Following the failure to meet quality norms, the Central Drugs Standard Control Organization (CDSCO) has asked Sanofi India to strictly monitor quality of certain strips of "substandard" Combiflam, a fever and pain medication and ensure their complete recall from retail shelves.
Company asked to investigate the matterTo ensure that the company takes pre-emptive action to prevent subsequent batches from failing "critical quality parameters", the Drugs Controller General of India (DCGI) has asked the pharmaceutical company to investigate why it's batches were found "not of standard quality". Under quality norms, medicines are subjected to the disintegration test, which checks if the time taken by the tablet to completely disintegrate in the blood stream is within the prescribed limit. And in March a batch of Combiflam, manufactured in October 2015 failed the test. The same issue was reported on three occasions, last year too i.e. in the months of February, April and June. The government had issued an alert, following which the drug was withdrawn from the market.
'No further stocks have been found substandard'While talking to TOI, Drugs Controller General of India Dr GN Singh told: " Drug inspectors who had picked up certain batches, had reported during quality assessment that it was not of standard quality, and hence not complying with quality parameters.The firm should ensure the entire batch is recalled." He added patients can continue to take the medicine. According to the pharma major Sanofi India, "The problem with four batches, samples of which were picked up by drug regulators, was the delayed impact once the medicine is consumed. The company announced the recall and has fixed the 'technical' issue. This is an old matter and no further stocks have been found substandard".
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