Anti-Acidity Drug Back In Civic Hospitals After Clear Test

MUMBAI: Anti-acidity medication, Ranitidine, will be available in civic hospitals and dispensaries almost three months after it was banned in public hospitals in Maharashtra and many parts of the world for containing a cancercausing impurity beyond permissible limits.

The BMC’s decision to revoke the ban followed a “clear” laboratory result on Ranitidine samples picked up for testing in the September-October period. “The tests carried out on the drug samples in a Food and Drug Administration (FDA)–approved laboratory showed no contamination, resulting in the ban being removed,” said a senior official of the civic central purchase department. The BMC letter revoking the ban was issued on Friday, January 3.

Incidentally, a similar ban on the drug in state government-run hospitals and dispensaries continues. “We have not received results of the samples sent to the FDA, but we will revoke the ban if we too get no contamination,” said a state official. State health services director Dr Sadhana Tayade said her department is likely to get the test results within a fortnight.

In September 2019, the United States FDA had issued an alert stating that an American online pharmacy had found higher-than-permissible levels of cancer-causing nitrosamine (N-nitrosodimethylamine NDMA) in Ranitidine.

While the American FDA did not ban the drug and asked for “caution” among users, countries such as France and Singapore decided to stop manufacturing and selling the drug till clarity was established. India’s central drug authorities followed the US’s lead, and only alerted state governments to check on the safety concerns. Maharashtra health officials banned the drug from its healthcare setup and sent samples for testing. In Mumbai, the BMC followed the same steps.

Ranitidine is an old molecule that was commonly prescribed by doctors for intestinal and stomach ulcers and Gastroesophageal Reflux Disease (GERD), with the Indian market estimated at Rs 750 crore for over 180 products based on the drug. Its global sales are over $412 million.

A doctor said, “The BMC’s step in revoking the ban seems premature as every day we hear of batches of Ranitidine being recalled in various countries. Pharmaceutical companies have voluntarily recalled samples, so why the rush?”

However, Dr A Rana of the civic central purchase department clarified that as contaminants were not found in the tests, there was no question of continuing with the ban. Another BMC official said the union government had not banned the drug and it is freely available at private chemists.-Times Of India