Ranitidine has an Indian market size of Rs 750 crore which is also commonly used OTC and prescription medicine by wide range of patients (pediatrics, adults and the elderly patients) commonly used for intestinal and stomach ulcers, Gastroesophageal Reflux Disease (GERD), esophagitis, Zollinger-Ellison syndrome etc., It is a H-2 blocking agent, which decreases the amount of acid created by the stomach.

Owing to the news on Sep 2019 pertaining to worldwide alert of presence of carcinogenic NMDA, our Indian drug regulatory authority has also alerted the state drug authorities to direct the manufacturers of ranitidine to ensure patient safety. The state drug regulators requested the Ranitidine manufacturers to verify their products and take appropriate measures to ensure patient safety.

Has Indian Regulatory body (CDSCO) recalled this drug completely?

Not yet! This drug is still in market use by Indian patients. It is advisable to all the prescribers and patients in India to look for alternative treatments and refrain from using the ranitidine containing medicinal products which could produce carcinogenic NMDA in body. Patients can request doctors or pharmacist in OTC stores for alternative medicines for the similar indications.

As per USFDA’s note, the level of NMDA impurity would be in greater proportion with higher room temperatures, which is more relevant to the climatic conditions in India. This medicine is recalled in many developed countries. The regulatory bodies recalled ranitidine part from USFDA, are-Health Sciences Authority (HSA) of Singapore, Italian Drug Agency, France’s drug safety regulator (the Agence Nationale de Securite du Medicament), Health Canada etc.,

Still Pharmaceutical companies are marketing Ranitidine in India to support their sales with minimal consideration of patient safety.