Last week, my colleague and I traveled to Bangalore to attend the PDA India Chapter’s meeting on Supply Chain Resilience & Quality Management Maturity. While I was intellectually aware of the important role that India plays in the global supply chain for pharmaceuticals, during my 2½ days at this chapter meeting, I was able to witness the level of personal commitment and passion that the Indian pharma industry has for maintaining this status.
First of all, it must be noted that this was a chapter meeting, not an annual meeting, which for my chapter (Metro) would have been a few hours on a weeknight evening. This “mega chapter meeting” may have been attributable to the fact that the subject matter was quite dense as well as that there were a number of FDAers (based in India as well as visiting) who were on the podium. Whatever the underlying reason, the fact that senior leadership of major Indian pharmaceutical companies took off two or three days during a workweek to attend speaks to their commitment.
During the presentations, several interesting nuggets were revealed by the speakers from industry and the FDA. For example, while we are all familiar with the increasing number of CRLs related to manufacturing issues (often at CMDOs/CMOs), I was shocked to learn that 50% of all pre-license inspections (PLI) inspections are resulting in CRLs. With respect to QMM, the FDA revealed that guidance is in process, but it is at least a few years out. In addition, the FDA is planning to issue a QMM “playbook” for industry that will provide granular advice on increasing a firm’s maturity level within the QMM strata.
Topics of the presentations spanned the broader areas of quality and resilience, management review, business continuity, and best practices from other industries to granular topics, such as forecasting versus demand, PDA TR-68, deviations, and the importance of preventive actions. The speakers ran the gamut from regulators from the FDA to CDSCO, and the moderators were industry professionals with leadership roles in the PDA India Chapter. Senior leaders in the audience peppered the panelists and presenters with questions, and the discussions were rapid fire. It was certainly reassuring to see such spirited discussions between and among representatives from different organizations that might be competing in the marketplace but clearly have a commitment to assuring the continued supply of medicines worldwide.
In a time of great global unrest, with geopolitical relationships between nations directly affecting the supply and development of medicines, it was truly heartening to see how committed the Indian pharma sector is to continued education and learning about the emerging compliance and regulatory landscape.
