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Combiflam, D-Cold Total among 60 other medicines substandard, declares drug regulator
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, the Indian Express noted.
New Delhi: Combiflam and D-Cold Total are medicines that are commonly used by many people in times of minor aches and pains and cold and flu respectively.
However, the Central Drugs Standard Control Organization (CDSCO) that regulates the sales and distribution for drugs in India has declared these two popular medicines as substandard.
Combiflam is manufactured by Sanofi India while D-Cold Total is made by Reckitt Benckiser Healthcare India.
According to a report in the Indian Express, the CDSCO conducted tests last month and, in addition to the two drugs mentioned above, found Cipla's Oflox-100 DT tablets and Theo Asthalin tablets, and Cadila's Cadilose solution to be substandard as well.
Oflox-100 DT is an antibiotic while Theo Asthalin is used for respiratory issues. Cadilose is usually prescribed for constipation.
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, the Indian Express noted.
Combiflam manufacturer Sanofi has assured appropriate action once it receives official notice from the drug regulator.
The company's 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.”
The Express also pointed out that Sanofi had previously recalled three batches of Combiflam last year after they were found to be substandard.