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| National |
| Rejected malaria drug in hospitals |
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by
Joseph Langa, 28 January 2006
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04:41:44
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Patients in government hospitals are being given rejected malaria drug which Pharmacy, Medicines and Poisons Board says may not cure because it failed laboratory tests at the National Drug Quality Control Laboratory based on the United States (USP) system.
Documents in Weekend Nation possession show that the Board, on August 29, 2005 rejected five batches of Novidar SP (Sulfadoxine Pyrimethamine) manufactured by Pharmanova Limited in Blantyre because the dissolution of Pyrimethamine was below the required standard according to a test conducted based on the USP system.
Board Registrar and Chief Inspector of Medicines, Wynn Chalira who signed the confidential analysis report sourced by Weekend Nation said in an interview Wednesday last week the rejected drug may not cure because it failed the dissolution test.
“This is an indicator of whether the drug is going to be available in high enough quantities to actually achieve a cure you are looking for,” said Chalira.
The five batches, AO42H, AO40H, AO 65H, AO67H and AO62H have a dissolution percentage of 27.58, 23.82, 16.78,16.95 and 17.93, respectively, and Chalira said any dissolution below 65 percent shows a failure of the drug.
“The product may not have high enough blood levels to actually have a cure. Because it’s failing the dissolution it won’t go in such quantities in the blood to cure you,” said Chalira.
However, our investigations showed the rejected batches are the ones that are currently being used in government hospitals.
Chalira said they conducted the tests on behalf of their client, Central Medical Stores and it was up to them whether to use the results or not.
“In this case, we are saying these products are not fit and the client would have observed that,” he said.
Health Minister Hetherwick Ntaba and Secretary for Health Wesley Sangala confirmed in separate interviews last week the drug failed the dissolution test using the newly introduced American system and it was withdrawn from government hospitals.
But the two said government was later forced to authorise the use of the drug because they failed to source an alternative medicine from the market and had to save lives of people who die in hospitals due to shortage of the anti-malaria drug.
“We were trying to find a drug that passes that test. It wasn’t available immediately. We were looking for the drug all over the place. We are saying with this situation, do we withdraw the drug and give no drug to the patients?
“Meanwhile, here is a drug that we have been using all these years. It is lying somewhere, patients are going to the hospital. They have no access to any anti-malarial drug. A number of them were dying. It was a high malarial season. We had to make a decision,” Ntaba said.
“While waiting for the drug that passes the dissolution test we agreed at that time that it makes no sense to let so many people die. Let them continue getting this until we get a proper replacement for it. So we instructed that the drug be sent to the hospitals and people are getting that drug,” he added.
But Ntaba said they have told the manufacturer not to send any more and to make sure they manufacture drugs that will pass the recommended test.
“They should manufacture subsequent drugs with other ingredients which will make that particular drug pass the American system and the British system (BP). The United States system is a newer invention.
He claimed the drug passed the dissolution test by the old BP system that the ministry has been using for years.
Ntaba, a medical doctor himself confirmed the drug dissolves “more slowly” but he disputed that it may not cure, saying it cures but at a lower rate and increases resistance to the drug which makes other patients not to be cured.
“They still get cured but at a lower rate. It means with the lower dissolution the resistance increases to 15 or 20 percent. But 80 percent still get cured,” said Ntaba.
But Pharmanova Vice Group Chairman Nick Pallister disputed the claims that there is something wrong with his drugs, claiming it passed all laboratory tests and was manufactured following all the required ethical standards.
“There is nothing wrong with the drug whatsoever. They were produced with conformity to the BP system. They were tested here and passed, they were tested in Lilongwe and also passed and the drugs are good drugs. I produce good drugs here,” Pallister said.
Asked whether indeed his drugs failed the test according to the USP system, he said: “I don’t produce the drugs on the USP system. I produce on the BP system.”
On claims that his drugs may not cure Pallister said the drugs have been in use for years and he has never received any complaint on the quality and effectiveness of the product and it will be misleading to say that there is something wrong with his drugs.
However, he said his company has no problems to start producing the drug on USP system if that is what government wants in the tender agreement.
Ntaba said the BP system was still being used in the country because government could not source modern equipment to start testing using USP system which is a newer invention used in most parts of the world.
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