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Kenya: Some 700 generic medicines researched in India, some popular in Kenya, have been suspended in Europe after it was discovered they have been formulated on cooked data.
This development comes barely months after generic drug manufacturers from India were accused of deliberately exporting poor quality medicines to Kenya and other African countries, while reserving better products for richer nations.
In an unprecedented move, drugs regulator for the European Commission, European Medicines Agency (EMA), has called on its members to immediately suspend the use of the 700 generic medicines because they are of unknown strength.
The list of medicines, which has been posted on the internet by the agency, includes hundreds of compounds that could also be in circulation in Kenya under various brand names.
Due to various reasons including cheaper labour, US and European pharmaceutical firms outsource some research components to Indian firms to, for example, do clinical trials on specific medical formulations on their behalf.
LOCAL MARKET
Such would include clinical trials on the safety, effectiveness or dosage of a particular medicine. This information will then be used by the contracting company in manufacturing own brands.
The quality and safety of the resultant brands, which are then distributed all over the world including Kenya, will depend on the integrity of the contracted data. In this case, EMA says this integrity has been breached.
To ensure the integrity of the generated data, Western pharmaceuticals routinely inspect the Indian research firms; in this case they say much of the information from GVK Biosciences of Hyderabad in India appeared to have been cooked.
EMA had probed 1,000 formulations at the GVK Biociences, finding only 300 to have satisfactory data with information and the rest suspected to have been manipulated. Following this information, Germany banned 80 generic drugs from its market in December.
"We are scrutinising this case to determine if any such formulations may have entered into the local market but we assure the public there should be no cause for panic," Government Chief Pharmacist Kipkerich Koskei told The Standard yesterday.
Some of the listed compounds include the widely distributed ciprofloxacin, ibuprofen and acyclovir, which could be selling in the market under different brand names.
Dr Kipkerich said in coming days, they would try to find out whether any products originating from the suspect Indian research company could be in the country.
"We will also be checking to see whether any of the European pharmaceuticals have exported products into Kenya, mainly through their sister companies," he said.
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