Pharma Bio World July 2019

VOL 17 | ISSUE 12 | JULY 2019 | MUMBAI | TOTAL PAGES 68 | PRICE ` 150

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4 ◄ July 2019

Pharma Bio World

FEATURES

08

08

Startups in Pharma, Biotech and Health-tech Sector - Now and the Way Forward Jayati Mukherjee

22

Startup Journey Case: Ayu Devices Pvt Ltd Jayati Mukherjee

24

Startup Journey Case: Module Innovation Jayati Mukherjee

26

Startup JourneyCase: Weinnovate Biosolutions Jayati Mukherjee

27

India’s Start-up Ecosystem: A big step towards realizing USD 5 Trillion Economy Dr. Suchita Markan, Asst. General Manager, Biotech Consortium India Limited (BCIL)

31

Union Budget 2019-20: A Frost & Sullivan Perspective Krishanu Banerjee, Consultant, Public Sector Practice, Frost & Sullivan

32

Union Budget 2019 - 20: Perspective of Industry Stalwarts

34

Forward to Innovation Enterprises Ashwini Kumar Nangia, Director, CSIR-NCL and Chairman, Venture Center Dr V Premnath, Director, Venture Center Pinky Raychaudhuri, Associate Manager - Incubation, Venture Center

39

Pharmacovigilance in India: An Overview Dr Viraj Suvarna, Medical Director, Boehringer Ingelheim India Pvt Ltd Indu Nambiar, Senior Manager - Local Pharmacovigilance LPVM, Boehringer Ingelheim India Pvt Ltd

42

A Roadmap to Clinical Trial Efficiency Ketan Zota, Director, Zota Healthcare

27

NEWS 47

Press Release

41 CORPORATE AFFAIRS 56

Products

64

Events

BACKYARD 65

Book Shelf

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Ad Index

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6 ◄ July 2019

Pharma Bio World

Startups in Pharma, Biotech and Health-tech Sector – Now and the Way Forward

By Jayati Mukherjee

Since last few years, India has been witnessing a growing number of startups. Today’s increasing rampage of digitalisation has given the startup movement in India a very prominent impetus. Pharma, biotech, and health-tech industry are in a quest to exploit the power of innovation and digitalisation to reach out to the remotest corner of the country for the benefit of people who are deprived of getting minimum viable medical facilities. Startups are coming up in a big way to leverage this opportunity to provide affordable service.

Pharma Bioworld in its 17 Th anniversary edition endeavours to throw light on the country’s startup ecosystem in context of Pharma, Biotech, and Health-tech industry.

Pharma Biotech Startup Concept in India

Industry overview: By 2020, India is likely to be one of the top three pharmaceutical markets by incremental growth; and sixth largest market globally in absolute size. Growing at a CAGR of 15.92 percent, Indian pharmaceutical market is expected to touch USD 55 8 ◄ July 2019

billion by Yr 2020 with a present stock of over 10500 manufacturing units, 3000 pharma companies, and 60000 generic brands across 60 therapeutic categories.

Along with, Indian healthcare sector is expected to rise at a CAGR of 29 percent during 2015-20 with rising income, greater

health awareness, increased precedence of lifestyle diseases, and improved access to insurance. Brighter sides are always great to mention. However, to improve upon low-light areas, Government’s new initiative on National Health Protection Scheme is to provide hospitalisation Pharma Bio World

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India has the second largest startup ecosystem in the world witnessing a 10 – 12 percent YoY growth. coverage to poor and vulnerable families for secondary and tertiary care hospitalisation. Pharma companies have increased spending to tap rural markets and develop better infrastructure.

In context of Biotech industry, India holds 2 percent of the global market share and is currently among the top 12 biotech destinations of the world.

Indian biotech industry mainly includes biopharmaceuticals, bio-services, bioagriculture, bio-industrials, and bio-IT; and encompasses of approximately 800 companies. It is the home of the second highest number of United States Food & Drug Administration (USFDA) approved plants.

various schemes viz. Pradhan Mantri Jan Arogya Yojana, etc. With the consecrations of all these impetus, India is now a home of close to 5000 health-tech startups. However, India has to go a long-way to match up the technologically advanced western cities to enter the age of start-ups. Even though numerous health-tech startups are emerging in Indian ecosystem, their scope so far is really narrow.

Start-up Ecosystem:

The major makings of a start-up ecosystem are: • Access to Great Ideas: Great ideas are the seed of great business opportunities.

Therefore, it’s important to build platform over features and wisdom over widgets.

• Access to Talents: Prodigious entrepreneurs learn from mistakes and convert their slip-up into success, thus contributing to the success of the entire ecosystem with their experiential wisdom.

• Access to Capital: Great ideas and prodigious talents are best utilized with the capital to fund the vision. Availability of the capital is very critical for each stage of the development starting from the seed stage. Investors can be local, or may be from distance.

• Access to Customers: This is one of the most important piece, because:

Start-up opus: As of now the country Customers drive revenues  Revenue impresses investors  Investors fund has brought up around 20,000 startups. growth  Growth leads to big exits  Big exits lead to a robust ecosystem.

Almost 3 – 4 startups are being born every day. Major factors which made India the Key players of the startup ranch-house of startup, are: economical ecosystem are: People and cost of doing business, proximity to • Government: Be it Talents customers as well as vendors, and wide city-level, state-level, or enough domestic market. Almost 55 Support country-level, government Big Companies Organizations percent of youth, after finishing their always plays a very academics, prefer to start their own important role by providing Startup startup venture. Most of the startups in the various benefits viz. taxEcosystem pharma biotech and healthcare sector in concession for startup - Key Funding India are focused on improving access to launching and capital gain Academia Players Organizations healthcare and critical care due to lack of to stimulate investment, adequate expert healthcare and medical passing ecosystem professionals in remote rural India. Doctor friendly laws, establishing Service Research to patient ratio in allopathy sector stands venture capital funds Providers Organizations for 1:1596, which is far lower than WHO with a portion of their standard of 1:1400. This indicates a huge treasury, etc. potential for healthtech startups in the • Entrepreneurs: They 1.3 billion plus economy, to take charge need a team with equal balance of needed skillsets right from strategy, to marketing, of the preliminary medical scanning with to technology, and other associated arena. the help of innovative technology-based • Mentors: First-time entrepreneurs need experienced and successful entrepreneurs as well as devices. Indian government has also leaders to seek guidance to get them up the learning curve without reinventing the same wheel. contributed significantly to foster the drive for better medical reach to all through • Investors: Investors and investments can be of varied forms viz. government grant, 14 ◄ July 2019

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Doctor to patient ratio in allopathy sector stands for around 1:1596, which is far lower than WHO standard of 1:1400. This indicates a huge potential lies in front of health-tech startups in the 1.3 billion plus economy. individual angels, organized angel networks, venture capital firms, private equity firms, corporations, etc.

• Incubators: Incubators include everything starting from shared office spaces for startups, all the way up to formal startup accelerator program with formal educational curriculum. The objective is to foster peer-to-peer learning in the pool of entrepreneurs in close proximity.

• Universities: Many extra-ordinary ideas are spurred from university research wings.

The key is to have a healthy technology transfer process in place for business leaders to monetize those ideas.

• Corporations: Big companies help the start-ups in many ways starting from investing through corporate venture capital funds, to becoming the potential customers to new start-ups. A healthy interaction between startups and corporations work wonder towards a common goal.

• Associations: This could be industry trade associations, venture capital associations, entrepreneur networking groups, chambers of commerce, economic development groups, etc. These groups help organize and propel the ecosystem by leveraging their various interfaces, tools, and events.

• Service Providers: The lawyers, accountants, bankers, recruiters, agencies, advisors, and consultants all play a very crucial role. The more experienced they are with startups, the better advice they will bring to the ecosystem.

in different areas of biotechnology. To promote the Startup India initiative DBT along with Biotechnology Industry Research Assistance Council (BIRAC) has launched various schemes and programs. Accelerated translational grant for commercialisation (ATGC) has been launched to encourage technological innovation. DBT has also launched various biotechnology parks and incubators across the country to provide infrastructure support to scientists, startups, and mid-sized entrepreurs for technology incubation, technology demonstration, and pilot plant studies for quicker commercial development of Biotechnology.

While talking about biotechnology sector, critical low-light areas • Lack of funding, start-ups.

the highlights for some of the most are: majorly for the

Growth drivers, challenges, and the way forward: Indian government established Department of Biotechnology in 1986 under the Ministry • Patchy early stage funding (POC stage) of Science and Technology.

Since then there have been • Disconnect between entrepreneurs a number of dispensations and research organisations where bulk of the research spending happens in offered by both the India central governments and various states to • Lack of experience of entrepreneurs and mentors in commercialisation of encourage the growth of their inventions. the industry. Programs have been launched to Most likely sources of fund are the provide grants for biotech government grant and the venture capital. startups and firms seeking This is relatively a young industry in India. to expand. Department Government grants are relatively difficult of Biotechnology (DBT) to secure. On the other hand, venture has been successfully capitalists are majorly reluctant to fund coordinating with various those firms which have not yet developed a countries and philanthropic commercially viable product. Government organisations to run has addressed this problem in their collaborative programs National Biotech Development Strategy.

16 ◄ July 2019

Pharma Bio World

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Almost 55 percent of youth, after finishing their academics, prefer to start their own startup venture.

This plan induced a proposal to create a national task force that will work with the biotech industry to revise the curriculum for undergraduate and graduate studies in life sciences and biotechnology. The strategy also focused to increase the PhD fellowship by DBT. These human resources will further be leveraged with a “Bio-Edu-Grid” that will knit together the resources of the academic and scientific industrial communities.

Major organisations promoting countries’ startups in pharma, biotech and health-tech sector: 1) Biotechnology Industry Research Assistance Council (BIRAC): BIRAC is a wing of Department of Biotechnology (DBT) and a not-forprofit organization. It strengthens and empowers the emerging biotech enterprises in India, started off with the thought of highest level of government that there should be an organization to spur the technical knowledge and high level of risk-research in the industry and to encourage young entrepreneurs to think differently to discover breakthrough solutions of the problems. The key strategy of the organization is: innovation research for affordable product development and emphasis on not only for the funding, but also for complete handholding.

BIRAC’s vision is to stimulate, foster, and enhance the strategic research and innovation capabilities. It supports entrepreneurship thus funding by grants, investing in people, and investing in places.

2) Venture Centre: It is a trademark of entrepreneurship development center and a not-for-profit company hosted by CSIR – National Chemical Laboratory, 18 ◄ July 2019

Pune. It is country’s largest science and technology incubation center specializing in technology startups in the areas of biological sciences & engineering, materials, chemicals, etc. It strives to nucleate and nurture the technology and knowledge-based enterprises by leveraging the scientific and engineering competencies. It has received support from various entities of the Ministry of Science and Technology, Government of India, with a special mention of DST – NSTEDB and DBT – BIRAC. Venture Center is actively working on: • Identifying, creating, facilitating, and operating early stage funding opportunities.

• Facilitating access to government funding schemes.

• Other pockets of funding through CSR funding route.

• A unique pioneering program Lab2Mkt for creation of spinoff companies from research organization.

Venture center also helps connect entrepreneurs to mentors from other parts of the world. It conducts a wide range of events to build learning experience amongst first-time entrepreneurs.

To 3) SINE at IIT Bombay: create technology enabled new enterprises, IIT Bombay has developed various mechanisms and bodies. The Society for Innovation and Entrepreneurship (SINE) is one such umbrella organization to promote entrepreneurship and nurturing tech startups. It widens the scope of institute’s research activities by enabling commercialization of the IP generated through entrepreneurial ventures. Started in Yr 2004, it was one

of the earliest incubators in academia with a potential to create startups focusing on economic growth, strategic value, and social relevance. It gives prototyping grants, provide incubation support to tech startups, and also runs accelerator programs in corporate partnership. The vision of SINE is to provide an environment to translate knowledge and innovation into creation of successful entrepreneurs. Their support is divided into three parts : preincubation, incubation, and accelerator covering infrastructure & technical support, financial support, mentoring & coaching, business network, product development & manufacturing, testing & product certification support, visibility & media, and retainer services.

In the coming pages: The 17 Th anniversary edition of Pharma Bioworld is themed on “Innovative Pharma Startups”.

We have endeavoured to acquaint our readers with various startup aspects apart from our regular sections.

Resource acknowledgement: 1. www.startupindia.gov.in 2. www.makeinindia.com 3. www.ibef.org 4. www.investindia.gov.in 5. www.sineiitb.org 6. www.venturecenter.co.in 7. www.birac.nic.in

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Start-up Journey The journey of a startup initiates with right ideation followed by outcome validation. In this section we are going to cover a few Startup journeys in healtht e c h s e c t o r, w h i c h w i l l demonstrate how a social medical cause gives birth to appropriate mentation in order to create successful solutions.

20 â—„ July 2019

Pharma Bio World

Startup Journey

By Jayati Mukherjee

Case: Ayu Devices Pvt Ltd

Contextual Essence: Heart and lung diseases are the major reasons for death, not only in India, but in other countries as well. Around 3 lakhs children were born with congenital heart disease and detecting them at an early stage is very important. Most of such children are under the age of 4 years. Heart and lung sound play a very critical role in detecting abnormalities being backed up with adequate patient-history. However, interpreting those sounds are not easy, as often times these sounds are very low and unclear, thus causing hindrance for a conventional stethoscope to capture that sound. Moreover, interpretation of the captured sound is always subjective and varies in extent with the examiners. The pastoral part of our country faces the scarcity of expert healthcare professionals and physicians. Therefore, if this early screening can happen through device, it will ease up the situation as well as speed up the treatment procedure. Such circumstances give birth to the emerging need for amplification of the sound. Moreover, scarcity of expert healthcare professionals and physicians in rural India raised the need for recording the said sound in order to forward to the experts for onward proceedings.

Key Breakthrough: With above mentioned context, Adarsha K realized the need for a device which can remove the shortcomings of a conventional stethoscope. He understood the need for amplification and recording of heart-and-lung sound to diagnose the problem at the budding stage. On this note, with a few successive trials, he developed a tiny device which can easily be attached to the conventional stethoscope and which has the ability to amplify as well as to record the sound. This amplified sound helps to differentiate the abnormalities and the recordings help in onward treatment guided by the experts. The venture’s breakthrough product is the digital stethoscope having features of noise reduction and amplification for clarity, sound recording and sharing for future reference, and data storage with the scope of analysis for abnormality detection and preliminary screening. The device is tiny in size and can be easily attached to the existing stethoscope.

Formation of Startup: The venture has been spun out of BETiC, IIT Bombay. Whilst most of the startups follow the methodology of incorporating the business first and then developing the solution, Adarsha K followed the reverse methodology. He first built the prototype and then came up with the device with a few initial trials and modifications. Once the device got the first acceptance by the expert medical and healthcare professionals, he registered his startup venture basis that.

The device is also being used by telemedicine companies who are focused to deliver healthcare in rural areas. This device can be connected with doctors and / or clinics through mobile, laptop, kiosk, etc with the power of internet.

• AyuSynk provides effective auscultation for diagnosis of heart and lung diseases.

• AyuShare makes it possible to record, upload, and perform analysis on the sounds recorded through the device.

Moreover, it has the feature of wireless connection.

The Journey: Mr. Adarsha K, in spite of being an engineer by vocation, has remained interested in solving medical problems.

With this interest, his mission was to bring his expertise in the form of devices and

We have come out with our product first after surveying the need, and when the product was accepted by the doctors, with that acceptance we formed our company.

22 ◄ July 2019

applications for early detection of diseases – more specifically, heart and lung diseases.

Mr. Adarsha K is a Bachelor in Electrical and Electronics Engineering. After completion of his academics and before starting his venture, he was associated with L&T Infotech as a Software Engineer followed by an association with IIT Bombay as a Senior Project Technical Assistant, and eventually as a Research Assistant in BETiC Center of IIT Bombay. This device was first launched in April, 2018.

The initial challenges were: • From Design Perspective: The design of a conventional stethoscope is very critical.

Its look-and-feel cannot be changed.

• From Manufacturing Perspective: Initially it was required to manufacture in small quantities. Many of the vendors were not ready for it. However, eventually, the problem has been sorted out with an appropriate vendor.

The major competitive advantage of the device is: In spite of being low-cost, it integrates multiple features. This helps in commercialization. The device is being manufactured in scale; and India being the price-sensitive market, the device has been kept available at a low-cost yet yielding high value. During its journey, Ayu Devices received Biotechnology Ignition Grant (BIG) for ` 50 Lakhs from BIRAC. It has also been awarded by Bombay Management Association as an “Emerging Start-Up” in Yr 2017.

Resource Acknowledgement: Adarsha K, Cofounder & Executive Director, Ayu Devices Pvt Ltd @ Student Outreach Program, Chemtech Foundation, Feb 2019

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Startup Journey

Case: Module Innovation

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by Venture Center – an initiative by CSIR, National Chemical Laboratories at Pune.

Key Breakthrough: Invention of the solution – USense – for the above mentioned issue basis simple colorimetric read-out which does not require any complicated instrumentation or electronics.

The most prominent feature of this invention is quick delivery of the result within an hour against the two to three days requirement by conventional urine culture method, without needing any laboratory. It has the

capability to detect four euro-pathogens responsible to cause UTI. Other offerings: a. C-Sense: to detect Cervical Cancer. b. Eco-sense: to detect presence of E-Coli in drinking water.

The Journey: Early life of the founder Usman Khan in rural Rajasthan has made him acquainted with the common medical pain-points of the rustic part. As every constraint accompanies with an opportunity, this challenge made Usman Khan to realize that there is a huge scope for improving primary healthcare in pastoral zone. During the final year of his M.Tech persuasion in Biotechnology, he met up with Sachin Dubey who later became his start-up partner. Sachin Dubey was highly passionate about technology development. During their final year internship, they both got an exposure in National Chemical laboratory at Pune.

There, while Sachin Dubey was working on nano-material and polymer science, Usman Khan concentrated on microbiology. They came up with the ideation of detecting E-Coli contamination in drinking water. Basis this ideation, the duo formed their venture ‘Module Innovation’ at National Chemical Laboratories (NCL) by using their laboratory space and office space. Initially the project was funded by the prize-money of ` 3 lakhs they received from BIRAC’s call ‘Biotechnology Entrepreneurship Student Team’ and later through Biotech Ignition Grant for ` 50 lakhs sponsored by BIRAC.

Note for Future Entrepreneurs:

“ Although

the journey looks like a smooth sail, but it wasn’t. Huge struggle has remained as a part of it. For entrepreneurs, there are some ground-level hidden reality which comes as ‘terms & condition applied’. There are some opportunity costs involved during the journey.

For Module Innovation, the period from Yr 2012 to Yr 2014 was real tough. We had to survive without getting any persistent cash-inflow during this period. I had to let go a lucrative job-opportunity at Dubai, while Sachin Dubey had to forego his PhD opportunity at a renowned US university. However, with our strong will-power, we overcame this challenge. Therefore, to be an entrepreneur, one has to be their own mentor, motivator, financer, and care giver , said Usman Khan

”

Resource Acknowledgement: Usman Khan, Co-Founder, Module Innovation @ Student Outreach Program, Chemtech Foundation, Feb 2019

To be an entrepreneur, one has to be their own mentor, motivator, financer, and care-Giver 24 ◄ July 2019

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Startup Journey

Case: Weinnovate Biosolutions

By Jayati Mukherjee Contextual E s s e n c e : Diabetic footulcer is a pressing issue, which affects older people in general. So far more than 78 million people have been affected globally with this difficult to heal wounds. If not treated properly, it may lead to amputation and in the worst-case scenario – even the death. Treatments available so far is mainly concentrated on preventive mechanism; only a fewer options are available for healing of the wound. To add more to the misery, existing options are expensive and time-consuming with no surety for success.

the first place, but also to accelerate the healing of the wound. Its unique nanoparticles take care of the infection and their reoccurrence. This healing being a complex process, the formulation works through multifarious process at various stages. For being a novel formulation, Management has decided to make it patented.

Formation of Startup: With the above context, Weinnovate Biosolutions has been set up by Founder-CEO Milind Chaudhary in the year 2016. The venture is dedicated to healthcare solutions with a team comprised of interdisciplinary talent pool, where scientists and technologists are working together in harmony. Now Weinnovate Biosolutions has been stretching them in therapeutics, diagnostics and healthcare needs with the aid of advanced technological development.

a. RAPID: Almost 1 million people die every year worldwide by being infected with AMR bacteria. RAPID is a fully integrated and automated single module diagnostic system with fluorescence based highly sensitive detection system.

Key Breakthrough: The venture’s flagship innovation is Heal Rap to treat diabetic foot-ulcer. The formulation is a unique blend of small molecules, which not only prevents the wound to occur at

The formulation has a huge societal relevance as India is the diabetic capital of the World; and with increasing diabetic population, foot care is one of the major concern. By addressing this issue, the worst-case scenario of diabetic foot amputation can be assuaged by a large extent, more so in rural area.

Other offerings:

b. Silvo Clean: It is an all-purpose microsterilization, which proclaims to kill 99 percent of germs in 10 seconds. c.

SMADS: It is the technical services on formulation development of novel and smart materials assisted drug delivery system with a special focus on synthesis of novel excipients and their applications for the formulation development of smart nanoparticulate delivery systems for antibiotics.

“Weinnovate Biosolutions started with a group of innovators and technologists, who wanted to create new and sustainable business ecosystem around the technology and biotechnology”, said Milind Chaudhary, the Founder-CEO. 26 ◄ July 2019

The Journey: Before starting his journey with Weinnovate Biosolutions, FounderCEO Milind Chaudhary has been associated with many high-profiled organizations viz.

Ranbaxy and Serum Institute. Even though he acknowledged his immense knowledge acquisition during this tenure, his strong urge for research and development finally led him to make decision of pursuing PhD at Agarkar Research Institute Pune. During this period he has got ample scope to work on his interest. During this phase, he worked on Diagnostics, UTI wrap, DNA wrap, etc. During his last year of PhD, he captured a very valuable experience about how technology fails to become a product. He realized that research work needs to happen from societal perspective or customers’ perspective; and the journey from technology to productization is a long road through rigorous examination.

From business point of view, it is about the capitalization of an opportunity. With all these context, towards the end of his research, he identified the unnerving diabetic foot issue. He decided to start his own venture with Biotechnology Ignition Grant by BIRAC, which is today’s Weinnovate Biosolutions.

Note for Future Entrepreneurs:

“ Biotechnology students understand

the science and technology very well. If they can connect this with the product and business, they can be at the sweet-spot having all the things going together at same time , said Milind Chaudhary

”

Resource Acknowledgement: Milind Chaudhary, Founder and CEO, We Innovate Bio-Solutions @ Student Outreach Program, Chemtech Foundation, Feb 2019 Pharma Bio World

India’s Start-up Ecosystem: A big step towards realizing USD 5 Trillion Economy India is waking up to unleash the potential of its ginormous population to usher country’s Startup culture to foster country’s economic growth. In this article, author has explained in details about how different stakeholders are contributing to the ecosystem, with a prominent role of Government through the inducement of various schemes to ease up doing business for Startups.

The economic growth of any nation is a function of job creation. This can be effectively done by creating a sustainable mechanism whereby the job seekers become job creators.

India, in its journey to become a USD 5 Trillion economy, has already set the ball rolling by

taking a number of initiatives including earning the tag of a “Start-up Nation”. The Indian Startup Ecosystem has emerged as the 3 rd largest in the world and has witnessed the launch of an estimated 20,000 startups over the years, just behind the US as per the reports by Ministry of Commerce and Industry, Start-up India initiative, Government of India. Currently,

Dr. Suchita Markan Asst. General Manager Biotech Consortium India Limited (BCIL) Pharma Bio World

July 2019 ► 27

there are around 4,750 technology led start-ups in the country.

It has been observed that 1,400 new tech start-ups emerged in 2016 alone; implying that 3-4 tech start-ups were born every day.

Indian entrepreneurs are building world-class technology start-ups, attracting global investors’ interest and churning out successes and unicorns at a rapid pace. Some people often call this time zone as the “Golden Age for Entrepreneurs” to set-up modern business enterprises in India due to the enabling and supportive ecosystem in the country.

The Government has taken several nation-wide initiatives in the

start-up dream of potential entrepreneurs. As per the analysis of the sector and its location trends of startups, various start-up hubs/ clusters exist in India with dominance around Bangalore followed

by Delhi/NCR and Mumbai. While eCommerce and Aggregators have become mature; Fintech, Edutech and Healthtech are emerging verticals for start-ups in India.

With the intention to build a strong ecosystem for nurturing innovation and Startups in the country, the Hon’ble Prime Minister launched Startup India Action Plan on January 16, 2016 in New Delhi.

The Government through this initiative aims to empower Startups to grow through innovation and design and to accelerate spreading of the Startup movement. In order to meet the objectives of the initiative, Government of India had announced an action plan that addresses all the key aspects of the Startup ecosystem. Several programs have been undertaken since the launch of the initiative eg. I-MADE program, Pradhan Mantri Mudra Yojana, etc. These programs have catalyzed the startup culture, with startups getting recognized through the Startup India initiative and many entrepreneurs availing the benefits of starting their own business in India.

Some of the key drivers which have played a key role in boosting the Start-up ecosystem in the country include- Fiscal Policy initiatives by the Government of India,

recent years to foster innovation and entrepreneurship for catalysing development of a robust economy. Some examples include ‘Startup India’, ‘Skill India’, ‘Innovate in India’, ‘Make in India’, ‘Atal Innovation Mission’, etc. Budgetary allocations to the biotech sector have also increased with the objective of creating an innovation led ecosystem and to nurture start-ups. With the above objective, the Department of Biotechnology (DBT) has initiated several flagship programmes and schemes to promote bio-entrepreneurship amongst students, research fellows, young faculty, and scientists. Several programmes of other government departments such as Department of Science and Technology (DST) and Department of Scientific and Industrial Research (DSIR) have also been developed and aligned to provide opportunities and support to promising innovation led entrepreneurship ideas. Multiple public-private partnered incubation centres have been set up in different parts of the country and are creating a dynamic atmosphere for the entrepreneurial minds in the domain. Incubators, accelerators, angel investors and venture capitalist funding are also acting as enablers to realize life sciences’ 28 ◄ July 2019

Policies for Reducing Compliance and Enabling Operations, Infrastructure support and strengthening, Funding Support Initiatives, Intellectual Property Facilitation and facilitating Public Procurements etc. Apart from these key drivers, specific Mission Programs like Atal Innovation Mission, SETU program etc have also played a major role in changing the mindset to boost innovation and Startups in the country.

To encourage the start-ups, the process of start-up registration in the country has been made very simple. Acknowledging the long gestation period for Startups, the definition of the Startups has been amended where an entity shall be considered as a Startup for up to 7 years (from earlier 5 years) and a Biotechnology Startup for up to 10 years from the date of its incorporation/ registration. Policy for Reducing Compliance has been introduced

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by the Government to reduce the regulatory burden on Startups thereby allowing them to focus on their core business and keep compliance cost low. In order to make compliance for Startups friendly and flexible, the Government has introduced simplifications in the regulatory regime with regard to compliance to labour and environment laws. Startups are now allowed to self-certify compliance (through the Startup mobile app) with 9 labour and environment laws. The Government has received an over-whelming response from the start-ups where in the last three years 14,036 new ventures have been recognised as Startups by the DIPP. The “Startup India Hub” has been envisaged by the Government to be a key stakeholder in this vibrant ecosystem which is working in a hub and spoke model to collaborate with various stakeholders in facilitating the start-up issues. Under this initiative, more than 2.7 lakh users have been registered and the hub has mentored more than 660 Startups for incubation, funding support, business plans, pitching support, etc.

Government has taken-up various fiscal policy initiatives to foster start-up ecosystem in the country viz. Credit Guarantee Fund for Startups, Tax Exemption on Capital Gains, Tax Exemption to Start-ups for 3 years, Tax Exemption on Investments above Fair Market Value, to name a few. Such policy initiatives have further catalysed the start-up growth of the country.

India currently lacks availability of incubation facilities across various parts of the country which are essential for an entrepreneur during its initial stage of setting-up an enterprise.

Incubation facilities typically include physical infrastructure, provision of mentorship support, access to networks, access to market, etc of all these features, physical infrastructure entails large capital investment which can generally be facilitated by the Government. However, requisite skills for operating an incubator are pivotal as well, for which expertise of the private sector needs to be leveraged.

Considering this, Government is encouraging setting up of 35 new incubators in existing institutions. Funding support of 40 percent (subject to a maximum of INR 10 crore) is being provided by Central Government for establishment of new incubators for which 40 percent funding is being pooled by the respective State Government and 20 percent funding by the private sector. Incubator support is also being provided

by Ministry of Science and Technology through Department of Biotechnology, and Department of Science and Technology, Government of India.

The infrastructure support is also being provided by the Government through setting-up of Technology Business Incubators (TBIs), Research Parks, Innovation centres at national institutes etc. DST has so far funded over 60 TBIs, which have been set-up across the country.

Most are based within academic institutions but some are publicPharma Bio World

private partnerships with investors.

BIRAC, a public sector undertaking of DBT through its Bio-NEST scheme has supported 36 bio-incubators (sanction amount of about ` 235 Cr) so far creating a cumulative area of 3,91,849 sq. ft. for budding entrepreneurs. The impact has been multi-fold as over TBIs/ Bioincubators supported by DST 710 Start-ups have received benefits from these bio- incubators under various programmes viz Biotechnology Ignition Grant (BIG), Industry Innovation Programme on Medical Electronics (IIPME), Sparsh, Grand Challenges, BioNEST, etc.

Other incubation models available in India are also attracting huge number of start-ups in the country today.

These models include impact accelerators, coworking spaces, Bioincubators supported by BIRAC social venture academies, impact angel networks, prizes and competitions, etc.

One of the key challenges faced by Startups in India has been access to finance. Quite often, due to lack of collaterals or existing cash flows, Start- ups fail to justify the loans. Besides, the high risk nature of Startups wherein a significant percentage fail to take-off, hampers their investment attractiveness. In order to provide funding support to Startups, the Government has set-up a fund with an initial corpus of ` 2,500 crore and a total corpus of ` 10,000 crore over a period of 4 years (i.e. ` 2,500 crore per year). So far, 170 Start-ups have received funding from these fund-of-fund sources, often referred to as Alternative Investment Funds (AIFs) by the country.

July 2019 ► 29

India is considered most fertile in terms of raising low-risk grantin-aid funding for developing innovative technologies by startups.

The Indian Government through its scientific and industrial agencies offers an array of funding schemes for supporting technology development and commercialisation by entrepreneurs for all stages of technology development including early-stage development, validation, scale-up to full-scale commercialisation. The Government grants are mostly in the form of Grant-in-aid or soft loans. A number of national agencies i.e. Department of Biotechnology (DBT), Department of Science and Technology (DST), Department of Scientific & Industrial Research (DSIR), Council of Scientific & Industrial Research (CSIR), Ministry of Micro Small Medium Enterprises (MSME), National Research Development Corporation (NRDC), Defence Research & Development Organisation (DRDO), Technology Information, Forecasting and Assessment Council (TIFAC), etc have been supporting start-up companies with a view to strengthen innovative R&D and technology development by launching different programs / schemes. To name a few, there is Biotechnology Ignition Grant (BIG), Biotech Industry Partnership Programme (BIPP), Small Business Innovation Research Initiative (SBIRI), Promoting innovations in Individuals Start-ups and MSMEs (PRISM), Patent Acquisition and Collaborative Research and Technology Development (PACE), Techno-Commercial Support for Promising Inventions/Innovations, New Generation Innovation and Entrepreneurship Development Centre (NewGen IEDC), National Initiative for Developing and Harnessing Innovations (NIDHI) etc. A grant-in-aid fund ranging from ` 10 Lakhs to Rs. 5 Crores can be availed through these funding opportunities which is a good enough grant to de-risk technology and mobilise co-funding for a greater impact.

Several international agencies have also joined hands with Indian Government for providing funding support to the budding entrepreneurs eg. Grand Challenges i.e. Wellcome Trust, Bill & Melinda Gates Foundation, Lockheed Martin Corporation, Grand Challenges Canada, and bilateral / multilateral programmes with other countries etc considering Start-up boom in India, private sector funding through ‘Angel Investment’ and venture capital funding opportunities can also be availed by the start-ups.

Skill development for promoting entrepreneurship development and start-up creation is also on the agenda of the Government of India wherein specialised fellowship programs have been initiated and are being implemented by the Government as their flagship programs for more than a decade. Such programs which have really made an impact include DBT supported School of International Biodesign (SIB) program, Social Innovation Immersion Program (SIIP), etc.

Government has initiated a scheme “Startup Intellectual Property Protection (SIPP)” which provides access to high quality Intellectual Property services and resources, including fast-track examination of patent applications and rebate in fees. The SIPP is facilitating filing of Patents, Trademarks, and Designs for innovative Startups. Under this scheme, Patent applicants have received the benefit of up to 80 percent rebate in patent fees and free legal assistance. Startups have also availed benefit of fees rebate in expedited examination filing fees (Form18(A)). Trademark Rules, 2017 has been recently amended to provide 50 percent rebate in Trademarks filing fee to Startups. Overall, more than 2,000 Startup cases have been facilitated under the scheme so far.

No business is successful unless its investments have seen a multiplier effect with significant return on investments (ROI).

Although the startups addressing a long unmet market need are able to make sales through private sector engagement, gaining market access through public procurements is rather more taxing and has not been significantly achieved by startups. In order to promote public procurement through Startups, Government

has taken initiative to exempt Start-ups (in the manufacturing sector) from the criteria of “prior experience / turnover” without any relaxation in quality standards or technical parameters. This initiative has been taken to encourage startups and provide level playing field to the startups with the established manufacturers.

Therefore, India, an Asian tiger is waking up to unleash the intellectual potential of its billion people and truly ushering in the “Golden Age of being a Start-up Nation” and the stage is set for the Start-ups to flourish and make a sustainable social and economic impact.

To promote awareness and adoption of IPRs by Startups and facilitate them in protecting and commercialising the IPRs, 30 ◄ July 2019

Pharma Bio World

Union Budget 2019-20: A Frost & Sullivan Perspective Krishanu Banerjee Consultant, Public Sector Practice, Frost & Sullivan

Union Budget 2019-20 has been tabled in Parliament on 5Th July 2019, being presented by Finance Minister Ms. Nirmala Sitharaman. With this budget, the Government is intending to strengthen the growth and investment to secure the fastest growing economy tag for India.

Government’s promise to double the country’s economy size from USD 2.61 trillion to a staggering USD 5 trillion by Yr 2024 – 25

Along with other aspects, this budget confers several benefits for MSMEs and Startups. In this article, the author has made an inclusive analysis for the overall impact of the budget on Indian Economy and the highlights.

Overall Analysis:

To arrest the slowdown in the domestic economy, measures to boost investment and employment are necessary. With the launch of initiatives like ASPIRE and schemes like “Nari Tu Narayani”, it is encouraging to see direct government measures focused on boosting entrepreneurship and encouraging women’s participation to improve India’s growth trajectory. With a sharp eye to boosting FDI, National Investment and Infrastructure Fund (NIIF) will be used to organize Annual Global Investors’ Meet to attract global players to visit and invest in India. This is expected to be instrumental for start-up funding as well.

To encourage affordable housing for all, the Government has planned to construct 1.95 crore houses under Pradhan Mantri Awas Yojana. Raising the deduction claim slab on interest paid for ` 3.5 lakh per annum loans to buy an affordable house under ` 45 lakh, will provide an additional boost.

Since water scarcity is an ever-increasing concern, it is encouraging to see that Jal Shakti Ministry will work in tandem with the States towards ensuring India’s water security and providing access to safe drinking water to all.

Pharma Bio World

The Government’s agenda for this year’s budget was to put India back in the growth trajectory. The citizens of India voted for a strong and stable government for the second term with the belief that the weakening growth and investment will gradually reverse, thus stabilizing the economy. The planned structural reforms announced today in the form of investment in infrastructure; and digital economy, along with the measures to boost the entrepreneurial culture in the country, is a strong testament that the present Government is focused on turning around the economy. Asia’s thirdlargest economy is anticipated to be bullish in the next 5 years and may reach closer to the target of becoming the USD 5 trillion economy by 2024 or 2025.

Overall Impact: Positive Top 5 – Expected Growth Drivers for 2019-20: 1. Investment growth 2. Boost to entrepreneurship 3. Policy to restriction

eliminate

FDI

inflows

4. Strong structural reforms and citizencentric schemes to promote inclusive growth 5. Streamlining operations consolidations of PSUs

and

Union Budget 2019 – 20: Highlights for Start-up India 

Startups are not to be subjected to any scrutiny with respect to valuations of share premiums to resolve ANGEL TAX issue.



E-verification to resolve the issue of ESTABLISHING IDENTITY of the investor and source of his funds.



Startups are NO MORE required to justify FMV of their shares issued to Category – II. AIFs to protect them from unnecessary income tax scrutiny.



Relaxation in conditions to CARRY FORWARD and to SET OFF Losses.



EXTENTION of EXEMPTION on CAPITAL GAINS arising from sale of residential house for investment in Start-ups up till 31-March-2021.

Source: Press Information Bureau

July 2019 ► 31

Key Announcements: • Eighty livelihood business incubators and twenty technology business incubators to be set up in 2019- 20 under ASPIRE scheme to develop 75,000 skilled entrepreneurs in agro-rural industries.

• Annual Global Investors’ Meet to be organized • ‘Nari tu Narayani’, ‘Pradhan Mantri Awas Yojana’, and ‘Har Ghar Jal’ schemes

Union Budget 2019 – 20 : Perspective of Industry Stalwarts U ni on Fi na nc e , pr es en te d by 19 20 et dg Bu tra te d “T he U ni on , ha s co nc en an am ar th Si a al M in is te r N irm an d w el fa re of fo r th e gr ow th on si vi e th ha s no t m or e on al th ca re se ct or he e th gh ou th n, th e co un try. Al dg et , sa ni ta tio h du rin g th e Bu uc m d se n us ve gi sc be en be en di w at er ha ve e bl ta po d ie he al th r hy gi en e an a cl ea ne r an d te ea cr to r de h im po rta nc e in or us hm an Bh ar at en t, th ro ug h Ay nm er ov G e nd Th ou l-r so ci et y. m or e on th e al to co nc en tra te s m ai ts ou r , an na w ja d Yo ild re n an ch d an en om w no ur is hm en t of ei r he al th in a ki ng ca re of th ta er id ns co is a m aj or ci tiz en s to tiv e he al th ca re en ev Pr . ay w m or e se rio us le , w ho en d up ig no re d by pe op tly os m is at a m ed ic al is su e th n di ag no se d w ith he w ly on ns ia id er vi si tin g cl in ic ak e pe op le co ns e, in or de r to m or ef er th e Th , . re er fa rd di so al w el th an d pe rs on al he r ei th on n du ct io of in ve st in g d th e ta x de se ea cr in s ha id G ov er nm en t to ` 25 ,0 00 ’, sa fro m ` 15 ,0 00 e nc ra su in al B R Li fe m ed ic , G ro up C E O , ar m ar P gh in C ol H em ra j S H os pi ta ls .

“T he Bu dg et ha s ad dr es se d ex pe ct at io ns ar ea of en ha nc in th e in g he al th ca re co ve ra ge to th ci tiz en s th ro ug e In di an h Ay us hm an Bh ar at . C on so lid at gr an ts in to th io n of e N at io na l R es ea rc h Fo un da ho pe fu lly en ha tio n w ill nc e m ed ic al re se ar ch . Th e m de vi ce in du st ry ed ic al w ill st an d to ga in on ac co un t re du ce d cu st om of th e s ta riff an d in cr ea se in th e tu th re sh ol d to IN rn ov er R 40 0 cr or e fo r th e co rp or at e of 25 pe rc en t”, ta x ra te sa id A m it K um ar B aj aj , P ar tn G ra nt Th or nt on er, In di a LL P

“The increase in capital infusion in infrastru cture is indeed a welcom e move. The increase in budget allocatio n for the power sector is also much appreci ated. Further, the governm ent’s “One Nation One Grid” initiative will diagnos e India’s current power situation and underlin e steps to solve the

sector’s problem s. It is also expecte d to create further inroads towards policy reforms such as power

ad dr es se d no t se em to ha ve es do et dg bu “T his ing up of th e cto r dir ec tly. Op en th e he alt hc ar e se alt hc ar e. Th e FD I ma y be ne fit he to r cto se ce an ur ins . El se , sta tu s so me th ing th ou gh fin e pr int ma y ha ve M ed ic al ak Ba la ni , Ch ie f of ep De .

Dr id sa ”, is! qu o it ng al ur u or ld Ho sp ita l, Be W a kr Sa , es ic rv Se

32 ◄ July 2019

tariff reform, which will boost the segmen t. While these initiative s lays the road map for the growth, harness ing the benefits of these initiative s will

require greater account ability and faster executio n at

the ground level”, said Munira Loliwal a, Busine ss Head – EMPI, TeamLe ase Service s

Pharma Bio World

Union Budget 2019 – 20 : Perspective of Industry Stalwarts

lo ok po si tiv e an no un ce m en ts et dg bu e th ll “O ve ra s lik e fu nd s e ne w re fo rm Th y. dl en fri of an d pe op le qu ire sc ru tin y ps w ill no t re t-u ar st ps by t-u ar ra is ed e m ov e fo r st t is a po si tiv re d on ai ta x de pa rtm en be w ill pr og ra m s th at l ia ec sp m fro ill he lp in ap ar t by st ar t-u ps w ps t-u ar st r fo eu rs D oo rd ar sh an dd in g en tre pr en ot iv at in g th e bu m d an g in ud at ed uc al ly la th e gi on s. I pe rs on re l ra ru d an n rc en t in se m i ur ba lo ca tio n at 2 pe al nd fu l na tio di m ov e fo r an ad an d th is is a n by M SM Es ke ta s an lo r th e w or ld in te re st fo m en t. Ac ro ss rn ve go e th gr ea t m ov e by bu t El ec tro ni c s ar e kn ow n rm fo at pl g in ) fo r cr ow d fu nd st oc k ex ch an ge l ia oc (s rm fo at fu nd ra is in g pl gh m ov e by is a br ea kt hr ou es ris rp te en al in so ci al lis tin g so ci tio ns w or ki ng za ni ga or r fo t th e go ve rn m en ta tio n is go in g of its im pl em en d ee sp gh ou th ti ng se ct or, al , C hi ef O pe ra id R ah ul P ai th sa l”, ca iti cr to be nl in e O ff ic er, D oc O

ac tio n d to se e th at no ke oc sh l el sh e ar “We at Ai M ED th e ts un am i of e G ov t. to st em th by n ke ta ’s cr us hi ng ha s be en ` 38 80 0 cr th at at t en rc pe at im po rts of 24 ng to no tic e th g. It is ap pa lli rin tu ac uf an ze m et w ith ro In di an is th e fir st bu dg it , s ar ye 3 al lo ca tio n si nc e la st t ev en hi gh er no re ca th al m en tio n on he at h, Fo ru m sa id R aj iv N ”, at ar Bh an fo r Ay us hm A iM ed C oo rd in at or of

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“T he ex pe ct at io ns fro m th e U ni on Bu dg et w er e th at of 20 19 a bo ld re fo rm is t bu dg et , ho tu rn ed ou t to be w ev er, it an in cr em en ta l bu dg et at be st em ph as is on st . Th e ar t-u ps an d on th e ed uc at io n is a go od m ov se ct or e. H ow ev er, th er e w as no th in gr ow th in th e he g to fu el al th ca re an d ph ar m a se ct or s, is di sa pp oi nt in w hi ch g. I w as pa rti cu la rly ke en on a ch an ge in th se ei ng e w ei gh te d de du ct io n fo r R &D di d no t ha pp en w hi ch . A po si tiv e po lic y m ov e of th w ou ld ha ve sp is ki nd ur re d R &D an d in no va tio n in ph an d ot he r se ct ar ma or s” , sa id S at is h R ed dy, C ha D r. R ed dy ’s La ir m an , bo ra to ri es Lt d

“Th e ph arm a sec tor cou ld be inc en tivi zed in the bu dg et for ad op tin g glo ba l pra ctic es & sta nd ard s wh ich en ab le cou nte rfe it de tec tio n & au the nti cat ion .

Th e vis ion of GS 1 Ind ia is to sig nif ica ntl y en ha nce pa tie nt saf ety thr ou gh elim ina tio n of me dic ati on err ors , tra ck & tra ce, pro du ct rec alls , cou nte rfe it de tec tio n & au the nti cat ion of me dic ine s & me dic al de vic es” , sai d Ra vi Ma thu r, CE O, GS 1 Ind ia

July 2019 ► 33

Forward to Innovation Enterprises The biotechnology segment is the fastest growing segment in India. It is valued about USD 11 billion currently and it will touch the USD 100 billion mark by 2025 as per the forecast of the Association of Biotechnology Led Enterprises (ABLE). In 2017, the size of the Biotech industry was around USD 11.6 billion. The industry is expected to grow by approximate 30 percent rate every year. The increased demand for healthcare services, R&D activities, clinical capabilities etc will help this sector to witness fast growth in the future. The government’s initiatives like DST, DBT, CSIR and BIRAC are also supporting entrepreneurial individuals to establish startups.

The article is contributed by Venture Center with an intent to throw light on the current scenario of this industry all along introducing to some of biotechnology startups funded by Venture Center at CSIR-NCL.

34 ◄ July 2019

Dr Ashwini Kumar Nangia Director, CSIR-NCL and Chairman, Venture Center

Dr V Premnath Director, Venture Center

Such time periods are short in relation to the duration of exploratory research grants (3-5 years). Yet it is a challenge to woo investors and angel funding for pharma and biotech projects which can take years to complete and successfully demonstrate the product with all necessary regulatory approvals. CSR is an alternate funding mechanism which bridges BIRAC government grants with a committed corpus from private industry.

In order to achieve the USD 100 billion target by 2025, it is necessary that funding for research and innovation which is higher than the BIRAC model of typically under ` 1 Crore is arranged through a novel mechanism (Innovation fund) to successfully demonstrate clinical trials and market prototypes for the VCs to then become interested for deep investment in commercial ventures. We look forward to proactive steps from government and industry.

Pinky Raychaudhuri Associate Manager - Incubation, Venture Center

Turning innovative profitable enterprises

he decade old Venture Center at CSIR-NCL Innovation Park houses about 70 science and technology start-ups with an emphasis on chemicals, materials and biological science domain.

Each of these ventures aims to translate a fundamental science idea often from PhD or post-doctoral research to make a technology for the market. The entrepreneur scientists are daring trail blazers, confident of overcoming the odds to cross the valley of death from proof-of-concept to a market-prototype.

The innovation ecosystem funded by BIRAC and DST-NSTEDB is the bread and butter funding to demonstrate the technology and/or complete the clinical and regulatory studies in record time lines of 18-24 months.

The impact of Genrich Membrane’s Oxygen Enrichment Unit is enormous.

According to World Health Organisation (WHO) estimates, chronic obstructive pulmonary disease (COPD) will become the third leading cause of death worldwide

T

ideas

into

Gorakhpur’s encephalitis outbreak in 2017 killed over 200 kids due to a disruption in the supply of oxygen cylinders.

This tragedy highlights just one such example in the ever-rising need in the Indian biotech space for technological developments and innovations that can result in better availability of low-cost and accessible healthcare to people. Dr. Ulhas Kharul, scientist at CSIR’s National Chemical Laboratory in Pune, and the team of Genrich Membranes are working on a technology to avert such encephalitis disasters in the future.

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by 2030. Crude estimates suggest there are 30 million COPD patients in India, and well over 3 million pre-term babies born in rural India. The polymeric membrane technology was conceived and developed in an R & D lab at the publicly funded National Chemical Laboratory (CSIR NCL), but the technology is being brought to the market under Venture Center’s pioneering Lab2Mkt scheme, which has helped to create over 10 spin-offs from NCL technology, with funding support from BIRAC’s Biotechnology Ignition Grant and other sources.

Dr. Kharul and team with their portable, plug and play oxygen enrichment unit that offers on-site instant generation of oxygen enriched air

Genrich membranes, founded by Dr. Ulhas Kharul, is one among over 1,000 biotechnology start-ups in India and Dr. Kharul is part of the burgeoning 3000+ Indian bio-entrepreneur pool.

Over the last few years, a number of factors have boosted the biotechnology entrepreneurial ecosystem in the country, empowering and motivating an increasing number of students, professionals, scientists, researchers, and aspiring entrepreneurs to venture into the risky game of biotechnology innovation. In this article, we touch upon current trends and explore different ecosystem initiatives that are producing and attracting entrepreneurial talent and new ideas to become business creators.

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Ecosystem snapshot

The biotechnology sector is one of the fastest growing segments in India, and has gained global visibility for emerging investment opportunities. In the span of a decade beginning in 2007, the industry has grown exponentially in size from about USD 2 billion to over USD 11 billion in terms of revenue. As per the forecast of the Association of Biotechnology Led Enterprises (ABLE), it is targeted to touch USD 100 billion by 2025.

According to the white paper ‘India’s Biotechnology Start-up Ecosystem’ published by the Association of Biotechnology Led Enterprises (ABLE), over 1,022 new companies were started by 3,000 entrepreneurs. More than half of these start-ups are involved in healthcare - drugs, medical devices and diagnostics while about 14 per cent are in agricultural biotechnology and about 18 per cent in biotechnology services. Between 2012 and 2016, Indian Biotech start-ups raised ` 18,700 crore in investments, which includes private equity, grants and loans from families and friends.

A lot has also changed over the past decade in terms of the diverse nature of biotech companies. Many biotech companies set up before the current biotech boom focused on routine services, manufacturing, or contract research; in contrast, an increasing number of biotechnology start-ups today are developing deep science technologies with a potential to create global impact. Today, biotechnology firms are being founded by scientists, engineers, students including undergraduates, industry professionals, and serial entrepreneurs. Many of the biotechnology start-ups launched in the last few years are developing cutting-edge technologies in the areas of drug delivery, novel biomaterials, invitro diagnostics, medical devices, nutrition, sustainable energy, and agriculture, thereby stretching the very definition of biotechnology!

An enabling ecosystem Challenge 1: Funding

Starting one’s own venture is always a difficult proposition, but bioentrepreneurs face even tougher challenges. The obstacles include long go-to-market times, difficulty in raising money, manufacturing hurdles, regulatory hurdles, hiring people with high speciality skill sets and much more. Over last five to six years, various initiatives (mentoring, funding at every stage, first hub, startup friendly policies etc) by government agencies such as BIRAC, DBT, and DST have addressed the ecosystem issues at large that has, among other things, resulted in enhanced synergy between the different ecosystem pillars such as incubation centers, universities, corporate, VCs and angel investors. In light of these initiatives, there has been a surge in the number of investors coming forward to aid aspiring entrepreneurs in difficult sectors such as medical technology, agribiotech, and more. Ventures like 1 Crowd, Blume Ventures, India Quotient, Nexus Venture Partners, and Unitus Seed Fund are few active venture capital funds investing in the biotech startup space in India.

A case in point is Synthera Biomedical, incubated at Venture Center, which has received seed funding from both equity crowd-funding platform 1Crowd and the government’s Biotechnology Industry Research Assistance Council (BIRAC) SEED scheme via Venture Center.

Synthera Biomedical is the first bioactive glass company from India. The company’s flagship products - SynOst and PoroSyn are synthetic bone graft substitute products that can be used in dental and orthopaedic surgeries as implantable materials for repair and regeneration of bone that is lost or damaged due to disease, injuries or congenital deformities.

The increasing involvement of investors in these sectors at a relatively early July 2019 ► 35

The team of Synthera Biomedical poses with their flagship bone grant substitute products

stage (post-POC and prototype) gives an opportunity to these entrepreneurs to leverage the ecosystem of VC firms, which includes an investor community, a mentorship panel, and industry connects, and move faster towards regulatory approvals, production and sales.

Agencies such as DBT have also been tapping into private-public-partnerships to boost funding available for startups.

BIRAC also has excellent partnership programs with Wellcome Trust, the Bill and Melinda Gates Foundation and USAID, which bring in matching contributions.

Another promising trend in the ecosystem is an increase in corporate support to help innovators and entrepreneurs turn their ideas into viable businesses under their CSR programs.

According to a report in the Economic Times, only about ` 54 crore was spent on technology incubators under CSR during 2014-17; however, the scenario is likely to change with a government proposal to tweak the CSR framework to allow CSR funding to all incubators.

This move should greatly facilitate the involvement of India Inc in the startup ecosystem. Venture Center has received generous contributions from corporates such as Eppendorf, Indus Biotech, Bajaj 36 ◄ July 2019

Auto, and International Biotech Park to support innovative entrepreneurship, create sustainable impact, and accelerate development.

Thus, raising capital at all stages of business has gotten a little easier in recent years; however, a lot of earlystage biotechnology ventures remain government funded. The next few sections touch upon other initiatives to support and promote life sciences and medical technology start-ups across the country.

Challenge 2: Technology commercialisation expertise

Another problem plaguing the Indian biotech startup space is: lack of expertise in the form of consultants and mentors.

Unlike startup firms in other sectors such as IT and fintech, a biotech entrepreneur needs a lot more hand-holding at every step such as regulatory compliance, clinical studies, manufacturing etc.

BIRAC Regional Bioinnovation Center (BRBC) at Venture Center was set up in 2018 to address these gaps in the biotech

• Venture Center is India’s largest science business incubator.

• Venture Center is a section 8 company hosted by the CSIR-National Chemical Laboratory and is the first & only business incubator in the CSIR framework.

• Venture Center received the National Award for Technology Business

Incubation 2015 from the President of India on 11 th May, 2016.

• Venture Center has been recognised by the Asian Association of Business Incubation as the Incubator of the Year for 2018. This is Venture Center’s first international award. This annual award aims to recognise overall excellence in incubation performance.

• Venture Center was awarded the ISGF certificate of merit at India Smart Utility Week ISUW2019.

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ecosystem, and create a new and powerful support mechanism for biotechnology and biomedical engineering startups. One of the key initiatives of BRBC includes an actively curated mentor pool and mentor mixer clinics that match both prospective and experienced entrepreneurs with skilled volunteer mentors. BRBC also organises high intensity, focused, venture base camps on specific or advanced themes of relevance to start-ups, such as Intellectual Property and Licensing, Clinical Study Design, Fund Raising, and more.

In addition to these programs for startups and entrepreneurs, the incubation practice school at Venture Center also runs a program especially for managers and CEO-s of new and upcoming incubators, including bioincubators. The customised program is designed to cover topics such as incubator focus areas, programs, services , facilities etc, and funding schemes, all of which will help new incubator managers build a sustainable incubator and operate entrepreneurship programs that ably guide and support aspiring entrepreneurs to succeed in the business world.

Challenge 3: Regulatory Hurdles

Regulatory compliance is often considered another big challenge facing

medtech start-ups. Proper consideration of regulatory requirements from the start could significantly minimize any risk for the business in future. However, information on regulations, standards, and guidelines are often scattered, everchanging and confusing. The regulatory information and facilitation center (RIFC) at Venture Center, another BRBC initiative, was set up to raise awareness concerning regulatory compliance and help bio-entrepreneurs and startups take compliance issues into account from day one, and plan and secure regulatory approvals. The RIFC at Venture Center can assist with the following services: (i) General Advisory (ii) Planning Regulatory Pathway (iii) Standards Interpretation (iv) Document Preparation& Review (v) Risk Management (vi) Clinical Trial Study Plan (vii) Clinical Trial Advice.

“The Regulatory and Information Facilitation Center has been a valuable resource for us to navigate the complex world of medical device regulations.

They have provided detailed guidance on the regulatory pathway to be followed for our products. They have also worked with us on our various regulatory licence applications. We are fully confident that RIFC will continue to play a crucial role in helping us to

shape a successful regulatory strategy for our products.”, says Nilay Lakhkar, CEO of Synthera Biomedical, among 25 beneficiaries of RIFC. Challenge 4: Nurturing start-ups with global ambition

In terms of the startup ecosystem, never before have so many young Indian companies established operations on foreign soil so quickly. This despite strong competition from other global biggies, for example, Ola, managed to firmly establish itself in six Australian cities despite ruthless competition there from global biggies such as Uber. This trend has given a huge boost of confidence to entrepreneurs and start-ups aspiring to make their mark globally. Although, we are yet to see this sort of global expansion for a home-grown biotech or medtech startup, the tide is surely changing. Today, there are many Indian startups who are using novel technologies to build a quality product that not just address an unmet Indian need, but can also solve a global crisis.

Antibiotic resistance is one of the biggest threats to global health, food security, and development today, and the frequent misuse of antibiotics in humans and animals is accelerating the process. For example, urinary tract infections (UTIs)

Left: Usense – the flagship UTI diagnostic chip from Module Innovations; Right: the team of Module Innovations

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July 2019 ► 37

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Chemtech Hyderabad World Expo 2017

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Despite hurdles and roadblocks, the future of Indian biotechnology & the biopharmaceutical industry looks promising.

For people nurturing entrepreneurial dreams, the timing cannot get any better. Government agencies are

Sources

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The way ahead

The wheels to transform India into a global biotech hub by 2020, and a USD 100-billion biotech industry by 2025 have surely been set in motion.

Contribute to PBW VOL 16 ISSUE 04

To help start-ups with the potential for global impact confidently enter large new markets such as China and the US, the Department of Science and Technology has set up a NIDHI Center of Excellence (NIDHI CoE) at Venture Center. Such resource centers could prove to be a boon for startups such as Module Innovations.

Among other initiatives, the NIDHI COE will help Venture Center build a high density cluster of inventive enterprises with significant global connectivity, visibility, reach and footprint. Doing so will bring these start-ups in close proximity to financial investors in key markets such as US, market expertise, and access to global management talent, all of which lead to higher valuations. However, it remains to be seen how such homegrown biotechnology enterprises can compete with their well-funded overseas competitors in the long run!

doing their part with funding schemes, better academia industry collaboration, startup friendly policies, and closing gaps in the ecosystem. Biotech startups are also beginning to attract greater investor interest and corporate engagement. An increasing number of incubators across India, such as Venture Center, are supporting entrepreneurs with infrastructure, mentoring and business support, networking opportunities, high end scientific facilities, and funding options. At Venture Center alone, over 400 entrepreneurs and start-ups have benefitted from the various initiatives and services. They have created more than 400 jobs and generated more than ` 20 crore in revenue. In addition, to these direct effects of start-ups on economic growth, the entry of new technology intensive start-ups in the market injects competition, spurring follow-up innovation, the creation of newer markets, and an increase in overall productivity.

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are among the most common bacterial infections in humans; globally, there are 150 million reported cases of UTI every year, and it is believed that half of all women will contract UTI once in their lifetime. In many cases, broad spectrum antimicrobial treatment is initiated before the culture results are available. To address the rising threat of antimicrobial resistance across the world, Module Innovations at Venture Center has developed USense a credit-card sized diagnostic chip, based on color changing polymers, for rapid microbial detection. USense allows for the visual detection of the presence of 4 specific uropathogens, including E.coli in just 30-60 minutes, a significant reduction from the time required for standard culture testing (2-3 days).

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23-25, January 2018 20-23, February 2019 Venue: Ahmedabad, Gujarat, India Venue: Mumbai, India

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GUJARAT - 2018

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23-25, January 2018 20-23, February 2019 Venue: Ahmedabad, Gujarat, India Venue: Mumbai, India

Dear Readers, Launched by Chemtech Foundation in 1992, Pharma Bio World (PBW) features contents from Pharmaceutical and Biotechnology industries. PBW provides in-depth information on business practices, latest trends, technologies, research & innovation and processes across the entire industry pipeline.

Each monthly edition of PBW covers a separate area of pharma and biotech industry and includes articles from a range of peers, consultants and commentators, interview with industry experts, Market research analyzing industry trends, News Features, News Updates, Product Trends, Events Diary and Bookshelf.

Target readers for PBW are Drug manufacturers, Intermediates, Pharma machinery/equipment manufacturers and suppliers, Pharma packaging firms, Research institutes, Academic institutes, Biotechnology firms, Consultants and Government bodies.

You are most welcome to share editorial content with us such as technical articles, case studies and product write-ups. The length of the article should not exceed 1500 words with maximum three illustrations, images, graphs, charts etc. All the images should be high-resolution (300 DPI) and attached separately in JPEG or JPG format.

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To know more about Chemtech Foundation, Jasubhai Media and other publications and events, please visit our website – www. chemtechonline.com Thank you, Regards, Sujatha Vishnuraj Deputy Editor Jasubhai Media Pvt Ltd Tel: +91-22-40373636 E-mail: sujatha_vishnuraj@jasubhai.com

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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.

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

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.

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.

July 2019 â–ş 39

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.

40 â—„ July 2019

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

July 2019 â–ş 41

A Roadmap to Clinical Trial Efficiency This article will discuss the process and roadmap needed for optimizing clinical study and trial and review why and how are the Trials being performed.

Clinical study is a research which involves human volunteers, also called as participants, with an intention to add to the medical knowledge.

What is a Clinical Trial ntended for?

Mainly there a two types of clinical studies, namely: Clinical Trial (aka Interventional Study) and Observational Study.

Clinical studies are the experimental studies to determine a better treatment of a particular disease. They are designed to answer specific scientific questions like:

The main purpose of performing a clinical trial is nothing but a research and so strict scientific standards are followed mandatorily. These standards are required to be maintained for the protection of patients and generate study results which are reliable.

• What side effects do the drug have?

How are the Clinical Trials Aroed?

• Does it reverses or stops the disease for which it is designed to heal?

• Are the outcomes effective than existing treatments?

• Can it be given along with the drug which is already being given for the same disease?

The answer to every question above must come in the form of scientific data and not in the form of opinions or the impressions of the scientists, doctors or patients involved with the studies.

The results can be enclosed by many factors and can be affected by bias. It is to be made sure this does not happen.

What is a Clinical Trial?

Clinical trials are clinical studies for exploring a medical strategy, device or a treatment, which is safe as well as effective for humans.

etan ota Director ota Healthcare 42 ◄ July 2019

a particular group of people, these studies help to find out which medical approach will work better for their cure.

Also called as interventional study, clinical trial is a clinical study where participants are assigned to receive one or more inventions or sometimes no inventions at all, for the researchers to evaluate intervention's effect on health related outcomes. For certain illness in humans or

Before starting a clinical trial, the protocol or the plan of the trial is approved by an independent and unbiased group of researchers who are not going to be involved in the trials, which is called an indeendent scientific reie The trial protocol is reviewed by National Research Ethics Service, which is a Research Ethics Committee. The aim is to be concerned with the rights, safety, dignity and well-being of the patients taking part in trials. This committee is made up of  and 1 volunteers.

The researchers are bound with the protocol they proposed at the beginning of the trial. They cannot change the protocol without approval from ethics committee.

They have to report to the ethics committee in case of any happening of serious side effects in-between trial. The committee receive reports at the end of clinical trial.

How is the Clinical Trial Performed?

The process of a clinical trial begins in the laboratory. The scientists develop and test the ideas regarding the tests. Clinical trials are performed as a part of one of the final stages of a lengthy and carefully performed research procedure.

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If the basic idea of clinical research is worth promising, animal testing is performed as the next step.

• Why are animals used for clinical testing?

Using animals for clinical tests is because there is a need to find out what happens to a living body. Replacing animals with any other alternative method of testing samples is not yet discovered. As the basic cell formations of animals are all similar and human's body performs same tasks of movement, breathing, hearing, digestion, sight and reproduction, it is likely to perform tests on them rather experimenting them on humans first. Before testing ideas on humans, animals such as rats are used for sampling.

• What does the animal testing indicate?

It shows that how the biomedical approach will affect a living body and whether it is harmful or not.

However, it may be possible that the approaches working well in labs or on animals are not necessary to show exact results in case of humans. Hence, it is required to perform tests on humans.

As a safety measure, clinical trials are performed on a small group of people on initial stage and it is found out whether it affects or harms humans or not. The later phases of clinical trials involve larger amount of humans on which the study is focused.

Understanding the Trial Phases of a Clinical Trial The clinical trials are divided into stages called phases. There are three main phases of a clinical trial. Phase zero exist in some trials, which is an early stage.

Phase 4 trials are also performed in some cases after the drug is licensed.

Let us consider the phases are being performed for Cancer, as an example to understand the clinical trials easily.

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• Phase 0 Phase zero trials are intended to find out whether the drug behaves in the manner it is expected to perform as per the laboratory studies.

Involving a small number of people, phase zero trial volunteers are given a very small dosage of drug. This small dosage of drugs is very small to treat disease like cancer, but the researchers are looking for the answers to the following questions: 1. Whether the drug reaches the cancer or not 2. How is the body affected by this drug?

3. How does the cancer cells respond to this drug?

Because the dosage of drug is very minute in phase zero, there is no immediate effect on the patient, yet there is a benefit of not having any side effects of the drug.

Phase zero studies involve aiming at the speediness of developing new drugs.

More useful information can be obtained quickly in this case as testing drugs on animals is eliminated in this phase as the dosage is very small.

• Phase 1 Phase 1 trials, also called as Phase-I, are usually small trials, recruiting few patients only. Variety of cancer patients for example, can be taken for phase-I trial. It means that the trial is open for the treatment of the same disease having different sub-types.

When it is the time to find out a new treatment for curing a disease, Phase-I tests are done to answer following questions: 1. What are the side effects to the drug now?

2. Can this treatment shrink cancer?

Patients are recruited very slowly for this initial stage of trial. Although less number of patients are involved, it takes a long time to complete the test. The first few patients, also referred as cohort or group, are given the smallest dosage of the drug.

If it works well with them, the next group is given a slightly high dosage of drug.

The dosage is then slowly increased with each group. The researchers observe the effects of these dosages till it gives the best results and the best dose to give.

Lot of blood tests of the patients are taken as they are constantly under observation of researchers. This helps to identify how the dosage is affecting the patients. How the body is coping up with the drug effects and the resultant side effects are also recorded.

In case of cancer, patients who have taken part for Phase-I have already gone through every available treatments for cure. They might be having advanced cancer. They may be benefitted from these trials or may not be benefitted too. The dosages and side effects are repeatedly observed as a main aim in Phase-I. Before expecting any treatment to work well, it is necessary to test them in this phase.

• Phase 2 Phase 2 trials are often longer than Phase-I. Up to 100 or more patients might be involved for this second phase trial. Not every treatments that are tested in Phase-I lead to Phase 2 trials. Also called as Phase-II, these clinical trials are involving same sort of diseased patients.

For example, patients suffering from same type of cancer. Or different groups of people which are suffering from similar type of cancer.

These trials are aimed to find out:

3. How is the body reacting to this drug?

1. More about the best dose used

4. How much dosage is to be given on anaverage?

2. For which type of cancer the treatment is working well July 2019 ► 43

3. What are the side effects of drugs and how to manage those?

Phase-III trials are used to compare:

4. Is the new treatment working enough well to proceed to Phase-3 trials?

1. A completely new treatment with the existing treatment.

2. Different doses or ways of giving a standard treatment.

3. A new way radiotherapy can be given along with the existing standard way.

Although these treatments are already been tested in Phase-I, it is possible that the drug may show side effects later on, unknown even to the doctors. There are different ways a drug can affect patients.

Sometimes, in Phase-2 trials, the new treatment is compared with an ongoing treatment or with a dummy drug, called as a placebo. If it seems that this drug is showing positive results or is as good as an existing treatment, it is moved to Phase-3. In some cases, it is possible that the new drug may perform better than the existing drug too. These phase-2 trials are randomised. The researchers put people in trials in randomized manner.

• Phase 3 The standard treatment, also the best available current treatment already in the medical field is compared with the new treatment in Phase-3 trials.

44 â—„ July 2019

The number of patients are more in Phase-III in comparison to above Phases.

The differences in success rates might be small in Phase-I and II, so it is required to trials are needed to be performed on more patients to be able to show difference.

For an example, 6 per cent patients involved in trials may get a remission with the new treatment in comparison to standard treatment. For example, let us consider there are two groups of 50 people each, if three of the first group of patient are affected, it is possible that testing 5000 people, 300 new remissions are possible.

Thousands of people in different hospitals and even in different countries are possible to be

involved for Phase-3 trials. These trials are also randomised. The researchers put large number of people in random manner for treatment.

• Phase 4 This is the last stage of performing clinical trial. If the drug is showing work and is already granted a license, then it is mandatory to let it in for Phase-4 trial.

The intention to undergo Phase-IV trial are: 1. What are the long-term benefits and risks of the drug 2. Learn more about the side effects and safety of the drug.

3. Will it show same effective results if it is used widely?

Each phase of a clinical trial is important to understand the result of any particular drug in detail. Be it an animal or human test, every stage of a clinical trial must be executed with complete accuracy.

Even a second's negligence might give a wrong result.

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How are the Trials Noted?

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What are Blind Trials?

TOTAL PAGES 60

Different possibilities exist in case of expecting outcome. No certain outcome of a particular medical study can be forecasted. It is possible that the study may not produce any outcomes at all. It may have adverse effects on the patient or it may generate favourable or a positive outcome. If the generated outcome is positive, there is a possibility of getting a new treatment for a specific disease.

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Why are the Trials Randomised?

The trials are randomised by the researchers to avoid bias that may distort results and to make sure that the results are correct.

Lab Equipment

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Some of the trials are designed so that they stop recruiting into a particular group if the treatment is not working well in its early stages and is having adverse side effects in large number. This is called Multi-arm Multi-stage trial (MAMS). It is capable to add more people to new groups in order to look at more treatments.

What are the Outcomes of this Study?

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Many trials look for just one new treatment while some trials compare several new treatments.

The patients taking part in trials are still put into random groups and there may be three or more different treatment groups.

This is called a Multi-arm trial.

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What are MAMS Trials?

Until the end of trial, the list of patients and their code numbers are kept secret. In case of any emergency, doctors can look at their code numbers to find out which trial group they are in.

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Most trials may have one Phase. Others might include Phase-I and Phase-II. The highest safe dose of drug is the main aim of Phase-I while Phase-II is to know how well this dosage work. You may find trials written as Phase 1/2 or Phase 2/3.

assigned a code number by the computer.

And then the treatment groups are allotted code numbers too. The treatment for the patient then arrives with his code number printed on it, where both are unaware what they are giving or getting, that is, if it is a new treatment or the same old one.

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A blind trial is the one where the people involved in trials are unaware of the treatment they are getting. Either they will be given new treatment or may be continued with standard treatment. The patients receive identical treatments and injections which is impossible for the patients to find out what they are being given.

What are Double Blind Trials?

It is a kind of clinical trial where neither the researchers, nor the patients know what they are getting. Each patient is Pharma Bio World

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July 2019 ► 45

marketing initiatives

Innovative Vacuum Solutions in Pharmaceutical Industry

V

acuum pumps and systems are common place across a tremendous range of industries. Once the essential principles are understood, the possibilities for application become apparent.

In order to properly select a vacuum system, the principles of basic vacuum technology should be understood. Once the application is clearly defined, a solution can be found by applying these methods. Since we understand and can relate to atmospheric pressure, it is chosen as a reference point. Vacuum is simply a pressure that exists below atmospheric pressure.

To create a vacuum in a vessel, a vacuum producing device needs to remove mass from it. The more mass that is removed, the lower the pressure that exists inside the vessel. This is why it is important to understand what vacuum is and how to select the right type of equipment. It is very important to size vacuum piping correctly to minimize pressure loss. The greater the pressure loss, the larger the vacuum equipment needs to be.

The type, quantity of gas handled, and the operating pressure, normally defines what vacuum pump can be used. If the gas consists of mainly non-condensable, then most types of pumps can be used.

If the gas consists of non-condensable and condensables, then the choices will be limited. Therefore, a right solution considering the load of condensable and ultimate vacuum should be struck.

System Selection To select the best type of system for a particular application, the following list needs to be considered. Once it is 46 ◄ July 2019

determined which criteria is the most important from the list, then the vacuum pump that best meets this can be selected.

• Operating cost

A properly designed process condenser between your vacuum process and vacuum producing system will yield

• Solvent recovery • Effect on process • Materials of construction • Operating range • Reliability • Waste generation • Pollution abatement • Emission reduction • Maintenance cost • Ease of cleaning • Serviceability • Purchase price Pharmaceutical and Chemical Industry 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.

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 details contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road, Chennai 600 010 Tel: 044 - 2644 5626, 2644 8983 E-mail: sales@toshniwal.net Website : www.toshniwal.net Pharma Bio World

press release Hilleman Laboratories licensed Oral Cholera Vaccine Hillchol to Bharat Biotech

New Delhi, India: Hilleman Laboratories, a global research and development organization focused on delivering high-impact and affordable vaccines, announced that it has entered into a collaboration with Bharat Biotech International Ltd (BBIL), a leading vaccine and biotechnology company in India for further development, manufacturing and commercialization of its next-generation oral cholera vaccine, Hillchol.

This collaboration will strengthen the ability of both organizations towards prevention of Cholera through rapid and cost-effective deployment of vaccine doses in low and middle-income countries.

Cholera is an acute diarrheal infection caused by Vibrio Cholerae and has been responsible for seven pandemics till date. Cholera is a poverty-related disease, endemic in South Asia and Africa, and is on the WHO priority list . Globally, Cholera accounts for ~2.8 million cases and an estimated 95,000 deaths annually. In India, about 30 percent of the population - 375 million people - remain at risk. Deployment of oral Cholera vaccines (OCVs) are an essential public health component of comprehensive Cholera prevention and control, recommended by the WHO and an element of its “EndCholera” initiative.

Hillchol was designed at the University of Gothenburg in Sweden and subsequently developed by Hilleman Labs including demonstration of safety and immunogenicity in an age de-escalating Phase I/II clinical trial conducted in Bangladesh with the assistance of icddr,b and Incepta Vaccines Ltd. For further development of Hillchol, Hilleman Labs has entered into a licensing and manufacturing agreement with BBIL, who will scale the manufacturing process to commercial stage and establish product specifications required for WHO pre-qualification.

Prof. Jan Holmgren, University of Gothenburg who along with his colleague Dr. Michael Lebens and their team invented the vaccine commented, “Hillchol contains a single recombinant Hikojima strain which expresses both Inaba and Ogawa antigens, resulting in a shorter and simpler manufacturing process as compared to licensed OCVs. Hillchol will therefore be of great importance and value to help to meet the urgent demands from Cholera afflicted countries for much expanded oral Cholera vaccines manufacturing and supplies for the control of Cholera globally” Speaking about the partnership, Dr. Davinder Gill, Chief Executive Officer, Hilleman Laboratories said, “Vaccines play a critical role in improving healthcare outcomes globally, and Hilleman Laboratories is honoured to work with Bharat Biotech, a leading vaccine manufacturer in India for development, and if licensed, eventual manufacturing and commercialization of our innovative oral Cholera vaccine Hillchol.

Availability of an affordable Cholera vaccine is particularly significant considering that more than 50 GAVI eligible countries have been categorized as Cholera-endemic. We hope this collaboration will provide an innovative vaccine solution which is both affordable and accessible.”

Dr. Krishna Ella, Chairman & Managing Director of Bharat Biotech International Limited, said, “We are delighted to lead the scale-up, development, manufacturing, and commercialization efforts for Hillchol with our collaboration marking an important step. Our capacity to deliver 50 million doses per year and the addition of a WHO pre-qualification of Pharma Bio World

Hillchol in the future, will not only solve the demand uncertainty but aid in affordability thereby resulting in the wider use of such a vital oral Cholera vaccine worldwide.”

Dr. Gerd Zettlmeissl, Chairman, Hilleman Laboratories congratulated both partners on entering into collaboration agreement to align efforts and said “By working together, we can move even closer to meeting the critical public health goal of reducing Cholera burden by 90 percent by 2030, a key objective of WHO End Cholera initiative”

Dr. Reddy's Laboratories Announced the Launch of Tobramycin Inhalation Solution, USP in the US Market Hyderabad, India and Princeton, NJ, USA: Dr. Reddy’s Laboratories Ltd has recently announced the launch of Tobramycin Inhalation Solution, USP a therapeutic equivalent generic version of TOBI (tobramycin) Inhalation Solution, approved by the US Food and Drug Administration (USFDA).

The TOBI (tobramycin) Inhalation Solution brand and generic had US sales of approximately USD 97 million MAT for the most recent twelve months ending in April 2019 according to IQVIA Health*. Dr. Reddy’s Tobramycin Inhalation Solution, USP is available in a 300 mg/5 mL, single-dose Ampule.

Tobi is a trademark of Mylan. *IQVIA Retail and Non-Retail MAT April 2019.

RDY-0619-250

Cadila Encompassed a Major Coup with the Best Warehouse Workforce

Ahmedabad, Gujarat: The Gujarat based pharmaceutical giant got recognized for its human resource driven warehousing capabilities at the 2nd Annual Future Warehouses Summit and Awards 2019 held in Mumbai.

Shining bright amongst its peers in the pharmaceutical and healthcare industry, Cadila Pharma Ltd won the ‘Best Warehouse Workforce Award’ at the 2nd Annual Future Warehouses Summit and Awards 2019 that took place recently at St. Regis, Mumbai.

Discussing about the technological influx moving this unorganized rented warehouses and storing system towards an organized and automatized segment, this conclave saw active participation of industry leaders from FMCG, Construction, Third Party Logistics (TPL), Fashion & Retail, Finance, Military, and many other sectors.

Discussing more about the award, KVR Sarma, Head Supply Chain Management said, “Cadila is always keen to focus on leveraging the abilities of the workforce to handle stock and shipments as well as managing the storing facility. Our extensive range of finished dosage formulations manufactured are dispatched-received through our main units in Dholka and Jammu.”

Cadila recently won WorldStar packaging award from the World Packaging Organisation (WPO).

July 2019 ► 47

press release FOGSI and Bayer Zydus Pharma Launched VISION for Endometriosis to Improve Patient Quality of Life

Hyderabad, India: FOGSI (Federation of Obstetrics and Gynaecological Societies of India) in conjunction with Bayer Zydus Pharma has recently launched the key practice points for endometriosis – VISION (Valuable Insights in Indian Endometriosis - Redefining Outcomes) at the ‘National Conference on Technology, Advances and Infections in Obstetrics and Gynaecology’ in Hyderabad. Over 200 thought leaders from across India were involved in formulating the protocols of practice on endometriosis after a national meeting in Mumbai followed by regional meetings in Ahmedabad, Delhi, Chennai, and Kolkata early this year.

Endometriosis is a chronic disease that affects five to ten percent of women at their childbearing age. About 176 million women suffer from it globally, and of these 26 million women belong to India alone[i]. The objective of VISION is to understand the current usage pattern of various therapeutic options in Endometriosis and develop an algorithm to guide doctors at the point of care in the management of endometriosis based on different patient profiles. The protocol will focus on providing management recommendations for endometriosis to physicians and patients from an Indian perspective.

Highlighting the key focus of VISION, Dr Nandita Palshetkar, President - FOGSI said, “The key practice points aim to engage the medical fraternity to be more cognitive of diseases such as endometriosis and provide patients with the right diagnosis and treatment options.

Since management of endometriosis can be challenging for the patients and the treating doctors, VISION will enable us to execute a multi-disciplinary approach and expertise to improve patient’s quality of life. I urge all gynaecologist to refer to these practice points and ensure best treatment methods are followed.”

Manoj Saxena, Managing Director of Bayer Zydus Pharma, added further, “Collaborations like this have a potential to bring about development within the social structure and address the health concerns of women in the society. With almost nine decades of experience, Bayer has been a true pioneer in the field of women's 48 ◄ July 2019

health. We have been working closely with FOGSI over the years on several initiatives and this joint effort to develop a protocol for managing endometriosis, extends our practice of research and development for innovative medications and new therapeutic approaches, helping make a difference to lives of Indian women suffering from endometriosis. We will also continue to raise awareness on endometriosis as part of ‘Bayer for Women’ initiative where we address various women’s health topics, with an aim to improve their quality of life.”

Diseases such as endometriosis represent a great unmet medical need in the gynaecology field. These diseases generally have a substantial negative impact on the health and quality of life of affected patients. There is a need to develop more satisfactory drug therapies for these common disorders, which affect a large number of women in our society. For several years now, Bayer has therefore been focusing its research on women's health on developing new therapies for these gynaecological diseases. Bayer’s association with FOGSI highlights their efforts in increasing awareness for endometriosis at the physician and patient level.

Glenmark to partner with Novartis to promote, commercialize, and distribute three respiratory products in Brazil Mumbai, India: Glenmark Pharmaceuticals Ltd (Glenmark), a research-led global integrated pharmaceutical company, has recently announced that its Brazilian subsidiary Glenmark Farmacêutica Ltda has entered into an exclusive partnership agreement with Novartis Biosciences S A, a subsidiary of Novartis AG, for three respiratory products indicated towards treatment of the symptoms of chronic obstructive pulmonary disease (COPD) in Brazil. This agreement will be effective from July 01, 2019 onwards.

The products involved in the agreement are Seebri (Glycopyrronium bromide), Onbrize (Indacaterol) and Ultibro (combination of Indacaterol and Glycopyrronium), which are indicated for relief of symptoms in adults with COPD. “We are pleased to partner with Novartis in Brazil. This arrangement with a leading global pharmaceutical company will strengthen our respiratory franchise in Brazil. This partnership is in line with our vision to expand our respiratory product offerings for patients and prescribers in Brazil and further consolidate our position in this segment,” said Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals.

Under the terms of the agreement, Novartis remains the holder of the registration of these medicines and will be responsible to manufacture them with all technical excellence in line with its global commitment to quality, effectiveness, and safety.

Glenmark will be responsible for promoting, commercializing, and distributing of these products in Brazil.

Pharma Bio World

press release Next-Generation Open Air Orbital Shakers Set New Standards for Reliability and Technical Innovation

engineered to perform with a reduced noise level, in a temperature range of 5-40°C and humidity conditions from 20-80 percent noncondensing, thus being suitable for use in a wide range of laboratory settings. With their compact footprint, the shakers save valuable benchtop space and are available in two sizes, and with a wide variety of universal platform sizes, unique dual stack platforms, flask clamps and tube racks to support almost any capacity.

With a view to facilitating fully integrated laboratory workflows, the Solaris Orbital Shakers will soon enable seamless connectivity with other Thermo Scientific equipment, including incubators and environmental chambers, via the Thermo Scientific Connect. This will allow for effortless, real-time, and continuous monitoring of key operational and performance parameters.

Waltham, MA: Thermo Fisher Scientific has developed a new line of next-generation open air orbital shakers to offer unmatched reliability and superior user programmability in a compact benchtop design. As the first open air orbital shakers to feature a touchscreen user interface, the units will better meet the demands of scientists working in academic, cell culture, and industrial laboratories, and will reduce contamination with sample mixing, staining, hybridization, and washing.

Building on Thermo Fisher’s 40-year long experience in shaker technology, in combination with new, cutting-edge scientific approaches, the Thermo Scientific Solaris 2000 and 4000 Orbital Shakers feature a unique design to support operation inside a range of laboratory equipment, including microbiological incubators, environmental chambers and refrigerated environments. Accordingly, these technically advanced units are suitable for use across an extensive array of applications, including microbe and chemical handling, plant cell culture, molecular biology, and biochemistry.

"Our customers are always seeking ways for increased consistency within reliable operations. Our goal with the Solaris Orbital Shakers is to push the boundaries of shaker technology beyond what’s been available to date," said Sung-Dae Hong, Vice President and General Manager for growth, protection and separation products at Thermo Fisher Scientific. "The shakers are powered by a triple heavy-duty drive mechanism, meaning they can easily and reliably support heavy loads, while their unique large touchscreen user interface allows operators to simply and securely program the units and monitor set-points and status conditions from across the laboratory. This built-in efficiency helps save time while optimizing shaker resources, and enabling consistency and reproducibility across runtime operation to help drive science forward."

The Solaris Orbital Shakers also feature removable platforms and sealed internal mechanics that simplify and accelerate cleaning, minimizing the potential for cross-contamination. Furthermore, the belt is maintenance-free, and the 10-year warranty for the shaker mechanism comes with a five-year warranty on parts, and a two-year warranty on labor for customers’ peace of mind. The units have been Pharma Bio World

Sartorius Debuted the Intellicyt iQue3 at CYTO 2019

Sartorius has recently showcased the latest addition to its cellular analysis portfolio on booth #103 at this year’s CYTO conference and exhibition, with the launch of the Intellicyt iQue3. The event – which takes place in Vancouver, Canada, from June 22 to 26 – will give delegates the chance to explore a smarter way to perform flow cytometry experiments.

The iQue3 is designed to provide fully automated processing and analysis for flow cytometry workflows, taking you from samples to actionable answers faster than ever before. Successor to the iQue Screener PLUS, the new generation instrument offers even more userfriendly operation and enhanced process security to ensure consistent and reliable results with minimal user intervention.

One of the iQue3’s new features is an enhanced rinse station that actively monitors buffer usage. With built-in liquid level detection, this module offers a smarter way to ensure you always have sufficient buffers to complete your run. This is complemented by a number of updates to the system’s intuitive ForeCyt software, which uses a unique templated analysis approach to offer intelligent, fully automated data processing. This powerful software solution has been specifically developed to alleviate common processing bottlenecks by eliminating the need for manual data analysis and providing real-time visualization of your data for virtually any cell- or bead-based assay.

July 2019 ► 49

press release Piramal Pharma Solutions Invested USD 10 million to Expand its High Potency API Capability in its Riverview Facility in US

also provides significant benefits to the local economy, including the addition of new high-tech jobs. The local staff has increased from 80 to 127 people, with a projected total of approximately 150 employees in the near future. This includes high-tech staffing of PhD and BS degreed scientists, plus manufacturing operators and other skilled workers.

Vince Ammoscato, Vice President and Riverview Site Head, added “This new, enhanced capability opens the site up to a new base of customers, including the antibody drug conjugate (ADC) market.

We are equipped to offer ADC customers a seamless end-to-end solution, since we can develop the HPAPI payloads and linkers here in Riverview, send them to our site in Scotland for the antibody conjugation, then back to our Lexington, Kentucky site for sterile fill and finish.”

Riverview, Michigan: Piramal Pharma Solutions (PPS), a leading Contract Development and Manufacturing Organization (CDMO), has recently announced the Grand Opening of a new wing at the Riverview site dedicated to the production of high potency active pharmaceutical ingredients (HPAPIs) with low Occupational Exposure Levels (OELs). The total investment required to upgrade the site was approximately USD 10 million. This includes the new QC/analytical lab and two kilo-labs, as well as a doubling of the office space, which was needed to support the dramatic growth at the Riverview site. Local dignitaries participated in the event, including Riverview Mayor Andrew Swift, Wayne County Executive Warren C. Evans and other officials representing the City of Riverview, Wayne County and Michigan Economic Development Corporation (MEDC).

To date, the Riverview site has had the containment capability and engineering controls to safely handle HPAPIs with OELs down to 1mcg/m 3, at scales ranging from grams to ~250 kilos. The new wing, which consists of two kilo-labs and a QC/analytical lab, brings more to the table. It was designed with the required engineering controls and containment solutions to handle HPAPIs with OELs <1mcg/m 3 and as low as ~20ng/m 3. Materials will primarily be produced in this new wing at kilo-lab scales; lots of <5 kilos can be produced in this new state-of-the-art facility.

Vivek Sharma, CEO, Piramal Pharma Solutions said, “We are one of only a few companies in the contract development and manufacturing market that have the capability to produce HPAPIs at such low OELs. It’s another example of how we remain committed to partnering with our customers to serve the patient community and reduce the burden of disease.”

Historically, the site operated as one shift, five days a week. Presently the site operates twelve hours a day, seven days a week, and is headed towards being a full 24/7 site. The Riverview site expansion 50 ◄ July 2019

The ability to offer a fully integrated solution for the ADC market – from proof-of-concept studies to conjugation development, clinical and commercial ADC GMP batch manufacturing and fill/finish – represents a significant strategic advantage for Piramal Pharma Solutions.

According to Mr. Ammoscato, more expansions are forthcoming.

There is additional real estate available on the site for added capacity and new capability enhancements that will be designed to match the market needs of the pharmaceutical industry.

Dr. Reddy's Laboratories Announced the Launch of Phytonadione Injectable Emulsion USP Hyderabad, India and Princeton, NJ, USA: Dr. Reddy’s Laboratories Ltd has recently announced the launch of Phytonadione Injectable Emulsion USP, 10 mg/ml Single-Dose Ampules, a therapeutic equivalent generic version of Vitamin K1 (Phytonadione) Injectable Emulsion USP, 10 mg/ml, approved by the US Food and Drug Administration (USFDA).

“We’re pleased to bring this product to market for the customers and patients who will benefit from access to this medicine and who have experienced supply disruptions in the market place in the past”, explains Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy’s Laboratories. He added, “This is a great addition to our injectable offering in the US market as we continue to augment our portfolio to drive growth for the Global Hospitals segment”.

The Vitamin K1 (Phytonadione) for Injectable Emulsion USP, 10 mg/ml brand and generic had combined US sales of approximately USD 46.6 million MAT for the most recent twelve months ending in April 2019 according to IQVIA Health.

Dr. Reddy’s Phytonadione Injectable Emulsion USP, 10 mg/ml SingleDose Ampules are available in 1 mL Ampule containing 10 mg/mL of Phytonadione.

Pharma Bio World

press release Piramal’s Pharma Business Has Grown Prestige BioPharma Releases Positive over 10 percent to 4,786 Crore in FY19 Results from Phase I Study of HD204, Biosimilar Candidate to Bevacizumab Singapore: Prestige BioPharma (herein, Prestige) announced positive results from a Phase I clinical trial (SAMSON-I) evaluating the pharmacokinetics (PK), safety and immunogenicity of biosimilar candidate HD204 to Avastin (bevacizumab).

SAMSON-I is a double-blind, randomized, 3-arm, parallel group study to demonstrate the equivalent pharmacokinetic properties of a single intravenous dose of HD204, US-licensed Avastin and EU-licensed Avastin. A total of 119 healthy male volunteers aged 18-50 years old received a single infusion IV dose of 1mg/kg of study drug and monitored for 71 days.

Mumbai, India: Over 90 percent of Piramal’s Pharma revenues derived from niche businesses of complex generics and Contract Development and Manufacturing Operations (CDMO).

This is in stark contrast to most large Indian Pharma companies that have less than 5 percent of its business in these categories, opting for the large volume generics business.

Commenting on this growth, Mr. Ajay Piramal, Chairman, Piramal Enterprises states that “Our differentiated business model in Pharma has enabled sustained revenue growth despite pricing pressures and regulatory concerns that impacted the industry. During the year, our Pharma business grew 11 percent y-o-y to ` 4,786 crores. The margin profile for this business has improved significantly, over the last few years. Global Pharma business EBITDA crossed ` 1,000 crores in FY2019, with EBITDA margins at 23 percent in FY2019 as compared to 10 percent in FY2011.”

The business has completed 70 integrated projects of which 28 were completed in FY2019 alone.

Piramal Pharma Business has expanded its offering with integration of key acquired products from Janssen, launch of Sevoflurane Integrated Closure variant Miglustat in select European markets and MITIGO introduced in the US. The OTC business has also expanded with a Direct reach to ~4.2 lakh outlets.

Pharmaceutical business had a challenging regulatory environment.

Piramal focused on quality control, regulatory compliance, and reliable customer service to maintain strong growth. Over the past few years, Piramal Enterprises Limited (PEL) has made significant investments in activating various growth levers, which are expected to drive the next round of growth for its Pharma business.

Pharma Bio World

The primary objective was to establish pairwise PK similarity between all 3 drugs by evaluating the area under the concentration curve from time zero to infinity (AUC0–inf) as its primary endpoint. The 90 percent CI of the ratio of geometric means of log-transformed AUC0inf is used to assess bioequivalence between the test and reference using the bioequivalence interval of 80.00 percent to 125.00 percent.

Bioequivalence is declared if the 90 percent CI for the ratio falls within 80.00 percent and 125.00 percent for the primary PK parameter AUC0– inf for the comparisons: HD204 versus EU-Avastin, HD204 versus USAvastin. The analysis is repeated for secondary parameters Cmax and AUC0-last as well.

Results have indicated that the 90 percent CIs for the ratio of the geometric means of HD204 to US-Avastin, HD204 to EU-Avastin, and EU-Avastin to US-Avastin were all within the acceptance interval of 80.00 percent to 125.00 percent for AUC0–inf, AUC0-last, and Cmax thus demonstrating equivalency PK properties for all three treatments.

There are no notable differences between all 3 drug products in terms of vital signs, electrocardiograms (ECGs) or laboratory tests. No safety signals were observed in this study and no positive anti-drug antibodies were observed in the HD204 group.

Overall, the study demonstrated that HD204 is bioequivalent to both US-licensed Avastin and EU-licensed Avastin after a single IV infusion at 1mg/kg.

Dr. Lisa Park, CEO of Prestige BioPharma, commented that “our topline Phase I results for HD204 reflect Prestige’s commitment to provide millions of patients with greater access to high-quality, safe, affordable treatment. We also look forward to further progress in the Phase III global clinical study of HD204.”

Currently, Prestige BioPharma is performing a global Phase III study, SAMSON-II in patients with metastatic or re-current non-squamous non-small cell lung cancer. Prestige plans for filing with European Medicines Agency (EMA) and US Food and Drug Administration (FDA) in 2020.

These top-line positive results data will be presented at an upcoming scientific conference, ESMO 2019 being held September 31 – October 1, 2019 in Barcelona, Spain.

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press release SMT Announced CE* Mark for the Most Deliverable Stent Supraflex Cruz

Mumbai, India: A leading manufacturer of coronary stent systems, SMT (Sahajanand Medical Technologies) today announced that it has received CE* Mark for its highly deliverable next generation Supraflex stent system, called Supraflex Cruz.

Supraflex Cruz is a Sirolimus-eluting stent built on a Cobalt Chromium Platform having implanted in more than 2,50,000 patients in India and in selected International markets over last 3 years. The stent design provides physicians access to the most difficult and tortuous lesions with ease. The stent retains all the benefits of the Supraflex stent, viz, Ultrathin strut thickness (60 microns for all diameters and lengths), blend of proprietary biodegradable polymers to release the drug, very thin layer of polymers, high radial strength, and low crossing profile.

Cruz promises superior deliverability with an innovative design of dual Z link connecting valley to valley and better side branch access. With the help of Cruz, complex cases can be finished faster and harmful exposure of radiation to the physician will be reduced. Also, the trackability will void the need for additional hardware.

Clinical studies on Cruz (Current and Future): Supraflex Cruz has undergone multiple clinical studies including the most advanced OCT studies (Sibi and Taxco OCT study) showing healing pattern postdeployment of the stent. Faster endothelization represents better healing pattern.

Sibi OCT study demonstrated that Supraflex Cruz had close to 91 percent endothelialisation in 35 days. In the Taxco study, Supraflex Cruz was compared with market leading Everolimus-eluting stent in a head to head comparison at 6 months. The study showed both the stents had more than 97 percent endothelialisation at 6 months.

Further clinical studies on Cruz are planned across Europe, India, Latin America, and the rest of the world in the coming 2 years. These clinical trials will test Supraflex Cruz in a challenging patient population in Randomised clinical trials including Multivessel, Diabetics, ACS, High Bleeding Risk patients and Fragile patients (age over 75years).

Talking about the latest announcement the CEO of SMT, Ganesh Sabat said, “We look forward to working with physicians across Europe to offer this highly deliverable drug-eluting stent to the thousands of patients who would have been unable to undergo PCI due to complex anatomy.”

The company recently completed Talent trial in Europe involving 23 centres in 7 countries on 1435 patients which were published in the most renowned medical journal ‘The Lancet’. In this trial, SMT’s Supraflex came out with flying colors against the market leader stent, showcasing best in class safety and efficacy in global patients’ population. Also, this trial was presented at a US Cardiology conference TCT MD in the late-breaking session.

52 ◄ July 2019

Supraflex Cruz will help the patient and the doctors by • Decreasing the procedure time for physicians thereby reducing the intake of harmful radiation.

• Ensuring lesser complications during the complex procedure due to better deliverability of the stent.

• Saving more lives: Physicians are now able to treat a more challenging patient population which were left untreated or referred to bypass surgery. *The CE Mark indicates that the product satisfies requirements of EU Directives (EU: The European Union) and all products need to be CE certified to be sold in Europe.

Glenmark & Torrent Signed Licensing Agreement for Co-marketing Mumbai, India: Glenmark Pharmaceuticals Ltd. (Glenmark), and Torrent Pharmaceuticals Limited (Torrent) today announced that they have entered into a non-exclusive sub-licensing agreement to co-market sodium glucose co-transporter-2 (SGLT2) inhibitor, Remogliflozin Etabonate (Remogliflozin) in India. Under the terms of the agreement, Glenmark will receive an upfront payment, license fees and royalties for the non-exclusive sub-license rights from Torrent. Glenmark will manufacture and supply Remogliflozin while Torrent will market the drug under its own trademark ‘Zucator’ in India.

In April 2019, Glenmark received approval from the Drugs Controller General of India (DCGI) for Remogliflozin Etabonate after successfully completing Phase-3 clinical trials in which Remogliflozin demonstrated good efficacy and safety profile in a head-to-head comparison against Dapagliflozin. Subsequently, Glenmark launched Remogliflozin indicated in the treatment of Type 2 Diabetes Mellitus in adults under the brand names ‘Remo’ and ‘Remozen’ while Torrent will commercialize Remogliflozin under the brand name ‘Zucator’. Moreover, Remogliflozin is available at a breakthrough price that is significantly lower and cost effective over other SGLT-2 inhibitors available in the country. Infact, Remogliflozin is the only SGLT2 inhibitor to be manufactured in India from active pharmaceutical ingredient (API) to formulation.

“We are pleased to partner and work closely with Torrent to provide access to innovative solutions for efficient diabetes management in India. The burden of diabetes in India is growing at an alarming rate and through this collaboration, we aim to improve access to the latest, novel and globally-researched SGLT2 inhibitor by providing an effective, high quality and world-class treatment option to patients in India. This partnership will also lay the foundation for a long term collaboration with Torrent for Remogliflozin in terms of its additional line extensions and further clinical development,” said Sujesh Vasudevan, President, India Formulations, Middle East and Africa at Glenmark Pharmaceuticals.

Dhruv Gulati, Executive Director (India & ROW), Torrent Pharma, said “We are pleased to collaborate with Glenmark for the novel anti-diabetic drug Remogliflozin. The drug will augment the Type 2 Diabetes Mellitus treatment armamentarium in the country and this partnership will be an important step towards enhancing access to the growing needs of diabetic patients.”

Pharma Bio World

press release Glenmark Pharmaceuticals Received Tentative ANDA Approval for Clindamycin Phosphate Foam, 1% Mumbai, India: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (USFDA) for Clindamycin Phosphate Foam, 1 percent, a generic version of EVOCLIN1 Foam, 1 percent, of Mylan Pharmaceuticals Inc. According to IQVIA sales data for the 12 month period ending April 2019, the EVOCLIN Foam, 1 percent market2 achieved annual sales of approximately USD 17.0 million*.

Glenmark’s current portfolio consists of 156 products authorized for distribution in the US marketplace and 59 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

1All brand names and trademarks are the property of their respective owners.

2Market includes brand and all available therapeutic equivalents *IQVIA National Sales Perspectives: Retail & Non-Retail, April 2019

Prestige Biopharma and Pharmapark Announced License and Supply Agreement to Commercialize Prestige's Trastuzumab Biosimilar in the Russian Federation Singapore: Prestige BioPharma and Pharmapark LLC has announced that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige BioPharma´s Trastuzumab biosimilar in the Russian Federation.

Prestige´s Trastuzumab is a mAb biosimilar to Roche’s Herceptin, which is used to treat patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The product has recently been accepted for review at the European Medicines Agency (EMA), based on excellent clinical results achieved with regard to the products´ safety and efficacy profile compared to Herceptin.

The partnership arrangement includes the exclusive rights for Pharmapark to commercialize the Trastuzumab biosimilar in the Russian Federation, leveraging the company’s strong sales and marketing capabilities and experience in successfully bringing new biosimilars to market. Whilst the terms of the deal are not being Pharma Bio World

disclosed, Prestige BioPharma will assume responsibility for product commercial supply out of its manufacturing facilities in Osong, Korea, while Pharmapark will be responsible for local registration, sales and marketing in the Russian Federation with the option to manufacture the product in Russian Federation in line with the Russian import substitution strategy.

Lisa S. Park, CEO of Prestige BioPharma, commented: “We are very pleased to partner with Pharmapark to commercialize our lead biosimilar program in Russian Federation. We are excited to bring our high-quality product to another key market with the ultimate goal to make the product available globally.”

Vasily Skrypin, CEO of Pharmapark, commented: “The partnership with Prestige BioPharma demonstrates the successful execution of our strategy and marks a further milestone for our company as we work to expand our existing pipeline of biosimilars for the Russian and CIS markets. We are excited about the opportunity of bringing an additional biosimilar product to our market that would provide a new safe and effective treatment option for our citizens.”

Fitch Affirmed Glenmark Pharmaceuticals at 'BB'; Outlook Stable Singapore and Mumbai, India: Fitch Ratings has affirmed Indiabased Glenmark Pharmaceuticals Ltd's Long-Term Issuer Default Rating (IDR) at 'BB'. The Outlook is Stable. The agency also affirmed the rating on Glenmark's USD 200 million 4.50 percent senior unsecured notes due 2021 at 'BB'. The notes are rated at the same level as the IDR because they constitute Glenmark's direct and senior unsecured obligations.

Glenmark's geographic diversification and strong record of regulatory compliance help to mitigate business risks arising from its small size; and support its rating relative to other larger global generic drug makers. The rating also factors in Glenmark's adequate product pipeline, which will support revenue and profitability despite continued pricing pressure in the US generic pharmaceutical market. Glenmark's measured approach and derisking strategies in its novel drug development programme will help to preserve its financial flexibility from the inherent risks.

The Stable Outlook reflects Fitch's expectation that new productlaunch in the US will support Glenmark's profitability despite sustained pricing pressure. This, coupled with continued growth in other markets, will lead to a moderate increase in EBITDA. Improvement in leverage will however be limited as we expect free cash generation to be marginally negative after considering a moderate level of investments over the medium term.

July 2019 ► 53

press release Godavari Biorefineries Ltd Earned USDA Sale of Bosch Packaging Technology: CVC Certified Biobased Product Label Capital Partners and Bosch Reached an Godavari Biorefineries Ltd has earned the US Department of Agriculture Agreement (USDA) Certified Biobased Product label. The products, NaturoBG (1,3-Butylene Glycol), Acetic Acid Glacial, Crotonaldehyde are now able to display a unique USDA label that highlights the percentage of biobased content.

The following Godavari Biorefineries Ltd products have earned the USDA Certified Biobased Product Label: • Acetic Acid Glacial with 100 percent biobased content.

• NaturoBG (1,3-Butylene Glycol) with 100 percent biobased content.

• Crotonaldehyde with 100 percent biobased content.

Third-party verification for a product's biobased content is administered through the USDA BioPreferred Program, an initiative created by the 2002 Farm Bill (and most recently expanded by the 2014 Farm Bill). One of the goals of the BioPreferred Program is to increase the development, purchase, and use of biobased products.

The USDA Certified Biobased Product label displays a product's biobased content, which is the portion of a product that comes from a renewable source, such as plant, animal, marine, or forestry feedstocks. Utilizing renewable, biobased material displaces the need for non-renewable petroleum-based chemicals. Biobased products, through petroleum displacement, have played an increasingly important role in reducing greenhouse gas emissions that exacerbate global climate change.

Biobased products are cost-comparative, readily available, and better than their conventional counterparts.

Mr Samir Somaiya said, “The USDA BioPreferred label demonstrates our commitment to sustainability through providing industries with bio-based chemicals. It is another milestone in our journey to be the preferred source of sustainable products to our customers worldwide.

We are proud to add NaturoBG (1,3-Butylene Glycol), Acetic Acid Glacial and Crotonaldehyde made from renewable resources to our portfolio.”

"We applaud Godavari Biorefineries Ltd for earning the USDA Certified Biobased Product label," said Kate Lewis, USDA BioPreferred Program.

"Products from Godavari Biorefineries Ltd are contributing to an ever expanding marketplace that adds value to renewable agriculture commodities, creates jobs in rural communities, and decreases our reliance on petroleum."

According to a report that USDA released in 2016, biobased products contributed USD 393 billion to the US economy in 2014 and support, directly and indirectly, 4.2 million jobs. In this report, the research team estimate petroleum displacement of up to 6.8 million barrels in 2014.

The increased production of renewable chemicals and bio based products contributes to the development and expansion of the US bio economy - where society looks to agriculture for sustainable sources of fuel, energy, chemicals, and products.

54 ◄ July 2019

Stuttgart, Germany and Luxemburg: Bosch plans to sell its packaging machinery business, based in Waiblingen, to a newly incorporated entity managed by CVC Capital Partners (CVC). The company and its Pharma and Food units will remain intact. Based in Luxemburg, CVC is a leading private equity and investment advisory firm with 24 offices in Europe, Asia, and the United States. It currently manages more than USD 75 billion of assets.

The parties signed an agreement on July 11, 2019 affecting the transfer of the entire packaging technology business and its 6,100 associates in 15 countries. It has been agreed that the purchase price and other details of the purchase agreement will not be disclosed. Completion of the sale is subject to the approval of various bodies, including antitrust authorities, and is expected to close at the turn of the year.

Positive prospects for the packaging technology business : Dr. Alexander Dibelius, Managing Partner of CVC, said: “Bosch Packaging Technology is a strong company in an attractive market with long-term growth prospects. Packaging Technology has an excellent reputation for quality and innovation, a broad product range, a global footprint, and experienced associates. Together with the management team, we will work to take the business forward in the years ahead, and to make it even more competitive.”

Dr. Stefan König, the President of Robert Bosch Packaging Technology GmbH, said: “My colleagues and I in executive management regard this new partnership with CVC as a huge opportunity for our future success. Just under two years ago, we completely modified our strategy. It now includes working on a completely new range of smart and sustainable process and packaging technologies. This will allow us to offer our customers even more attractive product solutions and services in the future. Our customers and our associates will benefit from the progress we have made.”

Dr. Stefan Hartung, member of the Board of Management of Robert Bosch GmbH and Chairman of the supervisory board Robert Bosch Packaging Technology GmbH, said: “With its experience in growing companies over the long term, its broad industrial expertise, and its viable strategy for taking the division forward, CVC was the right choice for us. The growth concept it has presented, as well as the investments it plans to make, are very promising. For Packaging Technology and all its associates, our aim was to find a reliable new owner with a longterm approach, under whose leadership the business can develop successfully. We have achieved just that.”

Bosch is consolidating its resources : Bosch announced a year ago that it was looking for a buyer for its packaging technology business.

The company is giving increasing attention to mobility and connectivity over the internet of things. It is focusing its existing resources on areas of future importance, such as shaping the transformation process and preparing for further digitalization. Bosch firmly believes that the Packaging Technology division’s competitiveness, and thus also its future viability, can further be enhanced through this new partnership, and that significant stimuli for growth can be created.

Pharma Bio World

press release Agilent to Acquire BioTek, Strengthening Leadership Position in Growing Cell Analysis Segment New Delhi, India: Agilent Technologies Inc has announced last week that it has signed a definitive agreement to acquire privatelyowned BioTek for USD 1.165 billion. With anticipated tax benefits for Agilent, the net purchase price is expected to be approximately USD 1.05 billion.

BioTek is a global leader in the design, manufacture and distribution of innovative life science instrumentation. Its comprehensive product line includes cell imaging systems, microplate readers, washers, dispensers, automated incubators, and stackers. These products enable life science research by providing customers with high performance and cost-effective analysis across diverse applications. BioTek generated revenues of USD 162 million in fiscal year 2018 ending December 31 and is expected to grow approximately 10 percent in 2019.

The transaction is expected to be completed in Agilent’s fiscal fourth quarter of this year, subject to regulatory approvals and customary closing conditions. Agilent expects the acquisition will be accretive to non-GAAP earnings per share, contributing USD 0.02 – USD 0.04 for fiscal year 2020, and compounding growth thereafter.

“BioTek represents a strong strategic fit with Agilent,” said Mike McMullen, Agilent President and CEO. “The combination of these two companies will accelerate our multi-year growth strategy to expand our position in cell analysis. This is another example of Agilent investing in high-growth segments of the life sciences market to serve new and existing customers. Agilent is committed to continuing operations in Vermont and retaining the great team of nearly 500 employees that have been at the core of BioTek’s 50-year history of excellence and success.”

“BioTek and Agilent have already been in partnership for over a year, successfully unlocking significant value through joint development of customer solutions,” said Briar Alpert, Chief Executive Officer of BioTek. “Both companies share the same focus on customers and employees, as well as a similar purpose, mission and values. I am confident that this is the winning formula for our employees and customers around the world.”

Expanding Portfolio and Leadership in Cell Analysis: Agilent entered the cell analysis segment in 2015 with the acquisition of Seahorse Bioscience, a leader in providing specialized instruments and livecell, kinetic assays. Agilent Seahorse XF technology was a leap in the evolution of cellular metabolism analysis, allowing researchers to better understand metabolic profiles in live cells.

In January 2018 Agilent broadened its portfolio of cell analysis solutions through the acquisition of Luxcel Biosciences. Luxcel’s assays use soluble sensors to analyze metabolism, making them a perfect complement to Agilent’s Seahorse XF technology, providing researchers with more options to analyze live-cell metabolism.

In September 2018, Agilent differentiated its portfolio further through the acquisition of ACEA Biosciences, a pioneer in the development and Pharma Bio World

commercialization of high- performance cell analysis platforms for life science research. Upon closing, Agilent’s cell analysis business will be in excess of USD 250 million in annual revenues.

“By combining BioTek’s offerings with that of Agilent, we will deliver a breadth of differentiated workflows, enabling customers to obtain deeper, more reliable insights across a variety of cell analysis applications,” said Jacob Thaysen, President of Agilent’s Life Sciences and Applied Markets Group. “This positions Agilent well in the large and growing immuno-oncology and immunotherapy markets and expands our presence in biopharma, academia, and research as customers seek to understand complex cellular environments and interactions.”

Intas Became the First to Launch Romiplostim in India for Treating Thrombocytopenia (ITP)

Ahmedabad, Gujarat: One of India’s leading pharmaceutical companies, Intas Pharmaceuticals, takes a revolutionary step towards making therapy for chronic immune thrombocytopenia (ITP) more accessible to patients by being the first to launch Romiplostim in India under the name Romy.

Romiplostim is one of the most efficacious agents with proven longterm benefits in chronic ITP. It represents the standard of care but has been available only internationally since 2008. It is estimated that around 42,000 patients are diagnosed with ITP in India every year.

Less than 10 percent of patients which include adults as well as children, have access to the treatment, which is required to maintain adequate platelet counts for a longer duration. In ITP, long term use of drugs is required to maintain adequate platelet count.

The currently available standard of care therapy for chronic ITP costs approximately ` 60,000 per month, which can financially drain most patients. Hence, there was an unmet need for a drug like Romiplostim, which is accessible to the majority of patients and gives one of the best responses amongst the available treatment options. To fulfill this unmet need, Intas Pharmaceuticals Ltd. has introduced Romiplostim for the 1st time in India, with the brand name ROMY. With the launch of ROMY, which is priced at ` 2995 for a dose of 250 mcg, the monthly cost of treatment for most patients will be less than ` 12000, a huge relief to the chronic ITP patients across the country.

Dr Mammen Chandy, Director of Tata Medical Center, Kolkata and Padma Shri award winner shared his views on this landmark launch, saying that "Romiplostim's introduction in India will help clinicians immensely as it will add to their therapeutic armamentarium in managing thrombocytopenia due to Chronic ITP and Bone Marrow failure. Even in patients developing hepatotoxicity due to Eltrombopag, Romiplostim will be considered as a choice of treatment."

Talking more about the launch, Dr MB Agarwal, one of the leading haematologists in the country, said that "Romiplostim is an injection given below the skin (like insulin) once a week which was available in US, Europe, and Australia for almost a decade but was never marketed in India. Patients were using an oral pill - Eltrombopag on a daily basis.

July 2019 ► 55

Hydrogen Gas

Air-cooled Condensers

Hydrogen gas is used in various industries such as power plants, oil refineries, food, plastic and polymer manufacturing and has the need to accurately measure gas. It is mainly used as a circulating gas. It has very unique characteristics and requires a flow meter that has been calibrated considering operating parameters.

PCD offer in-line mass flow meter specialty design to measure low flow hydrogen gas and is available in sizes as small as ¼” tubing up to larger line sizes. PCD’s mass flow meter technology provides a 100:1 turndown with negligible pressure drop.

For more information, please contact:

Process Control Devices Plot No: 22, Rautara Indl Estate Shil-Mahape Road Shil Phata, Thane Maharashtra 400 612 E-mail: sales@pcd-flowmeter.com / sales,pcdpl@gmail.com

Air-cooled vapour condensers to condense steam and organic vapours using ambient air as the cooling medium. Wire wound fin tubes are used for making the condenser coils compact and economical. Base tubes of carbon steels, copper and copper alloys, SS-304 and SS-316 and other SS grades finned with galvanized mild steel, copper and SS fins are used in fabrication of air air-cooled condenser. The body material used so far is carbon steel and SS. The company designs complete fin fan heat exchanger assembly and also supply as assembled unit comprising of finned tube condenser coil, the transition piece and the fan.

For more information, please contact: Reliable Thermocraft S No: 81/82, Plot No: 18, MIDC, Ambad Nashik, Maharashtra 422 010 Tel: 0253-6628665 E-mail: works@reliablecrafts.com

Platinum-cured Silicone Tube Imapure is platinum-cured silicone tubing (regulatory market) designed for peristaltic pump and fluid transfer in pharma and biotech applications. Imapure is translucent silicone tubing known for its ultra smooth bore to prevent any particle entrapment. It is especially designed to comply with requirements of critical food and pharma standards of regulatory markets.

Imapure is manufactured by using PLC-controlled latest extrusion technology and advance grade platinum-cured silicone, and manufactured and packaged in Clean Room Class of ISO7, ISO 9001 QMS and ISO 14001 and OHSAS 18001 Certified facility. It is inspected by laser online inspection device to maintain critical dimensional consistency and laser etched for traceability. It is manufactured from NSF Certified platinum-cured silicone resin. It complies with FDA 21 CFR, USP Class VI and ISO 10993. It has excellent transparency with no odour and taste. It has Extractable study available upon request and excellent biocompatibility due to inertness to tissues and cells. It is sterilizable by using different techniques like autoclaving, ethylene-oxide and gamma radiation. It is also available with FDA compliant colour coding for ease of identification and custom-dimension, hardness and length size. Another most important part of tubing is its Extractable and Leachable studies from TOXIKON Lab, USA; can be provided upon request and by signing with NDA procedures.

For more information, please contact: Ami Polymer Pvt Ltd 319 Mahesh Indl Estate, Opp: Silver Park Mira-Bhayander Rd, Mira Road (E) Thane, Maharashtra 401 104 Tel: 022-28555107, 28555631, 28555914 E-mail: mktg@amipolymer.com

56 ◄ July 2019

Pharma Bio World

Air Coolers and Air Chillers Air coolers and chillers of the following types are offered by Reliable Thermocraft: water cooled finned air coolers, finned air cooling coils; chilled water cooled finned tube; brine cooled finned air coolers (cooling coils); glycol cooled air coolers (finned cooling coils).

Cooling of air may be necessitated when air is being re-circulated over equipment getting heated up during operation. Air coolers are used to cool air for cooling of large motors, alternators and generators.

Air chiller is used to cool air to a temperature low enough to condense out the moisture to achieve required relative humidity suitable for use in dryers after heating the chilled air. Our designs and construction is compact and economical even where the LMTD is low.

Wire-wound fin tubes are used for making the finned air coolers and chiller coils. This makes these heat exchangers compact, economical with lower pressure drops. Base tubes of carbon steels, copper and copper alloys, SS-304 and SS-316 and other SS grades finned with galvanized mild steel, copper and SS fins are used in fabrication air cooled condenser. The body material used so far is carbon steel and SS. For more information, please contact: Reliable Thermocraft S No: 81/82, Plot No: 18, MIDC, Ambad Nashik, Maharashtra 422 010 Tel: 0253-6628665 E-mail: works@reliablecrafts.com

Platinum-cured Silicone Hose Imawrap is platinum-cured silicone hose reinforced with SS-316L helical wire and 2-3 layers of polyester fabric wrapping. Imawrap is having multiple layers of high quality polyester fabric to enhance burst pressure rating. The product is suitable for high pressurized steam transfer application in pharma and biotech industries.

Imawrap conforms to US FDA 21 CFR 117.2600 Food Grade Standard, USP Class VI and ISO 10993-1. It is certified by ROHS and Animal Origin Certification (free of animal derived material), free of restricted heavy metals. It is free of Phthalate/Bisphenol/Volatile Plasticizer. It has USFDA DMF accreditation #26201. Complete validation package available upon request.

Imawrap has high pressure rating ensures safe material transfer handling process. It is designed for high vacuum rating applications.

It has excellent flexibility and kink resistance. It imparts no taste and odour. It is lot traceable. Its temperature range is -80°C to 180°C and is available with SS-316 L tri-clover end. It is sterilizable by autoclave, ethylene oxide gas and gamma radiation.

For more information, please contact: Ami Polymer Pvt Ltd 319 Mahesh Indl Estate, Opp: Silver Park Mira-Bhayander Rd, Mira Road (E) Thane, Maharashtra 401 104 Tel: 022-28555107, 28555631, 28555914 E-mail: mktg@amipolymer.com

Pharma Bio World

July 2019 ► 57

Closed-coupled SS Centrifugal Pumps Lubi Industries offers closed-coupled SS centrifugal pumps in the flow range up to 72 m3/h and head range up to 57 metres.

It finds application in water supply, pressure boiler feeding, pure water treating systems, pharma and food stuff, refining chemical industries, industrial washing and sprinkler system.

For more information, please contact:

Dosing Pumps Roto RJ Series pumps are developed for low flow applications that demand high accuracies and repeatability. These pumps can handle wide variety of fluids ranging from clean and clear liquids to abrasive, corrosive, viscous and solid laden media. These pumps are useful for high dosing accuracies; smooth and non-pulsating flow; low sheer and linear flow and single rotating element.

For more information, please contact:

Lubi Industries LLP Nr Kalyan Mills, Naroda Road Ahmedabad, Gujarat 380 025 Tel: 079-30610100 Fax: 91-079-30610300 E-mail: indsales@lubipumps.com

Roto Pumps Ltd Roto House, 13, Noida SEZ Noida, Uttar Pradesh 201 305 Tel: 0120-2567902 Fax: 91-0120-2567911 E-mail: contact@rotopumps.com

Single Stage Helical Gear Units With its single stage NORDBLOC.1 helical gear units the NORD DRIVESYSTEMS range includes innovative drive units with high efficiency and long service life. The drive specialist has now extended its successful series with three larger sizes.

The three new products: SK 871.1, SK 971.1 and SK 1071.1, have powers from 0.12 to 45 kW and cover the torque range up to 1,000 Nm. Thanks to optimised bearings, they can reliably handle large axial and radial forces. The robust, cast iron gear units are therefore optimally suitable for pumps and agitators.

The innovative NORDBLOC.1 helical gear units impress with their high efficiencies, compact design and ultimate reliability. They do not have any separating joints or closing caps. This increases the stability of the product and at the same time provides a smoother surface on which neither liquids nor solid materials can accumulate. The FEM-optimised UNICASE housing ensures max strength and rigidity.

The modular design provides wide application flexibility due to numerous configuration and mounting options. All variants are available as flange mounted (B5 or B14), or foot/flange mounted versions. Options for IEC and NEMA motor mounting as well as a wide range of equipment variants for shafts, bearings and lubrication can be flexibly implemented.

For more information, please contact:

NORD DRIVESYSTEMS Pvt Ltd 282/2 & 283/2, Plot No: 15, Village Mann Tal: Mulshi, Adj Hinjewadi MIDC Phase II Pune, Maharashtra 411 057 Tel: 020-39801-217 Fax: 91-020-39801-416 E-mail: monika.mishra@nord.com / pl.muthusekkar@nord.com

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Processing Machine The laboratory-scale version of the Romaco Innojet VENTILUS V 5 is used for granulating, drying and coating particle sizes from 10 µm to 2 mm. Due to its special design and enhanced processing efficiency, the VENTILUS V 5 allows up to 25 per cent shorter batch times. The homogeneous flow conditions inside the cylindrical product container enable extremely gentle intermixing of the batch. The process air is controlled by the ORBITER booster, an ingenious container bottom consisting of overlapping circular plates. Together with the ROTOJET, the central bottom spray nozzle, the ORBITER booster forms an innovative functional unit that meets all the requirements for linear scale-ups. The air flow bed technology ensures accurate control of the product movement and equally precise application of the spray liquids. The resulting formulations can achieve the required release profile with between 10 and 15 per cent less spray liquid For more information, please contact: Romaco Group Am Heegwald 11 76227 Karlsruhe Germany Tel: +49 (0)721 4804 0 Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com

Horizontal Flow Wrapping Machine Hermetic packages protect pharma products from external influences like humidity, oxygen and light. The new horizontal flow wrapping machine Sigpack HML from Bosch Packaging Technology, allows products such as blow-fill-seal vial cards, blisters and various medical technology products including pens and inhalers to be reliably hermetically packaged.

The Sigpack HML is suitable for the production of both small and large batches. Depending on the desired output volume, the film reels can either be changed manually during short machine stops or with the help of a splicer. The improved splicer fully automatic connects the old and new film to avoid disturbances, such as at the film former.

Products are delivered to the flow wrapping machine via a transport chain. The transverse and longitudinal film sealing uses the proven Longdwell heat sealing technology. The machine achieves an output of up to 350 sealed packages per minute. The sealing rolls used for horizontal wrapping can be opened from both sides. This prevents the film from coming into contact with the heated sealing rolls, and from being damaged during machine downtime.

For particularly temperature-sensitive products, the cover plates at the sealing station can be cooled. The Sigpack HML is also available with ultrasonic sealing, allowing customers to gently package heat-sensitive products. Upon request, the Sigpack HML can be equipped with options for additional product protection, such as the “no gap no seal” function. This is especially used for product piles in blister or BFS packages, which is checked once again shortly before it reaches the cross sealing. If the pile is not in the correct position, the cross-sealing stops. This avoids product rejection or damaged sealing jaws. The optional MAP module (Modified Atmosphere Packaging) offers optimal product stability by removing residual oxygen from the hermetic packages. Sensors precisely monitor and regulate the gas content of the packages. The Sigpack HML can be combined with other equipment, like cartoning machines as well as track and trace systems for seamless traceability of the packaged products.

For more information, please contact: Commha Consulting GmbH & Co KG Poststraße 48 69115 Heidelberg Germany Tel: +49 6221 18779-32 / F -11 E-mail: bosch@commhaconsulting.com

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Flushing Ring

Rotary Piston Blowers The flushing flange or ring is used for flushing solution combined with diaphragm seals. This type of flushing flange or ring is clamped between process nozzle and diaphragm seal. The reducer flange is used to mount a larger diaphragm seal to a smaller process connection

Rotary piston blowers (twin and tri-lobe design) from Swam Pneumatics Pvt Ltd are economical and ideal for pneumatic conveying, blending and fluidising of powdered or granular materials and aeration of liquids. The flow capacities are up to 85,000 m3/hr and pressures up to 1.1 kg/cm2. The blowers for high suction pressures are with mechanical seals and pressured lubrication and other design change.

For more information, please contact:

For more information, please contact:

Swam Pneumatics Pvt Ltd C-2, Sector 3, Gautam Budh Nagar Noida, Uttar Pradesh 201 301 Tel: 0120-4696222 Fax: 91-0120-4696200 E-mail: sales@swamatics.com

Chintamani Engg Industries India Pvt Ltd 201 New Rahul CHS, Suyog Nagar Chulne Bhabola Road Vasai (W), Dist: Palghar Maharashtra 401 202 E-mail: info@chintamaniengineering.com

Peroxide-cured Silicone Transparent Tube Imapex peroxide grade silicone tubing is designed for general, non-critical applications. Imapex is translucent silicone tubing having good flexibility and resiliency. It is suitable for peristaltic pump applications for non-critical fluid transfer.

Imapex is manufactured by using quality grade peroxide cured silicone rubber. It is manufactured and packaged in dust-free environment of ISO 9001 QMS, ISO 14001 and OHSAS 18001 Certified facility. It is odourless and tasteless.

It has good flexibility and flex crack resistance. It conforms to FDA 21. CFR. 177.2600. It is sterilizable by autoclaving, ETO and gamma rays. It is available with FDA compliant colour coding for ease of identification.

For more information, please contact: Ami Polymer Pvt Ltd 319 Mahesh Indl Estate Opp: Silver Park Mira-Bhayander Rd Mira Road (E) Thane, Maharashtra 401 104 Tel: 022-28555107, 28555631, 28555914 E-mail: mktg@amipolymer.com

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Pharma Bio World

ANSI Vertical In-line Close-coupled Pump ILL is top pull-out design, CI/SS impeller, packing box cover, casing-flanged suction, front wear rings, manual vent plug.

It finds application in chemical, petrochemical, petroleum, coal, fibre, pulp and paper, food and beverage, pharma fats and oil-soap, paint, automotive.

For more information, please contact:

Ruhrpumpen India Pvt Ltd Plot No: G-33, SIPCOT Indl Park, Vallam Vadagal Sriperumbudur Taluk Kanchipuram, Tamil Nadu 602 105 Tel: 044-33229969 Fax: 91-044-33229902 E-mail: shah@ruhrpumpen.com / slalit@ruhrpumpen.com / ashah@ruhrpumpen.com

Amine Contactor Temperature Measurement Temperature control is essential in amine contactors in order to minimise foaming and carry over. Quality temperature information also helps operators optimise contactor/stripper performance by locating where most of the heat of absorption profile is taking place. If temperature is too high, dirty process could be carried out of the contactor. If it is too low, stripper column energy is wasted. The Gayesco multipoint thermocouple array for amine contactors can be retrofit into existing contactors often through an unused nozzle or old thermowell location. The multipoint thermocouple array is threaded through the contactor trays and sized so that there is a measuring junction at specific tray heights.

Typically 18 trays are instrumented for temperature, allowing the operator a picture of how the contactor is performing and providing the necessary tools to optimise performance. The cooler the lean amine temperature, the better H2S absorption. However, temperature below the gas inlet temperature can cause hydrocarbons to condense and possibly foam. The lean amine solution temperature needs to be higher than the feed gas to the amine contactor and good temperature indications are essential for smooth operation.

The dirty process enters the column at relatively low temperature and is exposed to the lean amine. Adsorption is exothermic and the process fluid will experience a rise in temperature. Optimally, the bulk adsorption is done low in the contactor with the remaining height removing the remaining acid gas to low exit level conditions. By knowing where that heat of adsorption rise is taking place, the operator now knows where the bulk of the acid gas removal is going on and can made adjustments to the flow rate and energy consumption of the unit to maximise efficiency.

The Gayesco multipoint thermocouple array for amine contactors utilises a linear multipoint design with multiple junctions inside a single sheath.

This allows for a large number of thermocouples in a small cross-sectional area and minimum interference with the process flow in the contactor.

The thermocouples are ungrounded and available in a variety of types and sheath metallurgies. The sheath passes through contactor trays and is supported by specialised hardware that is easily assembled in the field and does not require any welding or hot work during installation.

For more information, please contact: Gayesco International 2859 Westside Drive Pasadena, Texas 77502, U.S.A. Tel: 713 941 8540 Fax: 713 944 3715

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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 pumping capacity ranges from 15 m 3/hr, 35 m 3/hr, 65 m3/hr and 100 m 3/hr.

TMS Series pumps has economical features which matches together to achieve: high pumping speed over the range of absolute pressure of 1,000-0.5 mbar; high water vapour tolerance and low noise level; no pollution; air-cooled: and built-in anti-suck-back system.

Designed for continuous operation at high intake pressure the pump is used in various applications like pick and place, packaging, degassing, low boil distillation, solvent recovery, heat treatment, bottle filling, vacuum drying, etc. Toshniwal also provides special B Series oil-lubricated pump for high-pressure (rough vacuum) application upon request.

For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road, Chennai 600 010 Tel: 044-26448983, 26448558 Fax: 91-044-26441820 E-mail: sales@toshniwal.net

Digital Mass Flow Meters/Controllers Metal seal gas mass flow meters and controllers are characterised by their unique patented metal-to-metal seal construction with excellent resealing capability. Further more they distinguish themselves by a high surface quality and are therefore especially suitable for meeting the semiconductor and solar industry requirements as well as other high purity gas applications.

Todayâ&#x20AC;&#x2122;s instruments are equipped with a digital PC-board, offering high accuracy, excellent temperature stability and fast response (settling time t98 down to 500 msec).

The latest EL-FLOW design features multi-gas/multi-range functionality, providing (OEM) customers with optimal flexibility and process efficiency.

Features very low pressure drop and contamination risk; longer lifetime when used on corrosive gases; easy to clean; and electro-polished stainless steel wetted parts.

They are available with control valve to constitute a complete, compact control loop and with industrial (IP65 weather-proof) housing.

For more information, please contact: Toshniwal Hyvac Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26448558, 26448983 Fax: 91-044-26441820 E-mail: sales@toshniwal.net

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Pharma Bio World

Laboratory Dry Vacuum Pump A laboratory vacuum pump is an adaptable tool that can aid a wide diversity of research scientists and engineers. They are used routinely in labs to provide suction to drive the aspiration or filtration of liquid or suspended samples; to induce or control solvent evaporation by reducing vapour pressure as in ovens, rotary evaporators, gel dryers and concentrators; and to collect gas samples from test chambers or the atmospheres.

Vacuum filtration uses a pressure differential (atmosphere above filter paper and vacuum beneath) to drive a solution through filter paper. The vacuum pump should pump under corrosive atmosphere, conventional vacuum pump often fails. The dry chemical vacuum pump will be suitable, eg, the Chemker can handle corrosive vapour basically a chemical resistant dry pump and for evaporation up to 100 Torr for corrosive media for laboratory oven for rotary flash evaporation.

For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road, Chennai 600 010 Tel: 044-26448983, 26448558 Fax: 91-044-26441820 E-mail: sales@toshniwal.net

Push-through Strips Together with Huhtamaki, the film and foil specialist, Romaco Siebler will premiere a push-through strip packaging for pharmaceuticals. The tablets can be removed simply by pressing them out of the pockets in the four-sided sealed foil pack. This innovative push-through strip thus combines the excellent barrier properties of strip packaging with the opening mechanism of blister formats. In direct comparison with cold formed aluminium blisters, the push-through strip scores with its lower consumption of packaging material. The thinner foil of the heat-sealed strips enables cost savings here. The new push-through strips are manufactured either from a multilayer laminated PET-PEAl-PE/Surlyn foil or from a transparent barrier foil. The material does not tear and can therefore be regarded as child resistant. Thanks to the targeted perforation of the upper polyester layer, the pack can be opened simply by pressing the tablet out of the laminated foil with the thumb. The push-through strips are also senior friendly and as such a good alternative to tear-open strip packaging or aluminium-aluminium blisters. Huhtamaki has a patent pending for the manufacturing process used for this special foil.

Romaco’s new push-through strips can be supplied either in the standard rectangular format or as so-called design strips. A Siebler HM 1-350 heat-sealing machine equipped with a special die-cutter is used to manufacture special formats. The continuous cutting station supports both round strip formats and heart, petal or even star-shaped ones. The Siebler HM 1-350 achieves a max output of 800 design strips per minute. The production of push-through strips in a heat-sealing process expands Romaco’s portfolio in the area of air, light and moisture-tight unit dose packaging.

For more information, please contact: Romaco Group Am Heegwald 11 76227 Karlsruhe Germany Tel: +49 (0)721 4804 0 Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com

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events diary       

  

Dates: 19-21 September 2019 Venue: Hitex, Hyderabad

Dates: 8-11 August 2019 Venue: India Exposition Mart, Greater Noida

This Expo is more than just an exhibition. Not only it brings buyers and sellers together for business and networking, it also offers ample of networking opportunities attracting thousands of pharma and R&D professionals – creating a complete pharma marketplace for your business.

Join local and international suppliers as they are exhibiting at analytica Anacon India and India Lab Expo to showcase latest laboratory and analytical instruments and technologies. It is an ideal place for you to connect with buyers, purchasing authorities and heads of procurements across India and promote your brand to right target audiences.

This event is a one-stop destination to address the

 Messe Muenchen India Pvt Ltd INIZIO 507 & 508, Cardinal Gracias Rd Chakala, Andheri (E), Mumbai 400 099 Tel: 022-42554710 E-mail: avisha.desai@mm-india.in

manufacturing requirements of the OEMs of various industry sectors in Tier II and Tier III cities of India. It will cover the entire gamut of metal working machine tools for both metal cutting and metal forming including automation and robotics, tooling systems, CAD/CAM and other technologies essential for today’s manufacturing.  Indian Machine Tool Manufacturers’ Assn Bangalore International Exhibition Centre 10th Mile, Tumkur Road Madavara Post, Bengaluru Karnataka 562 123 Tel: 080-66246600 E-mail: imtma@imtma.in

 

      

Dates: 25-27 September 2019 Venue: India Exposition Mart, Greater Noida

Date: 4-6 December, 2019 Venue: HITEX Exhibition Centre, Hyderbad

Electronica India is the leading platform in India focusing on electronic components, systems and applications. It features semiconductors, embedded systems, display, micro and nano-systems, and sensor technology, automotive, wireless and much more.

BioPharma World Expo 2019 is the best platform for both Indian and international manufacturers/service providers/ startups connected with pharma machinery, CR AMS, CROs/CMOs, packaging, logistics, exports, APIs, generics, biotech, regulatory affairs, etc . It offers a unique opportunity to meet, network and establish business partnerships.

The concurrent conference tracks would highlight latest technological developments, market trends, investment opportunities and challenges facing the industry. The technical sessions would cover pharmaceutical technology, biosimilars, green chemistry, compliance, etc.

 Messe Muenchen India Pvt. Ltd. INIZIO 507 & 508 Cardinal Gracias Rd Chakala, Andheri (E) Mumbai 400 099 Tel: 022-42554700 Fax: 91-022-42554719 E-mail: info@mm-india.in

64 ◄ July 2019

 Jasubhai Media Taj Building, 210, Dr. D.N. Road, Fort, Mumbai - 400 001 Tel: 91-22- 40373636 Email: amrita_patil@jasubhai.com

Pharma Bio World

bookshelf The Future of Pharma – Evolutionary Threats and Opportunities Author: Brian D. Smith Price: ` 3743.00 No. of Pages: 194 Publisher: Routledge About the Book: Pharmaceutical industry makes a notable contribution in Indian economy. Tracing back to history indicates its success so far. Owing to the profits-and-dividends this industry has added and also due to its counter-cyclical stock market trends, investors consider this industry as a relatively low-risk one.

However with significant global implications for employees, shareholders, governments, and patients, this important contribution appears to be petering out due to economic crisis. There are numerous examples indicating the stalling of the pharmaceutical industry. This book – the future of Pharma – throws light on the reasons for this potential decline through an in-depth analysis. It speaks about the emerging landscape, changing marketplace of mass-market consumers, institutional healthcare systems, innovative therapies as the alternate source of commercial value, super-efficient processes, supply chains and operations, closer customer relations, and increasingly tailored health services. The book also has mentioned about various significant long-term and mid-term challenges. The author Brian Smith’s insights are basically the wake-up call and a first step forward for all concerns with the future of this industry.

Leachables and Extractables Handbook Editors: Douglas J Ball, Daniel L Norwood), Cheryl L M Stults and Lee M. Nagao Price: $70.00 No of pages: 700 pages (Hardcover) Publisher: Wiley; (1 st Edition) About the book: A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP) - such as metered dose inhalers, dry powder inhalers, and nasal sprays - pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product.

Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, etc.

Talent Wins Authors: Ram Charan, Dominic Barton and Dennis Carey Price: $16.74 No of pages: 192 pages (Hardcover) Publisher: Harvard Business Review Press About the book: Most executives today recognize the competitive advantage of human capital, and yet the talent practices their organizations use are stuck in the 20th Century. Typical talent-planning and HR processes are designed for predictable environments, traditional ways of getting work done and organizations where lines and boxes still define how people are managed. As work and organizations have become more fluid - and business strategy is no longer about planning years ahead but about sensing and seizing new opportunities and adapting to a constantly changing environment - companies must deploy talent in new ways to remain competitive.

Turning conventional views on their heads, talent and leadership experts provide leaders with a new and different playbook for acquiring, managing and deploying talent - for today’s agile, digital, analytical, technologically driven strategic environment - and for creating the HR function that business needs. Filled with examples of forward-thinking companies that have adopted radical new approaches to talent, as well as the juggernauts and the start-ups of Silicon Valley, this book shows leaders how to bring the rigor that they apply to financial capital to their human capital - elevating HR to the same level as finance in their organizations. Providing deep, expert insight and advice for what needs to change and how to change it, this is the definitive book for reimagining and creating a talent-driven organization that wins.

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ad index Sr. No

Client's Name

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Mack Pharmatech Pvt Ltd

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Mettler-Toledo India Pvt Ltd

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Ravel Hiteks Pvt Ltd

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Toshvin Analytical Pvt Ltd

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Vacuum Drying Technology India LLP

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Vega India Level & Pressure Measurement Pvt Ltd

66 â&#x2014;&#x201E; July 2019

Inside Cover I

9,10,11,12

Pharma Bio World

R.N.I. No.: MAHENG/2002/08502. Date of Publication: 26th of every month. Postal Registration No: MCS/207/2017-19 Posted at Patrika Channel Sorting Office, Mumbai 400001, on 27th of every month. Total Pages:- 68

Process Industry's Gateway to Indian Market

ChemTECH SOUTH WORLD EXPO 2019

International Exhibition and Conferences

4-6 December 2019 Venue: HITEX Exhibition Center, Trade Fair Office Building, Izzat Nagar, Kondapur PO, Hyderabad, India Concurrent Events

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Jasubhai Media Pvt Ltd Taj Building, 3rd Floor, 210, Dr. D N Road, Fort, Mumbai – 400 001, INDIA. Tel: +91-22-4037 3636, Fax: +91-22-4037 3635, Email: sales@jasubhai.com Web: www.chemtech-online.com • Ahmedabad - 07238038888 • Bangalore - 09444728035 • Chennai - 09176963737 • Delhi - 09818148551 • Pune - 09822209183 • Vadodara - 09898061072