pharma-regulatory-checklisted

# Pharma & Health Regulatory Check Config gate: licence portfolio. Output = attorney-review compliance matrix. ## Anchors (links via `references/full-statute-corpus.csv`) | Instrument | Practice point | |---|---| | ঔষধ ও কসমেটিক্স আইন ২০২৩ | product registration, manufacturing/import/wholesale/retail licences, cosmetics newly in scope, offence schedule incl. adulterated/spurious drugs (severe penalties), DGDA powers; rules `[verify — issued/pending]` | | Medical Practice & Private Clinics Ord. 1982 | clinic/lab licensing, fee display — reform bill status `[verify]` | | BMDC Act 2010 | practitioner registration, professional-misconduct exposure | | মানসিক স্বাস্থ্য আইন ২০১৮ | admission/consent framework for facilities | | Human Organ Transplantation Act 1999/2018 | strict relative-donor rules | | Patent Act 2022 + LDC waiver | pharma product-patent transition — coordinate bd-ip-legal (graduation Nov 2026) | ## Procedure 1. Activity map → licence matrix (held vs required vs expiring). 2. Product file review: registration certificate scope vs actual indications/pack, pricing vs DGDA-fixed MRP for listed drugs `[verify current list]`. 3. Promotion: samples, HCP inducements, DTC advertising limits (drug ads restricted — clearance requirement `[verify]`); coordinate bd-consumer-product-legal on claims. 4. Inspection readiness: batch records, QC, recall SOP, pharmacovigilance reporting. 5. GREEN/YELLOW/RED with cure steps; criminal-exposure items (spurious/adulterated)