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Vital drugs fail quality tests

By Chathuri Dissanayake

Some of Sri Lanka’s commonly used drugs such as paracetamol, amoxicillin and penicillin injections have been found to be of poor quality. These are among the drugs that fail random quality tests forcing health authorities to recall them.

During the past thee months alone, in more than 40 instances, about 30 different essential drugs and medical items have been recalled by the authorities. In some instances, different drugs from the same manufacturer have failed quality tests. And worse still, they were recalled only after their expiry date, investigations have revealed.

Among other drugs that The drugs that fail the quality tests include paracetamol, paediatric Paracetamol oral solution and Bezyl Penicillin Injection which is used in treatment for pneumonia and meningitis and also given to patients recovering from surgery. Amoxicillin 50% solution which is also a rapidly moving essential drug and Salbutamal given for Asthma patients are among the other drugs that have failed the random quality test.All Ceylon Government Medical Officers Association Assistant Secretary Dr. Jayantha Bandara, said the recalls are the result of random checks.

“If they carry out compulsory tests I can’t imagine the outcome. There are many drugs which have a short expiry date. I don’t understand why this should be the case. So if we are using fast-deteriorating short-expiry drugs on people, it would mean that most patients are being given low quality drugs,” he said.

Dr. Bandara questioned the government authorities’ inability to get high quality drugs with a long life span. The Government Medical Officers Association spokesperson Dr. Chandana Atapattu said the people would soon lose faith in the health service if this state of affairs continued.

“The minister often blames the doctors saying that they don’t prescribe drugs in generic names but how can we do this when the drugs that are brought down are of low quality?” Dr. atapattu asked.

According to him, the country should have an independent national medicinal drug regulatory authority which is responsible for the registration, testing and storing of all dugs and medical items brought to Sri Lanka.

“The quality failures happen when there is no transparency in what the authorities do. This is the situation now. So we call for the setting up of an independent drug regulatory authority as has been suggested in the national medicinal drug policy which was approved by the cabinet in 2005 but still has not been implemented,” Dr. Atapattu said.

According to Dr. Ajith Mendis, Director General of Health Services, the quality failures are now surfacing because the authorities are more vigilant than before.

“We see more cases now because the drug recall committee is more vigilant now. Since the random tests have increased we have been able to identify and recall drugs that fail the quality test,” he said.
He said an investigation was underway about the recent quality failures.

According to him the suppliers and manufacturers of drugs that fail quality are black listed. However they can reregister with the authorities after a year.

 
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