The Directorate Health Services (Procurement Cell), Maharashtra Government has directed all the Government hospitals across the State to stop the use of Ranitidine injections and tablets. Following the USFDA alert, Drug Controller General of India had issued a notice to State FDAs to test the drug.
The development comes after a warning issued by the United States Food and Drugs Administration (USFDA) about the presence of ‘carcinogenic impurity’ in Ranitidine.
The direction has been issued by Dr Nitin Ambadekar, Joint Director, Health Services (Procurement Cell), to all Deputy Director (Health Services), District Health Officers, and Civil Surgeons across the State.
The Maharashtra Food and Drugs Administration (FDA) has also directed concerned medical authorities to inspect raw material and other aspects at the manufacturers of Ranitidine and submit a report. It also mentioned stopping the prescription of medicine to patients.
As per the letter issued by Dr Ambadekar, USFDA has found low levels of Nitrosamine impurity called N-nitrosodimethylamine (NDMA).
Ranitidine is prescribed for stomach ulcers and gastric problems like acidity. It is Schedule-H drug, that is, it cannot be sold without prescription.
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