For those outside the pharmaceutical industry, it was a revelation of sorts when action from foreign drug regulators several years ago outlined some of the transgressions seen among local drugmakers.
Some of them were sheer hygiene issues such as dirty glasses or open drains. In later years, as the domestic pharmaceutical industry took measures to control this, the regulatory action focussed on documentation issues and data integrity.
At a recent pharma industry conclave on quality, industry-watchers observed that the Indian pharmaceutical industry was indeed moving up that evolution curve, with regulatory issues now being centred more on root-cause analysis. Some regulatory experts hold short of endorsing that view entirely; they prefer to wait for more data over the years before making that call.
Having worked closely with the industry, Vikas Bhadoria, Senior Partner with consultants McKinsey & Company, observes that “everytime the FDA raises a theme of issues, it takes industry about two to three years to get up to speed.” That's the evolution curve among US facilities as well, he adds.
Then and now
About seven years ago, when the United States Food and Drug Administration (USFDA) started doubling down on Indian facilities, its findings were almost basic — like paint peeling, says Bhadoria. Companies went through a round of these observations, started keeping track of details on their plants and those of their peers, and gradually much of it got ironed out, he adds.
The challenge then was data documentation. This stemmed from companies having manual records: “there used to be data rooms with batchfuls of records,” he recollects. But about three-four years ago, companies started going electronic and becoming watchful about entries made in their records, says Bhadoria.
The next level of deviation involves how companies are handling lab and manufacturing issues and preventing them from occurring again, he says. The domestic drug industry is now going through massive training exercises and capacity-building to tackle this, he says, explaining observations made at the recent IPA Quality Forum organised by the Indian Pharmaceutical Alliance (a platform of large Indian drugmakers), along with a handful of foreign and local drug regulators.
Data still priority
Howard Skalmberg, former USFDA Deputy Commissioner for Global Regulatory Operations and Policy, counters that the FDA continues to emphasise data integrity. His response was to observations that the evolving curve of drug companies had to do with the evolution of the FDA as well.
“A drop in the percentage of 483 observations or warning letter citations mentioning data integrity does not indicate that the FDA has shifted priorities. The agency’s priorities remain the same, but it is finding a smaller percentage of data integrity violations even though it is a priority,” says Sklamberg, now Partner at Akin Gump Strauss Hauer & Feld LLP.
Strong and weak records
The US market is the largest for drugmakers. And its regulatory data provide a benchmark given the transparency and analytics involved. Gleaning from that data, Bhadoria points to the fewer inspections last year, though its frequency had gone up. The interesting part is that OAIs (offical action indicated) have gone down, he says.
Sklamberg agrees that the reduction in warning letters from India is encouraging. “I would hesitate to draw too large a conclusion from one or two years of data. The number of warning letters FDA issues is relatively small, so it is possible for percentages to vary a lot based on just a few inspections. The best indicator is a long-term trend. But the reduction is encouraging,” he adds.
Referring to comparisons with China where the rate of OAI inspections was relatively high, Sklamberg disagrees with categorisations by country, “Indian firms” or “Chinese firms”.
“I think that is inaccurate and not fair to the individual firms. There are firms with strong records and weak records in every country the FDA inspects, and the FDA judges each firm individually. Indeed, in my time at the FDA, the biggest pharmaceutical safety issue it dealt with was the 2012 meningitis outbreak, which was caused by an American firm,” he says, calling for more action that makes medicines safe, geography notwithstanding.
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