The quest for WHO prequalification by pharmaceutical firms
Annually, millions of patients in resource-limited countries receive life-saving medicines that are purchased by or through international procurement agencies such as World Health Organisation (WHO), United Nations Children Fund (UNICEF), United Nations Population Fund (UNFPA), UNITAID and the Global Fund to Fight AIDS, TB and Malaria.
While WHO Prequalification of Medicines Programme ensures that selected medicines supplied by these agencies meet international standards of quality, safety and efficacy, the WHO and the Global Fund spends over N20 billion annually in procuring drugs for malaria, TB and AIDS intervention programmes in Nigeria from especially India and Brazil because no pharmaceutical industry in Nigeria is pre-qualified.
With Nigerian pharmaceutical firms not currently in a position to participate in international tenders for medicines against the three pandemics that require WHO prequalification, health experts identify this as a major constraint on the local supply of medicines, especially anti-retroviral (ARVs), anti-malarial and anti-tuberculosis agents.
WHO pre-qualification is a prerequisite for any company that wants the WHO and other international agencies to buy their drugs through bulk purchase for distribution for health intervention programmes across the globe.
The cheering news is the fact that Nigerian pharmaceuticals such as May and Baker, Evans Medical, and Fidson HealthCare Plc are set to engage in global health interventions with modified production processes that conforms with WHO-Current Good Manufacturing Practice (WHO-GMP) standards, a condition for WHO pre-qualification by mid-2014.
As these companies currently jostle to attain WHO prequalification for selected medicines, this will increase the growth potentials of Nigeria’s pharmaceutical industry as these companies would establish strong quality management systems, obtain appropriate quality raw materials, establish robust operating procedures, detect and investigate product quality deviations, maintain reliable testing laboratories, to name a few.
In Africa, only South Africa, Morocco and Uganda have prequalified drug manufacturing companies and the right to participate in global health interventional and sell their pharmaceutical products to other countries across the globe.
The inability to compete in the global market is hinged on the fact that as of today, the nation’s pharmaceutical industry cannot withstand the drug armada from China and India which have better cost advantages and several WHO pre-qualified pharmaceutical firms.
According to PricewaterhouseCoopers (PWC) in 2010, India joined among the league of top 10 global pharmaceuticals markets in terms of sales by 2020 with value reaching US$50 billion. While the domestic market is worth $12.26 billion, sale of all types of medicines in the country reach around $19.22 billion by 2012. Globally, India’s pharmaceutical industry is ranked 4th and 13th in terms of volume and value. Indian firms manufacture at far lower costs than their counterparts in developed countries.
Most pharmaceutical manufacturers in India, China, United States of America, Germany, etc, have WHO prequalified facilities that produce pharmaceutical raw materials, vaccines, consumables and finished products and in turn export them to boost their foreign earnings.
Industry analysts believe that WHO prequalification of Nigerian Pharmaceutical firms will enable the country become self-sufficient in the manufacture of essential medicines. This is expected to have a multiplier effect on the Nigerian economy with attendant job creation and more foreign exchange earnings for the country.
While this development would not only ensure that locally manufactured pharmaceutical products in Nigeria gain international acceptance, the plethora of challenges confronting the pharmaceutical industry such as low capacity utilisation, high production cost, drug counterfeiting, and continued dependency on imported medical products and pharmaceutical inputs for drug production would be reduced.
We believe there is need to support local pharmaceutical companies, without which we may not have a sustainable health system in Nigeria. There is no gainsaying the fact that the pharmaceutical industry is one of the most valuable economic segments of the global economy.
We urge the Federal Government to create a pharmaceutical development fund, and a better operating environment that would encourage increased investment, and more efficient delivery of drugs by local pharmaceutical manufacturers.