Pharma regulatory check
Skill Zerif007/Claude_Legal-Bangladesh_Edition/bd-health-pharma-legal/skills/pharma-regulatory-check
Cluade Legal Bangladesh Plugin and Skill Suite
npx -y skills add Zerif007/Claude_Legal-Bangladesh_Edition --skill pharma-regulatory-checkAssembled from the repository path, not quoted from the project. Check it against their README if it does not work.
2 things to look at
- 21 days oldThe repository was created 21 days ago. New is not bad, but a brand new repository carrying a familiar-sounding name is the shape a typosquat arrives in, and there has been no time for anyone else to find a problem with it.
- 0 stars0 stars. Stars are a popularity signal and not a quality one, but at this level it is likely that nobody has read this closely except its author, and you would be relying on your own review.
What its author says it does
Copied from the file, not written here
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".
SKILL.md
2.2 KB, as published. Nobody here has run it
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.