The Central Drugs Standard Control Organization (CDSCO) has issued a nationwide alert on the potential cancer risk linked to ranitidine, a commonly used antacid, directing regulatory authorities to monitor and control levels of N-nitrosodimethylamine (NDMA), a probable human carcinogen, in the drug.
In a circular dated July 24, the CDSCO instructed all state and Union Territory drug controllers to ensure that manufacturers routinely monitor NDMA levels in both the active pharmaceutical ingredient (API) and finished formulations. The advisory mandates batch-wise NDMA testing, proper documentation of test results, and reduction of shelf life to two years where not already implemented.
NDMA is classified by the International Agency for Research on Cancer (IARC) as a probable human carcinogen. It may form during the manufacture or storage of ranitidine, particularly under heat and humidity, or due to degradation over time. Concerns over its presence in ranitidine led to global recalls in 2019 and 2020.
The CDSCO has also advised manufacturers to adopt risk-based measures such as modifying storage conditions and reducing expiry periods to minimize NDMA formation. Drug inspectors have been directed to collect market samples and send them for NDMA analysis to government laboratories. Regulatory action will follow if levels exceed permissible limits.
An expert committee has been constituted to study the mechanisms of NDMA formation during manufacture and storage. The Indian Council of Medical Research (ICMR) has been asked to conduct an independent safety study to assess long-term effects of ranitidine consumption in Indian patients.
Ranitidine, an H2-receptor antagonist used to treat gastric ulcers and acid reflux, remains widely available in India despite restrictions or bans in several countries. The CDSCO has not imposed a ban but is focusing on enhanced monitoring and regulatory oversight.
Pharmacists have been advised to discourage the use of expired ranitidine products. Manufacturers may need to withdraw older batches or relabel existing stock with updated expiry dates, which could lead to temporary shortages. Proton-pump inhibitors like omeprazole and pantoprazole are unaffected and remain available alternatives.
Some large pharmaceutical companies stated that they already conduct regular NDMA testing, while smaller firms expressed concern over the increased cost burden. Consumer safety groups welcomed the move and urged transparent implementation.
The expert panel's findings, along with ICMR’s study, will guide future decisions on ranitidine’s regulatory status in India. International agencies including the US FDA and European Medicines Agency continue to monitor nitrosamine impurities across multiple drug classes.
(Rh/Eth/DJR/MSM/SE)