The Bangladesh National Control Laboratory for medicinal products (NCL) has recently been recognized as compliant with WHO recommended standards of Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL). As such, the laboratory is added to the WHO list of prequalified medicines quality control laboratories.
Quality assurance of pharmaceuticals is a major public health challenge, particularly in light of growing cross-border health issues and the international dimensions of trade. The quality of pharmaceuticals has been a concern of the World Health Organization (WHO) since its inception. Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. With regard to pharmaceuticals, quality assurance can be divided into major areas: development, quality control, production, distribution, and inspections.
Bangladesh has now one of the 55 laboratories, globally, on the WHO list of prequalified medicines quality control laboratories. This is a great achievement for the country and a major step towards ensuring access to quality essential medicines at national, regional and global levels.
The NCL falls under the Directorate General of Drug Administration (DGDA). Under leadership of DGDA, a Coalition of Interested Partners (CIP) for medicines regulatory affairs was established in 2016 with technical guidance from WHO. Under the CIP, development partners mainstream their support to DGDA and coordinate regulatory system strengthening activities. Partners supporting the National Control Laboratory included: United States Pharmacopoeial Convention’s Promoting Quality of Medicines programme (USP-PQM); USAID; World Bank; UK-aid and WHO.
WHO remains committed in supporting Government of Bangladesh in strengthening country’s capacity for medicines quality control mechanisms and capacities, a key step in achieving Universal Heath Coverage.