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Combiflam fails drug test, but there is no reason to panic

The medicines in question failed the disintegration criteria, according to drug safety alerts posted on the website of Central Drugs and Standards Control Authority (CDSCO).

combiflam, sanofi, combiflam sanofi, sanofi combiflam, combiflam recall The medicines in question failed the disintegration criteria, according to drug safety alerts posted on the website of Central Drugs and Standards Control Authority (CDSCO). (Source: Thinkstock)

It is one of the most common medicines found in every household and if the withdrawal of some batches of Combiflam has sent alarm bells ringing — there is nothing to panic yet. Next time you have that sudden game of badminton and wake up with lactic acid deposits in the over-exercised muscles, you can still pop the pill. Only check the manufacture and expiry dates.

On Thursday French drugmaker Sanofi withdrew some batches of the anti-inflammatory drug manufactured in June-July 2015 (expiry May-June 2018) that were found to be unsatisfactory by the Indian drug regulator. The medicines in question failed the disintegration criteria, according to drug safety alerts posted on the website of Central Drugs and Standards Control Authority (CDSCO). Disintegration refers to the time that a drug takes once inside the body to break up into granules of a minimum specified size which is essential for it to start performing its action. Practically speaking a drug of that batch may take longer to act.

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Combiflam incidentally is one of the fixed drugs combinations to survive the recent purge by the Union health ministry which issued a notification banning 350-odd medicines that are a combination of fixed doses of one or more drugs for a range of reasons, from the lack of medical rationale for marketing such a combination to untoward side-effects. There is, however, no bar on the sale of Combiflam which combines the common anti-pyretic paracetamol and ibuprofen. The company has said in a statement that the slower rate of disintegration does not in any way affect the safety of efficacy of the product.

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The drug safety alert is a monthly feature. In fact the February 2016 notice in which Combiflam appeared, there were 26 other drugs whose samples lifted from across the country had failed on one parameter or the other. The April 2016 notice had 16 other drugs flunking on parameters like dissolution, assay etc.

First published on: 12-05-2016 at 20:23 IST
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