Drug regulator finds Combiflam, D Cold Total and Oflox 100 substandard
21 Apr 2017
The Central Drugs Standard Control Organisation (CDSCO) has found popular painkiller Combiflam and common cold medicine D Cold Total, manufactured and sold by Sanofi India and Reckitt Benckister Healthcare India, respectively, to be substandard in tests conducted last month.
Following standard test, CDSCO has found several other medicines, including Cipla's Oflox-100 DT tablets, Theo Asthalin tablets as well as Cadila's Cadilose solution to be substandard.
Oflox-100 DT is an antibiotic while Theo Asthalin is used for respiratory problems. Cadilose is usually prescribed for constipation.
CDSCO has also issued a drug alert on as many as 55 other medicines as they failed different quality tests carried out in March 2017, say reports.
Reports said Combiflam batch number A151195, manufactured in October 2015, failed the disintegration test. Last year, the drug regulator had found Combiflam to be substandard three times – in February, April and June – for failing the same test.
Certain Combiflam batches manufactured in 2015 were deemed substandard because the tablets showed a delay in the disintegration time. Drugs are routinely assessed on various parameters, including the one to check the breakdown of a tablet in the human body.
Sanofi claims the batch identified by the CDSCO in March 2017 was also manufactured in 2015, according to a report in The Indian Express.
Combiflam, a combination of ibuprofen and paracetamol, is one of Sanofi's leading brands with annual sales of Rs169.2 core.