A Kenyan pharmaceutical company has been given the green light by the World Health Organization (WHO) to start producing antiretroviral (ARV) drugs, which could result in significant savings for the government's growing treatment programme.
"While this is good news for us as a drug manufacturing company, it is more important to the thousands of people out there who need antiretroviral drugs,” said Herman Patel, a manager at Universal Corporation. “Local manufacturing means the drugs will now be cheaper, and hence accessible to many people."
Earlier in November WHO granted prequalification certification to the company, allowing it to manufacture the combination ARV drug, Lamizido. Prequalification is a service provided by the global health body to test the safety, quality and efficacy of medicinal products before they are released to the public.
Certification means international organizations providing ARVs can also supply the medication, and that use of the drug in the state's treatment programme is approved.
Lamizido, one of 255 drugs certified by WHO, is a combination of Zidovudine and Lamivudine, and will be produced in 150 and 300 gram doses.
"Once we start production we expect the cost of our drugs to be cheaper by at least 30 percent than what the government buys currently from foreign manufacturers," Patel said.
Kenya obtains most of its HIV medicines from India, but the high cost of importation has made it difficult for the government to put all those who need it on treatment. More than 400,000 HIV-positive people are receiving ARVs, but another 600,000 require the drugs and have no access to them. An estimated 1.5 million Kenyans are infected with HIV.
"I think local is the way to go... relying on imported medicines... makes it near impossible to offer access to all,” said Daisy Misula, an activist who advocates access to HIV treatment for university students.
She told IRIN/PlusNews that WHO should strive to certify more local manufacturers to produce high quality generic drugs. “It creates competition, and when prices become competitive… the patient is the overall winner."
Government officials welcomed the move. "It is an important step in efforts to provide HIV treatment to all those who need it and, more importantly, in our goals to meet our obligations to provide universal treatment to all. We hope the company will maintain the quality that has made it be certified," Mary Ngari, the Permanent Secretary in the Ministry of Medical Services, told IRIN/PlusNews.
Once the company starts production it can bid to supply the state’s ARV programme. "Whether the government will buy the drugs from the local manufacturer or not depends on how the drugs will be priced. Of course, the company will bid for tenders, and when its prices are lower the government will have no choice but to purchase from them," said Ngari.
Other African countries could also benefit. "The green light to produce drugs means we can sell the drugs even to governments and organizations outside Kenya, and we expect go beyond just selling antiretrovirals in Kenya," Patel said.
Kenya's Minister for Medical Services, Prof Anyang Nyongo, noted that “You can easily access the drugs in case of stock-outs," and said the government will put policies in place to protect smaller local manufacturers from being overwhelmed by the strengthened competition, which could include lowering the tax on key raw materials needed to produce the medicines.
"Local production of antiretrovirals has many advantages other than just the price,” Nyongo pointed out.
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"While this is good news for us as a drug manufacturing company, it is more important to the thousands of people out there who need antiretroviral drugs,” said Herman Patel, a manager at Universal Corporation. “Local manufacturing means the drugs will now be cheaper, and hence accessible to many people."
Earlier in November WHO granted prequalification certification to the company, allowing it to manufacture the combination ARV drug, Lamizido. Prequalification is a service provided by the global health body to test the safety, quality and efficacy of medicinal products before they are released to the public.
Certification means international organizations providing ARVs can also supply the medication, and that use of the drug in the state's treatment programme is approved.
Lamizido, one of 255 drugs certified by WHO, is a combination of Zidovudine and Lamivudine, and will be produced in 150 and 300 gram doses.
"Once we start production we expect the cost of our drugs to be cheaper by at least 30 percent than what the government buys currently from foreign manufacturers," Patel said.
Kenya obtains most of its HIV medicines from India, but the high cost of importation has made it difficult for the government to put all those who need it on treatment. More than 400,000 HIV-positive people are receiving ARVs, but another 600,000 require the drugs and have no access to them. An estimated 1.5 million Kenyans are infected with HIV.
"I think local is the way to go... relying on imported medicines... makes it near impossible to offer access to all,” said Daisy Misula, an activist who advocates access to HIV treatment for university students.
She told IRIN/PlusNews that WHO should strive to certify more local manufacturers to produce high quality generic drugs. “It creates competition, and when prices become competitive… the patient is the overall winner."
Government officials welcomed the move. "It is an important step in efforts to provide HIV treatment to all those who need it and, more importantly, in our goals to meet our obligations to provide universal treatment to all. We hope the company will maintain the quality that has made it be certified," Mary Ngari, the Permanent Secretary in the Ministry of Medical Services, told IRIN/PlusNews.
Once the company starts production it can bid to supply the state’s ARV programme. "Whether the government will buy the drugs from the local manufacturer or not depends on how the drugs will be priced. Of course, the company will bid for tenders, and when its prices are lower the government will have no choice but to purchase from them," said Ngari.
 I think local is the way to go ... relying on imported medicines ... makes it near impossible to offer access to all |
Kenya's Minister for Medical Services, Prof Anyang Nyongo, noted that “You can easily access the drugs in case of stock-outs," and said the government will put policies in place to protect smaller local manufacturers from being overwhelmed by the strengthened competition, which could include lowering the tax on key raw materials needed to produce the medicines.
"Local production of antiretrovirals has many advantages other than just the price,” Nyongo pointed out.
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This article was produced by IRIN News while it was part of the United Nations Office for the Coordination of Humanitarian Affairs. Please send queries on copyright or liability to the UN. For more information: https://shop.un.org/rights-permissions
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