Express Pharma (Vol.11, No.24) October 16-31, 2016

VOL. 11 NO. 24 PAGES 102

www.expresspharmaonline.com

Market

‘The Indian pharma industry is going through a highgrowth phase’

Research

‘Linezolid directly affects the ability of the mitochondria to produce energy’ 16-31 OCTOBER 2016,` 40

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CONTENTS Vol.11 No.24 OCTOBER 16-31, 2016

PURPLE HEALTH APLATFORM FOR INNOVATION

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

DRL’s endeavour seeks to institutionalise patient-centric thinking and design high quality interventions to address their needs in a bid to promote 'Care Beyond the Pill’| 52

Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Senior Designer Rekha Bisht Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Ajanta Sengupta Ambuj Kumar E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

MARKET

20

LEADERS AND GAME CHANGERS CONGREGATE AT HEALTHCARE SENATE 2016

22

USHERING THOUGHT LEADERSHIP IN INDIA'S PRIVATE HEALTHCARE

26

ANALYTICA ANACON INDIA AND INDIA LAB EXPO 2016 TO BE HELD IN HYDERABAD

MANAGEMENT

INTERVIEW P18: ‘The Indian pharma industry is going through a high-growth phase’

37

Peeyush Gupta, Director, Sales and Marketing, South Asia – UL

PUSHING THE BOUNDARIES OF COMMUNICATION IN PHARMA

P LIFE P44: Linezolid directly affects the ability of the mitochondria to produce energy Dr Salil Mehta, Volunteer and Consultant Ophthalmologist with MSF

P56: ‘We assessed the practicality of this solution in terms of technical feasibility and economic affordability’ Kanupriya Goel, Researcher and Designer

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AMBATI VENU IS NEW ABBOTT INDIA MD

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SINHGAD COLLEGE OF PHARMACY ORGANISES PHARMA RALLY

Dr Gautam Goel, Computational Biologist

Express Pharma® Regd. with RNI No. MAHENG/2005/21398,Postal Regd. No. MCS/164/2016 – 18. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2016. The Indian Express (P) Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

Abiding by the rules

T

he debate about replacing PET packaging with glass as packaging material for pharmaceuticals is reaching yet another milestone as the matter is due to come up for its next hearing before the National Green Tribunal (NGT).

The issue has been hanging fire since 2013, when NGO Him Jagriti petitioned for a ban on PET for medicines. Various arms of the government seem to be contradicting each other.

For instance, the 65th Drugs Technical Advisory Board (DTAB) report of 2013 recommended that PET/plastics should not be used to pack medicines and should be replaced by glass.

Frustrated by what allegedly were delaying the tactics of industry associations, Him Jagriti then approached the NGT for a blanket ban on the use of PET and plastics for packaging of medicines. The NGO could finally have its way, as the NGT has been waging a war against plastic and is reported to favour ‘restriction’ on plastic packaging of products including PET bottles.

The NGT invited PET manufacturers and the pharma industry to send their views.

The NGT asked the Health Ministry to form a committee to study the issue. A committee headed by MK Bhan, Former Secretary, Department of Biotechnology, Ministry of Science and Technology, was constituted, to look into the science behind the issue. The committee advised the need for better regulation and standards but found that “there is no conclusive, reproducible evidence to suggest that the use of PET, or additives used with it such as antimony, for pharma packaging may leach substances beyond limits that pose a threat to human health.”

The PET packaging industry should agree to abide by higher benchmarks and regulation, at least of the materials supplied to the pharma sector

In contradiction to this stance, the 71st DTAB report reiterated its previous recommendation, advising that the Ministry of Health & Family Welfare should ban the use of plastics and PET for packaging medicines for babies, the elderly and nursing mothers.

With the pharma sector accounting for a sizable 16 per cent of the `4,000-crore PET packaging industry in India, the powerful PET lobby will most likely seek to further delay any final decision contrary to its interests.

But there is a middle path. The PET packaging industry should agree to abide by higher benchmarks and regulation, at least of the materials supplied to the pharma sector. In doing so, it will raise its own standards, as well as help its client sector, the pharma companies, to abide by global norms.

But the push to change to better, if more expensive plastics/PET, should come from the pharma sector, which is currently resisting the move. In doing so, it will redeem itself in the eyes of the consumer/patient. Early movers to safer packaging materials can even position this as a USP in a crowded competitive market. Savvy pharma companies are already moving in this direction. For instance, Dr Reddy's Laboratories recently launched an initiative called Purple Health, wherein certain brands were repackaged deploying consumer friendly packaging devices.

(See story, pages 52-55). It is only a matter of time before this trend becomes the norm. Hopefully, the companies opposing the ban on PET packaging will follow the same trend.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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16 EXPRESS PHARMA October 16-31, 2016

MARKET I N T E R V I E W

‘The Indian pharma industry is going through a high-growth phase’ UL, a global independent safety science company providing testing, inspection, certification and advisory services, recently signed an MoU with Pharmexcil to be the Council’s knowledge sharing partner and subject matter expert. Peeyush Gupta, Director, Sales and Marketing, South Asia – UL, shares more details about the alliance and its objectives, in an exclusive interview with Lakshmipriya Nair What does the recent partnership between UL Pharmaceutical Export Promotion Council of India (Pharmexcil) entail?

With Pharmexcil, we signed an MoU on September 23, 2016. This is a knowledge sharing partnership under which we would support the Pharmexcil members and help them find solutions to their various requirements.

Under this partnership, we plan to do a series of workshops and events partnering with the pharma industry in India over 2017 and beyond. These workshops would comprise technical sessions wherein we will understand the challenges faced by the industry and address these challenges. We will also have consultative sessions wherein experts from UL as well as regulators and representatives of leading pharma companies will address the participants to work together and create a strong compliance and performance framework in India. At a higher level, with this partnership we intend to ensure that the pharmaceutical industry in India achieves greater heights of growth.

What are the three important goals that this partnership aims to achieve?

The three important goals of this partnership is to:

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EXPRESS PHARMA

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◗ Provide knowledge to the Indian pharma industry in terms of global regulations and global compliance ◗ Understand the challenges faced by the pharma industry and address them effectively ◗ To develop long-term, lasting solutions for the Indian pharma industry so that it looks beyond just compliance to business performance and business excellence How will it help the pharma players up their game?

The Indian pharma industry is going through a highgrowth phase. More than 40 per cent of generic drugs sold in the US are manufactured in India. We continue to see high growth in the exports to the US market as well as other global markets. However, this kind of growth comes with its inherent challenges in terms of quality as well as compliance and in terms of meeting both customer as well as regulatory needs. We, at UL, with over three decades' experience of helping lifesciences companies bring to the table a level of global expertise that can help the industry find solutions to some of the challenges that they are facing at this point of time.

Can you elaborate on the services provided by UL for the pharma industry?

We operate on a partnership

model. We work with clients and try to find solutions to their needs. Right from market access needs - if they are accessing certain markets what are the regulatory needs in those countries, right upto their training requirements whether they are on CGMP, data integrity, good clinical practices, validations, SOPs etc, we have a suite of courses that help clients understand their needs. More than that, we work with the clients to offer them relevant solutions customised to suit their needs.

Tell us more about the courses offered by UL? Who are your clients?

We have designed and implemented several courses to facilitate training and learning for pharma companies in India. We have over 700 e-learning courses.

These courses are addressed for people at different levels in

the pharma organisations, right from the workers to the senior management. We have advisory frameworks where we work with clients on a periodic basis and establish long-term associations to understand their needs and develop solutions for the issues they face. We have worked with a lot of leading pharma companies in India.

Gujarat government to train their FDCA inspectors on regulatory compliance.

We have signed an agreement sometime last year. Since then we have trained around 40 inspectors of the FDCA in two or three sessions. We have trained them on different aspects of good manufacturing practices and good clinical practices.

Are these courses accreditated/recognised by any industry/regulatory body?

Well, it is a very interesting story. We were one of the pioneers or one of the first organisations to be qualified by the FDA in the US to train their staff. So, these courses were jointly developed by UL and the FDA in the US. Now, for more than decade, we have been working with the US FDA and partnering with them to develop these courses which as used to train the FDA auditors. Leveraging on that experience, we have these courses in our course library which not only look at the requirements from a US FDA standpoint but also from a global regulatory standpoint whether its is the MHRA in the UK or regulatory bodies in China or Japan etc. These courses basically help clients to understand regulatory frameworks in different countries across the world.

Tell us about the agreement you have signed with the

What are the learnings you have gained from your presence in the Indian market that can be incorporated in the partnership with Pharmexcil?

We have been in the Indian market for some time and we have been trying to understand how we can leverage the global experience but provide solutions tailored to the local needs. We understand that there are specific areas where the Indian pharma industry is facing challenges such as data integrity, corrective and preventive action, inspection readiness, facing audits. So, in fact, a lot of the solutions that we are working on revolves around the understanding that we have about the challenges faced by the Indian pharma industry. So, we are becoming more local now, trying to understand the local needs and provide local solutions. lakshmipriya.nair@expressindia.com

MARKET REPORT

Leaders and game changers congregate at Healthcare Senate 2016 Deliberate and discuss on crucial issues in Indian healthcare and the ways to tackle them at the three-day conference held from September 22-24, 2016 in Hyderabad

E

xpress Healthcare, a leading publication from The Indian Express Group, inaugurated the first edition of Healthcare Senate – The National Private Healthcare Business Summit, in Hyderabad.

Held from September 22-24, 2016 at HICC, Novotel in Hyderabad; it saw private healthcare leaders and game changers come together to discuss the future of healthcare delivery in India.

Day 1: Setting the stage for a healthcare revolution The event began on an auspicious note with a lamp lighting ceremony by senior dignitaries such as NC Borah, Founder & CMD, GNRC Group of Hospitals; Dr A Velumani, Founder, CEO and Managing Director, Thyrocare; and Dr Sabahat Azim, CEO, Glocal Healthcare.

They were joined by Viveka Roychowdhury, Editor, Express Healthcare.

Roychowdhury welcomed the august audience and thanked them for their support in ushering a healthcare revolution in India.

It was followed by a very rousing key note address by Dr Velumani. His entrepreneurial journey from a small village with low resources to one of the most renowned players in the diagnostics sector, inspired and enthralled the entire audience.

“Experience is gained through problems and the learnings they offer as we overcome them. Lucky are those who are born poor. Life offers them more opportunities to learn,” said Dr Velumani.

“Move out of your comfort zones to succeed. In life there is security or prosperity. There is nothing called secured prosperity. Disruption brings about

20 EXPRESS PHARMA October 16-31, 2016

(L-R) Dr Sabahat Azim, Dr NC Borah, Dr A Velumani & Viveka Roychowdhury at the inauguration of Healthcare Senate 2016

growth. Be a disrupter or get ready to be disrupted,” he advised. The audience gave him a standing ovation for his valuable insights.

The day ended with Healthcare Citations, wherein visionaries who have chosen areas of practice with huge challenges, of serving the underserved and difficult to access corners of our country, were recognised for their invaluable contributions to improve healthcare delivery in India.

Thus, Healthcare Senate 2016 began on a very positive note and set the stage for more fruitful and informative sessions over the next two days.

Day 2: Enhancing healthcare delivery The second day of Healthcare

Senate 2016, the National Private Healthcare Business Summit, saw industry leaders deliberate and discuss on crucial issues in Indian healthcare and the ways to tackle them.

The first panel discussion of the day was on ‘Recent Practices in Accreditation and in Good Hospital Pharmacy Practices.’ The panel was moderated

by Dr Suresh Saravdekar, Director, The Rural Centre, Krishnamurti Foundation India, Varanasi – UP. The session focused on quality issues in healthcare and pharmacy practices and the role of accreditation to mitigate these issues.

The panelists, Dr Arun Palaniswami, Director – Quality Systems, Kovai Medical Center and Hospital and Dr Harish Nadkarni, Consultant for

NABH, CEO and MD, Quality Care, gave valuable insights from their experiences in ensuring that best practices are implemented and adopted at all levels in their organisations.

It was followed by a panel discussion which highlighted a challenge faced by all modern day healthcare organisations, ‘Medico-legal tangles and the cost burden arising out of them’.

It was moderated by Mahendra Bajpai, Advocate, Supreme Court of India. The panel for this discussion were Manpreet Singh Sohal, CEO, Global Hospitals, Mumbai & Hyderabad; Dr Vivek Jawali, Director, Fortis Hospitals, Bengaluru; Dr Suganthi Iyer, Deputy Director, Legal & Medical, PD Hinduja Hospital & MRI, Mumbai; Dr Alexander Thomas, Executive Director,

AHPI; Dr Nikhil Datar, Founder President, Patient Safety Alliance & Medical Director, Cloudnine Hospital, Mumbai.

The eminent panel offered their recommendations to deal with medico-legal tangles effectively.

The panelists advised that the medical fraternity to be more legally literate; introduce a grievance redressal cell; ensure that their practice is based on the values of integrity, compassion and effective communication as it would prevent medico-legal issues considerably; and regularly train healthcare workers in hospitals to minimise errors. The audience appreciated the session immensely.

The last session for the day was another panel discussion on an interesting topic which has huge relevance in the current times, ‘Patient-driven Innovation in Healthcare’. The panelists of this session were Lalit Pai, CEO, Nightingales Home Health Services; Dr Aniruddha Malpani, Director and Values Custodian at Solidarity Advisors; Dr Nagarjuna Mishra, Chief Officer – Business & Strategy & Co- founder, Purple Health; and Suresh Satyamurthy, Founder, Tarnea Technologies. The session was moderated by Chayan Chatterjee, COO and Co-Founder, Lattice Innovations.

Some of the key takeaways from the session were, patient first is the basis for all patientdriven innovation, technology plays an important role in the growth of this trend which can enhance healthcare delivery but there is an equal need to implement standards to ensure quality.

The second day’s itinerary also saw power discussions, networking opportunities and meetings.

MARKET Day 3: Knowledge sharing galore The third day at Healthcare Senate 2016, began with an impromptu yoga session which saw active participation from the esteemed speakers and delegates. After this invigorating start, industry leaders continued their discussions on quality and finance related issues within the sector.

Dr KK Kalra, CEO, NABH, keynote speaker for the day, reiterated how imperative it is to invest in quality and elaborated how accreditation helps to sustain quality standards.

Healthcare is India needs a transformation, said Dr Kalra and advocated the need for continuous quality improvement in healthcare.

The first panel discussion for the day, 'Raising Capital for Healthcare,' was addressed by an eminent panel which comprised Dr Rana Mehta, Leader – Healthcare, PwC India as the moderator, Apoorva Patti, Director, Currae Healthcare & Currie Healthtech Fund; Dr N Krishna Reddy, Vice Chairman, Care Group of Hospitals; and Dr Harish Pillai, CEO, Aster Medcity, Kochi & Cluster Head – Kerala.

The panelists shared valuable insights on fund raising and also spoke on the trends in this segment. Dr Mehta quizzed the panelists on their strategies to raise funds for their organisations. Dr Pillai pointed out that investors are studying the nuances and subtleties of different geographical markets before betting on any healthcare organisation.

He also stressed on ensuring good governance to enhance funding. Dr Reddy, whose hospital has raised five rounds of funding, advised that hospitals should look for investors who understand their organisation’s philosophy to build meaningful partnerships.

Patni recommended hospitals to find an underserved need and explore unexplored segments to raise funds. The audience appreciated the session immensely.

The last session of Healthcare Senate 2016 was also very interesting. CXOs of lead-

EXPRESS PHARMA

21

October 16-31, 2016

ing hospitals across the country shared the stage to discuss one of the most important issue s within hospitals – Balancing profitability with responsibility. Amit Misra, Head – Consulting Services, North India, IMS Health moderated the session. The panelists were Joy Chakraborty, COO, PD Hinduja Hospital and

Medical Research Centre; Dr Tarang Gianchandani, CEO, Jaslok Hospital; Dr Alok Roy, Chairman and MD, Medica Synergy; Dr J Sivakumaran, COO, Kovai Medical Center and Hospital; and Aloke Mullick, COO, KIMS were the panelists.

Improving operational efficiency, right pricing of serv-

ices, using feedback from patients to reduce errors etc were the suggestions given by experts to build a profitable yet responsible healthcare organisation.

The audience appreciated the session and interacted with the panelists for further clarity on the subject.

The day concluded with the

Express Healthcare Excellence Awards. Partnered by United Biotech, it sought to recognise the pathfinders, innovators and game changers from the private healthcare industry for their invaluable contributions to healthcare in India.

Thus, the inaugural edition of Healthcare Senate 2016 was a resounding success.

MARKET

USHERING THOUGHTLEADERSHIPIN INDIA'S PRIVATE HEALTHCARE Opinion leaders in India's private healthcare sector came together at Healthcare Senate - The National Private Healthcare Business Summit to share innovative ideas and create a roadmap to turn them into reality. Healthcare Senate citations and Express Healthcare Excellence Awards were also held at the three-day event to celebrate the spirit of excellence and leadership in healthcare delivery in the private sector Glimpses of the event....

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October 16-31, 2016

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To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

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October 16-31, 2016

MARKET

Healthcare Senate 2016 celebrates excellence and leadership in healthcare Recognises pathfinders, innovators and game changers from the private healthcare industry for their vital contributions to healthcare in India

T

he inaugural edition of Healthcare Senate 2016, the National Private Healthcare Business Summit, hosted by Express Healthcare, also sought to celebrate the spirit of excellence and leadership in healthcare delivery in the private sector.

Held on September 22, Healthcare Senate Citations, supported by Boston Scientific, were received by four visionaries who have chosen areas of practice with huge challenges, of serving the underserved and difficult to access corners of our country.

The winners of the Healthcare Citations were Dr Nomal Chandra Borah, Chairmancum-Managing Director, Guwa-

hati Neurological Research Centre (GNRC); Dr Neelam Kler, Chief of Neonatology, Sir Ganga Ram Hospital, New Delhi; Dr RD Ravindran, Chairman and Director Quality, Aravind Eye Care System and Dr Sabahat Azim, Founder, CEO and MD of Glocal Healthcare Systems.

Express Healthcare Excellence Awards, hosted on September 24, the last day of Healthcare Senate 2016 also recognised the pathfinders, innovators and game changers from the private healthcare industry for their vital contributions to healthcare in India. The eight winners across four categories were: Express Healthcare Excel-

lence Award for Innovative Marketing Practices: It went to Narayana Health (Registered as Narayana Hrudayalaya) for creating patient education videos and awareness materials across all the specialities which NH specialises in and effectively utilising the Internet to reach out to a large audience.

Express Healthcare Excellence Award for Inspirational Workplace: Lotus Hospitals for Women and Children, Hyderabad bagged the award for their initiatives to build a result-oriented organisation capable of making rapid decisions and create a highly competent workforce that can support it at every level Express Healthcare Excel-

lence Award for Corporate Social Responsibility: There were two winners in this category.

Six Sigma Star Healthcare (P) won it for their endeavour to provide free medical treatment to needy people, stuck up in high altitudes.

Indraprastha Apollo Hospitals, New Delhi bagged the award for their CSR project ‘A Healthy Start’ which attempts to improve access to sanitation and clean drinking water as well as spread hygiene awareness among underprivileged school children.

Express Healthcare Excellence Award for Patient Care: This crucial category had four winners. They were: PD Hinduja Hospital & Med-

ical Research Centre, Mumbai for their initiatives to provide quality healthcare for all.

Aster Medcity, Kochi, for their innovative robotic system which has reduced waiting time, eliminated dispensing errors and simplified inventory management.

Indraprastha Apollo Hospitals, New Delhi for their successful initiatives to reduce the numbers of errors and improve overall safety of high-alert medications.

Satguru Partap Singh Hospitals, Ludhiana for development of dedicated tracheostomy care nurses to decrease complications and ICU readmission rate of tracheostomised patients.

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MARKET PREVENT

analytica Anacon India and India Lab Expo 2016 to be held in Hyderabad 250 global and domestic exhibitors as well as 8,500 trade visitors from India and overseas expected THE NINTH annual edition of analytica Anacon India and India Lab Expo, leading trade fairs for the laboratory technology, analysis, biotechnology and diagnostics market, will be held from October 20 to 22, 2016 at the HITEX Exhibition Centre in Hyderabad. Internationally renowned exhibitors, consultants, business experts and key government officials will come together on one common platform to discuss global best practices and seek solutions to some of the most pressing challenges related to the industry.

Organised by the Indian Analytical Instruments Association (IAIA), the event focuses on technical subjects and market trends. From October 20 to 21, the conference will reportedly cover more than 18 technical topics under the following four key sessions: Regulatory Aspects for Pharmaceutical

Laboratories, Bioanalysis and Bio-Pharmaceuticals, Food safety and Clinical Diagnosis.

Bhupinder Singh, CEO, Messe München India and organiser of analytica Anacon India and India Lab Expo said, “Participants of our trade fairs can expect to see more this year. We bring new exhibitors, new technologies and new market trends from the world of laboratory, analysis, biotechnology and diagnostics to Hyderabad.”

Alongside the exhibition and conference, buyer-seller meetings would be one of the highlights of the event. They would facilitate direct contact between exhibitors and potential clients from domestic and international markets through prescheduled meetings. Top decision makers and VIPs are expected at the event, seeking for new equipment, technolo-

Conference will cover more than 18 technical topics under four key areas: Regulatory aspects for pharma labs, Bioanalysis and biopharma, Food safety and Clinical diagnosis

gies and solutions. “At Messe München India, we believe in offering strong value proposition to our participants by providing them ample networking and business possibilities. This year, we offer business matchmaking opportunities prior and during the event,” Singh added.

Reportedly, for the first time ever, the Indian trade fairs will stage a Live Lab. Following the model of the German parent fair analytica in Munich, lab bench presentations will allow manufacturers to present their latest products and systems in actual use. Visitors can get practice-oriented insights and experience all common techniques as well as special-purpose methods in real laboratory surroundings. Besides, an educational workshop and live demonstrations on health safety in laboratories are also being organised alongside the

exhibition. The trade fairs have garnered official support of leading trade bodies and associations including the Indian Analytical Instruments Association (IAIA), Ambala Scientific Instruments Manufacturers Association (ASIMA), Bulk Drug Manufacturers’ Association (BDMA), The Federation of Small & Medium Enterprises (FSME), The Federation of Telangana and Andhra Pradesh Chambers of Commerce and Industry (FTAPCCI), Indian Chemical Council (ICC), Indian Drug Manufacturer’s Association (IDMA), Telangana Chambers of Commerce and Industry (TECCI), National Small Industries Corporation (NSIC), SPECTARIStrade association Analytical, Bio and Laboratory Technology from Germany and the Swiss-Indian Chamber of Commerce.

EP News Bureau

POST EVENT

GIBS organises scientific congress on IC/BPS Held in association with Swati Spentose, more than 100 doctors from all over India participated in the event GIBS, in association with Swati Spentose (Lead Patron), recently held a scientific congress on interstitial cystitis/ bladder pain syndrome (IC/BPS) in Mumbai. The event aimed to create awareness among the medical fraternity about the disease and build consensus among them on the protocol for diagnosis and treatment . The objective was to develop standard guidelines to streamline the diagnosis rocess, shorten assessment time in disease and subsequently avoid

26 EXPRESS PHARMA October 16-31, 2016

delay in treatment.

More than 100 doctors from all over India and around 50 doctors from just Mumbai attended the event. Various scientific developments and clinical applications in pathophysiology, diagnosis, metabolic evaluation and medical treatment of IC/BPS were discussed during the meet.

Participant found GIBS to be a platform which helped them further their knowledge and interact with other specialists working on subject.

A team of physicians led

by urologists, Dr Rajesh Taneja and Dr Sanjay Pandey, conceptualised a body (Global Interstitial Cystitis Bladder Pain Syndrome Society) dedicated exclusively to interstitial cystitis and bladder pain syndrome and was assured full infrastructural, secretarial and financial support

by Vishal Jajodia, Managing Director, Swati Spentose Pvt Ltd (SSPL).

IC/BPS is one of the neglected diseases though it impacts literally one fourth of the country’s population. GIBS

aims to spread more awareness about the disease and streamline its diagnosis and treatment by creating standard guidelines.

Presently, the US is the only country in the world which has the necessary support system needed to deal with IC and BP patients.

GIBS plans to bring out a periodic publication and an interactive website for patients and doctors wherein modules to certify doctors as specialist of IC BPS, etc would be provided. Reportedly, the guidelines, being

developed by a panel comprising 10 urologists and gynaecologists led by Dr Taneja, are likely to be released by GIBS in a couple of months.

SSPL (the platinum, gold and silver sponsor of ESSIC 2016) also announced the next meeting of the international authority (ESSIC) on IC/BPS. The meeting is being held Nov ember 17-19, 2016 in Delhi.

Global experts on the subject will interact and share their experiences at the event.

EP News Bureau

MARKET POST EVENT

PharmaSafe India 2016 held in Mumbai Experts emphasise on innovation to tackle counterfeiting at the conference PHARMASAFE INDIA 2016, a conference on anti-counterfeiting and brand protection, recently concluded in Mumbai. Delegates with backgrounds like regulatory agencies, law, brand protection, enforcement, pharma manufacturing, authentication technology, pharmacy, anticounterfeiting etc. attended the conference.

In his inaugural address, Dr K Bangarurajan, Deputy Drugs Controller (DDC)I, discussed the causes of counterfeiting and measures undertaken by the government to counter them. He said, “There is a lot of money involved in counterfeiting, mainly in lifestyle medicines.

Moreover, manufacturing equipment are widely available and facilities like the internet and postal delivery have made distribution an easy process. Weak legislation and enforcement have also aided the growth of counterfeiting business.”

Though measures like strengthening of drug regulatory system in the country, amendments in Drug and Cosmetics Act- 2008, whistle blower scheme etc are in place, there are a few implementation challenges.

Bangarurajan explained, “Non uniformity in enforcement, lack of adequate manpower and infrastructure, difficult to trace manufacturers, no foreign site inspections, inadequate training, long list of pending cases in courts and lack of an intelligence network are some of the biggest worries in the implementation of anti-counterfeiting measures.”

Pramod Bhatt, Director, Security and Intelligence (South Asia), Sanofi India, spoke on anti-counterfeiting strategies and the need for innovation to manage counterfeiting. According to him, a strategy should not be reactive, it must be preventive. He

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said, “As far anti-counterfeiting strategy is concerned, the

focus should be on prevention, collaboration and co-opera-

tion. All the stakeholders should be involved Informa-

tion should be shared and mutual trust should be developed.

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MARKET Awareness campaigns are also necessary where target audience would be retailers, distributors, consumers, doctors and regulatory bodies and law enforcement agencies.” He added, “Counterfeiters are innovating faster than us. Technology should be such that it can not be replicated.”

A panel discussion on 'Industry initiatives against counterfeiting' was also one of the highlights of the conference.

Like Bhatt, Ashwani Sood, Senior Director, Industrial Affairs, Sanofi India also stressed on the importance of innovation during the panel discussion. He said, “Some-

Geographical complexity in the country and volume of medicines is making it difficult to handle counterfeiting. Weak legislation and enforcement have also aided the growth of counterfeiting business

thing innovative, which will raise patient's confidence that what he is consuming is safe, should be the objective. Geographical complexity in the country and volume of medicines is making it difficult to

handle counterfeiting. Our efforts are at a good level but not at the ideal level. Innovation is going to be the key in future.”

Shaunak Dave, Asian Market Director, Optel Vision,

discussed the role of technology in overpowering the threat of counterfeiting.

“Counterfeiting badly affects company's revenue. Single technology is not going to help. We need to use multiple

technologies to counter counterfeiting. Before the implementation of any technology, its ease of implementation, feasibility, cost etc. needed to be considered. Technology should be non-clonable, but at the same time, it should be user-friendly as well,” said Dave.

While highlighting the silver lining to the cloud, Dharmesh Kharwar, Director, Strategic Alliances, MSD (Merck Group), said that with more and more digitisation and automation, challenges are going to decrease while developing anti-counterfeiting solutions.

EP News Bureau

Pharmexcil organises Pharma CEOs Conclave 2016 The conclave saw overseas delegates from Africa, ASEAN, SAARC, GCC, CIS regions THE PHARMACEUTICAL Export Promotion Council of India (Pharmexcil) in association with Ministry of Commerce, Government of India, recently organised ‘Pharma CEOs Conclave’ as a part of Pharmexcil’s 12th Annual Meet in Hyderabad.

The event witnessed the presence of Sudhansh Pant, Joint Secretary (Policy), Department of Pharmaceuticals, Government of India, Anice Chandra Joseph, Director, Department of Commerce, Government of India, Madan Mohan Reddy, Chairman, Pharmexcil, Whole Time Director, Aurobindo Pharma and Dr PV Appaji, Director General, Pharmexcil and dignitaries representing the government and the pharma industry.

The theme for the conclave was ‘Public-Private Partnerships in Pharmaceutical Manufacturing – Strategies for Improving Access to Medicines Globally. It was was moderated

by Dinesh Dua, Vice Chairman, Pharmexcil and CEO and Director, Nectar Lifesciences.

The panelists were Dr Harish Iyer, Senior Advisor, Scientific Programs, Bill and Melinda Gates Foundation, Isabelle P Noblanc, Vice President & Head,

28 EXPRESS PHARMA October 16-31, 2016

(L-R) Anice Joseph Chandra, Ashutosh Gupta, Madan Mohan Reddy, Dinesh Dua, Dr PV Appaji

UL Eduneering, Dr Amar Bhat, Vice President, Open Health Systems Laboratory, Joseph Chandra, Mahima Datla, Managing Director, Biological E, Jayant Tagore, President, Bulk

Drugs Manufacturers Association. Pant was the Chief Guest for the conclave.

The conclave saw overseas delegates from Africa, ASEAN, SAARC, GCC, CIS regions.

Around 50-60 manufacturers of finished formulations and 40-50 distributors/importers of formulations took part in the conclave. In recognition of its member companies tireless

efforts and to further encourage their achievements, Pharmexcil also honoured its member companies with Export and Patent Awards.

EP News Bureau

MARKET

ISCR hosts 3rd National Pharmacovigilance Symposium The theme for the conference was 'Evolving a Pharmacovigilant Environment in India – Collaborations, Opportunities & Challenges' THE INDIAN Society for Clinical Research (ISCR) recently held its 3 rd National Pharmacovigilance (PV) Symposium on the theme ‘Evolving a Pharmacovigilant Environment in India – Collaborations, Opportunities & Challenges.’

The symposium brought together pharmacovigilance stakeholders from across biopharma industry, CROs, service providers, medical professionals, academia and regulators. Discussions were held on the evolution of a pharmacovigilant environment in India by facilitating collaborative efforts to aid the emerging regulatory initiatives.

Dr GN Singh, DCG(I), delivered the inaugural address during which he spoke about the Government of India’s initiatives to promote pharmacovigilance through the PvPI and invited stakeholders to share their knowledge with PvPI for furthering the cause of pharmacovigilance in India.

While delivering the Guest of Honour’s address, Prof Dr NK Ganguly, Former Director General of ICMR, iterated that more efforts have to go into building structured longterm collaborative ventures involving all stakeholders in order to benefit patients in India. Sessions covered during the symposium included the role of stakeholders in the evolving Indian pharmacovigilance environment, quality management in pharmacovigilance, pharmacovigilance in clinical trials and advances in pharmacovigilance.

EP News Bureau

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MARKET

SGRF organises sixth annual international conference NextGen Genomics, Biology, Bioinformatics and Technologies conference was organised in Cochin SCIGENOM RESEARCH Foundation (SGRF) recently organised the sixth annual international conference, titled ‘NextGen Genomics, Biology, Bioinformatics and Technologies (NGBT)’ in Cochin.

Sam Santhosh, Promoter of SGRF (SciGenom Research Foundation), a non-profit organisation with the objective of spreading scientific education in the country emphasised the importance Next Generation Sequencing Genomics to the participants at the conference. The conference had interesting sessions like genomics in healthcare, plant, insect biology and genomics, NexGen Sequencing, (NGS) data analysis solution etc.

Dr Oommen V Oommen, Chairman, Kerala State Biodi-

versity Board was the Chief Guest for the conference along with Kris Gopalakrishnan, Executive Vice Chairman, Infosys who was the guest of honour.

The co-hosts for the NGBT meeting included Tata Institute of Fundamental Research (Biology Department),

Mumbai; The Centre for the Commercialisation of Antibodies and Biologics and The Toronto Recombinant Antibody Centre, Toronto; Institute of Bioinformatics, Bengaluru and Tamil Nadu Agricultural University, Coimbatore.

The three-day programme had speakers from renowned research institutes from across the globe. Some of the speakers at the meeting include Dr Aakrosh Ratan, University of Virginia, US, Dr

Nandula Raghuram, GGS Indraprastha University, Dr Ratna Dua Puri, SGRH, Dr Analabha Basu, NIBMG, Dr VB Reddy, AgriGenome, Dr Ravi Gupta, MedGenome, Dr Andrew Peterson, Sr Director, Genentech, US, Dr Ramprasad VL, COO, Medgenome, Bengaluru, Dr K Thangaraj, Group Leader, Centre for Cell and Molecular Biology (CCMB) and Dr Chirantan Bose, MedGenome, Bengaluru.

The conference featured

The three-day programme had speakers from renowned research institutes from across the globe. The conference featured drug discovery as a major theme and encompassed various key note lecturers with a spectrum of expertise from genomics to cancer immunotherapy, to pant genomics and cancer signalling

drug discovery as a major theme and encompassed various key note lecturers with a spectrum of expertise from genomics to cancer immunotherapy, to pant genomics and cancer signalling.

Young scholars presented their work as posters and an international panel of experts judged their scholarship for awards sponsored by journals of repute including Life, PLOS, FEBSJ and Journal of Cell Science. Young scientists got an opportunity to obtain career advice as well as interact with prospective employers as part of this job fair.

Prominent providers of sequencing solutions such as MedGenome and Illumina and various scientific journals and prominent names like Centre for the Commercialisation of Antibodies and Biologics, Agrigenome, Intel, Nanostring, Affymetrix etc., have partnered with SGRF for this conference.

EP News Bureau

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30 EXPRESS PHARMA October 16-31, 2016

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32 EXPRESS PHARMA October 16-31, 2016

(

R After a lull, the Indian clinical trial industry is likely to witness progress, due to a slew of regulatory measures adopted by the government. However, a lot needs to be done to position India a clinical trial hubs

BY USHA SHARMA

To subscribe: bpd.subscription@expressindia.com

THE MAIN FOCUS

ecent years have seen a slowdown of clinical trials in India in the wake of stringent directives from the Supreme Court asking the government and regulatory agencies to take measures to ensure safety of patients participating in clinical trials of new medicines.

Over the last year and a half, the Ministry of Health and Family Welfare has taken various steps to address the challenges posed by regulatory uncertainty. Regulations were amended and further guidance was given on existing ones.

India accounts 17 per cent of the global population and 20 per cent of the global disease burden but still accounts for a significantly low number of clinical-trials.

Suneela Thatte, President, Indian Society for Clinical Research (ISCR) informs, “For a country that has the second highest population in the world and the highest burden of disease, around 1.4 per cent of global clinical trials takes place in India (https://clinicaltrials. gov/ct2/search/map?map=SS).

That in itself is indicative of how under represented India is in terms of clinical research.

Besides a high patient population and a significant representation of diseases characteristics of both developing and developed economies, India also has well qualified English speaking investigators and good infrastructure. So, we have all the requisite requirements needed for clinical research.”

However, market reports explain that the situation was not so unfavourable for the Indian clinical research industry till 2010 from between 2004-10, many multinational and domestic pharmaceutical companies choose India as the preferred destination for conducting clinical trials. Then why did the situation turned so bad?

Kamal Shahani, MD, Clinminds explains, “New

regulatory framework and changes took a long time. This made leading global pharma companies feel uncomfortable as the cost escalated due to the flong waiting period, ultimately resulting in delay of global studies. Once companies leave any market, it is difficult for them to come back with new projects.”

So how badly was the clinical trial industry in India hit? Is it picking up now?

Apurva Shah, Founder and Group MD, Veeda Clinical Research apprises, “All the trials of new molecules are moving at a slow pace due to bureaucratic delays of the Subject Expert committee (SECs, formally known as New Drugs Advisory Committees). There is still a lack of clearly defined role for them and meetings are conducted at less frequency.” The frequency of their meetings as not sufficient.

Rebuilding trust Undefined regulation over the past few years have forced companies to conduct many clinical trials to move outside India which has impacted the industry's growth largely. What efforts should be taken into consideration to re-gain the position and build a trust under global business market?

Shahani suggests, “We need to provide a stable and predictable regulatory environment to multinational companies. This will be the most important step to win back the confidence.”

Advocating a more patient approach, Thatte says, “We cannot expect a dramatic reversal in the near term as the clinical research life cycle is a long drawn out one. In addition, rebuilding trust and confidence of global stakeholders in conducting clinical research in India is a long and slow process.

We will probably see normalcy restored in 2017-2018. What is important and reassuring, however, is that stakeholders are now beginning to re-look at India to place clinical trials.”

Two prominent steps taken

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cover ) Regaining trust and confidence is a long and slow process. It is the responsibility of all stakeholders to work collectively to ensure that we bring clinical trials back to India

Compensation guidelines are now clear, and reduces the ambiguity. Also, recent changes in mandatory audio video recording would help it further

In the current scenario, priority is to reassure the government and community at large about the standards adopted by the industry

Kamal Shahani

Apurva Shah

Suneela Thatte

Managing Director, Clinminds

Founder and Group MD, Veeda Clinical Research

President, ISCR

by the government, clinical trial compensation formula and mandatory audio video (AV) recording of the informed consent process provides some hope and stability to the industry.

Clinical trial compensation formula The government has already taken a few steps to give relief to the industry and announced compensation guidelines and mandatory audio video recording of the informed consent process. In December 2014, amendments were made to the Indian compensation guidelines by the regulators via a Gazette Notification No. GSR 889 (E) which became effective in June 2015. Many of the contentious clauses of the Rule 122 DAB of the Drugs and Cosmetics Act (released in January 2013) on compensation were addressed, making the regulation balanced and less prone to misuse and litigation. The revised guidelines rationalised compensation and medical management for injuries caused during and due to participation in clinical research, thereby balancing the interests of the patients and pharma innovators, while at the same time bringing clarity in the process.

Thatte informs, “For the first time in the world, formula have been introduced by the

34 EXPRESS PHARMA October 16-31, 2016

regulators for calculating the financial compensation based on no–fault principle. This not only provides ease of implementation and consistency but also helps the sponsor of the trial to understand the maximum possible liability and plan appropriately while protecting the patient well being.”

Shahani argues saying, “Compensation guidelines are now clear, and reduces the ambiguity. Also, recent changes in mandatory audio video recording would help it further.”

Mandatory AV recording With regards to mandatory audio visual (AV) recording, via a Gazette Notification dated July 31, 2015, the Ministry of Health and Family Welfare made amendments in the Drugs & Cosmetics Rules, 1945, to provide clarity on the nature of clinical trials where the informed consent process needed to be audio-visually recorded. Such recording is now necessary only for vulnerable patients and for trials involving new medicinal entities.

Thatte informs, “The regulators have been requested to issue a clarification on which patients will be deemed 'vulnerable' and what will qualify as 'new medicinal entity', so that there is no ambiguity in this regard. We expect this clarification in the near future.”

Shah while expressing his views on mandatory steps on this aspect says, “In the current scenario, priority is to reassure the government and community at large about the standards adopted by the industry. AV recording is a positive step ahead to build trust and confidence in clinical research industry in India.”

Exploring opportunities So will all these efforts help the industry move forward?

Regulatory reforms have started showing positive outcomes and the industry is slowly regaining its position. Shah informs, “There has been a rise in clinical trial activities. Various types of trials have different levels of risk and expertise and therefore have varied growth in India. Regulators have realised that they have to be differentiated and cannot be just put in one basket of clinical trials.”

He continues, “The BA/BE trials of old drugs on healthy volunteers has grown steadily due to the fact that the risk levels are very low. This is the strongest segment in India in terms of expertise and volume.

However, the patient trials for generics are not growing at the same pace due to the lack of full understanding from the regulators of the changing needs of the industry. This is the new wave of drugs and we need to move fast

to build expertise here. The risk level is relatively very low considering these are single dose trials of old drugs.”

Shah further elaborates, “The trials of biosimilars isn’t growing fast enough and this is a very bad thing. The segment is very promising and India cannot afford to lose the opportunity to gain a strong foothold in it. Being strong in this segment, will deliver a lot of social benefits because it can provide cheaper alternatives to very expensive international products for our population. I hope that all the stakeholders, right from the government to the volunteers, have realised that the world of research isn’t going to stop for India. If India wants to play a role in this industry (which is very important for us due to the huge disease burden which needs economical treatment), we need to attract clinical trials to our country. Price is not an attraction for the industry but reliability of data and predictability of timelines are the most important factors. We still have most of the ingredients that we had before to become an important centre for drug research and development.”

Shahani says, “For a country like India, it is important to have access to new drugs. This would require quicker regulatory approval process, both for clinical

trials and marketing authorisation. The clinical trial application (CTA) approval process should be faster and transparent. At present, CTA approval time frame is lengthy and unpredictable. Apex committee meetings should take place on a regular basis. Changes like accreditation of sites, investigators and ethics committees should be implemented on a priority basis to end the uncertainties.”

Collaborative approach According to the data available clinicaltrials.gov (as on 11/03/2015), 1.4 per cent of global clinical trials are currently carried out in India compared with 3.2 per cent in China, 1.5 per cent in the Czech Republic, 1 per cent in Turkey and 0.9 per cent in Thailand. Half of all the trials being conducted worldwide are based in North America, with the UK hosting 5.5 per cent of the trials.

Shahani suggests the growth prospect for the Indian clinical industry and says, “We need to reduce regulatory approval timelines. The government should constantly interact with the industry and other stakeholders to create a better dialogue-based environment We need to ensure that we provide a stable and predictable regulatory environment to pharma companies to encourage them

( to grow their investments in India.”

Thatte too opines, “Regaining trust and confidence is a long and slow process. It is the responsibility of all stakeholders to work collectively to ensure that we bring clinical trials back to India.”

Lessons learned A well constituted regulatory framework becomes a sign of stability and reliability to any country. However, the undefined regulatory framework of clinical trials industry had led to drop.

Commenting on the key learning from the mistakes, Thatte says, “A considerable drop in clinical research in India from 2013-2015 was therefore largely due to the uncertainty and unpredictability in the regulatory environment. The biggest learning for India that we need to have a clinical research agenda of our own and that regulations and guidelines should be determined with a focus on research, science and good governance and should not have knee jerk responses to judicial and social activism.”

Shah adds, “One-sided negative publicity due to ignorance of right procedures and systems can cause a lot of damage and therefore open communication and transparency from the industry will help to neutralise some of it. The ethical and social angle is very strong for our industry and therefore it is very important for all the stakeholders to understand it well.”

Moving ahead All the stakeholders of the Indian clinical trial industry seem optimistic about steps taken by the regulators. Frost & Sullivan estimates that the Indian clinical trial market was expected to achieve a double digit growth year-on-year (YoY) starting from 2008 till 2016.

Since the number of clinical trials in India have dropped, the possibilities of understanding and evaluation process of each clinical trial are likely to go up and ongoing trials may go through tough process. The

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issue has become so sensitive that even the Supreme Court of India has stripped the DCG(I) of its powers to approve clinical

trials as now there is a three-tier system for all trials. There is a subject committee of 10-12 members for each therapeutic

THE MAIN FOCUS

area, a technical committee, which has 20 members, and an apex committee. The application reaches the DCG(I)

only after approval from all three tiers.

Commenting on the move towards more rational guidelines,

cover ) Thatte says, “The strengthening of the regulatory-ethicaloperational framework for conducting clinical research in India has led to an ongoing process of streamlining and stability and we have seen several new orders and guidelines introduced over the last year.”

Due to a lack of streamlined regulations, the industry has already suffered a lot. However, India with a large pool of patients and disease profiles, the clinical research industry has an immense potential to grow. Today, the regulators have realised the need of streamlining regulatory process for making the Indian clinical trial industry an organised sector.

Shahani mentions, “Though it was good to learn from our own mistakes and find our own solutions, we could have adopted the internationally accepted best practices from the regulated matured markets of the US and Europe.

Regulatory approval process needs to change. The process is still extremely slow and complex in comparison to other markets, and this discourages major pharma companies.”

Shah expresses his concerns on the market which the country has lost due to undefined regulatory framework.

He says, “We have lost a huge market share to several Asian countries. These countries have grown at the expense of India.” He suggests, “We need to win back the confidence of the key global players.”

Due to a lack of streamlined regulations, the industry has already suffered a lot. However, India with a large pool of patients and disease profiles, the clinical research industry has an immense potential to grow. Today, the regulators have realised the need of streamlining regulatory process for making the Indian clinical trial industry an organised sector

An uphill task There is a still a long way to go for the Indian clinical trial industry. How can companies pursue this opportunity and win the confidence of global pharma players to bring clinical trials to India especially when the country (India) has such a vast patient pool and resources?

In reply to this, Thatte replies, “I would like to quote from a recent interview with the DCG(I) where he says, “I can tell you with certainty that India is ready to do extremely

36 EXPRESS PHARMA October 16-31, 2016

good work in clinical trials now. We have created a platform through which India will become a preferred destination for clinical trials. In the next eight to 10 years our contribution to the global clinical trial industry should be at least 10 per cent. That's the plan.

This will create a huge job opportunity. It will also result in huge skilled manpower for drug discovery research, where exactly India’s true strengths lie.”

She feels that, “This is a very encouraging statement coming as it is from our regulatory authorities and we are confident that we now have a more robust regulatory framework and a government committed to bring clinical research back on track in India.

Clinical research in our country is a health imperative and important to the progress of the health of our people and the economy. We need a robust, regulatory framework

that ensures that clinical research is conducted in a fair and transparent manner, safeguarding the interests of patients while keeping in line with the basic tenets of science.”

Shahani believes that India has the potential to attract global clinical trials to India.

He informs, “India has a talent pool of qualified and experienced medical professionals and scientists, diverse patient pool, globally competitive

infrastructure, certain cost advantages and presence of all key global pharma companies.

This makes India an attractive destination for clinical trials.”

While signing off, Shah mentions, in response to Indian Prime Minister Narendra Modi’s plan to make it easier to do business in India, the health ministry proposed pre-submission meetings in a bid to enable technical deliberations between stakeholders and drug regulators. The meetings will take place before drug companies make a formal application for clinical trials. The move is expected to enhance efficiency in the sector, given its muted growth over the past two years, and increase transparency, predictability and accountability.

Following the right steps will signal a healthier and transparent business environment for conducting clinical trials in India. It may not immediately get reflected on paper but things seem to be headed in the right direction finally. u.sharma@expressindia.com

MANAGEMENT

Pushing the boundaries of communication in pharma Shailesh Dudani, Chief Sales Officer, Flock, an enterprise messaging app for teams gives an insight on how pharma companies can adopt better technology to change the way they communicate

A

s global markets begin to evolve, mediums of communication and collaboration are also evolving at a steady pace. Statistics prove that the Indian pharma industry ranks third in terms of volume, globally. And herein lies an incredible opportunity for pharma companies to adopt better technology to change the way they work and communicate.

It is no longer viable for companies to rely solely on face to face conversations, or

SHAILESH DUDANI, Chief Sales Officer, Flock

to invest their time in lengthy phone calls during work hours. More often than not, emails are not an ideal fit for addressing time sensitive issues. As ‘instant’ is the new norm and everything happens on-the-fly, pharma and healthcare industries are also moving to smarter communication methods. Therefore, it is imperative to understand and adopt collaboration mechanisms that accomplish tasks faster and with more efficiency.

For an industry that is so immensely indispensable, here are a few tips they could use while adopting better communication methods:

Team communication and collaboration While addressing the exigent demands of the pharma industry, it is possible that more redundant methods of communication might slip through the cracks. The medical demands of this set of businesses need immediate attention and action. The demand and supply chain of

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MANAGEMENT these companies are more ad hoc than other industries, and hence need real time attention. Therefore, team messaging apps serve as a one stop solution that serves the ad hoc needs of this industry.

With everyone available on the go on a single platform, all stakeholders are always kept on the same page.

Addressing research and development needs To sustain in a digital world, the R&D department in a pharma company needs to aim for seamless processes, real time communication and transparency. It is vital for the key members from sales and operations to be aware about drug development pipelines and clinical-trials. Most of the R&D documents are highly confidential, and security is of highest concern for pharma companies. What makes enterprise collaboration tools highly suitable for critical file sharing is that most of the industry players like Teamchat and Flock follow the highest security and encryption standards in the industry today.

For instance, Flock has industry standard TLS 1.2 data encryption, and is hosted on secured AWS data centres. If required an on-premise infrastructure can be established as well.

To sustain in a digital world, the R&D department in a pharma company needs to aim for seamless processes, real time communication and transparency Instant collaboration for sales teams Medical sales representatives are often required out in the field, as they travel to speak to

the key decision makers of the pharma industry. Nevertheless, they need to be in constant touch with their back end office. Hence, accessibility

across platforms and on various operating systems is crucial for teams that function onthe-fly. Team messaging tools empower managers to get immediate sales updates, collate timely data and make instantaneous decisions. Endless threads of emails with subject lines like ‘Urgent: Please respond ASAP’, or morning team meetings no longer make the cut. Enterprise communication apps are also beneficial for sales representatives, as unified collaboration and communication apps enable them to be better informed and connected. It also helps them to coordinate with their peers and managers for quick resolutions. Since, in sales it is all about achieving targets, it is highly imperative that the entire team remains unified to take faster decisions.

Staying connected with key stakeholders Pharma companies are often known to control both creation and propagation of product related information. However, it is important that they adopt capabilities to track progress and performance of drugs. Being connected with important stakeholders like medical specialists or even healthcare centres will enable them to react to issues and avoid misinterpretations

of data.

With a plethora of communication options for corporates to adopt, they’re basically spoilt for choice. Skype for business, Team Chat, Hipchat and Flock are just a few of these big names. Flock, an Indian team communication platform, is enriched with amazing features such as video conferencing, to-dos, reminders and screen sharing.

Companies across industries are adopting Flock to revolutionise their professional collaboration needs.

1mg (previously known as Healthkart), the e-pharmacy marketplace is one such known name in the industry that has adopted Flock. “I'm one of the power users of Flock here at 1mg. Flock is convenient and real time and is making communication seamless and easy. My entire team today is on Flock,” says Prashant Tandon, CEO and Co-founder of 1mg.

Flock also caters to the team collaboration needs of Ziggy and Universal Medicare, in this industry.

Considering the rate at which the business world is adopting apps for their needs, it is only a matter of time before enterprise messaging apps become indispensable for pharma and healthcare companies.

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

❒ We welcome information on new products and

regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industryaccepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant.

services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph.

Preferably in colour, postcard size and with a good contrast.

38 EXPRESS PHARMA October 16-31, 2016

Email your contribution to: The Editor, Express Pharma, Business Publications Division,

The Indian Express (P) Ltd, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021.

Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 viveka.r@expressindia.com

MANAGEMENT

Start-ups and pharma industry Poorvi Sanjanwala, Partner and Zil Shah, Associate, Rajani Associates, give an overview on the growth drivers in the pharma industry and the role of start-ups in furthering progress THE INDIAN pharmaceutical industry has been growing phenomenally. It is globally ranked third in terms of volume and 14th in terms of value1.

Nearly 70 to 80 per cent of the Indian market2 is constituted of branded generics. Apart from being a front runner on the home ground, India is also the largest provider of branded generic drugs globally, with Indian generics accounting for 20 per cent of global exports in terms of volume3. The Indian pharma industry, which is expected to grow over 15 per cent

POORVI SANJANWALA Partner, Rajani Associates

ZIL SHAH Associate, Rajani Associates

per annum between 2015 and 2020, is also expected to outperform the global pharma industry, which is set to grow at an annual rate of five per cent between the same period.4 The pharma sector is highly sensitive and hence is subjected to significant control and regulation, right from the manufacturing stage to its marketing, promotion, storage and consumption.

Critical licences to set up a pharma business in India The most critical licence for setting up a pharma business in India is the drug licence from the Food and Drug Administration (FDA) department. The Central Drug Stan-

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MANAGEMENT Opportunities to look out for

dard Control Organization (CDSCO) and the State Drug Standard Control Organization (SDSCO) control the issue of drug license in India.

Separate licences are required for every plant where the drug is being manufactured, and also for every type of product (such as tablets, syrups, injections etc).

Moreover, in order to import or export drugs in India, a person must have an Import Export Code (IEC) number. It is obtained through registeration as an importer or exporter. The number is received from the office of the Director General of Foreign Trade.

Apart from these, standard licences are required for an entity to operate any business in India (e.g. PAN/TAN/local licences).

Growth prospects According to data from the Ministry of Commerce and Industry, India has maintained its lead over China in pharma exports with a year-on-year growth of 7.55 per cent to $12.54 billion in 20155. India is clearly enjoying an important position in the global pharma market. With a large pool of human resources (both qualified and unqualified) and the gradual efforts put in by the Government of India, there is potential to steer the industry to a higher level. Relaxations in foreign direct investments in India are also expected to provide an impetus to the growth of this industry.

Bulk drugs or active pharma ingredients6 are those components in a medicine that gives it the therapeutic effect.

Up until the year 2000, foreign direct investment (FDI) was allowed up to 74 per cent in the case of bulk drugs, their intermediaries and formulations under the approval route. Any FDI which exceeded this threshold was considered on a case-to-case basis for (i) manufacture of bulk drugs from basic stages and their intermediates; and (ii) bulk drugs produced by the use of recombinant DNA technology as well as specific cell/tissue targeted formulations, provided it involves manufacturing from basic stage7.

40 EXPRESS PHARMA October 16-31, 2016

The pharma sector was unbolted for 100 per cent FDI in the year 20018 making India an attractive destination for investments. This relaxation coupled with India’s low cost of production, availability of skilled workforce, lower cost of labour, rising levels of education resulting in increased health awareness, increase in patient pool, etc. has aided in an unprecedented growth of this industry.

Further, with escalating growth, the sector was placed under the Special Focus Sector for National Manufacturing Policy, 2011 as it enjoyed com-

company engaged in pharma activity.

Up until 2016, FDI in pharma sector was permitted to the extent of 100 per cent under the automatic route for greenfield investments and FDI in brownfield11 investment was permitted to the extent of 100 per cent under the approval route. The only condition for foreign investment in this sector was the non-allowance of non-compete clauses in both routes of investment. Such clauses were allowed only in special circumstances, with prior approval of the FIPB. This restriction has

greenfield investments. Apart from restriction on the inclusion of a non-compete clause which was present earlier, additional conditionalities with respect to brownfield investments have been introduced. FDI in brownfield investment, under both automatic and government route, is subject to maintaining the production levels of National List of Essential Medicines (NLEM ) drugs, consistency in research and development (R&D) expenses and providing complete information about technology transfer to administrative

Sector: DRUGS & PHARMACEUTICALS Year

Amount in ` crores ($ in millions)

2013-14 (April - March)

7,191 (1,279)

2014-15 (April-March)

9,052 (1,498)

2015-16 (April,15 – March, 16)

4,975(754)12

parative and competitive advantage.9 From then on, the concept of greenfield and brownfield investment were introduced vide Press Note 3 of 201110.

Greenfield investment is foreign direct investment in a new pharma venture in India whereas brownfield investments refer to foreign direct investments in an existing

been reserved in order to protect domestic companies.

With a recent amendment by way of a Press Note 5 of 2016, released by the Department of Industrial Policy and Promotion (DIPP), 74 per cent FDI is now allowed in brownfield investment under the automatic route. 100 per cent FDI will continue to be allowed under the automatic route for

authorities.

The fine print to this relaxation has been released with some conditionalities. Considering that conditions levied on FDI in brownfield investment has been relaxed, one can still expect to see a significant increase in mergers and acquisitions (M&A), private equity transactions and entry of new players in the pharma space.

In any industry, growth and sustainability assume importance. The pharma industry will also need to focus on improving operational facilities and productivity which will have to be achieved without triggering any consequential cost increase which may then result in increase in prices. India is highly dependent on China for bulk medicines, nearly 75 per cent of its bulk drugs come from China13. The Government of India had decided to come up with a policy which would help boost manufacturing of bulk drugs. This would have not only reduce our dependence on China but also help in advancement of the domestic pharma sector. However, it appears that the government is now intending for the states to come up with bulk drug parks which will help boost manufacturing of bulk drugs14.

Research is a vital aspect of the pharma industry. In the Union Budget 2015-16, the government has provided various incentives for industry/ private sponsored research programmes like a weighted tax deduction to assesses under section 35 (2AA) of the Income Tax Act as well as a weighted deduction of 200 per cent for any sum paid to a national laboratory, university or institute of technology, or specified persons with a specific direction, subject to certain conditions. Further, there is a separate provision for benefits to companies engaged in manufacturing with in-house R&D centers under section 35 (2AB) of the Income Tax Act for both capital and revenue expenditure incurred on scientific R&D15. Such incentives pave the way for more development and expansion. Amongst the new entrants in the field of R&D is Vitas Pharma.

Incorporated in 2011, it has involved in drug discovery and development16.

The hiccups Every industry has its own strength and weakness, and the pharma industry is no different.

India’s pharma industry has grown to become a global

MANAGEMENT competitor. However, in recent years, Indian companies have been facing credibility issues in terms of manufacturing practices, quality etc. with the US-FDA17.

Start-ups have been exploring the e-commerce space in the pharma industry, for instance, the online pharmacies concept. However, ambiguity about whether online pharmacies can exist and operate in the space that they currently operate persists. This necessitates the need for defined clarity in the form of a regulatory framework.

There is no doubt that the pharma industry has major growth opportunities, however, pharma companies will have to revamp their business strategies to increase as well as sustain growth levels. They will also need to adopt innovative or refined business models. Progress in medical and mobile technology has the ability to provide further impetus for growth of the pharma industry. Though the pharma industry may face certain legal issues, it also has tremendous potential to grow manifold and continue to participate in enhancing global confidence in India’s growth story.

References 1. Report by Business Standardhttp://www.business-standard.com/content/b2b-chemicals/success-strategies-for-indian-pharma-industry-in-an-u ncertain-world114021701557_1.html 2. http://www.ibef.org/ industry/pharmaceutical-india.aspx 3.http://www.makeinindia.com /sector/pharmaceuticals 4. http://www.ibef.org/industry/ pharmaceutical-india.aspx 5. http://www.ibef.org/industry/ pharmaceutical-india.aspx 6. Schedule M part 1F 7. Press note 2 of 2000 8. Press note 4 of 2001 series.

Provided the activity does not attract compulsory licensing or involve use of recombinant DNA technology, and specific cell / tissue targeted formulations.

FDI proposals for the manufacture of licensable drugs and pharmaceuticals and bulk drugs produced by recombinant DNA technology, and specific

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cell / tissue targeted formulations required prior Government approval 9. Press note 2 of 2011 series 10. http://dipp.nic.in/English/ acts_rules/Press_Notes/pn3_20 11.pdf 11. Vide press note 3 of 2011, a Brownfield company means an

existing company 12. http://dipp.nic.in/English/ Publications/FDI_Statistics/2016/FDI_FactSheet_JanuaryFebruaryMarch2016.pdf 13. http://www.livemint.com /Industry/QqSWwdIchcS59r1o Ab1WvN/What-pharma-willlook-like-in-2016.html

14. http://www.business-standard.com/article/economy-policy/no-bulk-drug-policyananth-kumar-116082901082_1 .html 15.http://www.makeinindia.com / sector/pharmaceuticals http://articles.economictimes.indiatimes.com/2015-01-

18/news/58200765_1_drugdiscovery-indian-angel-network-antibiotic-resistance 16. http://articles.economictimes. indiatimes.com/ 201603-16/news/71573260_1_indianpharmaceutical-alliance-fdaissues-us-fda

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MANAGEMENT

Digitalisation of pharma industry Mudit Vijayvergiya, Co-founder, Curofy, speaks on the advancements of technology and the revolution it is bringing about in the pharma industry

DIGITAL REVOLUTION is here and in a big way. It has in a way revolutionised the way we go about our daily business. We don’t catch up with our friends in a coffee shop, we Whatsapp them. We don’t stand on a walkway waiting for the next cab to arrive, we book an Uber. We don’t shop at a mall instead we will get it from Amazon. In every aspect of life, digitalisation is involved also. Beyond the realms of an individual life, industries are being defined by their adoption of technology.

The Ubers, Amazons, the Air BnBs of the world have truly disrupted industries and have made lives of the people infinitely better.

However, the pharma industry has been able to resist the temptation of riding the digital wave for long now. This in no way gives us the right to tag them as technology laggards. In fact, the reality is quite the opposite. They have been early adopters of technology in many aspects. Their Internet adventures can be dated back to 1996. 24 X7 rep visit was an initiative that was aimed at reduction of sales force. However, that failed.

Sites like WebMD do indicate that the intent was always

42 EXPRESS PHARMA October 16-31, 2016

there, but the doctors, the focal point of the healthcare ecosystem never went digital.

And hence the entire industry was branded as a late adopter.

Meaning of digitalisation It is almost trivial to ask ourselves this question. However, the crux is simpler than we think. Digitalisation is bringing an offline phenomenon online. It’s that simple. This basic bare bones definition holds true for any industry as well.

Today, customer engagement happens on Facebook. Twitter is the preferred channel to listen to what your customers think about you. Even interviews happen over Skype, and dates on Tinder. Wherever you look today, whatever we do, we have an alternative in the palm of our hands. Hence the activities, which used to happen offline, have now shifted to online platforms.

Market dynamics One of the major markets out there for digital wave to kick in is the consumer healthcare market. A market that calls for direct to consumer marketing. It is a four billion nascent and ever-growing market that is waiting in the wings for

MUDIT VIJAYVERGIYA, Co-founder, Curofy

the digital marketers to take advantage of. Right from the very inception of the idea of the drug to the brand perception, customer engagement and social listening could hold the key to arrive at actionable inputs. This can reduce the efforts of the offline team to painstakingly collect data.

The best part here is that the consumer is already online.

Hence, it makes a lot of sense to shift the direct-to-customer marketing to online. Digital platforms can give the pharma marketers ample opportunity to market products more effectively and at a fraction of a cost. It’s no wonder that YouTube is slowly taking over from TVCs for the social animals. This is in line with how a heavy spending FMCG industry took digitalisation seriously and using it for their own advantage. Today, FMCG companies spend an average of 12-15 per cent of their mar-

keting budget in digital technonogy. However, there are some companies who are already spending 30 per cent or above on the technology.

That being said, for pharma companies, the marketing towards doctors takes the brunt of the budget.

Hence for them the latter has to be brought online. They spend on an average 20-25 per cent of the sales towards reaching out to doctors which is roughly $4 billion out of $16 billion pharma industry today.

Taking analogies with other industries, if doctors are online, at least 10-15 per cent of this $4 billion will go online in next four to five years.

Status: Present and future Digital marketing is merely an extension to orthodox methods and makes up for one to two per cent of their marketing budget. It’s time it increases.

Doctors are slowly but surely waking up and taking notice of digital platforms.

The pharma industry is already taking baby steps towards it. And the possibilities are immense. Digital platform makes the inaccessible accessible. For example, Facebook

has not only redefined the way we interact today, but also the way we think about various products.

From market research to brand recall, to brand building to e-detailing, every function can be moulded in the form of buttons. Think webinars and you get ‘Register now’ button for a doctor. Think scientific contentment or detailing and you get ‘Learn more’ as the action button for a doctor.

Market research, competitive intelligence, quick feedbacks will be converted into a few buttons for doctors on the digital platforms. With mushrooming of niche networks like Doximity, Sermo, Curofy and Figure 1, doctors are taking a liking towards it. The time is right for pharma big guns to embrace the digital makeover.

Pharma industry needs to take a RoI-driven approach to penetrate deep in the markets. With regulations taking its toll, going digital will go a long way in reducing the burden on these companies. Who knows it might turn out to be the ultimate marketing avenue for them. Today, digital marketing is merely a platform change from bill boards to laptop and mobile.

MANAGEMENT REPORT

Cardiovascular disease market set to grow to $146.4 bn by 2022: GBI Research THE CARDIOVASCULAR disease market, which includes hypertension, dyslipidemia, and thrombotic events, is set to grow from $129.2 billion in 2015 to $146.4 billion by 2022, at a very modest compound annual growth rate of 1.8 per cent, according to GBI Research.

The company’s latest report states that this relative stagnation can be attributed to major product approvals coinciding with key patent expirations.

Within cardiovascular disease there are a number of blockbuster products that have recently gone off-patent, and others are expected to in the coming years, many of which belong to significant players.

For example, the current market leader, AstraZeneca’s Crestor (rosuvastatin), generated around $7 billion in 2011, with revenues expected to drop sharply following the expiration of its patent on July 8, 2016. Total annual revenues are forecast to be around $1.3 billion in 2022.

Thomas Jarratt, Associate Analyst, GBI Research, explains, “Unlike AstraZeneca, some key players will experience revenue growth resulting from the introduction of new products to market. In particular, Sanofi’s Praluent (alirocumab) is expected to help mitigate losses associated with falling revenues of its key products Lovenox (enoxaparin) and Plavix (clopidogrel). Novartis’ heart failure drug Entresto was introduced to market in July 2015, and GBI Research expects its revenues to increase dramatically during the forecast period.

Entresto is a combination drug which has shown efficacy shown in clinical trials. Coupled with a high cost, which amounts to over $4,500 annually per patient, the drug contributes to a very high revenue forecast of $5.7 billion by 2022.”

EP News Bureau

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RESEARCH I N T E R V I E W

Linezolid directly affects the ability of the mitochondria to produce energy Dr Salil Mehta, Volunteer and Consultant Ophthalmologist with MSF, recently published a paper on optic neuropathy in DR-TB patients in Mumbai. He discusses key takeaways of his research with Sachin Jagdale

Any specific reason behind selecting patients from Mumbai for Linezolid associated optic neuropathy in DR-TB patient study?

There is a combination of reasons. Firstly, MSF has an excellent and a wellestablished TB/HIV clinic in Mumbai. Hence, the expertise is available. Secondly, and more importantly, Mumbai is a global hot spot for tuberculosis (TB). A perfect storm of several factors including extreme population densities, incorrect treatment and poor compliance are leading to high incidence of primary drug sensitive TB and subsequent drug resistance. Worryingly, an increasing number of patients are presenting with primary drug resistant tuberculosis.

This makes Mumbai an ideal city to undertake such a study.

Can you take us through this entire study. (How and why was it started? Have you managed to achieve your targets?)

Ever since the use of linezolid

44 EXPRESS PHARMA October 16-31, 2016

became wide spread, available literature suggested potential ocular toxicity. Accordingly, the staff and doctors of MSF conducted primary screening and evaluation for all these patients. Suspect cases were then referred for further evaluation. These patients were fully evaluated, treated and followed up till resolution.

It's an ongoing process and hopefully in a few years we will have more data for more research.

What was the role of Lilavati Hospital and Research Centre in this study?

As I mentioned previously, MSF referred suspect cases for further evaluation. These patients were sent to Lilavati Hospital which provided the facilities for treating these patients.

How does HIV as a coinfection decide/affect the level of optic neuropathy?

HIV per se can cause optic nerve disease. This most likely is due to a direct effect of the virus on the cellular

components of the nerve.

While HIV positive patients have a very high rate of developing systemic TB, the development of optic nerve disease in these patients is due to either TB meningitis, encephalitis or due to drug toxicity caused by ethambutol or linezolid. However, exact correlates will need a larger sample size.

Will the outcome of this study have a universal application, since the patients with varied gene pools and ethnicity will be showing different response to linezolid?

We believe it will. With alarming levels of drug resistance, the use of linezolid will increase and also the number of patients potentially at risk of toxicity. So far, world wide data suggests that all ethnicities are at risk. We need more research to suggest whether certain ethnicities or geographies may be more at risk due to genetic influences or local factors such as nutrition etc.

Linezolid has come off the patent and its consumption is definitely going to increase in future. What are the chances of TB strains becoming resistant to linezolid as well?

Mumbai is a hot spot for the development of resistance to a wide range of antibiotics which is not only restricted to anti-TB drugs. The development of resistance leads to poor recoveries, which act as demotivating factors for patients to continue the treatment even after therapeutic measures have been undertaken. Given this scenario resistance to linezolid is very likely. Various factors including poor compliance, resource depletion and even systemic factors contribute to resistance to linezolid.

Is optic neuropathy a Linezolid-specific adverse effect? Which are the alternatives to this antibiotic?

Linezolid directly affects the ability of the mitochondria to

produce energy. This is most apparent in the optic nerve but affects a wide range of tissues. Commonly affected are the bribes, especially the peripheral nerve where neuropathy occurs.

Alternatives will have to be chosen based on the results of culture studies.

How are you going to use the results of this study to frame the future course of treatment?

Patients on linezolid need regular visual screening, early interception and treatment.

Early screening allows us stop the drug, initiate treatment early and follow up with the patient. The early detection of patients in our case helped full recoveries. With this protocol, it may be possible to reduce the incidence and severity of toxicity. Staff at outreach clinics should be trained to conduct basic visual screening. This may be during the follow-up interview or by the use of simple devices. sachin.jagdale@expressindia.com

UPDATES

Spectrum bladder cancer drug not effective: US FDApanel The agency is scheduled to make its decision by December 11, 2016 SPECTRUM Pharmaceuticals’ experimental bladder cancer treatment apaziquone is not effective in delaying the time to recurrence of the disease, an advisory committee to the US Food and Drug Administration concluded. The committee, which convened to advise the FDA on whether to approve the drug, voted unanimously that the treatment has no more effect on the disease than a placebo over a two-year period.

The FDA is not obliged to follow the advice of its advisory committees but typically does so. The agency is scheduled to make its decision by December 11, 2016. Apaziquone is inserted directly into the bladder following surgery to remove tumours.

In 2012, two late-stage clinical trials failed to meet their main goal. The company subsequently initiated a new late-stage trial which it said incorporated input from the FDA and included pooled data from its two previous trials. The pooled data, as opposed to data from individual trials, showed a reduction in disease recurrence over two years.

The new trial protocol called for patients to be given either one instillation of the drug, or two, or a placebo. In the previous late-stage trials all patients received just one installation or a placebo. Apaziquone is activated by enzymes that are over-expressed in bladder cancer cells.

Most bladder cancers are treated with surgery, either alone or with other treatments.

Surgery can often remove early stage bladder tumours, but new tumours frequently form in other parts of the bladder. Some 80 per cent of patients experience a recurrence within five years, many within two years.

Removing the entire bladder avoids this but the procedure can have a significant impact on a patient's quality of life.

Reuters

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RESEARCH

GSK shingles vaccine remains effective after four years: Study The company plans to file for US, European and Japanese approval this year, and the vaccine could reach the market in 2017

Experts in Pharmaceuticals, Cosmetics and Nutraceuticals Products

GLAXOSMITHKLINE'S (GSK) experimental vaccine to prevent the intensely painful condition known as shingles remained 90 per cent effective in people over age 70 even four years after receiving the injection, according to data published. In clinical trials, GSK’s Shingrix has shown greater protection for older recipients than what has been demonstrated by Merck & Co's rival Zostavax vaccine. The drug is one of GSK’s biggest new product hopes. It plans to file for US, European and Japanese approval this year, and the vaccine could reach the market in 2017. The latest four-year data on Shingrix, which appears in the New England Journal of Medicine, shows it may also provide an additional significant advantage by maintaining its effectiveness over time.

"It's a real step forward for vaccinology for elderly patients," the study's lead author, Dr Anthony Cunningham of the Westmead Institute for Medical Research in Australia, said. Zostavax efficacy declines with age, dropping to only about 18 per cent in adults over 79 versus 70 per cent for people in their 50s. A Kaiser Permanente study found it was 69 per cent effective in patients age 60 and older, yet only 4.2 per cent remained protected seven years later. Researchers found no

46 EXPRESS PHARMA October 16-31, 2016

such drop with GSK's vaccine in the study of 13,900 volunteers over age 69.

"Although the follow-up period was limited to four years, there was little decline in effectiveness in the years following vaccination," said Dr Susan Rehm, VC of the department of infectious disease, Cleveland Clinic, who was not involved in the study. GSK had previously reported 90 per cent protection with Shingrix in recipients over age 69. It worked as well among people in their 70s as it did in people in their 80s and 90s, and that effectiveness "was maintained for the duration of the trial," said Dr Kathleen Neuzil of the University of Maryland School of Medicine and Dr Marie Griffin of Vanderbilt University Medical Center, in a Journal editorial.

It also protected against residual pain caused by shingles in 89 per cent of cases.

The risk of shingles, which is caused by reactivation of the chicken pox virus, increases with age. There are about 1 million cases of shingles in the US each year, according to the Centers for Disease Control and Prevention.

The vaccine contains a component from US biotech Agenus, which is entitled to royalties on future sales, but no live virus.

Reuters

RESEARCH

Merck scraps development of osteoporosis drug Heron’s Sustol can protect patients for five days MERCK & CO said it would stop developing its experimental osteoporosis drug after an independent analysis confirmed the treatment raises the risk of stroke. While the drug, odanacatib, reduces the risk of osteoporotic fractures, the increased risk of stroke in a latestage study in postmenopausal women does not support further development or regulatory approval, the company said.

Osteoporosis, which means "porous bone", occurs when bones become weak and brittle.

About one in two women and

Astrazeneca’s Forxiga combination beats use of drug alone ASTRAZENECA SAID combining its Forxiga type-II diabetes drug with older medicine Bydureon was more effective at controlling blood sugar levels than treatment with either drug on its own. In a late stage trial, Forxiga and Bydureon were tested on patients whose blood sugar levels could no longer be sufficiently kept in check under an initial standard diabetes therapy with metformin.

The combination therapy led to a 1.95 per cent reduction in HbA1c, a measure of longterm blood glucose levels, better than the 1.58 per cent and 1.37 per cent reduction from using Bydureon and Forxiga on their own, respectively.

The drug combination was also shown to be better in terms of the secondary study goals weight loss and blood pressure reduction.

Reuters

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October 16-31, 2016

up to one in four men aged 50 and older will break a bone due to osteoporosis, according to

the Virginia-based National Osteoporosis Foundation. Merck had said in 2014 that treatment

with the once-weekly odanacatib had resulted in higher cases of stroke versus

placebo in the key late-stage study.

Reuters

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RESEARCH

Asterias stem cell therapy shows promise in spinal cord paralysis: Study Three months after the cells were implanted, the study met its efficacy goal of two patients regaining return of two motor levels of functioning on at least one side of their body AN EXPERIMENTAL stem cell therapy developed by Asterias Biotherapeutics restored some movement to patients paralysed by recent spinal cord injuries, according to interim data from a small study being presented. One of the five patients in the trial regained use of both arms and hands, and is now able to feed himself, send texts on a phone and operate a wheelchair, the Fremont, Californiabased company said. Three months after the cells were implanted, the study met its efficacy goal of two patients regaining

unique capabilities to combat various medical conditions, including paralysis and heart failure.

"I am very encouraged by this first look at efficacy data in complete cervical spinal cord patients," Dr Shekar Kurpad, a trial researcher and Director, Spinal Cord Injury Center, Medical College of Wisconsin, said in a statement. The company had not expected to reach the efficacy goal before six to 12 months after implantation of the 10 million embryonic stem cells dubbed AST-OPC1, Asterias

return of two motor levels of functioning on at least one side of their body, the company said.

All five people in the study have experienced some upper extremity improvement so far, Asterias said. Each motor level function measurement correlates with a reduction in the assistance and care a paralysed patient might require. A two-level improvement can mean a patient is able to live more independently.

The cells are injected by a neurosurgeon directly into the site of the spinal cord damage within two to four weeks of injury, before scar tissue forms. The hope is that they can help restore signals from the brain through the spinal cord to the outer extremities. Stem cells are able to transform into various other types of cells in the body, and scientists have been working for years to try to harness their

Chief Executive Stephen Cartt said.

"We came out early with the data because it was so compelling. We were expecting to wait until January," Cartt said, acknowledging that the work is still in the early stages and that it is a very small study. The interim results were presented at the International Spinal Cord Society meeting in Vienna, Austria.

There were no reported serious adverse side effects related to AST-OPC1 or the injection procedure, Asterias said. The company has secured regulatory approval to double the dose to 20 million cells in future studies. The five patients will be followed and assessed for 12 months. "It's certainly our hope that we see at least that these gains are maintained, and we hope to see continuing improvement," Cartt said.

Reuters

48 EXPRESS PHARMA October 16-31, 2016

RESEARCH

J&J psoriasis drug tops placebo,Humira in late stage study More than 73 per cent of patients who received guselkumab experienced near complete skin clearance compared with 2.9 per cent those who received a placebo AN EXPERIMENTAL biotech drug developed by Johnson & Johnson proved more effective at clearing moderate to severe cases of the skin condition plaque psoriasis than a placebo or Abbvie’s big-selling Humira, according to data from a late stage study presented. The J&J drug, guselkumab, met the trial's primary goal, demonstrating statistically significant superior efficacy after 16 weeks of treatment and maintaining its advantage through week 48.

More than 73 per cent of patients who received guselkumab experienced near complete skin clearance compared with 2.9 per cent those who received a placebo. In the Humira group, nearly 50 per cent of patients saw near complete skin clearance. "These responses were durable and maintained through week 48," Dr Andrew Blauvelt, lead researcher of the Phase III trial from the Oregon Medical Research Center, said. “Guselkumab also showed superior efficacy compared with adalimumab, with a separation in responses that was evident at week 16 and continued through the duration of the trial,� added Blauvelt, using the chemical name for Humira.

Humira, which also treats rheumatoid arthritis and other autoimmune conditions, is the world's top-selling prescription medicine. The J&J drug also scored higher than placebo or Humira in an assessment of the treatment's effect on quality of life, researchers reported. The data was presented at the European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria.

"The high and durable rates of response in skin clearance were associated with significant improvements in quality of life among patients treated with guselkumab," Professor Chris Griffiths, a member of the study's steering committee, said.

Serious adverse side effects, including some serious infections, were reported in 2.4 per cent of guselkumab patients, 1.8 per

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October 16-31, 2016

cent of those who got Humira and 1.7 per cent in the placebo group. Psoriasis is a chronic, au-

toimmune inflammatory disorder that results in sometimes painful, unsightly scaly and in-

flamed skin patches. An estimated 125 million people worldwide have psoriasis,

according to the National Psoriasis Foundation.

Reuters

RESEARCH

Novavax vaccine for respiratory disease fails in late stage trial The trial was intended to show that the Novavax vaccine could prevent moderate to severe respiratory syncytial virus ABOUT 40 per cent of chronic migraine sufferers taking an experimental drug developed by Novartis and Amgen saw the number of days they suffered a migraine cut by at least half, beating the placebo in the trial. The latest analysis from the mid-phase study amounted to a 'statistically significant reduction in monthly migraine days,' Novartis said about the experimental AMG 334 compound.

Novartis has struck pacts

with its US-based rival Amgen to develop migraine and Alzheimer's treatments as it seeks to bolster its neuroscience portfolio. "These important data further support the efficacy of AMG 334 in patients who currently have limited therapeutic options," said Vasant Narasimhan, Global Head of Drug Development and CMO, Novartis. The release follows data from June showing AMG 334, whose generic name is erenumab, had achieved its main goal of

reducing the number of monthly attacks, regardless of dosage, compared to a placebo.

According to the latest analysis of the 667-person phase II study, 40 per cent of those taking a 70 milligram (mg) dose and 41 per cent of those on a 140 mg dose saw the number of days they suffered a migraine cut by at least half.

Only 24 per cent of those getting the placebo drug had a similar reduction. “This is part of ongoing

research,� a Novartis spokesman said. "We are continuing to analyse the data from the chronic migraine trial and across the entire AMG 334 (erenumab) programme in an effort to better understand who will respond."

Novartis is also studying AMG 334 in people suffering from episodic migraines. The safety

profile for erenumab was similar to the placebo group. Under the collaboration agreement with Novartis, Amgen holds sales rights for the US, Canada and Japan, while Novartis would sell the drug in Europe and the rest of the world, if it wins regulatory approval.

Reuters

Merck’s drug offers big benefits in untreated lung cancer Keytruda halved the risk of disease progression and cut overall deaths by 40 per cent compared to chemotherapy MERCK & Co scored a double hit with new clinical data showing its Keytruda immunotherapy offered big benefits in previously untreated lung cancer patients, either when given on its own or with chemotherapy. As a monotherapy, Keytruda halved the risk of disease progression and cut overall deaths by 40 per cent compared to chemotherapy alone in pre-selected patients whose tumours had been tested using a biomarker. And when given with two older chemotherapy drugs in non-selected patients, it was almost twice as likely to shrink tumors as chemotherapy alone.

Another similar drug from Roche also demonstrated broad

50 EXPRESS PHARMA October 16-31, 2016

efficacy as a so-called secondline option in patients who had received prior treatment. "Remember this day. It's a new day for lung cancer treatment," Stefan Zimmermann of Lausanne's University Hospital told reporters at the European Society for Medical Oncology (ESMO) congress as the results were presented.

An editorial in the New England Journal of Medicine, where the Merck monotherapy results were published, said Keytruda could become "a new standard of care". The various findings suggest that treating lung cancer - the biggest cancer killer globally - with powerful new immune system-boosting medi-

cines is going to involve more permutations than some experts originally expected. Rival drugmaker Bristol-Myers Squibb had tried a catch-all approach with its Opdivo drug but it failed to help previously untreated patients when given on its own in a trial that included people with low levels of a protein called PD-L1. Keytruda, as a sole agent, was targeted only at patients with high PD-L1, making them more receptive to immunotherapy.

Lead researcher Martin Reck of Germany's Lung Clinic Grosshansdorf predicted that testing for the PD-L1 biomarker would now become standard "from today". US regulators are

expected to decide whether to approve Keytruda for first-line non-small cell lung cancer, the most common type, by Dec. 24.

Merck had already said in June that Keytruda worked in the trial but the scale of the benefit was only disclosed at ESMO. The second trial, mixing Keytruda with chemotherapy, was much smaller but was notable because it was the first time that a combination of immunotherapy and chemotherapy has been shown to work in a randomized Phase II study.

Many experts have been skeptical about this approach and investors' expectations, up until now, have been quite low. In the event, researchers reported that

Merck's combination cut the risk of disease progression or death by 47 per cent compared to chemotherapy alone after 10.6 months, while 55 per cent of patients saw their tumors shrink versus 29 per cent.

Patients in this trial were not selected by PD-L1 expression but the study did find that those with higher PD-L1 had a higher response. Roger Perlmutter, Merck's head of research, said both trials suggested Keytruda could offer a broad array of patients meaningful improvement over standard platinum-based chemotherapy, which is now more than two decades old.

Reuters

RESEARCH

FDAflags concerns about Pfizer’s quit-smoking drug study The drug did not significantly increase the incidence of serious neuropsychiatric side-effects PFIZER'S TRIAL data on Chantix, a drug to help people quit smoking, failed to impress US Food and Drug Administration scientists, in a blow to the company's attempts to have a serious warning removed from the drug's label. The FDA staff, in a preliminary review, expressed concerns about the collection and interpretation of data from a post-marketing study on the controversial drug.

Pfizer has been trying to have the 'black box' warning, which warns of psychiatric risks including suicidal thoughts, hostility and agitation, removed from the drug's label. In March 2015, the FDA left the warning on the label, following the recommendation of an advisory committee to wait for the outcome of the study in more than 8,000 adult smokers.

Results from the study, which compared Chantix or GlaxoSmithKline's Zyban with a placebo or a nicotine patch in smokers with and without a history of psychiatric disorders, showed that the drug did not significantly increase the incidence of serious neuropsychiatric side-effects.

However, FDA staff disputed the results, flagging inconsistencies in data collection and characterisation of the severity of some side-effects.

These factors could have led to biased results, they said, ahead of a meeting of independent advisers. The advisers will discuss the trial findings and decide whether the warning should be removed. The FDA is not obligated to follow the panel's recommendations, but it usually does.

James Rusnak, CDO, Pfizer's cardiovascular metabolic unit, said there were bound to be variations in investigators' judgement within the boundaries of the trial protocol, just like in the case of doctors in clinical practice.

Any subjectivity in investigator's judgement would be spread across the four treatment groups and not be limited

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to Chantix, Rusnak noted. In May, European regulators lifted a warning on the drug, sold under the brand name Champix in

Europe, based on the results of a large study. Investors were betting big on the drug when Pfizer launched it in 2006, but reports

of mental health problems in users led to the FDA imposing the black box warning three years later. Chantix, which loses

patent exclusivity in four years, generated global sales of $671 million in 2015.

Reuters

PACKAGING SPECIAL

PURPLE HEALTH

A PLATFORM FOR INNOVATION

O

ver the past three decades, Dr Reddy's Laboratories (DRL) has established itself as a leader in the Indian pharma industry. Now, it has taken a step ahead and reached out to patients through its newly launched initiative — 'Purple Health'. Through this endeavour, the company aims to understand patients' needs and provide them better services. MV Ramana, Executive Vice President and Head Branded Markets (India and Emerging countries), DRL explains about the initiative and says, “We see Purple Health as the next step in our journey, where we are making an effort to institutionalise patient-centric thinking in our organisation, and give this imperative the requisite scale and focus. It is a platform to inspire and promote 'Care Beyond the Pill”.

Shifting focus Last year, the company decided to move in a new direction with an aim to develop a deeper empathy for the needs of patients. Its core belief that ‘Good Health Can’t Wait’ has motivated the company to move in a new direction. Explaining the rationale behind launching this initiative. Ramana says, “We looked at the entire gamut of patient needs and realised that these needs range from lack of awareness, late diagnosis and access to treatment. We then examined how we could best leverage our capabilities as an organisation to meet some of these unmet patient needs. Based on this assessment, we defined our offerings around four pillars

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DRL's endeavour seeks to institutionalise patient-centric thinking and design high quality interventions to address their needs in a bid to promote 'Care Beyond the Pill’

BY USHA SHARMA

MV Ramana, Executive VP and Head - Branded Markets (India and Emerging countries), DRL and Purvish Parikh, Director of Precision Oncology and Research, Asian Institute of Oncology at the launch of Purple Health initiative at ITC Parel in Mumbai

i.e.; Awareness and Convenient Diagnosis, Access, Medicine Experience and Adherence.”

(Check Box on Pg 54) he continued further, “Through the 'Purple Health' initiative, we are working to delve deeper into understanding how patients experience their care, and accordingly design high quality interventions that address their needs.”

The company has already initiated a couple of projects which have been rolled out across the country. Ramana informs, “We have successfully offered few initiatives to our patients in different therapy areas, Purple Health is all about a holistic and unified platform to drive patient solutions.”

So, how is Purple Health different from DRL's past initiatives?

Purple Health – Packaging The company has decided to roll out the initiative in phases.

In the first phase, DRL has focussed on bringing innovation in packaging. In the first wave of this assessment exercise the company evaluated its 250 brands through a rigorous process and identified five brands that had a strong and consistent record of caring for ‘patients beyond the pill’. These five brands span a diverse array of therapeutic areas including hepatology, nephrology, oncology and paediatrics. Giving an overview about the kind of innovation introduced by the company under Purple Health- packaging, Ramana divulges, “We have designated the five brands as Purple Stars. Our new design of blister packs have features such as additional stubs to

include essential information needed by patients, a dosing matrix to enable easy recall of medication schedule, colour coding for different strengths of a brand, etc. In the case of syrup bottles, we have developed a drip-free bottle neck to prevent spillage, and rounded bottom of the measuring cup to enable easy cleaning. As we have often discovered, it’s the little things that make a big difference to how patients feel about the way their care needs are met.”

Ramana adds, “This assessment will be an annual exercise. I strongly believe that Purple Health can play a catalytic role in inspiring our business teams to delve deeper in understanding the needs of our patients around the world, and help them manage their disease better. As we move ahead,

we hope to see many more Purple Stars in our portfolio.”

The company informs that currently the innovation will be applied to products in blister packaging and bottles across therapies. So when will these innovations in product packaging be seen in the market?

The entire packaging initiative spanned a period of 24 months from research to concept development to implementation. Starting with the India market, the new packaging will be rolled-out in a phased manner over the next six months for 25 of DRL's focus brands, informs the company.

Commenting on the roll out activity, Ramana emphasises, “Through Purple Health we hope to be on a continuous journey of understanding patient needs, and developing solutions that address their needs. Along the way, we will evaluate various possibilities where we can enhance the therapy experience for patients. We believe this will enhance the therapy experience for over 20 million patients each year.”

The company has also introduced a “structured mechanism to assess its brand offerings on delivering care beyond the pill.

Ramana adds, “An important part of Purple Health is a system that we have set up to assess our product brands on being patient centric. We have developed an evaluation scale based on “patient-value score” This objective framework acts as an enabler to help our business teams innovate and progressively move towards a higher degree of patient centricity through our efforts.

But, we don’t decide ourselves if

we are patient centric! We have constituted a panel of external experts to evaluate our efforts and impact, and let them decide if we can truly call ourselves patient centric.

Since the company has chosen five key therapies for the first phase and is planning to add more to the list in the future, it also needs to communicate the changes to doctors. Talking about their ef-

forts in this direction, Ramana says, “There are multiple ways in which our sales and marketing teams are reaching out to the doctors, demonstrating innovative Purple Packs and explaining all the features.�

IDEO and DRL collaboration: A progressive partnership To make patient friendly packaging,

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PACKAGING SPECIAL DRL partnered with global design and innovation consulting firm IDEO in understanding the patient requirement.

Ramana elaborates on the role of the collaboration and says, “The team from IDEO and DRL met a cross-section of patients, doctors and pharmacists across the country, conducting in-depth interviews and observational studies to understand patient’s needs. Based on the insights, we redesigned our blister packs and syrup bottles to address the pain-points We partnered with IDEO, the global design and innovation consulting, and applied the ‘Human-Centred Design’ approach to finding solutions during the design phase of the project. IDEO’s role was to help us uncover the patient needs through ethnographic research and then create ideas/concepts to meet those needs, test

them through rapid prototyping and refine the design based on user feedback.”

Elaborating on packaging innovation, Ramana informs that the company would focus on simplifying the patient's medication experience, build convenience into medicine consumption and help the patient with adherence to therapy. Historically, medicine packs have been designed to meet technical and regulatory requirements. “Packs have rarely been designed to ensure convenience or usability. While there have been some efforts to make packs more usable and drive adherence, no platform level solution has ever been implemented. “In our studies, we identified packaging as being currently underserved and an opportunity to innovate,” adds Ramana.

The entire exercise has taken over a period of two years and the company

Awareness and Convenient Diagnosis: Critical to the cycle of care is the awareness or the diagnosis of the disease.Through our awareness and diagnosis camps across multiple therapy areas, we ensure that we educate doctors, patients and families on disease symptoms and if needed, support diagnosis through our partners. Example: To raise awareness about need to include zinc along with ORS, Z&D (a zinc sulphate formulation indicated as adjuvant therapy along with ORS) conducted the “Vacchan”campaign with over 18,000 pediatricians. Incidentally the campaign entered the Limca Book of Records for reaching out to maximum number of doctors within 6 days.

Access: Access is not only ensuring that medicines are available at every location but also how the company empowers their patients to access expensive therapies. Example: The are providing convenient loans at 0 per cent interest rates for Hepatitis C patients purchasing Resof.

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Medicine Experience: Who likes taking injections or pills which are hard to swallow! We deliver differentiated products to our patients to help improve their medicine experience.

This can mean changing the flavour of a pediatric syrup or make a faster acting medicine.

Example: Metformin, a commonly used molecule in management of diabetes has traditionally been a big pill – which surprisingly has been one of the reasons for lack of adherence.When we understood this challenge, launched Metsmall, our brand of metformin, which is 33% less in size compared to other Metformins.

Adherence: This has been the one of key challenges for everyone from doctors, governments to pharmaceutical companies. All of us, across the board are trying hard to assist patients to adhere to therapy. Examples: From sophisticated platforms to simple reminders, we offer programs like CHEER, Liv Positive to ensure our patients take medicines on time, while assisting them with diet, lifestyle and counselling support.

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54 EXPRESS PHARMA October 16-31, 2016

PACKAGING SPECIAL plans to invest around `10 crores and to execute this the company has worked with several partners. Sharing a note on this Ramana informs, “Over the course of two years, we collaborated with over 10 partners and undertook a major change management exercise involving seven functional teams to make new packaging system available to patients. And we believe the this added patient convenience will help us to build more credibility and differentiation in the market place.”

Since the company has planned to invest around `10 crores for the entire packaging exercise, will there be a cost burden to end consumer?

(Patient) Ramana informs, “The packaging costs will increase by about 20-30 per cent.

But we are not planning any price revision on account of this. We believe the added patient convenience will help us

To subscribe: bpd.subscription@expressindia.com

We have successfully offered few initiatives to our patients in different therapy areas, Purple Health is all about a holistic and unified platform to drive patient solutions build more credibility and differentiation in the market place.”

In pursuit of progress DRL, as a company, over the past three decades has gradually transformed themselves from being a provider of Molecules to Medicines, and now to Health. So moving ahead what are their future plans? Ramana enlightens, “We

want to continue to build on the Purple Health agenda and ensure across multiple products we are able to deliver care beyond the pill. We would drive more and more of our promotional spend on initiatives under the Purple Health umbrella.

We want to create a position for ourselves in the Indian market as the most patient-centric pharma company.” u.sharma@expressindia.com

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PACKAGING SPECIAL I N T E R V I E W

‘We assessed the practicality of this solution in terms of technical feasibility and economic affordability’ Kanupriya Goel, Researcher and Designer with specialisation in healthcare-related products and Dr Gautam Goel, Computational Biologist, inventors of a self expiring medicine packaging, divulge more details about this innovation, in an exclusive interaction with Sachin Jagdale Give us the outline of your project.

Self Expiring is a packaging material for medicinal products that visually ‘self expires’ over a fixed period of time. This packaging will graphically display a ‘not fit for consumption’ message as the medicine approaches its expiration date. The message will be displayed in universally accepted danger signs in regional languages that can be readily interpreted by people from all walks of life. The solution will prevent illegal sales of expired medicines and fatalities arising from their accidental consumption.

What was the intent behind this discovery?

The intent was to come up with a packaging material on which its expiration information was not dependent on language literacy, or a user’s ability to find the expiration date on the medication package/bottle. We wanted the packaging material to be as informative as universally accepted symbols/signs such as the danger sign or traffic lights, which impart

56 EXPRESS PHARMA October 16-31, 2016

the same message across cultures.

Equally important, we wanted the solution to be tamper proof that would prevent illegal sale of expired medications.

The concept of visually changing paper exists and we applied it to propose a packaging material that consists of various layers which bleed ink in a fixed time lapse to the layer above. Depending on the time frame of expiration, these layers could be increased or decreased and programmed to display the expiration message on the topmost layer of packaging alerting the user of the expiration of the medicine.

We proposed a graphical solution as it would prove useful to the third generation (aging population with limited vision and agility), the illiterate (one’s who cannot read or write or understand the concept of expiration of medicines), people constrained by language (most of the printed labels are in English, which is not spoken or understood in many parts of the world). We believe having the expiration message appear graphically on the packaging will

PACKAGING SPECIAL

Kanupriya Goel, Researcher and Designer

Dr Gautam Goel, Computational Biologist

The message will be displayed in universally accepted danger signs in regional languages that can be readily interpreted by people from all walks of life. The solution will prevent illegal sales of expired medicines and fatalities arising from their accidental consumption enable the user to understand when to stop using it, and lift off the huge burden of consumption of expired medicines and health repercussions due to the same.

What are the drawbacks associated with current method of imprinting the expiration date on medicinal packaging? What was the major challenge for you during the course of the development of this self expiring medicine packaging?

Consumption of expired medications can lead to prolonged illness, increased healthcare costs and in some cases life threatening situations. The current solution of imprinting the expiration date on medicinal packaging is ineffective for multiple reasons: ◗ The choice of language for indicating the expiration date is English, which is not the first language in several parts of the world ◗ The expiration date can be difficult to find and read due to the size of the font ◗ The printed date often wears off

with time or gets removed as the packaging is used or torn (as in case of medicinal strips).

All these issues can collectively lead to accidental consumption of expired medicines, which at times can prove fatal. Our challenge was to find a tamper-proof solution that would record and display the expiration date of the packaged medicine, starting from the point of origin when the medicine is packaged to the point till it remains fit for consumption.

What kind of background study was conducted by you for this project?

What is the actual mechanism of self expiring medicine packaging?

We performed ethnographic research of focused groups in India, like the elderly population, construction workers, slum dwellers, kids between age 6-12 and realised that in many cases people were not aware of the concept of expiration of medicines.

While in some cases the awareness of such a concept was limited, in several instances the inability to find or read it on the packaging posed additional

To subscribe: bpd.subscription@expressindia.com

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PACKAGING SPECIAL challenge especially for the elderly and the illiterate. We realised that the medicinal strips sold in India have the expiration information stamped in one corner. In the event when these strips were sold on a per pill basis, the expiration information would be missing as the needed numbers of pills, say two or three out of six in a pack, would be torn from the original packaging. In some cases it was observed that the retailers would willingly sell expired medicines at cheaper prices to earn profits. We wanted a solution that could solve the problem, and create awareness at all levels.

Our solution to the problem adapts an existing technology called the visually changing paper. We used

understood universally in a singular fashion. The time controlled release of the expiration will not interfere with the original medicine label and information, and hence the user will not be misled into believing the medicine has expired before it actually does.

We envision that a successful and widespread implementation of this idea would have to be enforced by FDA and pharmaceutical companies.

This idea, if made a norm in medicinal packaging, can save patients from prolonged illness and fatalities arising from the accidental consumption of expired medication.

It will also prevent retailers and black marketers from making profit off of selling expired medications to

This technology has been used to create a packaging material that will visually ‘self expire’ over a period of time. This packaging will be made of inexpensive label-like materials this technology to create a packaging material that will visually ‘self expire’ over a period of time. This packaging will be made of inexpensive label-like materials. It will have a twocomponent design where the foreground label will initially display the medicine information on a solid plain white background. The second component consists of the layer carrying the hidden message. These two layers will be separated by multiple sheets of diffusible material through which the ink from the hidden message will seep through as time lapses. The number of sheets will allow us to control the rate of diffusion of the hidden ink such that the ‘not fit for consumption’ message is revealed only at/around the time of expiration.

As part of the standard packaging material, this ‘timed colour-image change’ will be impervious to any of the issues with the current solution of printing the expiration date. The timing sequence will be initiated from the very point of packaging itself and this will prevent retailers from illegally selling any expired medications for personal gains. Our choice of colour(s) and design of expiration pattern include universally accepted signs of danger, which will be well understood, just like how traffic light signals are

58 EXPRESS PHARMA October 16-31, 2016

their less aware and illiterate consumers.

How practical is this solution?

According to you, how is the pharma industry going to respond to this concept?

We assessed the practicality of this solution in terms of technical feasibility and economic affordability.

We believe that since we adapted an existing technology of a visually changing paper to apply it to our problem context of interest, a prototype is warranted to establish the exact kinetics of the design.

Having seen some existing applications of this technology, such as ID-badges that self-expire over time and milk cartons that change colour as milk turns bad, we believe our solution is practical too.

However, pharma companies might not get behind this idea because unless the additional cost to packaging, however miniscule, can be profitably passed on to the end-user.

We imagine one could prioritise application of this concept to medicines ranked by severity of risk associated with post-expiration consumption. A mandate from a regulatory body, such as FDA, would be just as critical in this regard. sachin.jagdale@expressindia.com

PACKAGING SPECIAL VENDOR NEWS

Werum ITSolutions hosts Manufacturing Excellence Day in Mumbai The event focused on the latest trends in MES development, compliance, and successful PAS-X MES deployments

THE FIRST Werum Manufacturing Excellence Day was recently held in Mumbai, which was attended by 40 experts from leading pharma and biotech companies. The event was jointly hosted by Werum IT Solutions and Sarla Technologies, which focused on the latest trends in MES development, compliance, and successful PASX MES deployments.

Rajesh Thempadiyil from Dr Reddy’s Laboratories, Girish Vartak from Sandoz India, Vilas Dholye, an expert Indian pharma consultant, and Frank O’Loughlin, who provided a case study of the global Amgen MES programme, and several other internationally recognised experts in the fields of regulatory compliance took part in the symposium.

The key note presentation was given by Lars Hornung, Senior Director Global Sales at Werum IT Solutions, on drivers shaping the future of MES and how the pharma MES supplier is looking to develop its next generation products. Together, with the

latest guidance from the ISPE on data integrity, led by Dr Tony Margetts, one of the founders of computer systems validation and Editor of GAMP, a complete view across the changes in the industry was presented along with customer success stories.

The seminars were complemented by demo stations highlighting the latest features of PAS-X – Werum’s market-leading MES for the pharma and biotech industries, where guests from over 15 companies took part in discussions and discuss and networking.

David Margetts, MD, Werum IT Solutions, Thailand said, “The level and seniority of our participants show the high interest in manufacturing IT solutions for increasing efficiency of pharma and biopharma plants by implementing our standard MES using our best practices. We really look forward to next year together with Sarla Technologies in making our event even bigger and better.”

To subscribe: bpd.subscription@expressindia.com

EP News Bureau

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PACKAGING SPECIAL

KWE India launches GDP compliant pharma warehouse at Hyderabad Mulls to set up similar warehouses in Mumbai, Delhi, Bengaluru and Ahmedabad in a phased manner KWE INDIA, the Indian subsidiary of Kintetsu World Express (KWE) and part of Kintetsu Group, has launched a Good Distribution Process (GDP) warehouse at the Hyderabad airport cargo satellite building to exclusively handle pharma logistics. Mineo Suzuki, MD, KWE India inaugurated the facility.

Reportedly, this facility will be exclusively utilised to provide logistics support for the pharma shipments – including both export and import trade.

Set up in non-bonded area, the facility is equipped with

24×7 temperature ambient control, CCTV, control access, racking, temperature and humidity indicators, alarm system and skilled & trained manpower to follow GDP compliant process throughout shipment handling.

Commenting on KWE’s initiative, Karthi Baskar, Deputy MD, KWE India, said, “We have been at the forefront of introducing innovative logistics solution in India and this project marks a new milestone in our journey to carve a niche in offering contemporary solutions to address

The facility will be utilised to provide logistics support for the pharma shipments, including both export and import trade

Agarwal Movers Group celebrates 29th Foundation Day Crafts virtual warehousing solution ahead of GST launch AGARWAL PACKERS and Movers Ltd (APML), which recently celebrated its 29 th Foundation Day, is betting big on its trucking cube solution.

With the solution being introduced last year, the company has been able to notch around `450-crore turnover in the last fiscal.

On the occasion of the 29th foundation day of the company, Ramesh Agarwal, Chairman – APML said, “After GST is implemented, this product will have great value as far as storage and warehousing is concerned. To avoid GST, earlier companies used to have several smaller warehouses at the state level.

But in a uniform tax regime that will be not required.

With this solution, we can offer the big companies the Virtual Warehousing Solution

60 EXPRESS PHARMA October 16-31, 2016

(VWS). They can just continue with their regional distribution centres (RDCs)/Fulfilment Centres (FC) to deal with their clients while their goods can remain parked with us in cubes in our stock yards. At the regional level, the clients just have to let us know where it has to be delivered and we will take care of this last mile bit.”

"APML presently has 34 hubs and we are targeting to take it up to 50 as our cube volume climbs to over 10,000.

All the hubs (RDCs/FC) have been categorically and strategically located giving an impetus to truck transport throughout India. Motherhubs have been made at Dudhu, Malkapur, Malegoan, Hosur and Asansol and child-hubs have been created

at Palwal, Ambala, Navi Mumbai, Kolkata and many more."

“The logistics cost for our customers will actually come down by eight per cent even as they are catered to a superior and more efficient service. It can also be used for the movement of household goods where we are a market leader in the country,” he further said.

"In the next two to two and a half years, APML will pump in over `100 crores in this solution. Most of the investments will be routed in to have a much larger inventory of cubes, more stockyards throughout the country and having a trained manpower to support this solution,” concluded Agarwal.

EP News Bureau

unique needs for the growing economy.”

According to Karthi Baskar the pharma companies in the region have evinced overwhelming response for utilising the services provided by KWE at the dedicated warehouse. Following this response KWE management is keen to further expand its warehousing space and has already reserved two additional block spaces in the upcoming cargo satellite building of GMR Hyderabad.

Going forward, KWE is keen to set up similar warehouses

in Mumbai, Delhi, Bengaluru and Ahmedabad, in a phased manner, he added.

Reportedly, since there is no single global GDP standard, KWE’s Hyderabad warehouse is designed and set up to comply all the basic handling, storage and transportation of temperature sensitive pharma products as per guidelines from IATA, CDSCO, European Commission, USP, IPEC, PDA and other different health regulatory bodies in different countries.

EP News Bureau

MedGenome acquires Illumina Hiseq XTen platform The machines are expected to be operational in India and the US by next month MEDGENOME HAS purchased the Illumina Hiseq X Ten platform to fuel its genomic research services capability and capacity, informed a company release. Reportedly, MedGenome joins a small number of global players in the genomics research space, and the first one in SouthEast Asia, to own one of these high throughput Illumina sequencing platforms.

“We are passionate about improving human health through use of genomics research and insights,” said Sam Santhosh, Chairman and Global CEO, MedGenome.

“We will have these machines operational in India and the

US by next month and will be looking forward to collaborating with various large scale genomic projects in the region and abroad,” he said.

“The HiSeq X Ten System is the first and only platform to break the $1000 barrier for high quality human whole genome sequencing. We are happy to partner with MedGenome to drive the genomics revolution in India and continue to work towards our vision of unlocking the power of the genome,” said Tim Orpin, VP Asia Pacific, Illumina.

EP News Bureau

PACKAGING SPECIAL

The Waters ACQUITYArc System receives 2016 Frost & Sullivan New Product Innovation Award Bridging the gap between HPLC and UPLC performance, the system is favourite of QC laboratories testing small molecule pharmaceuticals

WATERS CORPORATION announced that its ACQUITY Arc System has received a 2016 New Product Innovation Award from market research and growth consulting firm Frost & Sullivan. The Waters ACQUITY Arc System is a liquid chromatograph (LC) that gives drug development and quality control laborato-

ries running routine, established LC methods a single LC platform for replicating or improving the performance of their separations methods regardless of the LC platform on which they were first developed.

With the introduction of the ACQUITY Arc System, and its enabling Arc Multiflow path technology, scientists are able to

emulate the gradient dwell volume and mixing behaviour of liquid chromatographs from a variety of manufacturers without altering the method’s gradient table. Waters formally introduced the ACQUITY Arc System in 2015 in Beijing.

EP News Bureau

METTLER TOLEDO Thornton announces RMS for pharmaceutical waters The on-line 7000RMS delivers continuous measurement of microbes and inert particles in real time METTLER TOLEDO Thornton, a supplier of online analytical instruments for monitoring purified waters announced the introduction of its 7000 Real-time Microbial System (RMS) analyser for real-time, continuous measurement of bioburden in the pharma industry.

Determining microbial contamination has almost entirely relied on laboratory measurement of cultures.

The time taken to grow cultures, and the multiple testing of points-of-use, results in many days of delay in identifying microbial excursions.

James Cannon, Thornton’s Pharma Market Manager commented, “This tech-

The 7000RMS provides continuous analysis of microbial and inert particle contamination wherever required in a water system or at point-of-use nology will be invaluable in assisting pharma companies validate water systems in real time, reduce off-line sampling costs and help eliminate false-positive tests.”

The 7000RMS provides continuous analysis of micro-

To subscribe: bpd.subscription@expressindia.com

bial and inert particle contamination wherever required in a water system or at point-of-use. The compact unit not only provides realtime assessment of water loop bioburden levels, it lowers labour costs via reduced sampling and testing, re-

duces energy use through better management of sanitisation cycles, and leads to increased process understanding and product safety.

Unlike other modern techniques for measuring microbes in water, the laser-induced fluorescence (LIF) technology employed in the 7000RMS does not require time-consuming staining or use of reagents. The implementation of LIF in the analyser, in conjunction with Mie scattering detection and advanced software algorithms, allows the simultaneous measurement of particle numbers and determination of whether particles are microbes or inert material.

EP News Bureau

ACG Inspection launches Convel Srl’s liquid inspection machines in SAARC region ACG INSPECTION, a member of ACG Worldwide, has entered into an agreement with Convel Srl, Italy to sell its liquid inspection systems in the SAARC countries.

Asia is considered to be the fastest growing injectable drug delivery market owing to high prevalence of chronic diseases. With this development, ACG Inspection, known for its reliable, hi-tech inspection systems for solid dosage forms, enters into the liquid inspection systems market. The vision inspection machines, viz. C2 and C2D, are 21 CFR Part 11 compliant and enable reliable and efficient inspection of foreign matter and cosmetic defects in ampoules, vials and carpoules. These machines are well suited for medium and large scale production capacities. With the addition of these machines to its diverse portfolio of inspection systems, ACG Inspection now offers a complete range of inspection solutions for solid and liquid dosage forms.

Ettore Cucchetti, CEO, ACG Inspection said, “ACG Inspection has been a pioneer in providing regulatory compliant solid dosage inspection systems. With these advanced liquid inspection machines, we have amplified our inspection competencies.”

EP News Bureau

EXPRESS PHARMA

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October 16-31, 2016

PACKAGING SPECIAL PRODUCT

Safe and environmental-friendly dock shelters from Gandhi Automations ENTRANCE AUTOMATION and loading bay equipment company, Gandhi Automations offers a complete range of Dock Shelters available for every requirement and environment.

Dock shelters are installed mainly to seal the gap between the building and the vehicle in such a way that when the sectional overhead door is opened, goods and personnel are protected against harsh weather conditions outside. Dock shelters provide a seal between the internal and external environments, thus assisting in the reduction of energy consumption. The savings in energy costs are considerable.

Retractable dock shelters: The retractable PVC front panel dock shelter is commonly in use. With its simplicity and efficiency, it grants for a constant payback of the investment. These are available for dock level installation or for ground level installation for the protection of doors without dock. The front panels are made of high resistance black PVC reinforced with a double weaving of polyester that works like a spring in order to seal the vehicles of different shapes. The flaps are flexible and have high wear and tear resistance. It has been designed to retract under the shock of any possible wrong manoeuvres of the docking vehicles and extend when the vehicle drives away.

Cushion dock shelters: Due to its high insulation factor, the cushion dock shelter is an ideal solution for controlled temperatures. The three cushions are made of elastic polyurethane foam, covered with PVC coated polyester fabric, supporting the vehicle pressures

62 EXPRESS PHARMA October 16-31, 2016

Dock shelters are installed mainly to seal the gap between the building and the vehicle in such a way that when the sectional overhead door is opened, goods and personnel are protected against the harsh weather conditions outside and perfectly sealing the three sides, including the space between opened rear doors and sides of the vehicle. The two vertical cushions have continuous overlapped anti-friction limpets allowing for the up and down heavy friction of the vehicle on its suspensions, during

the loading. It is available with fixed or adjustable horizontal top cushion, adjustable to the different vehicle heights.

Inflatable dock shelters: The inflatable dock shelter is the best solution for insulating and improving the working environment. It can be rapidly in-

flated with a fan and it creates a perfect insulation between the vehicle and the loading bay, sheltering from cold, rain, wind also dust and humidity.

The inflatable dock shelter is made of polyester fabric, PVC covered, a material resisting to hot temperatures and bad

weather conditions. Inflatable dock shelters provide the most versatile seal available to service the widest variety of truck and trailer configurations.

Contrary to other types of dock shelters the vehicle does not push towards the shelter instead the shelter is inflated around the vehicle.

Contact details Gandhi Automations Chawda Commercial Centre, Link Road, Malad (W), Mumbai – 400064 Tel: +91 22 66720200 / 66720300 (200 lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website: www.geapl.co.in

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EXPRESS PHARMA INAUGURATION OF GMP UNIT-3 GMP BHIWANDI PLANT INAUGURATED BY MR.R.VASUDEVAN GMP BHIWANDI PLANT

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CLEAN ROOM SPECIALIST Contact us with Confidence and we will make your vision or idea come true.

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SPECIALIZED IN PLATINUM CURED SILICONE TUBES,BRAIDED HOSES & INFLATABLE SEALS/GASKETS 1st Indian Silicone Rubber Product Mfg. Co. certified with Clean Room of Class 10000

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Product List Humidity Chamber

Walk in Chambers I Humidity ( Stability) Chambers Cooling Chambers I BOD Incubators Bacteriological Incubators I Deep Freezers Ovens I Photo Stability Chambers I Vacuum Oven Muffle Furnace I Auto Clave I Water Chillers

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Walk in Chamber Cooling Chamber

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Alternative PLC with touch screen display with Ethernet with automatic change over facility.

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Complete validation package comprising DQ, IQ, OQ & PQ. 24 x 7 Online service support.

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PRODUCT

FUNCTION

Omega max

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Repairs hair damage

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Protects collagen

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Sun protection

Capilmax

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Alcamen

Phytoscreen

Fotoderm

EXPRESS PHARMA

Novachem, an Argentina based company appoints ChemsparkÂŽ India Pvt. Ltd. as their exclusive distributor for their products for India and Sri Lanka region.

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Tempo Instruments Pvt. Ltd. ISO 9001:2008

MANUFACTURERS OF LABORATORY & SCIENTIFIC EQUIPMENTS

Product Range • Stability Chambers • Humidity Chambers • Multi Cell Ageing Ovens • Plant Growth Chambers • Walk in Chambers • Seed Germinators • Muffle Furnance (1200°c) • Staker Water Baths • Photo Stability Chambers • Heavy Duty Ovens • Lab. Precision Ovens • Deep Freezers (-20°c/-40°c) • Tray Dryer Ovens • Lab. Refrigerator • Lab. Drying Ovens • Vaccum Ovens • Autoclaves • Furnace (1500 °c) • BOD incubators • Cryo Baths

For More Details: Log on to : www.tempoinstruments.com E-mail : enquiry@tempo.net.in / Contact: 09820464003 10-11, prospect Chamber Annex, 317-21, Dr. D.N. Road, Fort, Mumbai - 400001. www.tempoinstruments.com ; Email: enquiry@tempo.net.in

70 October 16-31, 2016

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PACKAGING PRODUCTS FOR HEALTH CARE

RUBBER STOPPERS

RUBBER WADS

DROPPER ASSEMBLY

BEAK TYPE DROPPER, OPVD DROPPER & BUILT IN DROPPER

DIFFERENT SIZE CAPS

RUBBER DISCS WITH EUROHEAD CAPS AND FLASH BLUB

DIAGNOSTIC PACKAGING

RUBBER DISCS & PLUNGER FOR DENTAL CARTRIDGES

TABLET & GELL APPLICATOR

EYE / EAR DROP BOTTLES (CONTROLLED DROP SYSTEM)

SYRUP SPOON

SCOOPS

LIDS FOR TIN CONTAINERS

DOSING SYRINGE WITH ADAPTOR

PLASTIC MEASURING CUPS/SPOONS (FOR LIQUIDS & DRY POWDERS)/ PLASTIC CAPS (ROPP)

30ML, 60ML & 100ML DRY SYRUP BOTTLE WITH CAP & MEASUGINC CUP

SINGLE & DOUBLE SIDED FEEDING SPOON

BHARAT RUBBER WORKS PVT LTD.

B-46, Girikunj Industrial Estate, Off. Mahakali Caves Road, Andheri (East), Mumbai - 400 003. INDIA. Tel.: +91-22-2687 5361 - 64 l Fax: +91-22-2687 5221 / 22 Email: marketing@brworksindia. com l Website: www.bharatrubberworks.com

HVAC System Modular Clean Room PUF/EPS WALL/CEILING Partitions-Thickness Range : 50-200 mm.

Reverse Laminar Air Flow (Dispensing & Sampling Booth)

Clean Room

Horizontal LAF Unit

Air Showers

Dynamic Pass Box

Static Pass Box

Garment Cubicle

The leading air management solution provider...

Airtech is a customized air solutions provider. Since its inception in 1992, Airtech has cultivated an in-depth understanding and expertise of executing turnkey HVAC & Clean Room Projects.

Airtech undertakes complete project management comprisig of design, supply, installation & commissioning and validation of HVAC and Clean Room Systems.

Airtech’s Clean Room system provides an ultra-clean environment ranging from Class 100 to Class 100000 with effective control of Air flow, Pressure, temperature, Relative humidity and Filteration suitable for Clan room applications.

EXPERTS IN HVAC & CLEAN ROOM SOLUTIONS 502 & 503, 5th Floor, Satellite Silver, Andheri - Kurla Road, Marol Naka, Andheri (East), Mumbai – 400 059.

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72 October 16-31, 2016

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EXPRESS PHARMA Group Companies:

KILITCH HEALTHCARE LLP

NBZ

NBZ PHARMA LTD.

Manufacturing Facilities Accrediation: n n n

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Head Office: Kilitch Healthcare LLP, 902/B Godrej Colesium, Behind Everad Nagar, Near Priyadarshani Cirlce, Sion (East), Mumbai – 400022.

Tel. : 022 6137 2222 Mr. Divya Mehta : +91 9819724957

Factory: NBZ Pharma Ltd. R-905, T.T.C. Indl. Area, M.I.D.C, Rabale, Navi Mumbai - 400 701.

Tel. : 022 2769 9174, 6516 2146 Mr. Krishnakant Yajurvedi : +91 7710040409

www.kilitchhealthcare.com

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info@kilitchhealthcare.com

info@ekl.kilitchhealthcare.com

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LABORATORY EQUIPMENTS Laboratory Centrifuges

Laboratory Stirrers

Bench Top Orbital Shaking Incubator

Magnetic Coupling

Humidity Chamber with TFT Display

Ultra Low Frezeer Gerber Centrifuge

Neya Centrifuges

UTC Freezer

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Medico Plus

Walk in Chamber

REMI SALES & ENGINEERING LTD.

Remi House, 3rd Floor, 11, Cama Industrial Estate, Walbhat Road, Goregaon (East), Mumbai-400 063. India Tel: +91 22 4058 9888 / 2685 1998 l Fax: +91 22 4058 9890 l E-mail: sales@remilabworld.com l Website: www.remilabworld.com

Knauer, Germany Azura Bio HPLC

Biostep GmbH, Germany HPTLC Densitometer CD 60

Knauer Germany- HPLC, UHPLC & Semi Prep Columns

Biostep GmbH, Germany Chromajet DS 20

PSS GmbH, Germany GPC/SEC Calibration Standards, GPC Columns & 21 CFR Compliant GPC UniChrom software

Biostep GmbH, Germany - HPTLC Applicator AS 30

Azura Analytical HPLC, UHPLC, Compact HPLC Systems

Microwave Digestion system

Knauer, Germany Semi-Micro Osmometer K - 7400

For further details contact Exclusive Distributor:

CHROMLINE EQUIPMENT COMPANY

Unit No. 17, Udyog Bhavan, Sonawala Road, Goregaon (East), Mumbai 400 063, India.

Tel.: 022 2686 0816 / 61887317 l Website: www.chromline.in l E-mail: mail@chromline.in

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ARE YOU AWARE ?

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EXPRESS PHARMA Experiment With The Truth Certified ISO 9001: 2008

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Shah Brothers introducing BIOPROCESSING SOLUTION: SINGLE USE BAGS BY CHARTER MEDICAL u

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Wiper Type Sight Glass

DIN 100 Light Glass LED

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PHARMA LIFE APPOINTMENTS

Ambati Venu is new Abbott India MD The board approved the appointment of Ambati Venu as an additional director on the board and managing director of the company for a term of five years

A

bbott India announced the appointment of Ambati Venu as its new managing director. “The board at its meeting held recently approved the appointment of Ambati Venu as an additional director on the board and managing director of the company for a term of five years effective September 29, 2016, subject to approval from the central gov-

ernment and shareholders of the company,” Abbott India said in a BSE filing.

An IIM Ahmedabad alumnus, post a degree in mechanical engineering, Venu has had a long innings in GSK Consumer Healthcare, joining in 1999 and rising to become Vice President and General Manager – Asia in 2013.

EP News Bureau

OPPI re-elects office bearers Four vice-presidents were elected unanimously along with the president for the year 2016-17 OPPI HAS recently concluded its statutory Annual General Meeting of members and re-elected its office bearers. Dr Shailesh Ayyangar, MD India and VP South Asia, Sanofi, was unanimously elected as the President for the year 2016-17.

Dr Ayyangar has held this position for the past three years. At the same meeting, four vice-presidents were elected unanimously – Sudarshan Jain, MD – Healthcare Solutions, Abbott Healthcare, Sharad Tyagi, MD, Boehringer Ingelheim India, KG Ananthakrishnan, VP and MD, MSD India and Sanjiv Navangul, MD, Janssen India – Johnson & Johnson.

The elected office bearers of OPPI will have their tenure till the next annual general meeting in 2017.

90 EXPRESS PHARMA October 16-31, 2016

The elected office bearers of OPPI will have their tenure till the next Annual General Meeting in 2017

Commenting on his reelection, Dr Ayyangar said, “I would like to thank my fellow colleagues in the executive committee for their tremendous support and guidance over the years and for reposing their faith in me to lead the OPPI in its 51st year of existence.” He congratulated the elected office bearers and reaffirmed OPPI’s commitment to work with all stakeholders to contribute signifi-

cantly towards the healthcare agenda of our nation.

Kanchana TK, Director General, OPPI said, “On behalf of all our members I welcome our team of office bearers for 2016-17. Under their guidance, OPPI is committed to work with all external stakeholders to ensure that we keep the patient at the centre of all that we do.”

EP News Bureau

CAMPUS BEAT

Sinhgad College of Pharmacy organises pharma rally Creates awareness about the role of pharmacist in prevention and management of diabetes ON THE occasion of World Pharmacist Day and 55th National Pharmacy Week, Sinhgad College of Pharmacy organised pharma rally. The motive of the rally was to create awareness about the role of pharmacist in prevention and management of diabetes.

Over 300 Students from Sinhgad College of Pharmacy, 50 NSS volunteers and staff members participated in the rally. Students distributed informative pamphlets to the

residents of Vadgaon and college road area to create awareness on Type II diabetes. Dr KN Gujar, Principal, Sinhgad College of Pharmacy inaugurated the rally. The rally evoked a good response among the local residents. SS Kale, NPW co-ordinator and HA Ranpise, NSS programme officer, along with Prof SK Mandlik and Dr MS Gambhire coordinated the rally successfully.

EP News Bureau

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