KARACHI: Low quality kits being used in hospital labs
By Nizamuddin Siddiqui
KARACHI, April 9: In the absence of a regulatory framework, the pathological laboratories of Pakistan are using imported kits and procedures of dubious quality.
As a consequence, a lot of resources are being wasted on procedures the results of which are not always reliable, two experts told Dawn on Wednesday.
“Pakistan has become a dumping ground for some multinationals,” said Dr Altaf Ahmed of the Liaquat National Hospital. “We see all kinds of kits in use here. Many of these kits and procedures are of inferior quality.”
There is also the problem of use of testing kits after the date of expiry, said Dr Altaf Ahmed. “This is something for which the pathological laboratories, and not the multinationals, are responsible.”
He was of the opinion that the authorities should play a role in this regard. “I have been working in laboratories for the last ten or 15 years.
“But I have never seen a government official visiting the laboratories and asking questions about the expiry of kits and the quality of kits. It’s time that the government plays its role in this area.”
In comparison, America has the FDA which monitors not only the quality of the kits and procedures to be used but also the medicines to be prescribed. “The European countries also have such a system,” said Dr Altaf Ahmed.
Dr S. Abdul Mujeeb of the Jinnah Postgraduate Medical Centre expressed similar views. “Many low quality kits and procedures have found their way into the Pakistani market,” he said.
“The local laboratories should preferably use the kits and procedures which have been approved by the FDA of America or the Paul Ehrlich Institute of Europe.” But since the FDA- and PEI-approved kits are very expensive, the local laboratories make do with the ones imported from the Far Eastern countries.
“Ironically, many such kits and procedures are not in wide use even in the countries of their origin,” said S.A. Mujeeb. “This is what we should guard against.”
Dr Mujeeb was of the view that the WHO should look into this matter. “Since, the FDA- and PEI-approved kits cannot be used widely in most of the developing countries and since these states are largely incapable of establishing a reliable regulatory framework, the WHO should move in to fill the vacuum.
“It follows then that no laboratory should use kits that don’t have marketing rights in the countries of their origin and also those that are not acknowledged as being of acceptable quality by the WHO.”
Turning his attention to the practices in vogue at the local pathological laboratories, he said: “There’s a lot of room for improvement.
“That’s why we feel that there should be a body with powers to register laboratories in view of their standards.” Such a body should ideally award accreditation only to good laboratories, he said.
In response to a question, he said in case the standards of a previously accredited laboratory decline then it should be de-registered. “This idea has been mooted several times before, but has never been considered properly.”
