Time for DCGI to respond

We in practice are confused about “sartans” (ARBs or angiotensin receptor blockers). Every other day, a preparation is withdrawn from the market.

Now Torrent Pharmaceuticals Limited  is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The Recall is expanded to include an additional 36 lots of Losartan Potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP.

The impurity detected in the API is N-Methylnitrosobutyric acid (NMBA). Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA.

The Drugs Controller General of India (DCGI) should act to ensure availability of such information on its website. The safety profile of all internationally debated drugs should be updated to keep up with the latest developments.

Today, most patients come to know of such controversies through Google and they begin to question their doctor.

As doctors we need to talk in “one voice” and that to what the DCGI has conveyed to us.

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