Decoded: Why India’s $130 billion pharma ambition faces a hurdle as investigation backlogs delay drug batch releases

India’s pharmaceutical industry is working towards a $130 billion ambition by 2030. However, as manufacturers look to expand production and strengthen their position in global markets, operational challenges within factories could affect how efficiently they manufacture and release drug batches.

A study by management consulting firm Vector Consulting Group has highlighted one such challenge: the growing burden of manufacturing incidents and delays in closing investigations. These backlogs are affecting batch-release timelines and consuming a significant share of senior management’s time, raising questions about how efficiently pharmaceutical plants can scale their operations.

The white paper, The Compliance Spiral in Pharma Manufacturing, draws on a survey of professionals from multiple mid- to large-scale, USFDA-approved formulation plants in India. It finds that every surveyed plant had incidents awaiting closure, with some investigations taking as long as six months.

About 80% of respondents reported that open investigations directly delayed batch releases. Senior leaders also reported spending as much as 27% of their time managing investigation backlogs.

The findings highlight an operational challenge for pharmaceutical manufacturers: maintaining compliance while ensuring that documentation and investigation processes do not become bottlenecks in production.

Why are investigation backlogs delaying drug batch releases?

Pharmaceutical manufacturing involves multiple quality checks and documentation requirements to ensure that products meet prescribed standards. When an incident occurs during production, manufacturers are required to investigate the deviation, document the findings and establish the necessary corrective measures before the matter can be closed.

However, delays in completing these investigations can affect the release of batches.

According to the Vector Consulting Group study, the problem is not limited to the time taken to investigate an incident. The process of documenting, reviewing and closing investigations can itself involve repeated revisions and coordination between different teams.

Around 83% of respondents reported multiple revisions to investigation drafts, while 77% linked delayed evidence capture to information gaps. Another 73% said differences in functional priorities contributed to delays or rework in closing investigations.

These findings suggest that investigation timelines can be affected by how information is captured, how different departments coordinate and how quickly investigation reports move through the review process.

How documentation and supervision affect pharma manufacturing productivity

The study also points to the role of production processes and supervision in the occurrence of manufacturing incidents.

Human errors accounted for 56% of reported production incidents. Operators were found to make an average of 120 entries in Batch Production Records (BPRs) per shift.

At the supervisory level, 80% of respondents said supervisors oversee five or more production lines per shift.

The combination of extensive documentation requirements and supervisory responsibilities could make it difficult to identify and address problems at an early stage.

The findings also raise questions about whether recurring manufacturing incidents should be viewed only as individual employee errors or examined in the context of how work is structured, documented and supervised.

Chandrachur Datta, Partner at Vector Consulting Group and co-author of the white paper, said, “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.”

He added that manufacturers need to look beyond individual incidents to understand why they keep occurring. When underlying work processes are difficult to execute or verify, adding more checks may not address the root cause.

How much time do pharmaceutical companies lose to investigation delays?

The findings indicate that investigation backlogs are not merely a documentation issue. They also place demands on management time and manufacturing operations.

Senior leaders in surveyed plants reported spending as much as 27% of their time managing backlogs. This can leave less time available for other operational and strategic responsibilities.

The delay in closing investigations can also hold up batch releases, creating an additional challenge for manufacturers seeking to improve production efficiency.

The study identifies two areas where pharmaceutical companies could improve their processes: reducing the number of new incidents entering the system and accelerating the closure of investigations that are already pending.

What can pharma manufacturers do to reduce investigation backlogs?

The white paper proposes interventions aimed at addressing both the occurrence of manufacturing incidents and the time taken to investigate them.

According to Vector Consulting Group, its proposed interventions could deliver a 30%-50% reduction in new incident generation. A structured approach to investigations could also reduce closure timelines by 20%-40% for existing incidents.

The recommendations focus on improving documentation, strengthening supervision, capturing evidence closer to the time an incident occurs and making investigation workflows easier to complete and review.

The objective is to move away from reactive compliance management towards a system that identifies recurring problems, addresses their underlying causes and enables investigations to be closed faster.

What does this mean for India’s $130 billion pharma ambition?

As India works towards its pharmaceutical industry growth ambition of $130 billion by 2030, manufacturers will need to focus not only on expanding production capacity but also on improving the efficiency of existing operations.

The ability to release batches within shorter timelines, address manufacturing deviations and maintain consistent compliance will remain important to pharmaceutical manufacturers, particularly those operating USFDA-approved facilities.

The Vector Consulting Group study suggests that incident management and investigation backlogs are operational areas that warrant attention as the industry scales.

Reducing the number of recurring incidents and improving investigation closure timelines could help manufacturers improve plant productivity without compromising quality and compliance requirements.