India’s drug regulator this week began looking into concerns of potential cancer-causing substances contaminating popular acidity drug ranitidine. The move came over a week after the US Food and Drug Administration flagged the issue to American patients, some companies have suspended sales of the product worldwide, and some other countries have ordered recalls of the product:
What is ranitidine?
- Ranitidine, popularly known through brand names like Aciloc, Zinetac, Rantac and Rantac-OD, R-Loc and Ranitin, is an over-the-counter, prescription antacid used in the treatment of acid reflux and peptic ulcer diseases.
- It is commonly used to relieve acid-related indigestion and heartburn by decreasing stomach acid production.
- While other medicines like pantoprazole and omeprazole too treat these symptoms and are more commonly prescribed today, ranitidine is still widely used in India.
What is the problem?
- On September 13, the US FDA stated in a release that it had learned that some ranitidine medicines contained “low levels” of a substance called N-nitrosodimethylamine (NDMA).
- An environmental contaminant found in water and foods, NDMA has been classified by the International Agency for Research on Cancer as probably carcinogenic to humans, which means it has the potential to cause cancer.
- This is the same impurity that the US FDA had investigated in blood pressure drugs valsartan and losartan over the last year.
How has India responded?
- India’s top drug regulator wrote to state regulators asking them to direct ranitidine active pharmaceutical ingredient (API) manufacturers to “verify their products and take appropriate measures to ensure patient safety”.
- Drugs Controller General of India (DCGI) asked states to inform it of action taken in this matter “at the earliest”. So far, the DCGI has not called for any halting of supplies, which means the ranitidine brands marketed in the country can continue to be sold until further notice.
Source – Indian Express
Question – What is ‘ranitidine’? What are the concerns attached to it? How should India respond to it?