As India’s pharmaceutical industry works towards a $130 billion ambition by 2030, a study by Vector Consulting Group highlights an operational challenge that warrants closer attention: how high the number of manufacturing incidents and a large backlog of open investigations become a drag on plant productivity.
The white paper, The compliance spiral in pharma manufacturing, draws on a survey of multiple mid- to large-scale, USFDA-approved formulation plants in India. It finds that incident and investigation management processes can place a significant burden on manufacturing operations, affecting batch release timelines and leadership bandwidth.
The findings indicate that every surveyed plant has 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.
When compliance processes become a bottleneck
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.
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. According to the survey, 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 [SM1] 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,”
said Chandrachur Datta, Partner and co-author of the white paper at Vector Consulting Group.
The cost of delayed investigations
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.
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.
Building manufacturing capability alongside compliance
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.
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.
As India works towards its $130 billion pharma ambition by 2030, scaling output will need to go hand in hand with the ability to release batches in a shorter lead time and pass USFDA inspections consistently. Reducing incidents and investigation backlogs is an important step towards building that capability.