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 physical inspection process, it is very taxing on inspectors and the logistics make it a far from efficient use of time, money and resources. Moreover, these delays have a serious impact on the approval and supply of essential medicines to patients.
As part of a complex ecosystem, the pharmaceutical industry is an integral part of the process to ensure the supply of high quality medicines to patients. And yet, it remains a daunting challenge, especially for the Indian pharmaceutical industry. Of the 712 inspections conducted by the FDA at Indian manufacturing sites between 2018 and 2020, no less than 14.6% of inspections were classified as official action required (OAI), even more than those of China.
So how can the industry prepare for the virtual inspections that now seem inevitable? Short answer: technology. But the longer answer is as much cultural as it is behavioral – the adoption of digital tools and services, the viability and acceptance of remote working, and the full digital transformation of manufacturing. Equally important are advances in Industry 4.0 applications and interactive communication that allow a virtual workplace to emulate offline experiences.
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 ( IA) for real-time quality monitoring, or deploying chromatography to set up analytical data review processes remotely, tremendous opportunities have opened up to support regulatory controls. Offering a similar immersive and interactive experience while securing the integrity of sensitive data shared between stakeholders, it can make the whole process much more efficient and streamlined. Going further, Industry 4.0 can be used to test manufactured products for defects, and regulators can take appropriate action before a batch is shipped or needs to be physically recalled later.
From the perspective of manufacturers, the digitalization of operations can go a long way in enhancing India’s position as the “pharmacy of the world” by delivering benefits across the value chain. It can help pharmaceutical companies address one of the biggest challenges from a compliance perspective: data collection, integrity, and documentation. Additionally, blockchain-based technology for real-time geolocation and biometric tracking capabilities has proven to facilitate traceability and quality control throughout the product lifecycle, a key priority for manufacturers. . Going further back in drug development, the technology improves ‘quality at source’ and ‘quality by design’, allowing manufacturers to manage regulatory complexities even before they are involved in the drug development process. approval and inspection.
The asymmetry in the use of technology between different stakeholders is perhaps the greatest paradox of the healthcare ecosystem. On the one hand, we have the technology and the ability to decode a deadly pandemic virus and develop multiple vaccines against it in just over a year. And on the other hand, the same industry still relies on physical inspection of facilities and documents despite the availability of viable technological alternatives.
As with most innovative technology interventions, some of the concepts suggested here seem futuristic and require extensive testing before adoption. However, with the increasing complexity of product development and manufacturing and the need to accelerate the development of breakthrough therapies, now is high time to begin the journey towards virtual regulatory inspections in the pharmaceutical industry.