New Delhi: The Central Drugs Standard Control Organization (CDSCO) has found popular medicines like Combiflam, a painkiller and D Cold Total tablets to be substandard in a test done last month .
Combiflam is manufactured by Sanofi India at its Ankleshwar plant, while D Cold Total is made by Reckitt Benckiser Healthcare India at its Baddi unit in Himachal Pradesh. It is reported that Combiflam had failed the drugs test three times last year and Sanofi had to recall the affected batches.
Other drugs found substandard by CDSCO include Cipla’s Oflox-100 DT tablets and Theo Asthalin tablets, along with Cadila’s Cadilose (Lactulose Solution USP). It issued an alert for a total of 60 drugs which failed quality tests in March 2017, according to The Indian Express.
A spokesperson for Sanofi had told 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.”
Cipla’s Oflox with annual sales of Rs 20.7 crore 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.
Cadila Pharmaceuticals’ Cadilose which is the brand of molecule category Lactulose also 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.”