Pharma regulatory check

Skill Zerif007/Claude_Legal-Bangladesh_Edition/bd-health-pharma-legal/skills/pharma-regulatory-check

Checks pharma/health operations against the 2023 drugs regime and clinical regulation — DGDA licences and renewals, registration of products, pricing (essential list), promotion rules, clinical-trial and pharmacovigilance duties, private clinic/lab licensing. Use for "launch this product", "DGDA inspection", "clinic licence", "drug promotion review".From its SKILL.md

Install

npx -y skills add Zerif007/Claude_Legal-Bangladesh_Edition --skill pharma-regulatory-check

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One thing to look at

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SKILL.md

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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

Activity map → licence matrix (held vs required vs expiring).
Product file review: registration certificate scope vs actual indications/pack, pricing vs DGDA-fixed MRP for listed drugs [verify current list].
Promotion: samples, HCP inducements, DTC advertising limits (drug ads restricted — clearance requirement [verify]); coordinate bd-consumer-product-legal on claims.
Inspection readiness: batch records, QC, recall SOP, pharmacovigilance reporting.
GREEN/YELLOW/RED with cure steps; criminal-exposure items (spurious/adulterated) always escalate.

Guardrails

The 2023 Act's penal provisions are severe (up to capital-adjacent maxima for spurious drugs [verify]) — never characterise exposure casually. Rules/SROs under the 2023 Act are new and shifting: date-stamp every verification.

What ships with it

Read from the repository

Just SKILL.md. No reference files, no scripts.