E-DRUG: Ghana to recall substandard antimalarials
[Good to hear that Ghana is acting upon the discovery of both substandard and
counterfeit malaria products in its market. But how can health workers recall
substandard products if the product names and companies are not (yet) made
known? Obviously there is no need to recall counterfeits. But have the
suppliers of these counterfeit problems been arrested? And have people who
procured such products learned from their procurement mistakes? Debate welcome!
Copied as fair use. WB]
Ghana to recall substandard antimalarials
09 November 2010
Anju Ghangurde, Scrip
Ghana is recalling 13 key antimalarials following the uncovering of
substandard and counterfeit versions of these products across the country.
The detections were made under a surveillance programme of the Ghana Food
and Drugs Board (FDB) in collaboration with the US Pharmacopeial Convention
(USP) and the US Agency for International Development (USAID). The programme
samples antimalarials across the public and private sectors.
Dr Stephen Opuni, chief executive officer of the FDB, said that some of the
medicines discovered contained no active pharmaceutical ingredient, while
others failed to meet required quality standards. Brand name details of the
products could not be immediately ascertained.
A statement from the USP said that the counterfeits were in use at a
government-run hospital and private clinic, and being distributed through
many pharmacies. The names of the outlets where these substandard products
were found have been publicised and manufacturers of some of the recalled
medications are to meet with the FDB for required regulatory sanctions, the
The USP is a non-profit scientific organisation that sets standards for the
quality, purity, strength and identity of drugs, food ingredients and
dietary supplements. Its drug standards are legally enforceable in the US
and its standards are used in more than 130 countries.
Earlier this year, the USP had told Scrip that it expects to assist the
governments of African nations such as Madagascar, Senegal and Uganda on
certain technical aspects, following the detection of a large proportion of
substandard antimalarials there as part of a study by the World Health
Organization (WHO) and the Promoting the Quality of Medicines (PQM)
programme ( scripintelligence.com, 23 February 2010).
PQM is a USAID-funded programme implemented by the USP through which it
works in developing countries to help verify and improve the quality of
medicines to treat diseases such as malaria, HIV/AIDS and tuberculosis.
In 2009, the programme had uncovered a counterfeit version of Novartis'
Coartem (artemether/lumefantrine). Earlier, the Quality of Antimalarials in
Sub-Saharan Africa (QAMSA) study, which is a 10-country collaborative
programme conducted by the WHO and PQM, found that about 44% of the sampled
medicines from Senegal, 30% from Madagascar, and 26% from Uganda that
underwent full quality control laboratory testing failed such testing and
Substandard medicines are those that do not meet the quality specifications
set, mainly because they do not contain the correct amount of active
ingredients, do not dissolve properly in the body or include unacceptable
levels of potentially harmful impurities.