Pharma & Life Sciences · India
Schedule M readiness turned from an opinion into a number
Sahyadri Pharma
Formulations and API, 6 manufacturing sites, 40 export markets
- unit-level obligations from one schedule
- 340unit-level obligations from one schedule
- to produce a board-ready readiness position
- 3 wks → 1 dayto produce a board-ready readiness position
- contract manufacturers found materially behind
- 2 of 4contract manufacturers found materially behind
- across quality, environment and labour
- 1 registeracross quality, environment and labour
The challenge
Where they started
Revised Schedule M was being managed as a quality project with a site-by-site narrative status. When the board asked which units would be compliant by the deadline and what the residual risk was, producing an answer took three weeks and the answer was contested internally. Separately, the company relied on four small contract manufacturers whose readiness was entirely unknown.
The approach
What we did
- Decomposed the revised Schedule M into 340 unit-level obligations with evidence expectations
- Assessed each of six sites against the full set, producing a comparable gap position rather than six narratives
- Extended the same assessment to four contract manufacturers through a vendor attestation workflow
- Linked remediation items to capital expenditure approvals so the investment case referenced specific obligations
- Layered environmental, hazardous waste and state factory obligations onto the same register
“Schedule M was treated as a quality project until someone asked which of our units were actually compliant and by when. Nobody could answer without a three-week exercise. Now it is a screen.”
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