Comment

Pharma major may have erred in not taking timely remedial action.

What’s coming next for Ranbaxy? That’s the most common question among pharmaceutical professionals these days, not just in India but in several MNCs. First, the US Department of Justice charged the company with serious deviations from manufacturing standards as laid down under US laws. And then, after three years of investigations, the US Food and Drug Administration (US FDA) blamed Ranbaxy for lapses on several quality and operations parameters and handed out a warning notice and a ban on 30 drugs manufactured by it.

Though the industry seems to be non-committal to the treatment meted out to the largest Indian drug maker, the US FDA cannot be faulted as its actions have culminated after microscopic investigations at Paonta Sahib and Dewas over the last three years. By its reputation, the US FDA makes all its decision on the basis of strong and unquestionable data and is likely to have sent warning notices, pinning down Ranbaxy blow by blow.

And it’s not by sheer coincidence that Ranbaxy is facing the music from the US drug watchdog. After the fiasco of contaminated Chinese Heparin that allegedly killed a few American patients not very long ago, the agency has come under severe attack from John Dingell, chairman of the US committee on energy and commerce and Bart Stupak, chairman of its sub-committee on oversight and investigations. That’s not all. A strong US lobby has also asked for a raised budget to ably fund the US FDA and lace it with more investigative tools.

One of the agency’s recent actions also includes prohibiting certain products manufactured from an African site of the world’s second-largest generic drug producer, Sandoz. That indicates the US FDA has nothing motivated against one particular company. In fact, so stiff has the agency been in its new drug approval processes that many big pharma companies have subtly voiced their concern about its stringent examination processes. They go to the extent of blaming it for their thinning drug pipelines. For 2007, the US FDA approved only 17 new drugs - the lowest figure since 1983. Surely, the regulator has learnt all its lessons ever since Vioxx happened.

So, why is it that Ranbaxy is facing the US FDA’s ire even as the agency has clearly mentioned in its statement that it has no evidence to date that Ranbaxy has shipped defective products? Perhaps the US FDA wants to do damage control to revive its waning reputation yet again as the strictest regulator.

The US FDA’s September 16 warning notice to Ranbaxy spoke about multiple serious deficiencies at Dewas. The specific areas include beta-lactum containment programme and inadequacies in batch production and control records, failure investigations, quality control programme and aseptic operations. Those working in QA/QC departments in the drug industry would understand that these lapses are anything but minor. The FDA does the nit-picking at every stage and companies which encounter these routine examinations or audits on a weekly basis know that compliance is of utmost importance to those examiners.

The same warning notice refers to a Ranbaxy response dated April 3, 2008 and specifies a particular point of dissatisfaction. It says that Ranbaxy was aware that beta-lactum compounds such as penicillin and penems have human sensitising and cross-reactivity properties that require manufacturing controls to prevent cross-contamination of non-penicillin products in the company’s multi-product manufacturing campus. These rectifications may not have been very tough for a company of Ranbaxy’s size. The big question is why it took so long to comply with the Inspectional Observations or FDA 483s that the agency issued at the first instance of plant examinations.

Now there is news that even Health Canada, MHRA and a few other regulators are considering a close inspection of Ranbaxy’s plants. The sooner Ranbaxy acts, the better placed it would be to stem the tide of negative news and a resultant loss of reputation for the company as well as the country.

Pillman is an executive closely linked to the global pharma industry.