April 18, 2016
The support PQM provided to a pharmaceutical manufacturer in China will help bring some relief to patients who suffer from parasitic worm infections, especially in countries most affected by neglected tropical diseases (NTDs). On April 12, the World Health Organization (WHO) Prequalification Programme listed the active pharmaceutical ingredient (API), mebendazole, manufactured by Changzhou Yabang-QH Pharmachem Co. Ltd., as being fully prequalified under its API prequalification procedure.
The WHO prequalification certifies that mebendazole APIs from Changzhou are made according to international quality standards. This is the first mebendazole API used to make medicines to combat neglected tropical diseases (NTDs) to be prequalified by the WHO. Medicines containing mebendazole API are primarily used to treat people with parasitic worm infections.
To prepare Changzhou for WHO prequalification, Promoting the Quality of Medicines (PQM), a program funded by the U.S. Agency for International Development and implemented by the U.S. Pharmacopeial Convention, provided technical assistance on Good Manufacturing Practices (GMPs) to build their capacity in quality assurance and groom their facility for WHO prequalification inspection. PQM also helped Changzhou compile the dossier—the technical documentation required for product registration—submitted to the WHO Prequalification Programme.
Manufacturers of priority medicines can identify affordable, quality sources of APIs that are produced in compliance with international quality standards by referring to the WHO List of Prequalified Active Pharmaceutical Ingredients. Obtaining quality-assured drug ingredients is critical to the production of quality-assured medicines. By referring to the WHO List of Prequalified APIs, manufacturers of medicines can avoid a common pitfall that often leads to production of substandard finished pharmaceutical products (FPPs), especially in low- and middle-income countries—unintentional use of poor-quality APIs.
The PQM program works with pharmaceutical manufacturers to strengthen their quality assurance systems and help them prepare for the WHO prequalification process by building capacity in GMPs and compiling quality dossiers to support product registrations. More than 15 priority medicines have received WHO prequalification or Stringent Regulatory Authority approval as a result of the technical assistance PQM has provided to local manufacturers in the past four years. These efforts have helped to increase the availability of affordable, quality-assured APIs and medicines on the global public health market, thereby averting supply shortages and resulting in millions of dollars in cost-savings. They have also helped to increase the pool of eligible medicines for USAID procurement and supply to field programs.
Combating parasitic worm infections and NTDs is a global public health priority. Only 45 percent of school-aged children with parasitic worm infections received treatment in 2014, according to the WHO.1 To increase treatment coverage in this population to the global goal of 60 percent this year, an estimated 540 million treatments will be needed. Building the capacity of local manufacturers to ensure the availability of adequate supplies of quality-assured mebendazole APIs and FPPs is vital to achieving these treatment coverage goals, reducing the global burden of hookworm, roundworm, and other parasitic worm infections, and improving the health and well-being of communities in need.
1 World Health Organization. 2016. Intestinal worms