The Hindu Business Line : ‘Ranbaxy’s epilepsy drug recall may not attract lawsuits’

Pointers
FDA says company voluntarily recalled all lots at retail level.
Recall of 73 m tablets may cause Rs 4-crore loss, say analysts
Medicines were made at Ranbaxy’s plant in Simour, Himachal Pradesh.

P.T. Jyothi Datta

Mumbai, Nov. 23 Ranbaxy’s recent voluntary recall of epilepsy drug gabapentin in the US is unlikely to trigger consumer lawsuits against the company, say industry representatives, drawing a distinction from the high-profile recall of Merck’s pain drug Vioxx in September 2004.

The recall of Gabapentin tablets by Ranbaxy was a Class III recall, the industry representative said. And the regulatory US Food and Drug Administration (USFDA) defines a Class III recall as: “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”

In the case of Merck’s Vioxx recall, recent reports say that the company has agreed to fork out $4.8 billion to settle legal suits filed by consumers who claim to have been directly or indirectly harmed by the consumption of the recalled drug.

Examples this year

Recalls are not unfamiliar to the pharmaceutical industry and some of the examples this year include the recall of contaminated batches of HIV-drug Viracept by multinational drug major Roche and the recall of Novartis’ irritable bowel syndrome medicine Zelnorm due to heart-attack and stroke-related risks.

In Ranbaxy’s case, the USFDA said that the company had voluntarily recalled all lots of its 600 mg and 800 mg gabapentin tablets at the retail level as the product may have exceeded the impurity specification for related substances during shelf life.

While analysts are divided on the financial impact the recall of 73 million tablets would have, they point out that gabapentin is a difficult product to make, with stability-related issues. Some analysts point out that the company may take an estimated Rs-4-crore-hit on the recall, with another three months of inventory also standing to be affected.

But others point out that the estimate could be larger, since a few months inventory must be already in the pipeline. No comments were, however, available from the company.

There is no clarity yet on whether the recalled medicines will be destroyed, and on whether the problem was created by sourcing, the process of formulating the medicine or during actual manufacturing, an analyst said.

The recalled medicines were made at Ranbaxy’s plant in Simour, Himachal Pradesh. And if the recall was manufacturing-related, it may draw the FDA attention to the site, the analyst said.

This recall makes it the third US-related incident that Ranbaxy has been faced with in the recent past, the analyst said, referring to concerns raised last year by the USFDA on its HP-based Paonta Sahib plant and raid earlier this year at Ranbaxy’s Princeton office in New Jersey.