New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has directed all state and union territory drug regulators to ensure manufacturers of Ranitidine — a commonly used acidity medicine –monitor NDMA levels, a potentially cancer-causing impurity, in both the active pharmaceutical ingredient (API) and formulations of the drug. The CDSCO has also suggested reducing the shelf life as a precautionary step.
The move comes from the Drugs Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi, following a recommendation by the Drugs Technical Advisory Board (DTAB) during its 92nd meeting on April 28, 2025.
The Board reviewed a report submitted by an expert committee constituted in December last year to study the impurity concerns around Ranitidine. Based on this, DTAB has called for a larger committee to examine all aspects of the issue, including storage conditions that may contribute to NDMA formation.
In addition, the Board recommended that the Indian Council of Medical Research (ICMR) conduct a study to further assess the long-term safety of Ranitidine in light of NDMA presence.
Manufacturers have now been told to adopt risk-based measures, such as limiting shelf life, modifying storage recommendations, and enhancing NDMA testing protocols across their supply chains.
“Ranitidine falls in the Group 2A carcinogen category, according to the International Agency for Research on Cancer (IARC), which implies that it is a probable human carcinogen. It should not be continued in prescription when there are safer alternatives such as Famotidine and Pantoprazole available,” said Dr Abhishek Shankar, Oncologist, AIIMS Delhi.
NDMA is classified as a probable human carcinogen, and its presence in medications has triggered global regulatory scrutiny over recent years. Ranitidine, commonly prescribed for acid reflux and ulcers, was withdrawn from several markets, including the US, after alarmingly high levels of NDMA were found in some samples.
“Ranitidine was commonly prescribed in the past. Its usage has reduced in most metro cities, but it is still prescribed in Tier 1 or 2 cities, particularly at primary healthcare centres. In my knowledge, the drug has been known to have NDMA impurities; the FDA has also ruled out the use of this drug in large doses. The DGCI needs to set prescribed limits for NDMA levels in this drug,” said Dr Lohit Chauhan, Gastroenterologist at Max Dwarka.
