Dr YK Gupta gives clarification on speculation 'Ranitidine' being removed from NLEM due to cancer
Sep 15, 2022
By Shalini Bhardwaj
New Delhi [India], September 15 : India on Tuesday dropped the antacid Ranitidine, which is sold as Zantac, from the National List of Essential Medicines 2022. It was earlier on the list of essential medicines.
According to Dr. Y K Gupta, the Professor, Vice Chairman, Standing National Committee on Medicines and Health Care Products, "Sometime back FDA noted that in some of the batches of a few drugs like Ranitidine, losartan and metphormin an impurity known as nitrosodimethylamine (NDMA) was observed. This substance can cause cancer. As a response, the FDA put some pause on such products while a detailed investigation is still awaited. It is still not established that what amount of exposure of this substance will be carcinogenic particularly when the drug is taken on as and when needed basis."
"There are the drugs that proton pump inhibitors such as pentazole, omeprazole which are effective safe and affordable. These alternatives are already listed in NLEM and ranitidine has been deleted. The deletion of ranitidine shouldn't cause panic in patients taking ranitidine."
He said further, "All are advised to take medication only on the advice of the doctor as any medication if not taken appropriately may cause harm."
"There should not be any panic or misconception that drug is banned," Dr Gupta said.
The US FDA, in 2020 requested a manufacturer's market withdrawal of ranitidine, known commonly by the brand name Zantac.
According to the updates on NDMA present on the FDA website, "FDA has found N-nitrosodimethylamine (NDMA) levels in some ranitidine products increase with time and temperature posing a risk to consumers, and therefore the agency has requested the withdrawal of all ranitidine products from the U.S. market. Consumers should stop taking any OTC ranitidine they may currently have."
"People keep on taking these drugs for long duration that can give some kind of side effects. I must say that these drugs should be used for a specified duration and only under prescription and treating physician or gastroenterologist," emphasized Dr. S Chatterjee, Internal Medicine Physician, Indraprastha Apollo Hospitals.
