pharmaceutical regulations outline
TRANSCRIPT
Public Health Law Session
Aga Khan University & Hospital
PHARMACEUTICAL INDUSTRY Legislation & Regulation
Essential Medicines & Technology
Obaid Ali, R.Ph., M.Phil., Ph.D. Civil Service Officer at Drug Regulatory Authority of Pakistan
BecauseDrugs are public good and not simply just another commodity: first for their high social value, and then because consumers and prescribers are unable to assess their quality, safety and efficacy.
Quality cannot be observed by every one and/or by naked eye.
Quality cannot be tested in a laboratory but has to be built in to the product
New
Too
ls
Approaches
Stan
dard
sE
Q
P
S
REGULATORY
SCIENCE
Science driven by scientific methods
Difficult to capture art of pharmacy or medicine
Uncertainty and Complexity in real world practices and
realities
Hard Boundaries
Flexibility
Judgment space
Space and Boundary for today’s discussion
Outline of key legislations regarding pharmaceuticals in Pakistan
Drugs Act
1976DRAP Act
2012
Regulatory bodies & processes regarding Pharmaceuticals, Technologies and Devices
Regulatory Bodies/ Regulatory Processes
• Federal Government through Drug Regulatory Authority of Pakistan
• Provincial Government through Health Department of their province
Federal Government
• License to manufacture drug
• Registration/Market Authorization of Drug
• Pricing of Drugs• Advertisement of Drugs• Import & Export of
Drugs
Provincial Government
• Sale of drugs• Storage, distribution
and transportation of drugs
Pharmaceutical regulation-Post18th Amendment
Resolution of provinces to authorize formation of centralized DRAP
Promulgation of DRAP Act 2012
Adoption of Drugs Act, 1976 under DRAP Act, 2012
Re-notification of all rules framed under Drugs Act, 1976
Additional Rules e.g. medical devices, Natural Health Products
Constitutional threats-provinces can withdraw their authorization any time
Drug Act1976
Drug Regulatory Authority Act 2012
Rules & Regulations
Punjab
KPKPunjab
Balochistan
Manufacturing Registering Licensing Advertising Pricing Sale
Drugs Biologics
Laws and regulations – national and international regarding price of pharmaceuticals with special emphasis of essential medicines
Prices are controlled in Pakistan under law
WTO rules and debates about access to critical medicines in developing countries at affordable price – example HIV/AIDS medicines
Data protection Patent
Intellectual property
rightsData
exclusivityCompulsory
licensing
Patent period
Patent expired
Trust on Safety, Efficacy & Quality is not simple but so complex
Look Back Ground Stage Move forward
1 2 3
Look Back Ground Stage Move forward
1 2 3
Thalidomide Tragedy
DiethyleneGlycol
ContaminationHeparin
Catastrophe
Pyrimetamine Mixup Medication Errors Cutter Incidence
Kellse
Look Back Ground Stage Move forward
1 2 3
Pre Market
Manufacturing & Supply
Post Market
Translational Science
Pre Market
Clinical Trial
Safety
Quality
Efficacy
Label Claim
Pre Market
Safety
Brain
Heart
Lungs
Liver
Kidney
Blood
Smart Strategy
No new drug will be approved unless it has
passed the scrutiny and experience of developed world
Pre Market
Pre Market
Safety
USA
Europe
CanadaJapan
Australia
Pre Market
EfficacyFrom where the challenge
begin specially with generics
Pre Market
Same Label Claim
Chemistry, Manufacturing & Controls
Bio-Studies
GMP Compliance
Pre Market
Bioavailability is the only surrogate marker of clinical
studies
Pre Market
Dissolution is the mathmetical
marker of bioavailability
studies
1 2
3 4
Solubility
Permeability
Highly SolubleHighly Permeable
Highly SolubleLess Permeable
Less SolubleHighly Permeable
Less SolubleLess Permeable
Pre Market
Quality
Identity
PurityStrength
Quality Safety Efficacy Identity Purity Strength
Pre Market
Quality
Contamination
Mix-up
Consistency
Label claim
Manufacturing & Supply
Lab Scale
Pilot Scale
Scale up
Commercial scale
Consistency Contamination
Mix-up
Post Market
Surveillance & Vigilance
Quality
Risk & Alerts
SafetyMedication errors
Signal detection
Look Back Ground Stage Move forward
1 2 3
Data integrity, risk mitigation and management
Reasonable balance between safety and
innovation
Knowledge sharing and mutual recognitions
Smart, progressive model to reduce
regulatory burden
Fast access to drugs for the patient
Drug shortage, Culture of quality
and Cost of quality
Off-shore working and contract
services
Move Forward
Regulatory world is touching sky and
getting so complex Requires interpretation and somehow leniency to promote evolution of science such as off-label
use by physicians
Learn
De-learn
Re-learn
DISCLAIMER
Not the view of DRAP
Current judgment
No obligation on DRAP
Regulatory experience
It has nothing to do with any specific commercial
product
It is just a knowledge sharing exercise nothing
more than that
