The batches of 60 medicine discover point out in CDSCO’s March security bulletin which describes these medicine as “not of Customary High quality/Spurious/Adulterated/Misbranded”.
Each the batches of Combiflam and D-Chilly tablets failed the check due to “disintegration” points. Purpose of failure for Cetrizine was “associated substances”. Ofloxacine and ciprofloxacine failed “assay” which is a quantitative assessments for elements. A gentamicine injection failed the check for “particulate matter”. Pantoprazole failed the check for “dissolution”.
A listing of those medicine and their issues is offered on the
CDSCO web site.
In response to the story above, Sanofi has clarified:
Sure batches of Combiflam® that had been manufactured in 2015 had been deemed substandard as a result of the tablets confirmed a delay within the disintegration time. Basically, there are a number of pharmaceutical parameters which can be routinely assessed, one in all which is to examine the breakdown of a pill within the human physique. The batch recognized by the CDSCO in March 2017 was additionally manufactured in 2015. As soon as we obtain the official discover, we are going to confirm the discovering and take applicable motion.
Within the case of those particular 2015 batches of Combiflam®, though the disintegration time was delayed, medical doctors and sufferers could be assured that there isn’t a influence on the protection and efficacy of the product. Because the matter first arose final yr, we now have analysed the issue and brought applicable remedial steps to make sure that the tablets disintegrate throughout the specified timelines.
Combiflam® has been within the Indian marketplace for over twenty-five years and continues to be a protected and efficacious analgesic used for relieving ache.