Last week, I had the privilege of attending The Indian Pharmaceutical Alliance’s 10th Global Pharmaceutical Quality Summit in Mumbai. Not only was the event loaded with excellent content presented by leaders of the generics industry, it also provided invaluable chances to discuss innovation and opportunities for the industry with individuals in quality from around the globe. The discussions, by panels of distinguished professionals, had a few recurring themes: the potential that artificial intelligence (AI) has to transform our industry, the as-yet unknown impact that the new administration in the U.S. may have on the generics industry as a whole, and concern regarding the specific impacts that tariffs announced by the new U.S. administration may have on the generics industry generally and India particularly.

The focus of this meeting (as its title implies) was quality, but the panels consisted of people with a myriad of different perspectives. The keynote address was given by Arvind Virmani from the National Institution for Transforming India (NITI), India’s top policy think tank. Panels included regulators representing India (Drug Controller General of India), the UK (MHRA), and Europe (EDQM), joined by two ex-FDAers. There were also contributors from other regulated sectors, such as finance and defense, as well as representatives from academia, such as the Indian Institute of Technology Bombay, and organizations such as the Indian Foundation for Quality Management (IFQM), McKinsey, and the Kaizen Institute.

A common topic touched upon by the speakers from industry was the need for greater harmonization between regulators from different international markets, with the goal being standardization of regulatory expectations. At a more granular level, desire was expressed for guidances to be issued with companion Q&A documents, allowing for easier implementation. Although there was no representation from the U.S. FDA to address this question, given the undercurrent at this meeting, one wonders whether it would be possible to achieve something like this using AI. EDQM let us know that the eCTD is changing so that it can be read by AI; perhaps guidances can be structured so that AI can easily generate Q&As and, perhaps, learning sessions for industry (or at least “points to consider” or outlines of topics to be covered in learning sessions for industry). On a related topic, can AI be used by regulators to detect themes over a firm’s multiple sites to detect global wholistic trends across the entire organization? Collaboration like this between regulators and the regulated would certainly move our industry closer toward the desired state of wholistic, proactive compliance.

A recent benchmarking study, cited by a presenter from McKinsey, pointed out a few trends in the Indian pharmaceutical industry. These are:

  • U.S. FDA observations related to inadequate investigations into deviations in manufacturing operations are increasing;
  • Changes are needed in relation to core manufacturing infrastructure, including low-touch sentient plant operations, in order to improve operational efficiency and remain competitive on a global scale; and
  • Companies should aim for zero-error operations.

While these disparate issues may seem unrelated, there is potential to address them all with machine learning/AI. At their root, these issues are all addressed by analyzing myriad data points, which could be realized by utilizing machine learning/AI.

It doesn’t seem like science fiction that AI could help with the supply chain by allowing a predictive analysis for supply. Indeed, it should be possible to integrate an entire organization, from marketing to procurement, using digital technologies/AI. One of the speakers used the predictive analysis currently being performed with weather data in India to forecast how monsoons will propagate as an example. It is clear that digital technologies are here to stay and that adoption of digitization in an institution will naturally lead to predictability. As a natural result, there would be no need to create “workarounds” when faced with unanticipated situations (which could include deviations). This would all lead to a strengthening of quality culture and a concomitant increase in compliance.