February 25, 2017 4:55:30 am
Drugs from the American Embassy’s Medical Centre have often been sent back for the want of efficacy, United States Food and Drug Administration country director Dr Mathew Thomas said on Friday. “I have a rapid assay tool in my office which is not very… but I have sometimes tested drugs with it. I got a strip of paracetamol and I found that there was absolutely no drug in it,’’ Thomas said at the Indian Pharmaceutical Forum here. “They come to me and say ‘Mathew this is not working’. These are lipid lowering drugs, anti-hypertensives, diabetes drugs… when the patient has taken three-four doses and has not reported the difference in readings that they should have.’’
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Thomas later clarified that the rapid test is not too accurate and hence the results may not be admissible for serious regulatory action. He added that it is possible that the medicines he has tested may have contained active ingredients that the assay missed. “The idea was to emphasise the importance of quality. All of this is anecdotal,” he told The Indian Express.
Thomas’s statement came a week after a Union health ministry survey found that the percentage of Not of Standard Quality (NSQ) drugs in India was 3.16 per cent and that of spurious drugs 0.0245 per cent. Of the 47,012 samples tested for the survey, 13 were found spurious and 1,850 NSQ.
Separately, guidelines were released at the two-day forum on data reliability as regulators from the US, Europe and India addressed issues of quality control and data integrity. They emphasised quality is a culture and that Indian companies have often found to be wanting even in the quality of applications submitted. The importance of foolproof paperwork and preservation of documents was highlighted.
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