Combiflam, D Cold among drugs found to be substandard by national drug regulatory agency

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In a shocking development, specific batches of 60 drugs, some of which have been widely used, have failed quality tests in a sample-based screening conducted by the national drug regulatory agency Central Drugs Standard Control Organisation (CDSCO).
Popular medicines such as painkiller Combiflam, over-the-counter cold medication D Cold, anti-allergy drug Cetirizin and antibiotics containing Ciprofloxacin, Ofloxacin and Amoxycilin have been declared ‘sub-standard’ by the regulatory authority.
These drugs feature in the list put up by CDSCO titled ‘Drug Alert for the Month of March’ on the agency’s website and have been tested in CDSCO’s zonal offices. Findings of the test declare the drugs as ‘Not of Standard Quality’, ‘Spurious’, ‘Adulterated’ or ‘Misbranded.’
According to the report, the widely-consumed painkiller Combiflam and the cold medication D Cold have been declared sub-standard because they failed the disintegration test. Likewise, antibiotics Ciprofloxacin, Ofloxacin and Amoxycillin have been featured in the list due to assay. Panza-40, a medicine prescribed for reducing stomach acid, has also made it to the list due to ‘dissolution.’Sanofi India 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.”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,” Sanofi India spokesperson added.
When Combiflam was found to be substandard three times last year, Sanofi India had recalled the affected batches. According to QuintilesIMS, a technology-driven healthcare service provider, the annual sales of Combiflam is of Rs 169.2 crore. The details of all the 60 drugs which includes their composition, manufacture and expiry date, names of manufacturers, the reasons for failure and the zonal offices where they are drawn from are mentioned on the list put up on the website.

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