USFDA Alert On Ranitidine: No Major Impact On Exports Yet, Says Pharmexcil

As the ring of suspicion on quality concerns over heartburn drug ranitidine continues to linger and more companies recall the blockbuster drug, both drugmakers and millions of consumers are keeping their fingers crossed.

- G Naga Sridhar M Somasekhar

On September 13, the USFDA had issued an alert that indicated traces of N-nitrosodimethylamine had been found in the popular drug.

Leading drugmaker such as Novartis and GSK have recalled their versions of the drug in some markets, and many smaller players, both in the APIs and formulations, are in wait-and-watch mode. Dr Reddy’s has suspended shipments of the drug worldwide.

While the drug, popularly indicated for acidity, has been sold without any issue in pharmacies so far, companies that have it in their over-the-counter portfolio as well as Active Pharmaceutical Ingredients (APIs) are still evaluating the impact.

When contacted by BusinessLine on the issue of ranitidine, pharma major GlaxoSmithKline Pharmaceuticals Ltd (GSK) responded by saying that it has initiated a voluntary recall of some Zinetac tablets from retail sales.

GSK manufactures Ranitidine Hydrochloride IP Tablets 150 mg and 300 mg (Zinetac) using an API from Saraca Laboratories Ltd and another supplier, SMS Lifesciences India Ltd, for supply to the Indian market.

GSK's response