Synopsis
And for good reasons. As of June 2021, the FDA had a backlog of over 2,500 foreign inspections, including nearly 500 and 400 in India and China, respectively. Given the current process of physical inspection, it is highly taxing on the inspectors, and the logistics make it a far from effective use of time, money, and resources.
After a pandemic-induced break of nearly two years, the US Food and Drug Administration (FDA) has announced the resumption of physical inspections of foreign manufacturing facilities starting April. These inspections bring back the ghosts of quality and compliance issues for the Indian pharmaceutical industry. At the same time, the postponement has also brought some Congressional scrutiny to the FDA’s ‘Foreign Inspection Program’, largely from an operational perspective.
And for good reasons. As of June 2021, the FDA had a backlog of over 2,500 foreign inspections, including nearly 500 and 400 in India and China, respectively. Given the current process of physical inspection, it is highly taxing on the inspectors, and the logistics make it a far from effective use of time, money, and resources. Moreover, such delays have a serious impact on the approval and supply of essential drugs for patients.
As part of a complex ecosystem, the pharma industry is an integral part of the process to ensure the supply of high-quality drugs for the patients. And yet, it remains a big challenge, particularly for the Indian pharma industry. Of the 712 inspections carried out by the FDA at Indian manufacturing sites between 2018 and 2020, as much as 14.6% of inspections were classified as official action required (OAI), which even more than China’s.
So, how can industry be prepared for virtual inspections that now seem inevitable? Short answer: technology. But the longer answer is as much cultural and behavioural -the adoption of digital tools and services, the viability and acceptance of remote working, and the complete digital transformation of manufacturing. Equally important are the advances in Industry 4.0 applications and interactive communication that enable a virtual workplace to emulate offline experiences.
From 3D glasses and AR/VR (augmented reality/virtual reality) headsets that mimic real-time walkthroughs, ‘digital twin’ solutions enabled with the Internet of Things (IoT) and artificial intelligence (AI) for real-time quality monitoring, or deploying chromatography to set up analytical data review processes remotely – tremendous opportunities have opened up to support regulatory inspections. Offering a similar immersive and interactive experience while securing the integrity of sensitive data ..
From a manufacturers’ perspective, digitalisation of operations can go a long way in strengthening India’s position as the ‘pharmacy of the world’ by delivering benefits across the value chain. It can help pharma companies address one of the biggest challenges from a compliance perspective – data collection, integrity, and documentation. Furthermore, blockchain-based technology for real-time geolocation and biometric tracking capabilities have proven to facilitate traceability and quality contro ..
As with most innovative technology interventions, some of the concepts suggested here sound futuristic and need extensive trialling before being adopted. However, with increasing complexities in product development and manufacturing, and the need to accelerate the development of breakthrough therapies, now is as good as any time to begin the journey towards virtual regulatory inspections in the pharma industry.
