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focus on quality
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A Review Of Us Fda Site Inspections In India Reveals Strong Focus On Quality
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A Review Of Us Fda Site Inspections In India Reveals Strong Focus on Quality

A recent study looking at the findings from site inspections conducted by the United States Food and Drug Administration over the past seven years displays India in a surprisingly good light, despite some of the negative press coverage and misconceptions about the market. In fact, Indian sites are holding up well against the criteria set by one of the worlds most critical regulatory bodies. What is not well-known, is that many of the research sites and service providers in India are trained on and operate along India Good Clinical Practice IGCP guidelines. These guidelines match and go beyond those set by the International Council on Harmonisation. This approach appears to be showing up in the results on the inspections

In total, just over thirty inspections were completed during the seven year period and included in the analysis. At the time of this article publishing, there had not been a single OAI finding by the FDA at Indian sites across any of the inspections. Such a finding is a black mark for any site which receives one and is the most negative of the findings which can be levied by the agency during an inspection. Summarized in the bullet points below are some of the high level findings from this study:

• USFDA inspections started in India in 2005

• 30 site inspections were conducted between 2005-2011

• Inspections have been conducted for 10 therapeutic areas

• Inspections have been for DA (data audit) – the focus of such audits is verification of study data

• All data formed part of USFDA NDA Submissions

• The inspections also included review of local Informed Consent Forms and Ethics Committees

• Excel Life Sciences was involved in managing 4 of the sites inspected

Results:

  • Not a single OAI (Official Action Initiated) called to-date
  • 53% of cases had a NAI (No Action Initiated) classification
  • 47% of cases had a VAI (Voluntary Action Initiated) classification

There has been unprecedented growth in the contract research and contract services market in India during a very short time period. The respected global consulting firm PRTM puts the number of CROs operating in India at some 175 today. This in a market that is really only about 9-10 years old at most as it relates to participation in global clinical trials. Compare that to Europe and the US which have been doing global trials for decades and it becomes even more impressive. Of course, with that growth comes the tremendous need for oversight, guidelines and legislation to ensure that credible organizations are conducting trials according to international standards and that patients rights are being protected.

The acceptance of ex-US data and the dramatic growth in the submission of foreign data as part of USFDA marketing applications has got the FDA a little spooked. In the past decade the agency has received criticism for how little oversight they have been able to achieve and for drug safety problems and now the potential problem has been magnified several times over again.

In response, the FDA is mobilizing a greater number of resources, setting up operations in other countries and putting pressure on local regulatory bodies in those countries to enact tougher guidelines. Likewise, local regulatory authorities, concerned about the number of studies of foreign compounds taking place within their borders have also established tougher standards and guidelines.


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