Like a bad knock-knock joke, the FDA is reportedly considering surprise visits to manufacturing plants in India in hopes of mitigating the over-the-top violations that continue to make headlines. Whether surprise inspections will do much to change practices significantly is uncertain at best, but the real issue is the extent to which Indian drugmakers understand that the FDA is sending a serious signal.

Consider events of the past year or so. The FDA recently issued yet another import alert to Ranbaxy Laboratories, this time for a facility in Mohali, India, not long after the drugmaker agreed to pay $500 million to the U.S. Department of Justice to settle criminal and civil charges associated with an eye-opening manufacturing scandal involving two other plants in India. A consent decree is still being enforced.

Then there is Wockhardt. The Indian drugmaker was recently banned from making drugs for Europe and the UK’s Medicines and Healthcare Products Regulatory Agency has twice issued recalls for a total of 16 drugs, citing manufacturing concerns at different plants. And last May, the FDA issued an import alert that effectively banned several drugs from entering the U.S. following a failed inspection.

In fact, so far this year, more than 20 manufacturing factories across India were barred from supplying medicines to the U.S., according to FDA data cited by The Business Standard. If this sounds like a lot, consider that, during the same period, Chinese drug manufacturing facilities faced seven FDA import alerts; Australian, Canadian and Japanese units had two each; and South African and German sites had one each.

This is a dubious distinction. And the timing could not be worse, given that the Indian pharma industry has become a key supplier of low-cost generic medicines as more and more countries struggle to contain healthcare expenses. Of course, such opportunity also brings challenges, including the ability to successfully balance quality control with accelerated production. Indian drugmakers accounted for 37% of Abbreviated New Drug Applications in 2012 and 12% of FDA warning letters, according to the Indian Pharmaceutical Alliance.

Whatever the reasons for the larger number of FDA actions taken against facilities in India, the problem would appear to be systemic. This is not to say serious quality control issues do not occur in other countries. The FDA, of course, regularly cites plants in numerous countries, including in the U.S., and some of these belong to the world’s largest drugmakers.

Moreover, individual companies run afoul of the FDA by violating regulations at multiple facilities scattered around the globe. Novartis has been a notable example. During the past two years, the agency has found infractions at plants run by its Sandoz unit in Canada and two others in Colorado and North Carolina in the U.S. The drug maker was also scolded by the FDA for gaffes in Austria and Lincoln, NE, prompting a managerial shake-up and new edicts about a commitment to quality.

Look around. There is no shortage of manufacturing ills. But Indian drugmakers seem to be pushing the proverbial envelope. During an inspection at Wockhardt last March, an FDA investigator spotted torn raw data records in the waste area and asked a quality assurance officer to remove the documents for review. The employee returned with about 20 papers, none of which included raw data entries that were seen in the waste area and, when asked three times, had insisted “this is all of the records.”

So what happened next? The FDA investigator returned to the waste area and found that the documents — which contained worksheets from anti-microbial effectiveness studies, master batch records and stability protocol records — had been placed in a different holding bag. This stalling tactic — which was, essentially, an amateurish game of cGMP hide-and-seek — was written up by the inspector as a deliberate attempt to delay the inspection.

Such behavior is not confined to drugmakers in India, of course. In fact, the FDA recently issued a draft guidance that says products can be considered adulterated when a facility will not agree to a proposed inspection start date and does not give a reasonable explanation for its failure to do so; or after scheduling an inspection, a facility requests a later start date without giving a reasonable explanation, and fails to respond following FDA’s attempt to contact the facility’s designated contact.

How one defines “reasonable” will, no doubt, cause considerable haggling and earn sizeable fees for attorneys. But the draft was clearly prompted by agency frustration over more episodes of recalcitrant managements. Yet given the track record displayed by some Indian drugmakers, no one should be shocked that the FDA plans surprise inspections. In fact, this form of oversight is nothing new in the U.S. and other developed countries, but the FDA has struggled to find ways to get tough with foreign companies ever since the heparin scandal a few years ago.

Since then, the agency has been on the defensive following attacks by Republicans in Congress for not doing more to push the Chinese government to cooperate with its oversight efforts. This past summer, for instance, the issue threatened to turn into a diplomatic spat after the agency encountered an ongoing delay in obtaining visas for FDA staffers to work on a long-term basis in the country.

In some respects, though, one could argue that Indian drug makers have practically begged for this added attention. And Ranbaxy unquestionably set the tone. That drugmaker, you may recall, was charged by U.S. officials with using raw chemicals from unapproved sources, fabricating in-house test data to meet FDA standards and concealing these activities from FDA inspectors by falsifying records.

Still worse, Ranbaxy perpetrated a nearly decade-long cover-up in order to boost profits and maintain its edge as a leading purveyor of low-cost generics to the world. Scientists were reportedly ordered to manipulate data; other employees were forced to illegally carry supplies of brand-name drugs to India and duplicitous statements were allegedly issued by high-ranking executives.

Of the $500 million settlement, $350 million went toward settling a civil lawsuit that claimed Ranbaxy caused federal healthcare programs — Medicare, Medicaid, Tricare, the U.S. Department of Veteran Affairs and the U.S. Agency for International Development (USAID), which administers the President’s Emergency Plan for AIDS Relief, or PEPFAR — to overpay for medicines. The FDA did not issue recalls, but one has to wonder about the veracity of Ranbaxy medicines that some Americans were taking.

Now consider the insights gained by Dinesh Thakur, a former Ranbaxy employee who became a whistleblower and worked with U.S. authorities in dissecting the mess. “With the big sourcing from global locations, there has to be a process to verify the quality. There is a lot of focus on cGMP violations,” he told us earlier this year. “The Justice Department came out earlier this year and said it will be an area of enforcement for them.

“The FDA global initiative is on track to address this problem. And Congress gave FDA resources to bring (overseas) manufacturing facilities on par with what exists in the US. I think we need to have strengthened rules so that companies know they are going to get caught. . .  The challenge in this particular case was because they knew they could get away with it.”

And this statement is crucial: At Ranbaxy, he continued, “they knew ahead of time the FDA inspector was coming to Paonta Sahbi (one of the plants that was at the heart of the controversy and is subject to the consent decree). If you take that comfort away, they will know they will be subject to the same standards before they do that kind of nonsense.”

Clearly, his observations made an impact on the FDA, which is now trying to translate the notion into a ‘boots on the ground’ strategy. Certainly, this makes sense, if only because surprise visits do hold the potential for altering behavior. And the agency is likely to make examples of some of the larger drugmakers in hopes of sending a strong signal that lax and indifferent behavior is not acceptable.

There are finally indications that the FDA is being taken seriously. Recently, the Indian Pharmaceutical Alliance, which represents the domestic drug manufacturing industry, Ranbaxy, Wockhardt and Lupin, has approached the FDA for a meeting to understand the issues that have prompted regulatory concerns, according to The Business Standard.

Whether a dialogue is sufficient is a big unknown. For now, though, surprise inspections are not enough. The FDA is, more than likely, going to have to follow up these unscheduled visits with something more than 483 reports and warning letters. The real change will come with consistent enforcement actions, whether these involve declaring that one or more drugs is unadulterated or issuing an import alert. FDA inspectors, after all, cannot be ex­pected to play hide-and-seek with key documents all the time.

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Ed Silverman is a prize-winning journalist who has covered the pharmaceutical industry for The Star-Ledger of New Jersey, one of the nation’s largest daily newspapers, for more than 12 years. Prior to joining The Star-Ledger, Ed spent six years at New York Newsday and previously worked at Investor’s Business Daily. Ed blogs about the drug industry at Pharmalot, at www.pharmalot.com. He can be reached at ed.silverman@comcast.net.