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Tainted medicinal drugs: Urgent need for quality assurance labs
The lack of quality assurance labs to evaluate imported medicinal drugs has led to dozens of product recalls, adverse reactions among patients and also rejected or outdated stocks piling up in the State Pharmaceuticals Corporation stores, awaiting destruction. There are more than 8,000 registered pharmaceutical drugs and not every one of them is tested for quality. There is also no known drug formulary in Sri Lanka.
The only quality guarantee is registration with the drug regulator. A report by the Committee on Public Enterprises, presented in parliament early last year, revealed that pharmaceutical drugs worth more than Rs 47 million were in storage at Maguruwila and Gonawela in Kelaniya. Commenting on the report, COPE chairman and JVP lawmaker Sunil Handunetti expressed concerns about the waste and the appalling state of the storage facilities.
Public health safety issues and the possibility of outdated drugs entering the market were also raised in the report. State Pharmaceuticals Corporation Chairman Sarath Liyanage said substandard drugs were flooding the market because there were no quality assurance labs. He said a huge amount of substandard pharmaceutical drugs got cleared by the National Medicinal Drugs Regulatory Authority (NMRA).
The authority which monitors quality compliance at pre- and post-marketing stages and which issues recommendations on the findings ensuring quality, safety and efficiency, has just one quality assurance lab. As a result, the authority depends on the integrity of importers and suppliers. NMRA chief executive Kamal Jayasinghe admitted that quality assurance labs were needed.
“We are planning to set up state-of-the art quality assurance labs. Until such time, we will accept quality assurances from quality accredited laboratories,’’ Dr. Jayasinghe said. Former SPC Chairman S.D. Jayaratne said manufacturers usually submitted good quality samples for testing, but there were possibilities they could supply substandard drugs to the market.
Ideally, every stock of drugs must be checked for quality, he said. As for private importers, it is important that the NMRA should carry out post-marketing surveillance. Explaining how quality drugs remain in storage, Prof. Jayaratne said that sometimes excessive quantities were ordered. “We order 10 percent excess to ensure that we do not fall short. Information is collected from all hospitals on a drug requirement for a particular year and sent to the SPC. After that, worldwide tenders are called. It takes around 24 to 30 months for a consignment to arrive and by this time the drugs ordered may be no longer be necessary, not in use, or ordered in excess. Sometimes, the health sector could have a shortage depending on the demand due to an outbreak of disease,’’ he said.
Prof Jayaratne insisted that all pharmaceutical drugs must be tested. He suggested imports only from reputed companies until more testing laboratories were set up in the country. “The cost might go up, but it is safer,’’ he said. Dr. Renuka de Silva, nutritionist and NMRA member in the committee to review pharmacy laws, said the Government was responsible for setting up state-of-the art laboratories to test imports.
“India and Pakistan have well developed quality assurance labs,’’ he said, and questioned whether Health Ministry bureaucrats understood the importance of quality assurance labs. Such labs are also needed for the agriculture sector, quarantine departments, and for sports, he said. The Government must invest in quality assurance labs. “If we cannot have state-of-the art labs, at least we should have clusters of labs,’’ he said.
Although there are private quality assurance labs, government departments have misgivings about their efficiency and do not use them. “Such conservative thinking should be shed and assignments given to private labs. If, in doubt, they should be monitored by the Government,’’ Dr de Silva said. Private importers now depend on quality assurance certificates from facilities in Singapore for pharmaceutical drugs, he said.
Chinta Abeyratne, former president of the Sri Lanka Pharmacists Association, said the regulator should have a system whereby the pharmaceuticals were quality checked at the point of sale. “Officials should visit pharmacies and take random samples and check quality,’’ she said.
Also, the Government should form a network of regulatory authorities of exporting countries and request officials of those authorities to visit and determine the quality of the pharmaceutical drugs to be imported.