Hyderabad: Ranitidine, the drug used for acidity, is safe. The existence of the probable cancer-causing substance N-nitrosodimethylamine (NDMA) in ranitidine products is the same as that in common foods, the USFDA has stated.
Ranitidine, manufactured by Aurobindo Pharmaceuticals among others, had been recalled earlier this year due to high levels of impurities allegedly found in it.
The Drug Controller in India too had taken sample batches from different wholesalers and retailers and tested them. Their results have still not been declared.
The US FDA which has certified 14 units of Ranitidine in India and has the highest number of checks being carried out in the country outside of the US, has found that these medicines are safe.
The US FDA developed a simulated gastric fluid model for testing. In this model they found that there is no additional NDMA generated in the stomach.
The acceptable limits are 96 nanograms per day or 0.322 ppm. Only those batches which have more than these acceptable limits are a cause of concern, they have stated.
Dr Sanjay Reddy, president of the Telangana Pharmacists Association said, “The clearance is a relief as many patients are using this drug. But the concern of impurities being present has not been completely done away with as the result from the particular batches is not released. Hence those who are taking these medicines have to be alert.” The impurities is likely to have got mixed during the manufacturing of the APIs.
