How PLM accelerated pharma compliance cycles.
The challenge
India's largest e-pharmacy was running compliance across 22 states with disparate documentation. OTC formulations lived in spreadsheets. Evidence collection was manual, with state-specific CDSCO, ASU drug and FSSAI requirements changing more often than the spreadsheet could keep up with. Every new product launch took three to four months of compliance review before a customer could see it.
The solution
Polluxa PLM replaced the spreadsheet stack. Every BOM is now attached to its CDSCO, state, and ASU drug regulatory evidence at design time. The Compliance Agent flags missing certificates before a product enters the launch queue. Recipe versions are tracked with full audit trails, so a regulator question that used to take a week to answer now takes minutes.
The outcome
Compliance cycle time dropped 38% in the first year. Rework — products kicked back to design for missing evidence — fell 62%. New product time-to-launch went from 6+ months to 3. The compliance team didn't shrink — they shifted from reactive evidence-chasing to proactive regulatory strategy.
We finally have one place where the regulators, the designers and our auditors agree. The evidence isn't in someone's inbox anymore. It's in the BOM.
Anil Naik, VP, Product Operations · PharmEasy