In what could come as a shock for many, commonly used drugs such as Combiflam, D-cold Total, anti-allergic Cetrizine have failed quality tests in sample-based screening conducted by Central Drugs Standard Control Organisation (CDSCO), the national drug regulatory agency.
According to a report by The Economic Times, the national reulatory agency has rejected specific batches of 60 drugs, including drugs containing antibiotics ciprofloxacin and ofloxacin.
All the drugs have been mentioned in CDSCO's March safety bulletin which describes these drugs as "not of Standard Quality/Spurious/Adulterated/Misbranded".
"Disintegration" issues were the major reason why both the batches of Combiflam and D-Cold tablets failed the test. For Cetrizine the reason was "related substances". Ofloxacine and ciprofloxacine failed "assay" which is a quantitative tests for ingredients, the report adds.
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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. It means a drug of that batch may take longer to act.
The complete list of these drugs and their problems is available on the CDSCO website.
Last year, the drug regulators of seven states alleged that as many as 27 medicines sold by 18 major drug companies in India including Abbott India, GSK India, Sun Pharma, Cipla and Glenmark Pharma are of “substandard” quality, reported The Indian Express.
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The primary reasons included false labelling, wrong quantity of ingredients, discolouration, moisture formation, failing dissolution test and failing disintegration test.
