Drug Regulator in India Warns of Potential Cancer Risk From Common Acidity Medicine, Initiates Investigation
The Central Drugs Standard Control Organisation (CDSCO) in India has issued orders to drug manufacturers, following recommendations by the Drugs Technical Advisory Board (DTAB), to closely monitor the levels of a potential carcinogen, N-Nitrosodimethylamine (NDMA), in both the Active Pharmaceutical Ingredient (API) and the finished drug formulations of Ranitidine.
The concerns about Ranitidine, a commonly-used acidity medicine, were raised due to the presence of NDMA, a probable human carcinogen, in the drug. In recent years, NDMA has sparked scrutiny by regulatory bodies around the world due to its presence in medicines.
The DTAB has suggested the formation of a larger expert committee to review all aspects of Ranitidine’s safety, particularly focusing on the drug’s storage conditions. They also recommended that the Indian Council of Medical Research (ICMR) conduct a study to assess the drug’s long-term safety related to NDMA impurity.
The CDSCO's orders apply to all states and union territories in India, and are aimed at ensuring the safety and quality of Ranitidine for consumers. The measures respond to the potential health risks associated with the use of Ranitidine.
The CDSCO has directed authorities in all states and union territories to monitor levels of NDMA, a potential cancer-triggering ingredient, in Ranitidine. This includes adopting measures such as limiting shelf life, changing storage guidelines, and enhancing NDMA testing protocols.
Dr. Lohit Chauhan, a gastroenterologist, stated that Ranitidine is still prescribed in Tier-1 or 2 cities, particularly at primary healthcare centres. However, these precautionary steps are essential to mitigate safety concerns associated with NDMA presence.
The expert committee's findings served as the basis for the DTAB's call for a larger committee to study the issue. The committee will examine all aspects of the NDMA issue in Ranitidine, including storage conditions that may lead to its formation.
The move by the CDSCO comes after Ranitidine has been banned in several countries due to dangerously-high levels of NDMA found in its samples. The CDSCO's actions are a response to the potential health risks associated with the use of Ranitidine.
[1] Source: Drugs Technical Advisory Board (DTAB) Recommendations [2] Source: Central Drugs Standard Control Organisation (CDSCO) Orders [3] Source: Indian Council of Medical Research (ICMR) Study Proposal
- Despite the ban in several countries, Ranitidine, the common acidity medicine, is still prescribed in some Indian cities, specifically primary healthcare centres, resulting in a need for careful monitoring of its levels of NDMA, a potential cancer-causing ingredient.
- Recognizing the potential health risks associated with the use of Ranitidine, the Central Drugs Standard Control Organisation (CDSCO) in India has directed authorities in all states and union territories to adopt measures such as limiting shelf life, changing storage guidelines, and enhancing NDMA testing protocols to ensure the safety and quality of Ranitidine for consumers.
- To address the safety concerns associated with Ranitidine and the potential presence of NDMA, the Indian Council of Medical Research (ICMR) has been proposed to conduct a comprehensive study on the drug's long-term safety related to NDMA impurity, as recommended by the Drugs Technical Advisory Board (DTAB).
