USFDA alert on ranitidine: No major impact on exports yet, says Pharmexcil

G Naga Sridhar / M Somasekhar Hyderabad | Updated on September 27, 2019 Published on September 27, 2019

Drug makers evaluating issue, in wait and watch mode


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

GSK's response

When contacted by BusinessLine on the issue of Ranitidin,  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.

In his response a GSK spokesperson said: "GSK has been contacted by regulatory authorities regarding the detection of genotoxic nitrosamine NDMA in ranitidine products. Based on the information received and correspondence with regulatory authorities, GSK made the decision to suspend the release, distribution and supply of all dose forms of ranitidine hydrochloride products to all markets, including India, as a precautionary action pending the outcome of ongoing tests and investigations.

Subsequently, Saraca Laboratories Ltd was notified by the European Directorate for the Quality of Medicines (EDQM) that its certificate of suitability for ranitidine hydrochloride had been suspended with immediate effect. 

As a precautionary action, GSK said it had initiated a voluntary recall (at the pharmacy/retail level) of Zinetac Tablets 150 mg and 300 mg products manufactured in India using API sourced from Saraca Laboratories Ltd.

"The product, manufactured using an API from SMS Lifesciences will not be recalled from the market at this point. However, all such products will remain on hold and they will not be released to the market while we await the test results," the spokesperson said.

"GSK is continuing with investigations into the potential source of the NDMA. These investigations include continued engagement with our API suppliers. Patient safety remains our utmost priority and we are taking this issue very seriously,” he added.

Dr Reddy's response

Asked about the impact of the alert, pharma major Dr Reddy’s Laboratories told BusinessLine: “We expect to provide an update in the coming days.”

Dr Reddy’s, which had stopped shipments of the drug worlwide after the USFDA alert, has both a prescription and over-the-counter portfolio of the product.

An executive of a major Hyderabad-based producer of APIs for the drug said that as the USFDA had not asked individuals to stop taking the drug, production was still on, but had “slowed down.”

Hyderabad-based SMS Pharmaceuticals, which makes the drug, did not respond to a query on the impact, while Granules India Ltd, which has a licence, has minimal exposure in the market to react now. Saraca Pharma, another Hyderabad-based, API maker, has also been featured in reports.

Pharmexcil’s take

According to R Uday Bhaskar, Director-General, Pharmaceutical Export Promotion Council (Pharmexcil), a few drugmakers had made a presentation before Indian drug regulators a couple of days ago and presented their version.

“We have significant exports of the drug. But there is no major impact as yet, and we are closely monitoring the situation,’’ he said.

The Drug Controller General of India ( DCGI) has also directed State drug regulators to take up sample studies wherever required and the process is on.

The USFDA had also said it was working with global regulators and industry to determine the source of this impurity in Ranitidine and was examining levels of NDMA in it, and evaluating any possible risk to patients.

Dr Reddy’s had also advised consumers and healthcare professionals to report any adverse reactions with Ranitidine to the FDA’s MedWatch programme to help the agency better understand the scope of the problem.

Published on September 27, 2019
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