Heres Why the GoI Restricted the use of Ranitidine

Story Highlights
  • The health ministry removed Rantac and other anatcids from National List of Essential Medicines (NLEM).
  • The salts used in the antacid are said to be carcinogenic beyond a limit.
  • Ranitidine has been at the centre of investigation globally.

Little did we know about the salts used in those antacids and its side effects the future of the Indian pharmaceutical world would have been different. With the health ministry’s decision to remove the Ranitidine and Zintac from the National List of Essential Medicines (NLEM) a choas has emerged.

Ranitidine has been at the center of investigation ever since low levels of carcinogen impurity were detected in the salt. The salt was developed by Glaxo Holdings Ltd, now part of GlaxoSmithKline PLC, and got its first American approval way back in 1983, alongside 31 countries.

According to the NIH, the salt in this OTC and prescribed drug Rantac had low-level N-Nitrosodimethylamine (NDMA), which was flagged to be cancerous for human system. Studies have shown the effect of NDMA was synergized by heat and time on parts of the digestive system

Ranitidine- a salt, which is widely sold across India under the brand names Aciloc, Zinetac, and Rantac, among others, and is commonly prescribed for acidity and stomach ache-related issues. It is prescribed to treat gastroesophageal reflux disease (GERD), gastric ulcers, and duodenal ulcers and prevent stress ulcers. The salt, according to the National Library of Medicine (NIH) under the National Centre for Biotechnology Information, inhibits both gastric acid secretion and basal gastric secretion, induced by secretagogues such as histamine and pentagastrin.

Should you be worried if you consumed RANTAC?

As per the advisory by US FDA, if an individual has consumed the drug below the carcinogenic limits, risk to cancer is extremely minimal.

The drug was banned in the US on risk versus benefit ratio in 2020.

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