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

February 07, 2013

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) program--a 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 PQM--supporting 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 program--which works to combat substandard and counterfeit medicines in developing countries and increase the supply of quality-assured medicines--offers 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 treat--often 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 WHO--in 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.
-end-
More information about WHO prequalification is available at http://apps.who.int/prequal/default.htm. For details about PQM technical assistance, visit www.usp.org/around-world/pqm-uspusaid/increasing-supply-qa-medicines. For media inquiries, please contact mediarelations@usp.org.

The American people, through the U.S. Agency for International Development, have provided economic and humanitarian assistance worldwide for nearly 50 years.

USP - Advancing Public Health Since 1820

The United States Pharmacopeial Convention (USP) is a scientific, nonprofit, standards-setting organization that advances public health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP's standards are relied upon and used worldwide. For more information about USP visit http://www.usp.org.

US Pharmacopeia

Related Tuberculosis Articles from Brightsurf:

Scientists find new way to kill tuberculosis
Scientists have discovered a new way of killing the bacteria that cause tuberculosis (TB), using a toxin produced by the germ itself.

Blocking the iron transport could stop tuberculosis
The bacteria that cause tuberculosis need iron to survive. Researchers at the University of Zurich have now solved the first detailed structure of the transport protein responsible for the iron supply.

Tuberculosis: New insights into the pathogen
Researchers at the University of W├╝rzburg and the Spanish Cancer Research Centre have gained new insights into the pathogen that causes tuberculosis.

Unmasking the hidden burden of tuberculosis in Mozambique
The real burden of tuberculosis is probably higher than estimated, according to a study on samples from autopsies performed in a Mozambican hospital.

HIV/tuberculosis co-infection: Tunneling towards better diagnosis
1.2 million people in the world are co-infected by the bacteria which causes tuberculosis and AIDS.

Reducing the burden of tuberculosis treatment
A research team led by MIT has developed a device that can lodge in the stomach and deliver antibiotics to treat tuberculosis, which they hope will make it easier to cure more patients and reduce health care costs.

Tuberculosis: Commandeering a bacterial 'suicide' mechanism
The bacteria responsible for tuberculosis can be killed by a toxin they produce unless it is neutralized by an antidote protein.

A copper bullet for tuberculosis
Tuberculosis is a sneaky disease, and the number one cause of death from infectious disease worldwide.

How damaging immune cells develop during tuberculosis
Insights into how harmful white blood cells form during tuberculosis infection point to novel targets for pharmacological interventions, according to a study published in the open-access journal PLOS Pathogens by Valentina Guerrini and Maria Laura Gennaro of Rutgers New Jersey Medical School, and colleagues.

How many people die from tuberculosis every year?
The estimates for global tuberculosis deaths by the World Health Organisation (WHO) and the Institute for Health Metrics and Evaluation (IHME) differ considerably for a dozen countries, according to a study led by ISGlobal.

Read More: Tuberculosis News and Tuberculosis Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.