USFDA Asks Companies To Remove Ranitidine Products; Will Indian Regulator Review Its Stand?

The Indian drug regulator may now have to review its position on a decades-old popular heartburn drug ranitidine, and possibly seek independent testing. This comes amid the US Food and Drug Administration (USFDA) asking companies to withdraw prescriptions and over-the-counter (OTC) ranitidine drugs from the market immediately.

The USFDA is investigating presence N-Nitrosodimethylamine (NDMA), a probable cancer causing impurity in ranitidine products. It has determined that the impurity in some ranitidine products increase over time and when stored at higher than room temperatures, which may result in consumer exposure to unacceptable levels of this impurity.

“As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the US,” USFDA said in a statement.

Strides Pharma is possibly the only India company selling the drug in US market. Dr Reddy’s stopped selling the drug some time back had had recalled its products from shelves in US after tests found presence of NDMA more than the permissible limit. Aurobindo Pharma had also recalled its products from the US for the same reasons.

Indian implications

Many doctors still have faith in ranitidine as they have been using the drug for years. They consider it to be more effective at bedtime in controlling acid breakthrough, with much less side-effect profile than Proton Pump Inhibitors (PPIs). They also see it as a safe medication to use for neonates, infants and children. The other compelling reason is that the drug is inexpensive.

However, with the USFDA reporting fresh evidence, doctors may be forced to rethink.

To be sure, the Indian drug regulator has not given any directive for companies to recall products. It had earlier asked pharmaceutical companies to conduct impurity tests, submit the data and remove products if they contain impurities above the permissible limit.

The Indian market for rantidine stands at around Rs 700 crore. The three brands — GSK’s Zinetac, Aciloc of Cadila Pharmaceuticals and Rantac of JB Chemicals and Pharmaceuticals — cornered 98 percent of the market share.

–Money Control