CDSCO warns against Cancer Causing Impurities in anti-acidity drug Ranitidine, writes to state drug controllers
New Delhi: To ensure patient safety, the country's apex drug regulatory body, Central Drugs Standard Control Organisation (CDSCO) has ordered an investigation into the popular anti-acidity drug Ranitidine, for a probable presence of carcinogen impurity. In its directive, the regulator has further asked to ensure that the drug is sold only under prescription.
In this regard, CDSCO has written to all the state regulators asking them to “communicate to the manufacturers of ranitidine API (active pharmaceutical ingredient) and formulations under your jurisdiction to verify their products and take appropriate measures to ensure patient safety.”
It has been reported from other countries that some ranitidine medicines contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.
Medical Dialogues had earlier reported that Dr Reddy's Labs suspended the supply of its drug Ranitidine worldwide as a precautionary measure, following the ongoing probe by the US Food and Drug Administration into the reported impurity N-nitrosodimethylamine in it at low levels.
The regulator flagged the concern, ordering to check the presence of N-nitrosodimethylamine in Ranitidine. N-nitrosodimethylamine has been classified by the Internal Agency for Research on Cancer (IARC) as probably carcinogenic to humans.
As per the letter issued by CDSCO, “The drug Ranitidine is approved for multiple indications in the country and is available in various formulations including tablets, injections, etc. It is a prescription drug included in Schedule H and, therefore, it should be sold by retail only under a prescription of a registered medical practitioner.”
Ranitidine is a commonly prescribed medicine for countering acidity and is on the World Health Organisation’s ‘Model List of Essential Medicines’. In India, a host of companies including the GalxoSmith Kline, JB Chemicals, Cadila Pharma, Zydus Cadila, Dr Reddy’s, Sun Pharmaceuticals sell over 180 versions of the drug. The market size for Ranitidine brand in India is Rs 688.6 crore, as per data shared by AIOCD PharmaTrac.