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Indian pharma industry calls on US FDA to conduct virtual inspections in the wake of COVID-19 pandemic: Dr Sandhu

Yash Ved, Mumbai
Monday, October 26, 2020, 08:00 Hrs  [IST]

Indian pharmaceutical industry has called on the US FDA to consider conducting virtual inspections of their plants and facilities in the wake of COVID-19 pandemic.

The shift from physical to virtual inspections would certainly ease the challenges and smoothen the continued availability of life-saving medicines, which would involve a significant transition which, when made possible, would be a giant step in embracing the post-COVID-19 scenario, stated Dr Gurpreet Sandhu, president, Council for Healthcare and Pharma & Founder Reva Pharma.

The virtual inspection can be slightly more challenging for the highly toxic products manufactured in contained facilities due to limited visibility of internal infrastructure used despite having windows in place. The additional physical inspection may be added for ensuring the safety of products, but this may delay the approval and launch of life-saving drugs.

With COVID-19-enforced imperative to protect its personnel, the US FDA had suspended physical inspections in March and indicated towards late July that it was looking to restart domestic inspections.  

In view of the sheer severity of the ongoing pandemic, the US FDA has proposed a series of alternative tools of inspection such as product sampling at borders, summoning of records in advance, examination of a company’s compliance history and even making use of information shared by other governments as part of mutual recognition and confidentiality agreements.

Dr Sandhu added that unlike the physical surveillance inspection in which trained drug inspectors make a physical visit to plants, virtual inspections would involve deploying advanced IT, internet, and video technologies for an inspector to make an assessment.

India has not only traditionally been one of the largest suppliers to the US meeting 40% of the latter’s generic demand, it has emerged as a critical source for COVID-related medications.

Even assuming that the US FDA would have the best technology options available at its end, the Indian plants and facilities – some of them located in the remote areas of the country – would need an upgrade so that the two systems are able to communicate and engage with each other seamlessly for an immaculate inspection, stated Dr Sandhu.

“Since COVID-19 came unexpectedly, there has been no prior technological arrangement between the US FDA and the designated manufacturing plants, putting in place a remote inspection and assessment architecture. The alignment of technologies, platforms and standards along with data protection and confidentiality measures must be speeded up because of the efficiencies and rigour that this arrangement can potentially achieve”, added Dr Sandhu.

The appeal by the Indian pharmaceutical industry may be worth exploring at this juncture because of the substantial improvement and upgradation of infrastructure achieved by it in the last decade.

Dr Sandhu added that the integrity of the whole process would in the end be contingent on the integrity and the intent of the pharma manufacturers whose plants are under inspection. As a result, the credibility of a virtual inspection is likely to depend on the veracity of a few random physical inspections so that the transition to the new process can be embedded as a norm for posterity.

 

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