Probing presence of carcinogenic impurities in high BP drugs: DCGI
Following a spate of recalls of drugs containing sartans with carcinogenic impurities, the Drug Controller General of India is probing whether these hypertension and heart failure drugs, particularly , have impurities that may be carcinogenic, DCGI VG Somani said here on Thursday.
Several lots of drugs containing key ingredient Valsartan were recalled voluntarily by Indian and global generics makers, including Aurobindo Pharma, after traces of impurity N-Nitrosodimethylamine (NDMA) or N-Nitrosodiethylamine (NDEA) were found.
“That (carcinogenic impurities) was a batch specific phenomena. We are looking at it and we are investigating it. We will take appropriate decision on whether to accept it as a risk, whether to take some action on prescribing the product or whether to ban the product...we have a subject expert committee, we have chemical experts, we are going through all the things,” DCGI VG Somani told newspersons on the sidelines of the two-day International Regulators Meet organised by Pharmaceuticals Export Promotion Council of India (Pharmexcil) here.