Inferior quality drugs continue to be imported to the country despite concerns raised by those in the medical fraternity with the Ministry of Health having to recall more than 10 different drugs within the first seven months of the year for failing qualiy tests.
Last year, at least in 25 instances, drugs were recalled due to their poor quality while during the past three years more than 50 different types of drugs have been recalled for the same reasons, the Sunday Times learns.
Most of the drugs which have failed the quality tests are those contained in the essential drugs list maintained by the Health Ministry and were imported from various producers in India.
Fourteen containers of drugs are kept in the State Pharmaceuticals Corporation premises in Ratmalana to be destroyed or to be returned to the manufacturers as they have either failed the quality test or have passed the expiry date, SPC Chairman Dr. W. G. Gunawardane said.
“We are dealing with the lives of patients. If inferior quality drugs are given to patients it may cost them their lives. There are instances where even the most basic and essential drugs such as Paracetamol have been recalled due to failure to meet the quality requirements,” Senaka Bibile Commemorative Association Secretary Dr. Jayantha Bandara said.
Health Ministry Secretary Athula Kahandaliyanage said it was normal to recall some stocks of drugs which did not meet quality requirements. “This does not mean the government is importing low quality drugs. The drugs may fail in quality due to many reasons such as poor storage,” Dr. Liyanage said.
But Dr. Bandara insists that bad storage is not the main reason for the poor quality drugs.
“The biggest problem here is that the drugs are not tested when they are imported. They are importing low-cost, low quality drugs. It is not a problem in storage that drugs like Paracetamol which are stored even in normal shops fail the quality standards. It is a problem in import procedures,” Dr. Bandara said.
According to Dr. Bandara there are also problems in the transport of drugs. “Some drugs are transported in trains where the temperature goes above even room temperature.
There are specifications for storage and transport of drugs. The methods used here do not conform to them. For instance drugs are transported by lorries most of the time, but they don’t have proper facilities needed to do that. Even in the case of storage in drug stores the same thing happens,” he said.
Government Medical Officers Association (GMOA) spokesperson Dr. Upul Gunasekera, said the issue of poor quality drugs had been discussed even with the President, but little or nothing has been done by the Ministry of Health.
“We submitted a full report to the President over the matter but nothing has happened since then. There is a racket going on in the procurement of drugs for the state health institutions that is why this keeps happening. When the drugs are recalled a shortage of drugs is created which enables the authorities to buy drugs from the local market without following proper tender procedures. This leaves room for a lot of malpractice that is why I say this is a racket,” Dr. Gunasekera said.
He said these problems arose due to the lack of a comprehensive national medicinal drugs policy. “We have recommended the implementation of the policy but little or no action has been taken,” the GMOA said.
Draft legislation to implement Professor Senake Bibile’s essential medicines concept was approved by the Cabinet in October 2005 but legislation to implement it has still not been presented in Parliament.