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Dr Venkateswarlu Memorial Lecture 2015

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Purpose of this talk is to request you to consider the following 4 Steps
1. Strengthening the ‘Culture of Quality’ – the focus of this talk
2. Improve efficiency with confidence in controls by integrating India’s engineering and statistical know-how and technologies
3. Working together – ‘One Quality for All’ to say proudly – Made in India: Pharmaceutical Factory to the World
4. 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.

Published in: Health & Medicine

Dr Venkateswarlu Memorial Lecture 2015

  1. 1. 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
  2. 2. “Pharmacy to the World” is the right aspiration for India 6 June 2015 IPA Convention 2015, BKC, Mumbai 2 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
  3. 3. ‘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 6 June 2015 IPA Convention 2015, BKC, Mumbai 3
  4. 4. 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 6 June 2015 IPA Convention 2015, BKC, Mumbai 4 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’
  5. 5. 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. 6 June 2015 IPA Convention 2015, BKC, Mumbai 5
  6. 6. Background: India Pharma The narrative on India Pharmaceutical Sector 2005 Current state Looking forward to 2020 6 June 2015 IPA Convention 2015, BKC, Mumbai 6 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’?
  7. 7. Background: 2005 a special year 6 June 2015 IPA Convention 2015, BKC, Mumbai 7 February 25, 2005, Mumbai The ISPE India- US FDA PAT forum…. Sharing the stage with… Dr. M. Venkateswarlu, then Deputy DCGI
  8. 8. 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 6 June 2015 IPA Convention 2015, BKC, Mumbai 8
  9. 9. 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 6 June 2015 IPA Convention 2015, BKC, Mumbai 9
  10. 10. Viewpoint 2005: As a regulator 6 June 2015 IPA Convention 2015, BKC, Mumbai 10 “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
  11. 11. 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 6 June 2015 IPA Convention 2015, BKC, Mumbai 11
  12. 12. Way forward to 2020 Culture of Quality 6 June 2015 IPA Convention 2015, BKC, Mumbai 12
  13. 13. What is Quality? Medicine made correctly when no one is looking. 6 June 2015 IPA Convention 2015, BKC, Mumbai 13
  14. 14. 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. 6 June 2015 IPA Convention 2015, BKC, Mumbai 14
  15. 15. 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 6 June 2015 IPA Convention 2015, BKC, Mumbai 15
  16. 16. 6 June 2015 IPA Convention 2015, BKC, Mumbai 16  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
  17. 17. 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! 6 June 2015 IPA Convention 2015, BKC, Mumbai 17
  18. 18. 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. 6 June 2015 IPA Convention 2015, BKC, Mumbai 18
  19. 19. When no one is looking? Our intention guides our behavior. 6 June 2015 IPA Convention 2015, BKC, Mumbai 19
  20. 20. We are humans Our thoughts and beliefs are powerful and influence our actions and also outcomes. 6 June 2015 IPA Convention 2015, BKC, Mumbai 20
  21. 21. 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 6 June 2015 IPA Convention 2015, BKC, Mumbai 21
  22. 22. Also, as humans “we can be blind to the obvious, and we are also blind to our blindness.” Daniel Kahneman, Thinking, Fast and Slow 6 June 2015 IPA Convention 2015, BKC, Mumbai 22 http://web.mit.edu/persci/people/adelson/checkershadow_proof.html
  23. 23. 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’? 6 June 2015 IPA Convention 2015, BKC, Mumbai 23
  24. 24. 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”
  25. 25. 6 June 2015 IPA Convention 2015, BKC, Mumbai 25 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
  26. 26. 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. 6 June 2015 IPA Convention 2015, BKC, Mumbai 26 I disagree with this statement I completely agree with this statement N=263 Skipped = 0
  27. 27. 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 6 June 2015 IPA Convention 2015, BKC, Mumbai 27 It is already easy – so this is not urgent. It is very difficult currently so this is very urgent topic N=259 Skipped =4
  28. 28. 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) 6 June 2015 IPA Convention 2015, BKC, Mumbai 28
  29. 29. A simple framework for CoQ 6 June 2015 IPA Convention 2015, BKC, Mumbai 29 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
  30. 30. 6 June 2015 IPA Convention 2015, BKC, Mumbai 30  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
  31. 31. 6 June 2015 IPA Convention 2015, BKC, Mumbai 31
  32. 32. “Not so highly regulated” Export quality “Highly regulated” “Pharmacy to the World” Domestic quality Standard = Highly Regulated 6 June 2015 IPA Convention 2015, BKC, Mumbai 32
  33. 33. 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. 6 June 2015 IPA Convention 2015, BKC, Mumbai 33
  34. 34. Since 2000 organizations based in India have received the most Deming Prizes 0 5 10 15 20 25 Deming Prizes since 2000 6 June 2015 IPA Convention 2015, BKC, Mumbai 34 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?
  35. 35. 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 6 June 2015 IPA Convention 2015, BKC, Mumbai 35
  36. 36. Knowhow for ‘world class quality’ is right here 6 June 2015 IPA Convention 2015, BKC, Mumbai 36
  37. 37. Viewpoint 2015 “Dil Se” 6 June 2015 IPA Convention 2015, BKC, Mumbai 37 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
  38. 38. Viewpoint 2015 “Dil Se” to Solutions 6 June 2015 IPA Convention 2015, BKC, Mumbai 38 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’!
  39. 39. 6 June 2015 IPA Convention 2015, BKC, Mumbai 39 • 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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