dr venkateswarlu memorial lecture 2015

Dr. M. Venkateswarlu Memorial Lecture

Culture of Quality

Indian Pharma Inc. : Adapting to the Rapidly Evolving Global Challenges

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6 June 2015 IPA Convention 2015, BKC, Mumbai 1

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“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


http://www.cnbc.com/id/42551921

http://www.cnbc.com/id/101966191

http://wap.business-standard.com/article/opinion/it-is-now-india-s-turn-to-sustain-asia-s-success-115052300806_1.html

India is set to become the youngest country by 2020Girija 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

http://images.alfresco.advanstar.com/alfresco_images/pharma/2014/08/22/fcb413f5-f60b-4316-a400-c5e2f02cb9e8/article-178644.pdf

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 ActFDASIA ……………….

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

http://www.goodreads.com/author/show/72401.Daniel_Kahneman

http://www.goodreads.com/work/quotes/16402639

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’?


4/14/2015CONFIDENTIAL – © AJAZ S. HUSSAIN |

INSIGHT ADVICE & SOLUTIONS LLC24

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

43.4At 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.

5.86.6

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?

http://blog.deming.org/2014/10/2014-deming-prize-awardees/

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

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