Expert Panel Suggests Deeper Review Of Antacid Ranitidine, ICMR May Assess Cancer Risk
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The widely used antacid is sold under popular brand names like Aciloc, Rantac, and Zinetac
The Indian Council of Medical Research (ICMR) may now conduct a study to assess the safety of the popular antacid, Ranitidine, News18 has learnt.
Facing controversy due to cancer-causing concerns, the drug Ranitidine works by reducing the amount of acid made in the stomach, and it relieves acid-related indigestion and heartburn. It is sold under popular brand names such as Aciloc, Rantac, and Zinetac.
The drug regulatory authority, Central Drugs Standard Control Organisation (CDSCO), may also ask manufacturers of the drug to closely monitor certain parameters in the medicine and implement risk-based measures, such as reducing shelf life, to mitigate potential risks.
On April 22, News18 reported that the apex panel of experts, the Drugs Technical Advisory Board (DTAB), is slated to discuss a report recommending the 'suspension of the drug ranitidine for manufacture, sale and distribution in the country".
However, the panel has now recommended the formation of a larger expert committee to comprehensively examine concerns related to the widely used antacid drug.
After detailed deliberation, the apex board concluded that all aspects of the drug, including its storage conditions, need to be re-evaluated, especially in light of the presence of NDMA (N-Nitrosodimethylamine) impurity, which is a probable human carcinogen.
'After detailed deliberation, the board recommended that a larger committee is required to be constituted, which will look into all aspects, including the storage conditions of the ranitidine drug," according to the DTAB's minutes of the meeting, seen by News18. 'DTAB, further, recommended that ICMR may conduct a study for assessing the safety of the Ranitidine drug considering the presence of NDMA impurity."
Further, the panel opined that 'manufacturers should monitor the NDMA levels in the API/formulation and also take risk-based measures such as reducing the shelf life, etc".
According to a senior official who is part of the expert panel, the majority of Indian houses have been consuming Ranitidine for decades now without facing any significant concerns. 'Do they all have cancer?" he asked while adding, 'We need to find out under what circumstances the drug becomes carcinogenic… We need to understand that now we have a new line of antacid molecules as well. We, as a panel of experts, won't wonder if there is any other lobby which is trying to push their new molecules over the already settled ones, like Ranitidine. Hence, we need to take a balanced and data-based approach before discarding the otherwise proven antacid."
Ranitidine has been under scrutiny since 2019, when the American health watchdog, the US Food and Drug Administration, alerted and said the drug contains low levels of cancer-causing substances.
The US agency had suggested that some Ranitidine medicines contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. 'NDMA is classified as a probable human carcinogen – a substance that could cause cancer – based on results from laboratory tests," the FDA had said earlier.
In 2022, the central government dropped the drug from the national list of essential medicines (NLEM) due to cancer-causing concerns.
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