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October 2016 Vol 15 | Issue 03 | Mumbai | Price ` 150 Total Pages 60

www.pharmabioworld.com PHARMA BIO WORLD OCTOBER 2016 VOL 15 ISSUE 03 MUMBAI ` 150

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4  October 2016

Pharma Bio World


INTERVIEWS 08

Consolidating Market Position by Building Robust Pipeline and Enhancing Product Portfolio - Dr Rajiv Modi, CMD, CPL Biologicals Pvt Ltd

20

“To sustain our position, we are going in line with technology” - Ketan Zota, Director, Zota Healthcare

FEATURES

8

24

How Technology is Bringing Revolution in Pharma and Bio-Pharma Industry - Phanish Chandra

32

Emerging Technologies for Indian Pharmaceutical & Life Science Industry - Chetan Pathak

34

UDIs: Make Your Mark - Nicola Rapley

36

Regulatory Crisis for Indian Pharma Industry: Who are the Real Culprits?

24

- Swadeep Srivastava

39

Terminal Sterilization: On the Safe Side - Isa Alkan

WHITEPAPER 41

Biosimilars: How can We Realize the USD 240 Billion Opportunity? - Dr Pushpa Vijayaraghavan

MARKET RESEARCH 43

32

Lacklustre Quarter; Better Times Ahead - Centrum Broking Limited

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6  October 2016

Pharma Bio World


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interview

DR RAJIV MODI

Consolidating Market Position by Building Robust Pipeline and Enhancing Product Portfolio CPL Biologicals, a joint-venture by USA based Novavax Inc and Cadila Pharmaceuticals Limited India, aims to create a diversified range of quality products through inhouse Research and Development along with co-development and joint ventures opportunities. “We will leverage our inhouse innovative technology and R&D c a p a b i l i t i e s , a u g m e n te d by s t r a te g i c partnerships to take leadership position in chosen biologics market segments," says Dr Rajiv Modi, CMD, CPL Biologicals Pvt Ltd. Following are the excerpts of the interaction with Mahesh Kallayil. Could you please tell us about CPL Biological's journey so far? Based in Ahmedabad, India, CPL Biologicals Pvt Ltd is an independent joint-venture biotechnology company established in 2009 by Novavax Inc, USA and Cadila Pharmaceuticals Limited, one of India's largest privately held pharmaceutical companies. The company develops vaccines based on Novavax, Inc's Virus Like Particles (VLPs), recombinant nanoparticles and adjuvant technologies, which are groundbreaking innovations that improve global health through safe and effective vaccines. CPL Biologicals conducts end-to-end research, development and manufacturing based on these technologies in India. The current biologics and diagnostics portfolio of CPL Biologicals comes from original technologies developed at Cadila Pharmaceuticals. CPL Biologicals is currently developing new biologics and diagnostics products on its own. The company has a strong management team comprising of deep expertise and experience in the areas of Research, Process Development, Medical Affairs, Manufacturing, Commercialization etc and is governed by the Board of Directors with representation from both Novavax and Cadila leadership. 8 ď‚ƒOctober 2016

What are the key thrust areas for CPL Biologicals? CPL Biologicals has a three pronged approach to providing novel, affordable solution for global healthcare via vaccines, biologics and diagnostics with integrated capabilities from early stage research and development to clinical and commercial manufacturing along with dedicated sales and marketing teams. The strategy is growth oriented, realistic and focused on biologicals. For vaccines, along with the vaccines based on VLP and Nano-particle technology, we also have an innovative Pancreatic Cancer Vaccine, completely developed in India, in phase I human clinical trial. This cancer vaccine is a platform technology and can be applied for other types of cancers as well. We will leverage our in-house innovative technology and R&D capabilities, augmented by strategic partnerships to take leadership position in chosen biologics market segments. We are expanding our presence in the biologics area with novel and biosimilar antibodies based therapeutics in oncology. In diagnostics, we are developing novel immunediagnostics for infectious and non-infectious diseases to prov ide c omplete s olutions for g lob al he ath Pharma Bio World


interview from prevention (vaccines) and diagnosis (diagnostics) to treatment (biologics). The overall strategy is to continuously consolidate the market position by building a robust pipeline and enhance our product portfolio. What is a virus-like particle, and how is it produced? Virus Like Particles (VLPs) are similar to a virus in structure but without the genetic material required for viral replication. VLP vaccines are created by incorporating the gene sequences of multiple immunogenic proteins to produce a complex envelope particle vaccine. The end result is highly immunogenic spherical structures that are roughly the same size as original virus. The vaccines are manufactured in the wellestablished insect cell/BV recombinant platform which is the basis for several licensed biologic products and vaccines, including a vaccine licensed for Human Papilloma Virus (HPV), which showed >95 per cent effectiveness in reducing the incidence of cervical cancer. We can use the insect cell/BV technology to produce a wide range of vaccine candidates derived from viruses, bacteria and protozoan parasites. Please elucidate the essential role of VLP technology in new-generation vaccines?

and Nano-particle technology completely takes that risk away providing safer and more effective vaccine compared to other available vaccines. Finally, because of the structure and components of our VLPs, they may have greater immunogenicity in two vulnerable populations - pediatrics and older adults. What are the other significant developments in vaccine manufacturing that are replacing traditional production methods? Before looking at new developments in vaccine manufacturing, it is important to understand the difference between the production of vaccines and other biopharmaceuticals, the risk-safety consideration related to working with pathogens and pathogenic antigens is a key driver. As with all biomolecules purified from crude biological material, the removal of contaminants (eg, derivatives from host cell such as DNA, protein, or leachables), must be documented. However, the removal or inactivation of adventitious viruses remains a unique challenge. Despite the advances in vaccine manufacturing across the globe, regulatory, technical, and manufacturing hurdles remain. Identifying suitable antigens, adjuvants, and delivery methods are important aspects in developing new platforms for vaccine development and production. Public demand for safe and effective vaccines continues.

In addition, regulatory requirements have led to an emphasis on well characterized, safe vaccines. Traditional vaccines are produced; 1. In eggs a. Old and familiar technology that has been practiced for more than 60 years b. Requires a large number of specific pathogen free (SPF) eggs c. Process is labour intensive d. H i g h l y s u s c e p t i b l e t o b a c t e r i a l contamination. e. Individuals who are allergic to eggs might have allergic reactions to such vaccines. 2. In mammalian cells a. Animal cell-culture processes are encouraged by regulatory authorities for reduced uncertainty and puts more controls on process. b. The tumorigenic and oncogenic potential of the cells in which the virus is propagated is major concern c. The use of animal-derived components in the cell-culture media - whether serum-sourced from calf or trypsinsourced from porcine - could be potential sources of animal viruses. The use of recombinant DNA technology (rDNA) like VLPs for the manufacturing of vaccines is becoming more popular. The advantages of an rDNA vaccine platform

VLP's virus-like qualities activate the immune system to stimulate both antibody B-cell and cellular T-cell responses. Once injected into the body, VLPs trigger a specific and targeted immune response against the VLP thereby generating a strong response and protection against the disease. Also, since there is no genetic material (DNA or RNA) in these VLPs, it is impossible for them to infect host cells and, therefore, present no threat of infection to a person being vaccinated, unlike other vaccines which are developed based on the viruses which can replicate in human body thereby causing disease by the vaccine itself. Our recombinant VLP 10 ď‚ƒOctober 2016

Pharma Bio World


interview

Infographic representation of CPL timeline

is that one does not need to handle a live pathogenic virus. This process rules out the need for a containment facility like BSL 3 or 4. There are no safety concerns and the process is easily scalable to large quantities and more economical in terms of facility, materials, labor, and utility costs. The rDNA technology can easily be adapted to single-use platform processes to reduce complexities, ensure safety, and maintain timelines to market, therefore, is only growing. Additionally, because process development provides a technological foundation for manufacturing, analytical methods and assay development for characterization and potency determination must be part of a company's approach. Such an approach helps to lay the groundwork for successful commercialization. Could you please shed some light on launch of your Recombinant Influenza vaccine? CPL Biologicals is launching world's first VLP based Influenza vaccine. Influenza vaccines are a very important intervention to improve health and productivity of both pediatric and adult populations, however, it has not caught up in India due to lack of awareness and availability of options. CPL Biologicals Seasonal Influenza and Swine Flu vaccines are important steps in this direction. A huge advantage of our technology is that we can quickly respond to any potential Flu pandemic in India in the future. Our cutting edge technology allows us to have a vaccine ready for human use against a new pandemic within 3-4 months of identification of genome 12 October 2016

sequence of the virus while the vaccines based on conventional technologies may require more than 8-9 months for the same. Please apprise us on CPL's vaccine facility at Dholka CPL Biologicals has established state-ofthe-art integrated manufacturing facilities in Dholka, Gujarat (India), comprising of independent bulk vaccine manufacturing, bulk biologics manufacturing and fill-finish & packaging facility for both vaccines and biologics. The facility has the capacity to produce up to 25 million vials and 10 million Pre-Filled Syringes (PFS) every year.

are supplied at very competitive prices. Therefore, it's a big challenge for current Indian vaccine industry to provide cost effective vaccines with compliance to best regulatory standards like WHO and US FDA. These have stressed vaccine manufacturers to sustain business by investing in new technologies and newer vaccine candidates. Developing novel, high impact vaccines is a major challenge for Indian vaccine industry to re-invent and sustain itself in the long run. CPL Biologicals is taking a major step in that direction by developing novel vaccines based on cutting edge technology.

What kind of growth are you looking at in the Indian vaccine market?

Why do you think India have not much indigenous vaccines to our credit?

The future growth for the vaccine market in India will be driven by expansion of vaccination coverage for new borne, new approvals and inclusion of new vaccines like Rotavirus in national immunization program as well as emerging area of Adult vaccination.

• Lack of participation of academia in understanding a disease agent, its pathogenesis and identification of the antigens. • Lack of availability of the challenge animal models/challenge facility • Lack of discovery of surrogate markers of protection to newer disease agents • Lack of central laboratory like CDC in USA to support discovery of disease causing agents and providing seed vaccine strain • Absence of firm Epidemiological data

Adult vaccination is a proven way of improving the overall health and productivity of the society, however, it has not caught up in India due to lack of awareness and availability of options. CPL Biologicals is spearheading the campaign for adult vaccination in India with its Seasonal Influenza and Swine Flu vaccines. Currently, what are the major challenges for Indian vaccine industry? India is largest supplier of vaccines in the world by volume. However, most of these vaccines are traditional vaccines and

May we have your comments on the pros and cons on producing combination vaccines? Pros: 1. Cost of vaccine is reduced 2. Number of pricks and visits to clinic are reduced 3. Lesser cost of logistics Pharma Bio World


interview Developing novel, high impact vaccines is a major challenge for Indian vaccine industry to re-invent and sustain itself in the long run. Cons: 1. Immune response variability 2. Actual protection rate may vary 3. Stability 4. O v e r i m m u n i z a t i o n w h e n o n l y o n e vaccine is needed 5. Analytics to ensure quality of product

the cost of vaccine down and how can we make the treatment accessible to lthe ast man in the society.

How supportive is the regulatory landscape for research and development of vaccine in India?

Balance between cost of vaccine and volume need to be achieved. For example Unicef supplies 50 per cent doses world over but the revenue of these is only about 5 per cent of total revenue. India is major supplier to Unicef. To realize the vision of 200 billion industry we need to shift to contribution to remaining 50 per cent of doses. The challenges in achieving this is shift of focus from quantities of doses to niche vaccine producers.

It is very difficult to develop new vaccines in India. The Indian regulation currently deals with biologics, vaccines and small molecule drug in same manner. There are no separate guidelines for each of these, though currently there are efforts being made to layout these. There is sense of respect from regulators for companies who do new developments of bring in new technology but their support is retarded by >50 years old drug and cosmetic act. Additionally the scanty availability of knowledge of new technology and diseases adds to the complexity while review process relies on fixed set of experts from academia and health care professionals who may not have knowledge of vaccinology There is growing interest in the space of personalized vaccines globally in advanced nations. How do you see the future of this field in Indian context? Yes, personalized vaccines, rather treatments, are picking up interest for treatment of complex diseases like cancer. The major deterrent for India is cost of treatment. India being price sensitive market, unless the cost of treatment and availability to last man in society are addresses future of personalized vaccines looks very gloomy. We at CPL Biologicals are currently working on some of such targets where we can keep 16 ď‚ƒOctober 2016

What are the challenges that we need to address to realize the vision 2020 to reach USD 200 billion industry?

How do you plan to leverage on Make in India campaign? We will license our vaccines globally starting with India first. Given the superior technology, our vaccines will be either first-in-class or best-in-class across the globe. We will manufacture them here in India and supply to the global population. We are exploring possibilities of collaborating with different government and other agencies to participate in the Make-in-India campaign.

Our next vaccine to be commercialized will be a 3 dose Rabies vaccine based on the Nano-particle technology which is currently in phase III human clinical trials. CPL Biological's Rabies vaccine with a 3 dose regimen (0-3-7 days) will be a significant improvement over currently available vaccines around the globe where one needs 5 doses over a period of 28 days (0-3-7-14-28). Our vaccine will significantly improve compliance towards full course of immunization as the dropout rate for the current Rabies vaccines is maximum for doses 4 and 5 (Day 14 and 28). Our eventual target is to reduce the number of doses for the Rabies vaccine to a single dose. That will help us significantly improve the coverage and compliance of the vaccine and save human lives across the world. Our Rabies vaccine will be world's first recombinant Nano-particle based Rabies vaccine. The next vaccine in the early stages of development is a Varicella Zoster Virus (VZV) vaccine. Currently, no VZV vaccine is manufactured in India and all of them are imported as bulk or finished formulations. This results limited supply/shortage of the vaccine. Our VZV vaccine will be the first VZV vaccine to be completely developed and manufactured in India and will address the current shortage of this critical vaccine in Indian market.

Which are the areas that CPL is currently working on? Could you update us on CPL's product pipeline? We have already licensed Recombinant influenza vaccines for H1N1 (Swine Flu) and Seasonal Flu. They are world's first VLP based influenza vaccines and offer significant advantages over the currently available conventional influenza vaccines. We will be applying for registration in multiple countries outside of India for these vaccines in the coming year. Pharma Bio World


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interview

“To sustain our position, we are going in line with technology”

KE TAN ZOTA

Through prompt deliver y of innovative products at fair prices, Zota has carved a winning niche in the pharmaceutical industr y. Ketan Zota, Director, Zota Healthcare ascribes this acquirement to their vibrant range of products that are developed in line with costomer needs. In an interview with Mahesh Kallayil, he further talks on their business strategies, IPO plans, current industry scenario and future prospects. Could you please tell us about the company, its journey so far, specific achievements and offering to pharmaceutical industry? We started with Zota Pharmaceuticals and its subsidiary firm, ATOZ Pharmaceuticals, which were merged later to form Zota Healthcare Pvt. Ltd. Zota Healthcare is a business of manufacturing and marketing quality medicines, with them being affordable by people. It's the fastest growing pharmaceutical brand in India, comprising of a varied range of pharmaceutical formulations along with Nutraceutical and Ayurvedic products available for India as well as abroad. Zota Healthcare has seen many ups and down. But besides them, we have been able to acquire many pharmaceutical companies like Sayona Medicare Pvt. Ltd., Vadodara, Corpus Pharma and many more. To mention a few of our achievements, we have been awarded patents for 6 of our unique formulations. In addition to that, our plant in SURSEZ received WHO-GMP approval. We have been proud winners of BUSINESS EXCELLENCE AWARDS in the category of Company of the year "MID SEGMENT", for two consecutive years, 2015-16. Please apprise us your complete products portfolio/ services provided by you and the market opportunities of these products/services in India as well as abroad? Zota Healthcare Pvt. Ltd. produces a varied range of ailment specific products which target acute and chronic treatments like Liver Disorders, Osteoarthritis, Diabetes 20 October 2016

and more. The product range includes tablets, capsules, oral liquids, dry powders, injectables, oral liquid spray, ointments, cream, lotion, medicated soaps, eye/ear/ nasal drops, Ayurvedic and Herbal products, tooth gel, mouth wash, gum paint, shampoos, prefilled syringes, Nutraceuticals and cosmetics. Zota holds a strong market base of over 21 marketing divisions in India. Our production facility for exports is set up at Surat's Special Economic Zone (SurSEZ). The products manufactured by Zota include the special patented formulations which opens a different market for them. Besides that, as they have specific ailment drugs, these are rare to find which keeps the drugs in demand, nationally and internationally. The medicines are backed by in-depth research and latest technology to not leave any gap in treatment. How you are currently placed in the Indian and International market? We, at Zota Healthcare Pvt. Ltd., develop products that are in line with customer needs and this has, in turn, helped us establish a strong presence in many untapped segments of the pharmaceutical market in India. The range of our products broadens our market space as we offer generic, ayurvedic, herbal, and nutraceutical drugs. This results in an increased rate of sales as we can target different segments simultaneously. While considering international market, we have entered into marketing alliance agreement with ASTRA IDL LIMITED. ASTRA IDL LIMITED has a good name in pharmaceutical market and has presence in global Pharma Bio World


interview market too, in terms of selling generic drugs. This division will enlarge our company's presence in generic market. The recent development has made us enter the FMCG and OTC segment with the launch of our energy drink product, Dip Sip. What are the initiatives that you are undertaking currently to sustain the frontier position you have in the Indian market? To sustain our position, we, at Zota Healthcare Pvt. Ltd, are going in line with technology too. Besides the website, we have launched our Nutravedic App which broadens our market, online. We are due to launch our portal, Davaindia.com, and its application, for selling of low cost medicines. For increase of sales of the company in foreign countries, we have applied to the FDA department of various Asian, African and CIS counties and have successfully received approval from more than twenty countries. In next few months, our other FMCG brands are awaited to enter the market on a national scale. How do you evolve the research and development to keep a pace with the changing dynamics of the Indian market? The scientists at Zota Healthcare Pvt. Ltd. work closely with the business development team to generate innovative concepts and leads, exploiting both, market needs and synergies across therapeutic areas. Our Research and Development team works extensively on unique and novel formulations, especially in nutraceuticals. Our research, strategy and implementation are well supported by a strong intellectual property team having expertise and experience in chemistry, analytical techniques, dosage forms and global patent laws. Our research capability has not only helped us gain rich dividends but has earned us an enviable reputation for quality as well. Please tell us about your proposed export plant in Sachin. For exports, the production facility is set up at Surat's Special Economic Zone (SurSEZ), Sachin. The plant has been established to 22 ď‚ƒOctober 2016

encourage business growth and extending wellbeing in other parts of the world. Our company manufactures products covering a range of general tablets and capsules under various pharmaceutical categories in this facility, exclusively for exports, to cater to several regulated markets and semi-regulated markets. The manufacturing capabilities under this manufacturing facility possessed to produce the range of tablets and capsules are 90 million per month and 50 million per month, respectively. The plant has helped us to strengthen our global presence in Kenya, Nigeria, Niger, Burundi, Sri Lanka, Vietnam and many more countries. Kindly apprise us about the proposed IPO offering Zota Healthcare plans to raise a capital of ` 50-60 crore via Initial Public offering (IPO) by listing itself on NSE. The IPO, once offered, will be utilised to effectively set up manufacturing plants as well as expansion of existing business model. Apart from this, working capital will be given importance to grow and increase along with the company. The same funds will also be utilized to set up a comprehensive marketing program for Zota Healthcare's upcoming products as well as existing/ upcoming projects. What new markets are you planning to target? Zota Healthcare is having a network of 1200+ distributors throughout the country and is planning to strengthen its presence in rural India. Besides domestic market, Zota is aggressively focusing on Asian, African, CIS, Latin American countries. How do you plan to leverage on Make in India campaign? India is expected to become the third largest market for pharmaceuticals by the year 2020 in regards to incremental growth. What makes India the largest provider of generic medicines globally is its 20 per cent of global exports in generics. Benefiting from this, we are in the process of getting product approvals in various foreign countries.

Henceforth, we have initiated our process of exports. Also, a few approvals are awaited by the end of this fiscal period which will boost our presence in overseas generic markets. In addition to this, we have started manufacturing products for foreign countries. Government has fastened clearance of projects with their Make in India initiative, leading to ease in handling business. Government agencies' approval and clearance have become more transparent and are done at a faster rate which helps the companies to focus on core business aspects. Under this campaign, approvals for export have become simpler, enabling us to export more. This helps us to work in coloration and strategic alliance with foreign players. Please detail about your future plans Zota Healthcare Pvt. Ltd. is in continuous efforts to enlarge its market base and trying to cover almost all parts of rural as well as urban areas of India and world as well. For fulfilment of the above target, we have entered into marketing alliance agreement with the ASTRA IDL LTD. Following the alliance, we have launched two new divisions called "Astgen" and "Astcon" in the state of Rajasthan and Madhya Pradesh. In future we plan to launch this division throughout the country. Apart from the above mentioned agreement, we also plan to cover the overall market of India by company's wide range of products. In order to raise our manufacturing output, we have decided to make some in-house changes. We plan to reschedule the current work shift timings for our staff to result in 24 hours of manufacturing, non-stop. Zota Healthcare is coming up with their new division, Zota Generics. It will help fulfill the needs and gaps of the domestic generic market. In addition to other developments in the firm, we are coming up with an OTC segment which includes chronic therapeutic categories like cancer. It can result into breakthrough benefits seen in the study of cancer. Pharma Bio World


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How Technology is Bringing Revolution in Pharma and Bio-Pharma Industry This article discusses the role that technology and data is already playing within the pharma and bio-pharma industry and how future digital innovation will enable the changing landscape of these industries.

T

he 21 st century is the century of technology. After the advancement of computers and internet during the 20 th century, no industry is left untouched. The technology now plays most important role in business processes in all industries across the globe. Every 1.5 years our technical capabilities are almost doubled, as predicted by Moore's Law. In last 10 years or so we have seen a big boom in Pharma and Biopharma industry too. Pharma and Bio-Pharma continues to evolve with expectations of a positive future. Much of this expectation is driven by pressure for the next blockbuster thing, demand for better processing technologies, and by concerns about weak development pipelines. A lot of the drive for change will come from the new electronic and medical technologies that are in development at the moment. Faster and more powerful computing will spearhead the advancement, enabling researchers to perform more gruesome tasks and tackle more demanding problems in silico. Similar to the airline industry, more design and testing, eventually even preclinical and clinical testing, will be done virtually. In parallel, the global communication network will connect everyone and allow the instantaneous and secure sharing o f information. Patient rec ords , drug development data, messages, ideas, instructions and many other things are already being transmitted around the world through the technology.

Phanish Chandra CEO Docplexus 24 ď‚ƒOctober 2016

In order to bring about the revolution in healthcare that modern IT promises, there are legal, technical and cultural/societal barriers that must be addressed. Similarly, costeffective rapid evaluation of new technologies is pivotal to the industry achieving this expected progress in the Pharma and Bio-Pharma sector. However, evaluating and implementing new technologies in the regulated pharmaceutical environment

can be sometimes slow and costly to both innovators and to the end-users in the Pharma and Bio-Pharma industry. Patients are increasingly getting connected to the healthcare network, yet at the same time less inconvenienced by it. The treatments patients take will be better suited to their needs, and their response to it will be observed. This will require pharma to communicate with doctors and other healthcare providers to gather more real time data and to connect with the real end-user the patient through doctors. More efficacious, personalized and specialized drugs can have a higher price, but on the other hand a drug that does not work will abolish from the market. In future, outcome-based sales and payments will keep entire pharma industry on it's toes while reassuring healthcare professionals that they are providing the best treatment available. Targeted therapeutics and associated diagnostics developed with the help of powerful computing technology will require smaller clinical trials and be faster and cheaper to bring to market. The resulting reduction in the importance of the blockbuster model need not mean lower pharma incomes. How Technology Impacts Pharma Sector? Internal business processes such as finance, accounting and planning were first to taste the success of technology. Engineering and manufacturing divisions were next in line to implement widespread technological solutions in the Pharma industry. However, other crucial functions such as marketing and sales still have not implemented technological transformation as they should have. Technology in Manufacturing Manufacturing divisions were on the forefront of implementation of the technology. It makes Pharma Bio World


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Big data offers quite accurate predictive analysis of impact of new products in the pipeline on patients, the most important trigger for personalized medicine. The continuing evolution of new technologies, such as 3-D biological printing, ultrahigh-resolution analytical instruments, next-generation sequencing, desktop electron microscopy, gene therapy, translational research, stem cell therapies and microbiomics are changing the traditional rules for drug development.

sense. The pipeline for any new drug is in billion dollars and sometimes extends over the decade. The upstream cost management started from manufacturing sector with implementation of more technically advanced processing technologies. Processes got more automated over the time due to both cost pressures and regulatory pressures. Eventually, robotics and advanced automation kicked in which has reduced the production costs, giving manufacturers better margins. With new analytical technologies, quality control processes also got automated, quality of products increased substantially across the board. Moreover, monitoring quality of products and control reduced time-tomarket, reducing the overall costs for any pharmaceutical company. What reduced production costs are doing is that they are reducing overall supply chain costs. In addition, technology also brought visibility in supply chains giving better control to manufacturers. Technology in Research and Development Pharmaceutical and biotechnology companies endure to make investments in research techniques and technologies 26 ď‚ƒOctober 2016

including those using high-performance computing technology. Much of this research is fueled by the need to analyze and explore the ever-growing of genomic and proteomic data which is indicative of the success of their future products. However, many research and development investments, including techniques to mine newly produced genomic data, are yet to provide the anticipated improvements in productivity. It has raised the questions whether advancements expected from next-generation computing technology can translate into tangible benefits for pharmaceutical and biotechnology researchers, and whether researchers can capitalize on an increased understanding of biological systems using tools made more readily available in high-performance computing. This hesitation will soon be cleared through the adaption of big-data technologies. What was holding back was the lack of technology to understand and analyze the big data. But new technology is providing this opportunity.

Advances in technologies not directly linked to biology have also contributed to the increasing availability of biological information. Improvement in the broad range of electronics and information technologies underlying the medical imaging technology is one of the most important example. Medical imaging technologies allow physicians to view diseases and injuries directly, without the need for invasive surgeries. Also, improved information display and control, such as three-dimensional audio-visual displays of bodily organs or drug interactions, enable improvements in diagnosis, decisionmaking, and treatment. Technology in Compliance Strict regulatory compliance is a unique challenge for Pharma and Bio-Pharma sector. There are multiple regulatory frameworks across the world. Many Indian companies have to comply with multiple frameworks across the globe. Regulatory compliance software development is major area of healthcare IT. Indian IT companies have been exploring this area for quite some time now. Technology offers an escape from a truckloads of paperwork that needs to be submitted to regulatory bodies. Now

Advances in technologies not directly linked to biology have also contributed to the increasing availability of biological information. Pharma Bio World


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many regulatory bodies accept digital documentation for compliance. Real-time tracking and regulatory planning has also become mainstay. As the timelines are reduced, costs have also come down. Impact of Technology in Marketing Perhaps it is a sad thing that marketing function is the last function to get penetrated by technology or digital solutions. We have seen the way digital age has transformed how information is shared amongst humans. The internet initially started providing means to obtain information. Now the internet is not only a huge database for information but has evolved as an essential tool for communication that spreads across the edges and corners of the world. This shift in the technology has taken all the aspects of life in its strides. This emerging trend is now set to bring about a revolution in healthcare sector too.

The explosion in the social media began in year 2000s with the founding of LinkedIn in 2002, MySpace in 2003, Facebook in 2004, YouTube in 2005 and Twitter in 2006. Each of these platforms initially started as a person-to-person communication channel. These channels of social media have penetrated our lives in such way that we find them imperative for communicating between us. These new platforms also brought about different and innovative ways of interactions for personto-person and community-to-community communications. The boom in social media has encouraged many marketers to find innovative ways in order to position themselves. Somewhat static marketing approach in the marketing is now renovated into much more responsive dynamic approach. Even though various sectors are moving to multichannel marketing, Pharma sector is still a laggard. It was assumed that the use of the internet is only for acquiring the

Marketing with new technology is becoming more efficient and has a potential to further streamline all the processes in the Pharma sector. 28 ď‚ƒOctober 2016

information which mattered in research. But that notion is slowly but positively changing. Many pharma companies, one of the larger stakeholders in the healthcare industry, are trying to brace themselves for this emerging trend. Pharma companies have been focusing on the small groups customers till today and unwary of a large pool of potential customers they are missing. However, technology has brought visibility about potential customers, such as professional platform of doctors like Docplexus. Marketing with new technology is becoming more efficient and has a potential to further streamline all the processes in the Pharma sector. Pharma companies have been employing push strategy to sell their products and services. The market was fragmented and there was hardly any way to know what customers really wanted. But, social media platform like Docplexus now provides better exposure and far better insights about the potential customers- the doctors. Social data analytics is something Pharma needs to implement change in their strategy from costlier to push approach to more efficient pull approach. Pharma Bio World


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Most importantly the challenge is to adapt technology and digital marketing initiatives. Following are some of the reasons why Pharma should adopt technological solutions for marketing activities: • To change the negative perception by doctors: The majority of doctors interact with Pharma only through there field force. Our recent survey about MRs showed that about 53 per cent of doctors have negative perception about the Pharma companies due to their inadequately trained MRs. Many time their interactions fail to communicate the value that Pharma companies can add to doctors' practice. Thus this negative perception regarding "unwilling to help and pushy" Pharma needs to be reworked. • Increasing digital interactions by d o c t o r s : T h e d o c t o r s o f t h i s 2 1 st century are tech-savvy. In India alone, 50 per cent of registered doctors are interacting with each other on p ro f e s s i o n a l so cia l m e d ia su ch a s Docplexus. In addition, doctors are extensively using other non-specific social media platforms like Facebook and Whatsapp. There is a need for a comprehensive strategy to connect with doctors on professional platforms since they cannot be reached at open social media platforms due to

30 October 2016

guidelines such as UCPMP guidelines. Pharma needs to reinvent its identity so that doctors do not hesitate to interact with them due to hesitation. The digital solutions provide ethical way to connect to the doctors and still market the product and services. • Lack of Trust: Reports by Deloitte and GLG both highlighted that there is a lack of trust from doctors' side on information provided by the Pharma companies. This is because doctors cannot verify the claims made by Pharma as the majority of proprietary data is still not shared by Pharma with the doctors. Doctors trust the data and Pharma needs to come out as trusted partner and provider of data and associated clinical benefits. Pharma needs to increase their digital presence through neutral channels in order to provide the clinical insights. Technology can help Pharma companies to project themselves in more efficient way. The Future On average, technologies are getting 1,000 times faster every 10 years. It is a hope that it will not be long until pharma will be able to practically employ molecular design and modelling and predict native protein structures to aid in the design, development and testing of new drugs. Wh ile we c an already antic ipate this

development now, in the next decade it may become part of the standard pipeline of drug development. Patients' medical records are a great example of the type of information that will be digitally held in the future. This will allow all healthcare providers with the authority to access all information concerning a patient's health. The marketing has great potential to be more effective with collecting, storing and retrieving information of the digital society. However, medicine is not only about curing illness; increasingly it is about preventing it - an area that only few pharma have so far investigated. The impact of new technologies and availability of information will be highly visible in this domain. Realtime information from doctors, wearable devices can start to gather information about key health parameters. However, it will be a long time before the real impact of these technologies is assessed. Pharma companies need to take incremental steps towards digital transformation. Strategic foresight, not technology is something that is more critical while embracing the technology. Contact: shreya@vspark.co.in

Pharma Bio World


Emerging Technologies for Indian Pharmaceutical & Life Science Industry Technology savvy lifescience industry is now adopting new technologies which directly align and support their more nimble business strategies. This article tries to figure oud how the end-toend IT solutions bring in efficiency in operations, comply with regulatory aspects, and manage products efficiently.

A

ccording to India's Ministry of Commerce and Industry, the Indian pharmaceutical industry, which is expected to grow over 15 per cent per annum between 2015 and 2020, will outperform the global pharmaceutical industry, which is set to grow at an annual rate of 5 per cent between the same periods. The India pharmaceutical market is expected to grow to USD 55 billion by 2020, thereby emerging as the sixth largest pharmaceutical market globally by absolute size. India has also maintained its lead over China in pharmaceutical exports with a year-on-year growth of 7.55 per cent to USD 12.54 billion in 2015. The above data points paint a very rosy picture for the future of India's pharmaceutical industry but one cannot ignore the challenges that pharmaceutical industry will face as it outperforms the global pharmaceutical market. The changes in economic, political, technological and social environment will continue to affect the pharmaceutical industry and pharmaceutical companies will have to strategize to streamline their journey to become USD 55 Billion Industry by 2020. As per the industry experts, the major points to be concerned about will be the evolving regulatory and risk environment; ongoing pricing, cost, competitive pressures; and overall manufacturing cost optimization. Pharmaceutical Companies, although slow adopters of information technology, have been taking support from IT systems to

Chetan Pathak Executive Vice President Tectura India 32 ď‚ƒOctober 2016

overcome the internal and external industry challenges. Existing technologies like Enterprise Resource Planning (ERP) and Customer Relationship Management (CRM) systems have become second nature to pharmaceutical companies. These systems support pharmaceutical companies in ensuring regulatory compliance, controlling costs, driving process efficiencies, targeting the potential customers, rapidly ramp up sales and marketing efforts with new drug approvals, improve field sales productivity and marketing effectiveness and much more. However, both ERP and CRM systems have their own limitations and would not be enough for pharmaceutical companies for the times to come. Leading services providers realize the limitations of the current ERP and CRM solutions available to pharmaceutical industry and hence, are integrating their ERP/CRM offerings with path breaking technologies like Analytics and Internet of Things (IOT). The volume of raw data with pharmaceutical companies captured over decades are like gold mines waiting to be extracted and valued. Using Analytics to find associations, recognize patterns and identify trends that allow a company to shape customer experiences for increased engagement and greater profits is a great way to bring the perspective of the customer into business decisions. Recently Microsoft launched Microsoft Dynamics CRM platform Field Services

The volume of raw data with pharmaceutical companies captured over decades are like gold mines waiting to be extracted and valued. Pharma Bio World


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with IOT capabilities that can help Life science equipment manufacturing companies to take predictive and proactive measures to tackle the medical equipment service challenges. IOT enabled devices continuously monitor the anomalies in the medical equipment, creates alerts that trigger automated actions or service tickets, leading to delivery of exemplary customer services even before customer has realised its need.

The time has come for pharmaceutical companies to indulge into technologies like BIG DATA and IOT. Many have already started looking into technologies that will help them pursue excellence across their organization not only in the sector of manufacturing but also in the areas such as Finance, Research & Development, Safety Control and Customer Satisfaction. Contact: Nishant.Vashishth@Tectura.com

With this solution, the availability of right service technicians can be increased by skill matching against the service requirement and routing the service agent to customer location to take the preventive actions. The IOT technology promises increased uptimes for Pharmaceutical Industry thus allowing them to cater to demand in a highly predictive manner and reduce production costs. With a network of Internet-connected devices and an intelligent CRM system, Life Science equipment manufacturer companies can continuously monitor and collect device data for accurate analytics, perform predictive (instead of scheduled) maintenance, proactively identify next best actions for maintenance and repairs, leverage machine-to-machine diagnosis, and self-healing. Pharma Bio World

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October 2016  33


UDIs: Make Your Mark The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States. The UDI is expected to improve patient safety facilitate and improve the recall process, and create efficiencies.

U

nique Device Identification (UDI) is a system used to identify medical devices entering the healthcare supply chain. Each device (and version or model thereof) will have a designated number assigned by the manufacturer or labeler, which must be added in both machine (AutoID) and human readable form to both the packaging and, in some cases, the device itself - provided it is required to do so under the regulation. The rule also requires dates on medical device labels to conform to a standard format year-monthday (eg, 2013-09-30) to ensure those dates are unambiguous and clearly understood by device users. The standards have been developed by regulators such as the US Food and Drug Administration (FDA) in order to increase patient safety via the ability to effectively track devices through their distribution and use. In Europe, the European Commission is involved in ongoing discussions with regard to developing draft regulation for UDI - the results of which are due to be announced in the first half of 2016. As a globally recognized standard, every medical device manufacturer will be required to comply with the regulations, which state that a UDI must be included on device labels and packages, unless there is an exception or alternative stated within the rules. Of what does a UDI consist?

Nicola Rapley Global Marketing Manager - Pharmaceutical and Medical Devices Videojet Technologies 34 ď‚ƒOctober 2016

To explain the components of a UDI, there is a simple formula that can be employed - DI + PI = UDI. DI stands for Device Identifier, which provides information as to who placed the UDI on a specific product (the labeler or manufacturer) and the model or specific version of the device itself. PI stands for Production Identifier, and is the section of the code that provides information such as; lot or batch number; expiration date; serial number and manufacturing date. Codes must be issued by agencies accredited by the regulator, for example

GS1, and once employed must be submitted to a c entral databas e c a lle d GUDID. The Federal Drug Administration (FDA) administers the Global Unique Device Identifier Database (GUDID). What are the benefits of UDI? The system has been designed in order to identify specific medical devices wherever they are throughout the global supply chain and providing the medical professionals employing the devices with accurate information. This will enhance patient safety due, for example, to reduce misidentification or confusion regarding a specific device's appropriate use, preventing confusion with any similar device which might lead to misuse of the device. It will also allow for far superior management of medical device recalls. Health care providers will no longer have to access multiple, inconsistent, and potentially incomplete sources in an attempt to identify a device. Access to this level of information will also allow for more rapid development of solutions to reported problems, allowing them more opportunity to identify potential issues and to make necessary adjustments, and more effective safety communications through the ability to precisely focus alerts. The ability to keep a track of medical devices throughout their time in the healthcare supply chain will also enable manufacturers to learn about their performance and quality in the long term. How do we define medical devices? Medical devices are separated into four classes, Class I, Class II, Class III and Implantable, life-supporting and lifesustaining devices. Each is based on the risks associated with the device in question, with Class III representing the highest risk category. Class I devices represent the lowest risk, for example, products such as dental floss and band aids fall under this Pharma Bio World


category. Class II devices are higher risk and, according to the FDA guidelines, 'require greater regulatory controls in order to provide reasonable assurance of the device's safety and effectiveness'. Blood pressure kits are a good example of a Class II device. The higher risk Class III category includes items such as knee prostheses and replacement heart valves (devices under this category usually require FDA approval before they are allowed to be marketed), and finally, implantable devices are items such as pacemakers. In addition to the label or packaging being clearly marked, it is important to note that medical devices that are intended to be used more than once, and which will be reprocessed before each use, require a UDI as a permanent marking on the device itself. This is because they will almost certainly be separated from their original packaging after first use. The table below illustrates the timelines required for compliance with UDI.

UDIs cannot exist without coding and marking technology When it comes to regulatory and traceability codes and high read-rate bar codes, contrast and legibility are not areas that are negotiable. It is imperative that manufacturers have the correct printing or marking technology in place in order to be compliant with UDI legislation. The correct method to employ will largely depend upon the substrate that is being marked. Thermal Inkjet Printers (TIJ), for example, have been popular for medical device packaging for many years. They are best deployed to print onto the lidding web before it is heat sealed, and are easily integrated with thermoforming or FFS (Form Fill Seal) packaging equipment. The printers perform extremely well on common substrates used for the packaging of medical devices, such as DupontTM 1059B and 1073B, TyvekÂŽ and medical grade paper, and are capable of operating at high speeds on production lines without fear of compromising on print resolution. TIJ solutions are commonly used to print 2D DataMatrix codes and are ideal for marking

on to folding cartons. In addition, new TIJ Flex Solvent inks from Videojet provide advantages on certain non-porous substrates that were previously difficult to mark. Glossy packaging, flexible films and foils can now be marked consistently with more durable codes. Continuous Inkjet is also a versatile solution, capable of printing up to five lines of text as well as 2D and linear bar codes across a wide range of packaging formats and materials, while Thermal Transfer Overprinters are perfect for coding onto flexible films and labels For those devices that require a permanent marking, laser technology is an obvious choice. The process is non-contact and produces high quality, permanent marks with very few consumables used throughout production. There are several options for laser marking in terms of laser source, from CO 2 and Fiber to UV and YAG. Systems available on the market are configured in different power outputs, allowing for use on a wide range of substrates and applications. Always plan effectively In order to prepare a production line for UDI coding purposes, it is advisable to plan carefully before making a final decision on which technology is best suited. Production line audits are invaluable, as is sample testing on the substrates that are being dealt with. Taking the time to get it right by working in partnership with a technology provider will help to optimize operations and achieve maximum uptime. The medical device industry, as we have seen, demands the highest quality when it comes to variable coding and, in order to remain compliant, companies must ensure legibility and contrast are second to none, alongside the ability to maintain accurate records for reporting purposes. Through working with Videojet, medical device manufacturers can rest assured that their products are coded accurately, efficiently and at a cost that allows a solid return on investment. Contact: itan@abipr.com

Pharma Bio World

October 2016 ď‚„ 35


Regulatory Crisis for Indian Pharma Industry: Who are the Real Culprits? Having emerged as an important player in the global pharmaceutical supply chain, Indian pharmaceutical industry now faces a serious credibility crisis due to concerns regarding manufacturing practices, pricing controls, lack of clarity and certainty in regulations governing the drug industry. This article attempts to analyze such impediments to industrial growth and ways to overcome these barriers.

T

he current impasse of regulations, malpractices in the healthcare market, is making the essential drugs costlier for masses. A corrective action is required to provide cheaper, if not free, universal healthcare to all Recently a news report highlighted that private hospitals are selling cheaper drugs at higher costs making it unaffordable for even those who can spend on their health cover. The pricing of drugs has been a contentious issue despite the fact that our pharmaceutical industry accounts for 8 per cent of global production, and is exporting to over 200 countries. 1 The Indian healthcare and pharmaceuticals industries are going through an interesting yet challenging phase. The very basis of these industries - availability of drugs and healthcare services, their affordability and their easy accessibility - have become key concerns for the industry, the masses and the government. The ever flourishing industry that has been leading among the India Inc. since the 2008 financial crisis has been witnessing a slow growth. It is predicted that exports growth in formulations declining sharply to 10-12 per cent annually over the next 5 years (towards the end of the decade), compared with approximately 19 per cent growth seen in the previous decade. 2 However, recent move by the government to place the pharmaceutical sector under the ambitious 'Make in India' initiative has the potential to provide the necessary impetus to the industry. It is estimated to be an ` 2,400 billion industry and is expected to grow at approximately 12 per cent compound annual growth rate (CAGR) over the next three years. 3

Swadeep Srivastava VP & Country Head Ebix ADAM India 36 ď‚ƒOctober 2016

The Indian pharmaceutical market is dominated by Branded generic drugs which contribute 70 per cent of market share in terms of revenue. The patented drug

market contributes 21 per cent whereas; over the counter (OTC) drug market contributes 9 per cent of total market. 4 Internal domestic demand for more potent and affordable drugs, greater penetration within the rural market, fast growing prominence of healthcare insurance in the country are some of the factors that are driving the growth of the industry. Additionally, the formation of the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers (MoCF) will create some focused action. Challenges within the market But the road ahead is not going to be a smooth sail. There are multiple challenges to this growth. Challenges such as growing concern on the quality drugs, pricing controls, lack of clarity and certainty in regulations governing the drug industry are proving to be some of the impediments to this growth. Additionally, complexities pertaining to the intellectual property rights (IPR) and stringent regulations over research and development of drugs have slowed the pace of innovation and invention in the country. On the foreign soil too, the Indian pharma companies have been facing hostilities from the external regulators such as the Food and Drug Association (FDA), USA. The import ban by the FDA on certain products manufactured by Indian companies have tarnished the image of Indian pharmaceutical industry. While the international market seems to be much more organised, country's regulatory framework woven around the Central Drugs Standard Control Organisation is fragmented and presents problems for quality and standards. The most deprived of all is the rural sector which forms a large section of the underprivileged population, where there is Pharma Bio World


While the entire government machinery proved to be slow in controlling the drug pricing, the private sector too has been irrational in continuously pricing the drugs.

Amidst challenges, it is imperative to bring down the prices of drugs.

Despite existing National list of essential medicines (NLEM) and the passage of Drug Price Control Order (DPCO) in 2013 could not contain the controversy around the addition of new set of notifications in 2014. The controversy led to a rise in prices of approximately 509 essential medicines used for treatment of ailments such as diabetes, hepatitis and cancer. While the entire government machinery proved to be slow in controlling the drug pricing, the private sector too has been irrational in continuously pricing the drugs.

Why we cannot lower drug prices?

A nexus in working

There is scope for India to become a production giant for generic drugs in the world. It is worth mentioning that India has emerged as a world leader in generic pharmaceuticals production, supplying 20 per cent of the total global market for generic medicines. 5

Companies have been increasing the prices of drugs in the name of cost incurred in securing patent rights and inflation, especially for NLEM medicines.

a requirement of proper drug supply and affordable healthcare. This section of our society is not well served in comparison to their urban counterparts. Additionally, for generic drugs, there is a bulk supply of medicines that is being done from countries such as China. Supply of generic drugs might be critical for a large population.

Research by consulting firm, McKinsey, shows that production costs for commodity generic drugs continue to be low in India - the country ranks lowest in conversion costs, 50 per cent lower than the US or UK and other developed countries. As per the research, while the average cost of tablet USD 82, India has the same at USD 10. 6 However, drug pricing remains a challenge. The answer lies in the manner the market functions and the inefficacy of the regulations. The two factors are hurdles for drug pricing. India's masses are disease prone due to poor hygiene, poor living conditions etc. The instance of catching diseases, generic and fatal, is higher than the world average. Thus India has adopted a drug pricing policy. The National Pharmaceutical Pricing Authority (NPPA) under the MoCF controls the pricing and availability of drugs. Pharma Bio World

While the above challenges remain, a nexus sort of is formed between the practicing doctors and the companies producing the medicine. The nexus thus impacts the availability and accessibility of medicines by keeping the prices of medicines higher. The nexus is the real reason for the drugs to be priced higher. The cost of freebies accepted by doctors, bribe and unaccounted cash (at times) are factored into the marketing budget of the companies. Therefore the overall, final cost of the drug is higher. The menace is probably the biggest hurdle for the distribution and availability of medicines. Stepping up the problem is the fact that, the Medical Council of India (MCI) has failed to enforce new rules governing prescribing ethical guidelines under the Indian Medical Council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations 2015.

These guidelines, which have provision and define punitive action against those doctors who take favors from companies for promoting a certain medicine on prescriptions, could never be enforced in totality! The guidelines also empower MCI to delete name of those working in the nexus from the national medical register for a period of one year or more, but civil society fears that these can never be brought in practice in a country like India due to the large numbers it covers and also due to vested interests always prevailing over. The evolving regulatory space and the way forward Caution and a long term vision to change the functioning of the market and the government machinery is the way forward. Thankfully our policy makers understand the underlying problem of the nexus and the challenges of the market. Government is addressing these challenges by opening the market for foreign investments. Government's decision to increase FDI to 74 per cent in existing pharma companies is expected to boost mergers and acquisitions and private equity investments in the sector. The Department of Pharmaceuticals (Ministry of C&F) has indeed taken a noble initiative to make 'ethics guidelines' for the industry. The statutory code of principles has the potential to curb the unethical practices by pharmaceuticals industry involving prescribing doctors, who might favor a particular company for certain drugs. Called as the Uniform Code of Pharmaceutical Marketing Practices, these were first formulated in January 2015. But the implementation of the codes remain a challenge. Since the formulation, the implementation have been deferred several times. The deferment was done on the basis that these codes required more teeth to check the malpractices. The codes needed stricter penal measures against the errant doctors. October 2016 ď‚„ 37


When fully enacted, it is likely that revised codes will have penal provisions, besides tougher conditions to be enforced on doctors. These will include clauses such as limiting the amount of free samples, a clear process of registrations of doctors for conferences and a cap on the number of conferences that doctors can attend. However, the codes should not become impediments in the way of the multinational manufacturing companies and investment firms that are looking to invest into the sector. On the pricing front, a number of successful models have to be adopted to control the drug prices in the country. Government has already implemented some successful models for providing cheaper drugs and affordable healthcare. States of Tamil Nadu and Kerala are some of the examples in this line.

But what is actually required is the universalisation of healthcare and its accessibility. India needs to follow some successful examples of healthcare universalisation. Countries such as Australia, Sweden, France, Germany, Netherlands and Canada offer free healthcare system. Brazil is the new entrant that is experimenting with healthcare universalisation. These models can be adopted with proper identification of beneficiaries in the first phase of implementation. In addition to this, the government needs to increase the expenditure on the public healthcare system. This will automatically increase the access for healthcare and pharmaceutical drugs. Additionally, the government needs to streamline the drug review process, bring down approval time and simplify clinical trial regulations to boost clinical research and innovations in the pharmaceutical sector.

Hopefully, with under the Make in India campaign, the manufacturing of cheaper drugs and medical devices will enable accessibility and affordability. eferences  osition aper  olicy landscape reforms for strengthening Indian harmaceutical Industry  released at the Indian harma ummit  

risil esearch, ay 

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 ostudget ectoral iew, nion udget 



International ournal of scientific research and management, published in une 

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II esearch  ealising ake in India  ourney to become the most preferred manufacturer of high uality affordable medicines, released in ecember 

Contact: Akanksha.gurarebix.com

INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES

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38 October 2016

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Terminal Sterilization: On the Safe Side The article discusses terminal product sterilization, a major packaging quality requirement for both liquid and solid pharmaceuticals

T

erminal sterilization protects filled pharmaceuticals from microbes and ensures they are safe to use. However, the sterilization process is subject to differing requirements depending on both medication and primary packaging, posing various challenges to pharmaceutical manufacturers. How high can a sterilizer's temperatures be without damaging the efficacy of temperaturesensitive drugs? What pressure conditions are needed to maintain the containers' stability? Sterilization tests help to determine each product's processing parameters, from supporting pressure to loading procedures, thereby ensuring pharmaceutical product safety. At first glance, a syringe reveals little about how complicated its production is. It actually involves a very complex process, from developing the solution, choosing and filling the packaging to designing the container. Even after filling, the process is not yet completed. For instance, depending on the active ingredients, many countries require terminal sterilization of pre-filled syringes to ensure the safety of both product and patient. Parenterally administered pharmaceuticals, such as heparin preparations in syringes and infusion solutions in bags or bottles, generally place high demands on the sterility of the packaging. All these products need to remain free of microbes to prevent infections after administration. Terminal sterilization of the packaged drugs eliminates microorganisms to the maximum extent in accordance with official regulations. The challenge of plastics

Isa Alkan Sales Director SBM Schoeller-Bleckmann Medizintechnik Ges.m.b.H. Bosch Packaging Technology Pharma Bio World

Especially for new products, pharmaceutical manufacturers increasingly rely on customized packaging solutions made of plastic. These are often developed in close cooperation with primary packaging manufacturers to fulfill very specific design and marketing requirements.

During terminal sterilization, however, plastic containers may burst, warp or lose strength, making them unusable. Potential negative impacts on the product's final validation entail long delays and additional costs for the manufacturer. As a result, pharmaceutical and packaging producers must create the ideal sterilization conditions for different types of medication and containers. Here, invaluable support is provided by suppliers of sterilization equipment with a wide range of productspecific processes and comprehensive sterilization tests. Terminal sterilization is precisely tailored to pharmaceutical requirements. Depending on the medication and the approved procedure, different cycle times, temperatures and sterilization media are needed to ensure the containers remain sterile and intact, and the filled ingredients maintain their integrity. This can be accomplished by various different sterilization methods. Among the industry's most common and preferred methods are the vacuum-steam process, the steam/air mixture process, and the hot water shower. Modern combined systems incorporate multiple processes within a single sterilizer, thereby offering much greater flexibility in terminal sterilization. The appropriate process for each product Solid and porous equipment, pre-filled ampoules and blister-packed products are sterilized using the vacuum-steam process. The air is completely evacuated from the pressure chamber and containers, ensuring saturated steam to penetrate even into the tiny cavities of porous items like plastic stoppers. The latter are subsequently heated and sterilized by inflowing pure steam. Depending on the type of load, the process finishes either with vacuum drying or jacket cooling. Open, semi-sealed and completely closed containers such as vials and pre-filled October 2016 ď‚„ 39


syringes, as well as mono- and multichamber bags are sterilized by the steam/ air mixture process. It allows products to be removed in a dry condition at the end of the cycle. The direct inflow of steam, which is circulated by fans inside the chamber, provides for heating and sterilization, while cooling is accomplished by internal heat exchangers. Supporting pressure can be adjusted as desired, thus preventing deformation, excessive stopper movement and container breakage throughout the entire cycle. The hot water shower is particularly suitable for liquids in closed containers, such as blow-fill-seal products and closed IV bags. Fast heating and cooling cycles reduce thermal stress on temperaturesensitive products to a minimum. Considering all process parameters Liquids and packaging are subject to highly variable thermal and mechanical stress. In case of too high pressure within the containers, walls may soften or bag seams burst. To prevent syringe and vial stoppers from shifting within the containers, a so-called supporting pressure is generated in the sterilizer. Thermally instable pharmaceuticals risk 40 ď‚ƒOctober 2016

to spoil when exposed to high pressures and temperatures, thus losing their effectiveness. Hence, precisely tailored sterilization parameters for liquids and containers are crucial. But how can the necessary formulations be determined? Pre-tests including essential process parameters like loading, temperature, pressure, heating and cooling speeds, as well as product storage are key. Depending on container quantity and complexity, test runs can take from a few hours to several days. They precisely map the sterilization processes required by different products - and in case of doubt, they identify whether a new product or primary packaging material can be sterilized at all. Pharmaceutical and packaging manufacturers not only receive extensive documentation and practical guidance. The tests also provide them with important indications to further optimize their products and sterilization processes. Negative results are just as useful The required sterilization procedure for approved drugs has normally already been defined. In this case, test results can deliver valuable insights regarding which variables have to be adjusted in order

to achieve even more efficient process and cycle times. The same applies to containers. Packaging manufacturers receive a detailed analysis of a container's characteristics and potential weaknesses, resulting in important clues on how the packaging might be optimized. In case of a projected production line expansion, an evaluation of the loads capacities ascertained by comprehensive testing helps to determine the suitable size of the installation. Pharmaceutical manufacturers can thus invest in expansion projects according to their exact requirements, while saving time and avoiding unnecessary costs. If correct procedure and parameters are still to be determined, test runs can be conducted as a kind of "stress test" to answer questions regarding sterilizability and packaging quality, as well as the most suitable procedure. Manufacturers save a great deal of time and effort during qualification and validation, and can accelerate the product's market launch. Even if the test results are negative, they will certainly not lead to the cancellation of production. Instead, packaging and pharmaceutical manufacturers can target their efforts more accurately and accelerate the further development of their respective products. Moreover, specialized testing centers are also available to manufacturers who either do not own the right equipment or whose machines are already working at maximum capacity. Outsourcing sterilization tests to experienced equipment manufacturers is an alternative that saves both time and money - while manufacturers and patients are always on the safe side. Contact: benoit.wolff@commha.de Pharma Bio World


whitepaper

Biosimilars: How can We Realize the USD 240 Billion Opportunity? Biosimilars opportunity is nascent today with an estimated market size of only USD 2.2 billion. However, the recent USFDA approvals and market penetration stories emerging from Europe herald in the next phase of growth in biosimilars. Based on analysis of the currently approved biologic drugs, clinical pipeline and expectations around price erosion and market penetration, ASSOCHAM and SATHGURU estimate that global market for Biosimilars will be USD 240 billion by 2030 in the optimistic scenario and the Indian domestic market could be about USD 40 billion.

B

iologics have now gained significant traction in pharmaceutical industry with more than USD 150 billion in global sales in 2013. 48 per cent of sales come from 11 biologics that face loss of exclusivity over the next few years. This along with the increasing worldwide focus on improving access and reducing cost of care, presents an attractive biosimilars opportunity. The biosimilars opportunity is nascent today and the 2016 estimated market size was only USD 2.2 billion. However, the recent USFDA approvals and market penetration stories emerging from Europe herald in the next phase of growth in biosimilars. Based on our analysis of the currently approved biologic drugs, clinical pipeline and expectations around price erosion and market penetration, we estimate that global market for biosimilars will be USD 240 billion by 2030 in the optimistic scenario and the Indian domestic market could be north of USD 35 billion.

market access considerations. The Indian market has benefited from proactive release of guidelines, a forthcoming regulator and a recent revision in guidelines to make it more aligned with global regulations. Market Access: While regulatory ambiguity is declining, there is still need for structural evolution across regions on critical market access elements such as interchangeability. As the frontrunner biosimilar market in the world, EMA continues to set the trend on market adoption as well. With level of price erosion breaching 60 per cent in certain European countries, the myth of 20 per cent price erosion in biosimilars is now shattered. However, despite the steep price erosion, Europe sets an optimistic benchmark for market penetration with share of biosimilar being greater than 50 per cent of in several countries. Overall, we anticipate that next five years will provide a clear picture of market access considerations across developed markets and will pave the wave for greater industry investments.

Critical Elements for Success Technology: Technology has historically been one of the largest hurdles for entry into biosimilars. Over the last decade, several companies across the world have developed platform expertise across microbial and mammalian platforms. While technology continues to be an important cog in the wheel, access to technology is becoming less of a challenge with a vibrant development landscape and significant collaboration possibilities.

Dr Pushpa Vijayaraghavan Director Sathguru Management Consultants Pharma Bio World

Regulatory: Regulatory landscape for biosimilars has been evolving with the global pioneer EMA setting the trend. While USFDA has been slower to warm up to biosimilars, recent approvals in 2016 are symbolic of the world's largest market now being more receptive to biosimilars. The RoW landscape is a mix of countries with varying levels of regulatory maturity and

RoW markets offer lower regulatory barriers and are relatively easier to access. Given the low penetration of biologics in RoW markets due the high prices, biosimilars offer the promise of affordable alternatives that can expand access to vital drugs in these markets. However, this promise translating to accelerated market expansion in these countries will be critical to establish financial sustainability of RoW focused biosimilar investments. We would like to highlight that current levels of market expansion in several RoW markets is far from encouraging. Hence we believe that commercial strategies and policy efforts to expand markets will be the primary driver of RoW market success in biosimilars. Path to Success Leveraging the current vibrant landscape in India: Several large Indian companies October 2016 ď‚„ 41


whitepaper have invested in biosimilars and have developed in-house product development capability. They are largely focused on India and RoW markets as initial targets but intend to aim for the developed markets in the future. Indian biosimilar segment has today built a foundation on which global success can be steered with appropriate commercial strategies and policy environment required to succeed in this capital intensive and time sensitive opportunity.

INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES

The collaboration imperative: We believe collaborations will be fundamental to Indian industry's success in biosimilars, particularly to address following three challenges: 1. Accelerating time to market: While Indian industry has now developed high level of technical capability, given the time sensitivity in biosimilars, asset level collaborations for technology access could accelerate time to market and global competitiveness. 2. Breaking into developed markets through risk sharing: USA and Europe today represent bulk of the biosimilar opportunity. Given average investment of more than USD 150 million per asset, to build a portfolio of around 5 assets a company has to shoulder binary risk of USD 600 million to USD 1 billion. Risk sharing co-investment collaborations, both with MNCs as well as with other Indian companies can help break this barrier to entry. 3. Expanding RoW markets to build commercial sustainability: While RoW markets are easier to access, financial sustainability will be elusive until markets expand to their true potential. Collaborations amongst Indian companies as well as with RoW companies will be critical to pool resources to expand markets and render RoW attractive on its own. Policy Measures

PBW Spotlights  Indian Pharma and Biotech Industry Globalisation  Latest Developments in Pharma Innovation

and Technologies  Future Trends of the Industry

At the current threshold, following impetus from the Government could enable Indian industry to achieve global success in biosimilars in the next decade. A large quantum of binary risk in the capital intensive product development pathway continues to be a deterrent for industry. Non-dilutive funding mechanisms that offer sizeable funding could help make risk palatable, create initial pipeline of regulated market launches and seed sustainable engagement in the segment. Such nondilutive funding mechanisms should be extended to technology acquisition as well. While India benefits from timely adoption of regulatory guidelines, there is need to address concerns around time consuming processes and delays that render biosimilar companies and CMOs non-competitive in the global landscape. Lastly, globally comparable fiscal incentives will be important in light of efforts from several other countries to attract global investments in biological manufacturing infrastructure. 42 October 2016

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Pharma Bio World


market research

Lacklustre Quarter; Better Times Ahead As per the report published by Centrum Broking Limited, the pharma sector to report lacklustre results for Q2FY17 due to regulatory issues from US FDA , the recent ban on 344 Fixed Dose Combinations (FDCs) and price controls imposed by the government in the domestic market.

T

he domestic pharma market is expected to grow ~12 per cent in FY17, driven by good demand for drugs in the lifestyle segment, new products and line extension launches. The domestic pharma market has grown on an average of 10.8 per cent during the five months period April-August'16. The price-controlled products under NLEM have witnessed 2.9 per cent reduction in price April'16 onwards due to 2.9 per cent decline in WPI during FY16. This is unlikely to have a major impact as it would partly be offset by the increase in volumes. Despite the price reduction, the market has reported double digit growth.

As per AIOCD AWCS MAT August'16 data, the domestic pharma market was placed at ` 1,025.4 billion and grew at 10.5 per cent. The domestic market crossed the ` 1,000 billion mark in June'16 and has grown over ` 1,000 billion for the last three months. Over the next three years, the domestic pharma market is likely to grow at 12-14 per cent due to the sharp growth in lifestyle segments namely CVS, CNS, anti-diabetic and gastrointestinal. Table 1 indicates month-wise and MAT (TTM) market size and growth rates. Coverage companies expected to grow by 9 per cent YoY For Q2FY17, we expect lacklustre perforamce for the pharma companies under our coverage. The thirteen pharma companies under our coverage are expected to grow by 9 per cent YoY in revenues, 2 per cent YoY in EBIDTA and (-)2 per cent YoY in net profit. The domestic market was impacted by NPPA issues and ban on Fixed Dose Combinations (FDCs) during the quarter. Pharma Bio World

MAT(TTM) ended

Month

TTM

Sales Rs bn

Gr. Rate%

Sales Rs bn

Gr. Rate%

April'16

84.5

3.6

988.7

11.5

May'16

84.5

7.7

994.8

11.1

June'16

84.6

6.4

1,000.2

10.6

July'16

91.3

9.5

1,009.0

10.3

August'16

96.4

15.3

1,025.4

10.5

Average

88.3

8.5

1,003.6

10.8

Source: AIOCD AWACS MAT data Table 1: Domestic pharma market performance

The lower global growth is attributed to currency fluctuations in emerging markets, regulatory issues, Brexit problem, severe competition, consolidation of retail chains, slowdown in approvals by US FDA and higher base effect. We expect EBIDTA margin to decline by 130bps YoY to 22.2 per cent from 23.5 per cent due to slower growth on both domestic and export fronts. Despite price cuts by NPPA, the domestic pharma market is expected to report good growth of ~12 per cent in FY17. On the global front, ~ 35 per cent ANDA approvals by US FDA are in favour of Indian pharma companies. We expect faster ANDA approvals by the US FDA in H2FY17,which would help the companies garner good growth in the US generic market. Pharma companies under our coverage constitute ~32 per cent of the domestic pharma market. The AIOCD AWACS MAT data for July and August'16 indicates that Sanofi India (SIL) and FDC has grown faster than the market in July'16 whereas Sun Pharma (SPIL) and Dr. Reddy's Labs (DRL) have grown faster than the market

in August'16. Overall, the companies under our coverage had lower than the market growth during July-August'16. Table 2 presents sales and growth rates for July-August'16 for companies under our coverage. Margin expected to decline by 130bps We expect the 13 pharma companies under our universe to report 130bps decline in margin to from 22.2 per cent from 23.5 per cent due to: • Effect of price control by NPPA in the domestic market with 2.9 per cent reduction in prices of NLEM products from April'16 • Ban imposed on 341 Fixed Dose Combinations (FDCs) in the domestic market • Remedial measure expenses for the companies under US FDA scanner • Higher R&D spend by the companies in order to remain competitive • Sharp fluctuations in currencies in the emerging market • Lower purchasing power in emerging October 2016 43


market research Company (in Rs mn)

July'16

August'16

Sales

Gr. Rate%

Sales Gr.

Rate%

Gr. Rate%

Pharma industry

91,255

9.5

96,428

15.3

Sun Pharma

8,027

7.8

8,375

20.3

Abbott Group

5,553

4.1

5,937

12.6

Cipla

4,218

8.9

4,351

8.6

Lupin

2,906

7.8

3,059

9.3

Pfizer

2,550

3.0

2,620

6.8

Sanofi India

2,441

20.6

2,343

13.4

Dr. Reddy's Labs

2,032

4.8

2,241

17.3

FDC

885

10.1

879

9.6

Merck

549

3.3

547

3.6

Biocon

286

1.2

307

11.4

Total

29,447

7.4

30,659

11.3

Source: AIOCD AWACS MAT data

products in the US is likely to drive growth. Alembic, Ajanta Pharma, Aurobindo, Cipla, Div is Labs , Dr. Reddy ' s Lab s , Glenmark Pharma, Ipca Labs, Granules India, Lupin, Natco Pharma, Strides Arcolab, SPIL and Zydus Cadila are the pharma companies likely to benefit from the US generic market. However, some major pharma companies such as DRL, SPIL, Wockhardt, Ipca Labs, Lupin and Zydus Cadila are facing regulatory issues with the US FDA. Marksans Pharma (MPL) is facing regulatory issues with UK MHRA. The performance of these companies are likely to be impacted till their facilities are re-inspected and cleared by the regulatory authorities. In the emerging markets, Indian pharma companies have suffered due to currency fluctuations and lower purchasing power.

Courtesy: Centrum Broking Limited

Table 2: Pharma companies under coverage

markets • Brexit issue with depreciation of pound in UK market • Pricing pressure in the US generic market • Consolidation of retailers in the US market • Regulatory issues with US FDA and other authorities imposing ban on imports from several manufacturing facilities in India • Effect of higher base and absence of 180-days exclusivity in the US

in EBIDTA margin by 130bps.

Net profit likely to decline by 2 per cent YoY

Indian generic manufacturers cater to ~40 per cent of the US generic demand by volume and are likely to benefit from this strong growth in the US market. Indian pharma companies account for over 35 per cent ANDA approvals by US FDA. The constant introduction of generic

For the pharma companies under our coverage, we expect 2 per cent YoY decline in net profit in Q2FY17due to slower sales growth and expected decline

Top picks Aurobindo Pharma (APL), Sanofi India (SIL) and Granules India (GIL) are our top picks in the pharma companies. We expect these companies to report superior performance due to sales growth and margin improvement. Global pharma market - Challenging times ahead

Over the next three years, the domestic pharma market is likely to grow at 12-14 per cent due to the sharp growth in lifestyle segments namely CVS, CNS, anti-diabetic and gastrointestinal. 44 October 2016

Pharma Bio World


marketing initiative

Improved dosing applications using Coriolis instruments with CORI-FILL™ technology How to overcome the disadvantages of using weighing scales? How to shorten production time whilst improving the quality of the final product? The integration of (mini) CORI-FLOW™ instruments in your production line offers unprecedented improvement to process efficiency.

C

ORI-FILL TM technology features from one fluid to another, whereas an integrated batch counter instruments with CORI-FILLTM technology function together with the facility just require a short reset command to start to directly control shut-off valves, the next batch. The amount to be dosed proportional valves or (gear) pumps. Due can be easily preset by programming the to this technology, Bronkhorst Cori-Tech batch counter via a field bus connection. can offer compact assemblies of (mini) This batching method is faster and more CORI-FLOW TM instruments combined compact than the gravimetric method, and with a valve or pump, capable of dosing highly accurate. the exact desired amount of fluid. As a result of their small footprint it In contrast to the gravimetric method is possible to mount the (mini) CORI(weighing scales), multiple fluids can be FLOW TM instruments directly to the dosed simultaneously. Furthermore the shut-off valves, thereby minimizing scales need to be re-zeroed when switching the internal volume, resulting in a

fast response time and the highest accuracy (minimum delay-effects in the piping). Benefits • • •

• • • • • •

Reduced production time due to simultaneous dosing of compounds. Improved product quality due to less evaporation of volatile fluids. Compact solution due to small footprint, without extended tubing between flow meter and valve or pump. Reduced risk of gas inclusion that can cause delay effects. High accuracy due to Coriolis technique and compact assembly. Automatic overrun correction. Fast response times (to less than 0.5 sec.). Mass and volume dosage possible (using density information). Less overhead for PLC/operating system thanks to CORI-FILL™ technology using integrated batch counter and direct actuator control.

Markets

Pharma, chemical, food & beverage Applications

Dosage of additives, fragrances, flavors, colorants, H2O2 (for sterilization) in continuous or batch blending processes Coriolis Control Enables Cost Saving Vapor

In the research and testing of automobile catalysts the chemical dodecane, a liquid alkane hydrocarbon, is used in the simulation of diesel engine exhaust. Pharma Bio World

October 2016  45


marketing initiative all being wasted due to the coarse control methodology of the injection. The Bronkhorst solution was to establish that the researchers wanted to have do decane injected in a vapor state and therefore should be added via a highly accurate low flow Coriolis Flow Meter directly coupled to a Controlled Evaporator Mixing (CEM) system. This solution ensured that precisely the desired mass of dodecane was injected into the test reactor and that it was added in a complete vapor state. The CEM system allows for the accurate control of a liquid such that a specific mass of that liquid is vaporized. Because the CEM system can provide such accurate control the researchers were able to maintain a stable dodecane level at each stage of testing which lead to repeatable results and an efficient use of both materials and manpower thereby reducing overall project cost. For details Contact

Toshniwal Hyvac Pvt Ltd 267,kilpauk Garden Road Chennai - 600010 Ph no : + 91 44 26445626 /8983 Email : sales@toshniwal.net Website : www.toshniwal.net

Customers within this research field were unaware that the amount of dodecane could be precisely and accurately controlled and that it could be injected in the vaporous state that they preferred. During visits to a number of these research facilities several similarities 46 ď‚ƒOctober 2016

were apparent: the customer had created a " hand crafted " solution to injecting dodecane which made it challenging to maintain stable control of the amount of dodecane injected which lead to difficulty in getting to repeatable results. Time, effort, material samples, and dodecane were Pharma Bio World


marketing initiative

Schülke celebrates 25 years of Microshield® success in India

                                                                    

                                                                                                                                  Pharma Bio World

Press release, Schülke, sept 16.indd 47

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                                                                                                                                                                                                                                                                        October 2016  47

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marketing initiative                   *Air Liquide Healthcare                                                                            ¤                                       

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48 October 2016

Press release, Schülke, sept 16.indd 48

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21-10-2016 10:16:09


press release Eywa Pharma Announces USD 30 Million Investment

                                                                                                                                                     

          

                                                                                                                     

OPPI Reelects its Office Bearers                                                                                                

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

MedGenome Acquires High Throughput Illumina Hiseq X Ten Platform

Pharma Bio World

Press Release.indd 49

October 2016  49

21-10-2016 10:20:54


press release Merck Launches Regional Hub in Côte d’Ivoire

                         

                                                                                   

                    

                                                                         

FDNA, CENTOGENE Announce First Grant of Molecular Testing for Face2Gene

                                                 

Tata Trusts & GE Healthcare Partner

                                                                                            

                                                                                                                        50 October 2016

Press Release.indd 50

Pharma Bio World

21-10-2016 10:21:18


press release Pharmexcil Felicitates Founder and Co-Founder of Ajanta Pharma

                                                                                                                                                                                                          

Pharmexcil Organizes Pharma CEOs Conclave 2016

                                                                                                    

SGRF Organizes Sixth Edition of India’s Largest Genomics Conference

                                  Pharma Bio World

Press Release.indd 51

                                                                                                                October 2016  51

21-10-2016 10:21:18


press release Dr. Reddy’s LaunchesLamotrigine Orally Disintegrating Tablets in the US

                

                                                                                                                                                  

Domino Printech India Interacts with the Top Pharma Firms in Gangtok

Sun Pharma to Announce LateBreaking Results for Tildrakizumab

                                                                                              

                                                                                                                                                                                               52 October 2016

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Thermal Mass Flow Meter The Sage 200 thermal mass flow meter is cost-effective. The flow meter measures gas mass flow and has high accuracy, repeatability, low-end sensitivity, response time, turndown, etc. The meter has two compartments (compact housing) with separate wiring section containing large, easy to access terminals to simplify field installation. The power dissipation is under 2.5-watt, which is the lowest in the industry. It finds application in natural gas flow to burners, compressed air flow measurement and combustion air.

CORIOLIS Mass Flow Meter/Controller CORI-FLOW instrument (Digital Mass Flow Meter/Controller) can be used to control direct proportional valves, shut-off valves or pumps by using the integrated PIDcontroller. In CORI-FLOW technology, highly accurate filling applications are possible by using the integrated batch-counter. The maximum flow speed of the standard instrument is 600 kg/hr. This enables filling of 166.66 gram in 1 second or 10 kg/min. Features direct mass flow measurement, independent of fluid properties, integrated PID controller for control value or pump, fast response time, high accuracy, excellent repeatability, compact IP65 housing, optical: ATEX approval Cat 3, Zone 2, etc.

For more information, please contact:

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

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

 Hanna Instruments offers HI83300 family of multi-parameter photometers which saves valuable laboratory benchtop space, and doubles as a professional pH meter with its digital pH/temperature electrode input. Now one meter can be used for both photometric and pH measurements. It features nine models to cover a wide variety of applications. These meters are compact and versatile making them ideal for both lab or field operations. From aluminum to zinc, these photometer is essential for important water and waste water analysis using 60 different methods. This photometer features an innovative optical system that uses LEDs, narrow band interference filters, focusing lens and both a silicon photodetector for absorbance measurement and a reference detector to maintain a consistent light source ensures accurate and repeatable photometric readings every time. The meter is one of the most advanced photometers available with a innovative optical design that utilizes a reference detector and focusing lens to eliminate errors from changes in the light source and from imperfections in the glass cuvette. Two USB ports are provided for transferring data to a flash drive or computer and to use as a power source for the meter. For added convenience and portability the meter can also operate on an internal 3.7 V DC Lithium-polymer rechargeable battery. For more information, please contact: Hanna Equipments (India) Pvt Ltd Office No: 3/4/5/6, 1 st Floor, Aum Sai Bldg Plot No: 23 C, Sector 7, Kharghar, Navi Mumbai 410 210 Tel: 022-27746554, 27746555, 27746556 | Fax: 91-022-27746557 E-mail: marketing@hanna-india.com / jatin.thanekar@hanna-india.com

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 Bosch Packaging Technology offers Human Machine Interface HMI 4.0 suited for both stand-alone machines and entire lines. It provides an interface for data collection, data sharing and visualization. HMI consists in its guided workflows, which lead operators through each step of production processes. The same applies to format changes, cleaning and maintenance as well as other processes. The display resembles that of mobile devices like smartphones or tablets. Thanks to an intuitive, touch-sensitive surface, data can be entered with gestures (multi-touch), including zooming in and out with two fingers as well as navigation by swiping. Thanks to a clearly arranged, tile-structured menu, operators will benefit from a quick overview of all functions and processes of their machines. Tailored to specific user roles, such as operator or line manager, the HMI 4.0 only displays the processes relevant to the current user. The HMI 4.0 provides comprehensive, integrated support as well as more transparent processes and notifications. In case of production downtime, operators immediately receive a notification including information about the causes and troubleshooting support to quickly restart their machines. Direct links to user manuals and format changeover lists assist users in their day-to-day tasks. Furthermore, a new comment section enables users to add their own notes and share them with others. System and line competence implies shifting the focus from a single machine to the entire production line by offering complete solutions. For more information, please contact: Bosch Packaging Technology Communication Harmonists GmbH & Co KG Poststraße 48, D-69115 Heidelberg, Germany Tel: +49 6221 18779-27 | Fax: +49 6221 18779-11 E-mail: bosch@commha.de

 With high torque carrying capabilities reaching up to 6.14 mNm, the 17DCT provides outstanding performance with efficiency reaching up to 85 per cent while providing a long lifetime. Due to the inherent design of the 17DCT motor, it can deliver higher torque per ampere resulting in better battery life. This makes it ideal for demanding applications such as medical and industrial pumps, drug delivery systems, miniature industrial power tools and more. Other applications, including lab automation and humanoid robots, can benefit from the features of the 17DCT Athlonix motor. Athlonix 17DCT miniature DC motors are available in 2 variations, precious metal commutation and graphite commutation with a neodymium magnet inside. The unique constant force spring design for carbon brush provides consistent performance. An REE (restriction of electro erosion) coil is an available option, which prolongs the life of the motor and provides an environment of intrinsic safety especially at high speed conditions. Athlonix motors are available with encoders and gearheads of various sizes and ratios. They are manufactured in an ISO certified facility and are RoHS compliant. For more information, please contact: Portescap Unit No: 2, SDF-1, SEEPZ-SEZ Andheri (E), Mumbai 400 096 Tel: 022-42006200 | Fax: 91-022-42004036 E-mail: sales.asia@portescap.com

54  October 2016

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Weighing System for Pharma & Non-Pharma Foreview Engg and Technology Pvt Ltd, Navi Mumbai, offers weighing system for pharma and non-pharma products. A checkweigher is an automatic machine for checking the weight of packaged commodities. It is normally found at the off-going end of a production process and is used to ensure that the weight of a pack of the commodity is within specified limits. Any pack that are outside the tolerance are taken out of line automatically. A checkweigher incorporates a series of conveyor belts. Checkweighers are known also as belt weighers, inmotion scales, conveyor scales, dynamic scales and in-line scales. In filler applications, they are known as check scales. Typically, there are three belts or chain beds: an infeed belt that may change the speed of the package and to bring it up or down to a speed required for weighing. A weigh belt is typically mounted on a weight transducer, which can typically be a strain-gauge load cells or a servo-balance (also known as a force-balance) or sometimes known as a split-beam. Some older machines may pause the weigh bed belt before taking the weight measurement. For more information, please contact: Foreview Engg and Technology Pvt Ltd PAP-R-251, TTC MIDC Nr Golden Garage, Rabale Navi Mumbai 400 701 E-mail: marketing@foreviewengg.com / foreviewengg@gmail.com

Resources on Heat Transfer, Scale-up and Mixing Mettler Toledo offers new web-based resources focused on heat transfer and scaleup and mass transfer to control the reaction rate. Addressing common challenges for chemists and engineers working in process development in the pharma and fine chemical industries, the new online resources provide useful information to scale-up new products faster with decreased costs and high quality. A precise heat transfer coefficient is required to successfully scale-up a chemical process from lab to plant. Measuring the reactor and jacket temperature enables scientists to calculate the thermal resistance. Thermal resistance is utilized to model the heat transfer and determine the necessary predictions for reactors at large scale. Reaction calorimetry is required to define parameters that influence heat transfer and the heat transfer coefficients to develop models to maximize manufacturing productivity. Mixing is the removal or decrease of inhomogeneity between phases that are either miscible or immiscible. Process scale-up and optimization necessitates quantifying the impact of mixing on the reaction rate. Precise experiments can be run automatically in a lab reactor system to investigate the mass transfer correlation, and deliver the opportunity to quickly adjust the gas/liquid mass transfer and reaction rate. This accomplishes the required conditions for process scale-up or scale-down. For more information, please contact: Mettler Toledo India Pvt Ltd Process Analytics Solutions Amar Hill Saki Vihar Road Powai, Mumbai 400 072

Pharma Bio World

Product trends.indd 55

October 2016 ď‚„ 55

21-10-2016 10:26:02


events diary    

                                                                    

                                             

56 October 2016

Events.indd 56

                                                                     

                                                                 

Pharma Bio World

21-10-2016 10:27:47


bookshelf Good Laboratory Practice: The Why and The How (Hardcover) Author: Jürg P Seiler Price: USD 95.00 No of pages: 424 pages After more than twenty years of use Good Laboratory Practice, or GLP, has attained a secure place in the world of testing chemicals and other “test items” with regard to their safety for humans and the environment. Gone are the days when the GLP regulations were hotly debated amongst scientists in academia and industry and were accused of stifling flexibility in, imaginative approaches to, and science-based conduct of, all kinds of studies concerned with toxic effects and other parameters important for the evaluation and assessment of products submitted for registration and permission to market. The GLP regulations have developed from rules on how to exactly document the planning, conduct and reporting of toxicity studies to a quality system for the management of a multitude of study types, from the simple determination of a physical/chemical parameter to the most complex field studies or ecotoxicology studies.

Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance (Hardcover) Author: Syed Imtiaz Haider Price: USD 181.00 No of pages: 208 pages The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and related product applications are rejected by the FDA. In fact, only about 2 per cent of the applications submitted by foreign pharmaceutical companies are approved each year. This thorough guide provides the needed solutions and guidance for both foreign and U.S. companies to achieve FDA compliance and authorization to market their products in the United States.

Validation of Cell-Based Assays in the GLP Setting: A Practical Guide (Hardcover) Authors: Uma Prabhakar, Marian Kelley (Editors) Price: USD 192.95 No of pages: 312 pages The use of cell-based assays within pharmaceutical and biotechnology companies is driven in large part by the need to evaluate the plethora of drug targets derived from genomics and proteomics. In addition, the potential of biomarkers to facilitate the development of effective and safe drugs is being recognized as an integral part of all phases of drug development, and cell-based technologies are a critical part of biomarker discovery and development. Despite this critical role, cell-based assays have not been standardized and made compliant with Good Laboratory Practice guidelines. In this book, the editors have collected assays for which validation procedures have been developed, making this a vital purchase for anyone using such assays in drug development. Validation of Cell-based Assays in the GLP Setting provides the professional with an invaluable reference source, featuring key guidelines. The book will prove extremely useful to all scientists working in the areas of drug development. Pharma Bio World

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ad index                 

                

58  October 2016

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                

Pharma Bio World

21-10-2016 10:43:38


R.N.I. No.: MAHENG/2002/08502. Date of Publication: 26th of every month. Postal Registration No: MH/MR/SOUTH-284/2014-16 Posted at Patrika Channel Sorting Office, Mumbai 400001, on 26th & 27th of every month. Total Pages:- 60

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Pharma October 2016  

Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that...