MEDICINMAN · QbD principles promote innovation and continu-ous improvement of the product. When asked about the benefits of implementing QbD principles at the formulation development

MEDICINMANAugust 2018| www.medicinman.net Indian Pharma’s First Digital Magazine Since 2011

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Last month, Amazon was reportedly in talks to invest Medplus, the second largest Indi-an pharmacy chain after Apollo Pharmacy.

Whether Amazon succeeds in the healthcare market, or not, remains to be seen but the rea-son I believe healthcare is about to get ‘Ama-zonized’ is because of what Chris Holt, Amazon’s leader of Global Healthcare said recently:

“When we think about the healthcare space, our overall philosophy of obsessing around the customer has served us really well. So, we start with the customer and we work backwards.”

Such thinking comes as breath of fresh air – so antithetic it is to the current thinking in health-care. Incumbents might smirk at it, but custom-er obsession is the primary reason why Amazon and other tech companies have built giant cor-porations at an unbelievable pace.

The rules of the digital economy are different from what we are normally used to. That is why a shift in thinking and mindset is key to winning. New ways of doing business come with new rules:

Rule 1: Move from selling to engaging. The old business model was to sell products. The new business model is to engage customers and ensure that they consume your content and not someone else’s. (Customers do have a choice).

1 | MedicinMan August 2018

Amazon's drive to put the consumer at the center of their market strategy could very well topple well-established incumbents in healthcare.

THE 'AMAZONIZATION' OF HEALTHCARE

Salil Kallianpur

“... Amazon understands Indian

consumers better than most

other pharma players including

retailers due to their dependence

on data and business intelligence.

So, their move into the pharmacy

space might be better thought out

than we can possibly see now.

Salil Kallianpur | The 'Amazonization' of Healthcare

Rule 2: Data is the new currency. The old curren-cy was number of Rx, product sales etc. The new currency is data – about your customers, their in-terests, preferences – as much possible and con-stantly updated.

Rule 3: Customer experience is the new lever of competitive advantage. The old competitive ad-vantage was size of field force, better drug efficacy and safety, more SKUs etc. The new competitive advantage is customer experience. If your custom-er enjoys the experience that they have with your brand, content, website, rep etc., you’ve won.

Amazon has always had a track record of creating fundamental changes to any industry that they en-ter:

“We are just trying to figure out what we learned in other industries and how we have architected our own infrastructure to figure out how we can bring that to healthhcare and help healthcare migrate to simpler solutions.” – Chris Holt

I also believe that Amazon understands Indian con-sumers better than most other pharma players in-cluding retailers due to their dependence on data and business intelligence. So, their move into the pharmacy space might be better thought out than we can possibly see now:

“We aren't trying to fit into any traditional defini-tion of how things work in healthcare. We're trying to bring our own capabilities to the market. We've seen a tremendous willingness among our cus-tomer base to try out new things even though they know that it might not be something that they're used to.” – Chris Holt

Amazon has shown itself to have a ruthless, ‘win-ner-takes-all’ approach and it is that monopolistic approach to business that will worry the govern-ment more than anything else. But, if patients, caregivers and consumers are happy, the Ama-zonization of Healthcare will be complete. MM


Salil Kallianpur is Principal Consultant at Digital Trans-formation Lab and Executive Editor at MedicinMan

CONTENTS

Our mission is to collectively improve the pharma sales and marketing ecosystem - leading to better relationships with doctors and better outcomes for patients.

MedicinMan Volume 8 Issue 8 | August 2018

Editor and PublisherAnup Soans

Chief MentorK. Hariram

Executive EditorSalil Kallianpur

Editorial BoardProf. Vivek Hattangadi; Deep Bhandari; Hanno Wolfram; Renie McClay

Letters to the Editor: [email protected]

1. The 'Amazonization' of Healthcare ...............1

Amazon's drive to put the consumer at the center of their market strategy could very well topple well-established incumbents in healthcare.

Salil Kallianpur

2. Quality – A Key Issue at OPPI, IPA and IDMA Joint Summit .......................................................5

Vivek Hattangadi reports on the issue that is keeping industry CEOs awake at night, in an otherwise globally respected industry.

Vivek Hattangadi

3. DigiStorm 2018 - To 'Do' Dgital or 'Be' Digital - that is the Question ..........................................10

Digital is has changed how we travel, consume news, connect with friends and family and buy groceries - what is its true impact on healthcare?

K. Hariram


Connect with Anup on LinkedIn | Facebook | Twitter

Anup Soans is an L&D Facilitator, Author, Pharma Consultant.

muckrack.com/anupsoans/articles

Meet the editor

Pharma in the Digital Economy.

DigiStorm 2018Bangalore Edition

11th September, Lalith Ashok

About DigiStormDigiStorm is the flagship digital pharma event from MedicinMan.

Every year, DigiStorm brings together thought leaders from Indian pharma to decipher the impact of digital on the patient journey, phar-ma marketing, corporate L&D and the health-care landscape at large.

With speakers and participants from India’s biggest and most innovative pharma compa-nies and service providers, DigiStorm sets the digital agenda for the year ahead.

Karnataka Drugs and Pharmaceuticals Manufacturers' Association

REGISTER AT: medicinman.net/digistorm

Prabir Jha, President & Global Chief People Officer, Cipla

Salil Kallianpur, Principal Consultant – Digital Trans-formation Lab and Executive Editor at MedicinMan

K. Hariram is Chief Mentor at Medicin-Man and an executive coach. He is the former MD at Galderma India

Deep Bhandari, Editorial Board Member, MedicinMan

Sunil Attavar, Chairman and Managing Director, Group Pharmaceuticals

Anup Soans, Editor, Medicin-Man

Sankar Dass, Chief Executive Officer, Curatio Healthcare

Amit Bhakri, Business Unit Head, Specialty Care, AstraZen-eca

Suresh Subramanian, Head South Asia, Biocon Branded Formulations, Biocon

Raja MVSMA, Vice President, Marketing & Portfolio, Dr. Reddy’s Labora-tories

Varadarajan S, Vice President, Corporate Learn-ing & Develop-ment, Micro Labs

Dr. Karthik Anantharaman, Business Unit Head (Meta-bolics/Branded Formulations/Biosimilars), Biocon

Pankaj N Gursahani, PhD, Director, Sales Training, Astra-Zeneca India

Amlesh Ranjan, Deputy Director, Super Specialty, Sanofi

Jiten Karani, Senior Director, Sales Force Effec-tiveness, Biocon

IN PARTNERSHIP WITH

For more information and to register, visit:

medicinman.net/digistorm


The other day I asked a medical practitioner, a friend of mine for the last 41 years, as to which brand of amoxicillin+clavulanic acid would he

use if someone from his family needed it. “Augmentin”, pat came the reply. ”Why not…,” I named a few brands. “Because Augmentin is Augmentin. And I know that it comes from a top-class company with top class quali-ty. I do not wish to take a chance with any other brand.”

“Each time we pop a pill, feed syrup to little ones, vac-cinate our babies or inject a medicine into our critical-ly-ill loved ones, the obvious hope is that it will work. But, we are totally oblivious to the untold story of the medicine,” says an Organization of Pharmaceutical Pro-ducers of India (OPPI) release.

Millions of people all over the world are alive and in good health today because they have ‘trusted’ the pill to do its job. “Trust” that is a result of the doctor-pa-tient relationship and in the pill that is expected to do its work.

For the first time in the history of the pharma indus-try in India, all the three major pharma manufacturers bodies viz. the OPPI, the IPA (Indian Pharmaceutical Alliance) and the IDMA (Indian Drug Manufacturers Association) met on a common platform in June 2018 to set an agenda that would:

QUALITY – A KEY ISSUE AT OPPI, IPA AND IDMA JOINT SUMMIT

Vivek Hattangadi

Vivek Hattangadi reports on the issue that is keeping industry CEOs awake at night, in an otherwise globally respected industry

Vivek Hattangadi | Quality – A Key Issue at OPPI, IPA and IDMA Joint Summit

Ø Agree on the importance of setting and adopt-ing best-in-class global quality standards for the pharmaceutical industry;

Ø Bring all stakeholders together – regulators, industry and governments, both state and central – to create the enabling conditions for achieving this goal, and

Ø Define the quality roadmap for India

It is imperative to build a culture of quality in the country. The summit called for adopting global quality standards. “Bring all stakeholders like reg-ulators, industry and government to work jointly towards the growth of the sector”, was the rallying cry.

In an interview, Dr. Sanjit Singh Lamba, Chair - OPPI Technical & Supply Chain Committee & Managing Director, Eisai Pharmaceuticals India, spoke about the initiative taken by FDA (Food and Drug Ad-ministration) to inject Quality by Design (QbD) to build quality into the product right from the start of manufacturing.

This contrasts with the traditional Quality by Test-ing (QbT) approach that tests product quality by checking it against the approved regulatory spec-ifications at the end of the manufacturing stream.

QbD principles promote innovation and continu-ous improvement of the product.

When asked about the benefits of implementing QbD principles at the formulation development stage, Dr. Lamba said that there are many benefits of QbD at formulation development stage. A few of them are listed below:

Ø The product is developed considering custom-er’s (patients) need.

Ø A robust process is developed as it focuses on a control strategy rather than testing

Ø Overall development is systematic, and multi-variate experiments are conducted to under-stand the process and product which estab-lishes a design space.


“For the first time in the history of the pharma industry in India, all the three major pharma manufacturers bodies viz. the OPPI, the IPA (Indian Pharmaceutical Alliance) and the IDMA (Indian Drug Manufacturers Association) met on a common platform in June 2018


Ø The process can be adjusted within the design space rather than remaining a fixed process.

Ø Product life cycle is managed as a preventive action rather than through reactive problem solving.

He added that QbD principles can save costs in terms of both time and money as against QbT.

Mr. Annaswami Vaidheesh, President, OPPI and Managing Director GSK Ltd. said, "Quality of medi-cines are pivotal in delivering patient care and the entire pharmaceutical industry has come together to stress the importance of quality in delivering re-sponsible and safe patient care. Quality should be embedded in every stage of the medicine-making process and across the delivery chain – from the R&D laboratory to the pharmacy where the patient buys the drugs”.

The Indian pharma industry has contributed im-mensely to driving healthcare objectives and the economic growth of India. The industry has grown by 8.5% over the last 10 years and contributes to 3.1% of our nation’s GDP and close to 10% of India’s exports. One million Indians are employed in this sector, the release said.

Indian pharma has contributed not just to the health outcomes of Indians but to patients glob-ally. 60% of vaccines globally are produced in In-dia and India supplies 30% of the requirements of United Nations Children’s Fund (UNICEF). 60-80% of vaccines procured by the UN come from India.


“Dr. Sanjit Singh Lamba, Chair - OPPI Technical & Supply Chain Committee & Managing Director, Eisai Pharmaceuticals India, spoke about the initiative taken by FDA (Food and Drug Administration) to inject Quality by Design (QbD) to build quality into the product right from the start of manufacturing.

This contrasts with the traditional Quality by Testing (QbT) approach that tests product quality by checking it against the approved regulatory specifications at the end of the manufacturing stream.


No wonder then that India is called the ‘Pharmacy of the World’.

India will continue to drive the availability of high quality drugs at low cost. Quoting an example, the cost of therapy per month of the long acting insu-lin, LANTUS is US$42 in India, US$139 in China and US$186 in the US. Advair Inhaler costs US$10 in In-dia; in the US it is US$154.

The summit also highlighted the many instances of poor quality products manufactured in India that have recently surfaced. Drug quality is one of the major challenges faced by the industry. This has been reported extensively.

At the summit, adherence to a Quality Assurance Program was emphasized to make certain that each medicine reaching a patient is safe, effective and of a standard quality – all adhering to WHO-cGMP. The ‘c’ in cGMP stands for ‘current,’ requiring com-panies to use technologies and systems that are up-to-date, to comply with regulations, and assure the quality of every batch every day.

By implementing WHO-cGMP and PIC/S, India can aim for meeting stringent Global Standards. It highlighted the differences between GMP (Sched-ule M) and WHO-cGMP and why the latter needs to be adopted.

The summit highlighted the difference between pharmaceutical equivalence and bioequivalence. Two pills may look alike but they may not be the same. The determinants of pharmaceutical quality were discussed in detail.

Identity, purity, potency, uniformity and stability are defined in pharmacopoeias and stated in the certificate of analysis (COA) of each lot of the prod-uct.

Low quality of medicines can result in prolonging illness and even death. Besides it is a waste of limit-ed financial resources, loss of credibility and worse – distress to patients and family.


“By implementing WHO-cGMP and PIC/S, India can aim for meeting stringent Global Standards. It highlighted the differences between GMP (Schedule M) and WHO-cGMP and why the latter needs to be adopted.


The summit also discussed the underlying issues that drive a gap in quality from the manufacturer’s perspective. There were the gaps in ensuring ad-herence to standards or SOPs. Standards are not in line with best-in-class. Schedule M provides robust guidelines but needs to be upgraded to global standards. The need is to adopt WHO GMP & devel-op a roadmap for PIC/S.

There is a dire need for pharmaceutical manufac-turers to achieve excellence in quality on a sustain-able basis.

In conclusion, six potential themes emerged

1. Adopt to WHO-cGMP.

2. Develop a roadmap to join PIC/S

3. Strengthen drug filing requirements in India.

4. Extend regulatory and quality checks till the last mile

5. Cooperate with other regulators

6. Provide requisite financial support to ensure baseline standards

MM


“Low quality of medicines can result in prolonging illness and even death. Besides it is a waste of limited financial resources, loss of credibility and worse – distress to patients and family.

Vivek Hattangadi is a Consultant in Pharma Brand Management and Sales Training at The En-ablers. He is also visiting faculty at CIPM Calcutta (Vidyasagar University) for their MBA course in

Pharmaceutical [email protected]


Do a Google search on "digital transformation" and you'll get 11.5 million results, topped by ads from various technology giants. People

generally don’t explain what they mean by "digital transformation," and quite often it sounds like one of those buzzwords (or buzz phrases), like "paradigm shift" and "new normal," that don't mean much of any-thing at all.

Of course, Digital transformation is a current buzz-word, but the roots go far back. Today, the retail indus-try, hospitality and taxi services are three examples of what digital transformation really is and the amazon, the Airbnb and the Uber are a part of us on our smart-phones that we hold very dearly in our hands day in and day out.

Where is India pharma in this journey of digital trans-formation? The Ken, in an article titled “Indian Pharma doesn’t have a choice but to market digitally” was cat-egorical that Indian pharma has no option but to em-brace digitalisation of its marketing activities.

While Indian pharma has certainly been moving in this direction, there seems to be a lot of hesitation in wholeheartedly embracing it. Mostly, for Indian phar-ma digital is synonymous to “iPad detailing” which means transferring the visual aid onto glass (tablet) or each brand manager creating an app for the physician to download. At the receiving end is the pharma sales person who finds it very difficult to convince the phy-sician to download the app, much to his annoyance.

K. Hariram

DigiStorm 2018 - to 'do' digital or 'be' digital - that is the question.

Digital is has changed how we travel, consume news, connect with friends and family and buy groceries - what is its true impact on healthcare?

K. Hariram | DigiStorm 2018 - To 'Do' Dgital or 'Be' Digital - that is the Question

Couple of relevant questions pop up in my mind. Is this what digital means? Is the digital route just a different medium? Should it just be looked at through the marketing lens or should it grow be-yond? Should digital function be a separate one from marketing or should all marketers be savvy to embrace digitalization as part of their core market-ing function?

DigiStorm 2018, to be held on 11th September in Bangalore in partnership with KPDMA, provides an opportunity to deliberate and find some of the an-swers to the above questions and a way forward to adopting digital in pharma marketing.

One of the questions that will be asked in this fo-rum is: “Is Indian Pharma embracing more digital technology?” The relevant question in my mind is, “do we want to be ‘doing digital’ rather than ‘being digital’?” – which means using digital technologies to make incremental improvements to the status quo, but not yet weaving digital into their organi-sational and marketing DNA.

To have greater understanding, better perspective and deeper insights, do register yourself and join us on 11th September 2018 at The Lalit, Bengaluru for the DigiStorm 2018 event. Visit us for more de-tails at www.medicinman.net/digistorm. MM


K. Hariram is the former MD (retd.) at Galderma India. He is Chief Mentor at MedicinMan and a regular contributor. [email protected]

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MEDICINMAN · QbD principles promote innovation and continu-ous improvement of the product. When asked about the benefits of implementing QbD principles at the formulation development