New Delhi: India’s apex drug regulator has asked its state-level counterparts to get manufacturers to test anti-acidity drug ranitidine for the impurity N-nitrosodimethylamine.
The directive by the Central Drugs Standard Control Organisation comes just days after the US Food and Drug Administration (FDA) flagged low-level presence of carcinogenic substance in ranitidine.
“It has been reported from other countries that some ranitidine medicines contain a nitrosamine impurity called N-nitrosodimethylamine at low levels. The N-nitrosodimethylamine (NDMA) has been classified by the International Agency for Research on Cancer (IARC) as probably carcinogenic to humans," Drug Controller General (India) V.G. Somani said in the letter, a copy of which was accessed by Mint.
As a precautionary measure, some manufacturers have already sent their ranitidine samples to laboratories for testing.
GlaxoSmithKline Pharmaceuticals said it has responded to the queries sent by regulatory authorities regarding the detection of NDMA in ranitidine.
“GSK is continuing investigations into the potential source of the NDMA. These investigations include continued engagement with GSK’s API suppliers, including Dr. Reddy’s (Laboratories Ltd) and Saraca Laboratories Limited," a spokesperson for the company said.
The company has also engaged external laboratories to test the active pharmaceutical ingredient (API) and finished product batches of intravenous injections, and initial results are expected by the end of this month, it said. It will extend the test to include batches of tablets and possibly other dose forms as well.
The move by the DCGI was first reported by The Print. As per the report, JB Chemicals and Pharmaceuticals Ltd also sent samples of the drug for testing on a voluntary basis.
JB Chemicals manufactures ranitidine under the brand name Rantac, while GSK Pharma manufactures the drug under Zinetac. Other brands are Sun Pharmaceuticals Ltd's Histac, Torrent Pharmaceuticals Ltd's Ranitin, Ajanta Pharma Ltd's Pepitran, among others.
On September 13, the US Food and Drug Administration had issued a safety alert citing the low-level presence of NDMA in ranitidine.
Following the safety alert, Dr Reddy’s Laboratories suspended all shipments of ranitidine products worldwide until the investigation outcome is available. While Dr Reddy’s does not sell the product in India, it has both prescription and over-the-counter variants of rantidine in the US.