They were of the opinion that the decision to recall was purely voluntary by a few manufacturers
A group of doctors from different specialties recently met the media for a discussion to separate facts from myths about ranitidine, an active pharmaceutical ingredient (API).
Contrary to the popular perception created, ranitidine has not been banned. None of the key pharmaceutical regulators such as the US FDA, the Drug Controller General of India (DCGI) /CDSCO have asked for a ban. However, the recall by a few manufacturers in India was purely voluntary. The US FDA tested numerous ranitidine products and found levels of NDMA similar to levels one would be exposed to if they ate common foods like grilled or smoked meats.
Dr ME Yeolekar, Prof and Head, Dept of Internal Medicine, KJ Somaiya Medical College and Hospital, said, “Manufacturers are required to comply with the DCG(I)’s directives about ensuring safety of medicines. When manufacturers have verified products and taken the measures towards patient safety, the issue of scare and controversy should not arise. This applies to ranitidine as well.”
Dr Anil Kumar, Consultant Cardiologist, Bombay Hospital and Medical Research Centre, Mumbai and Prof of Cardiology, Grant Medical College and JJ Group of Hospitals, said, “I have been prescribing my patients ranitidine for several years and they have never reported any major side effect during their treatment and thereafter. Neither I nor colleagues from my profession have yet come across a relation between ranitidine and cancer. From my experience, I can say that Ranitidine is safe, efficacious and cheap option for the masses.”
Dr Rajiv Karnik, Cardiologist, Fortis Hospital, Mulund, “Cardiologists prescribe ranitidine to counter acid formation in patients as a side effect of other medicines that are given for different heart conditions. Ranitidine is the safest bet for controlling acid refluxes. The US FDA, in a statement, has also confirmed that ranitidine does not lead to NDMA formation in typical stomach conditions through their tests.”
Ranitidine was commercially introduced in 1981, and has stood up to the expectations of medical fraternity for being safe and efficacious. Ranitidine features on the World Health Organization’s List of Essential Medicines.