05 August 2014 - The USAID-supported Promoting Quality of Medicines (PQM) Program in collaboration with the Global Drug Facility (GDF) has helped attain WHO Pre-Qualification Program (PQP) approval for two important second-line TB drug products. The prequalification of Capreomycin and Levoflaxacin Active Pharmaceutical Ingredients (APIs) is a significant win in the global fight against TB. This new development will save many more lives from multi-drug resistant TB (MDR-TB) by increasing the quality and availability of TB medicines and also bringing about a reduction in price. These quality assured drugs are available through the Global Drug Facility (GDF) to countries to support their fight against MDR-TB.
USAID’s TB program has played a critical role in improving the availability, quality and affordability of drugs to treat MDR-TB for over six years. Mapping out the vulnerabilities of second-line drug supply chains with GDF and its partners is a key step to ensuring that a broader base of APIs and finished products is available to address the challenges of supply security and to promote a safer market where competition can further bring prices down. Substandard and counterfeit medicines can pose a dangerous public health threat in developing countries, where the lack of financial and technical resources make it already challenging to protect drug supply chains. This is especially true for TB, where drug quality is an important factor in the increasing emergence of multi-drug resistance.
An inadequate supply of quality-assured second-line TB medicines remains a major challenge in combating MDR-TB. To expedite the process of pre-qualification with WHO or support the process of medicines registration with Stringent Regulatory Authorities, thereby expanding the pool of manufacturers, USAID’s PQM program provides technical assistance to interested manufactures on the preparation of product dossiers for submission to WHO; makes suggestions on improving good manufacturing practices, including bio-equivalence studies and other product improvements; and conducts site visits as necessary to achieve WHO PQP certification.
As a result of these efforts, Capreomycin is the first second-line injectable anti-tuberculosis drug in the treatment of MDR-TB to attain prequalification status from WHO. With the increasing availability of this important drug, it is anticipated that the cost of the medicine will decrease significantly, thus making it more affordable.
Levofloxacin, another medicine currently in high demand as a TB drug, will also become more available and affordable for TB patients following this development. It is the 3rd second-line TB drug, in addition to Capreomycin and Cycloserine, that USAID’s PQM program has helped achieve WHO prequalification.
"The availability of WHO quality-assured TB drugs is essential for avoiding the emergence of further drug resistance and saving lives," says Cheri Vincent, chief of the Infectious Diseases Division at USAID’s Global Health Bureau. "USAID’s PQM program is helping expand access to quality medicines to people with the greatest need."
Photo credit: Souly Phanouvong, Manager - Asia Programs for Promoting the Quality of Medicines program, inspects anti-TB medicines at a manufacturing plant in Indonesia/US Pharmacopeia