Chennai, Dec 24 (IANS) Indian pharmaceutical major Torrent Pharmaceuticals Ltd is not facing any problem of impurities in its hypertension tablet Losartan manufactured and marketed in India like it faced in the US, said a senior official.
A couple of days ago the US Food and Drug Administration (USFDA) in a statement said: “Torrent Pharmaceuticals Limited is voluntarily recalling two lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.”
Queried about the recalling of Losartan tablets sold in India, Jayesh Desai, Executive Director told IANS: “Currently, we do not have this issue in India.”
“Pharmaceutical products go through testing processes to ensure safety. This impurity was recently detected and we have developed new method to measure it,” Desai added.
According to USFDA, the impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
To date, Torrent Pharmaceuticals Ltd has not received any reports of adverse events related to this recall, the statement said.
Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients.
Patients who are on Losartan should continue taking their medication as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment, the statement added.
Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication, the USFDA said.
–IANS
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