India pharma units fare better in US checks in 2023

In 2023, Indian drug manufacturing facilities exporting to the US demonstrated superior performance in regulatory inspections compared to the global average, as reported by the Indian Pharmaceutical Alliance and McKinsey & Company. The United States Food and Drug Administration (USFDA) classified 13% (19 out of 145 inspections) of these facilities as Official Action Indications (OAI), which is lower than the global average of 15% OAIs. This improvement marks a significant decline from 26% OAIs observed in 2014, reflecting enhanced adherence to current good manufacturing practices (CGMP) and regulatory standards.

An OAI classification from the USFDA indicates areas of non-compliance that may lead to regulatory actions like warning letters or import bans if corrective measures are not promptly implemented. Despite not affecting ongoing operations directly, OAIs can hinder new product approvals and necessitate increased spending on remediation efforts. The scrutiny also highlighted improvements needed in essential CGMP training, lab controls, and core manufacturing processes. McKinsey & Company's senior partner, Mr. Sathya Prathipati, underscored ongoing industry efforts to meet evolving quality expectations, noting specific increases in observations related to facilities, infrastructure, and root cause analysis over recent years.

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