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Stop popping painkillers: D Cold Total, Combiflam and 58 other medicines fail CDSCO quality tests

Combiflam batch number A151195, manufactured in October, 2015, didn’t manage to pass the disintegration test of CDSCO.


By   |  Updated On : April 22, 2017 11:49 AM
Drug alert: 60 household medicines including D Cold Total, Combiflam fail CDSCO quality tests

Drug alert: 60 household medicines including D Cold Total, Combiflam fail CDSCO quality tests

New Delhi :  

Do you pop pain killers and other popular medicines often? Think twice before you swallow the pills to get relief from pain or other ailments. It’s high time that you better stay away from such medicines as the Central Drugs Standard Control Organization (CDSCO) has found Combiflam, D Cold Total and 58 other medicines to be substandard in its tests done recently.

This update has definitely came as a shocker to those who find popping medicines an easy way out for all their pains. While Sanofi India sells painkiller Combiflam, cold medicine D Cold Total is manufactured and sold by Reckitt Benckiser Healthcare India.

Other medicines found to be substandard include Cipla’s Oflox-100 DT tablets and Theo Asthalin tablets, as well as Cadila’s Cadilose solution, Indian Express has reported. 

A drug alert has been issued for total 60 medicines, including Combiflam, D Cold Total, Oflox-100 DT, Theo Asthalin and Cadila’s Cadilose solution, by the CDSCO after they failed various quality tests in March 2017, the report said.

Combiflam batch number A151195, manufactured in October, 2015, didn’t manage to pass the disintegration test of CDSCO. 

Last year, Combiflam was found to be substandard thrice by CDSCO – in February, April and June – after it failed the same disintegration test, following which Sanofi India had recalled the affected batches.

“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,” Sanofi India spokesperson was quoted as saying by The Indian Express.

“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.

The annual sales of Combiflam is whopping Rs 169.2 crore, while Cipla’s Theo Asthalin’s annual sales is Rs 17.3 crore in India, according to QuintilesIMS, a technology-driven healthcare service provider.

The annual sales of Cipla’s Oflox stand at Rs 20.7 crore and it last month failed the “assay” test of CDSCO.

In its molecule category, Theo Asthalin has 91.53 per cent market share – Salbutamol Sulfate + Theophylline. Last month, Theo Asthalin had failed the disintegration test. The analysts checks the amount and quality of the ingredients in the molecule when conducting the assay test.

Last month, the D Cold Total tablets belonging to batch AD762 were found to be substandard after failing the disintegration test.

According to QuintilesIMS, the annual sales of Cadila Pharmaceuticals’ Cadilose are Rs 5.8 crore. The medicine failed the “assay” test of the central drug regulator. 

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“Cadila Pharmaceuticals Ltd has not received any communication on this development, hence it is not possible for us to comment on the same,” the company was stated as saying by the national daily.

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First Published: Friday, April 21, 2017 02:14 PM

POPULAR TAGS: Combiflam, Medicines, Painkillers, D Cold Total,


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