Download - 2 of 5 Overview by Obaid Ali
Saturday, October the 10, 2015
Culture of QualityOpening Note and Programme overview
Full day workshop
Drugs Regulatory Authority of Pakistan
Habib University, Karachi
Obaid Ali & Roohi B. ObaidCivil Service Officers/ Deputy Director
Not the view of DRAP
Current judgment of speaker
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
DISCLAI
MER
About Half a billion population died
4Lakh per year in Europe
Small pox Plague Meningitis Tuberculosis
Heart Attack Infections Psychiatry Diabetes
Hepatitis Ebola
Who Cares?
It is Pharmaceutical Industry … Science … Research ..
Pharmaceutical Companies
Regulatory Agencies
Very near to your and your beloved one’s lives
Drug Safety from Pre Market to Post Market"DO YOU KNOW IN 2008 ....., used to stop
bleeding during open heart surgery killed a lot of patients.
The lives of 22,000 patients in USA alone could have been saved if U.S. regulators had
been quicker to ban it. The same was extensively used in Pakistan too but no body
knows, it killed how many in our country
2008?
Over sulfated chondroitin sulfate (OSCS)
149 deaths
Test was passed
Signals not responded
Finally contamination
detected
Let’s think together
If it happened in Pakistan, were me & you able to catch?
What do you think can it be caught in testing?
Do you think we are capable to catch such level of contaminant or less?
No
YesDon’t know
100’s of
Deaths
2001-2005750m $ Mix up Too much or too
little API Contamination
A number of products, tablet, cream, comtrol release etc.
Regulations
EnforcementCompliance
Guarantee
?
1
2 3
4
Let’s identify attribute of culture
Let’s identify correct relationship
Girl and Mehndi
Boys and Mehndi
Girl and Tattos
Let’s identify correct relationship
Mehndi & Bangles
Boys and Bangles
Girl and Bangles
Let’s identify correct relationship
Eid
Exam day
Fun
A normal brain irrationally puts more weight on a small loss than big one or
sometimes a huge opportunity
TOOL
Approach
Stan
dard
Sorry for broken trust … ... I am endlessly sorry
Martin Winterkorn
4,82, 000 cars … > 18 billion USD fine………..
Sep 20, 2015
Hiding an alleged link b/w Pioglitazone & bladder cancer
Emails raising concern about the issue were deleted
9 billion USD penalty2014
Clinical Trial
2000 for HTN
Further trials for stroke & angina
EmployeesParticipatio
n
CoI not reported
Employees in data
analysis
Manipulation in
scientific reports
Data fabrication Reported
Retraction of several
papersPublicly
apologized
2014-2015Got temporary suspension of
business
Reputational hit Data tempering
False advertisingData hiding Ends up with sorry
1999 100 M2002 30 M2002 500 M2010 750 M
GMP
• Off-label use promotion
P
USA • 0.43 billion USD fine
2004
• Fraud
M
• Kick-backs
USA • 0.95 billion USD fine
2008
• Off-label use promotion
P
• Kick-backs
USA • 2.3 billion USD fine
2009
• Off-label use promotion
L
USA • 1.4 billion USD fine
2009
• Off-label use promotion
AG
USA • 0.60 billion USD fine
2010
• Off-label use promotion
AZ
• Kick-backs
USA • 0.52 billion USD fine
2010
• Off-label use promotion
N
• Kick-backs
USA • 0.423 billion USD fine
2010
• Failure to disclose safety data
• Off-label use promotion
G
• Paying kick-back• Making false
misleading statements
USA • 3 billion USD fine• Criminal & civil
fine
2012
• Off-label use promotion
AT
USA • 1.9 billion USD fine
2012
• Off-label use promotion
J
• Kick-backs
USA • 2.2 billion USD fine
2013
Recognition
• Publicly recognizing the gravity of the crisis
Responsibility
• Leaders taking personal responsibility to manage the crisis
Regret
• Expressing deep regret on behalf of company
Remedy
• Outline the steps going & continue to take to address the situation
Sorrythe worst nightmare
Mal-practices in drug manufacturing
Regulations came into force
Tragedies occurred
Regulations continue to be stringent & complex
Historical Perspective
PHARMACEUTICALSA Business driven Profession
New
To
ols
Approaches
Stan
dard
sE
Q
P
S
REGULATORY
SCIENCE
Innovation
Science
Need justifies Outcome
RiskBenefit
Reasonable Safety is required
Do you calculate a cost of poor quality at your site?
Do you calculate a cost ofimproving quality versus failure?
Science
Rational
QUALITY
METRICS
Econometrics
Pharmacometrics
Chemometrics
Science
Rational
Quality Metrics & Case Studies will be discussed
in next talk
Thank you of your attention