This document provides an overview and agenda for a full-day workshop on drug regulatory quality in Pakistan. It discusses the importance of pharmaceutical regulation in ensuring drug safety and preventing tragedies. Examples are given of contamination issues and medical product failures that resulted in many deaths. The workshop aims to identify attributes of a quality culture, correct relationships, and rational approaches to regulatory science through discussion of quality metrics and case studies.

1. Saturday, October the 10, 2015
Culture of Quality
Opening Note and Programme overview
Full day workshop
Drugs Regulatory Authority of Pakistan
Habib University, Karachi
Obaid Ali & Roohi B. Obaid
Civil Service Officers/ Deputy Director

2. 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
D
I
S
C
L
A
I
M
E
R

3. About Half a billion
population died
4Lakh per year in Europe

4. Small pox Plague Meningitis
Tuberculos
is
Heart
Attack
Infections Psychiatry Diabetes

5. Hepatitis Ebola

6. Who Cares?
It is Pharmaceutical Industry … Science … Research ..

7. Pharmaceutical
Companies
Regulatory
Agencies

8. Very near to your and your beloved one’s lives

10. 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

11. 2008
?

12. Over sulfated chondroitin sulfate (OSCS)

13. 149
deaths
Test was
passed
Signals not
responded
Finally
contamination
detected
Let’s think together

14. 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
Yes
Don’t
know

15. 100’s
of
Deaths

16. 2001-2005
750m $ Mix up Too much or too
little API
Contamination
A number of products, tablet, cream,
comtrol release etc.

17. Regulations
EnforcementCompliance
Guarantee
?

18. 1
2 3
4
Let’s identify attribute of culture

19. Let’s identify correct relationship
Girl and Mehndi
Boys and Mehndi
Girl and Tattos

20. Let’s identify correct relationship
Mehndi &
Bangles
Boys and Bangles
Girl and Bangles

21. Let’s identify correct relationship
Eid
Exam day
Fun

22. A normal brain irrationally puts more
weight on a small loss than big one or
sometimes a huge opportunity

23. T
O
O
L
Approach
Standard

26. Sorry for broken trust … ...
I am endlessly sorry
Martin Winterkorn
4,82, 000 cars … > 18
billion USD fine………..
Sep 20, 2015

27. Hiding an alleged link b/w
Pioglitazone & bladder cancer
Emails raising concern about
the issue were deleted

28. 9 billion USD penalty
2014

29. Clinical
Trial
2000 for
HTN
Further
trials for
stroke &
angina
Employees
Participatio
n
CoI not
reported
Employees
in data
analysis
Manipulati
on in
scientific
reports
Data
fabrication
Reported
Retraction
of several
papers
Publicly
apologized

30. 2014-2015
Got temporary
suspension of
business
Reputational hit Data tempering
False advertisingData hidingEnds up with sorry

32. 1999 100 M
2002 30 M
2002 500 M
2010 750 M
GMP

33. • Off-label
use
promotion
P
USA • 0.43
billion
USD fine
2004

34. • Fraud
M
• Kick-
backs
USA • 0.95
billion
USD fine
2008

35. • Off-label
use
promotion
P
• Kick-
backs
USA • 2.3 billion
USD fine
2009

36. • Off-label
use
promotion
L
USA • 1.4 billion
USD fine
2009

37. • Off-label
use
promotion
AG
USA • 0.60
billion
USD fine
2010

38. • Off-label
use
promotion
AZ
• Kick-
backs
USA • 0.52
billion
USD fine
2010

39. • Off-label
use
promotion
N
• Kick-
backs
USA • 0.423
billion
USD fine
2010

40. • 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

41. • Off-label
use
promotion
AT
USA • 1.9 billion
USD fine
2012

42. • Off-label
use
promotion
J
• Kick-
backs
USA • 2.2 billion
USD fine
2013

43. 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
Sorry
the worst nightmare

44. Mal-practices
in drug
manufacturing
Regulations
came into
force
Tragedies
occurred
Regulation
s continue
to be
stringent
&
complex
Historical Perspective

45. PHARMACEUTICALS
A Business driven Profession

46. New
Tools
Approaches
Standards E
Q
P
S
R
E
G
U
L
A
T
O
R
Y
S
C
I
E
N
C
E

47. Innovation
Science

48. Need justifies Outcome
Risk
Benefit

49. Reasonable Safety is required

50. Do you calculate a cost of poor
quality at your site?

51. Do you calculate a cost of
improving quality versus failure?

52. Science
Rational
QUALITY
METRICS

53. Econometrics
Pharmacometrics
Chemometrics
Science
Rational

54. Quality Metrics &
Case Studies will be discussed
in next talk

55. Thank you of
your attention