Express Pharma (Vol.12, No.9) March 1-15, 2017

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Healthcare Sabha 2017 discusses blueprint for a healthy India

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CONTENTS MARKET

Vol.12 No.9 March 1-15, 2017 Chairman of the Board Viveck Goenka Sr Vice President-BPD

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IDMA, NSF HEALTH SCIENCES LAUNCH TRAINING PROGRAMME IN PHARMA QUALITY MANAGEMENT

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BIOASIA 2017 HELD IN HYDERABAD

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ISCR CONDUCTS CLINICAL RESEARCH CONFERENCE

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GENERIC RESPIRATORY DRUG DEVELOPMENT 2017 CONFERENCE HELD IN MUMBAI

Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist

Healthcare Sabha 2017 discusses blueprint for a healthyIndia

MANAGEMENT

Policymakers and opinion leaders come together at the event hosted by Express Healthcare to discover a cure for the problems ailing the current public healthcare system | P14

Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads

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HEALTHCARE SABHA 2017: PAYS HOMAGE TO PUBLIC HEALTH CHAMPIONS

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EDITOR’S NOTE

Evolving an ‘India First’ policy

T

he countdown to the USTR for 2017 Special 301 Review has begun. This is the United States Trade Representative (USTR)'s annual round up of countries with poor protection of intellectual property rights (IPR) or unfair market access to IP-dependent US enterprises . The hearing for this year's Special 301 Review is slated for February 28 and organisations have been asked to submit their views.

Leading the charge on behalf of India's pharma sector is the Indian Pharmaceutical Alliance (IPA) which argues the case for removal of India from the Priority Watch List.

Besides highlighting several steps taken by the Government of India to improve the IPR ecosystem, the most significant part of the IPA's submission is equating Section 3(d) of India’s Patent Act with US Hatch-Waxman provisions. Arguing that Section 3(d) is merely an appropriate alternative in the Indian context to the Hatch-Waxman provisions, IPA points out that Section 3(d) is simpler, less litigious, patient friendly, and has potential to avoid “unjust enrichment” of the right holders.

As DG Shah, Secretary General, IPA argues, 'The legal framework in the US mitigates the problem of non-meritorious, secondary medicinal patents by providing the incentive of exclusivity to successful generic challengers but India does not have a comparable provision in its law. Nor is it feasible to have one as India does not have mandatory generic substitution (and the consequent rapid substitution of generics) as in the US. To make the incentive meaningful. Section 3(d) in India’s Patents Act provides an alternative. It is perhaps a more efficient way than to grant weak patents in the first instance and then impose the burden of litigation to set matters right.'

Section 3(d) is merely an appropriate alternative in the Indian context to the Hatch-Waxman provisions

In other words, Section 3(d) seeks to prevent weak patents rather than taking corrective action later.

Taking a diametrically opposing stance, the Global Intellectual Property Center (GIPC) of the US Chamber of Commerce recently released its International IP Index which ranks 45 countries by the ‘strength’ of their IP standards. Its submission to the USTR recommends India’s continuance on the Priority Watch List and subjecting it to an out-of-cycle review to ratchet up the pressure. The GIPC International IP Index ranks India ranks 42nd out of 45 countries, followed only by Pakistan and Venezuela. The highest ranked country is the US followed by the UK, Germany and Japan.

The GIPC specifically refers to India's poor record of protecting biopharma patents. The report also cited 2016 statistics, that 98 per cent of patents granted in India in 2015 were for applications over five years old, with one case stretching 19 years to prosecute and grant a patent.

It's ironic that US President Donald Trump's first executive action in office was to withdraw from the Trans-Pacific Partnership (TPP) Agreement to fulfill his election promise of putting America First. But when the Indian government takes all precautions to put India First, by including provisions in our patent law to prevent evergreening and monopolies, we're named and shamed.

There's no doubt that India's IP ecosystem is at a nascent stage but each country has the right to choose its own path. Just as President Trump chooses his own.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET POST EVENTS

Healthcare Sabha 2017 discusses blueprint for a healthy India Policymakers and opinion leaders come together at the event hosted by Express Healthcare to discover a cure for the problems ailing the current public healthcare system

By Lakshmipriya Nair

‘C

o-creating a Manifesto for a Healthy India’ was the theme for the second edition of Healthcare Sabha, – The National Thought Leadership Forum for Public Healthcare.

Held at Novotel Varun Beach, in Visakhapatnam, Andhra Pradesh, recently, it started off with a welcome address by Viveka Roychowdhury, Editor, Express Healthcare. She took the audience through the vision of the event and welcomed them to three days of knowledge sharing through debates and discussions on various aspects of public health.

Knowledge sharing galore Union Minister for Health Dr JP Nadda’s video message also awaited the participants of Healthcare Sabha 2017. He congratulated The Indian Express Group and Express Healthcare for creating a platform like Healthcare Sabha and highlighted the need for such events to facilitate constructive dialogues between the stakeholders in the arena of public health.

It was followed by an interesting panel discussion on a crucial topic which has severe

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(L-R) Dr Pravin Shingare, Dr Madhumita Dobe, Dr DK Sharma, Prof AK Mahapatra, Sudeep Srivastava, and Dr Farhat Mantoo discussing talent scarcity in healthcare

adverse effects on India’s goal to ensure Universal Health Coverage to its citizens – talent crunch. Moderated by Dr Farhat Mantoo, Regional Coordinator HR, MSF, South Asia, the session boasted of an eminent panel comprising Prof AK Mahapatra, Chief, Neuroscience Centre, AIIMS, Delhi; Dr Madhumita Dobe, Director- Professor & Dean, All India Institute of Public Health (AIIPH); Sudeep Sri-

vastava, Director, Pradhan Mantri Swasthya Suraksha Yojana (PMSSY); Dr Pravin Shingare, Director, Directorate of Medical Education & Research, Maharashtra; and Dr DK Sharma, Medical Superintendant, AIIMS. The panelists discussed the topic in detail and deliberated on the ways to mitigate the talent crunch, both in terms of capacity and competence in public health.

The panelists also recommended measures for talent generation and management which included assessing the current regulatory systems in terms of efficacy and effectiveness, creating more needbased skill slabs, training more allied healthcare workers, encouraging professionals to take up teaching which in turn will add capacity among medical practitioners, integrating AYUSH practi-

tioners in mainstream medical practice, charting a more clear career path for public health professionals to incentivise them, optimising the currently available resources, being more open to innovation in creating and retaining talent etc.

The next speaker, Jitendar Sharma, Director and CEO, spoke on sustainable health financing systems and elaborated on how it touches various segments of the healthcare sector including health services, medicines, diagnostic services and health promotion and education. He also gave a rundown on the myriad financing programmes being implemented in the various parts of the country and their impact. At the same time, he also cautioned on the need for more streamlined processes such as third part audits of these programmes for better transparency and efficiency.

The last session for the day was addressed by Dr Suresh Saravdekar, Director, The Rural Health & Education Centre, who spoke on NLEM, procurement practices and patient safety. He spoke on the need for quality in medicines as well as in their usage. He

also elaborated on bridging the difference between various generic medicines. He advised people to move from quality assumed to quality assured.

Challenges to conquer Policymakers and key opinion leaders in India’s public healthcare sector reconvened on the second day of Healthcare Sabha 2017 to continue the knowledge exchange with an aim to address the dominant challenges in the country’s public health system.

Sunil Sharma, Joint Secretary, Pradhan Mantri Swasthya Suraksha Yojana (PMSSY), Ministry of Health & Family Welfare, Government of India gave a great start to the second day of

Healthcare Sabha 2017 with an insightful keynote address wherein he reiterated that availability, affordability and reliability are the cornerstones of any successful public health system. He also gave an overview on various government measures to facilitate a robust healthcare system which would effectively serve all the citizens of the country. He went on to highlight how funds allotted to NHM have grown up in recent years and elaborated on various schemes introduced to curb out-of-pocket expenditure. At the same time, he also admitted that there are several chinks in our system that need to be ironed out to fortify it and make it more foolproof. He also addressed

queries from the audience to give them more clarity on the government’s stance and commitment to improve the healthcare scenario in the country.

In the next session, Angshuman Sarkar, Principal Consultant, ThoughtWorks Technologies, spoke on creating an integrated health ecosystem, empowered by technology. He put forth several ideas to demonstrate how technological advances can generate significant positive outcomes in health.

Sarkar also drew attention towards the myriad solutions provided by his organisation to strengthen the public health system.

The same theme was carried forward by subsequent

speakers, Dilip Bhosale, Head Marketing, India and Pranav Shah, Head Business Development, IT India, Agfa Healthcare who urged the public healthcare fraternity to join the digital revolution to attain the goal of Universal Health Coverage (UHC). They also gave an overview of their solutions for public health facilities.

Thereafter, in an interesting session by A Velumani, Founder, CEO and MD, Thyrocare, he shared the story of his rise from a PSU scientist to a corporate leader without losing the values of social good. Many of his success mantras like profit from volumes, making affordable care possible without compromising on quality, using technol-

ogy to reach out to a large number of people etc carried valuable insights for public health professionals as well.

The next session was on bridging delivery gaps in Indian healthcare through affordable medtech development and deployment. Dr Mauryashankar Sivaprakasam, Director, Healthcare Technologies Incubation Centre, IIT Madras, spoke on various innovations being incubated at his organisation and emphasised that affordable innovations are the key to create a good public health system.

Prof MV Padma Srivastava, Department of Neurology, Neurosciences Centre, AIIMS, New Delhi, addressed another significant issue – Rising incidence of strokes

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and the need to scale up stroke care in India’s public healthcare facilities. She also cited the example of Delhi’s ‘Code Red’ programme as a measure to tackle the growing menace.

The succeeding speaker, Sabu Jose, GM – Government, OEM & Corporate Accounts – India Cluster, Carestream Health, spoke on the future of imaging and his company’s offerings in this sphere.

Sumit Marwah, CEO and Director, Dispoline India spoke on their solutions for infection control and their advantages in public health in his session titled ‘Single use dilemma’.

The skill gap in healthcare was once again highlighted by Ashish Jain, CEO, Healthcare Skill Sector Council (HSSC).

He also spoke on his organisation’s role in mitigating the deficit and elaborated on various programmes undertaken

by HSSC to handle talent crunch among healthcare professionals, both in terms of capacity and competence.

Training the trainers and collaborating with NABH to assure that there are a certain number of HSSC-certified staff in accredited hospitals are some of the steps he mentioned in his session.

Prof Mukul Asher, Professorial Fellow, Lee Kuan School of Public Policy, took the stage next to share his insights on health sector governance and resource generation. He highlighted the need for good governance and a framework for efficient management of resources to evolve a robust public healthcare model. He emphasised that there is no society which can provide best health services all the time, hence management of existing resources is key.

Dr Damodar Bachani, Deputy Commissioner (NCD), MoH&FW, Government of India, another distinguished speaker at Healthcare Sabha 2017, called attention to the growing threat of NCDs, India’s preparedness to deal with it and the immediate measures to tackle this challenge effectively which other-

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(L-R) Dr Payal Laad, Dr RK Srivastava, Gajendra Kumar and Prof Dayashankar Maurya discussing on sustainable healthcare financing

(L-R) Dr Deepak Agarwal, Dr Atul Kharate, Dr Prateek Rathi and Dr Suleiman Merchant on good governance

(L-R) Lokesh Sharma, Dr RK Srivastava, Dr M Prakasamma and Dr Bejon Misra discussing access to essential medicines and health services

wise would have overreaching adverse effects. He also called for concerted efforts and strategic measures to win the war against this health menace.

The last session for the day was a workshop on NLEMbased hospital formulary in a public health facility, spear-

headed by Dr Suresh Saravdekar, Director, The Rural Health & Education Centre.

The workshop helped gain more understanding about the best practices in procurement that India can inculcate to improve its own drug quality standards. The delegates also got the opportunity to

share their experiences in this sphere and exchange learnings.

Transforming healthcare in India The third day of Healthcare Sabha 2017 began with a key note address by Bejon Misra, Founder, PSM India in which

he highlighted the role of the most important stakeholder in public heath – patients. He said that it is pivotal to empower the patients to create a sustainable and good public health system. The renowned patient activist was also emphatic on ensuring highest quality in medicines and healthcare services in his session.

The next speaker for the day was Vivek Tiwari, Director and CEO, Medikabazaar.

He gave a rundown on the various trends transforming healthcare in India and stressed on the need to adopt latest advancements to tackle the various public health challenges faced by the country.

Thereafter, KB Srinivas, GM, National Insurance Corporation spoke on the enhancing role of health insurance in creating a sustainable health financing system. He also elaborated on the myriad ways to finance healthcare and cited interested financing models in his session.

The subsequent speaker, Bhudeb Chakravarti, Honorary President, Centre for Development of Excellence, Hyderabad gave a session on the role of PHCs in strengthening the public health system and recommended measures to make them more efficient.

'Govt sponsored schemes: Meant for poor, but beyond their reach?' was the topic addressed by the next speaker, Prof Dayashankar Maurya, Chairperson, Healthcare Management & International Relations, TA Pai Institute of Management.

Three panel discussions were also part of the day's agenda. The first one was on Sustainable Health Financing Systems/Health Economics.

Moderated by Prof Maurya; an eminent panel comprising Gajendra Kumar, Advisor, Ministry of Railways, Government of India; Dr RK Srivastava, Sr Advisor, Public Health and Innovation, Wadhwani Initiative for Sustainable Healthcare (WISH) Foundation; and Dr Payal Laad, Assistant Professor of Community Medicine, Public

MARKET

An enrapt audience listening to the sessions

Health at Lokmanya Tilak Medical College and Hospital discuss ways to create an integrated and functional public health system which is reliable and accessible.

Dr HG Koshia, FDCA Commissioner, Gujarat took the stage and spoke on the regulatory practices in his state to ensure safe medicines for all. He also gave a rundown on the initiatives by the government to protect public health.

Next, RP Khandelwal, Chairman, HLL Lifecare, shared the story of HLL's growth trajectory from a condom manufacturer to a PSU involved in a range of activities. He also divulged HLL's future growth strategies and endeavours such as setting up 300 AMRIT stores to increase access to medicines.

A panel discussion on ensuring good governance followed wherein Dr Atul Kharate, State TB Officer, Madhya Pradesh, GOI; Dr Suleiman Merchant, Dean, Lokmanya Tilak Medical College and Hospital, Mumbai; and Dr Deepak Agarwal, IT Head, AIIMS, Delhi highlighted the need for development thinking, spending and action to ensure good governance in public health. Dr Prateek Rathi, Special Executive Officer at ESI Scheme, Department of Public Health, Maharashtra moderated the discussion wherein experts recommended IT adoption, right resource allocation, innovative solutions and best practices to create a efficient framework for public health.

The ensuing speaker, Dr Suleiman Merchant, Dean, Lokmanya Tilak Medical College and Hospital gave insights on the various advancements in healthcare and was emphatic on the need to adopt them to ensure better health outcomes.

The conference came to a close

with a panel discussion on 'Access to Quality Health Services and Essential Medicines'. The panelists, Dr M Prakasamma, ED, ANSWERS; Dr Bejon Misra, Founder, Partnership for Safe Medicines (PSM) India; and Dr RK Srivastava, Sr Advisor, Public Health and Innovation, WISH Foundation, Former Chairman, Medical Council of India, Former Director General of Health Service, Government of India; discussed on the way ahead to ensure quality in public healthcare and achieve UHC. The experts recommended fortifying public healthcare and safeguarding the human touch, which is fast diminishing in a high-tech world. They also highlighted the need for steps like Jan Aushadhi albeit with better distribution models, evolving better PPPs and engaging all stakeholders to strengthen the current public health system in India. Lokesh Sharma, Director, QuintilesIMS Institute India; Head of Government Solutions in India for QuintilesIMS Health, QuintilesIMS Health moderated the session. Thus, the conversation revolved around solutions to deal with the current challenges related to health expenditures, services and performance outputs.

The sessions were followed by Express Public Health Awards, an endeavour to recognise and celebrate the commitment shown by state governments, public sector institutes, government hospitals and NGOs to safeguard India’s health. It was held in collaboration with Glenmark, Public Health Foundation of India and KPMG. The second edition of Healthcare Sabha renewed the vigour among the public health stakeholders to reform healthcare delivery in India. lakshmipriya.nair@expressindia.com

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IDMA,NSF Health Sciences launch training programme in pharma quality management Priced at approx. 8100 GBP + taxes and other expenses, the programme consists of five four-day modules scheduled every eight weeks conducted at Bengaluru’s Acharya College THE INDIAN Drug Manufacturers Association (IDMA), in collaboration with UK-based NSF Health Sciences announced the launched of a customised intensive education and skill development programme targetted at pharma quality assurance professionals. The aim is to develop 'change agents for quality excellence and to make India the centre of excellence for pharmaceutical manufacture'. The initiative is the latest in a series of endeavours by industry associations to re-skill pharma professionals, in response to the prolonged regulatory woes being faced by some companies in India, stemming from poor GMP compliance. IDMANSF's Advanced Program in Pharmaceutical Quality Management (APPQM) is reportedly designed specifically for Indian companies who want to succeed in US and European markets. Designed as both as an education and mentorship programme, the intense and challenging MBA style programme will provide participants education related to best industry practices in quality culture, quality management, regulatory compliance, manufacturing operations, leadership skills, skills in risk based decision making, advanced problem solving, crisis management, simplification etc, according to the brochure. Delegates will complete a written assessment for each module. Successful candidates will be awarded an internationally recognised Certification from NSF and IDMA. According to the APPQM brochure, the course fee for a batch of 30-40 attendees, of approximately 8100 GBP + 15 per cent service tax plus actual travel and stay expenses at the venue, Acharya College,

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Delegates at the conference

Bengaluru. Exclusive hire of the faculty for 40 tutor days of in house training would come to around 150000 GBP compared to 10000 GBP for the entire programme.

In his welcome address at at the launch of the APPQM, S M Mudda, Chairman Regu-

latory Affairs Committee, IDMA and Director - Global Strategy (Technical), Micro Labs, thanked Sudhanshu Pandey, IAS, Joint Secretary, Department of Commerce, Ministry of Commerce and Industry, Government of India for his patience and support

over the past year as IDMA went through the process of selecting a partner to make global pharma quality certification more available and accessible in the country. Mudda also highlighted the value proposition of the course saying, “Wouldn’t an employer prefer to spend `8 lakhs approx per employee and develop in-house expertise, rather than relying solely on external expertise?” He exhorted his colleagues to educate their QA staff “as they are the face of the company during inspections” and reminded them that remediation costs far outweigh the prevention costs.

The meet was also addressed by SV Veerramani, Immediate Past National President, IDMA and Founder & Chairman, Fourrts (India) Laboratories who briefed the audience on IDMA’s initiatives for ‘Building Brand India’ followed by Deepnath Roy Chowdhury, National President, IDMA and MD, Strassenburg Pharmaceuticals. As Chief Guest at the launch, Sudhanshu Pandey, IAS, Joint Secretary, Department of Commerce, Ministry of Commerce and Industry, Government of India reiterated his support for this initia-

tive, saying, “Quality is all about trust - within the organisation, with the regulator and finally with society. If you invest in quality, profits will automatically follow. “The meet was also address by O Sadhwani, Joint Commissioner FDA, Maharashtra, Mumbai and Dr K Bangarurajan, Deputy Drugs Controller (I) CDSCO, West Zone Mumbai.

Both dignitaries applauded IDMA for this excellent initiative and taking training to the next level. This would be a good investment, as well equipped and trained personnel are a big asset to any organisation. They also expressed their desire to support IDMA in making this joint training programme a huge success. Explaining the contours of the APPQM, Martin Lush, President NSF, UK emphasised that the NSF – IDMA collaboration was based on shared beliefs that 'people’ were the active ingredient of every medicine, patients were at the centre of everything both organisations did, and a firm belief in the ‘fix the roof when the sun is shining’ approach. MNCs like Pfizer and Sanofi Pasteur have recoreded positive feedback of the course. In terms of return on investment, Lush cited savings attributed to SOP simplification ($1.2 million), getting batch manufacturing records (BMR) right first time ($2.2 million), reduction in cycle time and work in progress, increase in plant utilisation by 37 per cent, staff turn over reduced from 19 per cent to 3 per cent, and reduction of repeat deviations ($ 1.6 million).

The meet ended with a vote of thanks from Daara Patel, Secretary-General, IDMA. EP News Bureau

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BioAsia 2017 held in Hyderabad The inaugural ceremony of BioAsia 2017 witnessed many strategic partnerships and investment announcements of around `3,382 crores BIOASIA, Asia’s largest biotechnology and life-sciences forum and the annual flagship event of the Government of Telangana, was recently held at Hyderabad International Convention Center HICC. The 14th edition of BioAsia with the theme ‘Power of the Past, Force of the Future’, witnessed participation of delegates from healthcare, biotech, pharma, life-sciences, IT, academia and startups.

The event was inaugurated

by ESL Narasimhan, Governor for Telangana in the presence of industry leaders from government, corporate and regulatory bodies. He also presented Genome Valley Excellence Award to Nobel Laureate Prof Kurt Wuthrichand and Dr Paul Stoffels, Worldwide Chairman Pharmaceuticals and Chief Scientific Officer, Johnson & Johnson for their immense contribution in the field of life sciences and healthcare.

While inaugurating the event, Narasimhan said, “Telangana State has emerged as a leader in the life sciences sector and has immense scope

for further industrial growth.

Since its beginning in 2014, BioAsia as a platform has been instrumental for the state government to invite the global investors and business leaders, showcase the extraordinary infrastructure available in the state and attract investments.

Over 200 MoUs and about `14,000 crores investments have been announced at BioAsia. The event also has brought together leaders from over 89

countries at Hyderabad.”

The inaugural ceremony of BioAsia 2017 witnessed many strategic partnerships and investment announcements of around `3,382 crores. Earlier, the day started with a delegate visit to the BioPark at Genome Valley, as a part of BioAsia 2017, where several companies showcased their state-of-theart infrastructure to the high profile delegation.

Additionally, KT Rama Rao,

Jayesh Ranjan, Principal Secretary, Govt of Telangana, Industries, Commerce, IT, Electronics and Communications presenting a memento to Narayana Murthy, Founder, Infosys,

Minister of IT, Industries, MA & UD, NRI Affairs, Government of Telangana inaugurated MN Park’s iHub Phase II and SME Hub @IKP. He also unveiled building plans of country’s largest animal resource facility being set up by Government of India in partnership with Government of Telangana. The first half of the day also witnessed ground breaking of Biological E’s SEZ Campus in Genome Valley. Overall, projects totalling

`1,680 crores were inaugurated at Genome Valley on a single day.

While addressing the delegates, Rao said, “Hyderabad has always been known as the top pharma destination worldwide. The city is and will remain the pharma production and innovation hub for the world and the proposed Pharma City will strengthen its position significantly. With new industrial clusters like Pharma

Dr Patrick Vallance, President R&D, GSK, UK delivering a keynote during a session on day three of BioAsia 2017

Dr Vasanth Narasimhan, Global Head of Drug Development & CMO, Novartis, Switzerland signing an MoU with NIPER Hyderabad in the presence of KT Rama Rao, Minister for Industries & Commerce, IT E&S, MAUD, Government of Telangana

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City and Medical Devices park, Hyderabad is ready to assume leadership role of the life sciences industry in Asia and the world.”

Commenting on the occasion, Shakthi Nagappan, CEO, BioAsia said, “We are excited to witness the overwhelming response to the 14th Edition of BioAsia in terms of participation, investments and strategic partnerships. The presence of most influential leaders from global pharma powerhouses is a testimony to the stature where BioAsia has reached now. With participation from across the world, BioAsia has created a dominant position for itself and will continue to keep

strengthening its leadership through strong focus on the deliberation topics and experts.”

Day two of the event had key notes from Dr Stoffels, Prof Wuthrich, Dr Vasanth Narasimhan, Global Head of Drug Development and CMO, Novartis, Switzerland. A parallel Innovation Conference and Automation in Diagnostics Conference was also held.

The international partners were the State of Illinois, US and State of Selangor, Malaysia whereas the State of Rajasthan and Uttar Pradesh were the Indian state partners for the event.

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An MoU was executed with Cerestra to explore a Life Sciences Infrastructure Fund to the tune of `1000 crores to create sophisticated modular plug-and-play infrastructure for pharma/ biotech/ medical devices industry. This will be the first-of-its-kind fund in the country for creation of specialised infrastructure for the life sciences industry.

Inauguration of MN Park’s iHub Phase II initiative with two million square feet of Lab Space for R&D companies and start-ups at an investment of about `1000 crores

◗

Allotment letters for about six companies were handed over with a cumulative investment of `702 crores

◗

Unveiling of building plans of country’s largest animal resource facility to be set up by Government of India in partnership with Government of Telangana with a Central Government grant of `330 crores and 102 acre of land from state government

◗

◗

Ground breaking of Biological E’s SEZ Campus in Genome Valley with an investment of `300 crores and creating direct and indirect employment for about 1,000 people Inauguration of SME Hub @IKP in Genome Valley with 50,000 square feet incubation facility for Life Sciences SMEs at an investment of ` 50 crores.

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HVAC system for Sterile Area

EP News Bureau

PROJECTS ANNOUNCED DURING BIOASIA 2017 ◗

Air Handling Units

EXPRESS PHARMA

21

March 1-15, 2017

Laminar Air Flow

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MARKET

ISCR conducts clinical research conference Indian Society for Clinical Research launches Causality Assessment Portal at 10th Annual Conference THE 10TH Annual Clinical Research Conference was recently held in Mumbai. Launched on the occasion was a Causality Assessment Portal developed

by ISCR in collaboration with MRCT Harvard.

The portal aims to develop a comprehensive framework for clinical trials case causality assessment that will be relevant globally and within the Indian regulatory context for compen-

make our theme Patients First and Research for India a reality,” said Suneela Thatte, President, Indian Society for Clinical Research (ISCR).

A panel discussion on ‘Regulations for Clinical Research – has it led to better protection of patient safety?’, saw lively views from various stakeholders. Dr VG Somani, Joint Drugs Controller iterated the Government of India’s commitment to mak-

Dr Soumya Swaminathan, DG-ICMR felicitating Dr Sudeep Gupta, Deputy Director – ACTREC and Professor of Medical Oncology at Tata Memorial Hospital, with the ISCR Excellence Award for Academia

sation. This becomes particularly significant in light of the recent Indian regulations that directly link trial participant compensation for injury or death to causality assessment.

The portal will serve as a tool that provides guidance documents and training materials to enable clinicians and ethics committee members to follow best practice procedures in determining causality for adverse events in a clinical trial.

“Clinical research professionals need to take a more proactive role in conducting research for India. A more conducive regulatory framework for the conduct of clinical research will enable this and encourage local innovation, ensuring that Make in India is a reality for drug development and clinical research in India.

Such an approach will help

22

EXPRESS PHARMA

March 1-15, 2017

ing India a favoured destination for clinical research. “We are going through a transition phase where we are focussed on bringing about several improvements in the clinical research regulatory environment for the benefit of patients and the society at large,” he said.

Delivering the Prof Ranjit Roy Chaudhury Oration on TB: Challenges and Solutions for the 21st century, Dr Soumya Swaminathan, Director General, ICMR said, “It gives me great pleasure to note the many positive changes in the clinical research environment these past few years in India. ISCR has been working relentlessly in this direction. We must continue to invest in capacity building of subject experts, sensitise leadership at the political level, work with ethics committees who are increasingly responsi-

ble for patient safety, and encourage patient representation at various fora.”

ISCR presented the Academia Award for Notable Contribution to the Clinical Research Fraternity to Tata Memorial Hospital and the Industry Award for Notable Contribution to the Clinical Research Fraternity to Dr Arun Bhatt who has over thirty years of clinical research experience.

A panel discussion witnessed leading industry experts and academia who spoke of the need for improving stakeholder trust in clinical research, creating a more conducive environment for clinical research and further improvement in regulations. They highlighted the need for more investigator and patient testimonials on the benefits of clinical research, and its role in ensuring better health and patient outcomes. “Clinical research drives innovation and it is incumbent on us to do more clinical research to contribute to more drug development in India,” said Naz Haji, SVP and MD, R&D Solutions, QuintilesIMS India.

A parallel track was held on data management, medical writing and biostatistics which focused on e-technology advances in clinical operations, oncology trials and NCEs in India. Attending the conference were clinical research professionals from across the stakeholder spectrum. With India operating in a new regulatory environment, Thatte stressed on the key responsibility of each clinical research professional to renew their pledge to quality, patient safety and data integrity and set an example to the rest of the world as to how quality and ethics are not mere tokenism but truly reflect the spirit of the clinical research community in India.

EP News Bureau

‘India Pharma 2017’& ‘India Medical Device 2017’ International Conference held in Bengaluru According to Ananthkumar, Union Minister for Chemicals & Fertilizers, Bengaluru will soon become the pharma and Med Tech Zone THE 2ND edition of India Pharma & India Medical Device International Conference was recently inaugurated in Bengaluru by Union Minister for Chemicals & Fertilizers and Parliamentary Affairs, Ananthkumar. The three-day event, with the Vision-‘For Responsible Healthcare’, was organised by the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers and Federation of Indian Chambers of Commerce & Industry (FICCI).

Kumar called the International Conference as a ‘Pharma and Medical Devices Kumbh’.

He called upon all the stakeholders present to make India as the ‘Pharmacy of the World’. He said that Bengaluru, being the hub of information technology and skilled manpower, would prove to be the ideal location to set up a pharma and Med Tech Zone and hence the Ministry would work with the state government to establish it soon.

Siddaramaiah, Chief Minister, Karnataka said that this is the second time Karnataka is hosting this conference on medical devices and pharma sector, thus giving the state an opportunity to emerge as the desired destination for investments under pharma and medical devices sector and give a boost to Make in India mission in this sector.

The India Pharma exhibition, being held as part of the event, covered all the segments of the pharma industry starting from finished formulations, APIs, bio-pharmaceuticals, fine chemicals and intermediates, natural extracts and excipients.

India Medical Device exhibition showcased med-tech innovations in India across segments

from preventive to therapeutic care. Leading pharma and medical devices companies showcased their expertise and products to Indian and international healthcare community at the exhibition. Sessions on biopharmaceuticals include, The New Engine of Growth, Scaling MedTech Manufacturing and the Investors Meet, which was a step forward to the ‘Make in India’ mission of the Government of India. The event witnessed over 250 exhibitors from the pharma and medical devices sector. Buyers from over 24 countries, international regulators from eight countries (US FDA-USA, PMDA-Japan, MoH-Malaysia etc), over 29 embassy officials and over 10,000 business visitors took part in the event. Karnataka was the host state while Chhattisgarh was the partner state.

Other key dignitaries present during the inauguration function were Nirmala Sitharaman, Minister of State (IC) for Commerce & Industry, DV Sadananda Gowda, Minister for Statistics and Programme Implementation, along with Government of Karnataka Ministers, RV Deshpande, Minister of Industries and Dr Sharanapraksh Rudrappa Patil, Minister of Medical Education.

The distinguished gathering also included Jai Priye Prakash, Secretary, Department of Pharmaceuticals, Soumya Swaminathan, Director-General of the Indian Council of Medical Research, Henk Bekedam, WHO Representative to India along with other senior officers of the Ministry and doyens of pharma and medical devices industry.

EP News Bureau

MARKET

Generic Respiratory Drug Development 2017 conference held in Mumbai Team members from R&D, new product development, drug discovery. respiratory product development, regulatory, manufacturing team took part in the event GENERIC RESPIRATORY Drug Development 2017 conference was recently held in Mumbai. The conference was consecrated by Directors of Alliance India, Brian Nunes and Faisal Sheikh. Express Pharma was one of the media partners for the event.

The key note presentation was given by Dr Gur Jai Pal Singh, Head Cipla Respiratory Center of Excellence. The conference was also attended by Dr Guirag Poochikian - EX FDA, President - Poochikian Consulting, Mark Copley, Sales Director, Copley Scientific, Tim Freeman, MD, Freeman Technology and team members from R&D, new product development, drug discovery. respiratory product development, regulatory, manufacturing team.

Dr Singh addressed the delegates on evolution of the regulatory landscape, regulatory pathways for drug approval, approval process for new drug applications. He also discussed about the current regulatory paradigm for approval of generic inhalation products, in vitro evaluations.

Dr K Bangarurajan, Deputy Drugs Controller talked about the India regulatory requirement on respiratory product development and licensing requirements for product development and commercialisation. He also talked about the functions of CDSCO and various regulatory authorities in India.

Prof Ambikanand Misra, Department of Pharmacy, The Maharaja Sayajirao University of Baroda, spoke on critical attributes in development of dry powder inhaler.

Dr Manju Misra, Professor, NIPER Ahmedabad articulated about the urgent requirement of respiratory products in India because of the increasing pollution level. She also talked about various new methodologies to develop cost effective formulations targeting Indian population and discussed on formulation development strategies of respiratory product considering Indian context.

Dr Jaideep Gogtay, CMO, Cipla ad-

dressed about how COPD has become a third biggest threat to human life. Shital Kumar Joshi, Senior Manager, Ansys Software, focussed on state-of-theart CFD simulation methods for development of an inhaler, simulation in healthcare industry etc.

Mark Copley, MD, Copley Scientific, spoke about the recent innovation on respiratory product analysis, which has clinical relevance on in vitro testing method and also explained about the regulatory expectations on product development and analysis.

Dr Rakshit Trivedi, Senior Principal Scientist, Glenmark Pharma talked about analytical tests and techniques to characterise pressurised metered dose inhalers their formulation challenges, analytical Challenges, FDA CMC specifications etc.

Dr Amrita Bajaj, Professor, SVKM’s Dr. Bhanuben Nanavati College of Pharmacy spoke about various novel formulation strategies for developing products for pulmonary drug delivery, such as particle engineering, pulmosols, porous particles, pulmospheres. She also explained the advantages of this technology over the conventional technology through various animal and human models. She spoke about various technologies such as gamma scintigraphy, scanning electron microscopy, plethysmography, spirometry to characterise the formulation.

Dr Kapileswar Swain, Sr VP Formulation & Research, Wockhardt spoke about applying human factors and usability engineering to medical devices. He also spoke of USFDA guidance on applying human factors and usability engineering to medical devices.

The final presentation was addressed by Bharat Gangakhedekar, CEO, Marathwada Auto Cluster and Guruprasad Rao, Director & Mentor (Leadership Team) - Imaginarium India, where the importance of 3D printing was addressed.

EP News Bureau

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EXPRESS PHARMA

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March 1-15, 2017

MARKET GROWTH TRACKER

IPM registers ` 9,185 crores in January 2017 Domestic companies continued to dominate the market with a 78 per cent share in January 2017 with a growth of 7.5 per cent THE INDIAN Pharmaceutical Market (IPM) was valued at `9,185 crores in the month of January 2017. Impact of de-monetisation looked to be easing out with a seven per cent growth for the month vis-à-vis three per cent growth which was reflected in December 2016. On a MAT January basis, the industry was valued at `113,184 crores and reflected a 10 per cent growth with volumes contributing about 30 per cent of this growth and new introductions playing an important role with over 45 per cent contribution to the overall growth.

The retail channel remained the largest channel in IPM contributing 84 per cent of the overall sales and reflected a 10 per cent growth on MAT Basis. The hospital and doctor channel contributed to 10 per cent and six per cent of the overall sales and reflected a 10 per cent and 11 per cent growth respectively. It is expected that the hospital channel will continue to report robust growth rates due to rapid capacity expansion in this space. As per QuintilesIMS data which captures sales from trade stockists, more than 10 therapy areas in the IPM have already crossed a sale of `500 crores in the hospital segment and reflect healthy growth. Vaccines reflected de-growth on account of supply issues with key players in the market.

IPM continued to remain fragmented with top 10 companies occupying 43 per cent share.

While top 10 companies grew at eight per cent collectively, 11-20 companies reflected subdued growth at four per cent over previous year for the month of January 2017. Among the top 10 companies, Sun Pharma and Lupin were the only companies to reflect a double digit growth of 12 per cent and 14 per cent respectively while Glenmark grew fastest among the 11-20 companies at 12 per cent which helped

24

EXPRESS PHARMA

March 1-15, 2017

SNAPSHOT OF TOP 150 COMPANIES

Top 10 companies constitute about 44 per cent share of IPM on MAT and 43 per cent on month basis The top 150 companies continue to account for 97 per cent of IPM on MAT and month basis ● For the month,Top 20 companies contribute to 65 per cent ● For the month,Top 10 companies have reflected stronger performance over the next category of companies while the highest growth is in the companies ranked between 31-40 ● ●

Source: QuintilesIMS TSA & SSA, JAN 2017

TOP 40 BRANDS

Mixtard continues to be the top brand with a market share of 0.5 per cent Spasmo Proxyvon and Janumet have grown by 62 per cent and 41 per cent in January 2017 ● Other brands with remarkable growth are Zinetac, Duphaston and Gluconorm-G ● ●

Source: QuintilesIMS TSA & SSA, JAN 2017

MARKET it gain one rank over the previous month.

Domestic companies continued to dominate the market with a 78 per cent share in January 2017 with a growth of 7.5 per cent. MNCs on the other hand reflected a growth of five per cent for the month. Large MNCs like Abbott, GSK and Pfizer which contributed around 57 per cent of the total MNC share in the month reflected growths of seven per cent, six per cent and -8 per cent respectively. GSK’s new launch Enteroplus (LACTOBACILLUS RHAMNOSUS) clocked a value of ` 33 lakhs in one month of the launch.

Acute therapies remained the strongest pillar of IPM with a 64 per cent contribution to the total market which reduced from 67 per cent in the month of October 2016. Acute therapy areas continued to reflect a slowdown with a 4.9 per cent growth for the month of January 2017.

Chronic therapy areas on the other hand outpaced acute therapy areas reflecting a growth of 11 per cent for the month.

Cardiac continued to be the largest therapy area for the month for the second month in a row, clocking a revenue of `1134 crores. Rosuvastatin (11 per

cent), Telmisartan + HCT (17 per cent), Amlodipine + Telmisartan (21 per cent) were among the fastest growing cardiac molecules for the month while Atorvastatin (-13 per cent) and

Telmisartan (-5 per cent) were among the top molecules which reflected de-growth.

Anti-infectives retained its number two slot for the month with a value of `1066 crores.

Seven out of top 10 molecules reflected de-growth for the month.

Amoxyclav Solids (-4 per cent), Ceftrixone Injection (-21 per cent), Cefixime Solids (-11 per cent) Azithromycin Solids (-12.5

per cent) were among the top molecules reflecting de-growth.

Gastrointestinals continued to be the third largest therapy area for the month garnering a revenue of `961 crores with an impressive 11 per cent growth over SPLY. PPIs and their combination with Domperidone contributed around 18 per cent of the overall therapy area value.

Top 10 molecules in Gastrointestinals reflected an average growth of 16 per cent over same period last year with Dicyclomine combinations reflecting a 57 per cent growth for the month. Pantoprazole + Domperidone and Rabeprazole + Domperidone continues to be the largest molecules in the segment reflecting a 17 per cent and 15 per cent growth respectively.

Anti-diabetics maintained its fourth position in the IPM for January 2017 clocking a growth of 18 per cent over SPLY. DPP4 Inhibitors was the largest drug category in the anti-diabetic space with Teneligliptin contributing 20 per cent of the category by value. Top five categories in the anti-diabetic space which contribute 65 per cent to overall therapy area value reflected a growth in excess of 25 per cent with Glim + Met + Vogli

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EXPRESS PHARMA

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March 1-15, 2017

MARKET combination and Glim + Met combination reflecting 46 per cent and 29 per cent growth respectively.

Dermatology, one of the fastest growing therapy areas in IPM registered the highest growth for the month, clocking a growth of 20 per cent SPLY with a value of `679.5 crores. Antifungals, Itraconazole (130 per cent) and Terbinafine (33 per cent) reflected highest growth among top categories with emollients continuing to dominate the therapy area with a value of `83 crores for the month. Mupirocin gained 15 ranks and jumped from rank 21 in January 2016 to rank in January 2017 with a growth of 121 per cent.

Neurology reflected a nine per cent growth for the month over SPLY, Levetiracetam continued to be the largest molecule in the space clocking a value of `43 crores with a 14 per cent growth for the month. Escitalopram + Clonazepam reflected a healthy 21 per cent growth with a value of `20 crores for the month.

INDIAN VIS-À-VIS MNC TRENDS

● ●

Indian companies registered growth of 7.5% during the month and continue to dominate IPM in value terms Indian companies constitutes around 78% of IPM during the month and MAT basis

Source: QuintilesIMS TSA & SSA, JAN 2017

TABLE 1: PHARMA MARKET SIZE IN MILLION $ USD BY COUNTRY All values in Million USD

December Month

Month Growth per cent

MAT December

MAT growth per cent

Global Pharma Mkt

91836

-12.3

1047245

3.5

USA

44736

6.1

450604

5.6

Global (December 2016)

JAPAN

6939

-5.4

80104

9.6

The global pharma market is valued at $1047 billion growing at 3.5 per cent. The US continues to dominate the market with 43 per cent market share with growth of 5.6 per cent.

Amongst the top market, India has moved a position down and is ranked 11th in the month of December 2016. The markets which have shown value growth more than 10 per cent in the month of December globally are Venezuela and Australia. Critical observation to be made in the month of December is, all Top EU5 markets have de-grown.

Indian companies hold 1.4 per cent share in the global market and growing faster than the global market as per December 2016 data. The IPM showed growth and out of the top 10 companies, Cipla, Mankind, Zydus, GSK and Alkem showed degrowth whereas, Lupin showed double digit growth in December 2016.

(QuintilesIMS is a leading global information and technology services company providing end-to-end solutions to the life sciences and healthcare industry)

CHINA

6682

5.1

67837

-7.7

VENEZUELA

3437

13.9

18730

47.6

GERMANY

3255

-0.4

40653

3.8

26

EXPRESS PHARMA

March 1-15, 2017

BRAZIL

1926

30.5

21004

4

UK

1850

-19.8

23773

-7.3

FRANCE

1811

-35.4

32183

0

CANADA

1642

2.3

19253

-0.1

RUSSIA

1291

16.2

10953

-11.2

INDIA

1256

0.6

15317

5.7

AUSTRALIA

1118

11.9

13036

19.5

ITALY

905

-60.8

27197

0.4

SPAIN

848

-51.1

20150

-0.7

TABLE 2: INDIAN COMPANIES MARKET SIZE IN THE GLOBAL MARKET All values in Million USD

December Month

Month Growth per cent

MAT December

MAT growth per cent

Indian Pharma Market Globally

1256

0.6

15317

5.7

SUN PHARMA

105

5.8

1233

6.5

ABBOTT

81

1.4

981

5.2

CIPLA

66

-3.3

791

4.2

MANKIND PHARMA

45

-2.3

583

9.1

LUPIN LAB

44

11.6

499

8.1

ZYDUS CADILA

42

-2.4

516

1.4

GLAXOSMITHKLINE

41

-3.5

496

0.4

MACLEODS

39

0

496

9.9

INTAS

37

1.8

431

7

ALKEM

36

-0.2

477

8

EVENT BRIEF APRIL TO SEPTEMBER-2017 11

PharmaTech Expo 2017

25

Respiratory Drug Delivery (RDD) Europe 2017

3

PharmaTech Expo 2017

21

PHARMATECH EXPO 2017 Date: April 11-13, 2017 Venue: Parade Ground, Sector – 17, Chandigarh Summary: The 5th Edition of PharmaTech Expo 2017, an international exhibition on pharma machinery, lab and packaging equipment, will see a common platform for suppliers, manufacturers, industrialists, buyers and consultants. This year the focus will be on nutraceutical, food and cosmeceuticals and ayurveda. The event will be concurrently held with LabTec expo 2017.

More than 150 exhibitors from across the country participated in last year’s event and varied kinds of high tech pharma machinery, lab and packaging equipment were on display. With more than 5000 trade visitors took part in last year's event.

Contact details PharmaTechnologyIndex.com A Division of KNS Group 701 - 702, Corporate House, Opp Dinesh Hall, Income Tax, Ashram Road, Ahmedabad - 380009 P: +91-79-27540493/ +91-79-40306340

RESPIRATORY DRUG DELIVERY (RDD) EUROPE 2017 Date: April 25-28, 2017 Venue: Palais des Congrès d’Antibes, Nice, France Summary: RDD Online and Aptar Pharma will organise RDD Europe 2017, an event in the Respiratory Drug Delivery field in Europe. It will bring together pulmonary and nasal drug delivery experts from all around the world to exchange scientific knowledge and expertise, and also provide a dynamic forum for expanded opportunities for business networking. RDD Europe 2017 will feature podium sessions and debates, scientific poster sessions, technology exhibition and workshops sessions.

Academics, industrial and regulatory scientists involved in the research, development,

investigation will take part in the event.

Contact details Joanne Peart: info@rddonline.com

PHARMATECH EXPO 2017 Date: August 3-5, 2017 Venue: Gujarat University Convention Centre, Ahmedabad, Gujarat Summary: The 6th Edition of PharmaTech Expo 2017 will be Gujarat’s largest pharma expo and will be concurrently held with ‘Labtec’ & ‘Track & Trace’ Expo 2017. This year, the focus will be on pharma machinery and equipment manufacturing sector and pharma packaging. More than 150 exhibitors from across the country participated in last year’s event and varied kinds of high tech pharma machinery, lab and packaging equipment were on display.

Contact details PharmaTechnologyIndex.com A Division of KNS Group 701 - 702, Corporate House, Opp Dinesh Hall, Income Tax, Ashram Road, Ahmedabad - 380009 P: +91-79-27540493/ +91-79-40306340

INDIA LAB EXPO 2017/ ANALYTICAANACON INDIA Date: September 21-23, 2017 Venue: Hitex, Hyderabad Summary: India Lab expo, India’s largest exhibition on laboratory, scientific, analytical

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and biotechnology sector will see international as well as

Indian manufacturers and distributors. Decision makers

India Lab Expo 2017/ analytica Anacon India from sectors like hospitals, diagnostic labs, oil and petroleum, chemical, cosmetics and government departments will meet at the tradeshow. The event will be supported by Ministry of Science & Technology, Government of India.

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March 1-15, 2017

cover )

28 EXPRESS PHARMA March 1-15, 2017

(

THE MAIN FOCUS

ERA OF ELECTROCEUTICALS COMING SOON? Electroceuticals, hailed as the next frontier in medicine, is garnering considerable interest from medical researchers and entrepreneurs on the lookout for the next class of therapies

BY LAKSHMIPRIYA NAIR

S

ince time immemorial, the idea of a miracle cure to rid all the ailments afflicting the human body have held tremendous fascination for scientists, medical researchers, alternative medicine practitioners and even faith healers. Could it be that the panacea the world’s looking for is nothing but electricity? The concept might not have had too many takers a few decades earlier, but today ‘electroceuticals’ a term used to describe miniature devices which can alter electrical signals diffused by nerves throughout the body

to treat a wide range of illnesses, is being touted as the next great frontier in medicine.

Gaining ground Also known as bioelectric medicine, it is has generated considerable interest globally among medical researchers and entrepreneurs. Leading medical device manufacturers like Medtronics, Boston Scientific Corporation, Cochlear and even pharma majors like GlaxoSmithKline (GSK) are making significant investments for research in this arena. Even organisations like the Defense Advanced

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Research Projects Agency (DARPA) and National Institutes of Health (NIH) in the US have shown immense interest in the field of electroceuticals.

DARPA, an agency of the US Department of Defense in charge of the development of emerging technologies for military use, has initiated a $79 million project called Electrical Prescriptions (ElectRx), in this field. NIH's Stimulating Peripheral Activity to Relieve Conditions (SPARC) programme is another initiative that seeks to expand our current knowledge of nerve-organ interactions and propel progress in the field of

neuromodulation. In October 2016, NIH also announced $20 million in funding for the field. The endeavour’s goal is to understand more about the body’s electrical circuit – the peripheral nervous system.

Catalysts of change A MarketsandMarkets report predicts that the global electroceuticals/ bioelectric medicine market will reach $25.20 billion by 2021 from $17.20 billion in 2016, growing at a CAGR of 7.9 per cent from 2016 to 2021.

The reports also reveal that North

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cover ) America would be the leader in bioelectric medicine market because of the presence of several bioelectric medicine organisations in the region. Yet, the highest percentage of growth would be registered in the AsiaPacific region due to rising healthcare demands in the region.

A report on global bioelectric/electroceuticals market by Transparency Market Research highlights the factors which would drive growth and states, “Growing global geriatric population, rising cost pressures of drug based medicines, growing interest from major pharma players in the electroceuticals segment, and increasing incidence and prevalence of neurological disorders and chronic diseases across the world are some of the factors likely to boost the growth of the global electroceuticals market during the forecast period.”

A McKinsey report, 'Aging with tech support – the promise of new technologies for longer and healthier lives' outlines a few advantages which would aid growth in this emerging sphere. It states, “First, and most important, it holds out the promise of treating conditions that today’s drugs and medical procedures are unable to address, such as severe spinalcord injuries and blindness.

Second, miniaturised electric stimulators have the potential to deliver true precision medicine. Almost all drugs have a degree of systemic effect, but the precise targeting permitted by bioelectronics could limit the number and extent of side effects. Additionally, electrical dosing is much easier to adjust as a treatment’s effects on a patient become clear. An electrical current can be increased or reduced far more easily than a drug concentration, and unlike surgical procedures, the effects are reversible: the current can be switched off.” Thus, electroceuticals hold the potential to treat diseases and conditions where conventional therapies fall short.

The McKinsey report also claims, “As this therapeutic ap-

30 EXPRESS PHARMA March 1-15, 2017

“

Bioelectronic medicines allow us to treat a broad range of chronic disorders with greater precision and fewer side effects than with conventional medicines KRIS FAMM President, Galvani Bioelectronics

proach is applied more widely, the lines between medical technology and pharmaceuticals will continue to blur.” The belief that electroceuticals would be the gold standard of treatment in the times to come is also spurring progress in this arena. Here are a few instances:

GSK: Gung ho on growth A very important case in point would be GSK, one of the leading proponents of electroceuticals or bioelectric medicine.

Since 2012, it has announced various initiatives to catalyse research in this field and to unite researchers from these different disciplines including: ◗ Establishing a network of around 50 research collaborations around the world ◗ Launching a $1million innovation prize to incentivise research in this field ◗ Creating a $50 million venture capital fund to invest in companies that pioneer bioelectronic medicines and technologies In another crucial move, the company has also tied up with Verily Life Sciences, Google's sister concern, to form a joint venture called Galvani Bioelectronics with an investment of up to £540 million over seven years, to develop and commercialise bioelectronic medicine.

Kris Famm, President, Galvani Bioelectronics (former Vice President of Bioelectronics R&D at GSK) informs, “Bio-

North America would be the leader in bioelectric medicine market.Yet, the highest percentage of growth would be registered in the AsiaPacific region due to rising healthcare demands in the region electronic medicines represent a whole new frontier in the treatment of disease, potentially allowing us to treat a broad range of chronic disorders with greater precision and fewer side effects than with conventional medicines.”

Galvani Bioelectronics will be dedicated to the research, development and commercialisation of these medicines. By combining the worlds of health and tech – fusing GSK’s drug

discovery and development expertise and deep understanding of disease biology with Verily’s technical expertise in the miniaturisation of low-power electronics, device development, data analytics and software development – we believe Galvani has the potential to rapidly accelerate the development of these treatments for patients,” Famm informs.

Medtronic: Paving the path Medtronic, a leading medical device manufacturer, is also investing in electronic implantables that work with the nervous system. A company spokesperson gives a few examples: E.g. 1: In 2009, Medtronic began working to produce a pacemaker one-tenth the size of its standard models. The result was a breakthrough innovation -Leadless pacemakers. Unlike a standard pacemaker, Medtronic's leadless pacemaker in its small, capsulised form allows it to be implanted using a catheter through a vein in the leg, similar to how a stent is inserted. This makes the procedure much simpler, faster and leaves no scars of the surgery besides eliminating all lead (wires in traditional pacemakers) related complications that can impact patient outcomes behind, adding to the cosmetic value of the procedure.

E.g. 2: Medtronic’s belief in

meaningful innovations for positive patient outcomes led to the invention of Deep Brain Stimulation Therapy (DBS). DBS helps control movement symptoms when medications aren't working as well as they used to.

For many people with Parkinson's, DBS makes a difference when even small tasks have become challenging and helps people stay as independent as possible and keep doing the activities they love.

E.g. 3: Having an overactive bladder prevents patients from controlling when and how much a patient urinates. He/she may experience unexpected small or large leaks, or use the bathroom very frequently. Medtronic Bladder Control Therapy modulates the sacral nerves with mild electrical pulses. This helps the brain and the nerves to communicate so the bladder and related muscles can function properly. Medtronic Bladder Control Therapy may help the patient resume normal activities and help them avoid frustrating or embarrassing experiences associated with overactive bladder.

The spokesperson also speaks on Medtronic’s commitment in encouraging innovation and says, “Medtronic has been at the forefront of innovation and we have evolved our products through continuous technological innovation in all aspects of their design, materials and delivery mechanism in the areas of heart, brain, spine, urinary and gastrointestinal tract.

Over the years we have through innovation in our technologies built products that meet the needs of patients and caregivers as well as the needs of physicians with simpler and quicker procedures. Medtronic globally invests more than $1.6 billion in R&D every year and owns more than 53,000 patents across the therapy areas.”

GE: Partnering for progress In a very recent undertaking, GE Ventures and Northwell Health's Feinstein Institute for Medical Research (FIMR) have entered into a partnership

( to develop bioelectronic devices to treat nervous system-mediated acute and chronic diseases. Under the collaboration, the partners would provide up to $200 million in joint funding over seven years to set up a new Center for Bioelectronic Medicine (CBEM). Reportedly, the new partnership will build on the work between Feinstein Institute and a team of GE scientists specialising in bioelectronics research at GE’s Global Research Center in Niskayuna, NY. The alliance will be headquartered at the Feinstein Institute in Manhasset, NY. Thus, the world is witnessing a wave of such technologies.

Electroceuticals vs pharmaceuticals However, the rise of electroceuticals has given birth to many crucial questions. Can they become the mainstay of treatment in the times to come? Can they replace drugbased therapies? What would the future hold for pharma companies?

These questions become more relevant in the backdrop that the US FDA has already granted approvals to some electroceuticals. Today, they are being used as alternatives to medicines to treat certain conditions. For instance, Inspire Medical Systems’ treatment of sleep apnea by the implantation of a device that stimulates the airway muscles. A second example is a device to treat morbid obesity from EnteroMedics Inc (ETRM). This device stimulates the vagus nerve to make a person feel full. (Check Table 2 for more examples).

GSK, a pharma company is definitely moving towards becoming a leader in this emerging field. As Famm puts it, “Huge advances in lowpower electronics and the nanotechnology space have paved the way for the creation of gamechanging miniaturised devices, which we believe will enable the development of

THE MAIN FOCUS

TABLE 1: BIOELECTRONICS HAVE SIGNIFICANT POTENTIAL AND GROWING INVESTMENT Definition

Bioelectronics is an emerging area of medicine that uses miniaturised implantable devices to deliver electrical stimulation to nerves to control a wide range of bodily functions Illustrative examples Spinal cord For patients partially or fully paralyzed, injury bioelectronics could be used to bridge the injury site and restore function

Restore damaged circuits

Range of potential applications

Select players to watch

Replace damaged cells

Parkinson’s Dopamine-producing cells in the brain degenerate, disease leading to loss of control over voluntary movements.

Bioelectronics could be used to directly communicate with dopamine-producing cells’targets

Modulate signals for existing applications

Immunology Reduce cytokine production (cytokines help regulate applications the immune system) and block inflammation in diseases such as Rheumatoid arthritis or Inflammatory bowel disease

Entity Galvani Biosciences

Key investors GSK,Verily

CVRx

J&J Innovation

ElectRx (military program)

DARPA

Investment Up to $700M over 7 years (announced Aug.2016) $113M as of August 2016 $80M (announced Aug.2014)

Key objectives Develop devices to correct irregular electrical signals underlying a number of chronic diseases (e.g.,inflammatory, metabolic,and endocrine) Improve cardiovascular function for patients with heart failure Reduce blood pressure for patients with hypertension Restore functionality for wounded service members,including improving prosthetics and reducing chronic pain

SOURCE: McKinsey report: Aging with Tech Support

TABLE 2: EXAMPLES HIGHLIGHTING RECENT OR ONGOING BIOELECTRONIC EFFORTS Description

Key lessons

Remaining barriers

Second Sight

Bioelectronic retinal implant allows patients with a rare eye disease (retinitis pigmentosa) to regain a degree of lost sight (e.g.,perception of motion and recognition of simple objects)

The difficulty of developing bioelectronics increases exponentially with the number of neurons or signals involved; actual amount of vision restored for blind patients is relatively modest to date

circuitry at a systems level (specific pathways and targets) is needed to be able to more fully address complex conditions via bioelectronics (e.g., restoring brain function after a stroke)

SetPoint Medical

Electroceutical approach to treat inflammation by neuromodulation,stimulating the vagus nerve to blockTNF production in rheumatoid arthritis (in a pathway similar to that of biologic drug therapy)

Applications of bioelectronics are not just limited to musculoskeletal conditions like spinal cord injury: nerves exert systemic control over a huge range of pathways and conditions

Devices will need further miniaturization before they can hit specific nerve fibers rather than the entire nerve.

Miniaturization is particularly challenging for devices that need to be able to sense and deliver both excitatory (“turn on”) or inhibitory (“turn off”) signals

Ohio State University Wexner Medical Center

Brain implant connected to a sleeve of electrodes allows a paralysed man to play guitar and perform other activities, bypassing his damaged spinal cord

It is likely easier to intervene in cases where an element of voluntary control allows real-time feedback than in cases involving peripheral autonomic systems,which are harder to influence

Even in systems that are easy to monitor (e.g.,a patient can move their arm or they can’t), it can take years and the support of highly specialized expertise before interventions translate into benefits for an individual patient

SOURCE: McKinsey report : Aging with Tech Support

precision bioelectronic medicines. We believe the knowledge and IP we’ve built up over the past three years places GSK at the forefront of the

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bioelectronics field.”

Incidentally, other major pharma players like Pfizer, Novartis, haven't been as enthused about this field or

rather have not clarified their positions on electroceuticals.

The investments in this arena have not been made public. On the contrary, a larger number

of medical device players have been more vocal about their stance about electroceuticals.

Nevertheless, there is a growing number of those who believe that drug-based treatments are on their way out and it will be replaced by bioelectric medicine. However, it is more likely that a combination of both electroceuticals and pharmaceuticals will prove to be not only more effective but also reinvent healthcare delivery as we know it today.

Vanquishing the challenges The potential of this field is immense but then so are the challenges. As the McKinsey report explains, “A much more detailed understanding of the anatomy and function of neural circuits is needed to target treatments precisely in what can be viewed as the neural equivalent of gene therapy.” It further highlights that we are still a long way from fully understanding extremely complex pathways, given that there are upto 100 billion neurons in the brain.

Another big challenge is making the devices really small and enabling them to work on as little power as possible. Likewise, there is also a need to encourage more innovation to help electroceuticals and bioelectronics reach their full potential. Scepticism about the field and its potential is also rampant. While there are many supporters, the number of naysayers are also huge.

This too is a deterrent to progress.

Fortunately, some measure of success in establishing proof of concept and enhancing quality of life have helped galvanise progress in this promising new field. It is to be hoped that in times to come, further research will help us gain more understanding about this vast field to usher in a new era of medicine to provide sweeping therapeutic advantages to deliver significant clinical impact. lakshmipriya.nair@expressindia.com

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MANAGEMENT INSIGHT

Don’t shut down the pharmacy of the developing world Shailly Gupta, Deputy Head, MSFAccess Campaign (India) emphaises the need to ensure availability of affordable medicines within public health programmes, which is the need of the hour

O

ne of the fastest-growing economies in the world, our country is known globally as the homeland of the famed Taj Mahal and for its strong cultural heritage. However, and more significantly, India has had a farreaching positive global impact through its supply of vast quantities of low-cost, good-quality generic medicines, which have saved or prolonged the lives of millions of people.

Amongst a handful of developing countries with a huge production capacity to manufacture quality-assured generic medicines, India did not grant patents on medicines till 2005 and thus, its generic companies produce some of the cheapest life-saving drugs in the world.

Known as the ‘pharmacy of the developing world’, the country played a major role in scaling up treatment to 17 million people across the world by lowering the price of antiretrovirals (HIV medicines) from $10,000 per patient per year in 2001 to less than $300. As a medical treatment provider, Doctors Without Borders/Médecins Sans Frontières (MSF) relies on affordable, quality generic medicines to treat a number of diseases. In fact, 97 per cent of the medicines used by MSF to treat HIV are generics sourced from India.

When the country amended its patent law to comply with international trade rules in 2005 and started granting patents for pharmaceuticals, Indian parliamentarians ensured the inclusion of public health safeguards by granting patent monopoly rights only to genuine inventions. India’s patent law strives to strike an

32

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March 1-15, 2017

even handed balance between providing patent protection on innovative medicines and the necessity to protect public health needs. India’s public health safeguards have guaranteed fewer patents in India, more generic competition and thus, more affordable medicines for people and governments in developing countries.

In contrast, countries like the US have patent laws that blindly favour pharma companies over generic competition,

Source: MSF Access Campaign (India)

allowing multiple and extended monopolies on the same medicine, which, in turn, lead to exorbitant prices for lengthy periods of time.

Multinational pharma corporations view robust, affordable generic medicines produced and marketed by Indian suppliers as an enormous threat to their profits. Pressured by these corporations, foreign governments have utilised various platforms—including diplomatic talks, bilateral and regional trade deals— to coerce the Indian government to amend its patent policies to offer more

patent protections and restrict generic competition.

One such trade deal is the Regional Comprehensive Economic Partnership (RCEP). Big Pharma is attempting to restrict access to low-cost, lifesaving medicines and jeopardise public- health via the RCEP negotiations that were initiated in 2012 between 10 ASEAN countries and six trading partners – India, China, Australia, New Zealand, Japan and South Korea.

Like several other free trade agreements, the RCEP, too, is being negotiated behind closed doors with no inputs from pub-

lic health stakeholders. An online leaked draft text of this trade deal reveals that Japan and South Korea have proposed several provisions that go far beyond the World Trade Organisation (WTO) requirements and seek to extend patent monopolies of pharma corporations. This includes provision for extending patent terms for an additional five years beyond the present 20year limit. Another proposed harmful provision is introduction of data exclusivity to defer the registration or marketing approval of generic versions of medicines by several years which will effectively provide a backdoor monopoly status to pharma corporations – even for older medicines that do not deserve a patent.

If accepted, both provisions will delay the entry of affordable versions of medicines in the market and eventually, in the absence of generic competition, keep prices high for longer periods of time. In India, where people pay nearly 70 per cent of health expenses out of pocket and rarely have health insurance, high prices of lifesaving medicines will keep them out of reach of the most vulnerable sections of society.

With emerging public health challenges and the increasing burden of tuberculosis, hepatitis, and cancer in our country, the need to ensure the availability of affordable medicines within the public health programme is certainly the need of the hour.

In the current economic landscape, the RCEP trade deal has been lauded as it will bring in huge investments, infrastructure and jobs to India.

However, what is largely being ignored is that corporations are utilising such trade deals to disguise their attack on public welfare sectors such as healthcare and access to essential medicines.

This attempt to surreptitiously convert public healthcare into a commercial enterprise will allow medicine to be treated as any other profitable commodity, subject to monopolies and elevated product pricing. Consequentially, India’s revolutionary low-cost generic industry that stems from its public health-oriented patent policies will be shut down to make space for profit-focussed multinational corporations. Elevated levels of intellectual property rules in RCEP can dismantle the public health system of many developing countries and restrict governments’ capacities to protect public health in not only India but in other developing and least-developed nations of Asia and Africa.

So far, India has stood firm against the inclusion of these harmful patent provisions.

With the next round of RCEP negotiations set to take place in Japan in March, MSF, as a treatment provider that relies on affordable medicines sourced from India, hopes that India, along with other ASEAN countries, does not agree to a final text unless all provisions that go beyond international trade rules are removed. In its place, the trade deal negotiating text should ensure the protection of existing public health safeguards and enable developing countries like India to effectively balance its patent system with public health needs.

REPORT

Marsh India’s EH&B Survey 2017: Broaden your employee benefits insurance portfolio The 9th edition of Marsh India’s Employee Health & Benefits Survey analyses both employer and employee perspectives, to gain a holistic view of the state of the market and finds 92 per cent employees look up to employer facilitated voluntary insurance plans to manage their risk exposure A NEW market research report released by Marsh India shows that more than half of the surveyed employees depend on their own finances to address the top four risks – medical emergency, disability, loss of property, and loss of income.

According to Marsh India’s 9th annual Employee Health and Benefits Survey, 92 per cent employees stated that they are willing to share premium costs and buy voluntary insurance plans offered to them by their employers, with 33 per cent willing to spend one to two per cent and another 37 per cent willing to spend three to five per cent of their annual salaries on various voluntary insurance plans.

More than half of the employee respondents (53 per cent of those who are covered by group medical coverage and 57 per cent of those who are covered by group personal accidents) believe that the medical and accident insured benefit plans, respectively, provided by their employer are inadequate leading to out of pocket expenses.

Majority of the employees are keen to invest in top-up, outpatient department, and parents insurance plans to minimise their out of pocket expenses. Interestingly, almost 83 per cent are looking for options to customise the insurance offered by employer such as increasing room rent, maternity limits.

Almost 78 per cent employees are willing to spend ` 2,000 to ` 20,000+ on voluntary parent insurance plans.

Sanjay Kedia, Country Head and CEO, Marsh India said, “Globally, the working

INSURANCE PREFERENCES AMONG DIFFERENT AGE GROUPS OF EMPLOYEES Age Group

Baby Boomers

Gen X

Millennials

Spending capacity (as a percentage of the annual income)

3% - 5%

1% - 2%

3% - 5%

OPD

OPD

Medical top-up

Accident top-up

Medical Parents

Medical parents

Critical illness

Medical top-up

OPD

Medical top-up

Critical illness

Accident top-up

Income protection

Motor insurance

Motor insurance

Motor policy

Child plans

Home insurance

Retirement protection

Travel insurance

Travel insurance

Gadget insurance

Home insurance

Gadget insurance

Conventional products

Non- conventional products

Employee Health and Benefits Survey- conducted by Marsh India

BENEFITS PREVALENCE ACROSS INDUSTRY SEGMENTS Industry / Benefit Type

GMC

GPA

GTL

Industry Prevalence

100%

92%

74%

Advertising/Media/Entertainment

100%

67%

58%

Automotive

100%

94%

46%

Aviation & Aerospace

100%

100%

86%

Banking & Financial Services

100%

76%

71%

BioTech/Pharma/Research

100%

90%

71%

BPO/KPO

100%

100%

100%

Consulting

100%

100%

75%

Education

100%

100%

100%

Engineering

100%

80%

80%

FMCG

100%

100%

86%

Health Care

100%

100%

33%

IT/ITES

100%

95%

87%

Logistics

100%

90%

71%

Manufacturing

100%

87%

58%

Petro & Chemicals

100%

100%

100%

Power & Energy

100%

100%

100%

Real Estate & Infrastructure

100%

100%

67%

Retail / Wholesale

100%

100%

67%

Telecommunication

100%

100%

100%

Others

100%

67%

50%

Employee Health and Benefits Survey- conducted by Marsh India

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environment is transforming at a faster rate than ever, given the constant socio-economic changes and rising lifestyle standards. Employees form a critical asset in today’s knowledge-based economy and the workplace is an integral part of an employee’s life. A comprehensive benefit programme creates a win-win situation for both for the employee and the employer: the employee benefits from an inclusive and cost competitive company facilitated plan, while for the employer it contributes to employee well-being, loyalty and satisfaction.”

Marsh India’s survey showed a shift in employers’ outlook towards insured benefits. As compared to last five years, for the first time the median sum insured of medical insurance has increased from 300,000 to 350,000 along with an increase of 1,000 in room rent eligibility limit. Keeping pace with the past few years, the proportion of Indian organisations that facilitate parents’ coverage (fully employer paid plans and cost-

shared plans) has increased to 80 per cent, from 76 per cent in the previous edition.

Organisations seem to adopt a strategy that is critical to sustainability of parents insurance plans – increasing in prevalence of cost-sharing plans. 35 per cent companies fully pay for parents insurance as against 41 per cent in 2015 and 45 per cent share premium cost as against 35 per cent in 2015. To keep the insurance premium cost in check, organisations have started looking beyond benefit cuts. Top three measures are – Implement and leverage on network cost efficiency, adopt preventive health and wellness measures and increase the voluntary insurance plans offered.

Interestingly there is lot of importance on making the insurance plans more holistic.

Survey reveals that 31 per cent organisations have plan enhancements specific to address women employees, followed by 30 per cent towards medical advancements and 26 per cent for chronic conditions and longterm care needs.

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MANAGEMENT

Roche to gain most as Biogen remains leader in neurodegenerative drugs market by 2022 According to GBI research Ocrelizumab is expected to become a blockbuster drug within three years of its launch and will be Roche’s main growth driver in the market ROCHE WILL be the biggest mover in the neurodegenerative drugs space over the next five years, with the anticipated approval of ocrelizumab driving the company’s share of the market from less than one per cent in 2016 to approximately 15 per cent by 2022, according to business intelligence provider GBI Research.

The company’s report states that while Roche will make significant gains, Biogen will remain the largest player in the neurodegenerative drugs market – which includes Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis (ALS), Huntington’s disease, and multiple sclerosis (MS) – although its share will dip from around 33 per cent in 2016 to approxi-

Ocrelizumab is expected to become a blockbuster drug within three years of its launch and will be Roche’s main growth driver in the market. Roche’s revenue from neurodegenerative products is expected to increase at a very rapid CAGR of 66.97 per cent between 2015 and 2022 mately 26.5 per cent by 2022.

Qaisrah Khalid, Analyst for GBI Research, explains: “Roche has one drug in the market for neurodegenerative disorders, Madopar, for use in Parkinson’s disease, although this drug has not been approved for use in the US. However, Roche has three neurodegenerative disorder drugs

due to be approved in the forecast period, namely ocrelizumab, in 2016, and crenezumab and gantenerumab, both in 2019.”

Ocrelizumab is expected to become a blockbuster drug within three years of its launch and will be Roche’s main growth driver in the market. Roche’s revenue from

neurodegenerative products is expected to increase at a very rapid compound annual growth rate (CAGR) of 66.97 per cent between 2015 and 2022.

GBI Research also states that overall revenues for Biogen derived from neurodegenerative disorder products are expected to remain stable, in-

creasing at a moderate CAGR of 3.45 per cent. Their portfolio includes Tecfidera and Tysabri, both for Relapsing Remitting MS (RRMS), Pelgridy and Avonex, both for RRMS and Progressive-relapsing MS, and Zinbryta for relapsing MS. Khalid continues, “Biogen is the market leader in the neurodegenerative disorder space, thanks largely to Tecfidera which is not set for patent expiry until 2028. Biogen also markets several other drugs in this therapy area, with Plegridy expected to reach blockbuster status within the forecast period, meaning there will not be an overall revenue loss within this market for Biogen.

EP News Bureau

Pfizer, Novartis and Eli Lilly set to compete in the HER2-/HR+ breast cancer market GlobalData forecasts all inhibitors to collectively produce sales of $4.8 billion by 2023 in the US, Spain, UK, Italy, Germany, France, Japan, and China THE HUMAN epidermal growth factor-negative (HER2-) and hormonal receptor positive (HR+) metastatic breast cancer market will see fierce competition among Pfizer, Novartis and Eli Lilly in 2017. Individual development strategies will set these three pharma giants apart from each other in this lucrative segment, according to research and consulting firm GlobalData.

Cyclin D kinase 4/6 (CDK4/6) inhibitors have shown great improvement in extending progression-free

34 EXPRESS PHARMA March 1-15, 2017

survival in patients with HER2and HR+ metastatic breast cancer, with Pfizer’s Ibrance (palbociclib) the first CDK4/6 inhibitor to be approved in 2015. Having exploded onto the market, the drug has already reached blockbuster status, beating all other therapies to become the new standard of care and setting the bar high for new entrants. Hoping to follow in Pfizer’s tracks, two other inhibitors, Novartis’ ribociclib and Eli Lilly’s abemaciclib, are expected to be approved by the end of 2017 in the same disease.

Maxime Bourgognon, Healthcare Analyst for GlobalData, explains, “Ibrance and ribociclib are poised to dominate this drug class in terms of sales. While Ibrance has the coveted first-to-market advantage, Novartis hopes its combinatory strategy for ribociclib will lead to best-in-class status, setting it apart from the competition. Following impressive data presented in late 2016, Novartis was able to stop ribociclib’s registrational trial early and file for approval, making up for lost ground.”

GlobalData believes that, despite Novartis’ best efforts, it will not beat Ibrance in terms of sales by 2023. However, each company’s ability to win over stakeholders will determine how big the difference will be between both products.

Lagging far behind, abemaciclib has failed to meet the preplanned interim analysis of its pivotal trial, and has shown potentially limiting gastro-intestinal toxicities.

Bourgognon concludes, “While Pfizer will likely be the stand-out winner, with a long-

awaited mega-blockbuster in breast cancer to add to their oncology portfolio, all of the inhibitors are going to be widely adopted by physicians across the major markets.”

GlobalData forecasts all inhibitors to collectively produce sales of $4.8 billion by 2023 in the US, Spain, the UK, Italy, Germany, France, Japan, and China, corresponding to almost half of the overall HER2/HR+ breast cancer market size.

EP News Bureau

RESEARCH UPDATES

Postmenopausal hormone therapy exceeding ten years may protect from dementia Study shows that postmenopausal removal of ovaries,uterus or both was not significantly linked to the risk of Alzheimer’s disease,irrespective of the indication of surgery or hormone therapy use

P

ostmenopausal estrogenbased hormone therapy lasting longer than ten years was associated with a decreased risk of Alzheimer’s disease in a large study carried out at the University of Eastern Finland.

“The protective effect of hormone therapy may depend on its timing: it may have cognitive benefits if initiated at the time of menopause when neurons are still healthy and responsive,” says Bushra Imtiaz, MD, MPH, who presented the results in her doctoral thesis.

The study explored the association between postmenopausal hormone replacement therapy, Alzheimer’s disease, dementia and cognition in two nation-wide case-control studies and two longitudinal cohort studies. The largest study

comprised approximately 230,000 Finnish women and the follow-up time in different studies was up to 20 years.

Alzheimer’s disease is the most common cause of dementia, and two out of three Alzheimer’s cases are women.

One possible explanation for women’s higher dementia risk is the postmenopausal depletion of sex steroid hormones estrogen

and progesterone. Estrogen receptors are present throughout the body including brain areas primarily affected in Alzheimer’s disease. In in vitro and animal studies, estrogen has showed neuroprotective effects. However, studies on humans have yielded inconsistent results on the association between postmenopausal estrogen-based hormone replacement therapy and

dementia risk.

In the present study, longterm use of hormonal replacement therapy was associated with a better performance in certain cognitive domains – global cognition and episodic memory – and a lower risk of Alzheimer’s disease. Short-term use was not significantly linked to dementia risk, but in one cohort, dementia risk was higher among short-term users who had started hormone therapy in the late postmenopausal period.

The results were adjusted for various lifestyle, socio economic and demographic variables.

“In the light of these findings, hormonal replacement therapy may have a beneficial effect on cognition if started early, around the time of menopause. The protective effect of hormonal therapy may depend on the health

status of neurons at baseline and may be lost if therapy starts years after menopause,” Dr Imtiaz concludes.

The study also showed that the postmenopausal removal of ovaries, uterus or both was not significantly linked to the risk of Alzheimer’s disease, irrespective of the indication of surgery or hormone therapy use.

The research data was from the MEDALZ (Medication use and Alzheimer’s disease), OSTPRE (Kuopio Osteoporosis Risk Factor and Prevention Study) and CAIDE (Cardiovascular Risk Factors, Aging and Dementia) studies. The newest results were published recently in Neurology and Maturitas and the earlier results in the Journal of Alzheimer’s disease.

EP News Bureau

Vyome Biosciences announces top-line results from Phase 1 study of VB-1953 for patients with facial acne vulgaris Treatment with VB-1953 resulted in a reduction of inflammatory and non-inflammatory lesions and in IGA scores VYOME BIOSCIENCES, a clinical-stage speciality pharmaceutical company developing novel medicines for treating skin diseases caused by resistant microbes, announced topline data from its phase 1 clinical trial evaluating VB-1953, a topically administered gel designed to treat patients with moderate to severe acne. VB1953 exhibited a promising dermal safety signal, was generally well tolerated and showed the

potential to treat moderate to severe acne.

According to a preliminary analysis of the data from 12 patients, VB-1953 met its primary endpoint relative to pharmacokinetics, achieving plasma concentration less than 1 ng/ml and dermal tolerability. Also, in addition to demonstrating safety in this 12-patient study, treatment with VB-1953 resulted in a reduction of inflammatory and non-inflammatory

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lesions and in IGA scores, compared to baseline, suggested a potential efficacy signal in these moderate to severe acne patients.

“VB-1953 was generally well tolerated with a good dermal safety signal and the early parameters of efficacy were encouraging after only a short duration of treatment,” said study investigator Neal Bhatia, MD, Therapeutics Clinical Research in San Diego, CA. “Based on

these results, VB-1953 appears to demonstrate the potential to be a promising new treatment as further development continues.”

"These data are encouraging for patients with moderate to severe acne, especially the one-third of whom do not respond to available treatment options due to microbial resistance. With a promising dermal safety signal, and potential anti-acne and anti-inflamma-

tory activity, VB-1953 has the potential to fill this gap in acne treatment,” said Venkateswarlu Nelabhotla, Cofounder and CEO, Vyome Biosciences.

Trial patients received VB 1953 twice daily for a treatment period of 14 days following a required screening period. The clinical study was conducted in San Diego.

EP News Bureau

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RESEARCH

Fathers get depressed during Weak thigh muscles tied to knee and after pregnancy,too The men’s depression symptoms during pregnancy were tied to their being stressed or in poor health WOMEN AREN'T the only ones who may feel depressed when welcoming a newborn: a new study from New Zealand says some men also experience depression during and after their female partners’ pregnancies.

In the study of almost 4,000 men, about six per cent had elevated depression symptoms at some point during their partners' pregnancies or the nine months after the birth, researchers found.

“I think it’s important for couples to be aware that either of them can be depressed and they should be seeking help and seeking support,” said the study's lead author Lisa Underwood, who is affiliated with the University of Auckland.

Underwood and colleagues write in JAMA Psychiatry that nine per cent of men report depression at some point during their lives. About three per cent report a depressive episode in the past year.

Pregnancy and childbirth may put men at an increased risk of depression, they add, though research typically focuses on women, who are at an increased risk of depression during pregnancy and after childbirth.

Still, past research also links depressed fathers to emotional and behavioural problems among children, the researchers write.

For the new study, the team analysed data collected from the partners of women who took part in the Growing Up in New Zealand study and were due to deliver between April 2009 and March 2010.

The researchers conducted in-home interviews with 3,826 fathers during their female partners’ pregnancies. Another round of interviews were conducted with 3,549 of the fathers about nine months after their

36 EXPRESS PHARMA March 1-15, 2017

osteoarthritis in women

Optimising quadriceps and hamstring strength may help to lower the risk of developing knee osteoarthritis

children’s birth.

Underwood and her colleagues found that 2.3 per cent of fathers had elevated symptoms of depression while their female partners were pregnant.

During the postnatal period, 4.3 per cent of fathers had elevated depression symptoms after childbirth.

The men’s depression symptoms during pregnancy were tied to their being stressed or in poor health. After childbirth, symptoms were more likely in men who felt stressed during the pregnancy, or were no longer in a relationship with the child’s mother, men who rated their health as only fair or poor, those who were unemployed or had a history of depression.

The researchers can't say whether symptoms of depression cause poor health and other issues, or vice versa, said Underwood.

“It definitely points to the fact that we need to be giving couples more support,” she said.

Depression should raise flags about those other health concerns, said James Paulson, a licensed clinical psychologist and associate professor at Old

Dominion University in Norfolk, Virginia.

People should also think of depression’s influence on the entire family, said Paulson, who wasn’t involved with the new study.

“There are a lot of treatments for this,” he said. “We’ve been dealing with depression for a long time. While we don’t have tailored treatments for paternal depression, we do have interventions for depression and those are effective.”

Those interventions include medications and psychotherapy such as cognitive behavioral therapy (CBT), which can teach people how to address issues in their life that cause or worsen depression.

“We know that either parent's mental wellbeing impacts on the other, the relationship and family,” Underwood said.

Sometimes people may feel guilty seeking treatments when they just had a baby come into their lives, Paulson said.

“Consider seeking treatment for yourself as a way to treat the system that includes your child,” he said.

Reuters

WOMEN WITH weaker thigh muscles may be more likely to develop knee osteoarthritis, a recent study suggests.

When women had less strength in muscles known as the knee extensors, or quadriceps, which help straighten the leg for standing, climbing and kicking, they were 47 per cent more likely to develop knee arthritis than women who had stronger knee extensors, the study found.

Weakness in the knee flexor muscles on the back of the legs, also known as hamstrings, was associated with 41 per cent greater odds of knee osteoarthritis in women.

Thigh muscle strength didn't appear to influence the risk of knee osteoarthritis for men, researchers report in Arthritis Care and Research.

“While our recent study has highlighted the important role of strong thigh muscles in reducing the risk of knee osteoarthritis development, particularly in women, it is not possible to guarantee that having strong thigh muscles will protect women from developing knee osteoarthritis because there are many other factors that play into the disease,” said lead study author Dr Adam Culvenor, a researcher at Paracelsus Medical University in Salzburg, Austria.

“Nevertheless, our results suggest that optimising quadriceps and hamstring strength may help to lower the risk of developing knee osteoarthritis,” Culvenor added by email.

For the study, Culvenor and

colleagues examined data from MRIs of thigh muscles and muscle strength tests for 186 adults with knee osteoarthritis and another 186 without the condition.

Because obesity is independently associated with an increased risk of knee osteoarthritis, researchers also examined data on participants' weight relative to their height, a measure known as body mass index (BMI).

At the start of the study, participants were 61 years old on average.

Even after adjusting for BMI, women with weaker knee extensor muscles were 33 per cent more likely to have knee osteoarthritis, and women with weaker flexor muscles were 28 per cent more likely to develop knee arthritis.

With men, even after researchers accounted for BMI, they still didn't find a statistically meaningful association between thigh muscle strength and knee arthritis.

While the role of thigh muscle weakness as a risk factor for knee osteoarthritis is not fully understood, the quadriceps can help prevent the development and progression of this knee condition by acting as shock absorbers and stabilisers for the knee, Culvenor said.

Without strong quadriceps muscles, more stress is placed on the cartilage within the knee, and this has been suggested to induce a degenerative process, wearing down of the cartilage and ultimately osteoarthritis, Culvenor added.

Reuters

PHARMA ALLY VENDOR NEWS

Shimadzu bags APAC Mass Spectrometry Company of the Year Award The award was given for Shimadzu’s state-of-the-art mass spectrometry technologies

S

himadzu has received the 2016 Frost & Sullivan Asia Pacific Mass Spectrometry (MS) Company of the Year award. This is the second consecutive time that Shimadzu (Asia Pacific), the Asia Pacific subsidiary of Kyoto-based Shimadzu Corporation, has been bestowed the business leadership award. The award was given for Shimadzu's state-ofthe-art mass spectrometry technologies, which has also won several other accolades worldwide.

Interestingly, Shimadzu's Koichi

Tanaka is also the only person in the world to have won a Nobel Prize in Chemistry for pioneering MS analyses of biological macromolecules in 2002.

Shimadzu (Asia Pacific), which operates across 18 countries in APAC, ventured into providing MS technology to its customers in the year 2010. It has since emerged as one of the most sought after MS leaders in the region. Two key factors were evaluated while deciding the MS Company of the Year Award ‘Visionary Innovation and

Lonza expands airway disease portfolio with addition of IPF airway cells Lonza’s ability to provide primary cells coupled with detailed donor information enables researchers to relate donor characteristics to disease progression LONZA OFFERS cryopreserved lung fibroblasts isolated from donors diagnosed with Idiopathic Pulmonary Fibrosis (IPF) for use in research into this potentially fatal condition. Normal lung fibroblasts and small airway epithelial cells – from both smokers and non-smokers – are also available, offering a complete solution to facilitate IPF and other airway research.

Lonza’s ability to provide primary cells coupled with detailed donor information enables researchers to relate donor characteristics to disease progression. Donor history provides scientists with important insights, particularly as smoking is a known risk-factor for IPF. The addition of IPF cells further expands Lonza’s airway disease portfolio, which also incorporates cells from asthma, chronic obstructive pulmonary disease

(COPD) and cystic fibrosis donors, supporting some of the most important areas in respiratory research.

Research into IPF is a rapidly growing field with recent studies improving the understanding of the condition and enabling doctors to more easily make a diagnosis. However, a considerable amount of research is still needed if a cure is to be found, as the pathways of disease progression are not yet understood with the rate of progression varying from person to person.

In addition to providing a reliable source of IPF cells, Lonza offers ready-to-go optimised cell culture media, enabling scientists to rapidly start experiments. Both cells and media have been widely used in published studies to support many key applications in respiratory research. FGM-2 Fibroblast

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Growth Media, which is used to support IPF cells, is provided in Lonza’s all-in-one BulletKit format, which includes the appropriate basal medium, growth factors, cytokines and supplements. To streamline and reduce the complexity of experiments, FGM-2 Medium can also be utilized to support normal fibroblasts.

Lubna Hussain, Lonza’s Senior Global Product Manager for Primary Cells, commented, “Until now, IPF tissue has been difficult for researchers to source.

By providing these cells, Lonza is making it convenient for customers to quickly progress with their research. IPF cells are available together with normal lung fibroblast cells and culture media providing a complete cell culture solution for IPF research.”

EP News Bureau

Performance’ and ‘Customer Impact.’ The criteria for Visionary Innovation and Performance included addressing unmet needs, visionary scenarios through mega trends, implementation best practices, blue ocean strategy and financial performance; the criteria for customer impact included price/performance value, customer purchase experience, customer ownership experience, customer service experience and brand equity.

EP News Bureau

ACG launches MiniQuestTM-T ACG’S, ONE-OF-A-KIND perforated pan tablet coater, MiniQuestTM-T was recently launched at 68th Indian Pharmaceutical Congress (IPC), Visakhapatnam by Andhra Pradesh’s Human Resources Development Minister, Ganta Srinivasa Rao. The novel table coating machine is an ideal table top model for R&D and small scale commercial production.

Speaking at the inauguration, Rao said, “I am glad that ACG is making concerted efforts in developing the pharmaceutical R&D infrastructure. This machine will definitely be useful for R&D facilities and small scale manufacturers.”

Peter Neve, CMO, ACG Worldwide said, “ACG has always been in the forefront when it comes to developing innovative R&D solution that can cater to needs of the global pharma industry. With MiniQuestTM-T, we have added a user-friendly R&D tablet coating machine with latest German technology to our kitty.”

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PHARMA ALLY

Multisorb appoints Frédéric Laurent to lead EMEARegion for healthcare packaging Laurent will direct all healthcare packaging commercial activity in the EMEA region supporting his team of business development staff and respective customers MULTISORB Technologies has appointed Frédéric Laurent to the position of Commercial Director for Healthcare Packaging in support of its business in the Europe, the Middle East, and Africa (EMEA) region.

Laurent will direct all healthcare packaging commercial activity in the EMEA region supporting his team of

business development staff and respective customers.

“Frédéric’s comprehensive knowledge of the healthcare market coupled with his extensive experience in the active packaging industry will allow for the support and expansion of Multisorb’s healthcare packaging growing business and related success through efficiency pro-

gramme in the region,” said Adrian Possumato, VP, Healthcare Packaging, Multisorb.

“His appointment reflects Multisorb’s global commitment to providing leadership, innovation, and cost-effective solutions for active packaging components and related technical services to pharmaceutical, medical device, and di-

etary supplement manufacturers and packagers,” added Possumato.

Laurent earned a bachelor’s degree from the Negocia (ACI) business school in Paris and holds an MS in international marketing from South Bank University in London.

EP News Bureau

HP introduces high quality to entry-level commercial inkjet printing with HP PageWide Web Press T235 HD The T235 HD is a low total-cost-of-ownership platform for publishing, production mail and commercial print needs HP ANNOUNCED the launch of HP PageWide Web Press T235 HD, part of the T200 HD Colour series. This new entry level continuous-feed inkjet web press offers commercial print service providers (PSPs) the most economical entry point to high quality performance for digital commercial printing.

The T235 HD is a low totalcost-of-ownership platform for publishing, production mail and commercial print needs. It can be upgraded to the HP PageWide Web Press T240 HD for increased productivity.

“With the introduction of the HP PageWide T235 HD, it’s easier for more PSPs to make the analog to digital transformation,” said Eric Wiesner, GM, HP PageWide Industrial Division, HP. “As the HP PageWide Web Press platform reaches a milestone of 210 billion customer-printed pages, it

38 EXPRESS PHARMA March 1-15, 2017

further reinforces the market’s adoption of HP Thermal Inkjet technology.”

Using HP’s High Definition Nozzle Architecture (HDNA) with a native resolution of 2400 nozzles per inch, the duplex HP PageWide Web Press T235 HD delivers productivity at 400fpm (122mpm) in Performance mode, using single drop weight printing. It’s also

capable of producing 200fpm (61mpm) in Quality mode, using dual drop weight printing with seven levels of half-toning per colour, and finer grain printing for smoother skin tones, gradients and secondary colour solid fills.

“HP's high-volume PageWide solutions allow print service providers to add greater value to high-volume

data-driven print communications with uncompromising performance and color quality that brands demand,” said Wiesner. “The HP PageWide T235 HD makes it possible to deliver cost-efficient, relevant and targeted print that engages customers in more creative ways.”

EP News Bureau

PHARMA ALLY PRODUCTS

Gandhi Automations introduces various kinds of automated rolling shutters GANDHI AUTOMATIONS, an entrance automation and loading bay equipment company, manufacturer of rolling shutters, and an ISO 9001 2008 quality management system, has developed technical expertise in manufacturing various kinds of automated rolling shutters. The research and development team with its extensive know-how and experience are able to produce specific types of rolling shutters unique to certain sites and client requirements. A consistent quality product has thus become the hallmark of Gandhi Automations' manufacturing process right through installation to after sales service.

Gandhi Automations' rolling shutters are ideal for situations where side room is at a premium and security is required. The rolling shutters require very little headroom above the structural opening.

They combine strength with el-

egance along with durability and are designed for both external and internal applications. Gandhi Automations' rolling shutters are fabricated of interlocking galvanised insulated and non insulated, stainless steel, patented aluminum or polycarbonate profiles and

patented MS Rolling Grills.

Each of the rolling shutters are designed to client specifications conforming to IS 6248 and are constructed to promote trouble-free operation and long life.

Gandhi Automations' rolling shutters fit openings to

a maximum width of 30,000 mm and height of 40,000 mm with an endless array of options to satisfy both aesthetic considerations as well as working requirement.

Contact details Gandhi Automations Chawda Commercial Centre

Link Road, Malad (W) Mumbai – 400064 Off: +91 22 66720200 / 66720300(200 lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website: http://www.geapl.co.in/rollingshutters.html

Oven Industries launches 5R6-900 temperature controller with ramp/soak capabilities OVEN INDUSTRIES has launched its 5R6- 900 temperature controller with ramp/soak capabilities. The 5R6-900 benchtop controller has many outstanding user-friendly benefits. Contained all in one enclosure, the device can be plugged into the wall as a selfcontained temperature control system, which has its own power supply.

This distinctive detail makes the device unique, as well as highly convenient for users.

The temperature controller can also be used universally, which allows the user to use the device wherever they are located. As a solid state MOSFET bidirectional compact unit featuring an internal power supply, it is

ture controller a breeze.

Great for usage in universities, science laboratories, PCR research and any businesses that specialise in temperature control. The controller features an easy-to-read digital display for controlling functions, including adjusting output voltage and setting the desired temperature. Complete with an auto output shutdown if the sensor is opened or shorted, the unit also includes high, low and no alarm settings.

also capable of loading currents up to 10A. The compact size, as well as the

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isolated communication port, makes using the 5R6-900 benchtop tempera-

Contact details Rose Wescott 717-766-0721 info@ovenind.com

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PHARMA ALLY VALUE ADD

Preserve precious eyesight with Pycnogenol Frank Schonlau, Director of Scientific Communication, Horphag Research, elaborates on how Pycnogenol has helped people address retinopathy and preserve precious eye-sight VISION IS our predominant sense and maintaining good eyesight is more than assuring good visual acuity. Vision is the process of deriving meaning from what our eyes sense.

Vision is the paramount of all our senses and losing eyesight is among the greatest of fears to all of us. Indeed the eye is the most sophisticated, most complex sensual organ of our body, having a privileged immediate connection to the brain. In fact the light-sensing retina anatomically is regarded part of the brain.

On a per-size basis, the retina represents the most oxygen-demanding tissue in the body and with unattended oxidative stress, ageing and deterioration of light-sensing retina and the lens accelerate.

When the lens, with increasing age, loses flexibility or transparency, this fortunately may be compensated with corrective glasses, contact lenses or surgical interventions, as appropriate. In contrast, retinal damage accumulated during life, can neither be restored nor technically compensated for (prescription glasses are ineffective). The disorder representing the greatest threat for damage to the retina is retinopathy, which represents the leading cause of blindness in India (Gupta et al., 2016). Retinopathy involves destruction of the fragile capillaries supplying the retina, causing blood spillage into the retina, which in turn causes malsupply of photoreceptors with nutrients and oxygen, causing progressive, largely irreversible, vision loss. These processes occur in absence of pain or other sensations which would alert affected individuals. A major cause of retinopathy is a persistently high blood glucose level, such as in individuals with metabolic disorder, espe-

40 EXPRESS PHARMA March 1-15, 2017

cially diabetes, but also hypertension may contribute to the development of this disorder.

India is facing a particularly large increase of retinopathy patient numbers, with an estimated up to 20.4 per cent of the large diabetic population developing the eye disease [Frederick et al., 2016].

Decayed photoreceptors in the retina are not replaced, thus vision loss in retinopathy is permanent. Affected individuals do not sense pain, thus they lack suitable warning signs. Individuals developing retinopathy experience an increasingly coarse vision, yet

has been clinically investigated in more than 1200 retinopathy patients. In a study with patients diagnosed with retinopathy the sealing of retinal blood vessels was demonstrated by intravenous injection of a fluorescent dye, which allows to spot active retinal bleedings.

After 60 days treatment with Pycnogenol the retinal bleedings were found to have significantly decreased owed to the capillary-sealing effects of Pycnogenol. More relevant to the patients was the partial vision restoration, they experienced from taking Pycnogenol (Spadea et al., 2001). Best evi-

retinopathy commences, the better the conservation of vision and symptom improvement may be achieved with Pycnogenol Steigerwalt et al., 2009. Patients presenting with retinopathy at early stage showed visual acuity increase from 14/20 to 17/20 (Snellen chart). High resolution ultrasound measurements identified significantly reduced retinal swellings and better perfusion of retinal capillaries.

India deals with a diabetes challenge, unprecedented in the world, which tragically will translate into a serious eye health challenge. Public education and efforts for greater awareness will help to assist affected individuals receive timely medical attention. Pycnogenol may well represent a mainstay for preserving good eye health In India, with evidence-based eye health improvement in the diabetic population. Foremost, Pycnogenol is safe to use and was repeatedly successfully demonstrated in studies with more than 1200 patients to be efficacious.

References

with the slow progression of the disease, which may take several years, the deterioration of eye sight may progress unnoticed for a long time. Typically this disorder is discovered when affected individuals turn to an ophthalmologist in belief for requiring better prescription glasses. During such occasions, individuals often are diagnosed with retinopathy and made aware of metabolic disorder for the first time.

There exist possibilities to arrest progression of retinopathy by strengthening the frag-

ile blood capillaries of the retina, to put an end to bleedings in the eyes and save the remaining eye sight. An extract derived from bark of a specific pine tree (Pinus pinaster Ait), limited to France, bears substances which are demonstrated to potently strengthen fragile capillaries, rendering them less leaky and stopping further vision deterioration. This standardised extract, prepared according to United States Pharmacopoeia requirements, known under the brand-name Pycnogenol,

dence for the virtues of Pycnogenol for saving the eye sight in rertinopathy is a multi-centre field study carried out in Germany with 1,169 diabetic patients (Schรถnlau & Rohdewald, 2002). This large study demonstrated that treatment with Pycnogenol stopped progression of retinopathy and actually restored vision to some extent. Such very large studies have built the trust in Pycnogenol for helping people address retinopathy and preserve precious eye-sight. The earlier the treatment of

Gupta R, Misra A Epidemiology of microvascular complications of diabetes in South Asians and comparison with other ethnicities. J Diabetes 8: 470-482, 2016.

Schรถnlau F, Rohdewald P Pycnogenol for diabetic retinopathy.

A review. Int Ophthalmol. 24: 161-171, 2002.

Steigerwalt R, Belcaro G, Cesarone MR, Di Renzo A, Grossi MG, Ricci A, Dugall M, Cacchio M, Schรถnlau F. Pycnogenol improves microcirculation, retinal oedema, and visual acuity in early diabetic retinopathy. Ocul Pharmacol Ther. 25: 537-540, 2009.

Spadea L, Balestrazzi E. Treatment of vascular retinopathies with Pycnogenol. Phytother Res 15: 219-223, 2001.

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PHARMA LIFE AWARDS

HEALTHCARE SABHA2017

PAYS HOMAGE TO PUBLIC HEALTH CHAMPIONS Celebrates commitment to safeguard India’s health with Express Public Health Awards, in collaboration with Glenmark, Public Health Foundation of India and KPMG.

By Lakshmipriya Nair

E

xpress Public Health Awards, in its second edition, honoured state governments, public sector institutes, government hospitals and NGOs for their exemplary efforts to achieve UN’s Sustainable Development Goals (SDG) related to health.

Held concurrently with Healthcare Sabha 2017, at Novotel Visakhapatnam, it began with a welcome address by Viveka Roychowdhury, Editor, Express Healthcare. She explained that the awards were a tribute to public health champions for their commitment towards people’s welfare and good health in the face of diverse challenges like budgetary constraints, resource restraints and exacting timelines. She expressed her thanks to Glenmark, the Presenting Partner; Public Health Foundation of India, the Knowledge Partner and KPMG, the Process Partner.

She also introduced the eminent jury comprising Dr Srinath Reddy, Founder and President, PHFI and Chairperson of the Jury; Dr RK Srivastava, Sr Advisor, Public Health and Innovation, WISH Foundation, Delhi; and Bejon Misra, Founder, PSM India; Dr Sheetal Amte-Karajgi, CEO, Maharogi Sewa Samiti, Warora; Prof Yogesh Chawla, Immediate Past Director, PGIMER, Chandigarh; Prof Dr Bhabatosh Biswas, Vice Chancellor, Health University, West Bengal and Dr M Prakasamma, Executive Director, ANSWERS, Hyderabad. She also expressed her gratitude to all the jurists for their invaluable contribution in choosing the deserving winners.

In a Skype address, Dr Reddy stated that PHFI is very glad to partner with Express Healthcare in celebrating the game changers in India’s public health sector.

Rajendra Pratap Gupta, Advisor, MoH&FW, Government of India, in a Special Address, gave a rundown on the existing public health system of India and spoke on various endeavours by the government to enhance health and well-being of its citizens. He also gave several recommendations to augment the current framework such as making pharmacists and nurses the cornerstones of the public health system and integrating AYUSH with

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mainstream medical practice by making it more evidence-based. He also lauded Express Healthcare for creating a platform like Healthcare Sabha to bring all policymakers under one roof.

Roychowdhury took the stage again to explain the methodology and the selection process of the winners, followed by the felicitation ceremony.

The winners were as follows: ✦ Express Public Health Award for Most Efficiently Run Health Programme by a State Government: Government of Madhya Pradesh won this award for their comprehensive TB programme run by the Directorate of Health Services. The programme’s objectives included improving notification and success rates for drug resistant TB, morbidity & mortality of HIV associated TB as well as outcomes of TB care in the private sector. ✦ Express Public Health Award for Most Efficiently Run Health Programme by a Government Institution: It went to National Institute of Mental Health and Neuro Sciences (NIMHANS) for their hub-and-spoke model across the country comprising community health professionals, NGOs, GPs, non-specialists and lay counsellors to provide quality services. ✦ Express Public Health Award for Innovation in Increasing Affordable Access by a State Government: The winner in this category was Government of Andhra Pradesh for their initiative to provide free drugs to all patients visiting government institutions in 13 districts and 17286 villages, in a transparent way, through online indenting, monitoring, consumption and auditing with E Aushadhi, a software developed by CDAC. ✦ Express Public Health Award for Most Effective Health Technology System by a State Government: Government of Himachal Pradesh bagged this award for their Himachal Pradesh Tele Health Services (HP-THS), a project run by SPO (ehealth), Directorate of Health Services. It was given to laud the efforts of the state government, given the difficulties in providing telehealth services at high altitude regions and making specialist healthcare services including 24×7 emergency services available even in remote locations covered by the project: Kaza and Keylong in the districts of Lahaul and Spiti. ✦ Express Public Health Award for Most Effective Public Private Partnership: The Government of Andhra Pradesh received this award for their diagnostics project, NTR Vaidya Pariksha, which helped reduce out of pocket expenditure

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PHARMA LIFE

MOST EFFICIENTLY RUN HEALTH PROGRAMME BY A STATE

MOST EFFICIENTLY RUN HEALTH PROGRAMME

BY A GOVERNMENT INSTITUTION

INNOVATION IN INCREASING AFFORDABLE ACCESS BY A STATE GOVERNMENT

GOVERNMENT OF MADHYA PRADESH

NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES (NIMHANS)

GOVERNMENT OFANDHRA PRADESH

MOST EFFECTIVE HEALTH TECHNOLOGY SYSTEM BY A STATE GOVERNMENT

MOST EFFECTIVE PUBLIC PRIVATE PARTNERSHIP

MOST EFFECTIVE HEALTHCARE NGO

GOVERNMENT OF HIMACHAL PRADESH

THE GOVERNMENT OF ANDHRA PRADESH

RURAL HEALTH CARE FOUNDATION, KOLKATA

BEST GOVERNMENT HOSPITAL WITH A MEDICAL COLLEGE

SPECIAL MENTION: BEST HOSPITAL WITH A MEDICAL COLLEGE

SPECIAL MENTION: BEST DISTRICT GOVERNMENT HOSPITAL

INDIRA GANDHI MEDICAL COLLEGE & HOSPITAL, SHIMLA, HIMACHAL PRADESH

SHREE KRISHNA HOSPITAL, HM PATEL CENTRE FOR MEDICAL CARE & EDUCATION

MAHARAJA DISTRICT HOSPITAL, VIZIANAGARAM, ANDHRA PRADESH

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PHARMA LIFE (OOPE) from 54 per cent to 17 per cent in one year, while allowing 46.5 lakh patients in one year to avail free diagnostic services. ✦ Express Public Health Award for Most Effective Healthcare NGO: Rural Health Care Foundation, Kolkata was the winner in this category for innovation in service delivery. Their work in primary health centres of seven districts of West Bengal was found to be scalable, sustainable and replicable. ✦ Express Public Health Award for Best Government Hospital with a Medical College: Indira Gandhi Medical College & Hospital, Shimla, Himachal Pradesh received the award in this category. The hospital provides treatment free of cost or at nominal subsidised rates and has been able to attract people from all over the state including distant tribal areas of Himachal Pradesh.

Four Special Mentions were also part of Express Public Health Awards. They comprised: ✦ Regional Institute of Medical Sciences Rehabilitation Hospital, Imphal, Manipur received a Special Mention as the Best Government Hospital (Non Metro Region) for rendering services in remote areas.

Ziqitza Healthcare Limited (ZHL) received a Special Mention under the Most Effective PPP in Healthcare Infrastructure category for their ‘1298’ ambulance project and PPPs with various state governments to provide Emergency Medical

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Express Public Health Awards honoured state governments, public sector institutes, government hospitals and NGOs for their exemplary efforts to achieve UN’s Sustainable Development Goals (SDG) related to health. It was a tribute for their commitment towards people’s welfare and good health in the face of diverse challenges like budgetary constraints, resource restraints and exacting timelines Services (EMS).

Shree Krishna Hospital, HM Patel Centre for Medical Care & Education deserved a Special Mention as Best Hospital with a Medical College for their unique, physician-led governance structure standing on four pillars of quality; namely humane care, efficient care, rational care and affordable care.

Maharaja District Hospital, Vizianagaram, Andhra Pradesh, received a Special Mention as the Best District Government Hospital for innovative initiatives like the 24×7 emergency management for all referred cases, minimising further referrals to

tertiary care hospitals and having a separate place for biomedical wastage with segregation rooms.

Rajendra Pratap Gupta; Jury members, Dr Prakasamma, Dr Srivastava and Bejon Misra; AG Prasad, Divisional Head, Institutional Sales & Marketing at Glenmark Pharmaceuticals and Viveka Roychowdhury gave away the awards to the winners.

The event ended with a vote of thanks to all the jury members, dignitaries and delegates for being a part of Healthcare Sabha 2017 and the Express Public Health Awards. lakshmipriya.nair@expressindia.com

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