Pakistan Expands Local Manufacture of COVID-19 Medical Products with Support from USAID’S PQM+ Program

In 2020, the Government of Pakistan faced the challenge of effectively and efficiently responding to the COVID-19 pandemic and reducing the country’s rate of mortality from the new virus. Early in the pandemic, all countries lacked medicines needed to treat people infected with COVID-19. Hospital admissions increased in Pakistan and in many other countries. As researchers and health professionals worldwide began testing potential medical products to treat COVID-19, remdesivir, an antiviral medicine, emerged as a therapeutic with promising results.

In early 2020, Pakistan initially imported limited supplies of remdesivir at the price of about US $62 per vial because, at the time, there was no domestic manufacturer producing the medicine. However, as a result of technical assistance provided by the U.S. Agency for International Development (USAID) through the Promoting the Quality of Medicines Plus (PQM+) program, which is led by the U.S. Pharmacopeial Convention (USP), Pakistan began manufacturing quality-assured remdesivir for use in-country as well as for export.

Supporting the local pharmaceutical industry to manufacture remdesivir

In May 2020, Gilead Sciences Inc. signed a voluntary licensing agreement with five generic pharmaceutical manufacturers in Egypt, India, and Pakistan for the local production and export of remdesivir. Ferozsons, one of the five manufacturers engaged by Gilead, is one of Pakistan's largest pharmaceutical manufacturing companies.

Together with the U.S. Government, Gilead developed remdesivir during the Ebola outbreak as part of research into potential therapeutics that could treat similar viruses with the potential to fuel pandemics.

PQM+ provided technical assistance to Ferozsons to implement technology transfer protocols of the Gilead manufacturing process for remdesivir and to scale up production according to international best practices and local manufacturing requirements. PQM+ trained Ferozsons’ quality and regulatory staff on data requirements needed to file for Emergency Use Authorization (EUA) in Pakistan as well as regular market authorization applications in other countries.

The PQM+ team also conducted mock audits to help Ferozsons prepare for regulatory authority inspections led by Indonesia and the Philippines. PQM+ assessed the local supply chain to ensure the quality of locally-produced remdesivir throughout the production process and compliance with good storage practices and good distribution practices. This support included verifying that the manufacturer adhered to good manufacturing practices (GMP) and international standards for quality control testing laboratories and helping the company review specifications for procuring equipment needed to perform quality testing of remdesivir.

Ferozsons expanded its production capacity, received EUA approval from the Pakistan national regulatory authority (DRAP), and started supplying remdesivir to Pakistan’s markets in June 2020. It then began exporting remdesivir globally in September 2020. Since then, sixteen countries have granted Ferozsons-produced remdesivir EUA and are importing it to provide COVID-19 treatments to their populations. Those countries are Angola, Aruba, Belarus, Dominican Republic, Honduras, Indonesia, Jamaica, Kenya, Libya, Mozambique, Philippines, St. Maarten, Tanzania, Uganda, Ukraine, and Uzbekistan. Indonesia, however, granted remdesivir full market authorization. Indonesia is a member state of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), an international association that adheres to stringent manufacturing standards.

Former Special Assistant to Pakistan’s Prime Minister on National Health Services, Dr. Zafar Mirza, recognized this achievement. “Thanks to USAID assistance, it is the first time a manufacturer from Pakistan has been included in a global supply solution of this nature. This development represents an important step forward for Pakistan on the health and economic fronts. Not only did it help provide Pakistani citizens and frontline health care workers with access to the latest COVID-19 treatment in a fast-track manner, but it also represented an important export opportunity for the country’s pharmaceutical sector at a critical time,” he said.

Optimizing resources, expanding access to quality medicines

By December 2021, Ferozsons produced more than 475,000 packs of remdesivir, which could treat more than 79,200 critical COVID-19 patients in Pakistan and other countries, and help reduce death or progression to ventilation for those treated. As a result of local production, the price for remdesivir in Pakistan has been reduced by nearly 50 percent. The government has fixed the price at Rs. 5680/vial or about US $28, which can fluctuate due to exchange rates.

Ferozsons has supplied at least 122,000 packs to the domestic Pakistani market, saving the government an estimated US $3.6 million. In addition, Ferozsons exported more than 343,000 packs to foreign markets, bringing an estimated US $11 million into Pakistan’s economy. Ferozsons continues to produce remdesivir based on demand from Pakistan and other countries.

As a result of USAID’s ongoing support to strengthen Pakistan’s health system, the country is now better positioned to produce its own COVID-19-related medical products and support its population during the ongoing pandemic.