Investigation backlogs an operational challenge for Indian drug production units facing USFDA scrutiny, says report

Even as the US Food and Drug Administration (US FDA) tightens its oversight over Indian pharmaceutical manufacturing facilities the agency has approved, the procedural documentation and compliance reporting load FDA observations carry is becoming an operational challenge for several Indian firms, indicates a study by Vector Consulting Group indicates.  

A white paper prepared by the consultancy after surveying multiple mid- to large-scale, USFDA-approved formulation plants in India finds that the incident and investigation management processes can place a significant burden on manufacturing operations, affecting batch release timelines and leadership bandwidth.

India has close to 500 USFDA drug manufacturing plants, making the country home to the largest number of USFDA-approved manufacturing facilities outside the US.

USFDA’s annual report on the State of Pharmaceutical Quality (for the October 1, 2024 to September 30, 2025 period) indicates that 17.9% of the inspections carried out on Indian facilities approved by the US regulator belonged to the official action indicated (OAI) category. When USFDA issues an OAI, manufacturing facilities are required to take regulatory and/or administrative actions and submit the compliance reports to the agency.

Report suggests long timelines to manage backlogs

The findings of the report titled “The compliance spiral in pharma manufacturing” indicate that every surveyed plant has a backlog of incidents awaiting closure, with some taking up to six months to resolve. About 80% of respondents reported that open investigations directly delayed batch release, while senior leaders reported spending as much as 27% of their time managing backlogs, it said.

The study suggests that recurring incidents cannot be understood solely
as individual failures. The way production work is documented, supervised and investigated can also shape how frequently issues arise and how quickly they are resolved, it says.

According to the survey, human errors accounted for 56% of reported production incidents. Operators were found to make, on average, 120 entries in Batch Production Records (BPRs) per shift. The burden extends to supervision as well. It is noted that 80% of supervisors oversee five or more production lines per shift, potentially limiting the time available to verify work and identify problems early.

“The real test of a robust quality system is not how much documentation
it generates, but whether it helps prevent errors and resolve deviations without disrupting production. That requires looking beyond individual incidents to understand why they keep occurring. When the underlying work processes are difficult to execute or verify, adding more checks may not address the root cause,” Chandrachur Datta, Partner and co-author of the white paper at Vector Consulting Group, said.

Investigation delays are not always caused by the complexity of an incident itself. The survey found around 83% of respondents reported multiple revisions to investigation drafts, while 77% linked delayed evidence capture to information gaps. A further 73% said differences in functional priorities contributed to delays or rework in closing investigations.

According to the report, these findings point to opportunities to improve the process at multiple stages, from capturing evidence closer to when an incident occurs to making investigations easier to complete and faster to review.

The white paper outlines two distinct opportunities for pharmaceutical manufacturers: reducing the number of new incidents entering the system and accelerating the closure of those already open. Its proposed interventions could deliver a 30%-50% reduction in new incident generation, while a structured approach to investigations could reduce closure timelines by 20%-40% for existing incidents, it says.

“Every incident evidence caught early helps in conducting a thorough investigation and enables faster closure. By addressing the causes of recurring incidents and investigation delays, pharmaceutical plants can move from reactive compliance management to proactive quality management and sustained audit readiness”, it concludes.