USP, USAID to Aid Global TB Vaccine Manufacturing

The US Pharmacopeial Convention (USP), with the assistance of the U.S. Agency for International Development (USAID)- funded Promoting the Quality of Medicines (PQM) program, has announced that the first active pharmaceutical ingredient (API) for injectables used in the treatment of multi-drug resistant tuberculosis (MDR-TB) has been given prequalification status by the World Health Organization (WHO).

The anti-tuberculosis API Capreomycin is the first “second line” anti-tuberculosis API for injectables to achieve this status and is “a significant development in the global fight against one of the world’s most prevalent and deadly diseases,” according to the USP.

MDR-TB treatments are currently about 20 times more expensive than drug-susceptible TB, and the treatments take twice as long – with very low success rates. In fact, the USP says that only 34 percent of MDR-TB patients are successfully treated; more than half of the patients die, fail treatment, or stop taking the meds.

Focusing on quality

The World Health Organization (WHO) and regulatory agencies oversee the United Nations prequalification to ensure that the medicines are high quality and available for those who need them and that sustainable manufacturing and monitoring environments are built. The agencies also make sure to provide valuable information to those in the fight against TB and other diseases about which manufacturers they can rely on to provide high quality products that will enhance their efforts.

For any drugs produced to fight TB or other diseases like AIDS or malaria, quality must be at the forefront. Taking a full regimen of unknowingly contaminated or substandard drugs is just as harmful as not finishing a full course of antibiotics, hindering resistance to the disease.

“The dramatic growth of counterfeit and substandard medicines has made multi-drug resistant TB (MDR-TB) a growing threat to public health,” explained Dr. Patrick Lukulay, vice president of global health impact programs at USP and director of the PQM program. “Although the rate of new TB cases has been falling worldwide, in 2012, the number of people diagnosed with multi-drug resistant TB doubled. So, the availability of a quality-assured second line medication will fill a critical need and should make these medicines more affordable.”

Since 2009, the PQM program has enabled prequalification status for three vital TB drugs, including anti-TB medicine Cycloserine, 250 capsule; ZinCfant 20 mg dispersible tablet, produced by France-based Nutriset/Laboratoire, a zinc product for managing diarrhea in children; and now Capreomycin, produced by Zhejiang Hisun Pharmaceutical. As part of the PQM program, any technical assistance comes at no cost to the manufacturers.