The government officials on Saturday debunked the rumors about side effects like cancer from the drugs recently dropped from the National List of Essential Medicine (NLEM). India on Tuesday dropped antacid Ranitidine (sold as Zantac), Atenolol, Erythromycin and many more drugs from the list of essential medicines.
“Molecules like atenolol erythromycin and ranitidine and many more which are out of NLEM have been safe and efficacious for more than four decades,” a government official told ANI.
“There are no side effects or cancer concerns with these molecules as recently stated in international studies as well. They are authentic, safe and manufactured by large and small pharmaceutical manufacturers,” he added.
The official further added that the criteria for addition and deletion of drugs in the NLEM depend upon multiple factors like cost vs MRP, life-saving qualities, usage, etc.
“There has been some concern raised by FDA which are still not established about the possibility of some cancerous substances. One must be clear about it this is yet not very established and therefore there is no cause of concern or panic at all,” Dr YK Gupta – Professor, Vice Chairman, Standing National Committee on Medicines and Health Care Products told ANI.
He also informed that as the government now has better options, it is considering removing it, but, claiming that the removal is because it causes cancer is not true.
“It’s only allowed with the assurance by the company in India with an acceptable limit of nitrosodimethylamine (NDMA). There should not be any panic or misconception that drug is banned,” Dr Gupta said.
In 2020, US Food and Drug Administration (FDA) requested the withdrawal of Ranitidine (commonly known by the brand name Zantac) from the markets.
“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,” says the website of the FDA.
Indian doctors recommend the drug for a specified duration and only under a doctor’s prescription.
“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,” emphasised Dr. S Chatterjee, Internal Medicine Physician, Indraprastha Apollo Hospitals.
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