Hisun's capreomycin gets WHO prequalification
This article was originally published in Scrip
The World Health Organization (WHO) has prequalified Zhejiang Hisun Pharmaceutical Co's capreomycin, the first second line anti-TB active pharmaceutical ingredient (API) for injectables to achieve this status.
Hisun's efforts were supported by the US Pharmacopeial Convention with the assistance of the US Agency for International Development (USAID)-funded Promoting the Quality of Medicines (PQM) program.
The prequalification is significant in the backdrop of growing concerns over the impact of substandard drugs in engendering multi-drug resistance. Capreomycin API is manufactured by a specialized process of fermentation and the complexity is higher since the API is said to need to be sterile.
Dr Patrick Lukulay, vice-president of global health impact programs at USP and director of the PQM program, noted that 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," he said.
Last year Médecins Sans Frontières (MSF) and the International Union Against Tuberculosis and Lung Disease noted in a report Drug resistant TB under the microscope that prices of capreomycin had increased by 4.5% despite having five sources under evaluation by WHO prequalification, three dossiers of which were already under assessment [including those from Aspen and Macleods]. "A future price drop can be expected once these new sources are qualified," the report said.
The report also noted that the Global Drug Facility (GDF) had identified only two quality-assured sources available for supply of capreomycin: Akorn – which had bought Eli Lilly's US licence; and, in 2011 and the Greece-based Vianex – which has received stringent regulatory authority approval in Spain. Ely Lilly had earlier stopped production of the product and, and instead transferred technology to other companies including Aspen and Hisun, the report said. GDF is a mechanism hosted by the WHO to expand access to and availability of quality-assured anti-TB drugs and diagnostics through pooled procurement.
The USP statement also indicated that the PQM program had helped three key drugs achieve prequalification status: the anti-TB drug cycloserine 250 capsule produced by Korea-based Dong-A Pharmaceutical Co.; the zinc product for managing diarrhea in children ZinCfant 20 mg dispersible tablet (France-based Nutriset/Laboratoire) and now capreomycin. All technical assistance was provided by PQM at no cost to the manufacturers as part of the USAID funded program, USP said