Pakistan Begins to Manufacture, Export Quality-Assured Personal Protective Equipment to Fight COVID-19

At the start of the COVID-19 pandemic, Pakistan imported the majority of its personal protective equipment (PPE), at great expense, to shield its health care providers, frontline responders, and citizens from the highly contagious novel coronavirus. Today, local manufacturers in Pakistan produce most of  the PPE the country needs in compliance with international quality standards, allowing the country to provide PPE for its front-line health care workers and increase the supply of quality masks for the population. They are also exporting their quality-assured PPE to eight countries (Canada, Germany, Poland, Saudi Arabia, Spain, Tunisia, the United Kingdom, and the United States).

With assistance from the Promoting the Quality of Medicines Plus (PQM+) program, which is funded by the U.S. Agency for International Development (USAID) and implemented by the United States Pharmacopeial Convention (USP), nine private sector manufacturers in Pakistan seized the opportunity to build the required systems to reliably produce the needed volume of quality-assured PPE. This included achieving the necessary medical device production accreditation, improving their infrastructure and production areas, and investing in essential new equipment. PQM+ also helped the manufacturers to improve their production layout areas and boost their human resources capacity.

The cost savings have been substantial, not to mention the decreased lead time needed for supply. An imported N95 mask, for example, cost about 2,900 rupees (approximately US $17) at the start of the pandemic, while a domestically-produced N95 mask now costs only 70 rupees (approximately US $0.40). In addition, Pakistan’s PPE exports through July 2021 generated tens of millions of dollars in revenue.

Prior to USAID’s support through the PQM+ program, Pakistan imported most of its PPE from China. As COVID-19 spread last year, the demand for affordable, quality-assured PPE grew exponentially worldwide. A study published in the June 2020 issue of the journal Cureus analyzed data collected from 348 doctors in Pakistan between April 8 and May 5 of that year. The authors noted that half of doctors surveyed “were forced to work without PPE” and only 13 percent “reported having access to all forms of PPE including N95 and KN95 respirators/masks, gloves, gowns/full-suits, and face shields or goggles” within their hospitals. 1

“PPE are not only essential for reducing the risks of transmission of the virus to patients, but to the health workers’ families as well, after they return home from duty. The regular and affordable supply of locally-made PPE ensured everyone’s safety and reduced the spread of infection,” said Nurse Martha Sardar of the Pakistan Institute of Medical Sciences in Islamabad.

To address this challenge, PQM+ identified interested, capable local manufacturers via a publicly-available Expression of Interest published in local newspapers. The PQM+ program then supported the manufacturers to work toward ISO 13485 certification, which is a set of international standards designed to promote the safety and quality of medical devices, including PPE. In addition, PQM+ worked with these manufacturers to attain the Conformité Européenne (CE) mark. The CE mark signifies that the product can be sold in the European Union. Consequently, the Pakistani manufacturers were able to meet international quality measures and produce PPE not only for in-country use, but also for export to other countries in need of PPE during the pandemic.

PPE manufacturers must be able to test their product in a laboratory to ensure it meets quality standards. Prior to PQM+ support, the manufacturers did not have the capacity to test their products, so there was a regulatory barrier to supplying the market. PQM+ worked with the Drug Regulatory Authority of Pakistan (DRAP), the country’s national regulatory authority for medical products, to craft a regulatory approach harnessing private sector capabilities, whereby  ̶  for the first time in Pakistan  ̶ private quality testing labs were authorized by DRAP to provide testing services for PPE manufacturers. PQM+ assisted DRAP to develop a guidance document laying out the required conditions and criteria for private sector testing labs to qualify as independent testing laboratories for local PPE. The PQM+ team then supported the PPE testing labs to ensure they could determine that these locally produced products meet quality standards. The collaborative approach between the public and private sectors has been a resounding success.

As a result of USAID’s support, Pakistani manufacturers are now producing quality-assured PPE  ̶  surgical masks, N95 and KN95 masks, surgical isolation gowns, goggles, face shields, surgical coveralls, and gloves. Production began in November 2020 and by January 2021, the domestic supply was sufficient such that two manufacturers began exporting their new quality-assured PPE.

 1 Ahmed, Jawad, et al. “Availability of Personal Protective Equipment (PPE) Among U.S. and Pakistani Doctors in COVID-19 Pandemic.” Cureus vol. 12,6 e8550. June 10, 2020, doi:10.7759/cureus.8550. Accessed June 3, 2021, at