Express Pharma (Vol.14, No.1) November 01-15, 2018

CONTENTS PHARMA LIFE

Vol.14 No.1 November 1-15, 2018

Chairman of the Board Viveck Goenka Sr. Vice President-BPD Neil Viegas Asst. Vice President-BPD Harit Mohanty Editor Viveka Roychowdhury*

Rapid adoption of disruptive technologies are bringing in new approaches and outcomes in the pharma sector. An analysis| P22

BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Swati Rana, Tanuvi Joe New Delhi Prathiba Raju

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THROUGH NETAP WE WANT TO BRIDGE THE GAP BETWEEN EDUCATION AND EMPLOYMENT

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DESIGN Asst. Art Director Pravin Temble Chief Designer Prasad Tate Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma Digital Team Viraj Mehta (Head of Internet ) Photo Editor Sandeep Patil Marketing Team Rajesh Bhatkal Ambuj Kumar Debnarayan Dutta Ajanta Sengupta E Mujahid Nirav Mistry PRODUCTION General Manager BR Tipnis

P10: INTERVIEW Ishaan Khanna CEO, Diagnostic & BioBank Divisions, LifeCell International

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HEALTHCARE SABHA'S 4TH EDITION PRESENTS PHARMA PERSPECTIVE ON PUBLIC HEALTH

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70TH IPC TO ADD HEALTHCARE AND DIAGNOSTIC TO ITS SPECTRUM

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BECKMAN COULTER AND EXPRESS PHARMA, ORGANISE SEMINAR IN BADDI

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FLEXFACTORY, LIFE SCIENCE SOLUTIONS TO DRIVE GROWTH FOR GE HEALTHCARE

LOGISTICS SPECIAL

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TRANSFORMING PHARMA LOGISTICS WITH IOT PATCHEMS: PARTNERS IN PROGRESS

P32: INTERVIEW Yogesh Mudras Managing Director, UBM India

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DOMINO PRINTECH: A WORTHY PARTNER FOR CODING SOLUTIONS

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STERILIZATION OF HEALTH CARE PRODUCTS — CHEMICAL INDICATORS

LOGISTICS: A KEY ROUTE TO SUCCESS

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EDITOR’S NOTE

Competition watch dog raps pharma cos

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ndia is probably the only or one of the few pharma markets where we have a third category (branded generics) in addition to branded and generic medicines. The Competition Commission of India's recent policy note on ‘Making Markets Work for Affordable Healthcare’, comes down heavily on branded generics.

Addressing the quality perception behind proliferation of branded generics, the policy note points out that while worldwide, generic drugs are seen as a key competitive force against the patentexpired brand name drugs marketed at monopoly prices, in India, the pharma market is dominated by ‘branded generics’ which limit generic-induced price competition. The CCI note states that the price premium enjoyed by branded generics could be due to the perceived quality assurance that comes with the brand name, leading to prescription by doctors but it also cautions that it is equally possible that the brand proliferation is to introduce artificial product differentiation in the market, offering no therapeutic difference but allowing firms to extract rents.

The CCI puts the onus on the country's regulators to stop this practice, recommending that the regulatory apparatus must address the issue of quality perception by ensuring consistent application of statutory quality control measures and better regulatory compliance. Unless the quality of drugs sold in markets can be taken to be in conformance of the statutory standards regardless of their brand names, generic competition in the true sense of the term cannot take off, says the note.

The CCI's recommendation of a one-companyone-drug-one brand name-one price policy to address this practice of creating artificial product differentiation is not a new one. Why then has it not been implemented? Obviously the industry has managed to bury this recommendation each time it is raised.

The CCI note also highlights how pharma companies and trade associations contribute towards building up the high margins on drug prices and suggests that efficient and wider public procurement and distribution of essential drugs could be one solution. Electronic trading of drugs,

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While the CII note appreciates 'legitimate public policy objectives', it tries to determine the extent to which choice and competition can improve outcomes consistent with those objectives

with appropriate regulatory safeguards, could be another way to bring in transparency and spur price competition among platforms and among retailers.

The CCI has received 52 cases pertaining to pharma and healthcare sector over the nine years of enforcement of the Competition Act, 2002. The 'information asymmetry' in these sectors significantly restricts consumer choice and allows various industry practices (like branded generics, high trade margins etc) to flourish. While the CCI admits that such practices may not always violate the provisions of the Act, they create conditions that do not allow markets to work effectively and healthy competition to drive the market outcomes.

In light of these recommendations, one wonders how the CII will look at a recent suggestion from the US-India Business Council (USIBC), on behalf of some MNC pharma companies, to create a policy to allow a second portfolio of medicines, at a lower cost for distribution as part of the Ayushman Bharat (AB) scheme. This is clearly an attempt to tap the bottom of the pyramid market, but is it anticompetitive if it increases access to quality medicines at affordable prices?

While the CII note appreciates 'legitimate public policy objectives', it tries to determine the extent to which choice and competition can improve outcomes consistent with those objectives. In a nudge to regulators, it points out that the response to these issues can, in many instances, take the form of appropriate regulations that can pre-empt market-distorting practices and help create procompetition conditions. The CCI has shared the note with key ministries like the Ministry of Corporate Affairs, Ministry of Health and Family Welfare, Department of Pharmaceuticals and NITI Aayog. Since these are the Ministries which frame policies to regulate the pharma/healthcare sectors, one hopes these suggestions become part of regulations soon.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET I N T E R V I E W

Introduction of the molecular genetics confirmation, gives the much needed ‘diagnostic edge’ to the current newborn screening test After the government imposed restrictions on commercial banking of stemcells, LifeCell choose to diversify its business portfolio to diagnostics and tissue therapeutics through the launch of its RightStart division. However, low awareness about newborn genetic screening poses a lot of challenges for players in this arena. Ishaan Khanna, CEO of Diagnostic & BioBank Divisions, LifeCell International speaks on the opportunities and challenges in this field and the steps that need to be taken by the industry and the government to leverage the true potential of newborn genetic screening, with Usha Sharma

Why did the government impose restrictions on commercial banking of stem cells and how badly has it hit the industry?

As per the Indian Council of Medical Research (ICMR), at present there is lesser scientific evidence to substantiate clinical benefits with the use of stem cells derived from cord tissue, placenta, tooth extract, adipose tissue, dental pulp, menstrual blood and olfactory ensheathing cells etc. Yet, procurement and banking of these biological samples is increasingly becoming a commercial activity by few private stem cell banks. Most of these facilities that store umbilical cord tissue do so for a very high fee in lakhs of rupees.

Hence, care needs to be taken so that there is no exploitation and commoditisation of the resources. As of now, only umbilical cord blood banking is permitted and licensed by the CDSCO. Accordingly, commercial banking of all

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other biological materials not permitted until further notification.

ICMR was also concerned that some clinics may be offering stem treatments for medical conditions that cannot actually be treated.

The council wants to ensure that doctors do not mislead patients into trying untested therapies. Some doctors are fooling patients by offering stem cell therapy for conditions for which there is no scientific evidence. It may not be right to say that it has hit the industry in any way.

Its good that ICMR is working toward regulating this industry and Lifecell is in support of that.

In lieu of the recent guidelines issues, Lifecell has ensured and it complies with all the Indian medical guidelines and recommendation through the following measures: 1. Launch Community banking: 2. Stopped collection and storage of cord tissue which many other companies in

India are still doing 3. In order to support need for mesenchymal stem cells for approved therapies. ensure clients get access through an approved source while we work on building our tissue bank for the same Recently, LifeCell diversified its business portfolio to diagnostics and tissue therapeutic. Can you share the details of this development?

LifeCell Diagnostic, the diagnostic division of LifeCell covers wide range of biochemical and genetic test in Mother and Child portfolio. Started in 2012, Lifecell became the first diagnostic company in India to introduce two tier testing for new born screening backed up by a strong R&D team. LifeCell Diagnostics became the first commercial company in India to offer quantitative fluorescent polymerase chain reaction (QF-PCR) in prenatal settings and in 2018, LifeCell launched the revolutionary pentastic marker and became the first in the world to offer a biochemical marker test with a detection ratio of 98 per cent and FPR of 1.2 per cent. The RightStart programme, a recent initiative by LifeCell Diagnostic, is aimed to provide diagnostic confirmation to new born screening result. The integration of genetic sequencing to new born screening will help in reduction of false positives and also assist in faster initiation of treatment.

How is LifeCell’s ‘RightStart’ newborn screening different from other players’ offerings in the market?

In the current scenario, new born screening involves screening of biochemical analytes which predicts the probability of certain genetic conditions in the baby. This method has many complexities, influencing the result and test

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interpretations, thereby decreasing the precision and increasing the False Positive rate thereby contributing to parental anxiety.

LifeCell Diagnostics’ Rightstart test integrates biochemical screening with

molecular genetic testing.

The introduction of the molecular genetics confirmation, gives the much needed ‘diagnostic edge’ to the current newborn screening test. Though the current newborn screening

practices are effective, the addition of DNA based genetic test reflex enables a molecular diagnosis and rules out the possibility of false positives. Lifecell has packaged this in a single unit to avoid incremental costs.

To what extent is newborn genetic screening practised in India? Do you think it is going to increase in future?

Newborn screening is the most widely used paediatric initiative worldwide, but sadly in India it is still in a

MARKET very nascent stage considering high prevalence of many life threatening conditions. Our estimates suggest it is less one percent of the total births. With Government of India launching initiatives to create awareness about the importance of screening through its Rashtriya Bal Suraksha Karyakram and various PPP model the programme should see a wide acceptance in the future. Also at the level of pediatricians and gynaecologists, the awareness and understanding on the need for newborn screening has improved over the last few years. We are seeing more and more hospitals adopting this programme and expect that with a solution like ‘Rightstart’ the uptake should significantly improve.

The company is encouraging community banking, how is it going to play an important role in the future?

Recently, two important professional associations of doctors in India have issued statements against private banking of umbilical cord blood. Both the Indian Academy of Pediatrics (IAP) and the Indian Medical Association (IMA) have argued that the chance of a baby using its own stem cells is “negligible”. Both medical opinions consider allogeneic stem cell transplants to be the only valid use of cord blood, and only consider those diseases treated with transplants from a donor.

Hence, both the IAP and IMA recommend that families in India should preserve their baby’s cord blood in public banks rather than in private banks. A public cord blood bank is a common pool of stem cells, where patients in need can readily find matching stem cells for treatment In India.

Challenges faced by Public Cord Blood Banks in India Low Inventory: The total inventory of purely public

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LifeCell Diagnostics became the first commercial company in India to offer QF-PCR in prenatal settings and in 2018, we launched the revolutionary pentastic marker and became the first in the world to offer a biochemical marker test with a detection ratio of 98 per cent and FPR of 1.2 per cent cord blood units in India is below 6500 CBU. Jeevan, the only public bank that lists Indian cord blood units for transplant, has stopped to accept further cord blood donations due to lack of funds4. Globally there are about 750,000 public CBU spread over 55 major public banks in the world. But the ability to find a donor that is a close enough match for transplant depends on ethnicity, and calculations show that the chance of an Indian finding a match from these global cord blood banks is less than 10 per cent.

High Cost: Currently the cost to procure a single public cord blood unit in India is INR 15-20 lakhs. The cost to procure a public CBU from abroad varies by bank but is typically INR 30 lakhs.

An adult patient may require two CBU for a transplant, doubling the cost. Additional expenses, such as hospital costs, might accrue to INR 15-20 lakhs.

LifeCell’s Community Stem Cell Bank works similar to a public bank: Parents contribute their baby’s cord blood stem cells to a common pool for use by themselves and other members of the community. This increases the chances of finding a suitable matching donor and thereby expands the treatment options for patients. Thus the Community Banking model completely meets the IAP and IMA recommendations.

Not only does Community Banking solve the challenges and costs of the public

banking model, it is also a more sustainable business model compared to public bank LifeCell’s Community Bank currently has over 25,000 qualified cord blood units. This is over four times the inventory of India’s public banks and meets the required size to provide minimum matches for 96 per cent of Indian patients to learn more about cord blood banking. Basis this we see community banking as possibly a great solution for a country like India.

Why there is less awareness about newborn genetic screenings in India and what steps needs to be taken to increase it?

The level of acceptance in metros and in private hospitals has increased significantly in recent years but in tier II and III cities as well as government hospitals there are many challenges.

One of the main reason that can be attributed to the same is the cost involved in treatment and management of the disease. And another factor is the absence of doctor specialised on metabolic disorder who can counsel the patients on the diseases and management of the same. Another important factor that plays a role in the low level of acceptance is the high rate of false positives associated with the test and the subsequent high cost involved in confirmation of the screen positive results.

Steps that can help in the increase in awareness of the

programme: 1. Public-Private partnership models in endemic states to promote universal screening for every children born- Setting up labs in the government hospital 2. Set up NBS courses for paediatricians for counselling and disease management 3. Subsidised pricing for cost of treatment and management of disease Tell us the clinical challenges associated with newborn genetic screenings?

Clincal challenges are mostly around ensuring timely diagnosis, ensuring the right treatment and management to be provided which in many cases is not very straightforward and is expensive.

How genetic testing can improve new born screenings? How can state governments make it part of their programme?

LifeCell Diagnostics’ RightStart test integrates biochemical screening with molecular genetic testing.

RightStart enables the physicians to take the appropriate decision on disease management. The introduction of the molecular genetics confirmation, gives the much needed “diagnostic edge” to the current newborn screening test. Though the current newborn screening practices are effective, the addition of DNA based genetic test

reflex enables a molecular diagnosis and rules out the possibility of false positives.

Integration of genetic testing to new born screening helps in providing definitive diagnostic results and faster initiation of treatment. Steps that can help in the increase in awareness of the programme include publicprivate partnership models in endemic states to promote universal screening for every children born- by setting up localised labs in the hospital or developing nodal labs in the states.

How newborn genetic screening will empower the healthcare scenario from curative to preventive?

According to IMA 2016 data, one out of 20 newborn children is admitted in hospitals with genetic disorders. An efficient universal screening programme with integration of genetic testing will help in early detection and faster initiation of management and treatment of diseases thereby reducing the cost of the treatment and further reducing the mortality rate.

Most of the conditions in NBS are normally fatal and can incur huge cost of treatment and management if not diagnosed at the early stage. A simple example is of Congenital Hypothyroidism which is very common in India. If detected soon after birth, a very simple medication regime and prevent mental deterioration in the child, However if left undiagnosed till later, it can cause irreversible damage to the child's mental development.

Will new born screening be a part of Ayushman Bharat? And are you initiating dialogues with the state and central governments?

We expect it should, we are in discussion with various state governments and central health authorities to see how best this can get incorporated in the state health programmes. u.sharma@expressindia.com

MARKET POST EVENT

Healthcare Sabha's 4th edition presents pharma perspective on public health The national thought leadership forum for public healthcare continued with its mission of ushering crucial reforms with the sector Lakshmipriya Nair & Raelene Kambli Mumbai

THE INDIAN Express Group and Express Healthcare recently organised the fourth edition of Healthcare Sabha at Radisson Blu Airport, Delhi. Around 100 plus policy makers, thought leaders, pharma CEOs, national and international health organisations, social entrepreneurs, as well as technology and ancillary healthcare service providers congregated for this important meeting. .

The theme of the summit was Building the DNA for a Healthy Nation. The discussions revolved around subjects related to increasing quality, affordability and efficiency of medicines and health services.

Amongst several discussions and debates on pivotal issues, one interesting session was on ‘The path ahead in public health: A Pharma perspective’ which provided a fresh viewpoint on the role of pharma companies in public health.

The discussion was moderated by Viveka Roychowdhury, Editor, Express Healthcare & Express Pharma and the panelists were N Rajaram, MD, Sanofi India; Umang Vohra, MD & Global CEO, Cipla; Anuja Kadian, Head, Government Affairs,

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Inannuguration ceremony of the 4th edition of Healthcare Sabha

Dr S Eswara Reddy, DCGI speaks on the price control policies in healthcare

Dr Sujata Rao, Former Health Sect, Ministry of Health speaks on the Ethical Diemmas in healthcare

Lt Gen Bipin Puri, VSM, PHS Director General Armed Forces Medical Service speaks on the role of the Armed forces in public health

Panel Discussion on The path ahead in public health: A Pharma perspective

Dr V K Paul,Member, NITI Aayog speaks on strengthening India's public health system

Panel discussion on addressing the quality paradox in healthcare

Dr Abhay Bang, Director, SEARCH talks about the state of tribal health in India

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MARKET AstraZeneca Pharma India and AG Prasad, VP-Cluster Head, Sales & Marketing, Glenmark Pharma.

During this discussion, experts on the panel shared their companies’ vision toward building a strong healthcare ecosystem and ensuring quality medicines to every Indian citizen.

They also deliberated on challenges they face in doing so.

in order to be successful, socially responsible and sustainable in the long run. He further informed that Sanofi's involvement in public health is at three levels- ensuring access to medicines, investing in public health and innovating what is good for India.

Speaking about the most recent case of Bio-Med and the polio viral contamination,

Roychurdhury directed the discussion towards ensuring quality and efficacy of medicines.

Vora showcased Cipla's legacy of assuring quality access of medicines in India and abroad. He said that company was built on these principles and has evolved respectively. Vora also spoke about how Cipla is partnering with MNCs to stay committed to their mission. He said that access

is not equivalent to affordability, it is much beyond this, and it’s like building an ecosystem for healthcare where no citizen is deprived of medical aid.

Kadian shared AstraZeneca's strategy which is focussed on sustainability and how access to healthcare is primary to this vision. She explained how all their global initiatives are towards ensuring access to health-

care. She also spoke on the Ayushman Bharat scheme and how will be key to the process of India. Kadian also urged the corporate organisations to collaborate and invest in public health.

Similarly, Prasad spoke on the need for pharma companies to focus on solving India's health issues. He spoke on the need for more investment by both, the government and private sector

KEY HIGHLIGHTS ◗ Pharma sector is a major stakeholder of public health and has an important role to play in improving access to quality healthcare ◗ Access is not necessarily equal to affordability. It is beyond that and involves creating a conducive ecosystem for healthcare. ◗ As major stakeholders of public health the pharma sector needs to very vigilant about the safety and efficacy of their products. ◗ Ayushman Bharat is a bold initiative but it should not stop at UHC, cannot be solely driven by cost and should not be just about medicines and hospitalisations but also diagnosis. ◗ Every stakeholder of the healthcare system will have a role to play in making Ayushman Bharat a success.

Hence it is paramount to create capabilities to implement it effectively ◗ Ayushman Bharat is a bold initiative but it should not stop at UHC, cannot be solely driven by cost and should not be just about medicines and hospitalisations but also diagnosis

Roychowdhury began the conversation saying that health is not only the responsibility of the health ministry. It is a social matter and so every industry and every company needs to contribute to health and healthcare.

Rajaram stated that every industry and every company should imbibe the philosophy that what is good for the country is good for the company. He led the discussion towards understanding the social vision that pharma companies need to have

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MARKET in public health. Prasad highlighted that as an important stakeholder of public health pharma companies need to balance quality and efficacy of medicines.

Roychowdhury, while summing up the discussion, commented that Indian pharma companies while exporting drug to foreign countries are already contributing towards making them Ayushman, now the focus must shift to making India an Ayushman nation.

Apart from a thought-provoking panel discussion with pharma leaders, the event also witnessed interesting and riveting discussions on various pivotal aspects of public health.

To cite a few examples, an interesting discussion on Strengthening Public-Private Partnerships in healthcare saw industry stakeholders highlight that PPPs in healthcare should be designed on outcomes and not on inputs. Experts also stressed that if the intent is good and true, PPPs in healthcare will succeed. Both, the government and the private sector

should ensure focus on ‘value for all’ and not just ‘value for money’.

Likewise, another discussion on New Age New Realities revolved around demographic shifts and societal changes, which in turn, are giving rise to varied public health challenges and demanding new directions as well as approaches in the delivery of healthcare. It also explored all-inclusive strategies to deal with these issues.

Another discussion on ‘Why public health schemes fail in India?’, emphasised how better collaboration, improved synergies, more healthcare resources, effective use of technology are crucial to improve the success rate of health schemes in India. The discussion also highlighted that healthcare schemes need to be planned and built after considering the geographical and social conditions. Therefore, state-specific schemes might be more successful.

Addressing the quality paradox among medicines and services was also one of the

discussions at Healthcare Sabha 2018. It highlighted the need to ensure quality at each level of our public health system - be it procurement of quality medicines and medical devices or providing quality health services. It also focussed on providing a national framework for quality which will facilitate consistent implementation of quality improvement processes in every day public health practices.

The event also saw state health representatives from Jharkhand, Odisha etc, present the healthcare scenario in their state and the government’s initiatives to improve the public health system within these states. Representatives of railway hospitals also presented case studies of their programmes and endeavours to showcase their significance in the public health system of the country.

The event also witnessed attendance from leaders, regulators, patrons and game changers who addressed very crucial issues and aspects of public

health in India.

Dr V K Paul, Member, NITI Aayog spoke on strengthening India's public health system and how Ayushman Bharat will trigger quality improvement, bring in rationalisation of cost and accountability in the system. He assured that through Ayushman Bharat, the government is attempting to build a health system with a focus on making a gamut of healthcare services available to all.

Lt. General Bipin Puri, VSM, PHS Director General Armed Forces Medical Service who spoke on the role of armed forces in making public health a priority.

Dr S Eswara Reddy, DCG (I), in his special address, emphasised on how pharma regulators in India are keen to create an ecosystem for the industry which will propel progress and deter wrong doings. They are working on enhancing quality and fighting counterfeits through various monitoring and audit measures.

Sujata Rao, Former Health Secretary, Ministry of Health &

Family Welfare, Government of India gave a very thoughtprovoking address on the ethical dilemmas and emerging challenges in India's healthcare sector.

Dr Abhay Bang, Director, SEARCH gave a hard-hitting presentation on tribal Health in India. The economic burden due to poor tribal health is around ` 6000 crores. He also recommended measures such as sufficient political representation, better governance, adequate funding and financing mechanisms, ramping up the pool of human resources to improve tribal health.

Thus, there were several learnings from insightful sessions and thought-provoking at the two-day event. Apart from knowledge sharing galore, Healthcare Sabha also lauded deserving projects which have paved the path for reforms in the current public health scenario with Express Healthcare Public Health Awards. lakshmipriya.nair@expressindia.com raelene.kambli@expressindia.com

Anjana Malhotra,Health Care Rendered to Railway,SE Railway speaks on railways public health schemes

Power discussion on quality of medicines within government hospitals at Healthcare Sabha

Indian Express and Express Helthcare recognise the states for their contribution to public health through its Express Public Health Awards

Panel discussion on New Age New Realities in India’s public health

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70th IPC to add healthcare and diagnostic to its spectrum This year's IPC is going to have nearly 100 top notch industry veterans as speakers. Few of them will be international speakers as well Usha Sharma Mumbai WITH TWO months left for the 70th Indian Pharmaceutical Congress (IPC), preparations for the event are in full swing, informed committee members of IPC in its third Indian Pharmaceutical Congress Association (IPCA) meeting held on 20th October at Sun Pharma House, Mumbai.

The meeting commenced with a welcome address by

Dr TV Narayana, General Secretary, IPCA wherein he thanked all the members who had joined the meeting. He especially thanked Dilip Shanghvi, President IPCA and Founder, Sun Pharma. The meeting proceeded with a remark raised by Shanghvi that apart from pharma and academia, there is a greater need for the machinery manufacturers' fraternity to be part of this edition of the IPC. BR Sikri, LOC's Chairman

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informed that this year's IPC is also focussing on the healthcare sector. Dr Naresh Trehan,

Chairman and Managing Director, Medanta – The Medicity, will be the special invitee on

December 21 to launch the healthcare chapter at the 70th IPC. The event will also witness attendance by leading experts of the pharma, healthcare and diagnostics segments. He also informed that a Bhoomi Poojan will be held at the venue, Amity University campus, to initiate IPC work in November.

Giving an update on the work initiated by him and Atul Nasa, Organising Secretary, with support of other LOC members, Sikri informed that

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MARKET they have appealed to different industry associations like IDMA, HDMA, FOPE, BDMA, CIPI and Pharmexcil to extend their support and have received positive responses from them. He also gave an update on the registrations received so far. He revealed that the committee has received 2100 scientific abstracts, of which 1500 have been already evaluated.

Sikri also mentioned that there will be a session on success stories of stalwarts such as Pankaj Patel, Chairman Zydus Cadila; Dilip Shanghvi, Founder, Sun Pharma; RC Juneja, Chairman, Mankind Pharma; J Jayaseelan, National Vice President, IPA (Industry Division); Partha Sarathi Reddy, Chairman, Hetero; and Rajeev Nannapaneni, Director, Natco.

Nasa highlighted key activities related to the event and novel features of the congress.

He divulged that different topics related to training, placement and entrepreneurship, health startup hackathon, women empowerment, international speakers and delegation, industry – academia discussions, government regulators industry discussions etc will be addressed. He also informed that a special committee has been constituted under LOC to manage industry relations.

Besides these initiatives, under the guidance of Ravi Uday Bhaskar, Director General, Pharmexcil a symposium on 'Indian Pharma Exports – Regulatory Challenges' will also be held. It will have key

speakers from the industry as well as Indian regulators. The LOC is also trying to get Chinese regulators to attend the event, which would be a firstof-its-kind endeavour. He also informed that gala cultural evenings, to be held on December 21-22, 2018, will also be a part of IPC this year.

Informing about the scientific programme, Dr Arun Garg, Chairperson, Scientific Committee briefed on the progress on four different tracks and speakers. He also asked the LOC members for suggestions on speakers.

Taking over from Garg, Dr Ramkrishnan, Convenor, Scientific Committee provided detailed reports of each track along with speaker confirmation updates. He also informed about the in-principle confirmation of Kiran MazumdarShaw, Chairperson and Managing Director, Biocon for the Women Empowerment session.

It was also revealed that this year's IPC is going to be different from previous editions, now the ratio is 60 per cent academia and 40 per cent industry. And to add more

significant value to the IPC brand, the present LOC committee members are working aggressively on expanding the IPC spectrum and have added healthcare and diagnostic sectors to it.

The aim of increasing industry focus in this year's edition is to deliberate on key issues related to the industry, wherein all stakeholders of pharma fraternity come together and discuss challenges and solutions.

Besides this, it is the only platform where students get the opportunity to interact with industry stakeholders directly

and understand the industry's requirements.

Moreover, this year's IPC is going to have nearly 100 speakers and they are the cream of the industry. A few of them will be international speakers.

In a unique initiative, the present LOC of IPC has constituted 28 different committees and each committee comprises seven to eight members.

In his vote of thanks Garg thanked everyone for taking time and sharing valuable suggestions. u.sharma@expressindia.com

TOPICS TO BE COVERED AT 70TH IPC AT AMITY UNIVERSITY, DATE 21-23, 2018 Presidential symposium- Pharma vision 2030: ◗Indian Pharma Industry - A Global Leader ◗Award memorial lectures Track I Industry ◗ Session I: Discovering Innovative Medicines Global vs India ◗ Session II: Trends in Medical technology and Devices in Changing Regulatory Environment for cost effective Healthcare ◗ Session III: Opportunities & Challenges in development of Similar Biologics ◗ Session IV: Indian Pharmaceutical Industry can be a global leader ◗ Session V: Success Stories

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◗ Session VI: Pharmaceutical Innovations-Out of Box Ideas Missing Track II Regulatory Session ◗ Session I: Pharmexcil & AIDCOC, Seminar on “Indian Pharma Exports-Regulatory Challenges” ◗ Session II: IPR-Roadmap for Growth through protective innovation in pharma ◗ Session III: Comprehensive views on OTC product registration , License, Compliance, Safety & Risk Control ◗ Session IV: Can Industry and Regulators go hand-in hand?

Track III Pharma Academia ◗ Session I: Redefining the pharmacy Curriculum as per Industrial needs

◗ Session II: Research Using Animals: Demisting the myth ◗ Session III: Imparting Quality Pharmacy Education – Challenges? ◗ Session IV: Ethno Pharmacology – AYUSH – Traditional Medicines ◗ Session V: Women Forum Panel Discussion Track IV Pharmacy Practice ◗ Session I: e-Pharmacy, Track IV Pharmacy Practice ◗ Session II: Good Pharmacy Practices in Community & Hospital Settings ◗ Session III: Pharmacist: Yesterday, Today & Tomorrow ◗ Session IV: Pharmacovigilance: Streamlining pharma industry including herbal products

MARKET POST EVENT

Beckman Coulter and Express Pharma, organise seminar in Baddi The seminar on ‘Importance of impurities profiling and formulation stability studies in regulated pharma environment’ was attended by more than 80 delegates Prathiba Raju Baddi PURE WATER plays a crucial role in pharma and bio-pharma manufacturing process as presence of bacteria and other organic compounds in water can cause failure in filtration, storage and other components and

systems. Total Organic Carbon (TOC) analysers which conduct the standard test for quality is one of the significant component which ensures the quality of water used in pharma and bio-pharma products. Highlighting the importance of TOC analysers, Beckman Coulter Life Sciences recently hosted a

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seminar on ‘Importance of impurities profiling and formulation stability studies in regulated pharma environment’ in Baddi, Himachal Pradesh.

Organised by Express Pharma, the seminar witnessed participation of over 80 delegates, which included plant heads, quality control

officers, quality assurance managers, project heads, scientific officers and engineering heads from various pharma companies. The seminar began with a welcome address by Express Pharma correspondent. A presentation by Matt Harle, Senior Manager, Field Marketing, Particle and Automation

products at Beckman Coulter Life Sciences followed.

Mark said, “In pharma industry, high purity water is a key ingredient that is used throughout the production processes, purity of the water helps to eliminate the impact that bacteria and other organic compounds may have on the quality of product.

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MARKET

Matt Harle, Senior Manager, Field Marketing, Particle and Automation Products, Beckman Coulter Life Sciences

Neeraj Khurana, Head Marketing, Beckman Coulter

Tulasi Krishna, Sales Leader- Particle Business, Beckman Coulter

Delegates at the event

Unlike others Anatel TOC analysers not just helps with water purity but helps to improve compliance, get better data integrity and reduce operating costs.�

Explaining about Anatel TOC Analysers, Mark informed that it is a fully complaint and a unique solution that has UV detector combined with auto-switching main and standby UV lamps, which means even if one fails there is another one and there is no need to stop the production, as the instrument continues to run, and is still compliant. “Anatel is the first company to produce the online TOC analysers, which was initially used in semicon-

20 EXPRESS PHARMA November 1-15, 2018

Anatel is the first company to produce the online TOC analysers, which was initially used in semiconductor industry, but when the pharma industry realised that online TOC analysers exists they were interested in using it. Anatel TOC analysers is a genuine walk away method, where the technicians have to just load the standards, hit the start keys and walk away ductor industry, but when the pharma industry realised that online TOC analysers exists they were interested in using it. With increasing interest by the pharma manufacturers we

further developed the A643 analysers as per the needs of the pharma industry in late 1990s. In my view the Anatel TOC analysers are dynamic analysers with significant

benefits. We are very optimistic that many Indian pharma companies will use this advanced TOC analysers,� Mark added.

He also added that the

Anatel TOC analysers is a genuine walk away method, where the technicians have to just load the standards, hit the start keys and walk away.

Tulasi Krishna, Sales Leader- Particle Business, Beckman Coulter, pointed out the unique points of the Anatel TOC analysis in pharma waters. The event concluded with a vote of thanks by Neeraj Khurana, Head Marketing, Beckman Coulter.

The delegates also got an opportunity to see online TOC Analysers equipment and discuss on the unique features with their peers at the networking dinner that followed the event. prathiba.raju@expressindia.com

MARKET PRE EVENT

CPhI & P-MEC India to be held in Delhi NCR from Dec 12-14,2018 UBM INDIA is all set to bring in the third edition of India Pharma Week (IPW), a weeklong celebration packed with avant-garde events from December 12-14, 2018 alongside its flagship expo CPhI & PMEC India. CPhI & P-MEC India will be held in India Expo Mart, Greater Noida, Delhi NCR. Unlike the previous editions organised in Mumbai across a number of venues, this year all the engagements of the IPW, which is also South Asia’s largest pharma event will be held at the world-class venue - the India

Expo Mart - Greater Noida, with all its attendant facilities.

This will enable all the key stakeholders and professionals of the pharma industry the convenience to congregate, network and celebrate the industry under one giant umbrella for an entire week.

As the pharma industry is increasingly looking towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the perfect event for companies to pick up on the latest trends and innovations the market has to offer. Apart from India

Pharma Week, the 2018 edition will also feature dynamic engagements such as the Pharma Leader’s Golf PreConnect Congress, plant visits, Women in Pharma – Power Breakfast, India Pharma Awards, Networking Evening, and a closed-door CEO Roundtable, amongst others. The ultimate goal of all these intertwined events is to help nurture a complete pharma ecosystem in India and better enable networking with the country’s corridors of power. P-MEC India will represent the platform where in-

ternational and domestic pharma experts meet to to do business, network and shape the future of the Indian and South East Asian pharmaceutical industry.

Key reasons to attend P-MEC India ◗ Meet the biggest representation of pharma ingredients manufacturers in one single location ◗ Source high quality products at the most competitive price ◗ Network and do business with over 50,000 experts from 120+ countries

◗ Grow your client range and establish new business relationships Exhibitor’s profile include analytical equipment, automation and robotics, batching systems/equipment, cleanroomequipment, filling equipment, filtration/separation/purification, health and safety products, instruments, laboratory products and equipment, machinery, packaging equipment and supplies etc.

Express Pharma is the media partner for the event.

EP News Bureau

EVENT BRIEFS 23

Global Pack 2018

12

CPhI & P-MEC India

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Acrex India 2019 Mumbai - 400 059 Tel.: +91 22 61727272 Fax. +91 22 61727273

GLOBAL PACK 2018 Date: November 23-25, 2018 Venue: Labh Ganga Exhibition Centre, Indore, MP Summary: GLOBAL PACK 2018 is an International Trade Exhibition & Tech Summit for the packaging material, machinery and ancillary industry. Organised by Integrral Business Exhibitions & Media in association with SIES School of Packaging, it is being designed to serve as a platform for the packaging and printing industry, both in terms of business and technical content.

Contact Email: info@ibem-india.com

CPHI & P-MEC INDIA Date: December 12-14, 2018 Venue: India Expo Mart, Greater Noida, Delhi NCR Summary: UBM India is all set to bring in the third edition of India Pharma Week

ACREX INDIA 2019

(IPW), a week-long celebration packed with avant-garde events alongside its flagship expo CPhI & P-MEC India.

This will enable all the key stakeholders and professionals of the pharma industry the convenience to congregate, network and celebrate the industry under one giant

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umbrella for an entire week.

Apart from India Pharma Week, the 2018 edition will also feature dynamic engagements such as the Pharma Leader’s Golf Pre-Connect Congress, plant visits, Women in Pharma – Power Breakfast, India Pharma Awards, Networking Evening,

and a closed-door CEO Roundtable, amongst others.

Contact UBM India TIMES SQUARE Unit No. 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol, Andheri (East)

Date: February 28 to March 2, 2019 Venue: BEC Mumbai Summary: The event will focus on building automation (BMS) and indoor air quality (IAQ). The mega event will witness participation from more than 25 countries including Belgium, China, Czech Republic, Egypt, France, Germany, Italy, Japan, Korea, Malaysia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, the Netherlands, UAE, the UK, Ukraine and the US. Contact details NürnbergMesse India, German House, 2, Nyaya Marg, Chanakyapuri, New Delhi – 110 021 T : +91 (0)11 47168888

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cover )

22 EXPRESS PHARMA November 1-15, 2018

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THE MAIN FOCUS

Rapid adoption of disruptive technologies are bringing in new approaches and outcomes in the pharma sector. An analysis

By Lakshmipriya Nair

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cover )

W

ide-ranging factors like rising R&D costs to pricing pressures, and increasing regulatory burden to tax reforms in different countries have created an irrefutably perplexing innovation and commercial environment for pharma companies.

Hence, they are increasingly looking at automation and digital technologies to reimagine their current strategies across the value chain.

As Amitabh Mishra, Chief Information Officer and Chief Digital Officer, Emcure Pharmaceuticals informs, “Group business leaders in pharma are realising the following: first, digital is a crucial business need in order to obtain a competitive advantage. Second, digital challenges status quo and enables a paradigm shift. The result of all this is that digital (and, by extension, automation, which is a subset of digital) asks the tough questions on major business processes, and in some cases, even redefines the business model itself. Pharma leaders are waking up to these truths, and committing large budgets to automation and digital. And they are open to accommodating changes to major processes as a part of the technology push.”

Ram Yeleswarapu, President and CEO, TAKE Solutions also points out, “Companies that have a deep domain understanding, a holistic top down process understanding and a bottom up operational understanding are ready to evolve and meet the changing needs of the industry which will define the next generation of blockbuster solutions for these sectors. While late to get off the blocks, the pharma industry is rapidly advancing automation and digitalisation across the board.”

So, let’s take a look at a few key aspects of the pharma industry wherein rapid adoption of these disruptive technologies are bringing in new approaches and outcomes.

Enhancing value creation A report, ‘2018 Pharmaceutical

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and Life Sciences Trends’, from Clarkston Consulting points out, “As stakeholders in the healthcare value chain consolidate, align, and integrate for increased leverage and purchasing power, the life sciences industry will be further pressured to demonstrate the differentiated value they offer to patients, caregivers, and other partners in the healthcare landscape.”

To cite an interesting example, in 2017, Amazon applied for and received pharmacy-wholesaler licenses in several states of the US. This, in turn, led to a swift drop in the stock value of some of the largest wholesalers in the pharma industry. The foray of other tech giants/game changers like Apple, Microsoft, Google, and Facebook into the life sciences sector are also ushering newer business models and interesting collaborations to augment both, tech and pharma capabilities, thereby bringing about a paradigm shift in the way the sector operates.

Hence, the life sciences sector's machines, methodologies, processes, and most importantly, its workforce are undergoing a transformation.

Mishra explains it very well and says, “Machines cannot operate anymore on a standalone mode. They must be connected to a system that can track their operational parameters and record the numbers so

that they can be retrieved if needed, for example, in times of an audit. Which brings us to an important point. Pharma companies' profitability (and indeed their viability) depends on approvals from agencies such as the FDA, which depends on the results of audits. In the absence of digitalisation and automation, if a process document cannot be retrieved or a change in parameter value is found to be not documented, auditors could ban the company or lines of products, and cause billions of dollars in lost revenue. In order to support business in its push to clear regulatory audits, machines have to change (in order to be connected, monitored and optimised), as do methodologies (e.g. replacing manual techniques by automation), processes (unnecessary steps must be removed; processes must be simplified and automated 99 per cent or above) and workforce (workers need to be trained; professionals must be asked to think 'digital first' and innovation and ideation must be built into the culture of the organisation).”

Giving an instance of how Emcure Pharma, is planning to utilise these technologies to derive more sales, he expounds, “The use of big data and analytics is going to enable us to increase sales by 5-10 per cent.

We plan to collect, process and

visualise sales data to the most granular level, and provide detailed dashboards that enable senior management to drill down the sales data to the product (SKU) level. Consequently, sales challenges will be handled in real-time and not retroactively after the month's sales are over. All the data from our ERPs and other in-house software systems is being routed to a central analytics system that is capable of slicing and dicing the data in numerous ways. This consolidation and analysis of sales data is a brand-new capability for us, and is going to be a game-changer.”

And, thus, technology has emerged as a key enabler for pharma companies to derive enhanced value in their businesses.

Renewed approaches to problem solving The pharma industry is also turning to next-gen technologies in its search for a panacea to deal with its bottlenecks and challenges. An Infosys research report titled, Digital Outlook for the Life Sciences Industry, clearly highlights, “Life sciences organisations are using a range of technologies, from analytics to AI, to discover new drugs and treatments to spur growth, cut operational costs, and engage better with patients. Digital technologies deployed at organisations are improving existing

operations, solving new problems, and creating new opportunities.”

For instance, a Global Data study reveals, “Disruptive technologies such as AI, big data and block chain will impact the pharma industry, not only by helping to add value in terms of personalised treatment for patients, but also to counteract the unsustainability of skyrocketing drug prices.”

Yeleswarapu points out how these technologies are enabling compliance with regulations as well. He states, “The need by the regulators for ensuring clinical trial participation is extended to a globally stratified patient pool and the desire by biopharma companies to get their drugs approved and commercialised globally is yet another reason for adoption of digital technologies.”

He explains, “Regulations, quality and compliance requirements and above all the concern for patient safety have historically introduced redundancies and manual checks and balances and these are some of the reasons for a slower adoption rate within these sectors. With the advancements in technology, AI, machine learning (ML), and natural language processing (NLP) and the support extended by regulators to induce efficiencies while ensuring compliance with regulations are slowly settling in and this has warranted a new outlook towards methods and processes.”

Bettering R&D and manufacturing outcomes Pharma companies are looking at disruptive technologies to deliver quicker, and more responsive approaches to discover, develop and manufacture new drugs.

As Yeleswarapu highlights, “The healthcare sector has been under duress to make therapies affordable while ensuring they are safe and effective, and this has led to the adoption of technology solutions that are seamlessly allowing for data and information flow for decision making, rather than the more complex stove pipe systems of yesteryears that were lending to costly

( custom development and maintenance.”

Gaurav Tripathi, CTO, Innoplexus, explains, “AI adoption will increase across all stages especially in drug discovery, with companies relying more on data driven drug discovery instead of conventional methods.”

Ascertaining this, the Global Data study elaborates, “One of the most time-consuming phases in the process of drug development is the discovery phase, which takes four to five years on average. Identifying promising drug targets is one of the biggest challenges and this is the most crucial phase, where the right decisions have to be made about whether to proceed through to clinical trials. Luckily, the highly developed AI programs now have the increasing

capacity to delve into big data, identify patterns, and generate algorithms to explain them.”

Tripathi cites the example of Innoplexus’ offerings to explain this further, “Scientists working at pharma companies in drug discovery spend a lot of time in manually going through publications, scientific and clinical trials data online which is spread across few thousands of sources.

They have to manually search for relevant documents while trying to remember all possible keywords and their synonyms to locate the right set of documents. Then they have to manually extract specific data points from those documents and collate them in a document for further analysis. A few of the world’s largest pharma companies using our products are able to save 50 per cent of that time

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by using our products which uses AI based ontologies, information discovery, search and computer vision based information extraction to automate 70 per cent of the process already.

It is helping their scientists to free up their time performing manual redundant tasks around collecting and analysing information thereby helping them put that time in actual productive tasks.”

Thus, technology holds the potential to speed up the initial stages of R&D considerably and deliver outcomes faster.

Same is the case with pharma manufacturing as well.

As Dipankar Kaul, Global Head, Compliance & Auditing, Asia/Pacific, Novartis Technical Operations, Sandoz illuminates, “The increase in automation and emergence of new technologies

THE MAIN FOCUS

in the pharma industry over the last decades have altered our perspective of the science of pharma development and manufacturing operations. Also, the global expectations of the health authorities, to rationalise and validate pharma processes right from the moment of their development and establish scientific rationales undergirding the principal quality attributes and controlling measures are gaining greater acceptance. Consequently, the systems used to automate the process steps during manufacture, which are uninterruptedly evolving with the implementation of new instrumentation, are well within the gamut of regulatory compliance and this further diversifies the need for various autonomous technologies.”

He further explains, “As

pharma manufacturing plants operate on computerised/programmable logic-controlled machines, instruments or technologies within fixed operating parameters to produce products of standard quality and specifications, compatibility towards highly automated and robotic machineries is evident. Through integration with AI self-learning machines, these complex operations can be simplified to a greater degree. The further development of these technologies will facilitate ensuring that these operations become more intelligent and efficient.”

Recognising this fact, pharma manufacturing companies are also using cost efficient new technologies to augment operational performance and ensure agility and product safety.

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cover ) Ways to optimise potential of disruptive technologies Recognising this, the players of this industry are investing and strategising to create the underlying infrastructure in place. We are witnessing rapid adoption and installation of smart technologies to ensure a proven return on investment across the entire product and process chain in the pharma industry.

But, even as the industry ramps up its utilisation of technologies, the industry’s digital maturity lags in comparison to other industries. As Ankit Solanki, Co-Founder & CEO, Instinct Innovations points out, “Pharma is one of those few industries that needed a major digital revamp, given that different nodes in the ecosystem are still not digitised, so is the communication between these different nodes.”

So, how can life sciences companies work towards optimisation of their newly gained tech capabilities to further their progress?

Mishra points out that there are certain characteristics which organisations that have performed successful have and says, “First, the executive leadership team have a shared, clear vision that every one of the leaders has bought into. Second, they have a robust prioritisation framework that takes the hundreds of ideas around digital innovation, and reduces them to a list of about 10 or so priorities that can add the most value in the short run. Third, they invest time and energy into developing an organisation with the right kind of talent that sustains the momentum in the long run.

Finally, they adopt the best technology practices such as lean, agile, DevOps execution models.”

He further recommends, “What is needed is a digital strategy. The first piece is the vision, which is a statement of where the company wants to be in three to five years. Second is leadership: we need to align digital to business goals through leadership alignment and stakeholder buy-in. The Chief Digital Officer needs to be excellent,

26 EXPRESS PHARMA November 1-15, 2018

but the most influential leaders of the organisation, that is the members of the executive council, need to rally behind the push for digital. The last piece consists of three components which are equally important. First is people – we need to enhance the skills of our employees, and put in place the correct digital organisational structure. Second is process – how to work analytics, paperless and other digital technologies into our processes.

Finally comes the technology piece itself – how to bring in software and hardware systems based on IoT, analytics, AI, ML, and other staple digital technologies.”

Tripathi also recommends that the way forward is through integration and interconnection of all aspects of the pharma in-

dustry by mapping all the processes and finding out the ‘data handshake points’ between them. And, this is where he believes that partnerships with technology companies will be of help. He feels that these partnerships will let a technology partner focus on data while the pharma companies can focus on the science part.

Probably, the industry and the policymakers believe the same. As a result, we have seen several partnerships and strategic alignments between the life sciences and tech industries lately. To cite a couple of examples: Example 1: Recently, NITI Aayog and Microsoft India entered into an agreement to leverage the benefits of AI for the growth of the country. As part

of the agreement, Microsoft India will support NITI Aayog by combining the cloud, AI, research and its vertical expertise for new initiatives and solutions across several core areas including agriculture and healthcare and the environment. Microsoft will also accelerate the use of AI for the development and adoption of local language computing, in addition to building capacity for AI among the workforce through education.

Example 2: Indian Institute of Technology Mandi has tied up with RxDataScience Inc., a leading healthcare manufacturer in the United States, to create a portal documentation Artificial Intelligence and Machine Learning Research in the Pharmaceutical Sector. Reportedly, IIT Mandi team is also

ROLE OF DISRUPTIVE TECHNOLOGIES Power of artificial intelligence AI will drive more combination products, higher quality, and more personalisation across the industry. At its core, the power of AI for pharma lies in its ability to mine and analyse enormous sets of raw data, such as those generated through R&D – an area in life sciences with the most to gain in these nascent stages of AI adoption. AI stands to bring a stronger degree of certainty in the clinical stage by enabling a more thorough understanding of biological and disease complexities that would in turn enable a more targeted approach at the onset, thus increasing the likelihood of clinical success and decreasing the associated risks. As the volume of data collected increases, so too does the potential of AI to have a transformative impact on the industry. Like many technological innovations, AI success will depend on strong data management principles and the organisational ability to work cross-functionally as the tech will inevitably impact every side of the business.

Blockchain’s huge potential Strategy and planning around the blockchain technology underpinning cryptocurrency will continue to evolve in life sciences, particularly in the clinical and supply chain aspects of the business. As a decentralised ledger of information, the blockchain could allow for: ◗ Better clinical trial participation and overall patient safety ◗ Improved supply chain integrity These are just a few of the well-documented potential uses for blockchain technology, which will continue to grow in number as the technology is explored further.

A world of Internet of Things With increasing frequency, the internet of things (IoT) has been touted as a cure-all through the use of live data for real-time decision-making. More life sciences companies will start to explore these capabilities in earnest. First and foremost, the benefits to the supply chain and manufacturing side of the business will drive IoT investments to maintain product quality via live temperature and stability monitoring, increase manage supply and demand through real-time tracking and oversight, and improve traceability of the supply chain to meet regulatory requirements around serialisation. But these are just a few of the dozens, if not hundreds, of applications of IoT to drive true business value. As the success of IoT largely depends on a business’s ability to manage and act on their data, life sciences companies should invest in strong data governance and data management initiatives to ultimately realise the vast returns that IoT can offer.

Source: Clarkston Consulting’s report on 2018 Pharmaceutical and Life Sciences Trends

planning to work closely with RxDataScience Inc, to apply deep-learning methods and cognitive algorithms for discovering patterns among patient journeys and social ties among physicians. This is part of a longterm collaboration focused on performing machine-learning on healthcare datasets concerning patients and physicians and developing novel web-based visualisations.

Example 3: A lot of start-ups are attempting to iron out the various chinks in the pharma lifecycle, especially in distribution. For instance; Pharmeasy, NetMeds, Myra, 1mg, are apps which are enabling end consumers to order medicines online while the likes of PharmaRack and WantedNote enable SME retailers to order their inventory digitally from distributors, wholesalers and CNFs. Parallel to this are solutions like RedBook which enable each of these nodes to digitise themselves and hence lead to easier integration for aggregator or facilitators.

Multi-faceted role of next-gen technologies Well, whatever, be the strategy, it is clear that the entire pharma ecosystem is undergoing a metamorphosis catalysed by technology.

A tech-driven in future in pharma, amongst other things, will include: ◗ Deployment of automation to track and control processes with an aim to increase efficiency and minimise errors ◗ Making real-time decisions within R&D, manufacturing and supply chains lifecycle ◗ Generating and utilising evidence-based strategies for monitoring and reporting to ensure quality and safety compliance ◗ Track and trace all product data to improve their efficacy and effectiveness It is evident and inevitable that these new-age technologies like AI, big data, blockchain and other will continue to play a pivotal role in the pharma industry in times to come. lakshmipriya.nair@expressindia.com

MANAGEMENT

FlexFactory,life science solutions to drive growth for GE Healthcare India is a Top 5 market, life sciences is fastest growing segment of GE Healthcare

By Viveka Roychowdhury GE HEALTHCARE'S life sciences' portfolio tends to be overshadowed by its consumer facing healthcare solutions divisions, but this is one part of the healthcare value chain that med tech peers like Philips, Siemens, Hitachi etc. don't yet have.According to GE's 2017 integrated annual report, revenues of its healthcare segment grew revenue by 5 per cent, and margins by 70 basis points, with a nine per cent segment profit growth in the same year.

GE Healthcare (GEHC) comprising healthcare diagnostic imaging and clinical systems, life sciences products and services, and digital solutions, contributed revenues of $19.1 billion, and profit margins of 18 per cent in 2017. While the numbers look good for GEHC, GE is in reset mode, with 2018 set to be a year of reckoning. As part of a strategic review announced this April, GE will focus on three main areas (aviation, power and renewable energy) while GEHC will be hived off into a standalone company. GE expects to monetise 20 per cent and distribute remaining 80 per cent of GEHC to shareholders tax-free.Steering the transition to a standalone unit is GEHC's President and CEO, Kieran Murphy who has a deep background in the pharmaceutical industry. Joining GEHC in 2008 through GE's takeover of Whatman, he took over as President and CEO of the lifesciences business in 2011 and as President and CEO of GEHC in June 2017.

On a recent trip to GE’s Jack F Welch Technology Center, Bengaluru, Murphy stressed that the spin-off of GEHC would not be impacted by a transition in global CEOs (On October 1, John Flannery, with three decades in GE, made way for H Lawrence Culp, Jr who was

Kieran Murphy, President and CEO, GE Healthcare stressed that the spin-off of GEHC would not be impacted by a transition in global CEOs. He indicated that India was one of the top 5 markets for GEHC and while diagnostics imaging accounts for the biggest share of GEHC's revenues, life sciences is the fastest growing business in the segment

previously head CEO of Danaher Corporation). He indicated that India was one of the top five markets for GEHC and while diagnostics imaging accounts for the biggest share of GEHC's revenues, life sciences is the fastest growing business in the segment.Life sciences made up around 25 per cent of GEHC's revenues globally in 2017, according to Paritosh Dhawale, General Manager, Life sciences, India, South Asia and ASEAN, GE Healthcare (GEHC). This may seem a small share but life sciences could be a key growth driver in 2018, specifically within emerging markets. According to GE's 2017 integrated annual report, growth in the life sciences divi-

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sion will come through expansion of bioprocess solutions and cell therapy as well as continued growth in emerging markets and China.Consider the segment's offerings across bio process and research. Dhawale says GEHC has installed 25 FlexFactories across the world including Asia, Europe and the US. While the company is currently in talks with half of the top 20 biopharma players, India got its first FlexFactory more recently. Last May, GEHC announced the installation of India's first FlexFactory at Dr Reddy’s Laboratories (DRL).

Use of this single-use biopharma manufacturing platform, with associated process hardware integrated with au-

tomation and control components for start-to-finish manufacturing, is expected to expand the biologics production capacity at DRL's Hyderabad facility making it more flexible and responsive to customer demand as well as more efficient.

FlexFactory will allow DRL to reduce the overall project setup timeline to 9 to 12 months.

Single use technologies reduce product change over time by half or more, allowing for multiproduct manufacturing and improved productivity by increasing the number of lots manufactured, according to the release. Depending on current processes, FlexFactory could reduce carbon dioxide emissions by up to 75 per cent and water and energy usage by approximately 80 per cent.Other achievements of GEHC's life sciences division read like a roll call of India's biopharma prowess. 100 per cent of the latest generation pentavalent vaccine for infant health made in India reportedly use GE technology. GE resins are key to the

manufacture of all domestically produced insulin in India. Besides claiming to be market leaders in the protein chromatography portfolio, both in value and volume, the company posits that their plasma fractionation technology can address the huge lack of plasma products in the country, which today need to be imported.Thus while Murphy remains gung ho about the life sciences division in India, future business will depend on the timely roll out and success of DRL's experience with the FlexFactory concept. DRL's transition from stainless steel to single-use technologies will be aided by training at GE Healthcare’s Fast Trak Center at Bengaluru and it is hoped that more of India's biopharma players commit to making this move. viveka.r@expressindia.com (The writer was at GE's technology centre on the invitation of the company)

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LOGISTICS SPECIAL

Transforming pharma logistics with IOT The pharma industry is harnessing the power of disruptive technologies like AI, block chain and 3D printing to improve its supply chain and logistics systems. In this isssue, industry stakeholders share insights on how IOT is revolutinising pharma logistics to usher in better efficiencies

BY USHA SHARMA

STAKEHOLDERS WILL LOOK TO IMPLEMENT IOT ENABLED DEVICES TO CREATE SMART SUPPLY CHAIN

I

nternet of Things (IoT) has the potential to be a greater disruptor as tracking sensors and smart devices have gained prominence in manufacturing supply chains due to the proliferation of RFID technology and faster internet connectivity.

IoT devices or sensors do not need to be scanned like barcodes; they can transmit real-time data to any other IoT device on the same platform via the internet.

For pharma companies the benefits of real-time data are immense as the manufacturing process is complex and sensitive, the product quality needs to be perfect and the transportation has to be handled efficiently and often temperature controlled to ensure safe consumption for the customers. There is zero margin for error in both, production and delivery standards. By enabling their manufacturing facilities with smart sensors and their products with IoT devices (such as RFID tags), pharma

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companies can optimise their supply chains as follows: ◗ Manufacturing and operations: Ensuring product quality and productive asset utilisation Drug production including R&D can account for 50 per cent of sales revenue for pharma companies. Manufacturing new drugs is a complex process and IoT devices can ensure relevant data is available to ensure issues with formulations are proactively managed and batches are produced as per required standards. Trends that can cause delays or slowdowns and inefficient processes can be proactively identified and action can be taken. Preventive maintenance cycles can be analysed, set and adjusted

by IoT devices so equipment life-spans are increased and assets work more efficiently. ◗ Inventory Management: Smart warehousing Pharma companies need to maintain a fine balance

locations that add significant operational and management costs. Smart warehouses can improve warehouse asset (forklifts, stackers etc.) utilisation and also the visibility of products in the warehouse.

Furthermore, pharma companies benefit by reporting issues, better floor space utilisation and monitoring of drugs.

SAMIR LAMBAY Co-Founder & CEO, FreightCrate Technologies between under-stocking (which can have negative consequences) versus overstocking (which increases warehousing costs). Moreover, they have many facilities in many

◗ Order Management: Transparency and visibility With IoT devices pharma companies can track the shipment from the warehouse to the final delivery location including information on product condition and temperature along the way.

They can get access to detailed shipment tracking information on one single platform including: ● When the shipment departed and arrived ● Exact real-time location ● Exceptions regarding product temperature or condition ● Expected delays All this can be done with-

out any need for barcode sensors. RFID sensors attached to the pallets can automatically transmit data to smart devices. Moreover, without smart tracking, there is always the possibility of products being lost with an inability to analyse root cause.

With tags on all products, supply chain managers can assess where the loss occurred, and better analyse the issue and track if the product was stolen. Trends can also be analysed and supply chains and vendors modified accordingly. IoT for the pharma industry is expected to increase from $420 million in 2015 to $2,486 million by 2020. All major stakeholders will look to implement IoT enabled devices in an effort to create fully integrated smart supply chains. The vision is to enable every aspect of the supply chain to become a source of data, which can be analysed to continually optimise operations, and reduce costs while improving customer satisfaction.

IOT HAS THE POTENTIAL TO ENHANCE ALMOSTALL THE PROCESSES OFTHE PHARMA INDUSTRY

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nternet of Things is transforming the pharma industry at a rapid pace. IoT has the potential to enhance almost all the processes of the pharma industry ranging from clinical trials, drug disclosure, manufacturing, and supply chain to remote patient monitoring.

IoT applications for supply chain management have become popular investment areas for many industries. Connected equipment, men and material tracking, sample lifecycle management, smart packaging, and cold chain monitoring are among the IoT applications that are particularly well suited to the pharma industry. Warehousing is a crucial area for the pharma industry. IoT applications are placed in the storage area and on inventory items to interpret and transmit vital information (product location, inventory details) and report

inconsistencies, such as misplaced products directly to warehouse managers’ handheld devices/dashboards. Corrective measures take place in real time – significantly improving the speed, accuracy, and efficiency of the picking process.

Another area where IoT technologies can add value is the storage of temperature-sensitive products. Active and passive temperature loggers attached to refrigerators in warehouses and at other sites continuously record temperature. An IoT solution could connect these devices, compare their measurements against thermo stability tables, and prompt them to generate alerts in case of temperature variances.

IoT-based solutions can help pharma manufacturers remotely monitor cold chain environments in real time by embedding sensors on tracking

B.G. BARVE, Jt. Managing Director, Blue Cross Laboratories equipment with auto-start and shut-down mechanisms in warehouses, vehicles, or ship-

ments using smartphones and tablets. Tracking the movement of drug inventory at every point can potentially save supply chain participants billions of rupees.

When applied to packaging, the Internet of Things affords several advantages, including bi-directional communication, tracking, and status-display mechanisms. This is especially relevant in markets where counterfeit drugs regularly enter the value chain. 2-D bar codes, RFID tags and smart packaging labels make it possible to track each handshake in the supply chain, from manufacturing to dispensing. The result is a complete digital footprint. Digital technologies such as GPS location and condition monitoring afford real-time visibility and security during transport.

Control cold chain conditions: IoT technologies enable placing temperature-sensing tags with

shipments. Tags continually record temperatures and environmental conditions. The data is uploaded to the cloud. Recordings are instantly available to the control room. For pharma companies, the IoT extends visibility in virtually every area of the business – from development, to manufacturing, transport, distribution, dispensing and consumption. Real-time information, when coupled with advanced analytics engines, can become the basis for making faster, more accurate decisions; heightening efficiencies, verifying product quality, and assuring regulatory compliance. The risk of doing nothing must be evaluated against changing customer and regulatory expectations and market dynamics. The time is right for pharma companies to accelerate their implementation and utilisation of IoT platforms and solutions.

IOT ENABLES TO HAVE CLEAR VISIBILITY AND BETTER CONTROL OF PROCESSES ACROSS THE SUPPLY CHAIN SYSTEM

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OT - The Internet Of Things- is becoming an important part of the business as most number of things such as appliances, utility items, products, packs and vehicles are being connected over the internet and collecting required data to arrive at key business decisions to improve operations. ◗ It is heard that IOT spending will jump from approximately $700 billion in 2015 to $1.5 trillion by 2019. ◗ Supply chain system is also one of the beneficiaries of the IOT solutions. ◗ Each individual of the process such as packs, containers and transporting modes will be connected through IOT solutions for trace and tracking on real time basis.

◗ It enables to have clear visibility and better control of processes across the supply chain system which will help an organisation to lead with an effective and cost efficient supply chain system. ◗ As the supply chain system is highly diversified as per the industry, accordingly IOT operations will vary. ◗ It is predicted that within a few years, digitally connected processes will show 10-15 per cent productivity improvements in the manufacturing processes.

Major advantages ◗ Supply chain visibility ◗ Operational efficiency ◗ Better customer service ◗ Better inventory management ◗ Loss management

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S V VEERRAMANI, Chairman & Managing Director, Fourrts (India) Laboratories

Important stages in the pharma industry where we can apply digitally connected processes are: ◗ Manufacturing: Though batch manufacturing is the current practice in the pharma industry, we can deploy automation and controlled techniques for controlling men and materials movements to maintain safety and efficacy by enhancing visibility in various manufacturing activities. ◗ Warehousing: It is an important subject of any organisation to avoid shortages, excess inventories, and wastages at parent company as well as all the locations it is present at various places. Here the technology becomes an essential option to

have on line visibility through connectivity of various locations for better management of stock availability, facility optimisation, precautionary actions etc. ◗ Transportation: In a supply chain process, timely availability of stocks at consumer point is a major challenging task. But, by adopting new age IOT techniques there is a possibility to have a control on the same by having time-to-time monitoring of movements of stocks/vehicles through the GPS system. This will enable us to monitor the vehicle and the driver’s performance and direct us towards optimised decisions with respect to repeated movement of stocks, reduced time to reach market and ultimately cost saving.

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LOGISTICS SPECIAL

IOT IS THE PANACEA FOR RISKS THATARE INHERENT IN SUPPLY CHAIN

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oT has influenced the logistics function too in a big way and has presented many opportunities to the pharma industry the way it could improve its logistics operations.

An IoT-led ecosystem is bound to bring in more efficiency in the business operations especially in the supply chain.

IoT is the panacea for the risks that are inherent in supply chain especially the ones that could result in costly disasters. Some of the benefits that can be realised by the implementation of IoT include:

Improvement in the visibility of warehouse operations The needs of the hour is realtime visibility into warehouse operations without which it would be difficult to track products besides unviable wastage of warehouse space and also the temperature variations that could be an issue while handling sensitive products. IoT-enabled smart warehouses having sensors and readers would increase visibility of operations in the warehouse and presents the data seamlessly to the warehouse managers by reporting data about the products and

during transport – assuring product quality and efficacy with the usage of environmental sensors inserted into product packages/pallets in shipment containers. This would reduce wastage of drugs due to increase of temperature in the containers, ensure compliance with the regulatory requirements besides assuring quality of the products.

their condition so that business can take a supported decision.

Overcome short supply of drugs Implementation of digital technologies like IoT ensures that there is stable supply of drugs so that the needy patients could get their drugs on time. IoT helps the managing optimum inventories based on the business rules that the companies define so that planned decisions can be taken about manufacturing and also assist in sending out the relevant products to the market.

Enhance supply chain security IoT helps making the supply chain security more robust by facilitating bidirectional communication between the information seeker and the device, tracking of the inventory with respect to the location and the current status of the package in transit.

Supply chain security can be ensured through 2D bar codes, RFID tags and smart labels for packaging. IoT helps in tracking the movement of drug inventory at every point can potentially save supply chain stakeholders millions of dollars while ensuring that genuine products are deliv-

Drug theft during transit

SANJIT SINGH LAMBA Managing Director, Eisai Pharmaceuticals ered to the customers while deterring drug counterfeiters.

Reduce product recalls due to product degradation in transit It is important to track the temperature of stored drugs in transit to ensure they remain stable and within acceptable ranges till they reach their destination. IoT-enabled packaging continually tracks environmental conditions in cold chains

Pharma industry has experienced losses due to theft of drugs in transit which resulted in the losses to the companies and also deprived patients of the timely receipt of drugs. Digital technologies such as GPS location and condition monitoring afford real-time visibility and security during transport. IoT enables the logistics team to analyse and compare data on progress of the cargo from anywhere. With the implementation of IoT solutions it is possible to reduce time to market, prevent product damage and waste, and lower carrying costs.

Conclusion The pharma industry has high potential of adopting IOT and this could be in the patient or industrial manufacturing space.

Regulators and health providers including online pharmacies can empower people with intelligent devices to transmit data on usage, replinishments and usage habits; which will help the supply chain side of pharma industry.

Like in other industries which are now being driven by the digital technologies, pharma enterprises must constantly innovate and utilise emerging technologies to remain relevant, competitive, and profitable. As IoT is becoming more adaptable and its implementation makes the supply chains in pharma industry more robust while ensuring compliance to international regulations and meeting market needs. Surge in the number of software products and devices that are IoT ready the trajectory of adaptation of IoT is going to be only upward.

The time is now apt for the pharma companies to quicken the implementation of IoT by utilising easily adaptable IoT platforms and their conforming solutions. The potential to make considerable strides in tightening the pharma supply chain is here, and the differentiator is the Internet of Things. u.sharma@expressindia.com

Patchems: Partners in progress PATCHEMS, PART of Sical Supply Chain Solutions, offers integrated 3PL services for the pharmaceutical, medical devices, lifesaving products and consumer healthcare industries.

They understand the challenges in managing temperature-sensitive products in multiple temperature ranges, adhering to special handling and security requirements, and ensuring regulatory compliance.

Their best-in-class solutions are designed by an expert team that understands the complexities of the

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pharma and medical devices industry and collaborates with clients to better understand critical requirements.

Contract logistics services ◗ Proven expertise in solutions and operations including batch tracking, FIFO and FEFO ◗ Well experienced in-house quality and process excellence team ◗ Experience of building and operating large single/multiuser facilities ◗ Storage and MHEs: All

kinds of options are being used and can be customised for optimal efficiencies ◗ Best-in-class warehouse management system capable of customisations as per client requirements ◗ Flexible and scalable solutions ◗ Reverse logistics and returns management

system enables temperature monitoring ◗ Multi-chamber facilities ◗ GPS enabled multi-temperature vehicles- chilled, frozen, and ambient movement with real time location updates ◗ Absolute compliance on quality and safety ◗ Ability to invest and scaleup within reasonable timeframes

Temperature Controlled Services

Transportation Services

◗ Proven expertise in solutions and operations ◗ Best-in-class Infra, Technology and Processes ◗ Real-time data logging

◗ Combination of owned vehicles and leased vehicles ◗ Capabilities to service Full Truck Load, Part Truck Load, Milk run, Inter-city and intra-

city distribution and last mile delivery ◗ GPS enabled fleet ◗ On time and in full with electronic proof of delivery (e-PODs) ◗ Temperature controlled reefer vehicles with multiple temperature ranges ◗ Delivery to locations in Nepal, Bhutan and Bangladesh Patchems has years of experience in the industry, relevant ISO certifications and solutions to deliver better performance and help address all their clients’ challenges efficiently.

LOGISTICS SPECIAL

Logistics: Akey route to success Neeraj Bansal, CEO, DHL SmarTrucking India emphasises on the need to invest in logistics to take any business to greater heights THE IMPORTANCE of logistics has come to light for everyone to see; it has now taken centre-stage as India Inc. looks to address both its domestic and international audiences. The Indian logistics sector is estimated to be worth $260 billion in India, having grown at a rate of 14 per cent over the past five years, and is expected to grow to $397 billion by the year 2020, according to a study by ASSOCHAM. Logistics has evolved over the past couple of decades – a process that has been gaining momentum since the advent and proliferation of e-commerce.

The trend that triggered the current phase in the evolution of logistics Now, consumers make purchases online and retailers deliver the products to their doorstep. Consumers expect free, fast, and damage-free shipping of products. In recent years, e-commerce has come to include even oversized and irregularlyshaped products such as appliances and furniture.

And the volume of shipments is enormous. It was estimated that some of the biggest e-tailers in the country deliver as many as 400,000 to 500,000 shipments on a given day. Many offer consumers the option of ‘trying and buying’, and returning a product if it is found to be unsatisfactory. The reach of e-commerce has extended to remote, hitherto unserved locations in the country. The operating models of logistics companies have evolved to integrate emerging technologies into various processes – a move that will enable them to make the most of the fast-growing opportunity this segment offers.

Advantages of tech-driven logistics Today, logistics systems are increasingly being shaped by advancements in IoT, Big Data, and Data Analytics. This is an important and welcome trend. From experience, logistics companies that employ these technologies can offer vastly superior services with higher levels of safety and regulatory compliance, faster transit times, real-time visibility into the status of consignments, and much better customer service. Technology underlines many of the key features of logistics solutions that cater to the highly time-bound needs of industries such as e-commerce, FMCG, pharma, automobile, and agriculture.

Businesses that invest in such technology-driven logistics stand to gain a tremendous competitive advantage, as they are equipped to make more informed decisions,

increase efficiencies, and exceed customer expectations. If you wish to differentiate further between logistics providers, look at their reverse logistics capabilities. Logistics providers who offer real-time visibility and updates on the status of reverse shipments will truly distinguish themselves and outdistance competitors.

Importance of cold chain logistics Cold chain market in India deserves better and smarter logistics than what it had until recently, which presents an opportunity for logistics companies to expand their service offerings. It is estimated to grow at a CAGR of more than 20 per cent till 2019 but the sector is currently highly fragmented and unevenly distributed through the country. Almost 30-40 percent of all perishable goods in India are wasted before consumption because of broken cold chain infrastructure and unavailability of vehicles with high-quality cold-storage facility.

This challenge can be addressed, to a considerable extent, by using trucks with mechanisms for temperature control, location tracking, and rerouting. Businesses such as pharma; dairy and confectionery; processed foods; fruits and vegetables; quick-service restaurants; and more, can benefit greatly from cold chain logistics providers who offer fast transit times, and consistency and reliability in their temperature-control processes during transport.

The upgrading of transportation and back-end systems, and advancements in service offerings, by logistics providers may come at a relative premium for customers, but it will be easily offset by the vastly superior efficiencies. If you are a business leader who seeks to put their business ahead of the curve, you should consider partnering with a logistics provider who offers robust, state-of-the-art services. Logistics can be a very real and powerful differentiator for your business, if done right. It accrues long-term gains and, as developed economies have shown, it is the best way for your business to go places.

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PHARMA ALLY I N T E R V I E W

CPhI voices the combined opinion of over 100,000 attendees globally and will continue to do so CPhI India and its co-located event P-MEC, are one of the largest events for the pharma sector in South Asia. This year, CPhI & P-MEC India has a new address: India Expo Centre, New Delhi.

Yogesh Mudras, Managing Director, UBM India divulges more details on this year’s editions of these events, their key highlights and the impact they intend to create, in an exclusive interaction with Lakshmipriya Nair How will CPhI 2018 differ from its previous editions?

With every edition of CPhI, we succeed in bringing about an unparalleled thought leadership, community building and knowledge sharing experience that stands out from any other fair.

Consistently every year, we are keen to push the national agenda forward and break new frontiers, while offering our attendees the much celebrated features. By organising such a signature show in India, the CPhI-PMEC under the aegis of the India Pharma Week (IPW) firmly establishes the country as an impressive hub and global destination for the sector.

Within the realm of the IPW, the CEO Roundtable stands out as one of the most distinguished and successful events. For the last two years, the exclusive, closed-door CEO Roundtable has been eminently successful as a strategic gathering of CEOs of the nation’s leading pharma companies who deep dive into thought-provoking discussions on subjects. The recommendations from elite thought leaders results in a White Paper Report that is presented to policy makers and the power corridors of the nation.

This year, we move forward

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The Delhi-NCR region has become the heart of India for holding some of the biggest events in the country. Being in close geographical proximity to policy makers, consulates and government bodies, the show is poised to enhance the industry’s community building efforts

the country’s agenda of making India an uncontested Pharma Supergiant for the first time, to international shores, at CPhI Worldwide, in Madrid where eminent CEOs from the industry will participate in Discussion 1: ‘The Global Perspective’. This will subsequently be followed by Discussion 2: ‘National Perspective’ at the India Pharma Week in Greater Noida. Both the discussions will form an integral part of the 3rd edition of the CEO Roundtable.

For this edition, we have also added two new segments, under the India Pharma Week: a Paper Presentation — To boost and encourage the excellence of the young minds entering the industry, where a jury will pick top post graduate students to present their thesis on pharma during the Awards night and a Master Class – a feature that will consist of prestigious speakers from top organisations setting stage for knowledge sharing.

Apart from these, some exciting facets at the expo are; Innovation Gallery (an arena where participating pharma companies will be encouraged to showcase innovations on an international platform), and Exhibitor Showcase (a platform where exhibitors demonstrate how their new product

launches are going to be effective).

The India Pharma Week will be held from 10-14 December, 2018 (with the CPhI & P-MEC expo being held from 12th to 14th December) at the India Expo Centre, Greater Noida with space of 235,000 sq.m will have a week full of knowledge sharing and networking up its sleeve. The activities will include Pharma Leader’s Golf, Plant Visits, Pre-Connect Congress, India Pharma Awards followed by a Networking Evening, Women Leaders in Pharma and a CEO Roundtable.

The event has shifted base from Mumbai to Delhi. What have been the plans underway to make the transition smooth and hasslefree for the participants and the visitors?

One of the core commitments of UBM worldwide is to put our customers at the center of what we do and attend to their needs in dynamic ways. Keeping this in mind, the move of India Pharma Week – a weeklong celebration, packed with avantgarde events from Mumbai to Greater Noida, NCR will prove truly beneficial and convenient for the vast magnitude of exhibitors and visitors.

Given the stupendous growth of the show, and the infrastructural and travel logistics hitch in Mumbai, we felt it would be extremely beneficial to have a bigger, consolidated venue that offered the entire spectacle under one

umbrella. Besides, the DelhiNCR region has become the heart of India for holding some of the biggest events in the country. Being in close geographical proximity to policy makers, consulates and government bodies, the show is poised to enhance the industry’s community building efforts.

To smoothly incorporate the shift with due deliberations with our key long-term customers and buyers, we announced the move several months prior as we were deeply committed to making a grand success of the first CPhI and PMEC show in the Delhi-NCR region. This also provided stakeholders more time to firm up their plans for the event.

During the show, we will also be providing bus shuttle services from in and around Delhi, NCR to the venue for hassle free commute for visitors and exhibitors. We also have dedicated freight forwarding companies who cater to our exhibitors requirements with regards to releasing their machinery from customs, transporting, packing, unpacking, setting up their products / machinery at their booths. In addition to this, the show’s website also offers a preregistration link which is free of cost and will help visitors save time and money while attending the show.

As one of the top pharmerging markets, India's growth potential in this sector is huge. How is

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CPhI India transforming to help India Pharma Inc unleash its true potential and optimise the growth opportunities?

The Indian pharma economy has been lauded for its rapid growth in the recent decades and is expected to reach $100 billion by 2025. The industry clearly owes its success to its bold, ambitious approach, history of innovation and an ability to constantly adapt to the global market.

Currently, the Indian pharma sector accounts for about 3.1-3.6 per cent of the global pharmaceutical industry in value terms and 10 per cent in volume terms. The government has set a clear path for the future of the pharma industry and with the industry witnessing a market growth of 12.8 per cent due to an increase in consumer spending, rapid urbanisation, and increase in healthcare insurance, the government is keen on reducing costs and healthcare expenses. Despite this, the industry is at a very crucial juncture in its growth trajectory. Certain challenges continue to surround it such as, shortage of highly skilled talent, consumer approval process, sub-optimal infrastructure and lack of funding avenues to name a few.

To overcome these challenges and optimise opportunities, shows like CPhI & P-MEC India under the aegis of IPW help companies pass the hurdle. A convention of Indian and global companies, CPhI &

P-MEC India is a comprehensive industry platform for every company that deals with pharma in India.

The mammoth exposition strongly reflects and enhances the value of the prosperous pharma industry while concurrently aiding the industry with collective solutions to its diverse challenges. The event has become South Asia’s leading pharma meeting place, covering every step of the supply chain from drug discovery to finished dosage.

Apart from its regular features, this year, the event will lay emphasis on handpicking young talent, conducting knowledge sharing sessions comprising eminent industry stalwarts and will produce a special White Paper Report on the Challenges of the Sector that will be prepared based on the recommendations of the top CEOs of pharma companies and presented to the Prime Minister’s Office. Such different facets of the show aim to synergise with key governmental initiatives like Make in India, Start Up India, Skill India, and will act as a catalyst to raise the bar further for the nation as a global engine for the sector.

What does the future hold for this industry event? How is it poised to evolve with the shifts that the pharma industry is undergoing?

The pharma industry is no longer being rewarded for incremental innovation, me-too

products and selling the most pills. Companies will need to demonstrate that their brand adds value to patients and they will have to offer a package of products and health services that the market not only wants and needs but is willing to pay a premium for.

Creativity and a constant quest to be innovative has been the backbone of our show and the direct reason for its stupendous growth Y-O-Y. Trade events like ours, play a crucial role in upgrading, enhancing, encouraging and creating solutions for the pharma industry. From its initial days, the CPhI & P-MEC India, geolocated from the global CPhI & P-MEC brand, was a force to reckon with, and its contribution to the growth of the Indian Pharma industry has been second to none. With every edition, we have been always quick in spotting market conditions and formulate changes accordingly which have been seamlessly planned and implemented. To support the growth of the pharma market, CPhI voices the combined opinion of over 100,000 attendees globally and will continue to do so. It harnesses the power of its independent position within the industry, so that it can produce unbiased analysis of the global pharma industry, and help to see emerging trends and bring different perspectives together for cohesive industry growth. lakshmipriya.nair@expressindia.com

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PHARMA ALLY

ACG Group consolidates multiple business and regional brands into a single ACG identity The integrated pharma manufacturing group consolidates its portfolio into four businesses- capsules, films & foils, engineering and inspection ACG GROUP offers end-to-end manufacturing solutions for the pharma industry. In five decades the company has expanded its global footprint and its scope has grown from empty hard capsule manufacturing to include equipment production, packaging, inspection, testing, research and development.

With thirteen companies and five subsidiary offices spread around the world, a new identity was needed to reflect the group’s unified purpose throughout its diverse operations and entities. Under the new change, the group has consolidated into four key businesses namely ACG Capsules, ACG Films & Foils, ACG Engineering and ACG Inspection and has introduced a new strapline- Absolutely Committed. This strapline is a testa-

ment of ACG’s unwavering promise to its customers whilst delivering exceptional manufacturing solutions.

Today, ACG group is led by Karan Singh as the MD. The Group employs more than 4500 associates globally and is present in more than 100 countries.

On ACG’s new identity Karan Singh, MD, ACG, said, “This new dynamic shift will allow us to build on our existing capabilities to create a more integrated customer experience and help us create more intuitive solutions. The four businesses are being led by four superbly talented leaders and I am sure will be able to tap the synergies arising from our newly consolidated structure.

We are expanding our manufacturing footprint across the globe and are Absolutely Committed

to innovation and collaboration that makes us one of the best in the industry. We are also actively looking at ways to use Artificial Intelligence, IoT, virtual reality and other digital transformation technologies to bring the best pharma manufacturing solutions to our customers.”

Leading the mammoth brand identity overhaul project, Peter Neve, Chief Marketing Officer, ACG, shared, “It gives us a new way of thinking about our business—we are now aligned as one ACG rather than as separate businesses. Our core philosophy is to keep customer at the heart of everything we do.

We firmly believe in moving forward, steadfastly with synergy and in a collective drive.

These business segments come together seamlessly to convey

our promise of being Absolutely Committed to offering an integrated solutions platform. We have also launched our new and updated website recently that showcases our entire product and service portfolio in a single location.”

ACG (previously ACG Worldwide) was co-founded by brothers Ajit Singh and Jasjit Singh around 50 years ago as Associated Capsules.

ACG’s new structure ACG Capsules- constituting of Associated Capsules Pvt Ltd (ACPL), ACG Lukaps- Croatia and ACG do Brasil, offers everything you need to fulfil your diverse range of capsules requirements. The Capsules business is led by Selwyn Noronha, CEO, ACG Capsules.

ACG Films & Foils- consti-

tuting of ACG Pharmapack and Nova Nordeplast, Brazil, offers everything you need to produce reliable pharma packaging solutions. The business is led by SR Shivshankar, CEO, ACG Films & Foils.

ACG Engineering- constituting of ACG Pam, ACG Pampac, ACG Metalcrafts, ACG APT, offers everything you need to achieve superior manufacturing performance. ACG’s Engineering business is led by Richard Stedman, Group CEO, ACG Engineering.

ACG Inspection-offers everything you need to meet inspection and traceability demands. The business is led by Ettore Cucchetti, CEO, ACG Inspection.

Visit www.acg-world.com for more information

B&R Automation to exhibit at P-MEC 2018 Validation and compliance made easy At this year’s P-MEC 2018, B&R will be presenting modular and flexible hardware and software solutions for pharma machines and factories. Visit B&R stall in Hall 10, Stall 10.A29 at India Expo Centre, Noida, Delhi from December 12-14, 2018 to witness smart manufacturing solutions for greenfield and brownfield as well as ensure compliance to 21 CFR Part 11. Another highlight would be B&R's revolutionary mapp technology, which accelerates software development by an average of 67 per cent.

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dows or Linux to run alongside B&R's own real-time operating system, making it possible to combine a controller and HMI PC in one device. Pharmaceutical factories look at a seamless vertical and horizontal connectivity, which is satisfied by the vendor independent, secure OPC UA.

Applications in compliance with 21 CFR Part 11

Achieving operational excellence B&R will showcase various solutions for smart manufacturing enabling higher produc-

tivity, OEE and RoI. With ACOPOS P3, machine builders not only reduce cabinet space but also conserve energy and save costs. Hypervisor allows Win-

Pharma companies need the ability to log operations performed by users seamlessly without risk of tampering.

B&R's mapp Technology provides quick and easy way to implement and customise audit trails. System manufacturers

and end users benefit from maximum security without having to implement organisational measures. mapp Report helps to automatically generate PDF reports based on any machine data, with a possibility of customisation, layout and design. With mapp Database, it is possible to archive data directly from field level to a database, regardless of whether that database is located on site or in the cloud. This drastically simplifies the management of large volumes of data. With B&R solutions, machine builders achieve accelerated development and reduced investment risk for applications subject to 21 CFR Part 11 requirements.

PHARMA ALLY

Domino Printech: Aworthy partner for coding solutions The company brings global expertise, in-depth domain knowledge and vast local industry experience to successfully cater to wide ranging coding needs across various industry segments DOMINO IS one of the world’s largest manufacturers of coding and marking, digital printing solutions. Their products are used for date coding, product marking, serialisation and variable printing onto products you use in your everyday life. Their customers are some of the most recognisable brands in healthcare, food, beverage and commercial printing.

Domino Printech India is a fully owned subsidiary of Domino Printing Sciences plc.

Cambridge, UK. Domino was the first ink jet coding company to come to India in 1988.

Domino India is leading supplier of coding solutions in the country. Their primary and secondary coding technologies find application in large and key areas of Industry segments which include: food, pharma and healthcare, dairy, beverages, paints and chemicals, cosmetics and personal care, engineering, breweries and distilleries and a host of other industries.

Products produced by the company include Continuous Inkjet (Small Character) systems, Piezo Micro Drop on Demand (Piezo DOD) systems, Scribing Laser Coding and Marking systems, High Speed Binary Inkjets, Valve Jet Drop on Demand (Large Character) systems, Print And Apply Label Applicator Systems (PALM), Thermal Inkjet (TIJ) systems, Thermal Transfer - packaging printing systems Fume Extraction systems and Digital Colour Label Presses.

Software products produced by the company include Inkjet and Production line Controllers and Coding Automation software.

Domino is an expert to fulfill your serialisation and ag-

gregation needs. They have products, industry experts which and who can fulfill your needs and render your position as a global leader.

QuickDesign Stay fully compliant and in complete control of your package messaging, from product to pallet, right from the factory floor. Fully scalable to suit your production line, you can manage data simply with a touch screen PC interface and create accurate labels from our built-in product table.

Industry standards of

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The serialisation and coding of products is an essential part of the production process

product identification and coding are always evolving.

This is a good thing for the health, safety and security of customers – but it can prove a challenge for suppliers.

Domino understands that you need high quality, accurate product marking solutions

which meet this challenge, while also integrating with your existing production processes.

The serialisation and coding of products is an essential part of the production process. It ensures compliance with the latest legislation

and, ultimately, safeguards the health of users. But it can also prove challenging to implement – particularly when dealing with difficult to mark materials.

The company brings global expertise, in-depth domain knowledge and vast local industry experience to successfully cater to wide ranging coding needs across various industry segments. They offer reliable products, innovative solutions and dependable services at the best possible value to the customers.

Domino India has pan-India presence.

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November 1-15, 2018

PHARMA ALLY

International ISO Standard 11140-1? Sterilisation Of Health Care Products — Chemical Indicators SINCE SEVERAL years, steam sterilisation (autoclaving) is a very popular method used for sterilisation in hospitals, pharmaceutical, life science industries, etc.

Chemical and biological indicators are widely used to monitor the sterility of the contents being sterilised. ISO 11140-1 defines the general requirements for sterilisation of healthcare products for chemical indicators. It specifies performance requirements and/or test methods for chemical indicators intended for use with various sterilisation processes.

The chemical indicators described in this part of ISO 11140 are categorised into six types, viz. Type 1 to Type 6. Time, Steam (quality of steam) and Temperature are 3 important variables for steam sterilisation process. The user can opt for any of the six chemical indicators defined by ISO as per the sterilisation process as per the performance characteristics desired.

lating indicator is -2 °C, and the tolerance on the test time is -25 per cent.

Type V indicators

has been directly exposed to the sterilisation process ◗ Thus they can help users to distinguish between processed and unprocessed packs ◗ These are intended for use externally only, i.e. outside the load pack

Type II indicators These are intended for use in specific test procedures and for use in special applications, e.g.

Bowie and Dick-type test.

These are usually used once a day on an empty load and intended for use inside the autoclave machine to check for the efficacy of air removal by the autoclave. The end result is documented by the user.

Type I indicators ◗ These are called process indicators shall be designed for use with individual items (e.g. packs, containers) to show that the unit

Type III indicators These are internal indicators which are single variable indicator. This indicator only reacts to

one critical process variable and will indicate a ‘pass’ condition at a stated value (SV) of the chosen critical variable.

These are intended for use inside the pack.

These are not popularly used as monitoring only one critical variable may not be helpful for many ?applications.

These are internal indicator, called Integrating indicator.

This indicator reacts to all critical process variables. The stated values (SV) demonstrate how the indicator integrates over the temperature range.

It is intended for use inside the pack and are fairly commonly used.

The tolerance on the test temperature for a Type 6 emulating indicator is -1 °C, and the tolerance on the test time is -15 per cent.

Type VI indicators Type IV indicators These are internal indicator which is multi variable indicator.

This indicator only reacts to more than one critical process variable and will indicate a ‘pass’ condition at a stated value (SV) of the chosen critical variables.

These are intended for use inside the pack.

These are moderately used and usually in conjunction with either Type 5/Type 6 indicators.

The tolerance on the test temperature for a Type 6 emu-

These are internal indicators and called Emulating indicators.

This indicator reacts to all 3 critical process variables for specified sterilisation processes.

They emulate your cycle of sterilisation and the colour change is? noticed when ALL 3 critical parameters have been met with according your cycle of sterilisation. (Ex. 121 deg for 20 mins / 121 deg for 15 mins – There are different products for different cycles of sterilisation).

Hence these are also called CYCLE SPECIFIC INDICATORS. It is also intended to use inside the pack and are very commonly used.

The tolerance on the test temperature for a Type 6 emulating indicator is -1 °C, and the tolerance on the test time is -6 per cent.

These are stored for documentation post sterilisation along with cycle records.

Importance Note All Type 3, Type 4, Type 5 and Type 6 indicators are to be placed inside individual load items and to assess attainment of the critical process variables at the point of placement. Thus, it is clear that chemical indicators are available in different types depending upon the function they are designed for. It is important for the user to select the appropriate chemical indicator for his cycle of steam sterilisation in accordance to the performance characteristics desired.

Contact: Anchal Gupta Yogi Kripa Medi Chem Pvt Ltd., Director Contact: anchal.gupta @yogikripa.com www.yogikripa.com

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PHARMA LIFE I N T E R V I E W

Through NETAP we want to bridge the gap between education and employment TeamLease, one of India’s leading human resource service companies, is a part of NETAP, an apprenticeship programme in a Public Private Partnership endeavour initiated along with CII and NSDC under the National Employability Enhancement Mission of the Ministry of HRD (AICTE). Sumit Kumar, Vice President, NETAP, TeamLease Services, elaborates on the need to create talent to support Ayushman Bharat, role of apprentices in bringing more efficiencies to any organisation, and how apprenticeships has picked up in both pharma and healthcare, in an exclusive tete-a-tete with Lakshmipriya Nair TeamLease is one of the partners in the National Employability through Apprenticeship (NETAP).

Tell us more about it and the impact it intends to create?

NETAP is an apprenticeship program offered by TeamLease Skills University based on National Employability Enhancement Mission (NEEM) guidelines notified by Ministry of HRD. Vision of NETAP is to bridge the skill deficit in industry by enhancing the employability quotient of the youth through apprenticeships. There is a skill shortage of 127 million in the industry, and what better way to overcome than through apprenticeships which is a tried and tested model by evolved economies of the world. The impact we want to achieve through NETAP is to bridge the gap between education and employment; and make learning more effective and impactful that makes the output job-ready. We do this through blended form of learning where on the job training is the core that gets blended with either an online learning or an onsite classroom learning mechanism or both. The output is far more productive and the employers have a better ROI against buying talent.

54 EXPRESS PHARMA November 1-15, 2018

cater to the demand arising out of the program.

What are the major benefits of the apprenticeship model for the life sciences sector?

How is it a good model for up-skilling and recruitment of new talent?

Following are the benefits of apprenticeship for the life sciences sector; 1. To create pipeline of future potential employees 2. Create talent which is relevant for the organisation and for the industry 3. Prepare talent to match the changing dynamics of the world of work To get the right talent is a challenge faced by employers and buying is an expensive proposition. Through apprenticeships, trainees are exposed to real work which helps them build cognitive skills apart from getting domain knowledge. Also,

employers are able to gauge the efficacy of candidates and induct the best into the system. Hence, it becomes an efficient evaluation mechanism.

How will the apprenticeship model gain more significance in the backdrop of Ayushman Bharat?

Ayushman Bharat is about scale, addressing half a billion population who cannot afford medical treatment.

This would lead to creation of medial infrastructure to avail insurance facility. Hence, it would need skilled medical people to diagnose and provide medical treatment.

Also, creation of medial infrastructure would need skilled manpower.

Apprenticeships would be a better way to skill people to

How can apprenticeship programme`s serve to bridge the gap between the industry and the academia and enhance the pool of industry-ready human resources?

About 5 million people graduate every year with employability that is under question mark. As per occupational standards, 90 per cent of kids lack skills.

Apprenticeships help them acquire these skills through on the job exposure. They may be qualified but apprenticeships make them capable to be employed.

Tell us about some of the partnerships you have in the life sciences sector. Can you share the results of these partnerships?

We work with many large and medium pharma organisations that engage apprenticeships under NETAP and engage with trainees at various job roles.

While most of them are in back end process of manufacturing, few are deployed under R&D function. Not many organisations deploy apprentices under this role, but I would say the trend has started and will catch up.

Our programme has been running for about four years,

and it’s heartening to see the outcome. The intake on apprentices has risen by 60 per cent over last year and number of organisations in the sector has doubled.

About 30-40 per cent of these trainees are being absorbed by these employers and offered a wage premium ranging between 40-45 per cent.

How will these programmes generate more employment and lay the foundations for future workforce?

An apprenticeship paves way for formal employment by creating a consistent pipeline of talent that gets channelised towards formal employment. Employers tend to engage with informal labour which falls under grey zone and are quite unproductive or under productive. Through apprenticeships, the deployment is compliant and process of training is structured which ultimately enhances the productivity of the organisation.

NAPS under the Apprentices ACT, encourages SMEs to engage with formal apprentices instead of casual workforce and get a subsidy from Govt.

By doing this more work forces gets channelised towards formal employment. lakshmipriya.nair@expressindia.com

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