- New standards will provide a basis for evaluating the quality of animal medicines and serve as a measure against which national authorities can test for regulatory compliance.
The UN Food and Agriculture Organization (FAO) and the International Federation for Animal Health (IFAH) are working to establish the first published pharmaceutical standards for medicines used in treating Animal African Trypanosomosis, commonly known as Nagana.
Transmitted by the bite of the tsetse fly and other blood-sucking insects, Nagana is a fatal animal disease capable of decimating the herds that African smallholders depend on for their livelihoods and which worldwide is estimated as causing economic losses of up to $4.5 billion each year.
"The use of substandard drugs to treat Nagana not only leaves farm animals inadequately protected from the disease, but also permits the evolution of tougher, drug-resistant strains when insufficient doses are used," said FAO chief veterinary officer Juan Lubroth, who heads the UN agency's Animal Health Service. "And it can pose a threat to human health if harmful chemical residues accumulate in meat or dairy products that enter the food chain."
According to IFAH estimates, the value of the official market for veterinary drugs in Africa runs around $400 million a year. The trade in sub-standard and non-registered drugs is just as large and estimated worth $400 million in addition to legitimate, over-the-table sales. To tackle the problem, FAO and IFAH have submitted an application to the World Organisation for Animal Health (OIE) to formally register the first pharmaceutical standards for the manufacture and proper use of two drugs that kill the parasites that cause the disease.
These standards, called monographs in the pharmaceutical industry, will define the acceptable physiochemical make-up of the drugs, the proper dosages of their active ingredients, and the allowable levels of impurities they can contain. The standards will provide a basis for evaluating the quality of animal medicines and serve as a measure against which national authorities can test for regulatory compliance.
Empowering national animal health authorities
The standard-setting process is expected to be finalized later this spring. Meanwhile, FAO and its partners are moving ahead with efforts aimed at helping animal health authorities put them to good use once they come online.
By April 2012, two laboratories in sub-Saharan Africa will have been selected to carry out tests for quality control and verification of the two standard drugs developed by FAO, IFAH and a group of partner organizations, including the International Atomic Energy Agency (IAEA), the United Nations Industrial Development Organization (UNIDO), the Global Alliance for Livestock Veterinary Medicines (GALVmed) and the University of Strathclyde in the United Kingdom. The effort will also include training for laboratory staff.
A disease with major impacts
Nagana affects cattle, sheep, goats, pigs, camels, horses and donkeys — animals which are vital to the incomes and food security of millions of smallholder farmers in Africa and elsewhere. In cattle, it causes direct economic losses due to animal deaths estimated at more than $1.2 billion every year, while its wider costs — in terms of reduced output of milk and dairy products, abortions of unborn calves, and lost fertility resulting in reduced agricultural productivity — are estimated at some $4.5 billion every year.