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| April 10, 2006 | Monday | Rabi-ul-Awwal 11, 1427 |
Karachi lab’s faulty system exposed: NIH clears 40 drugs
ISLAMABAD, April 9: At least 40 samples of medicines declared substandard by the Central Drug Testing Laboratory (CDL), Karachi, have been cleared by the appellate laboratory - National Institute of Health - thus leaving a big question mark on the credibility of Karachi laboratory, according to documents available with Dawn.
According to these papers, the federal inspector of drugs in the ministry of health in July 2005 had sent samples from 43 batches of “ferrous fumarade” tablets to the CDL for re-testing after the same were found substandard by the CDL.
These tablets were to be supplied by one of the leading manufacturer of Rawalpindi/Islamabad to the government under the prime minister’s programme for primary healthcare and family planning.
The CDL declared that their potency of iron was not within the prescribed limit of 90 to 105 percent.
The manufacturer made a representation to the health ministry, arguing that its product was of standard quality and met all the requirements laid down in the British pharmacopoeia. The ministry referred the samples to the NIH for re-testing.
All the 43 batches re-tested at NIH were found to be in compliance with the requirements of “description, identification, different variations, disintegration time and potency/assay”, according to the documents.
The batch numbers thus declared of standard quality were 570, 571, 572, 573, 575, 582, 583, 584, 585, 586, 587, 588, 589, 590, 591, 592, 593, 594, 595, 596, 596, 598, 599, 600, 601, 608, 609, 610, 611, 612, 615, 616, 617, 618, 619, 620, 621, 622, 623, 624, 625 and 626.
According to the documents, majority of these samples were in the range of 95 to 103 percent.
When contacted, a representative of the pharma industry said it was unfair to declare the samples to be of substandard/doubtful quality because setting up a pharma unit cost something between Rs30 million to over several hundred million rupees.
“Our problem is that we cannot speak out against the ministry of health as we fear that in that case they would close our units on one pretext or the other and our premises would be raided un- necessarily on the pretext of checks,” the representative who asked not to be named said. “The industry unjustifiably gets a bad name because of such inefficient laboratories. Otherwise the standards of pharma industry and the drugs produced by it in Pakistan are generally good when compared with other SAARC countries.”
He said Pakistani products were not only being consumed by the general practitioners but also by leading specialized hospitals like the Aga Khan University Hospital, Shifa International Islamabad, Shifa Eye Trust, National Institute of Cardiac Diseases, Pakistan Institute of medical Sciences, Islamabad, Armed Forces Institute of Cardiology and all the military hospitals.
The representative suggested that only those officers who had sufficient experience of drug testing should be appointed in drug testing laboratories so that wrong reporting and harassment of the industry comes to an end.
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