Recall fails to affect ranitidine
Drug continues to be sold at retail pharmacies ■
Over-the-counter sales of ranitidine remain high as it is one of the fastest-moving medicines for controlling acidity. This is despite it being recalled from the market by major pharmaceutical companies due to traces of carcinogens being found in some ranitidine samples. It is stated its distribution at the wholesale level has been stopped.
The Food and Drug Administration of US had issued a warning against the use of ranitidine, a widely prescribed antacid. Following this, the Telangana Drug Control Authority also issued an advisory against prescription of this medicine.
But those who have old prescriptions and regularly use ranitidine have not stopped buying this drug, as they are unaware of its harmful effects.
R. Gupta, a pharmacist said, “Ranitidine is not an over-the-counter drug. But it has become one as people use the same prescription again and again to buy the medicine.”
“It is a widely used product and has been in the market for the last 20 years. The impurity is a cause of concern. But the medicine is required by a large section of people who are suffering from acidity, diabetes and other conditions. Senior citizens also take this tablet very regularly”,” Mr Gupta said.
The movement of ranitidine stocks worth crores of rupees has been stopped from the depot level. But the drug is still available with retailers.
A senior drug controller said, “We are checking various batches of ranitidine. Those that have no impurity will be considered and action will be taken accordingly.”
Sources in pharmaceutical industry say impurities limited to a few batches are due to a lapse in the good manufacturing process. There is a need to have stricter checks to ensure that end products are flawless.
Another senior member of the drug control department explained, “We have been constantly getting negative inputs from Indian pharmaceutical companies. The branded generics having a good market share though there has been a sustained campaign against them in the West. As this is a very sensitive issue, we need to check and verify various batches, and that is a time-consuming process.”