US FDA issues import alert for key Ranbaxy products

The US FDA has issued two warning letters to Ranbaxy Laboratories and an import alert for generic drugs produced by the company's Dewas and Paonta Sahib plants in India. The warning letters identify the Agency's concerns about deviations from US cGMP requirements, while the import alert covers more than 30 different generic drug products produced in multiple dosage forms at these two locations.

While the FDA noted that it was confident that other manufacturers could meet market demands, and no product recall had been issued, the Wall Street Journal has reported that some drug stores are looking for alternative suppliers and were nervous that if they did switch they would be liable for cost increases due to contract provisions. Meanwhile, other countries have started to look at bans. In New Zealand, for example, the Health Ministry's drug regulatory arm has said that it was checking with regulators abroad to see if audits since then had given it a clean bill of health, though like the FDA it noted that there were no concerns about the medicines themselves and that users should continue taking the drugs.

This is not the first time that Ranbaxy has been in hot water with US regulators, and represents the second time in less than three years FDA has issued a Warning Letter to Ranbaxy. In 2006, FDA cited the Indian firm for violations of US cGMP at its Paonta Sahib facility. Since then, Ranbaxy has been attempting to resolve the issue with US regulators. However, in 2007, US officials seized documents from Ranbaxy's US headquarters in New Jersey. Furthermore, in July 2008, the US Department of Justice claimed that the company submitted false information about stability and bioequivalence to support ANDAs for antiretrovirals distributed by the President’s Emergency Plan for AIDS Relief (PEPFAR) programme. Prominent Congressmen on the US House Committee on Energy and Commerce indicated at the time that they would commence a formal investigation into the Ranbaxy drug approvals and potential violations of GMP regulations.

Daiichi Sankyo, which agreed to acquire the majority of the voting capital of Ranbaxy in June, has yet to comment on the latest events, though both firms have previously stressed that the share purchase agreement is binding and final. North America is a significant market for Ranbaxy, however; the region constituted around 26% of the firm’s revenues in 2007. Ranbaxy is already looking aggressive in its attempts to overturn the FDA’s ruling, enlisting former New York mayor Rudy Giuliani to represent it in Court in an attention-grabbing move. Nevertheless, the firm may need more than PR to help it out of its current predicament.

Jonathan Way - Editor, World Generic Markets

Counterfeit definition debate causes concern in India

World Health Organization attempts to introduce a broader new definition of counterfeit medicines have come under fire from the Indian government. A draft resolution on the new definition was presented at the 61st World Health Assembly in May 2008; this has been the subject of intense discussion, as was a WHO Secretariat report on the matter. The change from the current terminology has been promoted by the International Medical Products Anti-Counterfeiting Taskforce, a WHO unit set up in 2006.

The new definition could cause the registration of drugs in various territories to be an issue, as countries could link the issue of substandard drugs with intellectual property infringement. A major concern of the countries such as India is that legitimate generic medicines may become targets in the enforcement of counterfeit goods. According to a Business Standard report, the Indian Pharmaceutical Association has expressed concern that generic medicines that are legal in some countries could be classified erroneously as fake. This, combined with tougher enforcement of intellectual property rights elsewhere in the world, could mean that goods passing in transit may be seized for being fake, on the grounds that they are not registered.

A decision on the matter is unlikely before May 2009. Before then however, the office of the Drug Controller General of India is likely to come up with its own definition to promote to the WHO; this would incorporate recommendations from domestic manufacturers and is therefore unlikely to be a radical departure from the existing definition.

Perhaps of even more concern to India and other countries in the South Asia region is the new Anti-Counterfeiting Trade Agreement (ACTA) being negotiated between the United States, the European Union, Japan, South Korea, Canada, Mexico, Australia and New Zealand. By negotiating between themselves, these countries could undermine the WHO discussions and could simply ignore India’s objections. Treaty negotiations are still at a preliminary stage however, and no draft has been released to date; while this is a good sign for India that agreement is still not close, the secrecy will not help to allay its fears.

Jonathan Way - Editor, World Generic Markets