Ranitidine hydrochloride is a histamine-2 receptor antagonist that is widely used to treat conditions like peptic ulcers, gastroesophageal reflux disease (GERD) and in other gastric condition by reducing stomach acid production. It was considered effective and generally safe until concerns emerged in 2019 about contamination with N-nitrosodimethylamine (NDMA), a probable human carcinogen
Ranitidine has been banned or withdrawn in many countries worldwide, including the US and EU, after studies showed that NDMA levels in the drug could increase over time and when stored at higher temperatures, potentially exposing patients to unacceptable cancer risk. Regulatory agencies concluded that the risk could not be reliably controlled.
In India, ranitidine was not banned for a long time and is still sold and marketed in the Indian pharmaceutical market. This medicine is very popular in India and is prescribed by many physicians. It is also readily available in both local and hospital pharmacies.
This raises an important question, if this medicine is banned worldwide, why is it not banned in India? There are multiple reasons and differing public opinions on this topic. According to some people, this situation may be due to corruption or regulatory loopholes within Indian regulatory authorities. Others claim that it is due to differences in regulatory decisions, mainly arising from variations in local testing data, risk assessment timelines, availability of alternatives, and regulatory processes.
MBH/PS