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First anti-tuberculosis medicine under USAID-supported PQM program achieves WHO prequalification

Helping to increase the availability of affordable, high-quality medicines to treat patients worldwide suffering from multi-drug resistant tuberculosis, technical assistance provided at no cost to manufacturers under the Promoting the Quality of Medicines (PQM) programa U.S. Agency for International Development (USAID)-funded program that is implemented by the U.S. Pharmacopeial Convention (USP)has yielded its first anti-tuberculosis medicine to achieve prequalification status from the World Health Organization (WHO). Produced by Korea-based Dong-A Pharmaceutical Co. Ltd, the medicine is Cycloserine, 250 mg capsule. ZinCfant 20 mg dispersible tablet, produced by France-based Nutriset/Laboratoire Pharmaceutique Rodael for managing diarrhea in children, additionally achieved WHO prequalification status with assistance from PQMsupporting PQM's work with other health programs relevant to USAID, including maternal and child health programs.

According to WHO, its Prequalification of Medicines Programme, "evaluates and assures the quality of medicines bought by international aid programmes and countries with weak pharmaceutical regulation." This improves treatment results in developing countries and beyond. The program was originally developed to aid United Nations (UN) agencies that were procuring large quantities of HIV/AIDS medicines for developing countries in their purchasing decisions. Under the program, WHO comprehensively evaluates the quality, safety and efficacy of medicinal products based on information submitted by manufacturers and inspection of the corresponding manufacturing and clinical sites. Its list of prequalified medicinal products is a vital tool that today is widely used beyond UN agencies by a range of groups involved in purchasing medicines in bulk. It now covers medicines to treat malaria, tuberculosis and those used for reproductive health. Given the mandate of many organizations that only medicines prequalified by WHO or approved by a stringent regulatory authority are suitable for procurement, the increase in demand for prequalified products has stretched WHO's resources.

To address this resource gap, the PQM programwhich works to combat substandard and counterfeit medicines in developing countries and increase the supply of quality-assured medicinesoffers technical assistance providing support to interested manufacturers in achieving prequalification. PQM can assist with preparing product dossiers for submission to the WHO program; guiding manufacturers toward compliance with WHO good manufacturing practices; and addressing WHO comments on manufacturer submissions. The assistance is focused on "second-line" anti-tuberculosis medicines, which are used for multi-drug resistant tuberculosis. This form of tuberculosis is more difficult and lengthy to treatoften requiring up to two years of treatment. Poor-quality medicines can contribute to drug resistance and undermine desired treatment outcomes.

"The concept behind the assistance we provide to manufacturers is simple: by expediting the process of prequalification with WHO, we can help expand the pool of viable manufacturers and, in turn, increase the supply of quality-assured medicines. Ultimately, these medicines can help prevent unnecessary patient deaths, particularly among vulnerable populations including many women and children," said Ms. Cheri Vincent, Infectious Diseases Division chief of USAID's Global Health Bureau.

The PQM technical assistance program supports the Global Drug Facility (GDF)a pooled procurement system for anti-tuberculosis medicines operated under WHOin its efforts to improve access to quality-assured medicines. PQM, in collaboration with GDF, USAID and WHO, identify promising manufacturers that receive PQM technical assistance.

PQM offers technical assistance for 12 types of medications treating multi-drug resistant tuberculosis. PQM is currently working with approximately 20 manufacturers of finished product or active pharmaceutical ingredients from around the world to prepare their products for prequalification. Some of these manufacturers produce multiple second-line tuberculosis medicines.

"Through this program, we are supporting manufacturers in meeting rigorous international standards," said Dr. Patrick Lukulay, vice president of global health impact programs at USP and director of the PQM program. "The availability of quality-assured medicines has long been a challenge. For multi-drug resistant tuberculosis, which is a growing threat to public health, a critical need exists and we hope to help fill this gap."

The PQM program is interested in partnering with more manufacturers on this technical assistance. Through a series of workshops held in conjunction with WHO and GDF, PQM has been reaching out to manufacturers in regions of the world with a high burden of tuberculosis or where manufacturers are working to improve their manufacturing practices. Upcoming workshops will be held in Brazil, China, Ghana and Indonesia.


Contact: Francine Pierson
US Pharmacopeia

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