Monitor NDMA levels in antacid Ranitidine: Drugs body CDSCO | India News
NEW DELHI: Drug controllers of all states and UTs have been asked by Central Drugs Standard Control Organisation (CDSCO) to direct manufacturers under their jurisdiction to monitor levels of NDMA in the active pharmaceutical ingredient or drug formulation of Ranitidine, a commonly used antacid. NDMA (N-nitrosodimethylamine) is a chemical which has been recognised as a probable carcinogen by International Agency for Research on Cancer (IARC), reports Durgesh Nandan Jha.CDSCO’s decision came after reports of NDMA impurity in the medicine. An expert panel was appointed to deliberate on the concern in Dec last year. Sources said the the committee’s recommendations were deliberated in a meeting of Drug Technical Advisory Body recently.DTAB recommended that a larger committee be constituted to look into all aspects, including storage conditions of Ranitidine, and also suggested that the Indian Council of Medical Research undertake a study to assess the drug’s safety in addition to directing manufacturers to monitor NDMA levels in the drug and, if required, take risk-based measures such as reducing the shelf life.
