The WHO has conferred “prequalification” status on capreomycin, an injectable antibiotic for multi-drug resistant tuberculosis (TB), produced by Chinese API-maker Zhejiang Hisun Pharmaceuticals. The organisation will work with regulators to build nations’ manufacturing capacity for the “second-line” drug.
Zheijang Hisun was helped with its prequalification submission by Promoting the Quality of Medicines (PQM), a programme run by the US Pharmacopeial Convention (USP) and the US Agency for International Development (USAID).
The head of PQM and USP VP of global health impact programs, Patrick Lukulay, told in-Pharmatechnologist.com that ahead of WHO review, PQM helps manufacturers prepare facilities to ensure GMP compliance, conducts third-party testing to confirm results, and assists with compiling dossiers, at no cost to manufacturers.
“The technical assistance provided by PQM helps manufacturers establish and build systems for quality management in their facilities. Once these systems are in place, manufacturers are expected to maintain and sustain these systems – not only for the product that has received WHO prequalification status – for all the products manufactured at a particular site.”
As well as building national capacity for sustainable manufacturing of certain medicines, the WHO’s prequalification programme is intended as a tool for international groups fighting TB and other diseases to know “which manufacturers they can rely on to provide high quality products that will enhance and not hinder their efforts,” said USP. The organisation’s website publishes a list of prequalified products, including the name, facility and country of their manufacturers.
Lukulay told us manufacturing capabilities vary broadly between countries. “Generally speaking, African countries are a bit behind some of the Asian and Latin American countries in having facilities that comply with international standards. However, the landscape is changing. As greater focus is placed on quality, more African companies are redesigning their facilities to meet international standards.”
Faulty drugs drive resistance
Although new tuberculosis cases are falling worldwide, the number of people diagnosed with multi-drug resistant TB doubled in 2012. Lukulay said poor drug quality was one of the root causes behind multi-drug resistance to tuberculosis, AIDs and malaria.
Multi-drug resistant TB’s “growing threat to public health” was effected by a “dramatic” increase in counterfeit and substandard medicines, he said. “Just as not finishing a full course of antibiotics can engender resistance, taking a full course of a substandard drug can have the same effect.”
“Substandard” drugs include those with the wrong amount of API (active pharmaceutical ingredient) or harmful levels of impurity.
A second-line medication for TB will fill a critical need and make treatment more affordable, Lukulay told us. Current regimens for MDR-TB can be up to 20 times more expensive than standard TB. Therapy is over twice as long, and only 34% of MRD-TB patients are successfully treated; more than half die, fail treatment or stop taking their medicine.