FDA bans 30 Ranbaxy drugs; rules out fresh approvals

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New Delhi, Sep 17: The US Food and Drug Administration, in its biggest action against an Indian pharmaceutical company, has banned over 30 generic drugs manufactured by Ranbaxy Laboratories Ltd (RLL) from entering the US borders.

FDA has also ruled out approval to any new Ranbaxy’ drugs for now.

Ranbaxy, India’s largest pharmaceutical company, has recently been bought over by Daiichi Sankyo of Japan, making the combined entity the fifteenth largest pharma in the world. Incidentally, Ranbaxy and Pfizer have recently settled a suit to market a generic version of the latter’s anti-cholesterol drug Lipitor in the US and other markets.

The US drug regulator termed the ban as a preventive measure to ensure that the company fixes its record keeping and alleged procedural irregularities at two of its manufacturing facilities in India- at Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh. However, FDA has simultaneously labelled the Ranbaxy drugs currently on sale as “out of danger” and urged consumers not to panic and stop having them, as repeated sampling of products made at the two plants shows no reasons for concern.

FDA said that procedural violations concerned the manufacturing process and not the drugs themselves. New approvals will be on hold until these violations are resolved, FDA said. The problems at the two locations first surfaced in 2006. Ranbaxy had US sales of $340 million in 2007 and $230 million in the first half of this year.

The market reacted nervously to the developments, with Ranbaxy shares losing 6.60% on the Bombay Stock Exchange (BSE) to close at Rs 379.10. The shares had hit an intra-day low of more than 10%.

The import ban will impact many widely used medications, including generic versions of anti-cholesterol drugs simvastatin & pravastatin, antibiotic ciprofloxacin & clarithromycin, the antiviral acyclovir, diabetes therapy metformin, the over-the-counter version of allergy drug loratadine, along with many AIDS medications.

An exception has been made in the case of AIDS drug ganciclovir because of a supply shortage. Analysts say it is difficult to assess likely losses to Ranbaxy since the ban is for an unspecified duration. Also, Ranbaxy operates from manufacturing facilities located in 11 countries while the ban is understood to be on products from the suspect factories in the two Indian locations. However, the two manufacturing facilities account for a substantial part of the total production.