USA pointed outpatients and stopped the sales for Ranitidine in all over the US. Also, suspended the sales and cancelled the orders in markets for the same. Numerous countries have already taken the step forward after the dropping of Ranitidine. As a result, the Indian drug regulator started looking into concerns of potentially cancer-causing substances contaminating popular acidity drug Ranitidine.
What is Ranitidine?
The accepted brand names for Ranitidine are Zinetac, Rantac, Rantac-OD, R-LOC, Aciloc, and Ranitidine. Ranitidine is used as over-the-counter prescription antacid used in the treatment of stomach acid reflux and peptic ulcer diseases. It is used for acid-related problems in the stomach like indigestion. Heartburn is one such example of indigestion. Ranitidine decreases the Acid level production in the stomach.
Pantoprazole and Omeprazole do the same function but Ranitidine is famous in the market.
Ranitidine is considerable old medication. It was always thought to be a very safe drug. It contains “low levels” of a material known as NDMA (nitrosodimethylamine). NDMA is also known to be environmentally hazardous. NDMA is carcinogenic to humans. It is the same impurity that the US FDA (Food and drug administration) had looked over blood pressure drugs valsartan and losartan, last year.
To ensure the patients’ safety, The Drugs Controller General of India(DCGI) pitched to state regulators to direct Ranitidine active pharmaceuticals ingredient (API) manufacturers to verify their products and take suitable measures. Till the new notice come, the DGCI has not exclaimed the supplies.
Two Indian firms; Saraca laboratories and SMS Life Sciences are responsible for making up of APIs.
Is it safe to have Ranitidine?
Since it is not clarified by the DGCI whether Ranitidine should be prescribed by the Doctor or not, we cannot just say not to have it. Even the US FDA has not given any directions to individuals declining the use of Ranitidine. Investigations are going on, let us wait for the final result. If, after investigations, NDMA would found it in large amount, it should be banned.
Countries including Canada, Italy, Singapore, Finland, Norway, Denmark, Switzerland and Pakistan have already recalled of ranitidine sold in their markets. Ranitidine is a part of WHO’s a model list of essential medicines. It comes under the category of Schedule H drug of Drugs and Cosmetics Act of 1945. Hence it should be sold under the doctor’s prescription.
It is not the first time
Earlier govt had banned 37 harmful FDC (fix dose combination) drugs. These are the drugs having two or more APIs. Cough syrups, dermatological drugs, painkillers are such examples of FDCs.