Dr Venkateswarlu Memorial Lecture 2015

Dr. M. Venkateswarlu Memorial Lecture
Culture of Quality
Indian Pharma Inc. : Adapting to the Rapidly Evolving Global Challenges
ajaz@ajazhussain.com
6 June 2015 IPA Convention 2015, BKC, Mumbai 1

“Pharmacy to the World” is the right aspiration for India
Strengthen
our culture
of quality
Affordability - Patient
focused, continually
improving system
based on deep
understanding &
integrating
engineering &
statistics.
One quality standard -
‘Do No Harm’ to
‘Providing a Healing
Touch’ – “India Pharma
Brand Identity – Made
in India, Proudly”.
Health Care for All –
Leadership in setting
the standards for
Integrative Medicine,
leveraging the
Wisdom Traditions.
1
23
4
Purpose of this talk is to request you to
consider the following 4 Steps
• Strengthening the ‘Culture of Quality’ – the
focus of this talk
• Improve efficiency with confidence in controls by
integrating India’s engineering and statistical
know-how and technologies
• Working together – ‘One Quality for All’ to say
proudly – Made in India: Pharmaceutical Factory to
the World
• Leverage India’s Wisdom Traditions to provide
leadership in setting the standards for Integrative
Medicine so as to deliver a model of ‘Health Care
for All’: Pharmacy to the World
Pharmaceutical Factory to the World
Pharmacy to the World

‘Factory of the world’ then ‘Pharmacy to the World’
India in 2020: the factory of the world?
• Ansuya Harjani | Wednesday, 3 Sep 2014;
•http://www.cnbc.com/id/101966191
'It is now India's turn to sustain Asia's success‘
• Narendra Modi | May 23, 2015
•http://wap.business-standard.com/article/opinion/it-is-now-india-s-turn-to-sustain-asia-s-success-115052300806_1.html
Pharmacy Vs. Factory - is there a difference? YES.
• Journey to 2020 would benefit from clarity of the vision

India is set to become the youngest country by 2020
Girija Shivkumar, The Hindu, April 17, 2013
By 2020, India is
set to become
the world’s
youngest
country
With 64 per cent of
its population in the
working age group.
Median age in India
will be 29 years.
• Institutional recovery
will have to be its
topmost priority
• Quality of teachers at
all levels
The impact of
institutional decay.
Krishna Kumar, The Hindu, 15
September 2014
In the immediate – short term, until 2020, industry will need to take-on ‘skills development’ for
the work-force it needs to be the ‘pharmaceutical factory to the world’!
In parallel, a strong focus on institutional recovery to excellence critical to realize the aspiration
to be the ‘Pharmacy to the World’

INDIA’S SCIENCE TEST
T. V. Padma, 14 MAY 2015 | VOL 521 | NATURE
“The Mars mission experience has once again strengthened our belief that we can.”
“pharmacy of the developing world”
“…great strides in research and development, but it has a long way to go.”
“Lack of even bare, minimal and sustainable funds for teaching, let alone research, has seriously plagued the quality and
standards of science education,” Krishna Ganesh, Director of the Indian Institute of Science Education and Research in Pune.
“Here [state universities], there are no good science teachers, no good Indian textbooks, and most of the science laboratories
are poorly equipped”
“There is over-bureaucratization within the universities and their controlling bodies”
“WE ARE CAUGHT IN A VICIOUS CIRCLE OF MEDIOCRITY” - Deepak Pental, former vice-chancellor, the University of Delhi.
“Often the appointed person has never been exposed to a good university in India or abroad,” Kizhakeyil
Sebastian, Chair of the science-education panel of the Indian Academy of Sciences in Bangalore.

Background: India Pharma
The narrative on India
Pharmaceutical Sector
2005
Current state
Looking forward to
2020
Independence-2005:
Nonexistent to a World Leader
Global sales: Value 1%, Volume
8%; ranking: 4 in volume, 13 in
value
Continued growth and
challenges to ‘Brand Identity’
What will ensure growth that
justifies the claim of ‘Pharmacy
to the World’?

Background: 2005 a special year
February 25, 2005,
Mumbai
The ISPE India- US FDA
PAT forum….
Sharing the stage with…
Dr. M. Venkateswarlu,
then Deputy DCGI

Background: My viewpoint on Culture of Quality
Viewpoint in 2005
Building successful business models for complex
generics, biosimilars, plant-based vaccines,..
Reconnecting with India and current practice in
India: “Dil Se”
Way forward to 2020: Culture of Quality

My Viewpoint in 2005: As a regulator
With increased complexity the current approach to development, manufacturing and quality
assurance are untenable
Need a effective methodology for QbD and for a focus on in –process controls as opposed to
just tests and SOP’s
Incorrect focus on compendial tests and their use for lot-release keeps the system in ‘corrective
action mode”; continual improvement unlikely within this mindset.
An integrated approach (e.g., PAT Team) to regulatory oversight is necessary to move towards
continual improvement.
We must transform our education system from ‘Industrial Pharmacy’ to Pharmaceutical
Engineering

Viewpoint 2005: As a regulator
“And like the heroes
of the French
Revolution, we
look to a future
that will bring us
everything or
nothing, depending
on the public trust”
 The Nation Needs a Comprehensive
Pharmaceutical Engineering Education and
Research System
 “A recent re-examination by the US Food and Drug
Administration of the current pharmaceutical quality
decision-making system raised fundamental questions
about its efficiency and its continuing effectiveness
to address the increasing complexity of
pharmaceutical systems.”
 “….low success rate for identifying the root cause
of deviations and out-of-specification observations
as well as the predominant focus on end-product
testing—often based on an inadequate statistical
consideration of inherent variability and static
process conditions— which, some argue, evolved to
facilitate regulatory document expectations for “process
validation.”
VIEWPOINT 2005
Pharmaceutical Technology SEPTEMBER 2005

2005 onwards, amazing opportunities to expand my
Viewpoint 2015
VP & Global Head Biopharmaceutical
Development, Sandoz
• Biosimilars & complex generics
VP Next Generation Product Assessment and
then Chief Scientific Officer at Philip Morris
International
• Plant based vaccines & Modified Risk Tobacco Products
President Biotechnology & Chief Scientific Officer
at Wockhardt Ltd
• Understanding the aspirations, opportunities and challenges
in India

Way forward to 2020 Culture of Quality

What is Quality?
Medicine made correctly when no
one is looking.

When is medicine
made correctly?
Our collective consensus, based on science,
objectively determines what are the good
practices – capability, capacity and commitment
to practice when no one is looking.

When medicine is
not made correctly…
People get sick. Some die. It is hard to detect
harm. Some of these people are already very
vulnerable, and proving the cause of harm from
impurities, adulteration, and counterfeits can be
elusive. Congressman Shimkus

 1937
 1962
 1989
 2007
 2012
FD&C Act Kefauver-Harris
1984 Drug Price Competition
and Patent Term Restoration Act
FDASIA ……………….
A partial, historical, ‘snap-shot’ of the US FD&C Act
Proactive risk
classification &
mitigation
needed

With increasing
complexity…
Mistakes cost more lives. Path to success must
be built on trustworthiness so as to proudly
proclaim to the world we (a company) make
the medicine you confidently give to your child!

What is Culture of
Quality?
Knowledge, beliefs, values, traditions,
behaviors and practices that give
confidence that medicine is made
correctly when no one is looking.

When no one is
looking?
Our intention guides our
behavior.

We are humans
Our thoughts and beliefs are
powerful and influence our
actions and also outcomes.

Placebo effect: A study
published in 2015 “opens our eyes to another
nuance of placebo effect with implications for
clinical practice, the research enterprise, and health
policy”. Editorial Neurology 84: 2015
“perceptions of cost are capable of
altering the placebo response in
clinical studies.” Neurology 84: 2015

Also, as humans “we can be blind to the obvious, and
we are also blind to our blindness.”
Daniel Kahneman,
Thinking, Fast and Slow
http://web.mit.edu/persci/people/adelson/checkershadow_proof.html

Do these questions continue to linger in Company X?
What is pharmaceutical quality?
Compendial testing sufficient?
Process validation – representative of commercial manufacturing?
Deviation from cGMP means the product is ‘adulterated’?

4/14/2015
CONFIDENTIAL – © AJAZ S. HUSSAIN |
INSIGHT ADVICE & SOLUTIONS LLC
24
Risk of unintended or intended normative support for
‘testing into compliance’?
attitude
toward
performing
the behavior
Process
validation is
done so
quality is
good;
test prone to
error
“Batch failure
means I
made a
mistake”
subjective
norm
Documents
not critical;
Compendial
testing
sufficient
Local
regulators
collect & test
samples – no
issue there!
“Testing into compliance”

Organization (Policies
& Sr. Mgmt.)
Technology
(Constraints & Controls)
Individual
(Training & Certification)
Team & Supervisor
(Soft Defenses)
Defenses
(Quality Management System)
Error
Latent अप्रकट conditions Goal conflicts & mixed messages
Design flaws
Production pressures
Fear of error
“We cannot change the human condition. But…we can change the conditions under which
humans work” James Reason

How would you
respond to this
statement? 15.21
9.9
14.1
17.5
43.4
At many Pharma companies
[in India] the staff would feel
afraid to question a
supervisor’s order even when
they know for sure that the
supervisor’s order is not in the
interest of patients.
I disagree with
this statement
I completely agree
with this statement
N=263
Skipped = 0

How would you respond
to this statement?
I think management
should urgently work
towards making
error/mistake
reporting Normal, Easy
and Rewarding.
5.8
6.6
17.4
32.8
31.54
It is already easy – so
this is not urgent.
It is very difficult currently so
this is very urgent topic
N=259
Skipped =4

Predictors of CoQ: Act consciously in the interest of
patients – when no one is looking.
Only four
attributes
actually predict
a culture of
quality:
Leadership
Emphasis
Message
Credibility
Peer
Involvement
Employee
Empowerment
People will
change their
behavior if they
see the new
behavior as
Normal (1)
Easy (2)
Rewarding (3)

A simple framework for CoQ
Culture
of
Quality
Normal
Easy
Rewarding
QMS
System
Knowledge
Variation
Behavior
Behavior
- GXPs
Fear
Removed
Mastery
Awareness
Environment Leadership Emphasis Message Credibility Peer Involvement Employee Empowerment
Deming’s Profound Knowledge
& James Reasons – Human Factors

 Systems thinking: System is the product of interacting parts; improving the parts
taken separately will not improve the system
CEO &
Sr. Management
Culture
of Quality
Managers &
Leaders
Effective
QMS
GXP
Compliance
All
Employees
Quality is Easy

“Not so highly regulated”
Export quality
“Highly regulated”
“Pharmacy to the World”
Domestic quality
Standard = Highly Regulated

Allopathy: Export quality = Domestic quality
If not - why should any one believe that, when no one is
looking, quality is delivered as promised?
The argument – that “affordability” demands two
quality standards is weak, indefensible and takes way
from the aspiration to be “pharmacy to the world”.
Commitment to a single quality standard – we are all
humans – is a measure of culture of quality.

Since 2000 organizations based in India have received
the most Deming Prizes
0
5
10
15
20
25
Deming Prizes since 2000
http://blog.deming.org/2014/10/2014-deming-prize-awardees/
•Commitment to Total Quality Management
•The foundation is total employee involvement!
What does it take to win the “Deming Prize”?
• Attrition rates 25-50%; primarily in QC/QA departments;
why? Is the fear level so high?
• How effective is their training in college? At the company?
How effective are supervisors in coaching and mentoring
techniques?
• How effective are the HR systems to mitigate the effects of
“Saala main to sahab ban gaya” attitudes in some
supervisors and senior management?
• Why 483 Observations are often not shared with the
employees?
• How many Sr. Management truly understand what is quality
– and are their messages credible?
Where are we today in India Pharma?

Empower professionals, give them the challenge to make
India the ‘pharmacy to the world’; slogans will not do it.
There is amazing talent & commitment to hard work
Urgent need for more effective training, coaching and
mentoring – to remove fear and to empower
Within India, but outside Pharma, there is an ongoing
“quality revolution” in some sectors; knowhow for ‘world
class quality’ is right here

Knowhow for ‘world class quality’ is right here

Viewpoint 2015 “Dil Se”
To remain true to ‘first do no harm’ we, the
legitimate pharmaceutical community, have
inherited, and accepted, a culture of quality
that demands that our intention, our
awareness and our skills deliver ‘quality by
design’ with continued vigilance to detect,
correct and to prevent errors that have caused,
or have the potential to cause, harm to the
patients we serve. We also recognize the
limitations of our pharmacovigilance.
We must more clearly recognize that CAPA is
not ‘continual improvement’ and that we
must strengthen our culture of quality to
deliver continual improvement in our ability
to assure quality, reduce costs and enhance
confidence in what we do. Ajaz S. Hussain, Ph.D., Mumbai, 24 March 2015
VIEWPOINT 2015

Viewpoint 2015 “Dil Se” to Solutions
In the immediate – short term, until 2020, industry will need
to take-on ‘skills development’ for the work-force it needs to
be the ‘pharmaceutical factory to the world’!
In parallel, a strong focus on institutional recovery to
excellence critical to realize the aspiration to be the
‘Pharmacy to the World’!

• Leadership emphasis
• Message credibility
• Peer involvement
• Employee empowerment
Re-shaping the Environment
• Quality is normal
• Quality is easy
• Quality is rewarding
Re-setting the Norms
• Commitment to the System
• Knowledge based
• Understanding & controlling variations
• Safe-guard human error; pride of workmanship
Ensuring effective QMS
• Fear removed
• Mastery
• Awareness
Promoting proactive behaviors
“Pharmacy to the World”: A champion for
Strengthen
our culture
of quality
Affordability - Patient
focused, continually
improving system based
on deep understanding
& integrating
engineering & statistics.
One quality standard -
‘Do No Harm’ to
‘Providing a Healing
Touch’ – “India Pharma
Brand Identity – Made in
India, Proudly”.
Health Care for All –
Leadership in setting the
standards for Integrative
Medicine, leveraging the
Wisdom Traditions.
1
23
4
Pharmaceutical Factory to the World
Pharmacy to the World 1

Dr Venkateswarlu Memorial Lecture 2015

Recomendados

Recomendados

Más contenido relacionado

La actualidad más candente

La actualidad más candente (20)

Destacado

Destacado (17)

Similar a Dr Venkateswarlu Memorial Lecture 2015

Similar a Dr Venkateswarlu Memorial Lecture 2015 (20)

Más de Ajaz Hussain

Más de Ajaz Hussain (20)

Último

Último (20)

Dr Venkateswarlu Memorial Lecture 2015