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On the potential impact of linguistic nuances in regulatory interactions

The event

A three-day pharmaceutical manufacturing conference hosted by ISPE in Mumbai in October 2018. The highlight of the event was the presence of senior members of the US FDA who presented current trends, their experiences auditing in India and other international locations, and their expectations from Indian companies w.r.t. quality of drugs. The most exciting part of the event was a long Q & A session where the FDA leaders patiently addressed queries of 300+ attendees from Indian Bio/Pharma companies.

The interactions

Most of us (Indian) attendees were able to understand the questions posed by our Indian colleagues during the Q & A session. But on more than a few occasions, the answers given by the FDA personnel had no connection to the question being asked. This was simply due to the fact that the experts were not able to completely comprehend the questions thanks to barriers within spoken English.

The diversity in Indian English due to regional accents, preferred vocabulary, pronunciation, and just the way us Indians like to indirectly approach a topic created a struggle for both sides. The fact that Americans themselves had regional accents and do not always speak “American English” added another dimension to the confusion.

The D-day Scenario

While this interaction with FDA was in the most amicable setup and no one was being assessed, you can imagine the stakes if the interaction were to happen between an FDA auditor and and Indian line operator or supervisor. With the pressure of a major regulatory audit on their minds, in a one-on-one setting with auditors, I wonder how much the training on facing audits will help our junior colleagues. I can hope that they will remember to respond in slow, short, and direct sentences, and hope that the auditors will always be receptive, patient and trusting, and not take the potentially confusing responses as a clouding tactic.

This is generally not a serious concern while interacting with Japanese, Russian or Spanish speaking auditors because an interpreter is there to modulate the content and filter out some of the confusion (an Indian interpreter works better). I wonder if we need one for American and British English too.

This article first appeared on the author’s Linked-In page on October 19, 2018


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