A chemist displays drugs in Nyeri. Universal Corporation’s Lamozid, an anti-retroviral drug, was pre-qualified last Friday and included in a list of about 255 drugs approved for the fund which spends Sh2 trillion annually on combating malaria, Aids, tuberculosis, and more recently, reproductive health. File
A Kenyan pharmaceutical company has won World Health Organisation (WHO) certification for one of its drugs, opening the door to lucrative tenders floated by the Global Fund.
Universal Corporation’s Lamozid, an anti-retroviral drug, was pre-qualified last Friday and included in a list of about 255 drugs approved for the fund which spends Sh2 trillion annually on combating malaria, Aids, tuberculosis, and more recently, reproductive health.
“Prequalification portends increased business for us and raises the bar in terms of the standard of factories in Kenya,” said Palu Dhanani the UCL managing director.
The company is also seeking to have the milder form of the same drug for children pre-qualified before May next year.
Researching and developing the drug cost Sh200 million ($2 million) whereas the construction of a new high standard laboratory — which is prerequisite for inspection — cost a further Sh400 million($4 million).
UCL currently exports its medicines to countries such as Sierra Leone, Malawi and Mozambique with Kenya Medical Supplies Agency being its major local customer.
“Initially, we will participate in tenders that are majorly within Africa before pursuing others from around the world,” said Mr Dhanani.
Kenya now joins South Africa, Egypt and Zimbabwe as the only countries in Africa with WHO pre-qualified drugs. In keeping with the now-intensifying pace to penetrate the export market, three other local drug makers have already submitted drugs to WHO for pre-qualification.
Cosmos Limited, Regal Pharmaceuticals and Lab and Allied Pharmaceuticals individually applied last month to have their medicines prequalified. If cleared, the drugs would be in line to compete in the next Global Fund tender due next June.
“Cosmos has recently submitted three drugs for prequalification with the intended target being the export market as well as global institutions which usually insist on WHO-certified drugs,” said Pratkash Patel, the Cosmos chairman.
The firm has submitted anti-malarial, anti-tuberculosis as well as anti-retroviral drugs — which it is already producing and supplying locally to public institutions— for prequalification.
Lembit Rägo, the coordinator of WHO’s quality assurance and safety department in Geneva said the UN body was working with other manufacturers in Africa who are seeking certification.
Cosmos and Lab and Allied are prequalified to supply some drugs to the European Union.
Pharmacy and Poisons Board (PPB) registrar Kipkerich Kosgey said that certification would mean quality medication for patients locally besides creation of more jobs while attracting contracts that have traditionally been gobbled up by Indian companies.
“Other than leading to mass funding going into production of these drugs, in the long term, this will create several thousands of new jobs as the companies improve their production lines,” he said, revealing that $700 million (Sh70 billion) is used to purchase ARV drugs for the local market annually.
The pharmaceutical industry in the continent is recording significant growth, buoyed by a bulging population and expansion of markets through regional trading blocs such as the East African Community, which has a market of 130 million people.
Production line
Laboratory and Allied recently announced a Sh1 billion expansion of its production line as it seeks to increase the supply of generic drugs.
The firm is seeking to step up production at its local plant fourfold to serve a dozen markets in Africa. It presently serves Uganda, Tanzania, Sudan, Zambia, Ethiopia and Malawi.
The push for certification comes soon after five out of 13 Kenyan firms that were subjected to good manufacturing practices tests by PPB failed to meet the requisite standards.
Their licences were either withdrawn or corrective measures initiated.
Dr Kosgey said that claims that the Kenyan market was awash with counterfeits were erroneous since no study to establish the incidence had been done.
“We only did a random check on 177 drugs and only four of them turned to be not genuine,” Dr Kosgey said.
The use of generic drugs — the cheaper but equally effective variants of patented drugs — is estimated to account for 75 per cent of all medicines sold in Kenya, according to the Kenya Pharmaceutical Distributors Association.
The generics have helped reduce the cost of the least expensive first-generation HIV treatment to $86 (Sh8,600) per patient annually from $10,000 (Sh1 million) in 2000.
This has intensified competition between pharmaceutical firms, spawning new investments in the sector and a search for new markets.
In 2009, pharmaceutical sales in Kenya reached a value of Sh27.12 billion, representing a growth of 15.4 per cent year-on-year.
The Kenyan drug market is expected to reach a value of Sh56.2 billion by 2014 and Sh95.44 billion by 2019.
