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