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Drug regulator finds D Cold Total, Combiflam, Oflox 100 to be substandard

When Combiflam was found to be substandard three times last year, Sanofi India had recalled the affected batches.

New Delhi |
Updated: April 21, 2017 9:04:12 am
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The Central Drugs Standard Control Organization (CDSCO) has found popular painkiller Combiflam and cold medicine D Cold Total, manufactured and sold by Sanofi India and Reckitt Benckiser Healthcare India, respectively, to be substandard in its tests done last month.

Moreover, Cipla’s Oflox-100 DT tablets and Theo Asthalin tablets, as well as Cadila’s Cadilose solution have also been found to be substandard. In total, the CDSCO has issued a drug alert for 60 medicines, including five aforementioned drugs, as they failed different quality tests in March 2017.

Combiflam batch number A151195, manufactured in October, 2015, failed the disintegration test of CDSCO. In last year, the CDSCO had found Combiflam to be substandard three times — in February, April and June — for failing the same disintegration test.

Sanofi India spokesperson told The Indian Express: “Certain batches of Combiflam manufactured in 2015 were deemed substandard because the tablets showed a delay in the disintegration time. Essentially, there are several pharmaceutical parameters that are routinely assessed, one of which is to check the breakdown of a tablet in the human body. The batch identified by the CDSCO in March 2017 was also manufactured in 2015. Once we receive the official notice, we will ascertain the finding and take appropriate action.”

When Combiflam was found to be substandard three times last year, Sanofi India had recalled the affected batches. According to QuintilesIMS, a technology-driven healthcare service provider, the annual sales of Combiflam is of Rs 169.2 crore.

“In the case of these specific 2015 batches of Combiflam, although the disintegration time was delayed, doctors and patients can be assured that there is no impact on the safety and efficacy of the product. Since the matter first arose last year, we have analysed the problem and taken appropriate remedial steps to ensure that the tablets disintegrate within the specified timelines. Combiflam has been in the Indian market for over twenty-five years and continues to be a safe and efficacious analgesic used for relieving pain,” Sanofi India spokesperson added.

Cipla’s Theo Asthalin has annual sales of Rs 17.3 crore in India, according to QuintilesIMS. It has 91.53 per cent market share in its molecule category — Salbutamol Sulfate + Theophylline. Theo Asthalin failed the disintegration test last month. Cipla’s Oflox has annual sales of Rs 20.7 crore. Oflox failed the “assay” test of CDSCO last month.

In assay test, the analyst checks if the ingredients in the molecule are in proper amount and of good quality. The D Cold Total tablets of batch AD762 were found to be substandard by the last month as it failed the disintegration test. Cipla and Reckitt Benckiser Healthcare India did not respond to specific queries sent by The Indian Express.

According to QuintilesIMS, Cadila Pharmaceuticals’ Cadilose has annual sales of Rs 5.8 crore. Cadilose, which is the brand of molecule category Lactulose, failed the “assay” test of the central drug regulator. In response to specific queries of The Indian Express, the company stated: “ Cadila Pharmaceuticals Ltd has not received any communication on this development, hence it is not possible for us to comment on the same.” In India, 60 other pharmaceutical companies are selling Lactulose under different brand names.

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