New Delhi, Sept 25 : India’s drug regulator has ordered an investigation into anti-acidity medicine Ranitidine after the US Food and Drug Administration (FDA) found a carcinogenic substance in some samples. The Central Drugs Standard Control Organisation (CDSCO) has asked state controllers and manufacturers to test their products for the impurity N-nitrosodimethylamine (NDMA). Ranitidine is an over-the-counter drug to ease heartburn.
“It has been reported from other countries that some ranitidine medicines contain a nitrosamine impurity called N-nitrosodimethylamine at low levels,” Drug Controller General of India (DCGI) VG Somani said in the letter, as seen by Mint.
NDMA has been classified as a possible carcinogenic substance by the International Agency for Research on Cancer (IARC).
In India, GlaxoSmithKline (GSK) Pharmaceuticals, JB Chemicals, Cadila Pharma, Zydus Cadila, Sun Pharmaceuticals sell over 180 versions of the drug, according to a report in The Economic Times.
GSK Pharma sells the drug under the brand name Zinetac, and JB Chemicals has named its product Rantac. Sun Pharmaceuticals manufactures the drug under the brand name Histac.
Some manufacturers have already sent their Ranitidine samples for testing following the CDSCO directive, according to the Mint report.
“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 GSK told the paper.
