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Danger Lurks in Suspect Generics
Studies show 56% of anti-malaria drugs in the market are ineffective
By: Arthur Okwemba
Published: Daily Nation
Date: May 2, 2002
Website: www.nationaudio.com
Kenya's poor regulatory, monitoring and surveillance systems are raising concerns about the quality of generic drugs in the market.
Pharmaceutical experts and doctors say the situation is worsening by the day.
The poor quality drugs cause patient resistance to the diseases they are meant to treat. They have also resulted in fatalities especially among malaria patients.
Pharmacists and doctors say loopholes in the drug regulatory procedures are being exploited by unscrupulous traders to smuggle generic medicines of suspicious quality into the country.
"One thing that does not raise questions is the safety of generics. They are as safe as their brand equivalents, since the latter have already passed the safety tests. The question is their quality," says Prof Isaac Kibwage, a lecturer at the University of Nairobi who has done a number of quality studies on drugs on the Kenyan market.
A drug analyst at the National Quality Control Laboratory, who preferred to remain anonymous, agrees there is concern about the quality of the generics. "Sometimes, we reject them but they still find their way in,'' he says.
It is estimated that more than 30 different types of anti-malaria generic drugs, for instance, are in the Kenyan market. Yet less than seven have gone through the required testing measures. Most of the others do not meet the required efficacy levels.
In their 2000 study, Sulphadoxine/Pyrimethamine (SPs) Tablet Products on the Kenyan market: Quality concerns, published in the East and Central African Journal of Pharmaceutical Sciences, Prof Kibwage and J. Ngugi, found that 56 per cent of the anti-malaria drugs in the market failed to produce the desired effect.
A more recent study on the Quality of Ampicillin Preparations published last year in the same journal by Drs F. Kamau, G. Thoiti and Prof Kibwage gives disturbing results on the drugs' quality. These pharmacists established that out of the 20 capsules they tested, 20 per cent failed limits on ampicillin content.
Ampicillin is a form of antibiotic recommended by the ministry of health, but which the same ministry has now replaced with amoxycillin due increasing resistance levels. The drug, however, still retails on the market.
Experts say the poor quality contributes to the development of resistance to either malaria or other micro-organism diseases targeted by antibiotics. Resistance to anti-malarial drugs is now a serious problem in Kenya.
The experts say Kenya's surveillance measures are not performing to the expectations.
Pharmaceutical companies and importers are exploiting this to the maximum. What happens is that the first drug batches they present to the national quality control laboratory in most cases pass the quality test. This gives the drug a clean bill of health, but the danger is, once cleared, some companies play around with the drug's quality in subsequent batches as away of maximising profits. If the surveillance machinery is functioning well, such manufacturers can be apprehended.
Officials at the National Quality Control Laboratory say the government is supposed to undertake impromptu sampling of certain drugs in the market and analyse their efficacy, but this is never done due to lack of funds.
Prof Kibwage says the problem with surveillance in Kenya is that it is just for research. "We should move from research and put in place a statutory surveillance system of quality of drugs, if we want to weed out products of low quality from our market."
Mr Jason Mwende, a pharmacists practising in Nairobi, argues that generics, especially the imported ones are the main culprits. Some of them are said to find their way into the market without being analysed for quality and approved by the government.
Having escaped tax and other government charges, such drugs not only threaten people's health, but also the survival of local pharmaceutical companies which are losing their share of the sales market and sometimes leading to closures.
Dawa Pharmaceuticals, which used to make generic drugs, went under for a number of reasons including unfair competition from imported generics.
An official at Assia Pharmaceuticals Ltd, says generic drugs coming through the so called ‘parallel importation's" has affected the market performance of about six of their different brand drugs.
But other pharmacists dispute the local companies claims, saying some of them manufacture poor quality generic medicines.
A generic medicine is a copy of the original branded medicine. It has the same active ingredients and dosage form, and is identical in strength to the original medicine.
The only difference is that they are cheaper than the original medicines because they do not involve research and development costs.
But Dr Kipkerich Koskei of regulator Drugs and Poisons Board says there are no generic drugs in the market which have not gone through the quality and efficacy tests or other regulatory measures as claimed by pharmacists and doctors.
He says the government is committed to ensuring that Kenyans have access to quality drugs.
"Most generics have been tested for their quality levels. The government is committed to making available safe, effective and affordable drugs to the public.''
Similarly, suppliers dispute arguments that they are of poor quality. But they say the government should strengthen surveillance and regulatory procedures to deal with such drugs if they are on the market.
Surgipharm’s sales and marketing manager Rakesh Vinayak says the generics the firm imports pass through the government's quality regulatory procedures before retailing in the market. The issue of the imports undercutting local products does not arise because locally manufactured generics like paracetamol are cheaper than imported ones, he adds.
Copyright ©2002, Nation Media Group Ltd. All rights reserved.
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