The national drug regulatory agency Central Drugs Standard Control Organization (CDSCO) has found widely-used painkiller Combiflam and cold medicine D Cold Total to be ‘substandard’.
Sixty drugs, including the two aforementioned, failed quality tests in sample-based screening done in March. CDSCO’s safety bulletin described these drugs as "not of Standard Quality/Spurious/Adulterated/Misbranded". Anti-allergic Cetrizine, Cipla’s Oflox-100 DT tablets and Theo Asthalin tablets have also been found to be substandard.
Combiflam is manufactured by Sanofi India while D Cold Total is made by Reckitt Benckiser Healthcare India. These pills are commonly found in many Indian households. For a number of health problems like cough, cold, allergies and pain, these are the go-to pills for many. These are easily available over the counter without a prescription at chemists.
A particular batch of Combiflam manufactured in October 2015 failed the disintegration test of CDSCO. Last year, the CDSCO had found Combiflam to be substandard three times – in February, April and June – for failing the same disintegration test.
Sanofi has responded with an official statement:
“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.”
“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.”