PBW February 2017

February 2017 Vol 15 | Issue 07 | Mumbai | Price ` 150 Total Pages 56 PHARMA BIO WORLD

www.pharmabioworld.com

FEBRUARY 2017 VOL 15 ISSUE 07 MUMBAI ` 150 HYDERABAD - 2017

GUJARAT - 2018

December 2017 Venue: Hyderabad, India

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PHARMA BIO WORLD

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4

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INTERVIEWS “Innoplexus is not just a business but a mission to create an impact” - Dr Gunjan Bharadwaj, Founder and Chairman,

16.

“We stay abreast of the developments in genomics on a regular basis by incorporating the most recent published research in this domain” - Dr Abdur Rub, Co-founder, Xcode Life Sciences,

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“Clearsynth adheres to the changing requirements by introducing advanced mechanisms and instruments” - Vijay Ambati, President & CEO, Clearsynth.

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26

35

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FEATURES The Evolving Role of Pharmacovigilance - Ketan Zota

29.

Pharmacovigilance in India: An Overview - Dr Viraj Suvarna & Indu Nambiar

32.

Unlocking Business Efficiency through Proactive AssetManagement - Ben Potenza

35.

Why Pharma Taking Interest in Nutraceutical Industry?

- Dr Samidha M Pawaskar

37.

NEWS FEATURES Budget 2017-18: Reaction from Pharma Industry Leaders

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NEWS UPDATE Press Release

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Next Issue Focus: Clinical Trials

8 February 2017

Pharma Bio World

interview

DR GUNJAN BHARADWAJ

“Innoplexus is not just a business but a mission to create an impact” Innoplexus focuses on product development for Big Data Analytics. The company helps in the future of how data is curated, analyzed and consumed by disrupting prevailing processes through cutting edge technology, innovation and a superlative ability to understand business challenges. Dr Gunjan Bharadwaj, Founder and Chairman, Innoplexus shares his Views on Data Analytics scenario in India and Globally and How Data analytics is enhancing accuracy and cost cutting in Pharma and Lifescience sector, in an email interaction with Mahesh Kallayil.

Could you please tell us about Innoplexus'offering to Pharmaceutical industry?

Innoplexus is on a mission to fundamentally transform the way data and analytics is produced and consumed in the Pharmaceutical Industry.

With growing volumes, veracity and velocity of data; the future cannot be hundreds of analysts curating data manually and selling it at a significant premium to Pharmaceutical companies and Healthcare players.

Smaller and medium sized players do not even have the resources to get such services. Imagine the inefficiencies when one cannot look at the competitive landscape in an environment where change is accelerated. Innoplexus with its Data as a Service platform iPlexusTM is providing real time decision support not only to Big Pharmas but also Research Institutes, Treatment centres, Investors and a number of small biotech. This platform crawls and analyses hundreds of terabytes of data from the external environment in real time for decision support.

Similarly, in Analytics as a Service offerings; even for use cases where decision support follows a repetitive schema, traditional offerings are all about positioning analysts. This is not scalable given that enterprise data is exploding at a tremendous pace. Our Continuous Analytics as a Service applications triangulate enterprise data with external data in real time providing decision 10 February 2017

support for various use cases. Be it repurposing your drug candidates, discovering Key Opinion Leaders, identifying biomarkers or any other use case - why should Pharmas be satisfied with one off projects and decision support through static presentation slides?

How does Innoplexus differentiate themselves from their competitors?

Innoplexus differentiates itself on three counts. First we believe in full automation, second is the breadth as well as depth of the data we cover that continues to increase each day and thirdly our emphasis on continuous decision support. Decision makers ought to get decision support where and when they need it.

Please share your views on Data Analytics scenario in India and Globally?

Data Analytics is going to grow at a tremendous pace in India as well as globally. However, the focus going forward is clearly going to be automation. DaaS and CAaS applications would eventually also empower startups in the healthcare space to create real innovations. Healthcare is one area that requires novel solutions for India.

Copying and pasting models from abroad won't always work for Indian scale and reality. Innovation in India has to happen in Healthcare! We need to Pharma Bio World

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interview empower physicians working tirelessly in rural and semi-urban settings as well as Researchers to research as well as start enterprises in India rather than going abroad. Government is playing a tremendous role in facilitating the same but the onus is on entrepreneurs like us!

Do you think life science industry is still dubitative about how to use and make the most of the new IT scenario?

Why is that?

Life Sciences Industry has the same inertia as others. I would look at this inertia with respect to two aspects : (1) Traditional paradigm of decision support (2) Traditional Organisational Design of IT organisations.

(1) Traditional paradigm for decision support: The order of complexity in the pharmaceutical market has increased substantially.

Regulations are tightening in various key markets capping the pricing power of pharmas.

This also limits the returns to innovate - given the limited period of market exclusivity that is followed by Gx competition.

Relatively smaller patient populations is a challenge for clinical development as centres remain dry of patients but regulatory agencies remain clawed to traditional ways. Real World Evidence remains a distant dream. A lot of investment gravitates in Oncology and Neurology, drying up Research & Development in other therapeutic areas where with sheer number of patients, its possibly needed more. Mortality rates related to diseases in other therapeutic areas, if treated and managed well, have come down drastically.

New drugs in these areas cannot promise substantial value over existing treatments, hence the returns for Pharma companies in these therapeutic areas are also limited.

On the other hand, more investments would not mean higher success rates in Oncology and Neurology. There will be a limited number of R&D assets and capabilities including people in these TAs that these investments 12 ď‚ƒFebruary 2017

will chase. In addition, statistically there is a limit to innovation throughput. This means by increasing the number of drug candidates in the beginning of the innovation funnel, one cannot get a higher number of successful drugs out in the end. In emerging markets, market access remains a big challenge as well. Pharmaceutical companies are trying hard to address this increasingly complex market reality.

However, the decision making remains a batch process. Decision support even for repetitive challenges is one off and requires manual effort, be it from internal teams or outside consultants. External environment is tracked using expensive manually curated data feeds and analytics for decision support is typically a dumb dashboard if not a slide deck affair. This takes time to change as executives still have old ways and time tested relationships with existing providers.

(2) Organisational Design of IT Organisations : For new digital models one needs a skunkworks approach. Colleagues need to learn new technologies fast as older ones get obsolete. One needs rapid prototyping and close interaction as well as understanding of the businesses. This doesn't mean that the traditional IT is not useful anymore.

However, it does mean either IT organisations need to embrace ambidexterity to balance the exploitative and exploratory nature of work or one needs to house the digital skunkworks outside the existing IT Organisations. It is also about the performance management frameworks and reward systems. Disruptive solutions need to be recognised and rewarded differently; only then can one have and retain the best in class talent in organisations.

How Data analytics is enhancing accuracy and cost cutting in Pharma and Lifescience sector?

Data analytics is driving value across the entire value chain from discovery to commercialisation. Industry is embracing automation in all aspects. This has

implications also for service providers.

Traditional business models of Data Services and Analytics as a Service have to reinvent themselves.

With growing volumes, veracity and velocity of data; the future cannot be hundreds of analysts curating data manually and selling it at a significant premium to Pharmaceutical companies and Healthcare players. Smaller and medium sized players do not even have the resources to get such services. Imagine the inefficiencies when one cannot look at the competitive landscape in an environment where change is accelerated. Innoplexus with its Data as a Service platform iPlexus TM is providing real time decision support not only to Big Pharmas but also Research Institutes, Treatment centres, Investors and a number of small biotech. This platform crawls and analyses hundreds of terabytes of data from the external environment in real time for decision support.

Similarly, in Analytics as a Service offerings; even for use cases where decision support follows a repetitive schema, traditional offerings are all about positioning analysts.

This is also not scalable given that enterprise data is exploding at a tremendous pace.

Our Continuous Analytics as a Service applications triangulate enterprise data with external data in real time providing decision support for various use cases.

Please elucidate us on the Importance of machine learning and artificial intelligence for Life Sciences sector?

AI has been misused by many enterprises to 'free ride' the wave. Many a times its used recklessly and interchangeably with Machine Learning. AI offers significant promise for the future. It is critical to DaaS and CAaS or any business model that envisions complete automation. We see driverless cars on freeways in California and AI based approaches predict treatment options. In India, we need innovation in automating diagnostics and treatment decision support for improving healthcare access. AI holds significant promise, but a lot needs to be done. We use both AI and ML in our Data as a Service Platform iPlexusTM and in many of our Pharma Bio World

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interview Continuous Analytics as a Service offerings, the real time analysis of data with high velocity and variability mandates AI for scale.

How Data Analytics has reached to next level and used widely with the help of Artificial intelligence?

Traditional approaches based on manual curation or stop gap arrangements using some tools using manual intervention cannot provide scale with increasing volume, velocity, variability and veracity of data. Decision makers need decision support at the time and platform of their choosing. It needs to be continuous and real time. AI holds promise for that new paradigm of decision making.

How Data analytics helping Pharma & Life Sciences companies to make wise decisions?

Data analytics provides companies in the Life Science Industry with decision support throughout the value chain from discovery till commercialisation. Be it discovering Key Opinion Leaders at a specific stage of the drug, understanding the competitive landscape, discovering new biomarkers or promising pathways, looking at possible drug repurposing options, right trial designs, regulatory strategies as well as field force sizing and channel mix during or post launch - data analytics is critical for all decisions.

Which are the prominent and focused sector for Innoplexus in India?

Innoplexus is not just a business but a mission to create an impact.

We want to democratise data and analytics, improving its reach to various stakeholders in the industry no matter big or small. We have recently concluded an MoU with Regional Cancer Centre, Gwalior to provide physicians with real time intelligence on discovery as well as clinical development and to assist them with tapping the power of analytics.

How iPlexus and KPlexus are useful for the enterprises? iPlexus provides real time decision support with respect to the competitive landscape 14 ď‚ƒFebruary 2017

of a drug or a therapeutic area as well as a specific company, biomarker, protein, pathway or gene. It covers enormous breadth of data that continues to increase each day. Enterprises can know about any development in their area of interest in real time. kPlexus is world's first real time Key Opinion Leader discovery and management platform. An enterprise can discover KOLs, can view the updates on their work, manage interactions as well as identify emerging players for specific use cases in real time.

Various enterprise data sources such as ISS/IST databases, CRM etc. can be integrated into the platform seamlessly.

Is DaaS (Data Analytics as a service) a workable model in India?

Given the cost of manually curated databases and consulting based decision support business models, DaaS is the only way going forward to provide intelligence to Indian enterprises and stakeholders.

Is Innoplexus in talks with any new company/government hospitals for providing services?

Our team is keen to partner with Government and Government institutions to leverage our platforms and technology to improve healthcare and healthcare outcomes for our citizens. Also, our strategy of building a Continuous Analytics ecosystem of applications on our iPlexus TM DaaS platform makes partnerships key to our growth. We want to collaborate with different companies to use our data and solve different problems to eventually improve health outcomes.

Innoplexus recently raised pre series A fund from HCS, what are the plans for next round of fund raising ( Timeline and tentative amount)?

We are speaking to a number of interested investors and partners to help us grow further in key markets and build our IP. We may close the next round this year.

What, in your opinion, are the challenges in regulation that need to be addressed?

We respect data privacy and protection rules as well as guidelines of all geographies our clients operate in. In India, specifically we need to work on unified patient registries to track healthcare outcomes. It remains a big challenge with data security and privacy related concerns - however its the need of the hour. We cannot sharpen policy tools, understand outcomes and assess performance of healthcare delivery centres until this is done. India has the potential to become the largest Real World Evidence data goldmine. We need to also invest in rule based diagnostics for better screening at the last mile of healthcare delivery.

All these themes present significant regulatory challenges for enterprises with respect to data security and governance in general.

What are the hurdles before Innoplexus in its march towards its goal of helping organisations move to continuous decision making by generating insights from structured and unstructured private and public data?

We need to remain agile than the competition and continue to scale fast - a challenge that's faced by all enterprises of our size. As Andy Grove said, "Only the Paranoid survive".

What are the future plans of the company in India and globally?

We want to be the DaaS standard with iPlexus TM platform in Life Sciences Industry, being a partner of choice for all stakeholders.

We want to build a comprehensive application ecosystem on top of this platform partnering with different players.

Doing this, we believe it is very important to also provide data and analytics access also to small and medium sized players.

In the next few months, we will also start scaling our first pilots in other industries, especially the Financial Services Industry.

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interview

DR ABDUR RUB

“We stay abreast of the developments in genomics on a regular basis by incorporating the most recent published research in this domain” W i t h ex p e r t i s e i n p r e c i s i o n m e d i c i n e a n d personalized preventive Health, Xcode believes that the era of “one size fits all” in medicine is over. Competing with other global players, Xcode is working closely with professional practitioners across domains to enable truly personalized solutions across the spectrum of human needs.

Dr Abdur Rub, Co-founder, Xcode Life Sciences, in an interview with Mahesh Kallayil discusses the evolving role of genomics and personalized medicine in Indian pharma industry and much more.

How would you summarize Xcode Life Sciences' vision & mission and accomplishments to date?

Our vision is to play a key role in the genetics-led transformation that is currently underway in curative and preventive Healthcare.

From our modest beginnings, we have grown quite a bit in terms of our product portfolio and product reach, and currently are one of the leading companies in India in preventive genetic testing.

What sets Xcode Life Sciences apart from companies with similar offering?

Xcode is one of the few companies that is established and run by scientists. Xcode is run primarily as a scientific research organization with a commercial arm. We work extensively with physicians and wellness professionals on research projects that are of high relevance in specialized practices and work on creating high health impact and low cost products that can make a meaningful difference in health outcomes for people.

Could you please explain to us the evolving role of clinical genomics and personalized medicine in Indian pharma industry?

16 February 2017

In the USA, 50 per cent of all drugs currently under clinical trial collect DNA information as part of the trial. Currently, Indian biopharma does not carry out much of independent drug development, but we expect this to change in the future, and for India to become a leader in Biopharma innovation. In the future, all drug development will involve clinical genomic aspects.

What are the competitiveness of Indian genomics market against the markets of other countries?

Just as India was able to dominate in the IT sector, we believe India will dominate the genomics sector as well, since much of genomics is what can be considered as Bio-IT. The wet laboratory part of it will be commoditized and the value will reside in big data genomic analysis. We anticipate that India will play a key role as a global hub for genomics.

How is the company positioned in the Indian and global market in the field of clinical genomics?

We are positioned well to benefit from the emerging trends of precision medicine through pharmacogenetics, nutritional genetics and Pharma Bio World

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interview predisposition genetics. We currently have partners in four countries outside of India and the number is growing.

Over the past several years, what are some of the changes that you've noticed in genomic arena, and how has Xcode Life Sciences responded to these changes?

In the early days of genetics, the focus of most companies was on vending broad genetic information, including aspects of ancestry, disease, etc. The market for such information-centric genetic services is limited. Our learning was that the end user is seeking not information, rather, they are seeking specific solutions. So, we turned our focus towards developing solutions for specific health issues in which genetics plays a key role.

On the other side, there are companies which sell very high cost genetic tests for critical conditions such as oncology which are struggling to gain traction. It's becoming clear that genetic services need to be high impact and cost-effective.

We have incorporated these aspects in our product development and costing.

Please share Nutrigenetics?

your

thoughts

on

Nutrigenetics, in our opinion, is a game changer for the health of the population.

At some point in time in the near future, we will look back and feel like our nutritional practice was archaic, in a similar way to how we feel about computers; twenty years ago, they were considered slow, expensive, clunky and archaic. To give you a simple example, more than 70 per cent of India is lactose intolerant and the vast majority of it consumes milk and milkderived products in large quantities. You would not do that if you had knowledge of Nutrigenetics. Milk is a wonderful food for those who can metabolize lactose, for others it could be the main reason for 18 ď‚ƒFebruary 2017

their gastrointestinal problems and other chronic conditions.

May we have your perspective on ethics of personalized medicines?

There are many such examples to cite, such as the individual's capacity to convert folate which is based on which version of the MTHFR gene one carries, or the capacity to synthesise DHA from omega's which is based on which version of the FADS1 gene is present.

Medicine should be personalized to the best possibility using all tools available as long as the cost-benefit is justified, that would constitute the most ethical medical practice. In that sense, personalized medicine is the best practice. Today, clinicians practice this with the tools that are available to them and genetics is one more tool in their arsenal to deliver the best outcome for the patients.

There is a vast disconnect between how nutrition is practiced today (one size fits all) to how it should be practised (personalized and customized), given that we now have affordable and effective tools to learn about our genetic metabolism of different constituents in our food.

This brings to mind an old maxim which goes along the lines of - with proper food, medicine is of no need; without it, medicine is of no use, which is true today as much as it was thousands of years ago. Thankfully, we have the tools to implement this maxim.

What new opportunities does pharmacogenetics offer in disease treatment and drug discovery?

Genetics can account for 20-95 per cent of the variability in an individual's response to drugs. 2.2 million severe Adverse Drug Events (ADEs) occur in the U.S. every year and ADEs are the 4th leading cause of death. As many as 33 per cent of all potentially clinically significant drug interactions, one of the possible causes of ADEs, are caused by drug-gene and drug-drug-gene interactions and may be missed by drug-drug interaction analysis alone.

Currently, there are 137 FDA-approved drugs which have pharmacogenomic information on their labelling. And 50 per cent of all clinical trials have genetic data collection as part of the trial. In future, it's hard to imagine any clinical trial and drug prescription without a genetic component to it.

Clinical genomics field is expected to reap the benefits in near future. In what ways are you competing for the same?

Our goal is to deliver the best value proposition at a competitive price, which is our product development goal at Xcode.

We have demonstrated the same in many areas. In fact, you will find that almost all of our products today offer the highest amount of genomic information content relative to a competing product of a comparable price.

Currently, what are the major challenges you are facing and how are you gearing up?

Consumer and professional practitioner education is a major challenge. We have stepped up to it and doing a lot of work in that area. We conduct courses and workshops to educate the professionals through certifications and CME events on how to integrate genetics into their practice.

Please appraise us on your recent collaborations. How you think these deals going to help Xcode Life Sciences to strengthen its market presence and R&D realm?

We have ties with several partner agencies such as HealthSpring, Medall, NM Medical, QUA Nutrition among other national and international partners. Our partners are a Pharma Bio World

interview foundation of the healthcare ecosystem and are key influencers in people's healthcare decision making process. They are key innovation partners who help determine the core needs of customer segments and help design products and services to fulfill those needs.

What, in your opinion, are the challenges in regulation that need to be addressed?

The challenges are not specific to genetic tests. It will come under the purview of general testing services.

How do you plan to leverage on GOI's Make in India initiative?

We are looking to develop and manufacture technologies of our own.

So far, we have developed our own saliva collection kit end to end, which costs the lowest in the world, while

Pharma Bio World

offering comparable functionality.

Many of the assays will be homegrown, eventually. We founded Xcode in India with the vision of making it a global genomics hub. There is a real opportunity for that as India offers a huge pool of trainable talent which is key to genomics and informatics. In the future, much of bioinformatics will happen in India.

technology platforms frequently to the ones that offer superior accuracy and cost advantage. To stay competitive, it's important for us to be nimble and stay abreast of the changes in the technology and research landscape and be the change makers wherever possible.

How does the company keep abreast with the ever-changing trends?

The last couple of years have been great for us in terms of technological and commercial progress. We hope to outdo ourselves in the coming years. We are happy about the tone and culture we have set for the company in terms of being a research and science-driven organization, rather than a marketing organization.

You will continue to see more and more scientific output from our team in the years ahead, which of course, will feed into our commercial success as well.

We stay abreast of the developments in genomics on a regular basis by incorporating the most recent published research in this domain. We also carry out research projects of our own with our partners. One key advantage we offer to our partners and customers is that we keep our tests current by updating them on a regular basis. We also change the

Kindly apprise us of Sciences, future plans?

Xcode

Life

February 2017 ď‚„ 19

interview

“Clearsynth adheres to the changing requirements by introducing advanced mechanisms and instruments”

VIJAY AMBATI

“Clearsynth intends to be the catalyst in accelerated discover y via synthesis of complex and difficult to make compounds.

The company is dedicatedly developing future molecules to meet the requirements of pharmaceutical industry and targeting new sectors such as enzymes, natural extracts, vitamins, hormones and petrochemicals.”

Says Vijay Ambati, President & CEO, Clearsynth. Excerpts from the interview he had with Mahesh Kallayil.

Could you please tell us about Clearsynth's offering to Pharmaceutical industry?

Clearsynth is a technology based research driven enterprise, with World's Largest Inventory of Reference Standards & Research Chemicals. The company specializes in manufacturing of pharmaceutical chemicals like Stable Isotope Labelled Compounds, Metabolites, Conjugate Impurities & Innovative Organo-chemistry, custom synthesis of Complex Glucuronides. It is one of the leading companies which is developing chemicals using stable isotopes labeled compounds such as deuterium, oxygen-18 and others.

The Company involves in supplying complex internal standards for Mass spectroscopy LCMS use. The research chemicals are in compliance with global regulatory standards and high purity.

How are you currently placed in Global as well as Indian market?

Headquartered in Mumbai, India the company has state of the art research and development centers in Hyderabad, India and Mississauga, Canada. The R&D centers are well equipped with advanced equipments. The cGMP compliant R&D facility based at Hyderabad is operational since 2010. The site has its expertise in synthetic organic chemistry offering custom synthesis services scaling from mg to kg with over 200 chemical fume hoods 20 February 2017

Also, newly expanded R&D facility at Canada is fulifilling the requirements of North American markets. This center is in the forefront of Clearsynth efforts for a successful entry into the advanced regulated markets. At present we are the world's largest inventory of deuterium compounds with around 2800+ internal standards and supplying it worldwide for LCMS use in PKPD studies. The company is catering to 60 countries, across five continents serving 5000+ clientele. Our major clients are Roche Diagnostics, Agilent Technologies (Instrumentation), Defence Research organization, Eurofins(Analytical), Anapharm, Glaskosmithkline (Drug Discovery), Teva (Active PharmaIngredients), Syngenta Crop protection Munchwilen AG (Agrochemicals), and Pharmacopeial institutes.

Please apprise us your complete product portfolio/services provided by you and the market opportunities of these products/services in India and abroad?

Clearsynth supplies Certified Analytical Standards and High End Isotope Research Chemicals of high purity. It is engaged in Custom synthesis of Reference standards, complex & "difficult to synthesize" chemicals which are in compliance with global regulatory standards and high purity.

Pharma Bio World

interview Major product portfolio comprises of API standards, stable isotopes, metabolites, impurities, glucurondes, deuterated solvents & reagents and chiral standards.

Some of the other target compounds are intermediates, fine chemicals, phytochemicals, catalysts, inhibitors, peptides, NMR solvents and others.

Approximately 70 per cent of our revenues come from the pharma companies as the products we deliver help in quantitative analysis of medicines and biological molecules. Apart from pharma, clinical research organizations, Universities, Research Institutes, Veterinary Sciences, Testing Labs, forensics, Agriculture, Material Sciences, Defense, Geology, Hydrology, Archaeology, microchips, and semiconductor manufacturers are using our products.

What are the initiatives that you are undertaking currently to sustain the frontier position you have in the market?

For every product we deliver we ensure that it is supplied with certificate of analysis and other quality reports. With the pharma innovation at its peak, and rising consumers awareness, quality and sustainability is our primary goal. Further

affordable cost, faster delivery, and meeting clients orders on time is what we aim for. All our products are developed through treatment plant such as effluent Plant. Clearsynth R&D facilities is accredited to Environmental Management System certification ISO 14001-2004 which assures company to fall in line with significant environmental aspects.

How do you evolve the research and development to keep a pace with the changing dynamics of market?

Clearsynth adheres to the changing requirements by introducing advanced mechanisms and instruments. Recently the company has established High-Field Bio-NMR/ 600 MHz facility at its R&D LAB in Hyderabad. The advanced facility will give scientists an easier and quicker way of quantitative analysis like never before. The spectrometer is ideally suited for solution-state NMR studies on biological macromolecules like proteins and nucleic acids.

Kindly appraise us on your recent collaborations. How you think these deals going to help Clearsynth to strengthen its market presence?

Clearsynth is partnering with world's strongest R&D companies such as GSK,

Teva pharmaceuticals, Lupin Pharma, Dr. Reddys Laboratories to supply them with innovative molecules on timely basis. Client satisfaction is our utmost priority. The company is meeting their requirements for complex impurities, analytical standards and future molecules.

The high purity chemicals supplied by Clearsynth support advance research and quantitative analysis. Partnership with global giants motivates us to deliver better with each order.

What kind of structural change you envisage for the Indian pharmaceutical industry, as the biosimilar and generics are likely to play a dominant role now?

India has an immense capability of becoming manufacturing hub in coming years. Indian companies are among the world leaders in the production of generics and vaccines.

Both of these areas are becoming more important following accelerating chronic diseases such as Malaria, dangue, HIV and cancer. India's epidemiological profile is also changing, so demand is increasing for drugs of cardio-vascular problems, disorders of the central nervous system and other chronic diseases.

The R&D pioneers Lupin, Sun Pharma, Cipla, Zydus are conducting intensive research and partnering with global pharma companies to market their drugs outside of India. India is also the potential place for conducting clinical trials much more cost effectively than in many developed nations. By government's initiatives like new patent regimes which might provide better protection of intellectual property rights, new pricing policy by the government , local players might look for new ways to boost drug discovery, reducing time to market the products and squeezing costs along the whole value chain.

As a catalyst to Indian pharmaceutical industry, what in your opinion are the challenges in regulation that need to be addressed?

Pharma Bio World

February 2017 ď‚„ 21

interview

As the pharmaceutical innovation is at its peak, quality for the products has become a major concern.

The industry is facing stricter regulations on manufacturing and quality practices in the domestic as well as the international markets. Consumers are also becoming more aware about the significance of quality of the products.

For every product we deliver, there is a demand for certificate of analysis and quality reports along with it. Issues related to conducting ethical clinical trials and stringent GMP practices need to addressed.

How do you plan to leverage on GOI's Make in India initiative?

Healthcare has become one of the key priorities of the Indian Government and it is launching new policies and programmes to boost local access and affordability to quality healthcare. The policies will make India a growing market, a potential competitor or a partner in manufacturing and R&D, and a location for clinical trials.

22 ď‚ƒFebruary 2017

The arrival of Goods and Services Tax (GST) may prove to be a strong incentive for greater streamlining, which could have potential positive impact to the final cost of medications in a price-sensitive market.

However, India historically has a pharma supply chain with a number of stops between the initial production and final consumer.

Logistics comprises 45-55 per cent of the costs in the Indian pharmaceutical supply chain from factory to shelf.

In order to meet the needs of its vast population, Government should provide drugs at the right price with improvements to local supply chains.

Your thoughts on budget 2017's impact on Pharma industry?

Budget was balanced from fiscal incentives perspective and a regulatory angle. The Budget has a good number of positive measures aimed at offering incentives to different stakeholders. The Government has shown its clear intention towards fast-tracking inflow of FDI, and the scrapping of FIPB is a notable step that would go a long way in supporting

the objective of ease of doing business.

Certainly it missed certain agendas such as there has been no announcement on incentives to research innovation and active pharmaceutical ingredients.

Corporate Tax reduction and job creation proposal were also missing.

Kindly outline the future road map of your company.

Clearsynth intends to be the catalyst in accelerated discovery via synthesis of complex and difficult to make compounds.

The Company is expanding its footprint in markets beyond North America & Europe. It is dedicatedly developing future molecules to meet the requirements of pharmaceutical industry. The company is also targeting new sectors such as enzymes, natural extracts, vitamins, hormones and petrochemicals. It aims to be the global leader in synthesis and supply of isotope labeled research chemicals.

Pharma Bio World

interview

“We aim to sharpen our product offerings while ensuring innovation and keeping pace with industry trends�

RAM YELESWARAPU

TAKE Solutions Ltd embarked on a fiveyear transformational scale-up plan with a mission to significantly magnify its size and scale, amplifying its revenues by five-time to emerge as an USD 500 million enterprise.

Ram Yeleswarapu, President & CEO, TAKE Solutions elucidates more on this in an email interaction with with Mahesh Kallayil.

Could you please tell us about TAKE Solution's offering to Life Science industry?

TAKE Solutions (TAKE) is a leading, globally recognized, knowledge intensive technology and services player in the Life Sciences sphere, delivering comprehensive and niche solutions for over 15 years.

As a trusted adviser to global customers, TAKE Solutions offers IP-based software and extensive knowledge-based solutions to enable efficiencies in the functional areas of clinical, regulatory, and safety during the pre-approval and post-approval phases of drug development.

During the third quarter of FY 2017, TAKE Solution posted 38.4 per cent growth in revenue over the corresponding period in the previous year. What have been the growth drivers for the company and how do you see the business in the near foreseeable future?

We are optimistic of good growth in the foreseeable future on the back of drivers like regulatory mandates and guidance, increased adoption of technology by the industry to gain efficiencies and enhanced optimization.

More and more companies are launching R&D efforts

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for rare and ultra-rare diseases, unmet needs and special indications even if it translates to safe and effective medicines that enhance the quality of life for smaller cohorts of patients. Companies are looking to maximize their revenues by seeking regulatory approvals in more global locations and interacting with more regulatory agencies than ever before. A concerted effort by the global regulatory bodies to communicate among themselves as well as with the industry more efficiently is also leading to increased adoption of data interchange standards and to global initiatives to protect and preserve the integrity of pharmaceutical supply chain.

Please elucidate us on the five-year reinvention plan of TAKE Solution?

Having established ourselves as a credible and trusted partner to a multitude of global biopharmaceutical companies, we are keen to accelerate and amplify our successful delivery and superior outcomes to our marquee customer base. We believe we are strongly positioned in the global market to serve the Life Sciences industry on the back of our deep domain expertise honed over decades and evidenced by our excellent track record of successful delivery of strategic February 2017 ď‚„ 23

interview consulting engagements, technology solutions, and a range of functional services.

Our attempt as part of the growth surge and way forward would aim at becoming an industry leader and establish eminence. We aim to sharpen our product offerings and expand into existing accounts as well as add new ones via an expanded sales team and leadership, while ensuring innovation and keeping pace with industry trends.

Please share insights into your presence in Global as well as Indian market?

We are globally located in the US and EU markets which drive most our revenues today and we expect to continue to expand in these geographies. Our delivery centers located in India which are already tuned to delivering great results within product engineering as well as functional services, will continue to get expanded while leveraging best practices.

What are the key strengths of TAKE Solution to compete in these markets?

Our deep domain expertise, our ability to innovate, our culture of entrepreneurship, our innate desire to deliver excellence each time, and our people strength are the key factors.

What are some of the biggest challenges that pharma technology solution and service providers continue to face in India despite the fact that India is one of the major pharmaceutical market?

The Indian market continues to be predominantly focused on generic pharmaceuticals and driven by cost arbitrage. While some of the leading companies are investing, and adding to their R&D spend by enhancing their portfolios of biosimilars and NCEs, the spend continued to be small. Most of the existing solution and service providers are 24 ď‚ƒFebruary 2017

not necessarily geared to support them adequately in the areas of innovative R&D. Please brief us on the need for improved connectivity between IT and life science industry.

The Life Sciences industry like all other industries needs to adopt IT and use it effectively for efficiencies and optimization, along with ensuring transparency, quality, and compliance with global regulations.

For a long time, the industry did not invest adequately enough in IT and it is playing a fast and furious catch up game. A desire to grow the top line while ensuring superior margins and to remain competitive is driving them to increased use of IT across the various departments.

leveraged rapidly in order to make a difference in the global arena.

There is a notion among global market that Indian pharmaceuticals are not of reliable quality as Indian industry is not fully compliant with GMP. As a technology service provider, what's your comment on this?

Exceptions to quality and reliability exist in all markets. Realization and action supporting a move away from legacy practices, and alignment to best practices and industry trends with an aim to compete against global majors needs to be recognized. We are increasingly witnessing adoption of technology across various functions and industry groups, and consortiums are constantly discussing and educating the work force and leadership.

Do you think life science industry is still dubitative about how to use and make the most of the new IT scenario?

Why is that?

What, in your opinion, are the challenges in regulation that need to be addressed?

We believe they are slowly but surely coming around. Companies that do not believe in their core competencies, and are wary of transparency and accountability will have serious challenges if they do not adopt IT and join the club.

There are several considerations that need to be addressed for ensuring compliance with regulations. Starting with adherence to GxP, adoption of Total Quality and ensuring CAPA is implemented and practiced, to complying with transparency and accountability with audit trail enabled data and document handling, companies must address several initiatives

What kind of structural change you envisage for the Indian pharmaceutical industry, as the biosimilar and generics are likely to play a dominant role now?

Indian pharmaceutical industry is under pressure on the generic side of their business. Increased investments against an already low margin business are squeezing profits, and in the face of increased regulation and frequent audits, this will only worsen with time. A race to the bottom will be meaningless, unless they switch to innovation and investment in R&D efforts towards the high end of biosimilars and NCEs. India has an abundance of scientific human capital that needs to be

What are the hurdles before TAKE in its march towards its goal of improving outcomes in life sciences?

Appropriate packaging and positioning of the value propositions to global customers segmented by size and their approach to market, time to market, speed of execution while ensuring delivery excellence, and the ability to hire exceptional talent on a scalable and sustainable basis are some of the hurdles in our march towards our goal.

How is TAKE Solutions supporting the increased challenges of expanding global pharma supply chains?

Pharma Bio World

interview Our roots and legacy in dealing with complex manufacturing and supply chains, knowledge of Total Quality and Six Sigma, a good understanding of global regulations and compliance allow us to effectively support our customers in the face of increased challenges faced by them

biosimilars market, collaboration and codevelopment is becoming commonplace, vertical integration of capabilities, consolidation via M&A, in- and outlicensing practices on the global arena are all driving opportunities for service providers.

According to you what are the major common problems being raised by the small scale pharma industrial units in the country? What role does TAKE play for their solutions?

Going forward how do you see IT to transform the space of life science industry?

Across the industry, we have been assisting companies understand and implement QMS and CAPA systems for quality and compliance, data acquisition solutions to address R&D requirements encompassing clinical, regulatory, safety, and medical affairs, and several solutions to support the post approval life cycle management activities.

How would you describe the current scene of clinical trials and contract research industry from a global and Indian perspective?

These are exciting times to be servicing the clinical trials industry. With the number of clinical trials and the scope and scale of the trials rapidly expanding to observational studies and the need to back up claims with real world evidence, more investments are being made in R&D efforts. Increasingly, trials are being designed to address rare and ultra-rare diseases as well as unmet needs and in many cases afflicting small cohorts of patients. Regulators are demanding more data and from a well stratified patient population.

While cost pressures are driving companies to greater adoption of technology, innovation is becoming key and having a diversified R&D pipeline is a good risk-mitigating strategy.

Indian companies are steadily moving towards gaining market share in the attractive Pharma Bio World

IT is fast becoming a common denominator across the industry and we are already w i t n e s s i n g a t e c h n o l o g y r e f r e sh era where legacy, outdated systems are being replaced by cutting edge, cloud based, social and mobile enabled applications, driven by analytics and cognitive computing algorithms.

IT is helping process vast hordes of structured and unstructured data, and the power of data and insights will be increasingly harnessed for improving R&D efforts. The last mile connectivity to health systems, providers, payers, and patients and a bi-directional flow of information and a seamless exchange of real-time information will define the future of safe, effective, and affordable healthcare.

While there have been no specific announcements pertaining to Life Sciences, the overall implications of GST and improvements in manufacturing will lead to newer opportunities.

How do you intend to steer the growth of TAKE Solution in the years to come?

We aim to be a $500 million Life Sciences company, serving delivery excellence and superior outcomes to a marquee set of global customers, while steadily driving profitability and growth. We are well positioned to take advantage of the decades of good work we have tirelessly delivered to our customers and build upon the legacy we have established as domain experts and trusted advisors to the industry.

How do you plan to leverage on GOIs Make in India initiative?

We are a global player with a firm foothold in India and have a history of delivering success and value to our customers in India. While being very local to the US and EU markets and fully sensitive to and informed of market and regulatory trends, we bring the very best of design and innovation to fruition at our engineering and delivery centers in India. We have been steadily investing in building human capital and other assets on a global basis and are equipped to leverage the best of available resources.

Your thoughts on budget 2017's impact on life science industry February 2017 ď‚„ 25

The Evolving Role of Pharmacovigilance Pharmacovigilance is a critical component for determining the benefit to risk ratio of treatment.

The potential for drug toxicity is determined throughout the lifetime of use of a drug or biological agent, including the development cycle. This includes both the preclinical as well as clinical data.

This article defines the science of pharmacovigilance and the process of adverse event reporting and reviews the new directions that pharmacovigilance has taken.

T

he World Health Organization (WHO) defines Pharmacovigilance as "The science and activities relating to the detection, evaluation, understanding, and prevention of adverse reactions to medicines or any other medicine-related problems".

Pharmacovigilance, shortened to PV, is the scientific and detailed study of collecting, monitoring, researching, assessing and evaluating pharmaceutical products. The word Pharmacovigilance comes from Greek and Latin words; Pharmakon (Greek) which means Medical Substances and Vigilia (Latin) which means To keep watch. All the information given by the healthcare providers and patients, are the main key to perform the Pharmacovigilance process.

The main purpose of this in Pharma industry is to improvise patient's care and safety in relation to the use of medicines.

It is very important to understand all the paramedical and medical interventions in order to serve good and safe public health. Pharmacovigilance assesses the beneficial and harmful attributes of the medicines that further indicate about their rational and safe use. It also promotes the clinical training and education involved in it. Thus, it helps in communicating effectively to the public and health professionals.

Ketan Zota Director Zota Healthcare 26 February 2017

Developed countries are actively involved in using the concept of Pharmacovigilance and the statistics by these countries have indeed focused on the issues and highlighted the benefits incurred. But under developed or lower income countries have major health issues that aren't being rectified because of their major setback. Such countries are in complete need of Pharmacovigilance.

Indulging this concept into the health infrastructure of such countries will help them generate reliable supply and quality of medicines, trained essential healthcare staff and proper access to its education, communication and technology.

Pharmacovigilance is very important for every healthcare professional to have an acute knowledge of every drug. Proper data documentation, drug benefits/risk profile, and other practices should be incorporated well in the Pharmaceutical industry. Hence knowing about every step of the Pharmacovigilance Management cycle will be an advantage for every health organization to educate every patient clearly about every drug.

To understand the topic in a well manner, there are certain terminologies used and are further categorised according to the health situation.

1. Harm Occurred.

Terms and its definitions: • • Adverse Drug Event (ADE)-Harm caused by the use of drug.

• • Adverse Drug Reaction (ADR)-An unintended reaction to a drug taken as a normal dose.

• • Serious Adverse Event (SAE)-An event which is fatal or life threatening.

2. Harm may have occurred.

• • Terms and its definitions: • • Medication Error-A preventable event that may cause harm to the patient.

3. Harm did not occur.

• • Terms and its definitions: • • Potential Adverse Drug Event - Situations that may cause harm by using the drug but does not harm the patient.

The above mentioned terms are frequently used to explain and understand the concept of Pharmacovigilance. It is very essential to deeply understand these terminologies Pharma Bio World

in order to avoid misconceptions. But the main three are ADE, ADR, and Medication Error that sums up the core elements of Pharmacovigilance.

What is Adverse Drug Event (ADE) in Pharmacovigilance and how is it important?

An Adverse Drug Event (Event) is defined as the harm caused by the overdose or overconsumption of drug. It may also be caused from the use of drug for discontinuing or reducing the dose of any drug therapy. It is precisely defined as an "injury caused by using a drug". This can also be a result of a medication error, but such scenarios hold a rare chance. The study of ADEs in patients during clinical trials must be recorded with the education sponsor or can willingly be given to the local ethics committee as well.

There are types of ADEs:

•• •• •• •• •• •• ••

Serious Non-Serious Expected Unexpected Study-related Possibly study-related Non study -related

Reporting all the types of ADEs plays a major role in Pharmacovigilance. Without these reports it becomes a difficult scenario to conclude the situation. The reporting of ADE involves data entering, triage, assessment, receipt, distribution, and archiving all ADE documentation.

After ADE, it is Adverse Drug Reaction (ADR) that educates about how reactions are caused during the process of Pharmacovigilance.

ADR is defined as the side-effect or adverse reaction after drug consumption.

It is broadly defined as the unwanted, uncomfortable, or dangerous effects that may be caused after consuming the drug.

The toxicity of the drug exceeds than the normal which leads to a situation of ADR. The over-ingestion of any drug reacts

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first with the blood levels resulting into an adverse reaction. It is very important for every healthcare provider to have knowledge about all possible risks and benefits of every drug. An ADR can be detected by paying attention to the patient's progress graph after consuming the prescribed drug. The types of ADR are classified as:

•• •• •• •• ••

Type Type Type Type Type

A - Augmented Reactions.

B - Bizarre Reactions.

C - Continuing Reactions.

D - Delayed Reactions.

E - 'End-of-use' Reactions.

The intensity of an ADR also depends on patient's characteristics (age, sex, ethnicity, genetic factors) and drug factors (type of drug, composition, dosage, bioavailability, etc) Apart from ADEs and ADRs, Medication error is another main element of study of Pharmacovigilance. Here the latter is comparatively easier to rectify than the others. The possibility of harm caused is less and can also be prevented at the right time. But a single error can also lead to major harmful situations.

A medication error is further defined as an unorganised prescribing, administration, and dispensing of drugs. It is not an obvious scenario for such errors to cause harm to the patient but the negligence might lead to inappropriate use of the drug by the healthcare provider, and this might cause harm to the patient as well.

Following are the causes that lead to a medication error:

•• •• •• •• •• •• ••

Unavailable Drug Information.

Incomplete Information of Patients.

Inaccurate Recording.

Inaccuracy in Transcribing Orders.

Unclear Labelling of Drugs.

Inadequate Knowledge of Drugs.

Deadline Pressure.

It is very important for every drug developer to consider a Pharmacovigilance plan during its first stage itself in order to

rectify the errors done and possible errors in time. Where Adverse Drug Event, Adverse Drug Reaction, and Medication Error give detailed insight to Pharmacovigilance, there are few other main elements that are equally important to educate every patient and healthcare provider with. Following are the other main elements that create a complete Pharmacovigilance: 1. Individual Case Safety Report.

A report that gives a detailed description of every doubtful adverse reaction by the administration of one or more drugs to an individual patient.

There are four elements of the ICSR An identifiable patient, An identifiable reporter, A suspect drug, and An adverse event. These four elements are important to be determined during the triage phase of a potential adverse event report.

2. MedRA. It is the Medical Dictionary for Regular Activities. MedRA is mapped from WHO-ART, the WHO Adverse Reactions Terminology. It is a medical coding dictionary that is used to convert adverse reactions information into terminology that can be easily analyzed and identified.

3. Clinical Trial Reporting.

Clinical Trial Reporting is the safety information about every drug used while performing a clinical trial. This kind of reporting is also known as Serious Adverse Event (SAE) reporting of clinical trials. The drug's effectiveness on human or in simpler terms drug's safety is the main component to consider while deciding the drug's market approval and presence. Every drug authoriser must have a keen eye on the details of every drug.

4. Aggregate Reporting.

Also known as periodic reporting, aggregate reporting plays a very

February 2017  27

important role in safety assessment of drugs. The records of aggregate reporting are a compilation of the safety drug data. These data's can be of a longer time period such as months or years. The main advantage of Aggregate Reporting is that it gives a broader view of drug safety.

Pharmacovigilance process in simpler words is defined as assessing the benefits and evaluating the risk. The evaluation of risks should begin at the preclinical stage of a medicinal product and it should extend throughout the life cycle. There is now added focus on safety and risk assessment after a product has received regulatory approval, when it is placed on the market and prescribed to large populations.

Although there is no international standard that dictates the components of an adequate Pharmacovigilance

system or the processes to be engaged in risk management, there is consensus among the major regulators that Pharmacovigilance is necessary and important in the development and commercialization of medicinal products.

Risk management in Pharmacovigilance is the main discipline that is responsible for signal detect and monitoring the risks and benefits of every drug profile.

Risk management is a compilation of Risk Management Plans (RMPs) and other aggregate reports such as Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR), and Periodic BenefitRisk Evaluation Report (PBRER).

Following are the other few elements under Risk Management that play a key role to carry out the process of Pharmacovigilance with an ease:

• Causality Assessment.

• Signal Detection.

• Risk Management Plans.

• Risk/Benefit Profile of Drugs.

A drug provider and analyzer should always make the patients and other healthcare providers understand the benefits and risk of every drug. A patient's reaction and effect after consuming any drug should be keenly heard by the drug provider and provide the patient's with solutions that can alter the possibility of the harm.

ontat infoariaprgmail.com

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Clinical trials are prospective biomedical or behavioral research studies on human subjects that are designed to answer specific questions about biomedical or behavioral interventions (novel vaccines, drugs, treatments, devices or new ways of using known interventions), generating safety and efficacy data. They are conducted only after satisfactory information has been gathered that satisfies health authority/ethics committee approval in the country where approval of the therapy is sought. In the March issue of Pharma Bio World, we intend to cover news and views of industry honchos that address trends, issues and opportunities pertaining to Clinical Trials.

To ensure Pharma Bio World continues to meet your needs, we would appreciate your feedback.

Please feel free to write to us at mahesh_kallayil@jasubhai.com if you think we can serve you better.

28 February 2017

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Pharmacovigilance in India: An Overview The origin of pharmacovigilance in India goes back to 1986, when a formal ADR monitoring system consisting of 12 regional centers, each covering a population of 50 million, was proposed for India. This article provides a brief overview about the current situation and the future prospects of pharmacovigilance in India and analyses importance of implementing proper pharmacovigilance in the Indian context.

Pharmacovigilance in India has come a long way. A formal system for adverse drug reaction monitoring started in 1986. There were 6 regional centers then, viz., Mumbai, New Delhi, Kolkata, Lucknow, Puducherry and Chandigarh. Three institutes are linked to the Uppsala Monitoring Center of WHO, viz., KEM, AIIMS and AMU. In 2004 CDSCO or the Central Drug Standards Control Organization established the National Pharmacovigilance Program with sponsorship from WHO and the World Bank. There were 2 zonal, 5 regional centers and 24 peripheral centers. Due to lack of funding it folded up in 2008.

In July 2010, the PvPI or Pharmacovigilance Program of India began in AIIMS which was the National Coordination Center for reporting adverse drug reactions.

Later it was shifted to the building of the Indian Pharmacopoeia Commission (IPC), Ghaziabad. Doctors in India get SMSes from PvPI from time to time alerting them to some clinically relevant adverse events reported with some drugs.

Dr Viraj Suvarna Medical Director Boehringer Ingelheim India Pvt Ltd

Indu Nambiar Senior Manager - Local Pharmacoviglance LPVM, Boehringer Ingelheim India Pvt Ltd Pharma Bio World

CDSCO expects companies to report to PvPI adverse events that occur, both during clinical trials, and during clinical practice (spontaneous adverse events). This practice helps in further characterizing a drug's safety profile. PV is a discipline which starts from the time a drug is discovered or invented, continues through its clinical development till it gets marketing authorization approval, and lasts for as long as the drug is in the market. In other words, PV is with you when you cross the road and even when you reach the other side (there could be potholes in the footpath).

So what exactly is meant by Pharmacovigilance? It is the science of being vigilant about a drug's safety profile. It is not enough to preach pharmacovigilance. One should practise what one preaches too. Over the years

drugs have been made safer for patients.

It is time to make patients safer for drugs. Pharmaceutical companies need to inform doctors about the benefits and risks of their products so that the doctor knows how to select the right patient for the right drug. In effect, they need to tell doctors where not to prescribe the drug too.

The locally approved prescribing information of a drug is available as a pack insert inside the pack of the product as a leaflet. However, this pack insert is with patients who buy the drug. The information in the pack insert is actually meant for the prescribing doctor looking at the way the language is so medically intensive. It is therefore imperative that the pharmaceutical company medical representative leaves behind the label of the drug with the prescribing doctor, as an LBL (Leave Behind Label). Ideally the medical representative should 'detail' salient features of the label (eg, dosage form/strengths, indications, contraindications, warnings and precautions, undesirable events and dosing recommendation) to the doctor and then leave it behind.

The doctor can sign and rate the medical representative on his/her detailing of the label on a tear-off that the medical representative can then send back to his/ her company. This can also protect the company just in case the doctor uses the product in an off-label indication which has undesirable consequences for the patient. It is important that a company should never promote its products in offlabel indications. A doctor may prescribe a product in an off-label indication, only when there is no other alternative, there is a credible medical body of evidence that justifies its use, and the doctor conducts informed consent as a process.

February 2017 ď‚„ 29

There is nothing adverse about reporting an adverse event. Not reporting an event can have adverse consequences, especially for the pharmaceutical company as and when they are intimated about the event. Doctors can and should report in confidence and with confidence.

The PvPI website has an adverse event reporting form, in different languages, separate for physicians and patients, that can be downloaded by anyone and used to report the event to PvPI. The Oxford Textbook of Clinical Pharmacology, in its chapter on adverse events, starts with the maxim that, "unless a drug is capable of causing some harm, it is unlikely that it will have much of an effect." In other words, there is no drug which does not have a single adverse event. One can have adverse events even to a placebo, when it is sometimes called a nocebo. Let us all understand that when a doctor decides to prescribe a drug to a patient s/he has evaluated the benefit to risk ratio of the drug and found it to be positive.

What is an adverse event and how is it different from an adverse drug reaction?

In the case of the former there is a temporal association of the event with the drug but it need not have a causal relationship. In the case of the latter, the causal relationship has been determined by a process which includes drug dechallenge when the event abates and drug re-challenge when the event recurs. For obvious reasons drug re-challenge is not always attempted.

A serious adverse event is one that results in death, or is life-threatening, or results in hospitalisation or prolongation of existing hospitalisation, or which leads to significant or persistent incapacity or disability or which results in a congenital anomaly. In addition, any important medical event may also be considered a serious adverse event if one has to take urgent medical or surgical measures to prevent one of the above five outcomes.

30 ď‚ƒFebruary 2017

In an investigator's opinion if the event is adjudicated to be a serious adverse event then it is also considered a serious adverse event.

In a clinical trial, the investigator is asked to decide whether the event is related or not related to the trial or drug used in the trial.

There is a third box which the investigator can tick if s/he is not sure whether the event is related or not related to the drug.

This is taken to mean that the event might be related to the drug and is clubbed with those events marked as related to the drug; only to be on the safer side.

Also, if any adverse event happens in the 28-30 day period after the last dose of the study drug, it is still taken to mean that the event could be related to the drug as it takes about five half-lives of a drug to fully exit a patient's body, and sometimes the effect of a drug may outlast its physical presence in the body (hit and run drugs, eg, aspirin irreversibly acetylates platelet cyclo-oxygenase, and even if aspirin is no longer in the patient's body, the platelet cyclo-oxygenase enzyme is irreversibly inhibited so the effect of aspirin lasts much longer, viz., about 2 weeks, till new platelets are synthesized; platelet life span is 8-11 days).

In short, during clinical trials, conscientious companies take a lot of pains to ensure safety of the study participants. When translated to the less standardised world of clinical practice the safety profile may change and hence it is important that one continues this safety surveillance for as long as a drug is on the market.

No matter how well a drug is studied in the controlled environment of a premarketing randomized clinical trial, postmarketing surveillance (observational, non-interventional, naturalistic setting) will always be needed to unearth rare adverse events.

When a doctor asks a pharmaceutical company how many adverse events have been reported on the company's product,

the answer is always accompanied by a disclaimer that one cannot use this information to estimate the incidence of the adverse event because at any point in time one does not know whether all adverse events of that nature have been reported, at any point in time one does not know how many patients have received the drug, and one is not always able to assess the causal relationship of the drug with the event. Though, in the case of spontaneous adverse events on marketed drugs in the real world, causality is taken to be implied.

It is not always that an adverse event is harmful. Sometimes it could just be a side effect, eg, dryness of mouth and nose with anti-histaminic drugs that also have anticholinergic properties. At times the side effect can be developed into an indication as happened with Viagra (sildenafil citrate) which was developed as an anti-anginal and then when patients in the trial experienced an erection as a side effect, it was developed as a treatment for erectile dysfunction.

Sometimes as with some targeted therapy in cancer, development of a side effect may indicate that the drug will be more effective in that patient, eg, skin rash and cetuximab or hypertension and sunitinib.

All this is fine but do patients, doctors and pharmaceutical companies in India report all adverse events? There is certainly scope for improvement. Doctors sometimes believe that if they report an adverse event they might get into trouble. Especially, if they use the product, not per its prescribing information. Or they feel that the event is only to be expected, eg, diarrhea with antimicrobials, as it is listed in the product's locally approved prescribing information.

But all events need to be reported so that one can fully characterize the safety profile of a product. It might lead to changes in the prescribing information and can even lead to withdrawal of a product. It was an astute doctor who first observed the gray baby syndrome with chloramphenicol.

And then he traveled the length and

Pharma Bio World

breadth of his country and tracked many more such events to make all aware of this adverse event.

Pharmaceutical company medical representatives are sometimes scared to report events thinking it might lead to loss of sales. However, they should realize that not reporting events can have this end result.

The doctor may stop writing the product, stop writing other products of the company or even tell his/her other colleagues about it, telling them not to write the company's products.

Reporting the event shows the doctor that the company is serious about its commitment to doctors and patients. The PV professional and medical affairs colleagues, based in head office and in the field, get in touch with the doctor, provide him with information on similar adverse events, and with this wealth of safety data, from both RCTs and in the real world, the doctor is reassured about the safety profile, and continues prescribing the product.

The pharmaceutical company can come out with patient profiles where the drug should Pharma Bio World

not be used. Or an eligibility score which can then be validated in the real world.

Even within a drug's label, there could be patients who respond to a drug optimally, in terms of safety, efficacy or both. And there could be some patients within the label who do not respond optimally. The pharmaceutical company can delve into its clinical trials database and try and correlate response of patients to clinical characteristics. Ideally the company should communicate this information to doctors so that they in turn can use this information to ensure the best patient is selected who can get optimal benefit from the drug. This enhances credibility.

The PV team can use this market intelligence to feedback to the brand teams at regular core committee on safety monitoring meetings, where risk management is also discussed. The PV team can facilitate drug utilization evaluation studies in the real world.

Sometimes a risk management plan may need to be in place as demanded by the regulator. At times the regulator may ask for a risk minimization action plan (MAP),

for products that are extremely critical but have serious adverse events associated with their use. Basically, a risk MAP ensures that the benefit to risk ratio is always positive.

The PV team must do field work which will help gain customer insight (eg, a drug safety poster can be a useful item to grace the wall of a doctor's clinic) and bring the doctor closer to the company as PV is also a core competence. It is in effect the seat belt of a company, not coming in the way of fast paced growth, but protecting the company from accidents.

PV is not just about reporting an adverse event on time and with due quality and completeness (initial and follow up). It is more than this. The PV professional must interact with her/his medical affairs and medical information colleagues and provide the reporting doctor with the requisite information that helps the doctor choose the right patient for the right drug.

Contact: pallavi.srivastava@mslgroup.com

February 2017 ď‚„ 31

Unlocking Business Efficiency through Proactive Asset Management This article discusses how the processes of asset redeployment, as well as the buying and selling of surplus and idle laboratory and production instrumentation can benefit the pharmaceutical industry.

T

he global pharmaceutical market is growing 7.8 per cent year on year and is estimated to be worth around USD 1.6 trillion by 2020. As the world's population continues to grow and age, so will this industry 1. At the same time, pharmaceutical companies are facing a range of challenges which are forcing them to reduce both time to market and costs.

For instance, more stringent healthcare regulations are being introduced and payers are putting pressure on companies to adapt their pricing policies and commercial models.

Mergers and acquisitions are becoming more common-place, which means that equipment can fall out of use even though they remain valuable for a variety of uses such as drug discovery, manufacturing and the packaging of commercially available products. Additionally, new products are constantly being launched across the sector, meaning that instrumentation needs are also evolving.

An Innovative Solution

Ben Potenza VP Marketing EquipNet Inc. 32 ď‚ƒFebruary 2017

An increasing demand from pharmaceutical businesses for low-cost laboratory and manufacturing instrumentation solutions has resulted from the need for companies to focus on leaner production, as well as meeting the fluctuations in demand.

These pharmaceutical companies are now beginning to purchase high-quality, used equipment in order to expand into new production areas, as well as to maximize budget; it is common to save between 50-75 per cent of the cost of new instrumentation.

Furthermore, the advantage with purchasing second-hand equipment is that

it is often available immediately, unlike new instrumentation 2.

In order to obtain returns from surplus machinery, time and expertise is needed.

Many pharmaceutical companies do not have this however and implementing a partnership with a specialist provider can help to execute an asset management strategy. These asset management experts can provide useful information on budgets, specification and risk mitigation (how reputable a supplier is, for example). Industry experts can then guide companies through the purchasing process by helping them to obtain existing warranties on equipment and provide follow-up support allowing an efficient process for the purchaser.

EquipNet provides a holistic approach to surplus asset management for both buyers and sellers and this is illustrated in the EquipNet 'Value Control Model' (See Figure 1 on next page), which is based on time and can be customized using a central tracking platform. This provides communication and workflow tools and ensures the exposure of all assets throughout a business. A variety of disposition channels, which include redeployment, negotiated sales with managed pricing through an online market and competitive auctions can also be used. Other options include clearance, disposal and scrap programs, which can be customized for each specific customer.

To redeploy equipment and keep track of surplus assets, partners should possess a reputable software platform to list assets across a business. A company can then view all equipment across a variety of locations worldwide.

Pharma Bio World

Redeployment Redeployment of instrumentation allows businesses to gain the highest possible value from equipment and is hard to achieve without a central tracking platform. This software allows users to post, track, identify and then internally redeploy an instrument that is laying idle or not being used in its current location.

Should this not be possible a company can then decide whether the external sale of equipment or the purchase of another instrument is necessary.

A proven example of a tracking platform used within this market is EquipNet's Asset Redeployment Management System (ARMS') platform, which features workflow management and multiple access levels for employees across a business, including plant managers and executives.

ARMS can provide in-depth information on the equipment a business currently owns and which site it is located at.

Looking to Sell?

Should the redeployment of an asset not be possible, a company should then look to sell the instrument. An auction is a reliable way to sell equipment. Dealing with the auction process however is difficult and success depends on a number of factors. An asset management partner can provide advice on how to approach this process for each individual customer.

            

Pharma Bio World

Therefore, using a company with specific industry experience and a good reputation is important. Options can include online auctions, live/webcast auction events, sealed bids and private treaty events. Further customized solutions for selling equipment include EquipNet's MarketPlace platform. MarketPlace lists used equipment available for purchase, however, in contrast to auctions, which are scheduled events for selling a large group

February 2017  33

of used equipment from client facilities, MarketPlace allows price negotiation for an instrument at anytime.

Should it not be possible to redeploy assets as they have little or no value, clearance by donations, scrap and environmental recycling are the best options. It can be the case that the scrap value of idle equipment can achieve the highest return. It is common for EquipNet to advise clients in this area.

The purchase of second-hand equipment Pharmaceutical companies now face the ever more difficult challenge of meeting rising demand, as well as more rigorous commercial targets. All kinds of businesses are now taking advantage of the savings to be made from purchasing pre-owned equipment from top-tier manufacturers. This is in contrast to constantly buying new instrumentation.

Buyer companies therefore, often invest in high-quality second-hand instrumentation in order to maintain a low cost-base while continuing to improve company processes and services. Asset management partners can inform businesses of appropriate auctions, as well as how to use negotiated sales platforms such as MarketPlace.

Collection and delivery are all that need to be organized following the purchase of equipment.

Summary

also able to purchase unwanted, highquality equipment for a fair price. An asset management partner can therefore provide important solutions for companies looking to redeploy, sell and purchase surplus assets.

Reference PwC-http://www.pwc.com/gx/en/industries/ pharmaceuticals-life-sciences/pharma-2020/ vision-to-decision.html NiceInsight-http://www.niceinsight.com/articles.

Contact: tmg@scottpr.co

As the pharmaceutical sector continues to grow, businesses are keen to further reduce time to market, as well as costs.

Redeploying and selling equipment with a reliable asset management partner can help businesses obtain the maximum returns on an instrument, as well as ensure operational efficiency. Buyers are

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34 ď‚ƒFebruary 2017

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Why Pharma Taking Interest in Nutraceutical Industry?

The nutraceutical industry globally can expect rapid growth, faster than pharma, and has a great future in India. As pharmaceutical products can cost much more than nutraceuticals, the size of the industry in monetary value terms may seem higher, but the reality lies in the volume of production.

Nutraceuticals are consumed every day of the year as they are meant to keep one from falling sick. Nutraceuticals industry will overtake the worldwide pharmaceutical industry in volume in due course.

H

ippocrates stated around 2000 year ago "Let food be your medicine and medicine be your food". India has a rich heritage of natural resources and pioneers in its knowledge of ayurveda and herbal medicines from ancient time.

Currently, people have started showing interest for their health and fitness. For this they are preferring options like diet, nutrition and functional ingredients of natural origin, with no side effects.

The term "Nutraceutical" was coined in 1989 by Stephen De Felice, he defined Nutraceuticals as a "food, or parts of a food, that provide medical or health benefits, including the prevention and treatment of disease". Nutraceuticals may be used to improve wellbeing, increase life expectancy, prevent cardiovascular diseases, or support the overall health of the body. Nowadays, Nutraceuticals has received considerable interest due to potential nutritional and therapeutic effects without causing any harmful effects. Some popular Nutraceuticals that are yogurt, green tea, ginseng, omega-3, lutein, folic acid, and cod liver oil. Majority of the Nutraceuticals possess multiple therapeutic properties for example green tea is good for inducing fat loss, improves brain function and include many other benefits.

Both this "supply" and "need" based scenarios are supporting the nutraceutical industry and are motivating the researchers and businessmen for the development of more and more new nutraceutical formulations.

Dr Samidha M Pawaskar Dean, Research & Extension Head Department of Biochemistry K J Somaiya College of Science and Commerce Pharma Bio World

The pharmaceutical and fast-moving consumer goods (FMCG) giants have mapped this business opportunity and started dominating the Indian market. These industries showcase

Nutraceuticals, functional foods and beverages sector as an extension of their healthcare sector. In the process these pharmaceutical companies began to lead the dietary supplement category.

A dietary supplement is considered as a product that bears or contains one or more of the following dietary ingredients: A mineral, a vitamin, an amino acid, a medicinal herb or other botanical, a dietary substance for use by human to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients Nutraceuticals, which do not pose an environmental hazard, may be easier and faster to market. Promotion of Nutraceuticals industry will also boost agricultural sector.

Farmers could gain from raising specialty crops such as garlic, cranberries and chicory with disease-fighting properties. Numerous new businesses are taking advantage of promising new markets for medicinal foods.

In contrast to Nutraceuticals, pharmaceutical companies need to follow stringent rules and regulations. Their drugs have to undergo extensive test procedures to check the bioavailability, efficacy and toxicity of the product that they plan to introduce in the market.

To bring a medicine to market can take about 10 years and may cost enormously whereas to market an unlicensed nutraceutical can take just fraction of this. No such strict norms are applicable for nutraceutical industry.

Also, pharmaceutical products cost much more than nutraceutical products because there are pricing norms in pharmaceutical companies, wherein there is a ceiling on MRP, based on the manufacturing cost of the product.

February 2017 ď‚„ 35

Moreover, the market demand for the pharmaceutical products (which falls under the curative medicine category) is low i.e., one generally will consume the product only when one falls sick, on an average 15 days in a year. In contrast, the ever increasing nutraceutical sector has a great market potential as the nutraceutical products can be consumed on daily basis to meet the RDA (recommended dietary allowances) of the body.

accepted practical guidelines could provide a positive impact on the outcome of future nutraceutical trials. Subjecting these products to the same quantitative levels of control and regulation required for pharmaceuticals would be too restrictive and would negate the need for this special category of medicines.

Nevertheless, qualitatively similar controls would allow better research, greater safety, and increased clinical benefits from Nutraceuticals.

Hence the use of Nutraceuticals, as an attempt to accomplish desirable therapeutic outcomes with reduced side effects, as compared with other therapeutic agents has met with great monetary success. The preference for the discovery and production of Nutraceuticals over pharmaceuticals is well seen by pharmaceutical and biotechnology companies.

The combination of nutraceutical formulation along with the pharmaceutical drug can now be an opportunity in pharmaceutical industry, example there can be an anti-carcinogenic drug which can be taken along with some nutritional supplement or extract of some plants having anti carcinogenic activity. If outcomes for such combinations will be effective then the patients would prefer combination therapies rather than taking nutraceutical and pharmaceutical drug separately. Another example can be vitamin D when taken with bisphosphonates class as osteoporosis drugs, may prove to be more effective than when taken singly or separately.

Nutraceutical however, is no new concept, it has always been around and practised by many mothers around the globe, but only after being given a fancy name tag is it suddenly in the limelight. Nutraceutical has potential benefits of becoming the most popular sector in the near future and now itself the products are selling like hot cakes. Nutraceuticals has many cures which are under stringent study and can be implemented in the future bringing commendable benefit to all mankind in general in a nutritious and organic way.

Nutraceuticals and related complementary therapies clearly have beneficial biological and pharmacological effects, but long-term stability and safety is largely unproved. This is not the case with pharmaceutical products which have long term safety & stability. Also for harnessing the optimal benefits from these products while preventing adverse reactions will increasingly require the better standardization of dosages and formulations. Strategic research planning and the development of internationally 36 ď‚ƒFebruary 2017

The multinational food companies now have their own scientific research institutes. They have sales forces selling some of their products to physicians.

However this doesn't mean that pharmaceutical is out of the game yet, but only that there is some new non-traditional competition in the area. The next few years will be an interesting time to be involved in the dynamic Nutraceuticals space.

Pharmaceuticals and nutraceutical companies need to focus on now on the "product innovation". India will be a strong market for such nutraceutical products.

Convergence of food manufacturing companies with pharmaceutical companies to manufacture and market nutraceutical or functional food products would be another emerging trend that would catch on in the near future.

Contact: pr@aarohancommunications.com

Few other drawbacks of nutracueticals are chances of self-medication, misleading advertisement, pricing, etc. Self-medication can be harmful if patient try to treat themselves using nutracueticals product during chronic disorders. Irresponsible advertising related to tall health claims may mislead the consumers. Nutraceuticals are produced from natural plant extracts, the process of extraction of Nutraceuticals product from plant sources is tedious and time consuming, and hence the products may be overpriced for common man.

Institutional focus on drugs and internal regulatory are two major areas that seem to challenge most pharmaceutical companies today which also leading them move into the nutraceutical space.

Pharma Bio World

news features

Budget 2017-18: Reaction from Pharma Industry Leaders

U

nion finance minister Arun Jaitley's budget for the year 2017-18 was definitely unique even historic in many ways. It was presented on a much earlier date of 1 st February as opposed to the usually date of 1 st March. If this wasn't enough, this budget is also special, as for the first time, the Railway Budget was not a separate event and incorporated into the General Budget. The Union Budget 2017-18 has evoked diverse reactions from pharma veterans as Budget come as a mixed bag for Indian pharmaceutical sector. While there is a certain positive momentum that the Government has highlighted in relation to the healthcare delivery elements in the budget, some are unhappy with the lowering of tax on medium and small scale enterprises, something that is likely to give a fillip to the domestic pharma sector. Here are some reactions from industry stalwarts;

“OPPI welcomes the commitment of the Government to - reduce infant and maternal mortality rates; eliminate certain diseases like TB, leprosy, measles and filaria and make structural reforms in medical practice and education. The Government’s intention of transforming 1.5 lakh health sub-centres is encouraging. We also appreciate the Government’s intent to amend the Drugs and Cosmetics Act which will be a step towards ensuring patient safety.

We had some expectations from the Union Budget 2017-18, given the Government’s past stated intentions of improving access to healthcare. Yesterday’s World Economic Forum said that that India’s public spending on healthcare is much lower than the global average. It is unclear whether the allocations will adequately address current healthcare challenges. We also hoped for some reform announcements on the regulatory front in the form of weighted deduction on R&D, incentives for patents, exemptions of certain duties and taxes, etc.”

Kanchana TK Director General Organisation of Pharmaceutical Producers of India (OPPI)

Overall, the Union Budget 2017 that was presented earlier today is a step in the right direction. While it has focused on economic reforms & liberalization of the economy, it has also allocated funds to bring more irrigation, roads, electricity and sanitation to rural India. Even though the economic survey paints a sober picture for 16-17 primarily due to a weaker second half, the budget provides the necessary impetus to sustain GDP growth at over 7%. Lowering tax on MSME’s Glenn Saldanha Chairman and Managing Director Glenmark Pharmaceuticals Ltd.

is a welcome step that would provide a much needed fillip - by creation of jobs and putting more money in their pockets in all sectors including Pharmaceuticals.

Government has shown its clear intent towards fast-tracking inflow of FDI, and the scrapping of FIPB is a notable step that would go a long way in supporting the objective of ease of doing business. Additionally Government’s impetus to reduce the borrowing cost and increase access to credit will surely help businesses to grow. We see the biggest ever allocation to the Infrastructure sector which would benefit all sectors, including the fast growing pharmaceuticals. The finance minister reiterates his commitment to keep current account deficit and fiscal deficit under control GST implementation as soon as possible.

Pharma Bio World

February 2017  37

news features “The Budget presented by the Finance Minister is a positive one, without being game changing.

There is no strong thrust or focused measures to bolster the healthcare sector, apart from a mention about improving rural health infrastructure with 1.5 lakh sub centres being upgraded to health and wellness centers and setting up of 2 more AIIMS. Some amendments have been proposed to the Drugs & Cosmetics act to provide a fillip for generic medicines but the details need to emerge on what exactly is being proposed. That said, one hoped for more decisive announcements to boost the sector, which did not happen.

Satish Reddy Chairman Dr Reddy's Laboratories

The abolition of the Foreign Investments Promotion Board (FIPB) is a big move as it was an impediment to FDI. Initiating reforms have been talked about in this area to increase fund flows into the economy, so we will need to see how the new policy unfolds.

Political Funding was addressed at last by capping cash donations. This is a long overdue step as it is impossible to tackle corruption without cleaning up at this level. The simultaneous introduction of electoral bonds is also a welcome move. Also, much awaited reforms in higher education have been set in motion which will provide access to quality education to students from across the sections.”

“The much awaited Union Budget 2017-18 on the back of demonetisation has a balanced approach to the healthcare sector. A 27 per cent increase in outlay for healthcare is a positive move by the finance minister but still misses the 2 per cent of GDP healthcare spend by the Govt.

The reduction in the cost of life-saving drugs and widening the availability of essential drugs is also in the right direction. The announcement of 5000 new PG seats in medicine should have been backed by significant reforms and policy change in medical education.

The budget is once again silent on giving boost to healthcare infrastructure. Like low cost housing, healthcare should have been given infrastructure status.This budget is at best incremental for the healthcare sector and once again misses the much needed reformist attention.”

Vishal Bali Chairman & Co-founder Medwell Ventures

“All in all a positive budget with focused approach on improving lives of a billion plus population. Higher allocation to healthcare and healthcare infrastructure, initiative for tele-medicine and addressing concern of shortage of healthcare professional will ensure better healthcare index. Gujarat is fortunate to get the bonanza of an All India Institute of Medical Science.

Allowing private hospitals to start Diplomate of National Board courses (DNB) and ensuring adequate availability of specialist doctors to strengthen the secondary and tertiary levels Dr Vikram Shah CMD Shalby Limited 38 February 2017

of health care and target of creating additional 5,000 post graduate seats will help address the issue of shortage of healthcare professionals. The move to convert 1.5 lakh health sub-centres to Health Wellness Centres will definitely give a big boost to Health for All.” Pharma Bio World

news features “Government’s objective is long term growth and it is trying to rationalize all issues for a good sustainable growth in years to come. High allocation to rural sector has set the right tone.

Giving relief to smaller businesses and taxpayer was much needed to widen the tax net as well as incentivize businesses to come into the main stream of financial legitimacy. Initiatives on women empowerment, rural electrification, housing for all, more roads for villages and focus on employment generation will definitely strengthen the rural economy.”

Rajiv Gandhi CEO & MD Hester Biosciences Ltd

“A long waited relief to the rural and lower middle class. With the rising medical cost it was impossible for certain sections of the society to even afford life-saving drugs. It’s a welcome step to reach and penetrate even remote areas with limited healthcare access. Building an efficient healthcare system seems to be high on the agenda for the present government. We need more trained doctors and that too specialists catering to the rural areas, by increasing the additional 5,000 post graduate seats per annum the government has shown its intent to transform the healthcare and its determination to eradicate diseases like Kala Azar, Filariasis, leprosy, measles and tuberculosis (TB) and bring down the infant mortality and maternal mortality is really applaudable. Assimilating disease information to senior citizen’s Aadhar card is a good way to understand the disease demographics in India. I am happy to state that the present budget satisfactorily promises the best to the people. This should garner positive result in the coming days.”

Sam Santhosh Founder and Chairman MedGenome

“The life sciences sector had great expectations from the Budget not only from a fiscal incentives perspective but also from a regulatory angle; more so, given the government’s vision of making India one of the top-three pharmaceutical markets by 2020.

Utkarsh Palnitkar National Head - Life Sciences Practice KPMG - India

However, this year, too, no specific impetus was given to the sector. While the move to eradicate certain diseases; the proposal to set up two new AIIMS; additional post-graduate medical seats; proposed amendments in the Drugs and Cosmetics Rules; and new rules for medical devices are welcome, the Budget has not specifically addressed imminent challenges directly affecting the sector.

In order to stay competitive in the overseas market and given the uncertain global climate, it was expected that specific impetus or incentives would be given to innovation in the form of weighted deduction on R&D, incentives for patents, exemptions of certain duties and taxes, etc.

These demands remained largely unaddressed, giving no specific reason to cheer for the sector as a whole in 2017–18.”

“The budget speech mentioned the Government’s commitment towards a structural transformation of the regulatory framework of medical education and practice. This is consistent with continuous reforms that we see from pharmacy and medical profession regulators”

Sameer Sah Associate Partner Khaitan & Co Pharma Bio World

February 2017  39

marketing initiative

Bry-Air BrySmartÂŽ Series (BBS) Dehumidifers

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he BBS is the all new, forward on various motors, thyristor control looking and intelligent for heaters and also includes mobile dehumidifiers. It is simple yet cost connectivity for sensor monitoring, effective solution, for all your humidity controlling and data logging. related problems across diversified industries. It integrates trends like The BBS dehumidifiers come in the Industry 4.0 and ISO 50001 that help range BBS40 (4000 CMH) to BBS250 dehumidifier customers take a giant (25000 CMH). It includes a 7 inch leap ahead in the quest for technology colour touch panel for easy operation/ upgradation and energy conservation. control and additional features like The product is embedded with the Bacnet/Modbus communication patented BrySmart ÂŽ and BryTherm TM protocol, Ethernet port, RS232 and technologies and is capable of RS485 communication ports, start/ stop delivering upto 48% energy saving, access from a remote location using plus an additional 20% through the android devices and at the same time customized rotor which reduces initial remote fault warning output. A special react energy input for equivalent algorithm to collectively modulate rotor performance of standard dehumidifiers. speed, reactivating airflow, temperature and process bypass is installed. No The dehumidifier not only optimizes the top-up heater is required and is specific performance but also optimizes designed aesthetically for ruggedness the specific performance on a dynamic and long life. basis with constantly changing loads and environmental conditions.

The eco-friendly dehumidifier is a step The product modulates various critical components to optimize the energy consumption on a continuous basis. It uses Variable Frequency Drives (VFDs)

forward in energy conservation through enhanced technology (on real time).

The user has the option to control parameters and ensure maximum flexibility in operation with the patented

BryTherm TM technology. It also has an option to incorporate predictive failure/ maintenance tool for continuously diagnosing and forecasting the component failures - Bry-Air Prognos TM, as an add-on.

Bry-Air, the leader in dehumidification... worldwide, is a global solution provider for humidity control, moisture removal, product drying, gas phase filtration, plastics drying, conveying & blending, high temperature heat recovery and adsorption cooling. BryAir Dehumidifiers are designed to meet the most stringent moisture/ humidity control needs and are available from compact models to very complex engineered systems. A Pahwa Group company, Bry-Air Asia has 3 state-of-the-art manufacturing facilities in India and fully owned subsidiaries in Malaysia, China, Switzerland, Brazil and Nigeria and an associate plant in USA, supported by a worldwide sales and service network.

For details Contact :

Gurgaon, Haryana Tel: 0124 4091111 Email: bryairmarketing@pahwa.com Website: www.bryair.com 40 ď‚ƒFebruary 2017

Pharma Bio World

marketing initiative

B & R I n n ova t i o n D ay 2 01 7 : I I o T & Au t o m a t i o n Software Takes Center-stage

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ver the years, software is Industry 4.0 ready. increasingly playing a vital "We offer secure and safe connectivity role in industrial automation, to the cloud from every level - machines, encapsulating the entire automation mechatronic units and sensors," pyramid - machines, factories and mentions Peter Gucher, General plants. With industrial internet of Manager International, B&R. things, the manufacturing world is witnessing a convergence of the Consumers are willing to pay a premium information technology (IT) and for personalized products. At the same operational technology (OT). To gain time, increasingly responsive production business value it is inevitable to extract technology is making it possible to information from the generated field create them under mass production data, which is facilitated by software conditions without a corresponding and vendor independent communication increase in unit cost. For manufacturers, technologies. Innovation Day 2017, a the resulting margin boost is an enticing conference on trend setting automation prospect. B&R's intelligent SuperTrak technologies, organized by B&R, system is the reliable, industrial-grade focused on automation software transport solution for flexible production providing higher business value to its lines that enable mass customization.

A live demonstration at the event customers. displaying this conveyor system in tight Today, users wish to have an Industry synchronization with two Comau robots 4.0 implementation in their machines was a crowd puller. and plants. However, it is a herculean task to implement in brownfield projects. Apart from this, B&R displayed a slew B&R provides unique solution for of innovations - mapp View: web based enabling not only greenfield projects HMI, mobile automation: automation but also brownfield projects to become solutions for outdoor applications,

motion technology for next generation machines, virtual commissioning and secure remote maintenance.

"One tool for all targets - has been a slogan for our highly acclaimed software tool Automation Studio. Owing to this software tool, every new innovation fits seamlessly into our existing matrix," quoted PV Sivaram, Managing Director, B&R India. "It also provides longevity of developed application across generations of hardware, reducing the application effort and investment for newer hardware platforms," he added.

Guest speakers from Hitachi, GĂźdel, ACG Worldwide, and Windsor Machines provided their expert views on changing industry demands and technology trends. In their talks, they gave valuable insight into the adoption of the industrial internet of things (IIoT) in manufacturing units, and the pivotal role that software plays in its successful implementation.

The delegates at the event, also witnessed the launch of the 2 nd edition of 'automotion India', a B&R technology magazine, comprising of various customer success stories from ACG Worldwide, A.T.E. Enterprises, IMA PG, Merck, AIM Machintechnik, Prasad Pneucon, PARI, Mahindra & Mahindra and Naveen Hydrocontrols.

The launch took place at the hands of guest speakers, B&R management and customers who contributed towards the articles published in the magazine.

This year's Innovation Day witnessed a 35 per cent rise in delegates and was very successful. The guests gained a deeper understating of the role of software in successful implementation of industrial internet of things in their plants.

Pharma Bio World

February 2017 ď‚„ 41

marketing initiative

Shimadzu Bags APAC Mass Spectrometry Company of the Year Award 2 Times in a Row

S

himadzu, the longest serving analytical instrument manufacturer in the world since 1875, and a global leader in providing scientific equipment, testing machines, balances and medical equipment, has received the 2016 Frost & Sullivan Asia Pacific Mass Spectrometry (MS) Company of the Year award. This is the second consecutive time that Shimadzu (Asia Pacific) Pte Ltd - the Asia Pacific subsidiary of Kyotobased Shimadzu Corporation - has been bestowed the business leadership award.

analyses of biological macromolecules in 2002.

Customer Purchase Experience, Customer Ownership Experience, Customer Service Experience and Brand Equity.

Shimadzu (Asia Pacific) Pte Ltd, which operates across 18 countries in APAC, ventured into providing MS technology to its customers in the year 2010. It has since emerged as one of the most sought after MS leaders in the region.

Mr Kiminobu Imura, Managing Director of Shimadzu (Asia Pacific) Pte Ltd, said that, "It is huge honor for us to receive the prestigious 2016 Frost & Sullivan APAC Mass Spectrometry Company of the Year award. The fact that we have been Two key factors were evaluated while awarded this for the second consecutive deciding the MS Company of the Year year proves that our innovations in Mass Award - 'Visionary Innovation and Spectrometry continue to be the best Performance' and 'Customer Impact'. in the world. I would like to congratulate The award was given for Shimadzu's The criteria for Visionary Innovation and every member of the Shimadzu Family for state-of-the-art Mass Spectrometry Performance included Addressing Unmet their dedication in working towards the technologies, which has also won several Needs, Visionary Scenarios Through Mega company philosophy of "Contributing to other accolades worldwide. Interestingly, Trends, Implementation Best Practices, Society through Science and Technology".

Shimadzu's Koichi Tanaka is also the only Blue Ocean Strategy and Financial The 2 awards in a row by Frost & Sullivan person in the world to have won a Nobel Performance; The criteria for Customer reinstates our commitment towards our Prize in Chemistry for pioneering MS Impact included Price/Performance Value, customers in line with our company's

Frost & Sullivan Award Ceremony 42 ď‚ƒFebruary 2017

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marketing initiative

Vol. 12

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INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES

PHARMACOVIGILANCE

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Shimadzu (Asia Pacific) is a subsidiary and the Asian headquarter of Shimadzu Corporation, which was founded in 1875 in Kyoto, Japan. The subsidiary was established in 1989 in Singapore as a distribution centre providing analytical

February 2014 l

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About Shimadzu (Asia Pacific) Pte Ltd

INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES

CLINICAL TRIALS

Mr Prem Anand, Senior General Manager, Shimadzu (Asia Pacific) Pte Ltd, highlighted that, "We would like to thank Frost & Sullivan for recognizing the strength of Shimadzu's Vision, Innovation, Performance and Customer Impact.

MS is the latest frontier of scientific technologies on which the Analytical Industry has been relying on. All of us at Shimadzu work towards making this frontier more efficient and affordable for all our esteemed customers. We diligently follow our Corporate Philosophy The company's instruments are relied of 'Contributing to the Society Through upon by researchers all across Asia from Science and Technology' and believe large multinational organisations to local that with 'Excellence in Science' we can academic research universities and a long transform the way analytical chemistry list of local, state and central laboratories. is experienced in labs. Shimadzu is the Through adoption of scientific inventions and cutting-edge technologies, Shimadzu future."

(Asia Pacific) provides its corporate Ms Sandhya Nargund (Sandy), Senior clients with the highest quality in product Manager, MS and Chromato, Shimadzu standards and delivers excellent customer (Asia Pacific) Pte Ltd, while receiving the support services in accordance with its award said that: "It gives me immense motto - 'Excellence in Science'. pleasure to reveal that in continuation with our commitment to provide state-of-the-art innovations, we have launched the new ICPMS-2030 this year and also plan to launch many more advanced instruments featuring Mass Spectrometry technologies in the near future. Shimadzu has always provided the best quality of products and services to its customers and winning this prestigious award 2 times in a row proves the same. Thank you Frost & Sullivan for recognizing the true leader in the analytical industry."

HEALTH

solutions, scientific equipment, testing machines, balances and medical equipment to a wide range of laboratories.

A fast paced growth of business in the region has seen the opening of 3 subsidiaries in India, Malaysia and the Philippines with application specialists, technical and sales engineers spreading across 18 countries throughout the region including, Singapore, Indonesia, Thailand, Vietnam, Bangladesh, Pakistan, Sri Lanka, Nepal, Myanmar, Brunei. Additionally, the company operates via a wide and carefully selected network of local distributors in every country in the region.

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slogan. 'Excellence in Science' is not just our motto but is a way of life for us at Shimadzu."

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press release Jubilant Gets Responsible Care 14001:2013 Certification Jubilant Life Sciences, an integrated global pharmaceuticals and life sciences company, receives 'Responsible Care 14001:2013 certification' under the American Chemistry Council's (ACC) Responsible Care program ® for its Corporate Office in Noida and for its manufacturing Unit in Gajraula. Awarded to the Life Science Ingredients business, the certification is a demonstration of Jubilant's continued commitment towards sustainable business operations.

Jubilant Life Sciences was presented with the certification for its robust management system that ensures highest standards of health, safety, security and environmental performance for both its products and operations. Jubilant Life Sciences is one of the very few companies in India to achieve the certification, the distinction is an evidence of company's exemplary business practices and good corporate governance.

GNH India Accredited with SGS Certification GNH India is rewarded with a certification by SGS for WHO (World health Organisation) GSDP (Good storage and distribution practise) in India. Currently shipping to over 180 countries globally, GNH India will now be able to expand its reach to institutional customers such as WHO, UN agencies globally and International tenders of Ministry of health of foreign countries.

SGS is a globally recognized leader in certifications in the pharmaceutical sector. GSDP is an internationally accepted quality system for warehouse and distribution centers in the pharmaceutical industry. The GSDP certification ensures that consistent quality management systems are in place throughout the entire supply chain, from the early delivery of raw materials to the manufacturing plants, to the final shipment of finished drugs to the end user. Companies are eligible for this certification post a thorough analysis of their processes and policies, conducted by highlyqualified auditors.Sharing his happiness, Dr. Piyush Gupta, Associate Director - GNH India, said "We have always maintained the quality standards in the services offered to our clients. The certification by SGS further justifies our commitment to service our clients with the required quality, safety and efficacy of the products. We are glad to receive this certification in our first attempt and we assure to continue to enrich the service experience of our customers."

GNH India has various others compliances such as Voluntary compliance of US FCPA and UK Anti Bribery laws, US GAAP accounting standards, Indian FEMA (Foreign Exchange Management 44 February 2017

Act) and many such others. The company has over 135,000 product lines to offer Hospitals, Ministries, Importers, Wholesalers, Pharmacists, Doctors, and others in the field of pharma.

Piramal Acquires Spasticity and Pain Management Drugs from Mallinckrodt Piramal Enterprises Limited's wholly owned Critical Care subsidiary in the UK has entered into an agreement to acquire a portfolio of intrathecal spasticity and pain management drugs from Mallinckrodt LLC in an all cash deal for a consideration of USD 171 million and up to an additional USD 32 million payable depending on financial performance of the acquired assets over the next 3 years.

The portfolio acquired includes Gablofen (baclofen), a severe spasticity management product, which is currently marketed in the United States, and two pain management products, which are currently under development. Gablofen has also been approved for launch in 8 European markets. Gablofen is the only intrathecal baclofen drug available in vials and pre-filled syringes, which are preferred by users over the competing products available in ampoules.

The pain management drugs under development are also for intrathecal administration. In the twelve months ending September 30, 2016, the acquired portfolio generated revenues of USD 44.6 million.

VAV Life Sciences Launches India’s First Phospholipid Manufacturing Plant One of the top phospholipid manufacturers, VAV Life Sciences inaugurated its cGMP compliant Phospholipid manufacturing plant in Mirjole, Ratnagiri, Maharashtra. The plant is set up in India considering the emerging healthcare applications of lecithins & phospholipids in functional foods, nutritional supplements, novel pharmaceuticals and cosmetics. With the plant, the company will mark products manufactured at the factory with a 'Made in India' label and will export 80 per cent of them to North America, Europe, Asia and ROW region.

The existing brands manufactured include LECIVA, LIPOVA, OLEOVA. The first phase of the plant is spread across 30,000 sq.ft. with EU cGMP standard facilities. The facility utilises state-of-the-art technology, which allows the production of its all-natural higher grade of phospholipids ingredient in accordance with the global industry standards. Most phospholipids are derived from nature, hence classified as GRAS (Generally Recognised as Safe) by US FDA. Through the plant, VAV will be building distinct production lines for refined soya, egg and synthetic Phospholipids. Ratnagiri location was the first choice to set up this plant due to its excellent infrastructure facilities, conducive business environment, suitable weather conditions and quality trained manpower.

Pharma Bio World

press release Protagen AG Join Forces with the US National Cancer Institute Protagen AG has executed a Material Transfer Agreement with the National Cancer Institute (NCI) under which the parties will utilize Protagens SeroTag immune system profiling technology to identify biomarkers that predict therapy responsiveness, to monitor patients receiving immunotherapies, and for early detection of immune-related adverse events (irAEs). This collaboration with NCI will be led by Jeffrey Schlom, PhD, Chief of the Laboratory of Tumor Immunology and Biology at the NCI's Center for Cancer Research. Protagen AG is a provider of pharma development services and novel companion diagnostic tests in the fields of immuno-oncology and autoimmune disease. NCI is part of the National Institutes of Health.

While targeted immunotherapies such as therapeutic vaccination and checkpoint inhibition hold great promise for treating cancer, they currently work effectively on a small subset of patients. In addition, as these therapies stimulate the immune system to target the body's own cells, they can also trigger immune-related Adverse Events (irAEs) and even the onset of autoimmune diseases. Through this collaboration, Protagen and NCI intend to provide valuable insight into utilizing immune system profiling to predict response, monitor patients and for detection of immune-related adverse events.

Need to Build Global Confidence & Trust in Clinical Research in India Given all the recent changes in the regulatory environment in the recent past and the regulators' commitment to a creating a favourable clinical research environment in India, there is now a strong need to rebuild global confidence and trust in doing clinical research in India. This was the unanimous opinion of industry panelists in the concluding session on Does India Feature in Discussions on Global Clinical Study Placements at the 10th Annual ISCR (Indian Society for Clinical Research) Conference. While on one hand, data of global inspections validates the high quality of clinical research being done in India, the clinical research environment is weighed down by negative perceptions of quality and therefore stakeholders need to take a more proactive approach to quality management, they said.

Speaking on the occasion, Suneela Thatte, President, ISCR said, "It is a key responsibility of each one of us to renew our pledge to quality, patient safety and data integrity and set an example to the rest of the world as to how quality and ethics are not mere tokenism but truly reflect the spirit of the clinical research community in India.

When this happens only then will we be able to bridge the gap between India's potential in the field of clinical research and the actual Pharma Bio World

clinical research being conducted in India at the moment and the gap between perception and reality. We at ISCR would like to reiterate our commitment to continue to engage with all our stakeholder and work towards the creation of a clinical research ecosystem that balances the interests of all stakeholders - particularly the patients."

Among the highlights of the concluding day was a panel on Research in Rare Diseases which had not for profit organisations, patients, medical and legal professionals talk about the needs of rare disease patients in India and what needs to be done to ensure access to research and early intervention for rare diseases. "Rare diseases are not so rare. If we were to put together the entire population of rare disease patients in the world, it would be the third most populous country," said Prasanna Shirol, Founder Member, Organisation for Rare Diseases India.

Chemtura Shareholders Approve Acquisition by LANXESS Specialty Chemicals Company LANXESS has taken a significant step forward in the planned acquisition of U.S. chemical company Chemtura. Chemtura's shareholders approved the merger at a special meeting in Philadelphia, United States. 99.88 per cent of the votes cast were in favor of the merger, representing 81.77 percent of Chemtura's outstanding common stock. Under the terms of the merger agreement, Chemtura shareholders will receive USD 33.50 for each outstanding share in cash at closing of the transaction.

Matthias Zachert, Chairman of the Board of Management of LANXESS AG, welcomed the vote approving the merger taken at the shareholders' meeting. "We are pleased that Chemtura's shareholders are so supportive of the planned acquisition. Their approval is an important milestone on LANXESS's route to becoming one of the major players in the field of additives chemistry."

Clearance for the acquisition from the U.S. antitrust authorities was already received at the end of December 2016. LANXESS expects to close the transaction in mid-2017 after all remaining regulatory approvals have been received.

Flame retardant and lubricant additives are the main pillars of Chemtura's business and would complement the current LANXESS portfolio. After closing of the transaction, these two business activities are to be integrated with LANXESS's Rhein Chemie Additives business unit to form a new segment. Today, Rhein Chemie Additives already supplies a broad range of special additives and service products for the manufacture of plastics, rubber, lubricants and coatings. It employs some 1,600 people at more than 20 sites around the world.

February 2017 ď‚„ 45

press release NSF & IDMA Offer Pharmaceutical Quality Management Education

in Hyderabad. Headquartered in Basel, Switzerland, Novartis has a significant footprint in India with a strong base in Hyderabad through its Global Drug Development and Business Services Center.

NSF International, a global public health and safety organization, is partnering with the Indian Drug Manufacturers' Association (IDMA) to offer a customised, five-module pharmaceutical quality management (PQM) education program in Bangalore, India. Pharmaceutical industry professionals who complete the graduate-level, advanced education program will earn an internationally recognised certification in GMP compliance from NSF International and IDMA.

Speaking about the partnership, Jay Krishnan, CEO, T-Hub said, "We are very excited to collaborate with Novartis, a world class leader in healthcare. Novartis will bring great value to the ecosystem and HealthTech startups will be greatly benefited. With HealthTech being one of our prime sectors, we are working towards ensuring that startups associated with T-Hub are well mentored and guided through various programs of ours, which will help them scale their business faster."

The Advanced Program in Pharmaceutical Quality Management consists of five modules, each lasting four days. With the modules taught every other month, the program can be completed in 10 months. Classes will be offered at Acharya College in Bangalore with a planned start in September 2017.

Subodh Deshmukh, Global Drug Development India Head, Novartis said, "As a global leader in biomedical innovation, we are excited about this potential partnership with T-Hub and its allied startups driving innovation in the healthcare space."

Pre-registration information sessions will be held in Bangalore, Hyderabad and Mumbai during the week of 12 February, 2017.

The information sessions will be led by S.V. Veerramani, National President of IDMA, S.M Mudda, Chairman of the IDMA Regulatory Affairs Committee & Program Coordinator, and program tutor Martin Lush, Global Vice President of Pharma Biotech and Medical Devices for NSF International. The event in Hyderabad is sponsored by the Pharmaceutical Export Promotion Council and organized by the Ministry of Commerce and Industry, Government of India.

Vyome Announces Top-line Results from Phase 1 Study of VB-1953

India has the highest number of GMP-approved manufacturing plants outside the United States and Europe. As global regulatory requirements become more rigorous, GMP compliance education is becoming a prime focus for the pharmaceutical industry. According to a report by Deloitte, 64 per cent of pharmaceutical companies in India say a shortage of skilled staff is curtailing their compliance ability and growth.

T-Hub Collaborates with NHPL T-Hub, India's fastest growing start-up engine, catalyzing innovation, scale and deal flow has signed a Memorandum of Understanding (MoU) with pharmaceutical major Novartis Healthcare Private Ltd (NHPL) to create and execute joint programs that would benefit Health Tech startups from across segments.

Being leaders in healthcare, Novartis will be working together with T-Hub to develop plans and programs that will help health tech, healthcare and pharmaceutical startups to scale and grow. As a part of the initiatives health, research and development experts from Novartis will mentor and guide startups, in compliance with T-Hub's mentorship framework and evaluation process, in their respective ventures. The MoU will help foster a close relationship in these areas while contributing towards the building of a thriving ecosystem 46 ď‚ƒFebruary 2017

Vyome Biosciences, a clinical-stage specialty pharmaceutical company developing novel medicines for treating skin diseases caused by resistant microbes, has announced top-line data from its phase 1 clinical trial evaluating VB-1953, a topically administered gel designed to treat patients with moderate to severe acne. VB1953 exhibited a promising dermal safety signal, was generally well tolerated and showed the potential to treat moderate to severe acne.

According to a preliminary analysis of the data from 12 patients, VB1953 met its primary endpoint relative to pharmacokinetics, achieving plasma concentration less than 1 ng/ml and dermal tolerability. Also, in addition to demonstrating safety in this 12-patient study, treatment with VB-1953 resulted in a reduction of inflammatory and non-inflammatory lesions and in IGA scores, compared to baseline, suggested a potential efficacy signal in these moderate to severe acne patients.

"VB-1953 was generally well tolerated with a good dermal safety signal and the early parameters of efficacy were encouraging after only a short duration of treatment," said study investigator Neal Bhatia, MD, of Therapeutics Clinical Research in San Diego, CA. "Based on these results, VB-1953 appears to demonstrate the potential to be a promising new treatment as further development continues."

"These data are encouraging for patients with moderate to severe acne, especially the one-third of whom do not respond to available treatment options due to microbial resistance. With a promising dermal safety signal, and potential anti-acne and anti-inflammatory activity, VB-1953 has the potential to fill this gap in acne treatment," said Venkateswarlu Nelabhotla (N. Venkat), co-founder and chief executive officer of Vyome Biosciences.

Pharma Bio World

High Vacuum Pump (Oil Immersed) The compact and quiet in operation, highly reliable and sturdy in design GL Series pump is an oil sealed belt driven pump operating according to the rotary vane principle with gas ballast valve. Oil, which is injected into the pump chamber, is used for sealing lubrication and cooling purpose. It is easy to maintain and guaranteed ultimate vacuum.

Single stage and double stage models from 36 m3/hr to 300 m3/hr are available to meet wide range of vacuum needs.

For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26448983, 26448558 E-mail: sales@toshniwal.net

Combo Deduster + Metal Detector Combo deduster + metal detector consists of vertical bottom to top deduster integrated with digital metal detector.

The deduster is provided with frequency and power control drive ensuring effective dedusting and deburring. The entire dedusting settings are controlled from the metal detector.

The inlet can be rotated through 360o and hence the same can be used for right or left outlet of compression machine conveniently. The system is designed to ensure ease of cleaning and the entire deduster assembly can be dismantled and assembled within minutes without any tools.

Area of application includes tablets.

For more information, please contact:

Technofour Electronics Pvt Ltd Gat No: 3(PT), 5(PT), 243(PT), Kasurdi (Kheba) Post: Khed Shivapur, Tal: Bhor, Dist: Pune, Maharashtra 412 205 Tel: 02113-305200, 305246, Fax: 91-02113-305250 E-mail: pcssales@tepl.co.in / teplinbox@gmail.com

Blenders The blender is an efficient anti-versatile blending machine for mixing and lubrication process of dry granules and powder homogeneously. Two-third of the volume of the cone blender is filled to ensure proper mixing. It can be used for pharma, food, chemical, cosmetic products, etc.

Customers can avail from their superior quality of pillar type bin blender. These column type bin blenders are also available in conta bin blender and bin blenders in the market. These pillar type bin used for mixing, lubricating and blending in pharma, nutraceutical, food, chemical, food industries, ceramics, pesticide, plastics and other allied industries of dry powder. It can perform homogenously dry mixing of free flowing powders, granules requiring low shearing force, mixing and blending of particles.

For tablets, capsules, dry powder, injection and API manufacturing for efficient mixing/blending of dry powder granules.

Highly effective for low volume active blending with a low as 1% active; processing of different size of production batched in single equipment with scale up data; docking and undocking of the bin; proxy sensors at entry door and other important parameters to avoid accidents; flexibility of accepting variable bin signs providing wide range of batch volume; cGMP construction with cladded SS sheets charging hole with cover is provided on top with quick opening and closing arrangements with dust-proof points for particle-free transfer.

For more information, please contact:

Shefa Industries Gala No: 1, U K Quari Compound, Gandhi Nagar, Vikhroli (W) Mumbai 400 083 Tel: 022-25942473 E-mail: shefaindustries@yahoo.co.in

Pharma Bio World

February 2017 ď‚„ 47

Fluid Bed Processing Tapasya Engg Works Pvt Ltd’s classic for all batch executed fluid bed processes for testing granulation, drying and coating processes. Ideal for minimum batch sizes of 50 g to 2,500 g. Processes in bottom and top spray methods. Flexible retrofitting if needed.

The TAP-FBP-10 SaiPro is multi-functional fluid bed equipment designed for research and development of drying top spray agglomeration and bottom spray encapsulation process. The Lab Model fluid bed processor processes minimal quantity with maximum quality. This feature makes it an ideal machine for drying, granulation and encapsulation trials on a small scale.

Feasibility studies can be extensively conducted on lab scale unit. This innovative small machine is easy to handle and extremely easy to clean. These detailing makes it perfect for use in pharma research and development laboratories. It is an unique all in one unit to suit drying, granulation and coating in single unit (standalone fluid bed dryer also available). This lab unit is optimised for scale up requirements of R&D like process parameters, geometrical impact and spray rate. Swivel bow with position locking allows convenient material handling. It has special attachment for drying small quantities up to 50 g.

For more information, please contact: Tapasya Engg Works Pvt Ltd Plot A-212, Road No: 30, Wagle Indl Estate Thane, Maharashtra 400 604 Tel: 022-61579400, Fax: 91-022-25825243 E-mail: sales@tapasyaindia.net

Triple Duty Valve Kirloskar Brothers Ltd is the first valve manufacturing company in India to be ISO 9001/ISO 1001/ISO 50001/OHSAH 18001 accredited/CE marked/FM approved and UL listed. It manufactures valves ranging from 25 to 5,000-mm in various design standards and MoC as per customer needs/specifications.

The KBL valves applicable for the chemical sector are resilient seat gate valves, tamper-proof kinetic air valves, butterfly valves, forged steel gate valves, steam trap device, suction diffuser, etc..One of the other valves that KBL manufactures is the triple duty valve. It is a noise-free operating multi-purpose valve that performs all the required functions on the discharge side of the Hydronic System Pumps (HVAC). The valves also have other industrial applications in pharma manufacturing plants, bottling plants, and chemicals and food and beverage industries. The valves are widely installed in multi-storied buildings, malls, airports, etc.The single valve behaves as an isolating-cumregulating-cum-non-return valve. The disc opening responds even at 25% of the rated pressure of the valve. The spring will assist in disc closure soon after the pressure drops down to prevent flow reversal and water hammering. The hand-wheel rotation assists in adjusting the flow discharge through the valve. In addition, its centre guided soft seal disc ensures zero leakage. The rising spindle design includes a position indicator (on request) for accurate disc positioning for throttling service. There is a provision for fitment of standard gauge taps at both the inlet and outlet side. The triple duty valve is made from cast-iron or ductile iron or cast steel with a stainless steel trim. Its flange drilling is customised to IS/BS/ASME/ANSI Standards in view of meeting the desired requirements (on request).

The primary feature of this low pressure drop and balancing valve with by-pass function is its unique re-positional inlet body for angle mounting configuration.

For more information, please contact:

Kirloskar Brothers Ltd Global Headquarters Yamuna Survey No: 98/(3-7), Baner, Pune, Maharashtra 411 045 Tel: 020-27214444

48 ď‚ƒFebruary 2017

Pharma Bio World

Super Adhesive Tapes Goodwill Retails Pvt Ltd offers a range of FiberFix super adhesive tapes. FiberFix combines industrial-strength fibre and specialised resin into a wrap that will bond to almost anything, hardens like steel and provides a permanent fix. Using FiberFix, consumers can fix things that either could not be fixed before or could not be fixed inexpensively.Simply dip FiberFix in water to activate the specialised resin and then wrap just like tape. Within about 10 minutes FiberFix hardens with incredible strength and rigidity. Where duct tape and other types of tape may provide a short-term band-aid, FiberFix provides a permanent fix. Product description: comes in four sizes –1” x 12”, 1” x 40”, 2” x 50” and 4” x 60”; each roll is considered a single use item; each roll comes in an air-sealed pouch; once this pouch is opened, the wrap needs to be used right away; and each roll comes with a pair of gloves which adds convenience in working with FiberFix. Product features: amazingly strong; simple to use; rapid cure (2-5 minutes); hardens like steel; waterproof; heat and cold resistant; and sandable and paintable.

For more information, please contact:

Goodwill Retails (P) Ltd Office No: 2, Novelty Chambers, 2 nd Floor 124 M S Ali Road, Grant Road (E), Mumbai 400 007 Tel: 022-23021220 E-mail: fiberfixindia@hotmail.com

Oil Lubricated Vacuum Pumps Toshniwal supplies oil lubricated vacuum pumps.

These oil lubricated vacuum pumps of the TMS Series are single stage, oil-lubricated rotary vane vacuum pumps with oil re-circulation system. The lubricant system is rated for continuous operation of high intake pressures so that the pump may be used in a versatile manner in most rough vacuum applications. The pumps are used for suction of air also in presence of water vapour and for continuous industrial use. TMS Series pumps are made from high quality materials, has economical features which matches together to achieve: high pumping speed over the range of absolute pressure 1,000 mbar-0.5 mbar; high water vapour tolerance and low noise level; no pollution; air-cooled: built-in anti-suck-back system. The pumping capacities available are 17 m 3 /hr, 35 m 3 /hr, 65 m 3 /hr, 100 m 3 /hr and 150 m 3 /hr.

For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road, Chennai 600 010 Tel: 044-26448983, 26448558 E-mail:sales@toshniwal.net

Canned Motor Pump Kirloskar Canned Motor Pump (i-CM) pump, categorised under i - CAN pumps Series, caters to industries such as refrigeration (cold storage), ice plants, chemical and process and windmill. i-CM pumps are mainly used for pumping hazardous fluids such as radioactive coolants, corrosive and noxious liquids (free of suspended solids and particles), liquefied gases, etc. The pump’s compact, lightweight yet sturdy design with less number of components ensures that it minimises assembly and dismantling time and occupies less space. The pump is hailed as a step-up from the conventional mechanical seal pump category, which requires heavy maintenance. It comes with innovative features, such as optimised stator and rotor design, apart from its compact size, 80% lighter body than conventional canned motor pump, and includes seamless stator band, off the shelf terminal box, three in one adapter plate, optimised bearings and sleeves, and improved aesthetics and application base bearing wear monitoring system. Besides, it is known to reduce assembly time by 50%.

KBL offers multiple value added features including advance monitoring systems with pump controller (temperature indication, discharge/suction pressure indication, vibration and dry run indication), alternative material for impeller and pump casing and alternative bearing material that ensures long life of the pump.

For more information, please contact:

Kirloskar Brothers Ltd Global Headquarters Yamuna Survey No: 98/(3-7), Baner, Pune, Maharashtra 411 045 Tel: 020-27214444

Pharma Bio World

February 2017  49

Fluid Bed Dryers TFluid bed technology offers several advantages such as no product lump formation/caking, no particle overheating/cooling, a well defined product residence time uniform product quality, better energy economy due to lower specific heat requirements, etc. In fluid-bed the material is suspended in an upward moving hot-air and the mass behaves like a boiling fluid after fluidisation.

This is the state of fluidization. The fluid-bed dryers are most suitable for drying granular, crystalline, coarse or similar material. It is also possible to dry very fine crystals or very coarse material. The air is passed from the bottom of the container which has got perforations of SS fine wire mesh. Hot air passes through the product container and therefore the turbulence in the product is obtained and hence the product moves up and down in the product container.

Due to this the heat transfer is very quick and the product is dried very fast without appreciable loss of heat. The fluid bed dryers are not suitable for drying liquids of pasty materials. The fluid bed dryer will be complete with 2,800 RPM, TEFC motor blower, control panel with timer, 2 temperature gauge, filter bag, SS-316 quality container with trolley and heater or steam radiator.

For more information, please contact:

Brilliant Process Machinery Pvt Ltd Unit No: 1, 2, 14 Mordan Indl Estate Opp: Ipol, Waliv Phata, Vasai (E) Dist: Thane, Maharashtra 401 208 Tel: 0250-3293636 E-mail: brilliantprocess@rediffmail.com / sales@brilliantprocess.com

Desiccant & Effervescent Packaging The AdPack desiccant sachets are made of Tyvek and ensure the efficient, safe and economic protection of moisture-sensitive drugs such as tablets or capsules inside the packaging. The AdCap desiccant capsules, in turn, offer 360 o moisture adsorption as well as the highest patient safety. Both desiccant solutions comply with all regulatory requirements and can be processed on all common dosing and filling lines.

Apart from these drop-in solutions, the portfolio also includes a number of integrated desiccant solutions. Customers can choose between different tubes and bottles, as well as types of closures such as screw caps, FlipTop or FlipOff closures with or without integrated desiccant. The closures can further be equipped with child-resistant and tamper-evident functionalities. Backed by the Atmo Guard System, Sanner offers customers a holistic service especially for desiccant packaging, which is designed to support a safe, timely and cost-effective market introduction of new pharma and healthcare products.

Sanner’s most recent portfolio addition to effervescent packaging solutions is the senior-friendly FOG 27 closure. It can be opened in about a third of the time and requires 70 per cent less physical effort compared to conventional closures. Together with the Brilliance Tubes, which are decorated using in-mould labelling (IML) technology, customers receive an all-in-one solution for highest convenience and attention at point-of-sale.

For more information, please contact: Sanner GmbH Schillerstraße 76 64625 Bensheim, Germany Tel: +49(0)6251 938-0, Fax: +49(0)6251 74672 E-mail: info@sanner-group.com

50 February 2017

Pharma Bio World

Sparker Filter Zero Hold Type

Dispensers

Shiv Shakti Process Equipment Pvt Ltd offers sparker filter – zero hold type for high value liquids.

It gives crystal clear filtration.

Models available are 8”, 14”, 18”, 24” and 33” dia.

Complete filtration of the batch without any hold-up due to reverse flow of liquid. The cake, filteraid and solids remain totally enclosed allowing filtration of toxic, hazardous and explosive liquids. No contamination of internal surface of the shell. cGMP construction with high pharma finish with documentation.

For more information, please contact:

Shiv Shakti Process Equipment Pvt Ltd Shiv Shakti, 407 Shivam Chambers Next to Sahara, S V Road, Goregaon (W), Mumbai 400 104 Tel: 022-26788480, 26798554, Fax: 91-022-26798284 E-mail: sales@shivshaktiequipments.com / sspepl@gmail.com

Toshniwal Hyvac Pvt Ltd offers dispensers to transfer set for flammable liquids (petrol, kerosene and diesel fuel). Pump with nozzle holder, easy to install on the barrel through the quick coupling. Dispensing unit equipped with telescopic suction tube for direct connection into the tank allows easy and clear use of the dispenser.

It has a cast iron body, anti-noise filter, flanged components pump, bypass setup with pressure relief valve, thermal protection, non-return valve (NRV) built and suction unit with integrated fine filter. Meter and filters can be installed or replaced without the use of sealant, making connection quick and safe.

For more information, please contact: Toshniwal Hyvac Pvt Ltd 267 Kilpauk Garden Road, Chennai 600 010 Tel: 044-2644 8558, 26448983 Fax: 91-044-26441820 E-mail: sales@toshniwal.net

Vacuum for Distillation & Drying The pharmaceutical and specialty chemical industries use vacuum for distillation and drying. Various types of dryers are used to purify products under vacuum. The chemicals are precisely mixed and then heat is applied in the dryer to evaporate the excess chemicals. This is done under vacuum for purer end products; reduce the amount of heat energy required for drying, and also to recover any of the solvents evaporated off thereby not affecting thermally sensitive products. Pumps that are reliable and easy to service in the field are the most important for this industry. If an unreliable pump is tried and it fails in the middle of a drying cycle, then the product is not useable and profit is lost. A typical setup used for this application is combining mechanical roots blower along with oil lubricated vacuum pump.

This kind of setup is used to minimize utility costs, drying cycle time and contamination.

A properly designed process condenser between your vacuum process and vacuum producing system will yield significant advantages. A process vacuum condenser can significantly reduce the size of the vacuum producing system, recover for reuse valuable product carried from your process with non-condensable gases, reduce amount of wastes produced by the vacuum system and lower the operating cost of your process.

Matching a vacuum condenser with the vacuum producing equipment is the best way to meet the objectives of your process. Toshniwal manufactures both the process condenser and the vacuum producing equipment. This single-source responsibility provides you with a unitized system matched to your process.

For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Gardens Road, Chennai 600 010 Tel: 044 26445626, 26448983 E-mail: sales@toshniwal.net

Pharma Bio World

February 2017  51

events diary                   

                 

                                                      

                                                   

                                                                    

                                                         

      

            

 

     

         

           

                                                                                                                                                          

                                                  

             52 February 2017

                                                                   

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bookshelf Cobert’s Manual of Drug Safety and Pharmacovigilance (Paperback) Author: Barton Cobert Price: USD 123.04 No of pages: 408 pages Completely revised and updated, the Manual of Drug Safety and Pharmacovigilance, Second Edition is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, government and legal professions. This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance) and side effects, as well as providing essential information on drug safety and regulations, including: recognizing, monitoring, reporting and cataloging serious adverse drug reactions. The Manual of Drug Safety and Pharmacovigilance, Second Edition teaches the ins and outs of drug safety in the industry, hospitals, FDA, and other health agencies both in the US and around the world, and presents critical information about what is done when confronted with a drug safety problem. Important Notice: The digital edition of this book is missing some of the images or content found in the physical edition.

An Introduction to Pharmacovigilance (Paperback) Author: Patrick Waller Price: USD 41.62 No of pages: 120 pages Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.

This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance. Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students.

Mann’s Pharmacovigilance (Hardcover) Authors: Elizabeth B Andrews, Nicholas Moore (Editors) Price: USD 298.10 No of pages: 866 pages Mann’s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics.

Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field. The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.

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February 2017  53

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Bring your technical knowledge to life with us

We have changed our name. But not of focus.

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• • Global presence across 5 Continents, 65+ countries

RE

ion at

PU

Core Process

• World class manufacturing facility with dedicated vessel fabrication, orbital welding & FAT areas • Project execution with Hub & Spoke model and localized support Effluent

Val id

g pin Pi

n

CIP /

Automati o

U S ITIE TIL

SIP

• Design Compliance to USFDA, UK MHRA, WHO, CE & cGmp guidelines

W AT E R

Biotechnology

S

Turnkey Solutions for Raw water to Pure water delivered at point-of-use.

• Pretreatment Systems - Domestic - Process - Utilities

- Manufacturing vessels

- Upstream processing equipment incl.

- Hold area equipment

- Overall integration

- Filtration equipment - Filling area equipment - Overall integration - CIP / SIP

- CIP / SIP

• Water For Injection (WFI) - Multi Column Distillation

Ointments / Emulsions

• Pure Steam Generators - RO / EDI Systems

- Fermenters and Bioreactors for microbial & cell culture applications

- Downstream processing equipment

•

•

Parenterals

• Storage & Distribution Systems

Liquid Orals

- Manufacturing of sophisticated equipment to manage agitation

- Raw materials handling & storage; including solids

- Carefully control physical properties of the product at all times.

- Sugar syrup equipment

- Transfers

- Manufacturing, holding

- CIP / SIP

Value Added Services • CMC • O & M •

• Spares • Audits •Passivation Services

Write to us: HEADQUARTERS (INDIA) For projects: info@prajhipurity.net For After Sales and O&M Services: customerservice@prajhipurity.net Customer Care toll free no-1-800102-9060

PRAJ PRESENCE: ARGENTINA | INDIA | SOUTH AFRICA | THE NETHERLANDS | THAILAND | INDONESIA | UAE | USA

Praj Hipurity Systems Limited

Solitaire Corporate Park, Unit No. 1211, 1st Floor, Guru Hargovindji Marg, Andheri (E), Mumbai 400093. India Tel: +9122 4088 8444 | Fax: 9122 28747129 | Email: info@prajhipurity.net | Web: www.prajhipurity.net