimed at strengthening domestic manufacturing and reducing dependence on imported inputs.
Kamal said such investment and export growth did not happen without government facilitation, arguing that regulatory reforms and international accreditation required active state involvement.
Giving an example of regulatory reform, the minister said registration of medical devices, which previously took between one-and-a-half and two-and-a-half years in some cases, had now been reduced to 20 days through digitalisation.
He said previously an applicant seeking registration of anything from a wheelchair to an MRI machine had to physically submit files and interact with officials, with the process taking years in some cases.
Under the new digital system, he said, applicants were no longer required to visit DRAP or meet any official.
“There is no human interaction,” Kamal said, adding that an applicant could fill out the required form online from home and receive the registration certificate through email within 20 days.
He said the reform had not only reduced processing time but also curtailed opportunities for unnecessary human intervention in the regulatory process.
Regarding medicine prices, the minister said drug pricing broadly involved two categories — hardship cases involving medicines already registered and marketed where manufacturers sought price revisions, and fixation cases involving new molecules entering the Pakistani market for the first time.
He said medicine pricing was a highly sensitive issue and required careful scrutiny to protect patients while ensuring that pharmaceutical companies remained commercially viable.
Kamal said the federal cabinet had constituted a committee comprising federal ministers, headed by the Finance Minister, to examine medicine pricing cases instead of leaving such decisions to an individual minister or ministry.
He said the committee scrutinised pricing formulas for individual molecules before cases were submitted for approval.
Kamal acknowledged that excessive delays in pricing decisions could also create unintended consequences.
He said pharmaceutical companies faced rising costs of doing business and, when certain medicines became commercially unviable, some products disappeared from pharmacy shelves.
Such shortages, he said, could force patients to seek medicines through unregulated channels or agents, a particularly serious concern for patients requiring critical medicines, including cancer drugs.
The minister stressed that the government had to strike a balance between keeping medicines affordable for the public and ensuring that legitimate manufacturers were able to continue producing them.
