November 2016 Vol 15 | Issue 04 | Mumbai | Price ` 150 Total Pages 64 PHARMA BIO WORLD
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4 November 2016
Pharma Bio World
INTERVIEWS 08
“Indian pharmaceutical packaging industry is undeniably in the midst of a technological reawakening” - K e t a n P r e m a n i , M a n a g i n g D i r e c t o r, C l a r i a n t M e d i c a l Specialties India Pvt Ltd
16
“We are trying to stay away from the me too business strategy”
8
- Dr Piyush Gupta, Associate Director, GNH India
24
HRS - ‘One Stop Shop’ for Heat Transfer Equipment - V Gokuldas, Managing Director, HRS Process Systems Limited
FEATURES 32
Drug Metabolizing Enzymes - Ketan Zota
36
Recent and Anticipated Regulatory Changes Impacting the Pharmaceutical Sector
16
- Sameer Sah, Pavi Jain
40
Avoid Package Coding Errors and Minimize their Impact on Your Pharmaceutical Business - Heidi Vanheerswynghels
44
Immunity Against Challenges of Conducting Vaccine Trials - Dr Preety Shah, Dr Pawan Singh
NEWS UPDATE
36
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Press Release
54
Biotech News CORPORATE AFFAIRS
56
Products
60
Events BACKYARD
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Next Issue Focus: Bioinformatics
6 November 2016
Pharma Bio World
interview
Ke tan Premani
“Indian pharmaceutical packaging industry is undeniably in the midst of a technological reawakening” “The growth of Indian pharmaceuticals packaging industry is directly linked to growth of pharmaceutical manufacturing industry,” says Ketan Premani, Managing Director, Clariant Medical Specialties India Pvt Ltd. In an interview with Mahesh Ka l l ay i l , h e f u r t h e r d i s c u s s e s I n d i a n pharma packaging industry, challenges and oppertunities, future plans and many more. Excerpts from the interview.
What is the standing of Indian Pharma Packaging Industry in international market? The primary and secondary packaging of pharmaceutical products is closely linked to their production and constitutes an integral part of the value-added process. It is vital for any pharma product that it remains in its original form and maintains it quality until it reaches the hands of end users. The pharmaceutical packaging market is constantly evolving in India and is expected to be worth USD 2.60 billion by 2020. The Indian pharmaceuticals market is expected to grow at a CAGR of 18 per cent by 2020 driven by the aging and growing population, rising income levels, emerging medical conditions and new diseases. This will directly augment the need for pharmaceuticals packaging India which is projected to grow at a CAGR of 5.46 per cent till 2020. The Indian pharmaceutical industry is the largest supplier of cost effective generic medicines to the developed world. With an extensive range of medicines available for exports clubbed with the largest number of approved pharmaceutical manufacturing facilities, India is poised to take the lead in pharmaceutical exports to the world. The growth of Indian pharmaceuticals
8 November 2016
packaging industry is directly linked to growth of pharmaceutical manufacturing industry. To support this bourgeoning demand, Clariant has also invested in a Greenfield manufacturing site in Cuddalore, Tamil Nadu for the production of desiccant - an important component in pharmaceutical packaging to maintain the integrity of active components and extend shelf life. What are some of the opportunities that are still under-utilized in this field? Pharmaceutical Packaging has undergone rapid evolution and manufacturers must embrace technological advances to improve productivity, compete against rivals, and maintain an edge with customers. The Indian pharmaceutical packaging industry is undeniably in the midst of a technological reawakening that is transforming the look, systems, and production process as a whole. One must embrace the technological developments made in this field and grow simultaneously. Due to the risks associated with mass implementation of new technology, there are still tons of opportunities in this field that are under-utilized: DNA Taggants: Highly specific DNA "lock and key" reagent systems can be applied to packaging by a
Pharma Bio World
interview variety of printing methods. They require a "mirror image" recombinant strand to effect the pairing, and this reaction is detectable by a dedicated device. Security is further assured by hiding the marker and reagent pair in a matrix of random DNA strands, but the test is tuned to work only with one recombinant pair. Biotech Injectable: Biotech injectable drugs primarily target persons with lifethreatening or chronic diseases, and are costly. They require specific temperature controls and special handling requirements. It may be therefore necessary to develop diverse packaging solutions for one product to satisfy various patient group needs which gives rise to a constant requirement for differentiated pharma packaging. What in your opinion are the challenges in regulation that need to be addressed? Pharmaceutical packaging industry has been undergoing radical changes in the past decade to keep itself updated with newer innovative technologies and to provide economical packaging solutions. However, the packaging industry w i l l h a v e t o o v e rco m e ch a lle n g e s b y lengthening drug development cycles and an increasingly complex regulatory environment - especially if those expansion plans involve crossing borders, in order to meet increasing demand from the growing pharma industry. Packaging plays a key role in maintaining the quality of pharmaceuticals throughout its shelf lives. As oxygen and moisture permeate the packaging over time, the quality of solid oral dosage medications degrades. Fortunately, sorbents such as desiccants and oxygen absorbers represent a class of active packaging components that can be used to guard against the effects of degradation. These ensure the integrity of packaged pharmaceuticals. That being said, determining the ideal packaging requirements can be challenging, and if a strategic approach isn't adopted to 10 ď‚ƒNovember 2016
drug packaging and testing, there can be serious delays in bringing a product to market. Furthermore, to comply with the ever evolving parameters set by the FDA, pharma manufacturers need to partner with experienced pharma packaging companies that offer in-depth expertise, sound knowhow and share the best, compliance-centric packaging solutions. What are the initiatives that you are undertaking currently to sustain the frontier position you have in the Indian market? With India being the largest provider of generic drugs globally, drug protection has been Clariant Healthcare Packaging's core business for many years, equipped with expertise to design, produce and market the full system of protection. We have over the years introduced a spectrum of solutions to cater to a variety of needs with active components and systems such as controlled atmosphere packaging solutions including pharmaceutical desiccants, equilibrium sorbents, adsorbent polymers, oxygen scavengers and pharmaceutical closures and containers. Driven by innovation, we offer a full range of protective packaging based on active agents, high-barrier copolymers and market-based functionality. For instance, one of Clariant's major recent innovations in this segment is: EQ-CAN TM , which is a functional desiccant used in bottledpackaged drugs. While most desiccants adsorb moisture in the package to bring i t t o a l m o s t n o t h i n g , E Q - C A N TM c a n maintain the moisture levels within a desired range. We have recently even invested CHF 10 million (approx. ` 70 crore) in a new healthcare packaging manufacturing plant in Cuddalore in Tamil Nadu which is the first ever greenfield Clariant plant in India. It is solely focused towards making moisture control products to support the growing pharmaceutical packaging market in India.
Can you explain more about Clariant's new healthcare packaging manufacturing plant in Cuddalore? How it's going to meet the requirements of India's domestic pharmaceutical packaging market? India's domestic pharmaceutical market is witnessing a double digit growth. Pharmaceutical packaging is becoming the major part of the drug delivery system. Companies are relying more on packaging and labelling as a medium to protect and promote their products. Clariant ensures that we serve our customers here as directly and efficiently as possible. Catering to that, in January 2016, Clariant paved way onto another milestone with a ground breaking ceremony of a new manufacturing plant in Cuddalore, for moisture-control products, intended for the pharma industry. The plant will effectively increase accessibility, decrease lead time and improve warehousing efficiencies for our customers. The focus is also on expanding the global manufacturing network which includes plants in the USA, Australia, France and China. This manufacturing facility in Cuddalore in India ensures quick delivery and competitive pricing, as well backup capacity to meet the BCP (Business Continuity Planning) requirements of many pharmaceutical customers. As a part of Clariant Healthcare Packaging business continuity plan, we will be investing in a Clean Room Class 100,000 and ISO 8 certified state-of-the-art manufacturing plant in India through which the customers will have the ability to procure Clariant's global standard products, directly produced in India. It primarily manufactures our market leading products specializing in moisture control for drugs in pharmaceutical packaging applications. We are committed to help our customers achieve product and service excellence Pharma Bio World
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interview and this facility has enabled us to expand current capacities and provide easy access to potential as well as existing customers in the pharma packaging segment. Please apprise us on Clariant's existing portfolio of packaging solutions. Clariant Healthcare Packaging designs and manufactures controlled atmosphere packaging that helps to protect healthcare products from humidity and oxygen. Its broad portfolio includes industry-leading desiccant canisters and packets, which are the most widely used canisters in the pharmaceutical industry, primarily due to their ability to be inserted at high rates of speed on high velocity packaging lines. In addition, Clariant Healthcare Packaging offers a wide range of desiccant packets in strip and single form. Unlike other desiccant packets that are marketed to be used on specific insertion machines, C o n t i n u - s t r i p TM p a c k e t s f r o m C l a r i a n t are versatile and can be used with any packet insertion equipment on the market with minimal modifications. Clariant's desiccant canisters and other products meet the safety standards of food and drug administrations in the US, EU and other major regions, thus helping customers achieve compliance in competitive markets. Clariant has introduced a new and improved family of Aroma-Can TM canisters to enhance nutritional products by adding a pleasant scent to product packaging. Modeled after Clariant's desiccant canisters for pharmaceutical and nutraceutical packaging, Aroma-Can TM canisters employ aroma technology that can give consumers a positive sensory experience when they open product packaging. The technology embeds food-grade flavors, such as vanilla, orange and lemon, directly into a plastic canister, which can be inserted easily into a container. We also have the new EQ-Stopper TM which is ideal for protecting moisture-sensitive products packaged in tubes, while the EQ12 ď‚ƒNovember 2016
Globally the healthcare industry has seen a shift in paradigm and is now skewed toward effective and meaningful packaging. Bag TM. Available in 37g and 255g sizes, it protects bulk packages containing empty capsules, powders, or other moisturesensitive product ingredients. Along with existing EQ-Pak TM and EQ-Can TM products, these new introductions actively control relative humidity (RH) in a pharmaceutical or nutraceutical package space to within a specific range. Clariant Healthcare Packaging has been present in India for over a decade, and extends to its range of active pharmaceutical packaging with all the major generic companies on its customer list. Apart from offering its core drug protection products, Clariant Healthcare Packaging offers expert consultation for various global compliances like USFDA, thus following a customer-centric approach to provide customers with innovative and technologically advanced solutions. The new Healthcare Packaging plant in Cuddalore, together with its existing plant in Changshu, China and the recent acquisition of healthcare packaging specialist VitaPac, located in Dongguan, southeast China, positions Clariant to play a major role in the expanding healthcare sector across Asia. How do you evolve the research and development to keep a pace with the changing dynamics of the Indian pharmaceutical market?
our research and development is focused on addressing the key trends of our time. Please share the charter of the Vision 2020 of Clariant Healthcare Packaging in India and the role of the Indian market for the growth of your organisation? The Indian pharmaceutical industry is the larges t s upplier of c o s t effe c tiv e generic medicines to the developed world accounting for 20 per cent of global exports in terms of volume, which leads to the packaging industry being one of the booming areas in the Indian economy. Globally the healthcare industry has seen a shift in paradigm and is now skewed toward effective and meaningful packaging. To cater to the burgeoning demand and to maintain market leadership, Clariant's aims to provide best solutions in pharmaceutical packaging with an enhanced focus on innovation and customizable solutions. With ten production sites in Gujarat, Maharashtra, Madhya Pradesh and Tamil Nadu and a state-of-the-art Regional Innovation Center in India, Clariant's new greenfield plant in Cuddalore will further reinforce its commitment to Make in India and Sell in India. The plant will also support to intensify growth and increase the market share in the emerging Indian region by rapidly addressing to customer needs.
The research ecosystem in India presents a significant opportunity for the Indian pharmaceutical corporations to develop products to cater to the local and overseas markets. Clariant contributes to value creation with innovative and sustainable solutions for customers from many industries. Our portfolio is designed to meet very specific needs with as much precision as possible. At the same time, Pharma Bio World
interview
“We are trying to stay away from the me too business strategy”
D r Piyush Gu p ta
“In GNH India, we are helping the local manufacturers to develop true generics of latest drugs by providing comparators hence supporting clinical research process,” says Dr Piyush Gupta, Associate Director, GNH India. Excerpts from an interview he had with Mahesh Kallayil.
Could you please tell us about GNH's offering to pharmaceutical industry? In trade terms, GNH is into specialty wholesale. We are wholesaler specialised in distribution of orphan drugs, rare drugs, life-saving drugs, etc. The government statutory term for our domain is merchant exporters. While 80 per cent of our business consists of exports, 20 per cent focus is on import and domestic supply within India. With close to two decades of experience, GNH India has evolved from traditional logistics to fully integrated supply chain solutions. We are one among few Indian companies who has WHO-GDP certification. We are the only Indian wholesaler who has registered with several ministries of health in International markets. We ship to over 180 countries and carry over 1,35,000 product lines. Rather than setting up a capital heavy set up of manufacturing plant, we have tied up with several reputed manufacturers. This enables us to supply a wide range of medicines. We are focused as a one stop shop for pharma. Our clients call us the supermarket for medicines as they have been able to find all their requirements at one place.
16 November 2016
In GNH India, we are helping the local manufacturers to develop true generics of latest drugs by providing comparators hence supporting clinical research process. During clinical trials, comparators are needed to assess development process at every step of progress. Comparative medicine are very costly and rare, so finding a right comparative medicine is like finding a needle in haystack. We are helping the Indian companies to get the right comparators at competitive price. GNH India is one of the few companies to supply a pedigrees dossier at the time of comparator supply. Each and every fact pertaining to the drug needs to be documented in a dossier. From where it was purchased, the purchase invoice, transport traceability, temperature, where was it stored, the custom duty receipt… everything needs to be documented and given as a dossier along with the comparator. What are the most demanding areas of clinical trial operations nowadays? The first most demanding area is getting patients. India being the second largest nation in terms of Pharma Bio World
interview population, yet we are shortage of patients. This is because the rules and regulations are convoluted.
is pretty complicated and is not easy, due to which lot of clinical trials are getting delayed in India.
The second largest problem is the availability of comparators. We do not have original comparators available here, easily. To bring one comparator it takes us two months. There is so much paper work involved.
How do you plan to leverage on Make in India campaign?
How significant is the role of logistics and SCM in the pharma industry? Logistic is one of the most important factor for pharmaceutical industry. Pharma cold chain is complicated. All the biologics which are living cells are temperature sensitive. We have to be very careful while exporting these biologics. The carton which we use for exporting biologics itself costs around ` 12,000 and comes from Singapore. We are using validated cartons in our warehouses for transport of biologic product. There is so much emphasize on logistics today. The government wants data loggers in every shipment. When we are sending medicine abroad, the ministry will ask for data logger, where temperature in transits can be recorded. That is how important logistics is becoming. Most of the pharma company focuses exclusively on pharmaceuticals and ignore logistics. In India, logistic is outsourced. Our company is one of the few to have in-house specialty logistic expertise in India. How supportive is the regulatory landscape for research and clinical trial in India? Regulation is a learning experience from the mistakes of past. In the past, regulations were flexible. Lot of things went wrong. The industry misused the leniency. Lot of foreign companies came, did illegal trials without the knowledge of patients. Because of these, now the regulations are tilted in the favor of patients. So, I can’t say that regulations are not supportive. There are lots of checks and balances, it 20 November 2016
Pharma industry can be flurished in a country which has a petrochemical industry. Most of the chemical entities are derived from petrochemicals. Second, you need qualified people. In India, we have both the raw material and the people. We have the history; we have the companies which have taken us globally. India has become a pharmacy to the world at least in generics. The world expect us to fulfil their pharma requirement. The world has started to expect India be the supplier to generic. Now, the same thing if we could leverage to biosimilar, India will become pharmacy hub to the world. In generic manufacturing, we have hit the ceiling. Our next frontier should be biosimilars and biobetters. If you check the product list of main Indian pharma companies, you will barely see any difference. Price has become selling point in Indian market. India’s export value has come down while volume has gone up. Sadly in India, we have something called 'herd mentality'. We replicate products which are doing well in market. We don't want to add some value to it. What is the point in copying someone's innovation and selling it in low price? When you add a value to it, you are adding pride in it and making the product even better. But sadly we don’t have any company in public domain which is working on biobetters. The cheap generics no longer sell. Human tendency is not to go for the cheap. On contrary, humans look for value. The selling point, the USP, cheap is not working anymore. It worked for the last 10-20 years because there was a gap in the market. Today, even the companies from Pakistan (Getz Pharma), Bangladesh, Jordan (Hikma) are manufacturing generics.
India's monopoly in generic market has come to an end. Now, future lies in 'betters'. The generic has to become better by adopting new drug delivery technologies. In your opinion, what are the Strengths, Weaknesses, Opportunities & Threats for the Indian Pharma companies? Our manufacturing bases are our strength. With regard to weakness, everyone is trying to sell the same product at same price. We have now reached the end of the road in this strategy. Almost every biosimilar developed in India is being challenged in courts by the innovators. The reason is we are trying to use the same formula of generics to biosimilar. Since 1970's, we are in the mind frame of generics. Generics are the photocopy of original chemical entity. This cannot be applied in biosimilar. Also, now even the innovators are ready to sell their drugs in half price. Opportunity - The world is our market. Our manufacturing facilities are registered worldwide. This gives us access to every country. Threat is ourselves. We need to work on innovation. In clinical trial, strength is easy availability of large volumes of drugs/comparators. Weakness is the lack of awareness, that the medicines available in India can also be used as comparators. By 2020, 100 billion worth of drug is going off patent. If we do not recognise that biosimilar and generic are two different things, we will lose this opportunity. The word here is 'similar' which we are not getting right. In generic it can be 100 per cent replica, in biosimilar it could be 98 per cent. The stress here is 'similar' in result, not 'similar' in molecular structure. From supplier point of view, we are already working on it. We are trying to spread awareness through interaction with the press, white papers and interaction with the government. Pharma Bio World
interview The general thinking among Indian manufacturers is 'reactive'. If they get a letter from USFDA, then only they will try to address the issue. If we really want to grow as a globally competent model, we need to be 'proactive'. We need to correct our fault before a regulator points out. When a regulator catches, it is called a 'Show cause notice', when we correct it ourselves, it is called as an 'amendment'. We need to bring 'proactive' approach in quality. How do you intend to steer the growth of GNH India in the years to come? Please detail about your future plans in terms of strategic alliances, capacity expansion, products launches, investment, etc. We are trying to stay away from the 'me too' business strategy. Our growth strategy is divided into several verticles: A) Domestic Supply chain solution: WHO GDP certified domestic supply chain
The general thinking among Indian pharma manufacturers is reactive. We need to bring proactive approach in quality. solution - today's pharma logistics is outsourced to regular logistics companies with no knowledge about recalls, ADRs, or pharmacy vigilance. We plan to offer an end to end solution to manufacturer from the factory gate to the retail shop, all under WHO GDP compliant process. This has over USD 2 billion market in India itself. B) Domestic Comparator supplies: Any development process consumes comparators worth USD 18 - 20 Million. Domestic comparator market is estimated to be over 500 Million USD annually. We are working to create awareness that there are Indian companies too which can supply comparators or references drugs at cost effective prices.
C) Domestic Orphan Drug supplies: This is a neglected therapy area in India and estimated to about USD 200 Million annually. We are one of the early starters in this area and plan to build a lead and continue maintaining it. D) International Markets - Global Speciality Wholesale: Global Pharma market is estimated to be around 340 Billion of which 80 Billion is Wholesale Trade. Again, we are among the first few or the only professionally run, organised global wholesaler operating from India, supplying medicines to over 180 countries globally. We target to capture a minimum of 10 per cent of this global pie in next five years.
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interview
V Gokuldas
HRS - ‘One Stop Shop’ for Heat Transfer Equipment HRS Process Systems Limited is a part of HRS Group, which operates at the forefront of thermal processing technology. HRS offers innovative and cost effective heat transfer solutions for an extensive range of processing applications across a diver se spectrum of industries like chemical, petrochemical, pharmaceutical and various other process Industries. V Gokuldas, Managing Director, HRS Process Systems Limited in an interview w i t h P h a r m a B i o Wo r l d t a l k s a b o u t the company’s key milestones, growth strategies, market trends and challenges. What is your organization involved in? How long have you been in this industry? HRS Process Systems Limited was incorporated in April 2003 and is part of HRS Group with headquarters in London, UK. We are a company with expertise in thermal processing technology with a focus on tubular, plate type and scraped surface heat exchangers. We provide innovative 'corrugated tube' heat exchangers under brand ECOFLUX* to the process industry. We have supplied over 15,000 units for various industries and applications. Our product range consists of Ecoflux* corrugated tube heat exchanger, Unicus® scraped surface heat exchanger, shell and tube heat exchanger and plate type heat exchanger. We not only supply heat exchangers like condensers, coolers, reboilers, chillers, evaporators, sterilizers, pasteurizers, recuperators, etc. but also built systems around heat exchanger with temperature and process controls. Could you please brief us on HRS Process Systems Limited's vision and mission? At HRS, we always believe in providing sustainable technology solutions to our customers. Our vision is to be one of the top thermal engineering companies globally with innovative heat transfer products. We believe in keeping our customers informed on the latest technology in heat transfer and how we can help 24 November 2016
them in enhancing energy efficiency and effective in their process. Our mission is to provide effective heat transfer solutions to our customers with a proper match of technology, product and application engineering. Which sectors do you cater to? HRS is a 'one stop shop' for various heat transfer equipments. Our range of heat exchangers and systems are used in key sectors like chemical, petrochemical, fertilizer, steel, cement, agrochem, edible oil, power, textile, pharmaceutical and various other process sectors including food, fruit, beverage, juice, dairy, etc. Our hygienic design heat exchanger is incorporated into systems and used as preheater, pasteurizer, sterilizer, chiller, cooler, recuperator, UHT, evaporator and such applications in the pulp processing, beverages processing, nutraceutical, probiotics and other processed food applications. What are the key thrust areas for HRS? At HRS, we believe that our technology and solutions should reach each and every customer who desires an energy efficient heat transfer process. We not only target the growing sectors like pharma, chemical, food and similar sectors, but also look at industrial segments where new technology has not been adopted. Food processing sector has very different requirements Pharma Bio World
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interview
of hygiene in design since the products processed is for human consumption. We have a special focus in this sector to help our customers upgrade from batch to continuous process and also reduce dependency on imported processing machinery. Please apprise us your complete products portfolio/services provided by you and the market opportunities of these products/services in Indian pharma and biopharma market? Pharma and Biopharma market has been experiencing a decent growth. HRS has been able to provide 'value for money' solution in this sector for various heat transfer solutions. The pharma sector has multiple products being handled at the same facility. Our heat transfer expertise, coupled with good engineering knowledge help us to offer our customers heat transfer solution which can work for a range of products. Thereby customer today has greater flexibility in plant operation which enhances productivity, product quality and also entails energy saving. We have also been able to offer Ecoflux* in stainless steel and exotic material like titanium, hastelloy, duplex and similar due to which they have been able to cost efficiently upgrade their 28 ď‚ƒNovember 2016
plant heat exchangers from glass/graphite to metal heat exchangers. We have also introduced various heat exchangers based systems for heating and cooling of process equipment in this sector, which is well received by our customers. We have combined our heat transfer knowledge, engineering skills, and food processing expertise to work on the emerging nutraceuticals and probiotic food process segments to supply processing units. This is an interesting combination pharma-food processing which is now been replicated by many other companies. Where in India HRS Process Systems Limited stands on innovation space? HRS Group has a global R & D facility in Murcia, Spain where we study and develop new product & application for existing and new products, based on customer / process re q uirement. Thes e tec hnologies are available to us immediately on development and thus we are able to offer Indian market the latest technology with indigenization and service back-up. We have recently developed tubular heat exchanger based systems for nutraceuticals and probiotic food supplements.
What are the initiatives that you are undertaking currently to sustain the frontier position you have in the Indian market? Are there any marketing initiatives being planned? Our primary focus is to be connected with customers at all times, inform them about recent developments in our products, services and application engineering. We participate in exhibition and seminars to reach out and thus enabling our innovative technology to reach various corners of our market. We plan to conduct a focused seminar for Indian Pharma and Biopharma companies which will help enhance technology in these sectors. How do you evolve the research and development to keep a pace with the changing dynamics of the Indian market? Our research and development program is a combination of requirements at domestic and international level. We work with multinational companies in product and application development, which helps developed technology which can be used globally. Heat transfer technology is pretty stable over the years. However, application engineering and selecting the right type Pharma Bio World
interview of heat exchanger is the key to enable efficient energy utilisation. HRS provides expertise in these areas and thus we are able to sustain and grow in the market. Our customers also come up with problems they face and processing improvements that they envisage, which we evaluate together and then decide on way forward. R&D effort is thus a combination of market requirements and product improvements over a period of time. What are the key successful factors of your company? Our customers have been the biggest success factor for our company. From day one, we have worked with the motto Once a Customer, Customer for Life''. This has been our guiding principle and I am proud to
say our business has grown from strength to strength because of our customers who have been loyal to us throughout the years. HRS is a well known and respected brand in heat transfer segment today. As a company, we have always ensured that our product performs to the satisfaction of the customers and beyond. We have always been open and fair in our dealing with our customer which has been very well accepted. What are the new challenges for HRS Process Systems Limited? Growing market and changing consumer taste and demands is continuous challenge for our customers and us. All segments of the economy do not grow at the same pace. Hence it is essential for organizations to understand these and take necessary steps
to align the business strategy to achieve their goals. Growing sectors have their own challenge of sustainability which we have been catering to. Sectors with low growth have an opportunity for innovation and value addition. All these factors bring in their own challenges and we work to achieve our goals. What are your future plans? HRS as a global group has plans to further expand in different parts of the globe / markets. In India, we plan to further penetrate various sectors with our innovative products and services. In pharma and biopharma sectors, we plan to further strengthen our present product range, at the same time, introduce new product and application for new product processing in the sector. We plan to be ` 1 billion company in the very near future.
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Pharmaceutical bioinformatics is a new discipline in the area of the genomics revolution. It is central to biomedicine with application in areas like pharmacy, medicine, biology and medicinal chemistry. The genomics revolution has given high throughput methods for massive gene sequencing, chemical synthesis and biological testing. This creates oceans of new information. Pharmaceutical bioinformatics is all about how to use all the new information effectively. In the forthcoming issue, themed on Bioinformatics, we intend to cover news and views of industry honchos that address trends and issues pertaining to pharmaceutical bioinformatics.
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Advt New.indd 39
6/22/2011 7:32:04 PM
Drug Metabolizing Enzymes Drug-metabolizing enzymes are called mixed-function oxidase or monooxygenase and containing many enzymes including cytochrome P450, cytochrome b5, and NADPHcytochrome P450 reductase and other components. Drugmetabolizing enzyme's role in the activation and detoxification of xenobiotics and carcinogens has been discussed in this article.
D
rug metabolism term can be simplified as metabolic breakdown of drug within the body of living organism, usually done by enzymatic systems in the body. The metabolism of pharmaceutical drugs is an important aspect of pharmacology as the rate of metabolism determines the duration and intensity of a drug's pharmacologic action.
P450s and Flavin Monooxygennase. The conjugative drug metabolizing enzymes usually converts xenobiotics or drugs to soluble form that are more readily excreted. The conjugative enzyme families include the UDP-glycosyltransferases (UGTs), glutathione transferases (GSTs), sulfotransferases (SULTs), and N-acetyltransferases (NATs).
The term drug metabolizing enzymes (DMEs) are a diverse group of enzymatic proteins that are responsible for metabolizing of xenobiotic compounds including drugs, environmental pollutants and endogenous compounds such as steroids and prostaglandins. To name a few the cytochrome P450 (P450 or CYP450) and flavin monooxygenase (FMO) families are known to metabolize more than 50 structurally diverse compounds. Past trend of research suggest that structure-activity relationship for Drug metabolizing Enzymes are important area of research in pharmacology, toxicology, and basic enzymology.
The breakdown of strange or foreign metabolic elements is one of the most essential processes that our body works on and needs the most. There are different phases comprising of different metabolizing enzymes. The combination of all the three phases further increases the detoxification of unwanted elements in our body.
Drug metabolism is divided into three phases. In phase I, enzymes such as cyt oc hrome P450 ox idas es introduc e reactive or polar groups into xenobiotics. These modified compounds are then conjugated to polar compounds in phase II reactions. These reactions are catalysed by transferase enzymes such as glutathione S-transferases. Finally, in phase III, the conjugated xenobiotics may be further processed, before being recognised by efflux transporters and pumped out of cells. Drug metabolism often converts lipophilic compounds into hydrophilic products that are more readily excreted.
Ketan Zota Director Zota Healthcare 32 ď‚ƒNovember 2016
The drug metabolizing enzymes are divided into two groups. Oxidative drug metabolizing enzymes, where oxygen atom is introduce into substrate molecule resulting in hydroxylation or demethylation. Cytochrome
Oxidative Drug Metabolizing Enzymes Cytochrome P450 CYP450: Cytochrome P450 CYP450 enzymes in the liver catalyze the initial step in the biotransformation of xenobiotic compounds, including most drugs. These enzymes are members of a large family of mixed function oxidases that catalyze the introduction of an oxygen atom into substrate molecules, often resulting in hydroxylated or dealkylated metabolites. More than fifty CYP450 isozymes are known to exist in humans and they have been further classified based on amino acid sequence similarities. The bulk of drug metabolisms is carried out by a few members of the CYP1, 2, and 3 families and occurs primarily in the liver, which contains the highest concentration of CYP450 in the body. However, the importance of extrahepatic metabolism in tissues such as the intestine and lung is also recognized. Oxidation of organic molecules by P450s is quite complex reaction, but the overall reaction can be represented simply as Reaction 1: RH + O 2 + NADPH + H + ďƒ ROH + H 2O + NADP + Pharma Bio World
There are different phases comprising of different metabolizing enzymes. The combination of all the three phases further increases the detoxification of unwanted elements in our body. An electron from NADPH is transferred via the flavin domain of NADPH-P450 reductase to the heme domain of the CYP450 where the activation of molecular oxygen occurs. Substrates react with one of the oxygen atoms and the other is reduced to water. Flavin Monooxygenases (FMOs): Flavin monooxygenases, like the CYP450 enzymes, a re a s s o c i a t e d w it h t h e e n d o p la sm ic reticulum and catalyze the oxidation of organic compounds using molecular oxygen and NADPH as the source of electrons for the reduction of one of the oxygen atoms (Reaction 1). However, they are mechanistically distinct from the CYP450s in that they react with oxygen and NADPH in the absence of substrate to form a 4α-hydroperoxy flavin enzyme intermediate. Thus, the FMOs exist in an activated form in the cell, and their interaction with a nucleophilic group such as an amine, thiol, or phosphate, is all that is required for completion of the catalytic cycle. The capacity to remain stable while poised in an activated state is a possible explanation for the extremely broad substrate specificity of the FMO isozymes. It has been proposed that essentially all of the energy required for catalysis is captured in the oxygen-activated intermediate, and that alignment or distortion of the substrate molecules is not required. It follows that the active site of FMOs is much less sterically defined than for other enzymes. FMO3 is the most abundant form in human liver and is believed to be the dominant member of this enzyme family in terms of overall drug metabolism.
glucuronidation of xenobiotics at hydroxyl, carboxyl, amino, imino, and sulfyhydryl groups using UDP-glucuronic acid as a donor molecule (Reaction 2). In general, this generates products that are more hydrophilic and thus more readily excreted in bile or urine. Reaction 2: UDP-glucuronic acid + R UDP + R-glucuronide Although glucuronidation generally is classified as Phase II metabolism the phase occurring after CYP450 dependent oxidative metabolism many compounds do not require prior oxidation because they already possess functional groups that can be glucuronidated. Glutathione transferases (GSTs): Glutathione transferases catalyze the formation of thioether conjugates between glutathione (GSH) and reactive xenobiotics by direct addition (Reaction 3) or displacement of an electron-withdrawing group (Reaction 4).
N-acetyl Transferases: N-acetyltransferases (NATs) catalyze the biotransformation of aromatic amines or hydrazines to the respective amides and hydrazides (Reaction 6) using acetyl coenzyme A as a donor. They also will catalyze the O-acetylation of N-hydroxyaromatic amines to acetoxy esters (Reaction 7). Reaction 6: R-NH 2 + CoA-S-COCH 3 R-NCOCH 3 + CoA-SH Reaction 7: R-NHOH + CoA-S-COCH 3 R-NHOCOCH 3 + CoA-SH There are two known NAT isoforms in humans called NAT1 and NAT2. The two isoforms have different, but overlapping substrate specificities, with no single substrate appearing to be exclusively acetylated by one isoform or the other. Contact: infoariapr@gmail.com
Reaction 3: GSH + R GS-R Reaction 4: GSH + R-X GS-R + HX The major biological function of GSTs is believed to provide defense against electrophilic chemical species. Sulfotransferases (SULTs): Sulfotransferase enzymes catalyze the conjugation of sulfate groups onto a variety of xenobiotic and endogenous substrates that possess acceptor moieties such as hydroxyl and amine groups (Reaction 5).
Conjugative Drug Metabolizing Enzymes
Reaction 5: R-XH + PAPS R-SO 4 + phosphoadenosine + H +
U D P g l y c o s y l tr a ns fe r a s e s (U G Ts ): UDP glycosyl transferases catalyze the
The cofactor 3'-phosphoadenosine 5'-phosphosulfate (PAPS) is required for
34 November 2016
sulfonation by these enzymes. Although sulfonation generally causes molecules to lose their biological activity, but there are a few instances where the addition of sulfate can lead to formation of highly reactive metabolic intermediates.
Pharma Bio World
Recent and Anticipated Regulatory Changes Impacting the Pharmaceutical Sector India, especially in pharma sector, provides efficient bottom line management, and therefore, its products are very competitive in terms of pricing. No wonder that India is one of the largest pharmaceutical exporters in the world. To add to this, India has a huge demand in the sector and which is only set to increase in the future. The government vision of pharma 2020 has reflected the government's inclination to further develop the industry. Several policy measures have been introduced by the government. This article covers some of these items.
Sameer Sah Associate Partner Khaitan & Co
T
he pharma sector has seen an inflow of USD 13.8billion of foreign investment between April 2000 and March 2016; and for reasons cited above, has been a frontrunner for global companies and investors to deploy their capital in. However, 2015-16 was a lacklustre year for FDI in the sector (around USD 754 million) compared to 2013-14 (USD 1.28 billion) and 2014-15 (USD 1.5 billion). While the thrust has generally been towards fostering greenfield projects, the Government has acknowledged that the brownfield sector also requires development. Therefore, the government has in 2016 allowed 74 per cent FDI under the automatic route in brownfield projects in the pharmaceutical sector while the government approval route will continue beyond 74 per cent. Under the previous FDI policy, any FDI in brownfield projects required prior Government approval. This move will benefit private equity players and other minority investors by enabling faster deployment of capital at the time of investment and also allow for quicker exits. This will also incentivise promoter joint venture deals and will be constructive for strategic joint venture investments to be consummated with Indian pharma partners. For a foreign investor unbeknownst to the market, sometimes having an Indian partner is a benefit. Hence, even for such investors the deal timing will be reduced significantly. Medical Devices - The Road Ahead
Pavi Jain Associate Khaitan & Co 36 ď‚ƒNovember 2016
The Indian market is one of Asia's largest medical devices markets. The medical device market in India is conquered by imports amounting to an overwhelming majority of its current sales. Currently there is no specific regulation in India to specify safety and quality of all medical devices. Certain limited medical devices are regulated as Drugs under the Drugs
Act and the Drugs Rules, others mostly unregulated. The regulated and notified devices are required to be registered with the Central Drugs Standard Control Organization (CDSCO). The nonregistered medical devices require no prior registration, are unregulated and can be imported into India with a mere compliance with the applicable custom rules unless there are other specific rules (such as for X-ray machines, etc.). The clinical trial sector for medical devices is trial specific. Again, there exists no regulatory framework specific for conducting clinical trials in medical devices. To make clinical trials in medical devices more lucrative and enhance the number of trials, the Drugs Controller General of India has exempted medical devices from Phase I clinical trial. Further, the government is gradually but steadily opening gates to promote the medical device business in India. 100 per cent foreign direct investment under the automatic route has been allowed in the medical devices sector in India for the last couple of years. A bill is pending in Parliament which will amend the Drugs Act to make specific provisions relating to medical devices, including, quality control, etc. With this, most medical devices will be covered by certain regulations. As and when this bill is passed, this should create some certainty and uniformity in regulation. It is noteworthy that there have been calls to provide for specific price control regulation for medical devices stents were included within the scope of price control earlier this year. As and when this bill is passed, the calls for price regulation are bound to gain more strength. Biosimilars The CDSCO has released draft Guidelines on Similar Biologics, 2016 to amend and streamline the existing Guidelines Pharma Bio World
on Similar Biologics: Regulatory Requirements for Marketing Authorization in India ("Biosimilar Guidelines") in India. These are meant to replace the existing guidelines. This move aims at simplifying the marketing process for vaccines and biosimilars in India. Biologics are medicinal products composed or derived from living entities such as tissues and cells. The draft guidelines include a wide ambit of products such as vaccines, blood and blood components, gene therapy, tissues and recombinant therapeutic proteins. The draft amendment guidelines propose various changes to the existing guidelines and are meant to streamline the authorisation process. Roche's recent litigation against Mylan is a result of ambiguity over interpretation of the earlier guidelines. While the draft guidelines may not completed address the issues raised in the Roche litigation, they are bound to bring more certainty for companies seeking to explore the biosimilars' route. Online Pharmacies With the increasing penetration of internet and mobile connectivity, and the growing acceptance of e-commerce in India, the concept of e-pharmacies has also seen a rapid growth. However, unfortunately, there is no express regulatory regime in India with respect to the online sale of drugs (both over-the-counter and prescription drugs). The provisions of the Drugs and Cosmetics Act, 1940 ("Drugs Act") and the Drugs and Cosmetics Rules, 1945 (the "Rules") are silent on specific compliances applicable to the business of online pharmacies. There have been quite a few controversies around similar business models, and the Government had constituted an expert committee in 2015 to assess what changes are to be made to the relevant laws.
Price Control and New NLEM There has been an ever increasing impetus to enhance the footprint of price control in pharmaceutical products. The Government has taken various measures for this from time to time. One such significant measure was the adoption of a revised National List of Essential Medicines in 2015 to replace the existing 2011 list. The new list was adopted as the basis of the price control net by way of notifications in March 2016. Gradually, price ceiling notifications are being released for the additional products now covered under the pricing net. Fixed Dosage Combinations For a few years now, the Government has had a concern around the approval of fixed dosage combinations for marketing without seeking approval as a new drug based on submission of clinical research data. Under the Rules, FDCs should be treated as "new drugs" for which marketing approval should
The panacea of survival for the pharmaceutical market in any country is the robustness, certainty and predictability of the regulatory framework. 38 ď‚ƒNovember 2016
be required from the CDSCO and the DCGI, as opposed to the State Licensing Authorities issuing such manufacturing and marketing licenses. The Government authorities have been seeking product stability data for quite a few years now, and eventually, from March onwards, the Government has banned FDCs which they have considered to be a public safety hazard. A fair amount of litigation is ongoing challenging such notifications, and future similar government measures are also expected. Conclusion The panacea of survival for the pharmaceutical market in any country is the robustness, certainty and predictability of the regulatory framework. The domestic pharmaceutical industry is flourishing and continues to with its incremental growth, as India ranks amongst the top 10 research and development hubs in the world. However, given the societal and public responsibilities associated with the sector, there is bound to be a continuous mismatch between public aspirations and entrepreneurial ambitions. With time, one hopes that the Indian regulatory scenario will also proceed towards certainty and predictability. Contact: rsengupta@perfectrelations.com Pharma Bio World
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Avoid Package Coding Errors and Minimize their Impact on Your Pharmaceutical Business As per a survey, 50 to 70 per cent of coding errors are caused by operator error, with the most common mistakes consisting of incorrect data entry and incorrect job selection. However, even where the problem is recognized, many companies respond by simply introducing more checks during operations. Code Assurance is a new approach to preventing or eliminating errors in the coding and marking process. It involves redesigning a structural flow of coding processes to minimize operator interactions and reduce the risk of errors, even to the point where automatic distribution of correct codes to the correct printers for the correct jobs, becomes the norm.
C
orrect product coding is vital for pharmaceutical manufacturers in order for them to provide customers with important information about the goods they purchase, whilst at the same time, improving supply chain efficiency and visibility. In today's world getting codes right isn't just important - it's crucial. We take a look at fundamental considerations pharmaceutical manufacturers need to undertake in order to avoid packaging errors that impact their business' bottom line. Prevent errors rather than calculate the damage Perhaps to a greater degree than other industries, pharmaceutical and medical device packaging demands the highest quality variable coding. Legibility and contrast are non-negotiable when it comes to regulatory and traceability codes and high read-rate bar codes. What's more, coding solutions must also facilitate line productivity and seamless
40 ď‚ƒNovember 2016
Mistake-proofing coding processes Pharmaceutical manufacturers need proactive solutions to address all these issues - from unaccounted costs, to ineffective countermeasures, to partner mandates - it is vital to respond to coding problems before they happen, so that rectification costs can be saved. There are two ways to deal with coding problems at the source, that is to say, the production line. First, is to avoid the issue to begin with. This can be achieved by selecting the appropriate printing solution for your c oding needs whic h c an c o mp le me n t your type of packaging and throughput
Perhaps to a greater degree than other industries, pharmaceutical and medical device packaging demands the highest quality variable coding. i n t e g r a t i o n o f c o d e s t o k e e p u p wi t h today's global and competitive business environment.
Heidi Vanheerswynghels Strategic Account Manager EMEA Pharmaceutical Market Videojet Technologies
in the manufacturer's self-interest to understand the scope and cost of coding mistakes and take countermeasures to virtually eliminate them. Not only does this increase plant efficiency, it also helps ensure strict compliance with legislative and retail partner coding standards are adhered to and implemented.
A recent survey conducted by Videojet found that 50 to 70 per cent of coding errors are caused by operator error, with the most common mistakes consisting of incorrect data entry and incorrect job selection. However, even where the problem is recognized, many companies respond by simply introducing more checks during the packaging operation, something that does not address the root cause of the issue - why the wrong codes are being entered in the first place. It's
speeds. Then secondly, if there is an issue to capture it as quickly as possible, in order to minimize waste and unnecessary downtime, and correct the error, getting back to production as soon as possible. It's important to remember it's not a case of one or the other, it's an integrated two-pronged approach; even if you're effectively preventing coding errors, you still need the ability to quickly respond if something goes wrong - in order to limit the damage. But clearly, resources invested in prevention will prove much more cost-effective, compared to the expense of remediation. Pharma Bio World
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In recent decades, pharmaceutical manufacturers have increasingly t u rn e d f ro m q ua lit y a ssu ra n ce b a se d on statistical sampling of products bound for market, to a more proactive philosophy of prevention. Often referred to as "poka-yoke," this approach focuses on up-front process design. Lean manufacturing processes are created with fail-safe features that allow operators to immediately detect a mistake and correct it - or, preferably, prevent mistakes from occurring at all, regardless of the operator's actions.
Code Assurance: Approach to Coding Quality Code Assurance is Videojet's comprehensive approach to preventing or eliminating errors in the coding and marking process. We believe that humanmachine interfaces - including both hardware and software components - can and should be designed to simplify data entry and help prevent operator errors, both at code entry and job selection. We firmly believe the structural flow of coding processes can be redesigned to
Videojet's complete Code Assurance methodology relies on four basic principles which are integral to avoiding packaging errors. First, we recommend that manufac turers s imp lify me s s a g e selection, so the operator selects the right message for the right job. Second, we suggest restricting operator input to essential information points of contact only. Third, we advise automating messages as much as possible, with predefined rules that help prevent incorrect entries. Finally, manufacturers should use authoritative data sources - such as manufacturing execution system (MES), supervisory control and data acquisition (SCADA), enterprise resource planning (ERP) or other enterprise IT systems - so that the appropriate information is pulled to the printer automatically when the operator selects a job. We recently conducted a survey that found 50 to 70 per cent of coding errors are caused by operator error, with the most common mistakes consisting of incorrect data entry and incorrect job selection. However, even where the problem is recognized, many companies respond by simply introducing more checks during operations. Code Assurance is a new approach to preventing or eliminating errors in the coding and marking process. It involves redesigning a structural flow of coding processes to minimize operator interactions and reduce the risk of errors, even to the point where automatic distribution of correct codes to the correct printers for the correct jobs, becomes the norm. Contact: itan@abipr.com
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Immunity Against Challenges of Conducting Vaccine Trials In this article, the authors highlight the operational challenges in conducting a vaccine trial along with salient strategies of mitigating them. Clinical research organizations work across the vaccine development spectrum and provide end-toend solutions. Much of the other challenges still remain to be shared such as vaccine trials such as study trial design and aspects of fast-track approvals for critical illnesses such as swine flu or Ebola. CROs with experience in vaccines trials are better equipped to mitigate these challenges, wherein their personnel are trained and manage the projects by bringing in their wealth of knowledge.
Dr Preety Shah Clinical Team Leader - Clinical Operations SIRO Clinpharm
Dr Pawan Singh Manager - Clinical Operations and Medical Services, SIRO Clinpharm 44 ď‚ƒNovember 2016
I
mmunization is considered as one of the most impressive success stories of medicine and the most cost effective intervention for reducing the mortality rate. Routine immunizations protect most of the world"s children from a number of infectious diseases that previously claimed millions of lives. However, satisfactory vaccines have not yet been developed against several widespread and life-threatening infections. Human immunodeficiency virus (HIV) affects more than 30 million people worldwide, while malaria and tuberculosis kill almost 3 million people every year, Pneumonia is responsible for more than one in every five child deaths around the globe and Cervical Cancer, generally caused by Human Papilloma Virus (HPV) infection, is the second most common cancer in women worldwide. The risks posed by the recent pandemics and epidemics of H1N1 and Ebola have further accentuated the need for vaccine development. Vaccines are biological products which are highly complex substances derived from living materials, and sometimes comprising living organisms making them less stable than drugs. They require specialized assays and testing to assure their quality and safety on a lot-to-lot basis. There are multiple strains for a single disease and there is always a possibility of new strains coming up by the time vaccines for old ones get approved. Before the start of clinical trials, a sound understanding of the epidemiology of the pathogen or disease of interest in the intended study population is needed. Different types of studies are required for different phases of vaccine development. Special emphasis must be paid on the choice of hypotheses, trial design, and biases that arise in the context of vaccine trials. A big issue in the design is to determine the primary endpoint. Assessing
immune responses to study vaccines as surrogates of protection plays a central role in vaccine trials. One of the most challenging gaps to fill in designing a vaccine trial is that of identifying biomarkers or correlates of protection. On the other hand, the statistical problems in vaccine studies range from small sample exact analysis for sample sizes of 2 to 8 people, to randomized field trials with hundreds to several thousands of people, to community trials with hundreds of thousands of participants, and finally to surveillance in populations with hundreds of millions of inhabitants. Such assessment is often required to continue post-licensure to evaluate the vaccine with respect to rare reactions, duration of protection, and ecological effects. With this article, we intend to highlight the operational challenges of conducting a vaccine trial, in a clinical site or community set-up, and strategies to mitigate them. Recruitment Recruitment in a vaccine trial is one of the biggest hurdles as it is a melange of many complex factors: 1) Vaccine trials are usually conducted in healthy individuals. By the time we stepup in the clinical phases of development, recruitment numbers increase manifold. Since most clinical trial-enabled sites do not have healthy individuals visiting their clinics/hospitals, meeting recruitment targets in a short period of time is a significant impediment. 2) Counselling healthy individuals for participation, where the risks associated with the vaccine is not sufficiently balanced by immediate benefit to the participant, is difficult. As a result, the motivation to participate in a clinical study is curtailed as there is no current health problem for the participant, but, Pharma Bio World
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only the possibility of prevention from an infection in future. 3) Pre-existing public awareness, culture and belief systems associated with vaccines such as the concern about risk of contracting the disease against which one is getting vaccinated cause additional constraints. 4) Vaccine development generally takes place in a stepwise fashion from adults to children. Despite the strict ethical code of conduct for research in pediatric population, most parents are hesitant in enrolling their children in vaccine trials involving injections and blood draws. 5) Large scale Phase III vaccine studies may be designed as community-based trials. Recruitment in such studies is dependent on the understanding, acceptance and support from the community. It is thus imperative that we encourage investigators to build strategies to identify healthy individuals. Customized recruitment plans need to be developed for individual sites. Vaccine studies involving children will often need to collaborate with Gynecology & Obstetric departments to pre-identify females in the last trimester. Investigators need to include the immunization clinics and peripheral health centres of the hospital to identify healthy infants. Pre-screening/identification logs can be used as an effective tool to identify subjects and set recruitment targets. In a community setting, participation can be achieved by education and capacity building for community leaders, awareness and education of potential trial participants and structured mechanisms for consultation. Community mobilization and inclusion of Community Health Workers (CHWs)/field Workers (FWs) are essential in these studies. Informed Consent A well-planned and conducted informed consent not only lays the foundation of a 46 ď‚ƒNovember 2016
successful and ethical clinical study, but also can substantially reduce withdrawals and loss to follow up. However, the informed consent process becomes even more critical in a vaccine trial involving vulnerable population like children. 1) Participants may not comprehend all the information provided in the informed consent due to the poor consenting process, literacy status or even misinformation about research in a community. 2) It is essential that in trials involving older children/adolescents, the assent process be executed patiently and in an easy-to-comprehend manner with no coercion by site team or even parents. Though monitoring this may be difficult, sites need to be trained and sensitized to fulfil this. In India, with the AudioVisual consenting in place, regulators may be better equipped to review the consenting/assenting process. 3) In a community set-up, it is essential that CHWs/FWs are adequately trained to provide study related information and eliminate coercion as they identify potential participants and refer them to the study team for the consent process. 4) A balance needs to be achieved while deciding the remuneration for healthy participants/parents. IRB/IEC would generally review payment amounts and remuneration plans to avoid undue influence. The consent form used should specify the payment scheme and that payment would be made on a prorated basis. 5) Sites should have necessary source documents like birth certificate or hospital discharge card in place to confirm that the consent has been provided by the LAR/parent. In India, higher compliance can be ensured when the decision maker for the family
is informed of the consent, even though he/she may not actually sign the consent form. Study Compliance 1) High retention rates are critical to ensure administration of all vaccine doses, adequate safety monitoring and accurate ascertainment of all endpoints. Strategies like avoid enrolling migratory population, infants who are born in the maternal house and are expected to move to paternal house etc. could be employed by the site. Additionally, site specific retention tools like reimbursing other vaccination cost as per immunization schedule or cost of efforts taken by parents for passive surveillance (e.g. mobile/transport bills) can be used. 2) Post-immunization safety follow-up in a vaccine trial includes completion of a Diary Card to record solicited signs and symptoms. This data is crucial in terms of statistical analysis and assessing the protocol objectives. It is important for site team to identify and train family members who will be available for real time diary completion (grandparents, nanny etc.). In community based studies it is often found useful that CHWs/FWs are trained to assist parents in completion of the diary. 3) V a c c i n e s t u d i e s m a y a l s o i n c l u d e training participants/parents on other skills like measuring oral temperature, collection of stool sample, identifying and reporting a key reaction in a stipulated time frame etc. It is thus essential that a close rapport is developed between all stakeholders and innovative training methods are employed. Techniques like preparing a training module in regional language, arranging community training
There are multiple strains for a single disease and there is always a possibility of new strains coming up by the time vaccines for old ones get approved. Pharma Bio World
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programs, using dummy kits, asking the participants to demonstrate skills as understood by them should be used effectively. Study Logistics 1) Vaccines are temperature sensitive biological products which may become less effective or even get destroyed when exposed to temperatures outside the recommended range. This increases the importance given to use of validated cold chain maintenance as compared to other clinical trials. Assessment of the refrigerator must be performed to ensure it is situated in a location with access to authorized individuals only and is placed in a room with limited temperature fluctuations with a backup plan in case of power failure (e.g. power generators) and to ensure that the refrigerator maintenance plan is in place. 2) Continuous temperature monitoring devices like-Libero, Escort, etc. should be used so that the exact time and duration of temperature deviation is identified. Also, an adequate alarm system needs to be in place for identifying the deviation at the earliest. 3) Process on reporting and managing temperature excursions needs to be defined at the start of the study and communicated to the site team. 4) Safety and Immunogenicity laboratory investigations are an integral part of vaccine studies. Collection of laboratory sample is challenging for the site team when children are involved, both in terms of the technique and handling apprehensive parents. As mentioned for vaccines, similar measures need to be taken for storage and shipment of the laboratory samples. 5) For trials being conducted in community set-up, rigorous planning on logistics and infrastructure is of paramount importance, given the limited resources in such set-up. 48 ď‚ƒNovember 2016
Monitoring By nature, vaccine studies are usually fast paced-in terms of recruitment, subject follow-up visits etc. It is thus essential that monitoring schedule and frequency is planned keeping in mind recruitment phase, experience of clinical site and the need to monitor peripheral health care centres/communities. The challenges of a vaccine trial oversight, particularly, increased variability in site experience, infrastructure, standards of health care facility, as well as challenges related to geographic dispersion of participants, can be mitigated tactfully by using risk-based approach to monitoring. The innovations in modern clinical trials can be used to monitor key data elements in vaccine studies that are fast-paced e.g. using electronic diaries wherein data can be transmitted to computers and analysed when possible and tracking active and passive surveillance visits/phone-calls remotely. A home grown, in-built alert to the database for any "related AE" is a very novel idea and can be used effectively in performing early phase trials.
could be to conduct a preparatory study that will mirror all the proposed procedures and activities of the actual study. These preparatory studies determine the burden of disease, feasibility of recruitment, follow-up and retention. These studies mimic the logistic and operational aspects of the study as well as ascertain community's understanding, acceptance and support. Thus, as vaccine researchers, one could test the water and be adequately prepared for the main study by employing this method. (With contributions by Dr Vatsal Shah and Partha Chatterjee) References: http://www.ncbi.nlm.nih.gov/pmc/articles/ PMC2831649/ http://www.fda.gov/biologicsbloodvaccines/ http://www.cdc.gov/vaccine Contact: ruchi.sanganeria@siroclinpharm.com (This article was originally published in March 2016 issue of PBW)
An innovative approach for conducting large scale community-based vaccine trials Pharma Bio World
press release Bosch Expands Pharmaceutical Portfolio
VESCOP to Bag Platinum Ranking in CII-AICTE Survey
Browndove Healthcare Expands its India Pperations
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press release Sanofi Gets CHMP Recommendation for Approval of Suliqua in EU
Dr Reddy’s Launches Raloxifene HCl Tablets, USP in the US Market
Wockhardt Launches LabHQ LIMS Pharma Bio World
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SteerLife, Manipal University Join Hands to Set Up Centre of Excellence
November 2016 51
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press release Novo Nordisk Partners with Schools for Enhancing Diabetes Awareness
Vyome Biosciences Closes USD 14 Million Series C Financing Analytica Anacon India and India Lab Expo Closes on a High Note
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press release IIL Introduces World’s First Vaccine Against Tapeworms in Pigs
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Everstone Buys Majority Stake in Rubicon Research
METTLER TOLEDO Announces Realtime Microbial Monitoring System
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biotech news NEB Ink Pact with AmpTec New England Biolabs, Inc. (NEB) has strengthened its position as a key supplier to the fast-growing RNA synthesis market by signing an agreement to supply critical reagents to AmpTec GmbH, a leading manufacturer of synthetic long RNAs and functional mRNAs for research, diagnostic and therapeutic applications. Under the terms of the agreement, NEB will manufacture and supply enzymes for in vitro transcription and capping of RNA. Established in the mid 1970’s, New England Biolabs, Inc. (NEB) is the industry leader in the discovery and production of enzymes for molecular biology applications and now offers the largest selection of recombinant and native enzymes for genomic research. AmpTec manufactures high quality synthetic nucleic acid products for research, diagnostic and therapeutic markets. AmpTec is ISO 13485 certified and its production facility (at present about 4,000 square feet) is compliant with FDA21 CFR part 820 (cGMP manufacturing).
Geovax, Viamune Join Forces for Cancer Immunotherapy GeoVax Labs, Inc, a clinical-stage biotechnology, announced its collaboration with ViaMune, Inc. for the co-development of each company’s cancer immunotherapy programmes. Both companies’ products target an abnormal form of the autologous cell surface-associated protein, Mucin 1 (MUC1), which is over-expressed in the majority of known tumor types. Due to overexpression and/or aberrant glycosylation of MUC1, this “tumour-associated antigen” (TAA) is often recognized as abnormal by patients’ immune system but is not sufficiently immunogenic to trigger an effective immune response needed to control or eliminate tumours. Therefore TAAs must be presented to the body in a different form, or in a different way, to enlist the immune system in fighting the cancer. The collaboration will assess each company’s vaccine platform, separately and in combination, with the goal of developing a tumour MUC1 vaccine that can produce a broad spectrum of anti-tumour antibody and T cell responses. The resulting MUC1 vaccine will be combined with immune checkpoint inhibitors (CPIs) as a novel vaccination strategy for cancer patients with advanced MUC1+ tumours. CPIs directed against CTLA-4, PD-1 and/or PD-L1 have led to dramatic clinical responses in patients with advanced cancers yet only 20-40% of patients benefit. Patients that do not respond to CPI therapy do not produce on 54 November 2016
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their own the levels of cytotoxic T lymphocytes (CTLs) needed for efficient killing of tumour cells. GeoVax and ViaMune will combine efforts in order to produce efficacious levels of CTLs in a greater percentage of patients, thus enabling more patients to benefit from CPI therapy.
Bionical Buys Global CRO Emas Pharma Bionical, the integrated outsourced specialist to the pharmaceutical, biotechnology and public health industry, announces the strategic acquisition of Emas Pharma (Emas), a global clinical research organisation (CRO). Emas, which provides pharmaceutical development and clinical research services to biotech, medical device and specialized pharmaceutical companies worldwide, will join Bionical’s existing fast growing clinical services business. Financial transactions were not disclosed. The acquisition is part of Bionical’s strategy to provide high quality clinical, commercial and communications services to pharmaceutical, biotech and public health companies in the global healthcare industry. The acquisition of Emas and the addition of clinical research, pharmacovigilance, regulatory, medical information and medical affairs capabilities will support Bionical’s mission to deliver improved health outcomes for patients. Bionical’s clinical division currently provides the supply of comparator products for clinical trials as well as nurse educator teams and public health services and has a wide base of clients internationally. Emas, which has a significant client base of emerging and specialized biopharma companies, brings an extended global footprint, with offices in the UK, USA, Canada, Australia and Ireland.
NIH Developes Assessment Against Drug-Resistant Bacteria Researchers at the National Institutes of Health’s National Centre for Advancing Translational Sciences (NCATS), Clinical Centre and National Institute of Allergy and Infectious Diseases (NIAID) have created a new way to identify drugs and drug combinations that may potentially be useful in combating infections that are resistant to many different antibiotics. They developed an assay (test) to rapidly screen thousands of drugs to determine how effective they were against a variety of types of resistant bacteria. The screening method provides a potential new approach to repurpose known drugs and compounds to potentially help deal with powerful, hospital-borne infections, as well as emerging infectious diseases. Pharma Bio World
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biotech news C3, OncoVent to Produce Vaccine Against Pancreatic Cancer Cell Culture Company (C3), a biopharmaceutical developer and manufacturer, has entered into an agreement with OncoVent-a China-based joint venture to produce a clinical-grade antibodybased therapeutic vaccine targeting pancreatic cancer. OncoVent, a joint venture between Shenzhen Hepalink Pharmaceutical Co. and Canada-based OncoQuest, began negotiations with C3 after its drug candidate had produced positive pre-clinical data for a combinatory immunotherapy targeting pancreatic cancer. C3 was ultimately awarded the contract and will complete the work at its Minneapolis-based cGMP bio production facility. C3 is headquartered in a 33,000 square foot facility that houses corporate offices, bioreactor manufacturing operations, GMPcompliant laboratory space, and a distribution centre. Anti-MUC1 MAb-AR20.5 is a novel immunotherapeutic drug for investigational use in the treatment of patients with malignancies expressing the tumor-associated antigen known as MUC1. MAb-AR20.5 binds with high affinity to MUC1, recognizing the tandem repeat peptide sequence DTRPAP of the high molecular weight MUC1 glycoprotein. MUC1 is expressed on many adenocarcinomas including pancreatic, breast, lung, colon and prostate, as well as in multiple myeloma, and this epitope uniquely exposed in malignant cells. A phase I clinical study in MUC1 expressing cancers has established bioactivity associated with dose and a favorable safety profile. OncoQuest is developing this antibody in conjunction with OncoVent for the treatment of pancreatic cancer.
human primates that are naturally resistant to Zika. While providing useful immunology data, they cannot provide relevant evidence of an effective means of controlling the spread or medical impacts of this disease by vaccination. In addition to reporting immunogenicity in such Zika-resistant species, this paper represents the first published research to also analyze a Zika vaccine using the special transgenic murine strain A129 lacking interferon alpha and beta receptors (IFNAR-/-), making them highly susceptible to Zika infection and disease. Taking this extra step provided data on how vaccine-generated immune responses could protect against a lethal viral challenge and demonstrates the benefit a Zika vaccine might provide in people.
Celtic Biotech Receives US Patent for Snake Venom-Derived Therapeutics Spotlight Innovation Inc. announced that the United States Patent and Trademark Office (USPTO) issued to the company’s subsidiary Celtic Biotech Iowa US Patent No. 9,345,751, entitled “Crotalus Durissus Terrificus Venom Administration for Cancer Treatment.” The patented invention relates to compositions isolated from rattlesnake venom (Crotoxin) and methods for intravenous administration of Crotoxin to cancer patients. Commenting on the significance of this patent issuance, Cristopher Grunewald, Spotlight Innovation’s president and chief executive officer, said, “A key component of Spotlight Innovation’s product development strategy is to establish a strong intellectual property portfolio to support our pipeline of therapeutic product candidates.” Spotlight Innovation Inc. identifies and acquires rights to innovative, proprietary technologies designed to address unmet medical needs, with an emphasis on rare, emerging and neglected diseases.
Inovio Pharmaceuticals Launches Inovio Vaccine for Animals LifeNet Health Acquires Vivo Biosciences Inovio Pharmaceuticals, Inc. announced that Inovio and its collaborators have published results in Nature Partner Journals (npj) Vaccines demonstrating that its Zika DNA vaccine (GLS-5700) protected animals from infection, brain damage and death. In this study 100% of GLS-5700 vaccinated animals were protected from Zika infection after exposure to the virus. In addition, vaccinated mice were protected from degeneration in the cerebral cortex and hippocampal areas of the brain while unvaccinated mice showed significant degeneration of the brain after Zika infection. Prior preclinical studies have tested potential Zika vaccine candidates in animal models involving normal mice and nonPharma Bio World
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LifeNet Health has acquired the assets of Alabama-based biotechnology company Vivo Biosciences, Inc., as part of the organization’s growing emphasis on applying cell-based innovations to the process of pharmaceutical discovery and personalized medicine. The technologies acquired by LifeNet Health can help pharmaceutical companies make their drug-discovery processes more efficient while reducing cost. They will provide research centers and drug companies a unique pathway to precisely evaluate drug sensitivity, toxicity, and pre-clinical endpoints — and, most importantly, patient-based therapy response. November 2016 55
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PANalytical offers Aeris, their new X-ray powder diffraction (XRD) benchtop instrument. Ease of use and max benefits for the user have been the key aspects of this system, which provides fast and precise phase information of the materials analyzed. Aeris is accessible for everyone – its built-in touch screen with the intuitive interface directly displays all results. At the same time Aeris is designed for low cost of ownership – it only requires a single-phase power outlet and neither needs cooling water nor compressed air. Nevertheless, its performance is exceeding typical benchtop X-ray diffractometer performance. Data quality and speed of data acquisition have so far only been observed on full-power systems. Aeris editions are available, which have been tailored to the specific needs of the cement, mining and metals industries. They provide fast and precise mineralogical phase information, which can be used for control and optimization of the production process. The Research edition of Aeris, on the other hand, is designed for quick XRD scans in any laboratory and is easily accessible for students. Especially with its unique 2D option it also serves as an ideal instrument for teaching XRD. For more information, please contact: PANalytical BV Lelyweg 1, 7602 EA Almelo The Netherlands Tel. +31 546 534444, Fax: +31546 534598 E-mail: info@panalytical.com
Romaco offers new Macofar MAC 2 intermittent motion capping machine. This technology is ideal for closing cylindrical glass vials that have been filled with sterile pharma powders or liquids. After inserting the rubber stoppers, the vials are transferred to the MAC 2, which seals them with flip-off closures or simple alu-caps. The MAC 2 is built with two closing heads for a max output of 12,000 vials per hour. The vials to be capped are positioned one by one on rotating bases and held there firmly from above. Idle blades which are in charge of the sealing process are equipped with springs to compensate the minimal differences between the vials within one batch. This kind of individual sealing reduces friction and prevents the generation of aluminum particles – a clear advantage compared to capping by means of a single fixed blade, especially when it comes to meeting cGMP requirements. The capping pressure is set via the HMI panel. Two built-in load cells verify this pressure on each individual vial. This method provides an accurate indication of the stoppering quality. In case of any deviations from the defined tolerance range, the vials concerned are automatically removed. The Macofar MAC 2 complies with all established guidelines and regulations for aseptic processes. With its strictly ergonomic design, the machine is easy to retool, clean and operate. For more information, please contact: Romaco Group Am Heegwald 11, 76227 Karlsruhe, Germany Tel: +49 (0)721 4804 0, Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com
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Multiparameter pH/ORP/EC/DO/Turbidity Meter From municipal wastewater treatment plants to a wide variety of industries, treated wastewater is discharged directly into natural waters, including rivers, lakes, estuaries and bays. In some instances, ecological monitoring is mandatory downstream of the wastewater discharge site in order to ensure there are no significant environmental impacts in these receiving waters. Typical parameters of interest include temperature, pH, ORP, conductivity, salinity, turbidity, and dissolved oxygen. For comprehensive environmental monitoring, Hanna Instruments recommends the HI9829 Multiparameter pH/ ORP/EC/DO/Turbidity Meter. The meter offers waterproof protection of both the meter (IP67) and the probe (IP68) ensures that the internal elements of the meter are protected, despite the harsh weather conditions; optional autonomous logging capability of the probe allows the customer to deploy the probe and log measurements for up to 70 days at 10-minute measurement intervals; optional integrated GPS receiver allows GPS coordinates to be stored with logged data; integrated temperature sensor allows for automatic temperature compensation of pH, conductivity and dissolved oxygen measurements; quick calibration provides a speedy, single point calibration for pH, conductivity and dissolved oxygen, standard calibration options are available including pH up to three points, conductivity at one point and dissolved oxygen up to two points; HI9829 allows users to store up to 44,000 continuous or log-on-demand samples with logging intervals from one second to three hours; and logged data can be transferred to a Windows compatible PC with the included HI7698291 USB adapter and HI929829 software. For more information, please contact: Hanna Instruments (India) Pvt Ltd 3/4/5/6 Aum Sai Bldg, Plot 23-C, Sector 7 Kharghar, Navi Mumbai 410 210 Tel: 022-27746554, 27746555, 27746556, Fax: 91-022-27746557 E-mail: sales@hanna-india.com
Tableting Solution For Mid-Sized Batches The Romaco Kilian S 370 Prime is designed for fully automatic production of mid-sized batches and compresses up to 330,000 tablets an hour. It offers excellent value for money and the low initial capital investment is a convincing argument for pharma manufacturers all over the world. This compact press combines several highlights such as GAMP compliant automation, an integrated lifting system to speed up die table exchanges and patented, wear-free brake magnets. Retooling and cleaning times are reduced to a min because easy access is possible to all components while the space efficient design means no external electrical cabinet is needed. The machine is controlled via the integrated HMI touch panel and Vicon visualisation software, so that operation is very straightforward. The Romaco Kilian S 370 Prime can be equipped with an automatic tablet tester and a trending function on request.
For more information, please contact: Romaco Group Am Heegwald 11 76227 Karlsruhe, Germany Tel: +49 (0)721 4804 0, Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com
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Double-Sided Rotary Press Cool, fast and clean – these three design features of the Romaco Kilian KTP 720X double-sided rotary press are attracting considerable attention among pharma manufacturers worldwide. Cool is a set of measures which enable the temperature in the process area to be maintained at a constant level below 30°C. Special compression rollers, bolts and bearings are used, for example, to restrict mechanical friction to a min. At the same time, the efficient cooling of the V-ring seals and drives prevents unwanted heat. The powerful rotary press is consequently ideal for processing temperature sensitive medications such as Metformin or Ibuprofen. Fast denotes the ability to speed up product changes in order to shorten the retooling and cleaning times, the number of product-contacted format parts has been systematically reduced and access to the various components is now easier than ever. Clean refers to the optimised hygienic design, which improves product quality and makes the process more reliable. The strict separation between the compaction and service areas prevents tablet dust from entering the machine compartment during the production process. The patented punch bellows moreover protect the tablets from contamination with lubricants. With a max output of 1,020,000 tablets per hour, the Kilian KTP 720X is classed as a high speed model. The HMI panels of this tablet press incorporate zoom and swipe navigation inspired by modern smartphones. The Romaco Kilian additionally impresses with innovative features on the operator side. For more information, please contact: Romaco Group Am Heegwald 11 76227 Karlsruhe, Germany Tel: +49 (0)721 4804 0, Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com
Can Stack Linear Actuator Portescap offers high power density Can Stack Linear Actuators, the 20DBM. These 20 mm linear stepper motors offer an optimized design ideal for applications demanding high linear force. The new 20DBM features an optimized magnetic circuit which provides improved performance over existing designs. The 7.5 deg step angle provides finer incremental movement with a high degree of accuracy and repeatability. With maximum holding force up to 50N, the 20DBM actuators are ideally suited for use in applications such as electronic pipettes, medical and non-medical analyzers, XY stages and valve actuators. Their fully customizable 20DBM actuators are powered by high energy neodymium magnets, optimized electromagnetic circuit and patent pending bearing preload design which ensures exceptional performance in a small package. Component standardization and design modularity ensures quick customization capability for samples across various applications. Standard configurations can be delivered with maximum one week lead-time. 20DBM is available in Captive and Non-Captive versions with various leadscrew pitch options on their online motor selection tool, MotionCompass. 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
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Laboratory Ramp and Soak Temperature Controllers The controller is the enhanced 5R6-900 bench top unit from Oven Industries Inc. Contained all in one enclosure, the device can be plugged into the wall as a self-contained temperature control system. The controller can also be used universally, which allows the user to use the device wherever they are located. As a solid-state MOSFET bidirectional compact unit featuring an internal power supply, it is also capable of loading currents up to 10-A. The controller easily connects to a computer through the electrically isolated RS232 communications port. The PC can be utilized as a connector and the temperature controller can stand alone, once the desired parameter settings are in place. These settings are kept in the non-volatile memory. Great for usage in universities, science laboratories, PCR research and any businesses that specialize in temperature control, the controller features an easy-to-read digital display for controlling functions, including adjusting output voltage and setting the temperature. Complete with an auto output shutdown if the sensor is opened or shorted, the unit also includes high, low and no alarm settings. The compact size, as well as the isolated communication port, makes using the 5R6-900 Desktop Temperature Controller a breeze. For more information, please contact: OVEN Industries Inc 434 Railroad Avenue, Camp Hill, PA 17011, U.S.A. Tel: 717-766-0721 Fax: (717) 766-4786 E-mail: r.wescott@ovenind.com / sales@ovenind.com
Tableting Robot For R&D Applications Romaco Kilian’s STYL’ONE Evolution tableting robot is predestined for a broad array of R&D applications and for producing small batch sizes. With a max output of 1,200 tablets per hour, this single-stroke press processes mono-layer, multi-layer or core tablets (tab in tab). Equipped with a gravity or paddle force fill shoe, the STYL’ONE Evolution is capable of processing up to three different components and compressing tablets with as many as five layers. Any standard rotary press can be simulated thanks to ANALIS, the intelligent PAT software. The user simply selects the machine model and predefines the required tablet thickness or compression force. ANALIS then automatically determines the optimal compression parameters for the production scale. Since the necessary compression force profiles are created independently by the tableting robot, the time saving is enormous. The remarkable precision of the test batches means the powder properties can be analysed very realistically. Apart from developing new formulations, the STYL’ONE Evolution can thus also be utilised to optimise processes or troubleshoot errors. The highly efficient PAT system offers a continuous improvement in product quality. For more information, please contact: Romaco Group Am Heegwald 11 76227 Karlsruhe, Germany Tel: +49 (0)721 4804 0, Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com
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bookshelf Designing Clinical Research (Paperback) Authors: Dr Stephen B Hulley MD MPH, Steven R Cummings MD, Warren S Browner MD MPH, Deborah G Grady MD MPH, Thomas B Newman MD MPH Price: USD 77.98 No of pages: 378 Pages Designing Clinical Research has been extensively revised and continues to set the standard as a practical guide for doctors, nurses, pharmacists, and other health professionals involved in all forms of clinical, translational, and public health research. It presents advanced epidemiologic concepts in a reader-friendly way, and suggests common sense approaches to the challenging judgments involved in designing, funding, and implementing. The book is divided into three major sections; (i) Basics including sampling, trial hypotheses testing and statistical analyses as well and general trial types. (ii) Designs which examines the various types of trials from randomized case control, cross-sectional, and other such classic trial methodologies, (iii) Implementation, including the ethical issues and data management.
Drugs: From Discovery to Approval (Hardcover) Author: Rick Ng Price: USD 79.94 No of pages: 552 pages About the Book: This book offers a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, Drugs: From Discovery to Approval, Third Edition quickly introduces basic concepts, and then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. The third edition incorporates the latest developments and updates in the pharmaceutical community, provides more comprehensive coverage of topics, and includes more materials and case studies suited to college and university use.
Validation of Active Pharmaceutical Ingredients, Second Edition (Hardcover) Authors: Ira R Berry (Editor), Daniel Harpaz (Editor) Price: USD 98.44 No of pages: 618 pages Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated, and expanded, this second edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. The basic philosophy and principles of GMP and validation have not changed, but new terminology had been introduced, and old terminology had been better defined, improving the understanding of related concepts and principles. The book gives you a working knowledge of the regulatory process that will facilitate your organization’s compliance with regulations.
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