Overview

• Manufacturers must conduct NDMA testing on both active pharmaceutical ingredients and finished Ranitidine formulations under the new order.
• Regulators are instructed to adopt risk-based measures such as reducing the drug’s shelf life and strengthening storage guidelines to curb impurity formation.
• The DTAB will convene an expanded committee to examine how storage conditions and manufacturing processes affect NDMA levels in Ranitidine.
• The ICMR has been tasked with launching a long-term study to evaluate Ranitidine’s safety profile and potential cancer risks for Indian patients.
• NDMA is classified by the IARC as a probable human carcinogen and has driven global Ranitidine recalls, prompting experts to recommend safer acid suppressants like Famotidine and Pantoprazole.