Reports of widespread cGMP noncompliance at various Indian pharmaceutical companies raise awareness on the need for one quality standard for both developing nations and those with stricter regulations.
As developing nations grow their pharmaceutical and biopharmaceutical industries, awareness is growing of the fact that some economies have two tracks for quality, one for domestic consumption and the other for exports to nations with stricter regulations.
This came to a head last year, with reports of widespread cGMP noncompliance at various Indian pharmaceutical companies. An FDA inspector’s repeated questions led some staffers at one company (you know the one) to tear up documents and try to hide them and even throw samples down the drain. There was the rampant backdating and fictionalizing of lab notebooks. And then there was the indelible image of the reused plastic gloves in an aseptic environment. And that other company, whose European owners simply fired, or threatened to fire, everyone involved in the inspection snafu.
Sometimes wires are crossed, and exported materials aren’t up to snuff, either.
As we all know, it takes time to build the kind of quality culture needed to make patient safety the real priority. And that can be difficult when there is tension, or if there are gaps in authority between central and local regulatory offices. We saw that with the compounding tragedy in the US.
Then there is the problem of quanxi, or its equivalent, which has led to serious lapses in ethics at so many companies operating in emerging markets.
Some Indian companies that were hit with import bans and warning letters last year took serious actions, hiring former FDA experts and others to help them establish stronger quality and compliance cultures. But that was just the larger companies.
Historically, it is stark and terrible events, such as death, that lead to change and to tighter regulations. Will the recent deaths in India, which may be connected to the use of contaminated antibiotics at the Bilaspur sterilization camp, be a wakeup call to India’s regulatory authorities to enforce stricter standards and exact stiff penalties?
So far, executives of two manufacturing companies have been held for questioning. One of the companies had its manufacturing license revoked two years ago for quality problems, but was then quietly allowed to get back into business. The company has denied any wrongdoing and insists that the medications were not contaminated, reported Fox News.
We’ll see how the story unfolds, but it has raised questions about how India regulates its drug manufacturers. In the recent past, we had heard that India’s central regulatory body would be assuming more authority. In reality, some see a very different picture. What is clear is the fact that India’s growing middle class is demanding quality and will expect it from drug suppliers. Will suppliers be ready?
Dinesh Thakur, now chairman of Medassure Global Compliance Corp., who blew the whistle against Ranbaxy’s questionable quality practices in the landmark US Department of Justice case, recently wrote this op-ed in India’s newspaper, The Hindu. He calls for a more proactive approach to enforcement at the top level, a Cabinet-level appointment to head India’s drug authority, and more enforcement power.