Post Ranbaxy episode, domestic pharma companies may face frequent inspections and deeper scrutiny. These companies need to ensure that not only their own quality and standards improve but also their vendors’ and service providers’.
The first sums up what it is that drives the FDA and the second is typical of the challenge the pharmaceutical industry faces.
(1) “The consent decree shows that FDA is serious about enforcing the manufacturing standards essential for safe and effective prescription drugs,” said John Taylor, Associate Commissioner for Regulatory Affairs at the FDA.
“It should also reassure the American people that we are doing everything we can to preserve the integrity of the American drug supply.”
(2) “FDA’s last inspection found Paxil CR tablets, approved to treat depression and panic disorder, could split apart. This deficiency could cause patients to receive a portion of the tablets that lacks any active ingredients, or alternatively a portion that contains an active ingredient and does not have the intended controlled-release effect. Additionally, FDA found that some Avandamet tablets, used to treat Type II diabetes, did not have an accurate dose of rosiglitazone, an active ingredient in this product."
Incidentally, both these quotes pertain to a consent decree signed by GlaxoSmithKline (GSK) in 2005.
The message is loud and clear. The USFDA has zero tolerance for manufacturing deficiencies. Compliance is a challenge for any company, whether Indian or American, generic or innovator.
The challenge is greater for an Indian company because the country for decades has lived and grown up in a regime with high levels of tolerance, whether it is drinking water, personal hygiene, food or medicine.
Hence, when an Indian company decides to operate under different and challenging standards, the entire organisation - from top to bottom - has to change its attitude to compliance.
This change demands compliance with not only technical standards but also ethical standards; it cannot be limited to one section of the organisation, for example manufacturing, but should be implemented across the organisation.
The attitudinal change requires time, patience and commitment from top management. Those companies that entered the US market early initiated these changes and are ahead of others.
Even early movers, however, have not yet been able to spread these changes across the entire organisation.
They are still in learning mode. They have done well so far; being driven by business ambitions, they will do better.
The Ranbaxy episode has underlined the loss of potential business opportunities if pharmaceutical firms do not change.
Hence, one impact of this episode will be greater focus on attitudinal changes to build quality organisations.
And building a quality organisation happens by design, not accident. It must be manifest in everything that one does - the plant layout, the equipment, the standard operating procedure, office ambience, and so on.
The improvement in the company’s standards and quality is not enough. It has to percolate through all its vendors and service providers.
This brings into the picture the “application integrity” issue.
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