Decision to drop drugs from Essential Medicines list not taken due to side effects or cancer concerns: Official sources

India on Tuesday dropped from the National List of Essential Medicines (NLEM) antacid Ranitidine, Atenolol, Erythromycin and many more molecules, but this decision was not taken due to side effects or cancer concerns, a government official told ANI.

Molecules like atenolol erythromycin and ranitidine and many more which are out of NLEM have been safe and efficacious for more than four decades,” he added.

“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,” a Government official source told ANI.

“The criteria for addition or deletion of the products in the NLEM depends on many parameters like cost vs MRP, life-saving qualities, usage etc,” the source said further.

India on Tuesday dropped the antacid, Ranitidine, which is sold as Zantac from the National List of Essential Medicines 2022. It was earlier in the essential list of medicines.

According to Dr Y K Gupta – Professor, Vice Chairman, Standing National Committee on Medicines & Health Care Products who recently spoke to ANI said, “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.”

“However, since we have better options available with us, so, we consider removing this but removing because it can cause cancer is an incorrect statement,” he said further.

“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.

The U.S FDA, 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 website of FDA, “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,” emphasised Dr S Chatterjee, Internal Medicine Physician, Indraprastha Apollo Hospitals.