Of FDA, Ranbaxy and lessons for the Indian regulator

Since 2006, the biggest concern of Ranbaxy Laboratories has been to deal with an increasingly aggressive US Food and Drug Administration (FDA) —- from the time that the regulator found significant deviations in the manufacturing processes of products to be shipped to the US from India to now when it has pointed out lapses in manufacturing standards at its Ohm Labs unit at Gloversville in New York.

After a series of investigations and correspondence with the company, in 2008 the FDA finally took the drastic measure, prohibiting 30 products manufactured at Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh from entering the US.

As a result, Ranbaxy saw significant drop in sales losing nearly half of its revenues from that single market, abdicating its market share to smaller competitors and more importantly suffering an irreparable damage to its brand reputation.

Four years since, this is most certainly one of the longest periods of investigations against a particular company and due to the sensitivity of the subject, it becomes important to understand what actually are the concerns of the FDA and why it is taking a more-than-usual time to find a solution.

Ranbaxy’s Paonta Sahib plant is said to have falsified data on a range of products, while the Dewas unit faced similar but less intense allegations, and now Ohm is said to have deviated from manufacturing procedures which the FDA believes may lead to adulterated products in the market. Surprisingly, FDA allegedly found unapproved products made at Ohm being marketed in the US.

The example of Ohm could be quite damaging to Ranbaxy, particularly because this is the most recent one in flouting the standard Good Manufacturing Practices or GMP production and laboratory norms.

But many experts frown and ask whether the FDA is being overly tough on Ranbaxy compared with others. Unlikely, because if that were the case, could the same regulator have cleared two other, bigger units belonging to Ohm in the US last year?

Some believe Ranbaxy had enough reasons to put systems in place to avoid any unwanted confrontation with the FDA on quality parameters. But clearly, the controversy continues. FDA is said to have an enormous amount of data to back its claims on the Gloversville facility.

In some instances, it has brought out inconsistencies in Ohm’s
stability protocols. The FDA, in its warning letter questioned the stability program of the company because there are variations in the explanations submitted by the company. Among the many points that nails Ohm, FDA has found black particles in metformin drug but explanations furnished by Ranbaxy are clearly inexcusable.

It is indeed a poor reflection on how the company is dealing with an extremely serious condition. What is more curious is that the deficiencies at the Ohm facility has occurred with Daiichi-Sankyo in control of Ranbaxy.

Considering that the Japanese drug major has been steering the issue as a high priority program, the faults detected at Gloversville were least expected.

Another important point to note is that the FDA warning letter has been very critical of the corrective measures being taken by Ranbaxy categorising those as “inadequate” and hinted that it should take a comprehensive look at its global sites to comply with the US standards. It goes one step ahead cautioning of more legal actions like injunction and seizures.

Now, Ranbaxy has few options left. First, it has to work with the FDA proactively and supportively and try to understand the basic faults in its entire approach to the problem, check with the best consultants on how to resolve the situation and set standards that are so high it becomes the new norm for the industry. Ranbaxy had taken help from global management consultant PRTM but obviously the issues have gone too deep.

The good part about FDA is that it gives sufficient time for the companies to respond. The US regulator is taking every measure to ensure that trust is restored in the way it handles manufacturing compliance. Unfortunately, of the hundreds of pharmaceutical companies, it is only Ranbaxy that comes under repeated probes.

Clearly, the FDA wants to send out a signal to the world. Though it may be spare in terms of staff strength, it certainly does a great job of protecting its citizens from sub-standard drugs.

Notwithstanding the woes of Ranbaxy, the Indian drug regulator has a lot to learn from the FDA’s actions.

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