After high blood pressure drug (sartan), the same carcinogenic impurity is back to haunt global pharma industry once again, this time for antacid ranitidine. On Tuesday, the Drug Controller General of India (DCGI) asked the state food and drug control administrations to verify the bulk drug and formulation (medicine) ranitidine made by manufacturers in their jurisdiction and take appropriate action to ensure patient safety.
In its communication, the DCGI noted that it has been reported from other countries that some ranitidine products (a common antacid) contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is considered a probable