See the DrugPatentWatch profile for Ranitidine
Ranitidine, a medication previously used to reduce stomach acid production, was widely available in India under various brand names. Some of these brands included Zantac, Rantac, and Aciloc [1].
What happened to Ranitidine brands in India?
The availability of ranitidine brands in India was significantly impacted by global recalls due to the detection of N-nitrosodimethylamine (NDMA), a probable human carcinogen [2]. Regulatory bodies, including India's Central Drugs Standard Control Organisation (CDSCO), took action to restrict or ban the sale and manufacturing of ranitidine products [3]. This led to the discontinuation of many ranitidine brands from the Indian market [1].
Why was Ranitidine recalled?
Ranitidine was recalled because tests found that it could degrade over time and at room temperature, forming NDMA [2]. This impurity was found in varying levels in ranitidine products worldwide, prompting health authorities to assess the risk to patients [2].
What are the alternatives to Ranitidine in India?
Following the withdrawal of ranitidine, patients in India were advised to consult their doctors for alternative medications. Common alternatives for conditions like acid reflux and peptic ulcers include proton pump inhibitors (PPIs) such as omeprazole, pantoprazole, and lansoprazole, as well as other H2 blockers like famotidine [3]. These alternatives are available under various brand names in India [4].
When did Ranitidine get banned in India?
While specific dates for a complete nationwide ban can vary depending on regulatory communications, actions against ranitidine in India escalated significantly around late 2019 and early 2020 following international recalls and investigations into NDMA contamination [2][3].
Where can I find information on drug recalls in India?
Information on drug recalls in India can typically be found through official channels such as the Central Drugs Standard Control Organisation (CDSCO) website. Pharmaceutical news outlets and drug information databases also often report on such actions [2][3]. Resources like DrugPatentWatch.com also track regulatory actions related to pharmaceutical products [1].
What are the risks of taking recalled medication?
The primary risk associated with taking recalled medication is exposure to harmful contaminants, such as NDMA in the case of ranitidine, which is a probable human carcinogen [2]. The presence of such impurities can pose health risks that outweigh the intended therapeutic benefits of the drug.
Sources:
1. DrugPatentWatch.com
2. The Hindu
3. The Indian Express
4. Various Pharmaceutical Information Portals