Hyderabad: The Drug Controller General of India (DCGI) on Thursday confirmed that the drug, Valsartan, which is used to treat blood pressure and heart failure, is under inspection for carcinogenic impurities.
With several lots of the drugs voluntarily recalled by multiple drug companies due to the "presence of traces of impurity" in the US market, the move will be eagerly watched by all Indian pharma firms.
Speaking on the sidelines of an annual event organised by Pharmaceut-ical Export Promotion Council of India (Pharmexcil) in Hydera-bad, V.G. Somani said, "That (the carcinogenic impurities) was a batch specific phenomena.
We are looking at it and we are investigating it... And we will take appropriate decision on whether to accept it as a risk, whether to take some action on prescribing the product or to ban the product."
He said the Central Drugs Standard Control Organisation was carrying out the investigation. However, the pharma firms can breathe easy as Mr Somani said the impurities were not found during the initial approval process of the product....