When the COVID-19 pandemic began, demand for face masks and other personal protective equipment (PPE) soared around the globe. Poor-quality products that did not meet international standards appeared in Pakistan’s markets, endangering health workers, their families and the general public. Pakistani doctors expressed serious concerns about the quality of the available PPE, especially products used in COVID-19 isolation wards. “Surgical masks and PPE should be tested for quality assurance to prevent health workers from infection,” said Dr. Saima Anees, Medical Officer, Benazir Bhutto Shaheed Hospital in Rawalpindi.
But in the early stages of the pandemic, Pakistan’s health system lacked public sector laboratories capable of testing face masks and other PPE to make sure they were effective for their intended purpose. Laboratories play a critical role in a country’s quality assurance system, forming the backbone of the regulatory process that detects and prevents substandard and falsified medical products from circulating in a country’s markets. The labs perform quality tests that generate the data used inform regulatory decisions across multiple areas, from market authorization to investigations of product complaints. Though behind the scenes, the labs play a key role in protecting the public’s health.
To address this challenge, the U.S. Agency for International Development (USAID) came forward to help devise steps to strengthen this important part of Pakistan’s regulatory system. A landscape analysis was conducted to determine the type of support to establish PPE testing facility in public sector laboratory. The report found that Drug Regulatory Authority of Pakistan (DRAP) invested significant resources to upgrade the Central Drug Laboratory (CDL) located in Karachi. The USAID-funded Promoting the Quality of Medicines Plus (PQM+) program worked with lab staff to identify the specific essential instruments needed to equip the CDL to conduct post-marketing surveillance testing of medical products, including PPE. USAID then supported the CDL to procure 11 internationally standardized PPE testing machines, and PQM+ team trained CDL’s technical staff how to correctly use and maintain the complex machines. The CDL can also use the new equipment to test the quality of other medical devices.
USAID’s PQM+ team worked with CDL staff to develop and implement a quality management system (QMS) for the new PPE lab. The QMS is a foundation for establishing all documentation for the equipment, including installation, operations, protocols for performance qualification and standard operating procedures. In essence, the system drives and guides internal processes and practices. International standards also guided DRAP's overall QMS to make sure quality standards are maintained for a medical product while it is going through various stages of design and development, production, storage and distribution.
USAID also leveraged approximately $1.75 million of CDL’s own resources to operationalize the national PPE testing lab. Through its PQM+ program, USAID engaged technical experts to build the staff’s capacity, by transferring the needed knowledge for making the PPE quality testing process sustainable. The CDL staff will also be able to support another ten public sector labs in country to conduct testing of medical products like PPE.
As a result of USAID’s investments, the CDL in Karachi now hosts a state-of-the-art PPE testing lab that is able to independently test N95 and KN95 masks, surgical masks, surgical isolation gowns, goggles, face shields, surgical coveralls, and gloves. This new testing facility will help to optimize health resources in Pakistan. Previously, the CDL paid $1,500 - $3,500 for a third-party laboratory to test a batch of these products. DRAP has also assigned three full-time staff members—a laboratory manager, a technical assistant, and a lab assistant—to manage the PPE testing lab activities, further helping ensure its sustainability and capacity to support DRAP’s post-marketing surveillance of medical products.
Pakistan can now rely on this public sector lab to generate reliable data to take regulatory actions around PPE. Consequently, the Government of Pakistan is better positioned to provide access to safe and effective PPE for its health workforce and the general public, an important step to help ensure uninterrupted access to quality-assured medical products during the COVID-19 pandemic and for future public health emergencies.