Founder commentary
India’s pharma quality reset will be won after the inspector leaves
In ET Pharma, Varun Sharma argues that pharmaceutical quality depends on what an organisation can prove after inspection: whether failures recur, remediation holds and accountable people can trace each decision.
NEUVIOR summary
Quality must survive normal operations.
An inspection can expose a failure and trigger enforcement. It cannot, on its own, show whether the correction will still hold on the next shift, during the next deviation or when commercial pressure returns.
Varun Sharma’s argument is that durable quality depends on evidence of recurrence, accountable decisions and learning that changes how an organisation allocates attention, people and capital.
Measure what returns, not only what closes.
Closing an action is an administrative event. The harder test is whether the same failure appears again, whether overdue work escalates, whether effectiveness checks use independent evidence and whether repeat deviations travel across products, lines or sites.
- Repeat findings and recurrence after closure
- Time to verified remediation
- Unresolved critical risks
- Management decisions that changed resources, maintenance, suppliers or production
Connect signals without claiming more than they prove.
Government figures published on 24 March 2026 reported risk based inspections at more than 960 premises since December 2022 and more than 860 regulatory actions. They also reported 116,323 samples tested during 2024 to 2025, of which 3,104 were not of standard quality and 245 were spurious or adulterated.
These are national totals. They cannot diagnose the quality system at any individual site. Their value is in helping regulators select risk, identify patterns and decide where verification deserves priority.
Keep accountable humans in control of automation.
The April 2026 IndiaAI and CDSCO hackathon invited teams to work on anonymisation, document summarisation, missing field detection, severity classification, version comparison and formal reporting from handwritten notes. It was a development challenge, not proof of a deployed regulatory system.
Automation may structure evidence and expose gaps. It should not own legal judgement. Each summary should remain traceable to source material. Each severity change should identify its approver. Each override should retain a reason.
Move recurring quality risk into board decisions.
A recurring risk ledger can connect quality evidence with capital expenditure, supplier qualification, staffing, maintenance and production incentives. This turns quality from a departmental reporting exercise into an operating responsibility shared by senior leadership.
Smaller manufacturers still need a demanding route. Common definitions, a minimum evidence standard, phased technical assistance and firm escalation for repeat failure can improve capability without rewarding paperwork for its own sake.
What this means for NEUVIOR.
The commentary reflects a governance principle in NEUVIOR’s public thinking. Technology may organise evidence and reveal gaps, but it must not conceal who decides, what remains uncertain or why an override occurred.
The article does not present PHARMORIS as the answer. It does not report a NEUVIOR deployment, a customer relationship, regulatory approval, clinical efficacy or demonstrated healthcare outcomes.
“Only what happens afterwards can change it.”
Varun Sharma, ET Pharma, 4 August 2026
Primary source context
- Government quality measures and sampling data
Ministry of Health and Family Welfare release dated 24 March 2026.
- IndiaAI and CDSCO hackathon announcement
Ministry of Electronics and Information Technology release dated 2 April 2026.
- Revised Schedule M notification
Official notification issued by the Ministry of Health and Family Welfare.