Months after specific batches of over 60 drugs were marked “substandard” in the quality test, the Central Drugs Standard Control Organisation (CDSCO) has directed its sub-offices to keep a watch on the “movement” of Combiflam. The authorities have also directed to them to take the required action if they sense any such “movement”.
“You are hereby requested to instruct your inspectorate staff under your jurisdiction to keep a strong vigil on the movement of the subject drug in your state. If any movement of such drug is reported, necessary action may kindly be taken in the matter, and required information may be forwarded directly to this office at the earliest,” Media Sources quoted excerpts from the letter by K Bangarurajan, Deputy Drugs Controller (India), West Zone, CDSCO as saying.
The letter has been circulated in all the zonal and sub-zonal offices of CDSCO. However, according to a report in the Indian Express, it is not clear what kind of action will be taken if any such movement is detected.
Earlier this year, batches of 60 drugs failed the quality tests and were marked “substandard”. 60 drugs include painkiller Combiflam, D-Cold Toral, Cetirizine and other drugs that contain antibiotics ciprofloxacin and ofloxacin. Most of these were reportedly termed as either “below the standard quality, spurious/Adulterated/Misbranded”.
The sample test was conducted on the basis of the time the drug took to disintegrate. “We have already addressed the issue of disintegration. We are working closely with CDSCO and have taken necessary action as required. Furthermore, we have not received any information or notification from CDSCO, as reported by you,” the spokesperson of Sanofi India, the manufacturer, and seller of Combiflam told Indian Express.