Pharma Bio World November 2019

Vol 18 | Issue 04 | november 2019 | Mumbai | Total Pages 60 | Price ` 150

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PHARMA BIO WORLD Vol 18 Issue 04 november 2019 MUMBAI

ChemTech

total pages 60

South World Expo 2019

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BioPharma World Expo 2021 24-27 February 2021 Bombay Exhibition Center Goregaon (East), Mumbai, India

PHARMA BIO WORLD R.N.I. No.: MAHENG/2002/8502 Chairman Maulik Jasubhai Shah Publisher & Printer

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Chief Executive Officer

Hemant K. Shetty

EditorIAL Editor Mittravinda Ranjan (mittra_ranjan@jasubhai.com) Deputy Editor

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Editorial Advisory Board Ajit Singh, Jai Shankar, Dr Narges Mahaluxmivala, Dr Prabuddha Ganguly,

Dr Satish Ravetkar, Utkarsh Palnitkar Design Team

INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES

VOL. 18 | NO. 04 | November 2019 | MUMBAI | ` 150

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4 ◄ November 2019

Pharma Bio World

features 12

API Business: Where Does India Stand

by Gronil Jain, CEO and Founder, Globofarm

18 The Advanced Pharma Factory

by Pooja Patil, Corporate Communication, B&R Industrial Automation 24 Feedback – The Most Underrated Management Tool

by Sanjeev Himachali, Principal Consultant & Talent Strategist, Ecliptic HR Solutions Private Limited; and Chief Curator, HRTales

12 31

Why is Pharma Taking Interest in Nutraceutical Industry?

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

33 Clinical Trials and Data Exclusivity: In Search of a Fine Balance

by Bhavik Narsana, Partner, Khaitan & Co Soumyadri Chattopadhyay, Senior Associate, Khaitan & Co Yashashree Mahajan, Associate, Khaitan & Co 37 Feasibility in Clinical Research – Foundation for Clinical Trial Success

by Partha Gokhale, Head Clinical Operations, Boehringer Ingelheim India

18

41

A Quality Approach to Components

by Mike Schaefers, Vice President – Global Product Management and Marketing Operations, West Pharmaceutical Services, Inc.

Company Profile 45

24

Mechanical Power Transmission Engineering Components from Tradelink Services Tradelink Services

marketing initiatives

46

Innovative Vacuum Solutions in Pharma Industry: The Right Solution from Toshniwal Toshniwal Instruments (Madras) Pvt Ltd

47

News Press Release

CORPORATE AFFAIRS 51 Products

30

6 ◄ November 2019

56

Events

57

BACKYARD Book Shelf

58

Ad Index

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API Business: Where Does India Stand In this article, author narrates his entry into Active Pharmaceutical Ingredients (APIs) business. He throws light on how India is doing and what’s the scope ahead, in a very comprehensive manner.

A

Gronil Jain CEO and Founder Globofarm 12 ◄ November 2019

s a child, I have always heard the generic names of medicines as opposed to brand names since I come from a pharmaceutical background which is primarily into manufacturing of bulk drugs and formulations so this business was in my blood. My struggle started when I was not allowed to join my father’s company and was told to earn my silver spoon which of course took time and involved a lot of failures in getting the desired job.

houses like ZMC, Sinolite as compared to the Indian manufacturers. We do not have enough export houses which are huge, reliable, and credible. And that’s the reason we are worried about the future growth – what it will lead to. I feel India can achieve a USD 5 trillion economy if it does exports worth USD 1 trillion. We can achieve all targets if we can focus on exports and promote make-in-India products across the globe as a country.

After completion of my MBA in Marketing, I started working with IPCA Labs’ marketing research department for choosing products for the US and Canada market.

That got me a fair idea of how product selection works. And soon I realized the need to start my own company. I started my venture Globofarm LLP in 2015 after gaining significant experience and knowhow of various departments.

Active Pharmaceutical Ingredients (APIs) denote the dosage in a drug or the key chemicals that make the drug work, while finished formulation is the process in which different chemicals, including the active ingredient, are mixed in specified ratios to produce a specific drug.

Globofarm LLP is an international marketing company exporting quality pharmaceuticals / cosmetic ingredients / herbal extracts from India across the globe. China has many huge export

What is API?

Why India has an opportunity for exporting API-s and herbal extracts?

The situation, for instance in China, cannot be trusted because Chinese government has shut down many plants due to pollution issues; at the same time there are many new manufacturers in India catering to this gap in supply and Pharma Bio World

demand. I am talking about this very opportunity which needs to be tapped upon and used efficiently.

How can an export house help?

Usually, an end-user needs many products to be shipped all at once from India as it is impossible for one manufacturer to provide all the ingredients needed; but we can help combine shipments and be one point of contact for their needs. This will enable the end-users to save freight costs and clear the shipments having multiple consignments under one bill and save time of correspondence for their orders.

We take guarantee to export quality ingredients to our clients globally.

Why Us? How Can Globofarm Help?

Pharma business is a business of follow ups; hence we take guarantee for the material we export and ensure its quality.

Our client can count on us for all the market information and the right price for the right product. We make conscious efforts to reduce the cost of raw materials for our clients so that they cut cost on healthcare. We aim to be a five-star export house from India.

Manufacturers have a lot of cost on them such as factory overheads, raw material cost, labour cost, etc; hence we would like to promote basket of products and represent our Indian producers at various 14 ◄ November 2019

exhibitions across the Globe which happens every month and is practically not possible for any manufacturer; however, since we have a basket of products we can always recover our cost.

We help importers/end users to get the right price for the ingredients from India due to our network and understanding of local players. We pass on the benefit to our clients so they can compete in their respective markets.

Due to our strong network presence, we assure prompt service to our clients for their inquiries. Due to our domestic division, we always have first handle knowledge about the new manufacturers.

We are reliable and genuine, handle our client’s money safely, and respect their time.

Global Opportunities: India and China both produce paracetamol, which is a very basic drug and required across the globe. Export houses should push our raw materials in the global market in order to compete with China, which is now the largest exporter in the world.

Vitamins viz Thiamine HCL, Riboflavin Phosphate, Methyl Cobalamin, Niacinamide are manufactured in auditable facilities and can be exported across the globe.

India is also producing Curcumin and Ashwagandha. Curcumin is the 209 th largest exporting item from India. India’s export of this product grew at a CAGR of 20.28 percent in the last five years. India has a market penetration of 70 percent for this product. Present markets are USA, Iran, UK, Morocco, Germany, Malaysia, Japan, UAE, and Sri Lanka. There are many products like these, which we can market across the world. (Source: FIEO)

Current Scenario:

looking at the size of the current population, India is currently not in the top ten countries in the world export market. We see it as a problem as well as an opportunity. The government should provide bank loans at a cheaper rate of interest so our products can be competitive in the global market, as for example, some European countries provide bank loans at 4 percent annual rate of Interest.

Credit facilities against orders – some financial Institutions provide finance for safe countries such as developed economies like the US and Europe.

There are 195 countries in the world and good opportunities for everyone.

In order to be everywhere, we need to have good financing back up. China is also importing bulk drugs from India and the demand is increasing year on year.

Pharma Bio World

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Why can’t this business go Digital?

Choosing raw materials for your formulations is a time-consuming job. It cannot be done overnight. We look at following aspects. There are customized specifications. If plant audit is acceptable by the manufacturer, if they are really manufacturing the product or just relabelling it, if the manufacturer has the ability to be competitive in the long run, input cost keeps changing from time to time as per the demand and supply. Manufacturers are not ready to disclose the price to everyone. Quality product with competitive price is what we achieve for our clients. We need to check if manufacturer has any capacity constraints and if the manufacturer makes the product on a campaign basis.

The pharmaceutical business still works on interpersonal skills as money, quality, and time are involved; hence the customer is very careful in choosing the right vendor for their project. We help them make the right choices.

Why is it a serious business and not just a game of sourcing on the web?

When one is dealing in the human health business, it is very important to source cost effective bulk drugs for the clients, so that they can get the desired efficacy of their formulations.

Countries across the globe have realized the importance of manufacturing their own formulations in their own country to be self-sufficient, so that they do not have to import from India. This will also generate employment.

There are manufacturing facilities developing in Srilanka & Africa; USFDA approved facilities are being developed in Bangladesh, USA , Europe, Israel, and Greece . So things are changing and a major hub for raw material is now based at India, China, and Europe.

16 â—„ November 2019

When companies are producing formulations, it is natural to have a competitive price for raw materials so they can compete in the market for the formulation business.

A recent study published in Hindu Business Line proclaims, Indian pharma exports stood at USD 19.14 billion in 2018-19 comprising of bulk drugs, finished dosage formulations, Ayush, herbs, and surgicals including the domestic share; thus, pharma industry touched USD 40 billion.

About

Globofarm:

Founded in 2015, Globofarm LLP aims to be a onepoint-service-provider to companies who buy raw materials for pharma and cosmetics business. For more information: http://globofarm.net Pharma Bio World

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Our technology enables manufacturers and CMO’s to comply with the validation requirements of Good Manufacturing Practice (GMP) and emerging global legislative standards, such as the DQSA, helping to secure the supply chain from Product to Pallet.

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Hall No. 14, Stall B47, India Expo Center, Greater Noida

Domino Printech India LLP Corporate office- Plot No. 167, HSIDC, Udyog Vihar, Phase I, Gurugram122016, Haryana, India Tel: +91 124 488 6100, marketing@dominoindia.com

The Advanced Pharma Factory In this article, the author narrates the advanced progression of pharma factories from traditional mode with the power of digitalization.

Figure 1: B&R’s Orange Box enables machine operators to collect and analyze data from previously isolated machines and lines and get them fit for the smart factory.

T

Pooja Patil Corporate Communication B&R Industrial Automation Email: pooja.patil@br-automation.com Web: www.br-automation.com 18 ◄ November 2019

hese days smart manufacturing is trending in various manufacturing sectors with internet of things (IoT), edge computing, and cloud computing.

With strict regulations to follow, pharma industry faces several challenges related to quality, productivity, efficiency, and wastage. Smart manufacturing practices actually offer the industry various cost-effective ways to tackle these challenges. With ever-growing market and increasingly complex ways of drug manufacturing, storage, and distribution, the prime focus for the pharma industry is to remain competitive. Being one of the heavily regulated industries, there is always a constant need for continuous product monitoring throughout the entire manufacturing continuum, right from the raw material sourcing to obtaining finished product.

Traditionally, pharma companies heavily rely on the human factors, whereas with Industry 4.0 – which is all

about digitalization, automation, and collaboration – now the processes are more autonomous and computerized. As a benefit, now any deviation or untoward occurrence can be easily predicted and corrected to avoid the down time or loss, which otherwise could damage the reputation of a pharma manufacturer.

Smart manufacturing comes up with the feature of continuous and real-time process monitoring, thus helping the companies to keep a track of prescribed parameters. Digital technology plays its part here very prominently by making an allowance for the data to be further analyzed and utilized towards better and faster decision making. Digitalization allows full integration of operations and thus improves manufacturing processes by making them more adaptive and responsive, thus resulting accurate planning, manufacturing efficiency and productivity enhancement, raw material management, quality assurance, and also waste reduction.

Pharma Bio World

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Figure 2: OPC UA enables seamless communication from the individual sensors and actuators up to the ERP / MES system or the cloud.

Challenges: Despite having numerous benefits, thanks to the contribution of IIoT to pharma manufacturing, certain challenges do exist. The unknown cost required for upgrading legacy equipment to more digitized equipment is one of the major barriers. Moreover in factories, owing to various islands of automation, having seamless vertical and horizontal communication i.e. machine-tomachine and machine-to-cloud is another challenge. Not only is that, with connected vertical and horizontal shop-floors, cyber-security is a raising concern owing to the amount of factorydata. Pharma companies need to find their ways to mitigate all these risks and take steps to adopt technology trends to leverage its benefits.

Retrofitting

brownfield

plants:

Adoption of smart manufacturing practices looks conceptually difficult in brownfield plants owing to legacy systems. In India, many factories have decade-old infrastructure; and up-gradation of existing equipment, machines, devices, and sensors incur high costs. These two factorials act as major barriers for technology adoptions.

Another challenge associated with these brownfield factories is collecting data and moving it to upper layers and IT. However, in order to overcome these challenges, setting up new greenfield facilities from scratch is NOT a viable solution. With minimum capital investment and small modification, brownfield facilities too can leverage smart manufacturing benefits

Traditionally pharma companies have been heavily relying on the human factors whereas with Industry 4.0 – which is all about digitalization, automation and collaboration – now the processes have become more autonomous and computerized.

20 â—„ November 2019

within no time. Orange Box from B&R was developed with this thought in mind to provide greenfield installation benefits to brownfield installation in a cost effective way. Orange Box enables users to access energy and to process data from previously isolated machines and lines, making them Industrial IoT ready with minimal effort.

An Orange Box can substantially reduce downtime and boost availability of existing machines and lines, which makes operations more productive and profitable.

Orange Box consists of a controller and preconfigured software blocks. The controller is able to collect operating data from any machine via its I/O channels or a fieldbus connection. With this data, the software module generates and displays overall equipment effectiveness (OEE) and other KPIs, and can share the information with higher-level IT systems using open source OPC UA or MQTT communication.

Installing the Orange Box requires no changes to existing hardware or software in the factories. Equipment owners can Pharma Bio World

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achieve a substantial boost in productivity with a remarkably small investment in time and cost. It is as simple and intuitive to operate as a smartphone. Orange Box is also equipped with advanced energy function, which can evaluate energydata collected from the machine. Energy consumption is measured directly on the machine and viewed on an industrial HMI screen. The software is also able to break down energy consumption by device and displays it in a clear graphical overview.

At a glance, operators are able to get an overview of any machine or entire factory power consumption.

Secure data connectivity with OPC UA: The increased networking in digitised shop-floor requires 24/7 connectivity and continuous access to the machinery.

However, with this connectivity, organizations entails new security challenges which need to be addressed systematically. For any pharma company, data of drug formulation, R&D, production knowledge is very sensitive and needs to be protected; otherwise, data, machines, and devices might be compromised or external entities might monetize this valuable data. OPC UA is the best solution, which insures data integrity and data confidentiality securely.

OPC Unified Architecture (OPC UA) is a vendor-independent communication protocol for industrial automation applications. It is based on the clientserver principle and allows seamless communication from the individual sensors and actuators up to the ERP / MES system or the cloud. The protocol is platform-independent and features builtin security mechanisms. Since OPC UA

is flexible and completely independent, it is regarded as the ideal communication protocol for implementation of Industry 4.0 ready factory.

OPC UA bridges the gap between the IPbased world of IT and the production floor.

Interfaces, gateways and the associated loss of information are a thing of the past because all production process data is transferred via a single protocol – within a machine, between machines or between a machine and a cloud database. OPC UA is eliminating the need for traditional factorylevel fieldbus systems. By adopting this industrial automation solution, Pharma companies can leverage the manufacturing advances where connectivity and security are major concerns.

Achieving operational excellence with Cobots: With growing demand for new drugs and medicines, pharmaceutical companies are continuously looking for new ways to increase efficient production, thus leading to increased reliance on robotics. Incorporating robots in pharma production and packaging – which operates at a very high speed as the volumes to be handled are high – can be benefited in terms of mass handle, super high cleanliness, accurate measurement, and higher productivity.

In laboratories, developing new drugs or performing some tests, usually involves repetitive tasks such as blending, stirring, titration, moving fluids and test tubes.

Robots are the perfect fit as they provide a high level of accuracy and consistency.

By using robots in such menial tasks, scientist can focus on important activities as new drug development and research.

Robots can work on certain tasks 24/7, thus enabling humans to avoid hazardous zones or repetitive tasks. They help in eliminating human error, increasing accurate repeatability & reproducibility, and removing the potential for human contamination in cleanrooms.

22 ◄ November 2019

Robots can work on certain tasks 24/7, thus enabling humans to avoid hazardous zones or repetitive tasks. They help in eliminating human error, increasing accurate repeatability & reproducibility, and removing the potential for human contamination in cleanrooms.

B&R’s openROBOTICS has opened up new dimensions of robotics for easy and quick integration of robots in any machinery and production lines.

With completely uniform programming for every component in the line – including robotics – customers around the world gain full benefits of holistic approaches to operation, diagnostics, and maintenance. openROBOTICS provides an option for total integration with a possibility of a single controller for robot as well as machine control.

These systems run on open source and are vendor independent, high-speed, real-time network Ethernet POWERLINK and follow a fieldbus independent, open source, and TÜV certified openSAFETY protocol. B&R has already a successful implementation for a human robot collaboration application where the robot is not bounded by cage, and works together with humans satisfying the entire safety requirement.

To the future: Even though pharma has been typically seen as a risk-averse industry, it is slowly and steadily moving towards digitalisation. With the easy to adopt technologies, the barriers are falling down. These new technologies are the actual game changers and lead to higher profitability. B&R offers machine builders and complete hardware & software solutions for the factories, comprehensive service, and hard-earned expertise in automation. Further, B&R enables digitalization of machinery helping machine builders and factories in their digital transformation journey, necessary to remain competitive in this new environment.

Pharma Bio World

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FEEDBACK - The Most Underrated Management Tool Feedback is one of the most effective process for employee development, which in turn takes the organization towards meeting its business objectives.

Still, the entire process is underrated. Although multinationals and giants have started implementing it, many smalland mid-sized enterprises are not up to it. Author, in this article, narrates the importance and relevance of giving FEEDBACK in the right way.

Sanjeev Himachali Principal Consultant & Talent Strategist Ecliptic HR Solutions Private Limited Chief Curator, HRTales 24 ◄ November 2019

E

mployee engagement is a critical contributor to business success and growth. However, organizations and HR are finding it increasingly difficult to engage employees, to get them to be more productive, to perform to the best of their abilities. The Gallup State of the Global Workplace Report 2017 found that nearly 85 percent of the employees across the globe fall in the categories of actively disengaged or not engaged. And even the best talent can feature in the actively disengaged category because the organization/ manager/ leader/ HR is able to make them feel valued or motivated to work. They actively or passively keep looking for newer jobs and better jobs, and when it comes around, they move on. Organizations are at a growing risk of losing the best talent if they are not able to engage them. The inability to retain talent is detrimental in today’s day and age when the war for talent is on.

Accordingly, HR and organizations are making efforts to improve employee performance and productivity through a range of employee engagement initiatives and management measures such as

higher remuneration, lavish perks, CSR initiatives, crafting positive work environments, and so on. In this scheme of things, one very potent management tool that could turn around employee engagement and help create a culture of high performance but is most underrated, is FEEDBACK.

What makes Feedback such a potent and valuable tool?

Feedback by definition is about providing information/ reactions/ statements of opinion about a person’s performance of a task that serves as a basis for improvement. Contrary to popular belief, it is not limited to criticism or have to be negative all the time. Negative feedback and criticism are the types of feedback that managers and leaders should consciously stay away from. There are other preferred types of feedback – positive, constructive, feed-forward, praise, instructional, motivational, etc. – that must be given at the right time, in the right way, and at the right place. Putting it differently, feedback needs to be effective and delivered in a way that employees are able to take actions based on it.

Pharma Bio World

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The Millennial Population Feedback Culture

and

The millennials comprise over 30 percent of the world population and are making up an increasing percentage of the workforce as well. It is predicted that by 2025, they will occupy over 75 percent of the global workforce. Millennials, having grown up in the age of the rapid and constant feedback loops created by social media, seek instant feedback at work too as it helps them learn faster and grow on their jobs. When their need for instant and regular feedback is not met adequately, they feel disengaged at work and do not mind quickly moving onto an employer who will meet this demand.

Effective feedback enables employees to: • Improve job performance by enhancing ability, valuing effort, and recognizing results. It enables them to understand their performance from a third-person’s perspective, providing rich insights on strengths and weaknesses.

• Reduce mistakes on the job and increase their efficiency on the job, if provided consistently, clearly, and constructively. Even top performers may have certain skill gaps (soft skills or interpersonal skills), inadvertent behavior, and other deficiencies that effective feedback can help them rectify before it escalates into something bigger.

• Understand manager ’s/ leader ’s/ organization’s expectations from them and accordingly, set goals and objectives for the short and long terms.

26 ◄ November 2019

• Resolve challenges that they are facing on the personal and professional front that is hindering their performance.

• It also enables them to remove uncertainties, gain confidence, and improve self-esteem as well as self-worth.

Accordingly, several top organizations such as Deloitte, Adobe, Google, etc have adopted a positive and regular feedback culture in place of the 20th Century tool of Annual Performance Reviews (APRs) which works well with the newer generations of employees. The numerous companies that have made this shift to a feedback culture have seen noticeable rise in productivity, performance, profitability and a reduction in absenteeism. This goes to show that an effective feedback culture has a high ROI.

Effective Feedback: How it should be?

• Regular: As discussed earlier, once in a year APRs are passé.

• Engage in meaningful discussions and build positive workplace relationships.

• Timely: It is ineffective if you provide feedback to an employee months after you noticed something that needs to be changed. Effective feedback is proactive and as close to the event as possible.

• Feel more valued and it improves their morale, thereby, enabling them to be more engaged at work.

• Specific: Vague feedback is ineffective. You need to let employees know of the specific context and

• Learn faster if the feedback continuous and constructive.

is

Organizations are at a growing risk of losing the best talent if they are not able to engage them. The inability to retain talent is detrimental in today’s day and age when the war for talent is on.

Pharma Bio World

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and by whom it is delivered; and how the person receiving it processes the feedback cognitively. You may deliver the feedback with utmost respect, empathy, and care in a constructive manner, but it could still lead to deteriorating performance. This is because the employees receiving it may not be equipped to cognitively process the feedback the way it should be and the way you desire it to be perceived.

For instance, employees with a fixed mindset, feel any feedback to be an attack on them. With his/ her natural flight or fight instincts kicking it, they will either fight back/ argue with the person giving the feedback or not take the feedback seriously and continue the way they always work. Employees with a growth mindset, however, consider their skills and abilities to be malleable and look at feedback as a tool for learning and growth. So, it is key that organizations and HR work with employees to help change their mindset and equip them to leverage the powerful tool that FEEDBACK is. instances based on which you are providing feedback for them to understand and use the feedback as actionable insights for the future.

• Constructive: Criticism is a big ‘NO NO’. Negative feedback should also be presented in a constructive way so that employees do not feel that they are attacked, and they are able to take corrective action to learn and grow.

Effective feedback must be appropriate and must be delivered in a tactful and non-threatening manner.

• Dialogue: Effective feedback is always a dialogue between the employee and the leader/ manager/ peer/ coach providing the feedback as it ensures both parties understand each other’s viewpoints and are able to be empathetic to each other. It cannot be a monologue delivered by one party.

28 ◄ November 2019

• Personal: One-on-one feedback is the most effective. It fosters dialogue, mutual understanding, and discussion on possible solutions and better interpersonal relationships.

Employee Mindset Impacts the Way They Process Feedback It is important for everyone in the organization, whether employers or employees, to understand that all feedback does not have the same desired result. Its impact varies on how, when,

Employees with personal traits such as low self-confidence and self-worth often find it difficult to process feedback. If they receive constructive feedback about things they can improve on and things they can avoid, their confidence and self-worth further dips and their performance suffers.

Similarly, employees who seek perfection in everything they do also find it difficult to take feedback. With positive feedback, they keep nitpicking on their performance, not giving due credit to themselves; and with negative feedback, their stress levels

Contrary to popular belief, negative feedback and criticism are the ones that leaders and managers should consciously stay away from. There are other preferred types of feedback – positive, constructive, feed-forward, praise, instructional, motivational, etc – that must be given at the right time, in the right way, and at the right place.

Pharma Bio World

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go through the roof. It is the key to work with such employees and enable them to process feedback better.

How to Give Effective Feedback?

The Key Do-s and Don’t-s: Base your feedback on credible information and be descriptive while providing feedback. Try to focus your feedback on behavior rather than on the employee’s personality or character traits. Most importantly, avoid judgmental language or words. The place, time, content, and the way of delivery are critical in ensuring that feedback is perceived properly and used as actionable insight for performance improvement, learning, and development.

Language Matters: Frame your thoughts appropriately, choose the right words, and then deliver feedback in the most possible

tactful and non-threatening manner. For instance, using the word ‘but’ could be counterproductive as people tense up on hearing the word and it accentuates the negative feedback over the positive feedback.

It would be better if you say something on the lines of, “You could do even better if…”, or “better still…”, etc as these do not take away from the positive feedback.

Listen: Whether you are giving or receiving feedback, you must learn to listen to the other person’s perspectives without interruptions, instead of hearing to argue or defend yourself.

Tying it up with action: Feedback is effective and productive only if it is tied to goal-setting, an action plan, and some review parameters; Ottherwise, it would be a waste of work-hours.

Millennials seek instant feedback at work as it helps them learn faster and grow on their jobs. When their need for instant and regular feedback is not met adequately, they feel disengaged at work and do not mind quickly moving on to an employer who will meet their demand.

30 ◄ November 2019

Embed Feedback in Your Workplace Culture: Giving and taking feedback on a regular basis must become a key part of your organizational culture. This will ensure that every employee, leader, and manager understand that feedback is the basis for professional and organizational development. Therefore they should not shy away from seeking and providing feedback to their peers, managers, and teams. Start with your leadership to ensure buy-in. HR and organizations must take measures to embed feedback in their workplace culture and make it an integral part of the job experience for everyone.

Contact: sanjeev.himachali@ecliptichr.com Pharma Bio World

Why is Pharma Taking Interest in Nutraceutical Industry?

The nutraceutical industry globally can expect rapid growth, faster than pharma, and has a great future in India.

As pharmaceutical products can cost much more than nutraceuticals, the size of the industry in monetary value terms may seem higher, but the reality lies in the volume of production.

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

H

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

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

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

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

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

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

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

A dietary supplement is considered as a product that bears or contains one or more of the following dietary ingredients: A mineral, a vitamin, an amino acid, a medicinal herb or other botanical, a dietary substance for use by human to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.

Nutraceuticals, which do not pose an environmental hazard, may be easier and faster to market. Promotion of nutraceuticals industry will also boost agricultural sector.Farmers could gain from raising specialty crops such as garlic, cranberries, and chicory with disease-fighting properties. Numerous new businesses are taking advantage of promising new markets for medicinal foods.

In contrast to nutraceuticals, pharmaceutical companies need to follow stringent rules and regulations. Their drugs have to undergo extensive test procedures to check the bioavailability, efficacy, and toxicity of the product that they plan to introduce in the market. To bring a medicine to market can take about 10 years and may cost enormously whereas to market an unlicensed nutraceutical can take just fraction of this. No such strict norms are applicable for nutraceutical industry. Also, pharmaceutical products cost much more than nutraceutical products because there are pricing norms in pharmaceutical companies, wherein there is a ceiling on MRP, based on the manufacturing cost of the product.

November 2019 â–ş 31

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

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

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

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

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

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

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

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

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

Nutraceuticals and related complementary therapies clearly have beneficial biological and pharmacological effects, but long-term stability and safety are largely unproved. This is not the case with pharmaceutical products which have long term safety & stability. Also for harnessing the optimal benefits from these products while preventing adverse reactions will increasingly require the better standardization of dosages and formulations. Strategic research planning and the development of internationally 32 â—„ November 2019

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

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

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

Pharma Bio World

Clinical Trials and Data Exclusivity: In Search of a Fine Balance Data Exclusivity refers to a practice whereby, for a fixed period of time, drug regulatory authorities do not allow the test data of the innovator company to be used to register an equivalent generic version of that medicine. This article analyses the concept of data exclusivity and addresses the question of how data exclusivity laws should be introduced in India balancing the competing interests of drug innovators and generic manufacturers.

Bhavik Narsana Partner Khaitan & Co

Soumyadri Chattopadhyaya Senior Associate Khaitan & Co

Yashashree Mahajan Associate Khaitan & Co Pharma Bio World

P

resently, Rule 122E of the Drugs and Cosmetics Rules, 1945 recognises a drug as a "new drug" for a period of 4 years from the earlier of its first approval by the Indian regulators or its inclusion in the Indian Pharmacopoeia.

All applications to manufacture generic versions of such "new drug" during such four years period are required to be made to the central licensing authority (i.e., Central Drugs Standard Control Organization (CDSCO)). Along with such application, the applicant is also required to submit fresh data collected from clinical trials conducted by the applicant.

Some media reports in the past had suggested that the Indian government was mulling a revision in the definition of a "new drug" in the Drugs and Cosmetics Rules, 1945 whereby a drug will be considered to be a "new drug" for a period of 10 years from the current period of four years.

While this proposal was lauded by the Organisation of Pharmaceutical Producers of India 1, it triggered a severe back lash from Indian generic manufacturers who branded this move as 'back door extension' of 'data exclusivity' norms, with India buckling to pressure from the US. They claimed that this would further delay access to clinical trial data and defer introduction of generics and adversely impact the Indian generics industry. The debates clearly reflected palpable tension between the researchbased pharmaceutical companies and the generics manufacturers, at the heart of which lies data exclusivity.

The process of launching a new drug in the market starts in the research laboratory and culminates with four phases of clinical trials to prove efficacy and safety of the

drug to domestic regulators and can be a very costly affair. Generics players, on the other hand, can bring competitor drugs for a fraction of this cost primarily because regulators were able to rely on the presubmitted clinical trial data while approving applications for generic drugs instead of having to run independent clinical trials.

The contours of data exclusivity, therefore, has significant policy implications.

What is Data Exclusivity Internationally, data exclusivity is a protection given to the clinical trial data generated by pharmaceutical manufacturers which prevents the regulator from relying on such clinical data submitted by a manufacturer of a drug for seeking approval of an equivalent generic product. In other words, data exclusivity is a recompense or reward for innovation that enables pharmaceutical companies as a means to recoup its investment by not only monetizing the successfully developed drug but also preventing competitors from using the same data to launch a competing drug.

As we will see below, data exclusivity is available so long as a drug qualifies as a 'new drug' in terms of Rule 122E even where such new drug does not qualify for patent protection. A longer data exclusivity period would mean generic manufacturers would have to carry out longer clinical trials and incur higher costs to come up with generic versions.

This will, therefore, make it more difficult for the generic manufacturers to launch generic versions.

The protection provided by data exclusivity is separate and distinct from the protection granted under the Indian November 2019 â–ş 33

patent regime. In terms of the Patent Act, 1970, a patent may be granted for an invention which is a new product or new process, involving an inventive step and capable of industrial application. While a new form of an existing drug may not be patentable, it would still qualify as 'new drug' under Section 122E of the Drugs and Cosmetics Rules, 1945. Accordingly, any other manufacturer of such new drug would be required to provide independent clinical data while seeking marketing approval for such drugs during the four year period. Thus, data exclusivity and the patent regime are mutually exclusive and separate protections. To illustrate, while patent protection for a new drug would be for a period of 20 years, data exclusivity for the clinical test data would be for four years. Even where a new drug is deemed non-patentable, data exclusivity protection would still be available for the customary four year period.

After expiry of the four year period, the requirement to submit fresh clinical data no longer applies and subsequent manufacturers may seek approval from state licensing authorities (as opposed to the CDSCO as required during the data exclusivity period) to manufacture the formulation while relying on existing data that has been submitted by the original manufacturer. This enables subsequent manufacturers to bring competing drugs into the market cheaper and faster which is one of the drivers of the growth of the generics drugs business in India as well as a key contributor to improving the access to healthcare, globally.

International Exclusivity

Standards

in

Data

Article 39(3) of the TRIPS Agreement 2 requires member nations to protect unfair commercial use of clinical research data submitted by manufacturers of pharmaceuticals and agricultural chemical products for procuring market 34 â—„ November 2019

approval. The protection accorded to member nations is in consideration for the efforts and expenses incurred by the pharmaceutical companies for research and development of the product. The clause in its ambiguity has been a source of academic and political debate among member nations.

The developed nations in its aggressive IP maximalist view insists that data exclusivity is a necessary component of the Article 39(3) of the TRIPS Agreement since allowing generic drug manufacturers to free ride on research data submitted by innovators/manufacturers would violate the essence of Article 39(3).

The developing nations, on the other hand, while recognising the need to protect innovators and the clinical trial data generated by them, argues that reliance on clinical research data by regulators while approving application by generic manufacturers should not amount to unfair competition. The adverse impact of TRIPS Agreement on access to medicine led to the Doha Declaration in 2001 where member countries resolved to give primacy to health over private commercial interest.

While TRIPS prescribes minimum conditions to be followed by member countries to protect intellectual property rights, countries have entered into bilateral or multilateral trade treaties which require countries to strengthen their IP regimes that go beyond the TRIPS mandate. The Trans-Pacific Partnership Agreement (TPP) 3 , for instance, requires member countries to introduce market exclusivity for biopharmaceutical products which requires countries to provide for data exclusivity prohibiting third parties from relying on clinical data submitted by originators without approval from the originator for a period of eight years or for a period of five years plus other market access barriers for

additional three years. The US has also been making the case for enhanced data exclusivity protection globally using the TPP plank.

The European Union Data Exclusivity Directive 2005 requires countries to introduce data exclusivity for new drugs for a period of 11 years of data exclusivity which includes eight years of data exclusivity, two years of market exclusivity with a possibility of a one year extension.

The US Hatch-Waxman Act requires data exclusivity to be granted to innovators for a period of five years and for 12 years, in the case of biologics.

Perspectives on the Data Exclusivity Debate The primary debate around data exclusivity centres around the need to protect the clinical trial data generated by a prior manufacturer from being free-ridden by generic manufacturers, hence being an impediment to sustained investment in innovation.

Traditionally, manufacturers and innovators enjoyed unlimited exclusivity over research data generated by them.

It was observed that the lack of access to existing research data was a major impediment in growth of generic drug manufacturers in US, who were unwilling to undertake steep expenses of conducting independent research trials.

In 1984, Congress introduced the Hatch-Waxman Act in order to promote competition among generic drug manufacturers by reducing the data exclusivity granted to innovators to five years. The Hatch-Waxman Act eased the process of a drug approval by allowing generic manufacturers to demonstrate bioequivalence 4 of their drug to that of an existing drug. Further, by granting exclusivity for a specified period to the first generic drug manufacturer Pharma Bio World

who demonstrates bioequivalence, the Hatch-Waxman Act incentivizes further competition among generics.

Commentators attribute the increased competition and innovation among generics manufacturers as one of direct impacts of the Hatch-Waxman Act. Data exclusivity in India cannot be debated without reference to the Indian pharmaceutical sector which is dominated by generic drug manufacturers, enjoying a market share of about 70 per cent. A vibrant generics sector has led to India becoming a substantial pharmacy of the world with India's exports accounting for 20 per cent of the generic drugs consumed globally. Apart from contributing a large chunk of foreign inflows, the dominance of Indian generic drug manufacturers results in access to cheaper medicines which has a direct impact on public health, globally.

At the same time, it is essential to recognise the importance of clinical trial data exclusivity in fostering innovation.

While the initial research and development of drugs is expensive, a majority of cost is incurred by the manufacturer at the time of clinical trials which are pertinent to prove the safety of the drug. In the absence of data exclusivity, there would be little to no incentive to develop a new formulation of the existing drug or invest in further adapting an existing drug to make it more safe and effective. Indian patent laws have a high threshold for qualifying what is an invention, therefore, modifications or improvements to existing drug would not be able to seek patent protection.

Thus, in the absence of data exclusivity, innovators may be disincentivized to spend on innovation and research which could lead to stagnation in the pharmaceutical market. This would lead to fewer new drugs being introduced which is detrimental to public health.

Pharma Bio World

The success of the US Hatch-Waxman Act has demonstrated that access to clinical research data can lead to innovation among generic manufacturers who can rely on such research to introduce cheaper and safer drugs. Evidently, availability of multiple brands fosters healthy competition in markets and prevents monopolisation where the consumer is the winner. The crux of this debate is fixing the period of data exclusivity to strike a fine balance between incentivizing innovation and enabling generic manufacturers to also come with cheaper variants. To this end, the current data exclusivity period of four years in India, which is lower by international standards and the stance of the developed countries, can also be attributed for the development and success of the Indian generic pharmaceutical sector as well as alleviation of some of the access to medicine problems ailing the world.

The other, slightly nuanced perspective on data exclusivity is pivoted on the need to prove efficacy and safety of generic drugs through the conduct of

independent and appropriate clinical trials including bioavailability and bioequivalence tests. This requirement is currently met under Indian laws which require generic manufacturers to provide bioavailability and bioequivalence of drugs manufactured by them with existing drugs in order to secure a regulatory approval.

However, there are provisions that permit waiver of such tests in public interest.

The concern here stems from the fact that waivers of the bio-availability and bio-equivalence requirements can, sometimes, prove to be counterproductive as the efficacy and reaction of the drugs to the local population may not be fully understood. In any event, bioequivalence studies are usually carried out on a very small set of subjects and at a fraction of the cost of a full-fledged clinical trial.

In 2012, a Parliamentary Standing Committee Report highlighted the worrying trend of CDSCO routinely providing approvals by waiving bioavailability and bioequivalence test November 2019 â–ş 35

TOTAL PAGES 60 ` 150

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The proposal to extend the period of clinical trial data exclusivity from four years to ten years was placed before the Drug Technical Advisory Board (DTAB), the committee that advises the Government on all technical matters and debated. While, this proposal did not go through, the DTAB recommended that licensing authorities should ensure that proper research has been carried out and that the safety of the product has been established by carrying out bio-equivalence studies of the product.

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References 1. OPPI's members are 30 odd foreign multinationals including Abbott, Bayer, Pfizer, and Novartis.

2.

While the access to cheap generic medicine remains a primary goal, the same cannot be achieved at the cost of compromising on quality or safety of generic medicines. Clearly, lack of infrastructure cannot be a good enough reason to waive bioequivalence tests for generic drugs. Further, irrespective of data exclusivity, there is a case for reconsidering the stance in relation to mandatory bioavailability/ bioequivalence tests for generic drugs in the post data exclusivity period.

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not only balances the competing interests of drug innovators and generic manufacturers, but also safeguards the consumers of medicines. Any policy initiative on this front in India must always seek to efficiently counterbalance these parallel interests to not unduly tip the balance in favour of one over the others. To this end, the decision by the DTAB to not disturb the existing data exclusivity equilibrium and instead focus on assessing drug safety through bio-equivalence tests is a step in the right direction.

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requirements. Thereafter, in 2013, the Ranjit Roy Chaudhury Report has also recommended that bioequivalence studies should be made compulsory before market approval is granted for any generic drug except in case of highly soluble molecules in line with the practice in the US. However, these recommendations fell by the wayside as the Drugs Consultative Committee (DCC) was of the view that mandatory bioequivalence testing could not possibly be made mandatory by way of a rule to have uniform application since Indian generic manufacturers do not have the infrastructural capability to implement the proposal. The DCC decided that it was sufficient to require bioavailability/ bioequivalence tests only where there are issues relating to patient safety and variable bioavailability.

The Agreement on Trade Related Aspects of Intellectual Property Rights, 1995

3. Parties to the Trans-Pacific Partnership Agreement are Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, Vietnam, and the United States

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PBW Spotlights » Indian Pharma and Biotech

Industry Globalisation » Latest Developments in Pharma

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4. India requires bioavailability and bioequivalence studies to be conducted to ensure that there is a therapeutic equivalence between the pharmaceutically equivalent test product and the reference product.

» New Product Launches

5.

» Event Alerts and Many More……

Parliamentary Standing Committee of Health and Family Welfare, FiftyNinth Report on the Functioning of The Central Drugs Standard Control Organisation (CDSCO), 2012.

6. Ranjit Roy Chaudhury Expert Committee, Report to Formulate Policy and Guidelines for Approval of New Drugs, Clinical Trials and Banning of Drugs, 2013.

7. 47th Meeting of Drug Consultative Committee, 30, 31 July 2014.

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Feasibility in Clinical Research - Foundation for Clinical Trial Success.

Clinical Trial Feasibility is a process that has several steps starting from Pre-feasibility/ Project level feasibility, country feasibility culminating in site feasibility. The present article aims to look at Clinical Trial Feasibility primarily from a New Drug Development perspective.

However the general principles enumerated here can also be applied with certain modifications for academic clinical trial feasibilities as well.

T

he word "Feasibility" as defined by the Oxford Dictionary states "The state of being easily or conveniently done". Clinical Trials Feasibility forms the foundation for translating the research idea into study execution.

Purpose The process of clinical trial feasibility is one of the first steps in conducting a clinical study. It aims at finding if a research idea can be practically executed by assessing various factors such as the epidemiology of disease in a particular geographic area, the therapeutic paradigm as well as the existing treatment options, eligible patient population, the ethical and regulatory requirements and availability of Investigator, staff and resources for doing the research. In many cases the feasibility process is carried out with a feasibility questionnaire that is customized for the individual study.

Site questionnaires should be designed to accomplish the sponsor's objectives (Goldfarb, 2009, p. 9). In particular, the questions should:

•• Be necessary to the purpose.

•• Be sufficient to the purpose.

•• Be clear and unambiguous.

•• Be straightforward to answer with readily available information.

•• Provide adequate options and space for the answer.

•• Allow a broad range of answers.

•• Accommodate the characteristics of different types of sites.

•• Generate answers that the sponsor can Partha Gokhale Head Clinical Operations Boehringer Ingelheim India Pharma Bio World

interpret and score.

•• Generate answers that the sponsor can validate for predictive ability.

A well-designed questionnaire gives insights into the site's complex, subtle personality.

The idea behind using a uniform questionnaire for all clinical sites is to have responses on those questionnaires that can be compared between sites and even between countries allowing the central study teams to take an informed decision about which sites are to be ultimately selected and which are to be dropped. The present article aims to look at Clinical Trial Feasibility primarily from a New Drug Development perspective.

However the general principles enumerated here can also be applied with certain modifications for academic clinical trial feasibilities which are primarily not drug development focused.

Broadly a clinical trial feasibility process aims to answer the following questions.

1. What is the prevalence and incidence of the disease in the country?

2. How is the disease being treated currently? What are the standard treatment options including the dosage of the drugs used?

3. What are the alternative treatment strategies? Are the alternative drugs approved in the country?

4. What are the ethical and regulatory requirements? Are there any specific requirements e.g. - concerns with use of placebo, compensation of patients for trial related injury etc?

5. Where have the patients under study found specialty; in-patient vs outpatients; primary, secondary, or tertiary healthcare etc?

6. Who are the potential investigators?

7. What can be recruitment rate?

the

potential

November 2019 ► 37

8. Is the study logistically feasiblee.g., availability of translations for patient scales, special requirements for transportation of biological specimens, experience on specialized clinical study procedures etc?

9. What are the limitation or expected bottle necks for smooth execution of the study?

Stakeholders A credible answer to the above mentioned questions in a timely manner can only be achieved by a collaborative approach between various stakeholders in a pharma company. These stakeholders are:

•• Clinical Research Department- This is the most important stakeholder as far as feasibility study is concerned and is responsible for collating and providing the feedback on the feasibility results to the global study teams. It provides input on the operational as well as some medical and regulatory aspects of the study design.

•• Drug Regulatory Affairs (DRA) DRA is primarily entrusted with providing feedback on the regulatory requirements for conduct of clinical studies and on registration of the product in the country. It also provides the status on the registration of comparator molecules and data on intellectual property rights associated with them.

•• Medical Affairs: This is also a very important stakeholder and provides inputs on the medical aspects of the study plan. It provides input on the positioning of the molecule in the current therapeutic paradigm for the disease. The medical affairs department also provides names of the Key Opinion Leaders (KOLs) who could be consulted by the clinical research teams along with the potential 38 ◄ November 2019

study investigators for questions on the study design and characteristics of the patient population.

•• Market Access and Sales DepartmentMarket Access and Sales teams are becoming increasingly important for future clinical development. Market Access teams in particular provide data on the size of the market as well as the competition. In countries where the healthcare is reimbursed by the government, market access will also provide feedback on probability of the new drug being considered on the government's reimbursed list.

Types of Feasibility Clinical trial feasibility is a process that has various steps as shown in the schematic below Pre-FeasibilityProject feasibility

The aim of this process is to find whether the study can be conducted in a particular country or not. This feasibility is usually conducted with a study synopsis or draft protocol. Hence the selection criteria for including the patients in the study are usually finalized by this time. This makes the country feasibility an extremely important part of the feasibility process as it helps in elucidating the capability of the country to recruit patients and thus in calculating the recruitment rate. Country feasibility also helps in identifying the regulatory requirements and the timelines for approval of the study within the country. Usually country feasibility is executed by discussing the synopsis or draft protocol with 5 to 6 potential investigators or KOLs and carefully validating their responses

12-18 months before study initiation

Country Feasibility

9-12 months before study initiation.

Site Feasibility

6-9 months before study initiation.

•• Pre-Feasibility/Project

Feasibility: This is a top line feasibility that is done at least 1 to 1.5 years before the initiation of the study. The intent of this feasibility process is to understand the prevalence of the disease under study in a particular country and also the standard of care used in treating the disease. Data from this feasibility will be used in shortlisting countries for the next level of the feasibility process.

•• Country Feasibility: This is the second level in the feasibility process and is usually conducted at least 9-12 months before initiation of the study.

on the same. Data on the regulatory aspects is also shared with the study teams. On the basis of the feedback provided by the investigators as well as the regulatory timelines a decision is taken on allocation of a particular trial to a country.

•• Site Feasibility:

This is the third level of the feasibility process and is responsible for site as well as investigator selection. Site feasibility is generally done with the help of detailed study specific feasibility questionnaires that evaluate several aspects of the site's and investigator's Pharma Bio World

capabilities. It assesses whether the investigator has the necessary qualifications as well as the experience and has the ability to contribute the required number of eligible patients as given in the study protocol. It also assess the support that is available with the investigator to successfully execute the clinical study like presence of qualified and experienced subinvestigators, study co-ordinators, pharmacist etc. Evaluation of site facilities like a registered institutional ethics committee that is compliant with the local as well as international regulations, time taken by the IEC to accord approval to the study, accredited laboratory, presence of diagnostic modalities like CT scan, MRI, X-ray etc also forms an integral part of this process. In addition to the aforementioned, compliance of the investigator and site to specific local regulations e.g. signed and valid site SOPs (Indian GCP guidelines, 2006), emergency handling facilities, etc. are also evaluated.

The Ground Reality in India Identifying, screening, and qualifying investigative sites is an ongoing challenge for every clinical study team.

The more accurate the initial feasibility assessment, more successful will be the study  meaning projects enrolled on-time and completed within budget.

Although sponsor teams in India have historically met the recruitment commitments, an in-depth analysis reveals that this commitment is achieved due to contribution from only 20-30 percent of the investigative sites (Data On File). The remaining sites either do not contribute or contribute less than half of their original patient commitment. While this does not impose any recruitment risk for diseases with widespread prevalence in India such as Type II Diabetes Mellitus, Asthma, COPD, or common Pharma Bio World

cancers such as Breast and Lung cancer, the lack of accuracy in feasibility numbers imposes challenges to meet the recruitment commitment in rare diseases such as Idiopathic Pulmonary Fibrosis, Cystic Fibrosis, Cerebral Venous Thrombosis, and many rare cancers such as mesotheliomas. The reasons for the inaccurate prediction of eligible patients during feasibility in Indian sites are multivariate.

•• Lack of Patient Database: Historically Indian sites have always relied on the patients visiting their OPDs or IPDs for participation in clinical studies.

They have relied solely on their own memory for providing recruitment data during study feasibilities. This strategy worked well in the past for common diseases as those mentioned above.

If the patients that were a part of the investigator's memory recall were for some reason not found eligible for a study, one or more new patients visiting the OPD (and who were found eligible for the study) could take the place of these patients and the recruitment commitment would be achieved.

However a similar strategy does not work for rare diseases as there may not be enough new patients seen by the investigator that could replace previously identified patients who were subsequently found ineligible.

To further compound the problem, hospitals have only recently started maintaining extensive electronic records of patients. Investigators in western nations as well as many South East Asian countries like South Korea, Singapore, and even China have started maintaining databases of patients with several ailments. These databases are updated through the hospital's MIS (Medical Information System) and hence are up to date with the patients' current disease and treatment profile. This has allowed these countries to have a good patient

contribution in clinical trials on many rare diseases. A similar patient database is sorely needed in Indian sites and is need of the hour.

•• Patient Factors: Although more than 80 percent of patients say they are willing to participate in clinical research studies, only around 10 percent actually do so. (BBK Healthcare, Inc/ Harris Interactive, 2006). Although this data is from UK, this is true for Indian sites as well moresoever after audio video recording of the informed consent process has become mandatory in India (File No GCT/20/SC/ClinJ2013 DCGI, 19 Nov 2013). It is a well-known fact that many potentially eligible patients are uncomfortable with audio video recording and hence ultimately do not consent for the study (Frazen, 2017).

Hence the figures given in feasibility by an inexperienced investigator are usually downgraded by a sponsor.

Usually the rule of the thumb is to have at least a 40-60% reduction in the patient numbers compared to those given by the investigator.

However there are exceptions to the above mentioned rule. In many specialties, India now has a growing number of experienced clinical trial investigators who do provide realistic patient recruitment figures.

•• Inadequate

Discussions on Draft Protocol or Synopsis with Investigators: When feasibility surveys are conducted by the sponsor with the potential investigators, study protocols may be in a draft stage or if "country feasibility" is being conducted, only a "Study Synopsis" may be available at the time. Sponsor teams are often found negligent in that they typically do not invest as much time as is needed in training the personnel who conduct the feasibility. Moreover as most of the feasibilities are done remotely, many November 2019 ► 39

important data points are not effectively communicated to the investigators leading to inadequacy of the recruitment figures given by the later. Investigators on their part are also negligent as they do not give enough importance as well as adequate time when a feasibility request comes from sponsor on a new study. Often the feasibility surveys are filled by study co-ordinators who are not medically qualified and therefore the patient recruitment figures do not accurately reflect the true picture.

Conclusion Given the importance of the feasibility process, it is imperative for senior

personnel within the sponsor's offices like a project manager to review each feasibility questionnaire carefully. Many times inaccuracies in filling the questionnaire can be discovered by simply reviewing the form. Patient commitment figures given in the questionnaire especially by new or inexperienced investigators must be reconfirmed by speaking with the Principal investigators themselves.

This also allows the project manager to gauge the understanding of the potential investigator on the protocol.

In my personal experience, this is quite effective as it leads to correction of many erroneous patient commitment numbers.

Incorrect clinical trial feasibility can cause significant delay in achieving

the recruitment target with significant cost implications and negatively impact an organization, regardless of size or financial stability. The potential for delays can be decreased or mitigated through comprehensive planning and adequate oversight by senior personnel in the sponsor organization who are owners of the feasibility process. Clinical Trial Feasibility is the best means we have for predicting the speed at which Investigators will enroll patients and how the data flow will occur over time and provides a strong foundation for ensuring future clinical trial success.

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Pharma Bio World

A Quality Approach to Components With a steady rise in injectable biologic drugs coming onto the market, there is growing need for safe and effective packaging that addresses the specialized characteristics of these novel therapies. This article discusses increasing demand for quality in drug packaging and the benefits of instuting a Quality by Design (QbD) approach to the design and development of packaging components.

D

riven by concerns for patient safety, regulatory agencies across the globe are asking pharmaceutical companies to build quality into their products from the start to ensure consistent quality throughout a drug products lifecycle. Increasing regulatory scrutiny and quality standards are placing added demands on drug manufacturers and their suppliers. Quality is particularly at the forefront with the influx of new biologic and biosimilar drugs.

Over the past several years, there has been a steady rise in new biologic drugs coming onto the market. This trend is likely to continue in the future, with the QuintilesIMS Institute predicting that biologic treatments for autoimmune diseases, including treatments for rheumatoid arthritis, psoriasis, ulcerative colitis, Crohns disease ,and a range of related disorders will continue to see increasing usage across geographies and will reach USD 75-90 billion in spending by 2021. In addition, biosimilars will be available for several of the leading autoimmune products by 2021, potentially allowing wider use of these medicines. 1 With increasing numbers of injectable biologic and biosimilar drugs becoming available for use by healthcare providers and patients around the world, there is a growing need for safe and effective pharmaceutical packaging that addresses the specialized characteristics of these novel therapies.

The Complex Needs of Biologics

Mike Schaefers Vice President - Global Product Management and Marketing Operations West Pharmaceutical Services, Inc. Pharma Bio World

Biologics and biosimilars offer many patients new hope in the management of their chronic conditions. However, despite the promise for patients, maintaining the safety and efficacy of these cutting-edge

therapies can present unique challenges around packaging, containment, and delivery for pharmaceutical manufacturers.

To begin, many biologic drugs are sensitive, creating potential for interaction with containers and packaging components.

Areas of concern include potential delamination of glass vials, interaction with silicone oil and tungsten from glass syringes, and extractables and leachables from elastomeric closures. All of these issues may compromise with a drugs 'quality and potentially put patients at risk.

Additionally, some biopharmaceuticals require storage at extremely cold temperatures. Such nuances inherent to these advanced therapies are leading drug manufacturers and their packaging and delivery system providers to think differently about containment and delivery to better ensure drug efficacy and patient safety throughout a drug products' lifecycle.

To that end, pharmaceutical manufacturers are now making packaging and delivery systems an integral component of drug development and research, as opposed to an afterthought to address right before bringing a therapy to market.

Increased Regulatory Focus on Quality With many sensitive biologics coming on the market as combination products, the compatibility of packaging components with injectable drugs and their delivery systems is being closely scrutinized. In order for a treatment to be effective, it is important to ensure that the drug delivery system is easy to use, reliable, and effective.

As part of an integrated delivery system, packaging components play an important role in drug quality, patient safety, and device performance. They, therefore, must be given careful consideration as part of the drug development process.

November 2019 â&#x2013;ş 41

F o r e x a m p l e , t h e U S Fo o d a n d D ru g Administration (FDA) defines a combination product as, "A product comprised of any combination of a drug and device; a device and biological product; a biological product and a drug, or a drug, a device and biological product." 2 Manufacturers of combination products in the US must abide by two FDA regulations for good manufacturing practice:

â&#x20AC;˘ â&#x20AC;˘

cGMP Finished Pharmaceuticals part 21 CFR 210-211 QSR Regulation for Devices 21 CFR 820

Some of the primary areas covered by CFR 820, and which differ from CFR 210211, include management responsibility, purchasing controls, corrective and preventive action, and design controls.

As part of the industrialization of syringe plungers using the QbD approach, aspects of CFR 820 must be incorporated into the manufacturing process.

These regulatory requirements are challenging drug makers to look for consistent, reliable, high-quality packaging components that meet the standards of good manufacturing process as well as the high expectations of end users.

Quality by Design for Drug Packaging Components To address these challenges, the adoption of Quality by Design (QbD) concepts in the design and manufacturing of packaging components is gathering momentum within the industry. QbD delivers an improved, data-driven output, providing manufacturers with superior product and process understanding that minimizes risk, emphasizes patient-critical quality requirements, and enhances drug product effectiveness.

The scientific, risk-mitigation based QbD approach is fast becoming an essential strategy for bringing high42 â&#x2014;&#x201E; November 2019

quality therapeutics to market quickly and efficiently. By building QbD principles into design and development from the very beginning, manufacturers can decrease variability in the manufacturing process and the end product. High-quality components designed using QbD processes can enhance the performance of drug delivery systems and protect sensitive drug products with exceptional cleanliness and barrier properties, while helping to ensure patient safety and drug product efficacy.

Combination products such as prefilled syringes, auto-injectors and other selfinjection systems are rapidly gaining momentum among drug manufacturers.

According to the "Drug Delivery Products" report from industry market research f i r m T h e F r e e d o n i a G r o u p 3, d e m a n d for parenteral drug delivery products is projected to rise more than 10 per cent annually to USD 86.5 billion in 2019, with prefillable syringes accounting for the largest and fastest growth among parenteral devices.

Market trends toward home-use and patient self-administration of drugs used to treat chronic conditions have made prefillable syringe systems - and selfinjection systems that utilize prefillable syringes - ideal choices for many singledose drugs. For drug manufacturers, prefilled syringe systems for biologics, vaccines and other injectable drugs offer convenient, fixed-dose options that are easily adaptable to automated injection devices. Additionally, prefillable syringe and self-injection systems may be able to reduce therapy and injection costs, as well as significantly reduce overfill when compared to single-dose vials. Prefillable syringe systems may also optimize the number of doses from the existing drug supply, while offering delivery options that can help to differentiate drug products in an increasingly crowded market.

For patients, prefillable syringe systems offer ease of use and enhanced convenience

for those who require frequent dosing and, when combined with an auto-injector system, can provide a more portable drug delivery system. Use of a prefilled syringe system also has the potential to minimize microbial contamination and reduce medication dosing errors.

By considering the impact that prefillable syringe systems and their components can have on a particular drug product early in the drug development process - and employing QbD strategies to overcome development challenges - drug manufacturers can minimize the risk to quality and position the product to meet the needs of the ongoing drug product lifecycle.

Instituting a Components

QbD

Approach

for

The QbD approach promotes a holistic understanding of the drug product, its integrated delivery system and the manufacturing process. Employing a QbD strategy starts with product development.

When designing and developing a product using QbD principles, manufacturers must define desired product performance goals and identify Critical Quality Attributes (CQAs). The product and process can then be designed to meet those attributes, potentially improving understanding of how material attributes and process parameters impact CQAs and enabling manufacturers to mitigate variability. As a result of this knowledge, a company can continually monitor and update its manufacturing process to ensure consistent product quality.

One class of products in particular that is essential to understand and assess during the QbD process is prefillable syringe plungers. Plungers (also called pistons and stoppers) are critical elements because they serve as the primary seal for container/closure integrity, help maintain the purity of drugs during shelf life, and function to transfer contents of the barrel and deliver drugs to the patient. Plungers Pharma Bio World

are typically made from butyl rubber and can be coated with a fluoropolymer film that can increase lubricity and serve as a barrier between the drug and the elastomer, reducing the potential for extractactables and leachables.

As industry demands for higher-quality components have evolved, there is growing need for plungers developed using QbD processes. The design and manufacturing of high-quality plungers should follow a development lifecycle program that uses a Quality Target Product Profile (QTPP) to establish CQAs for control of breakloose and glide forces. The QTPP can serve as a guideline throughout the development process - which should include riskbased design inputs, Finite Element Analysis (FEA) modeling, data generation on multiple concepts and final product performance verification with barrels from multiple suppliers - to ensure that targeted specification values for breakloose and glide force are met.

By applying a holistic, QbD approach to the design and development of plungers and other prefillable syringe components, packaging manufacturers can gain a thorough understanding of both the product and the process. This, in turn, enables multiple benefits for manufacturers and end users: •

•

Improved Functionality - High-quality plungers can enhance the functionality of prefillable syringes and self-injection systems. Using QbD principles can help to optimize breakloose and glide forces - aspects that are very important when syringes are used in combination with an injection system. By optimizing a delivery system's functional and dimensional performance, it is possible to improve the consistency of injections and the rate of injection times.

Patient Confidence - A self-injection system needs to function consistently

Pharma Bio World

and reliably in order for patients to have confidence that it will work. QbDdesigned components allow for largersize delivery systems and greater dosing volumes which may enable home administration, encourage device use and more accurate dosing, all of which can help boost a patient's confidence in their use of a selfinjection system.

•

Efficient Manufacturing - Employing a QbD approach in the manufacturing process can significantly reduce plunger variation from part to part.

This can help facilitate more efficient manufacturing processes and support a reliable supply of drug products.

Use of QbD principles ensures that components are developed using sciencebased and data-driven decisions, and that they meet critical specification for defects, visible and sub-visible particulate and extractables consistently. The knowledge gained throughout the QbD process can be used on an ongoing basis to maintain continuous improvement by the manufacturer.

Partnering for Quality Drug packaging components play a vital, but often overlooked role in drug safety and efficacy. Growing use of biologics and the trend toward self-administration mean manufacturers need to select components that have a high level of reliability, consistency and compatibility with sophisticated drug products and delivery systems over the course of their lifecycle. Components are a critical part of integrated combination products and are essential to ensuring delivery systems are safe, intuitive and easy to use, but it can be difficult to know which component is the best quality fit for a particular drug product.

Problems with primary containment materials can result in delayed regulatory approvals, packaging variability, and

shortages of needed drug product on the market. All three problems can significantly damage a company's bottom line as well as its reputation. But higher quality can come with higher investment, so the challenge for drug containment manufacturers becomes achieving the balance between managing the costs of provide higher-quality products while staying mindful of the customer's total cost and profitability.

Fortunately, there are new component offerings on the market designed to address the need for high-quality packaging solutions. These include prefillable syringe plungers designed using QbD principles to provide high reliability for breakloose and glide force, dimensional accuracy and consistency, sub-visible and visible particulate control, and low parts per million (ppm) defect attributes.

When selecting components for primary packaging, it is important that drug manufacturers also look for products that have barrier film technology, are vision verified and that are "ready to use."Careful consideration should be given to components that are designed and manufactured according to QbD principles and have optimal levels of dimensional and functional performance. These features can help minimize risk further down the line toward commercialization.

To maximize a drug product's safety and efficacy, pharmaceutical companies and their drug packaging and delivery partners should build new quality principles into the entire manufacturing process, from design and development to commercialization and administration. Selecting a packaging partner with expertise in QbD early in the development process can help drug makers choose a high-quality component for use in prefillable syringe systems that will meet demands for high quality, improved total cost, and increased safety and security for the drug product.

November 2019 ► 43

By working with a packaging partner that employs a QbD philosophy, pharmaceutical manufacturers can employ high-quality p a c k a g i n g c o mp o n e n t s t h a t ca n h e lp lower their total cost of ownership through reduced compliance risk, filling rejection rate and process costs. Full return on investment can be realized once a drug product is commercialized and has gained patient loyalty through ease of use, therapeutic benefit and high confidence in the delivery device. Perhaps most importantly though, components created through a QbD approach offer features that are designed to ensure the highest levels of reliability, which ultimately helps the pharmaceutical industry to achieve its most critical goal: providing the safest and most effective drug products for their patients.

Conclusion From early stage development, through manufacturing, to patient use, modern

biologics and biosimilars require innovative solutions for containment and delivery.

In addition, regulatory agencies and pharmaceutical companies have increased quality expectations in an effort to enhance patient safety.

As the next generation of drugs become available, the limitations of past approaches to containment and delivery are more pronounced, and greater scrutiny should be paid to the interaction between the drug product and its container closure system. Additionally, stability during shelf life, particulate burden and the ease of delivery to patients are important factors to consider.

In order to ensure that biologic drug products are used to their full potential, biologics and biosimilars manufacturers along with their containment and delivery system partners need to collaborate early

in the drug development process to gain a thorough understanding of the needs of both the patient and the drug product.

With this close collaboration, novel primary containment materials and innovative delivery systems can come together to drive product differentiation, patient compliance and caregiver safety for the cutting-edge therapies of the future.

References 1. QuintilesIMS Institute. Outlook for Global Medicines through 2021: Balancing Cost and Value. December 2016.

2. U.S. Food and Drug Administration.

Combination Produc ts . Ac c e s s e d February 2016.

3. The Freedonia Group. Drug Delivery Products. December 2015.

MuMbaI total Pages 60 ` 150 BioPharma South World Expo 2019 4-6 December 2019 HITEX Exhibition Center, Trade Fair Office Building Izzat Nagar, Kondapur PO, Hyderabad, India

Vol 18 | Issue 02 | sePTeMBeR 2019 | MuMBaI | ToTal Pages 60 | PRIce ` 150

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

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

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

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Vol 18 Issue 01

Dear Readers,

Vol 18 | Issue 01 | august 2019 | MuMbaI | total Pages 60 | PrIce ` 150

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Contribute to PBW

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44 â&#x2014;&#x201E; November 2019

Pharma Bio World

Company Profile

Mechanical Power Transmission Engineering Components from Tradelink Services

I

ncorporated in 1993 at Chennai, Tradelink Services is one of the most trusted names engaged in import and exclusive distributor of mechanical power transmission engineering components from prominent companies worldwide, like:

• Comprehensive range of industrial Cardan shafts – TRASMIL, Italy;

• Internationally acclaimed and unique ETP keyless bushes, Sweden;

• European leaders in Poly-V belts, Hutchinson, France;

• Technologically superior range of MAV locking assemblies, Italy;

• Patented vari-speed drives, Planetroll, Germany; and

• Popular and widely accepted ROTAR universal joints, Italy;

• Time-tested established range of collars/rigid couplings, Ruland, USA.

• Technically superior SAMIFLEX flexible couplings, Spain;

A synonym of quality, durability and precision, their range of MPT engineering

• Extensive options of flexible couplings – RU-Steel, Italy; • Pioneers in metal bellow coupling, StS Couplings, Germany;

products are being supplied to leading companies across the country and abroad.

Offer Solutions – not just marketing: This long experience and collaboration with their Principals in the field of mechanical power transmission products has allowed them to identify and solve various problems for their customers all over the country. Tradelink Services offer their services to clients in choosing the right product for their specific application by studying their exact requirements.

Mission: The company strives to attain market leadership in their chosen field of business activity by offering solutions to their clients - at the same time, broadening their perspective, knowledge of new technologies and products in the industrial market.

Vision: To be a valued strategic sourcing partner offering precise, technologically acceptable, optimized solutions to their patrons from their internal resources and that of their International Principals.

For details contact:

Tradelink Services

(Mechanical Power Transmission Engineers) # 5, South Phase Ambattur Indl Estate Chennai 600 058 Tel: 044-26231267, 26242184 E-mail: sales@tradelinkservices.in marketing@tradelinkservices.in Website: www.tradelinkservices.in Pharma Bio World

November 2019 ► 45

marketing initiatives

Innovative Vacuum Solutions in Pharma Industry: The Right Solution from Toshniwal

V

acuum pumps and systems are common place across a tremendous range of industries.

Once the essential principles are understood, the possibilities for application become apparent.

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

Vacuum is simply a pressure that exists below atmospheric pressure.

To create a vacuum in a vessel, a vacuum producing device needs to remove mass

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

The type, quantity of gas handled, and the operating pressure, normally defines what vacuum pump can be used. If the gas consists of mainly non-condensable, then most types of pumps can be used. The choice will be limited if the gas consists of condensable and non-condensable. Therefore, a right solution considering the load of condensable and ultimate vacuum should be struck.

System Selection

To select the best type of system for a particular application, the following list needs to be considered. Once it is determined which criteria is the most important from the list, then the vacuum pump that best meets this can be selected. * Operating cost, * Solvent recovery, * Effect on process, * Materials of construction, * Operating range, * Reliability, * Waste generation, * Pollution abatement, * Emission reduction, * Maintenance cost, * Ease of cleaning, * Serviceability, * Purchase price.

vacuum for purer end-products; reduce the amount of heat energy required for drying, and also to recover any of the solvents evaporated off thereby not affecting thermally sensitive products. Pumps that are reliable and easy to service in the field are the most important for this industry. If an unreliable pump is tried and it fails in the middle of a drying cycle, then the product is not useable and profit is lost.

A typical setup used for this application is combining mechanical roots blower along with oil lubricated vacuum pump. This kind of setup is used to minimize utility costs, drying cycle time and contamination.

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

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

For details contact:

Pharma and Chemical Industry

The pharma and specialty chemical industries use vacuum for distillation and drying. Various types of dryers are used to purify products under vacuum. The chemicals are precisely mixed and then heat is applied in the dryer to evaporate the excess chemicals. This is done under 46 â&#x2014;&#x201E; November 2019

Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26445626, 26448983 E-mail: sales@toshniwal.net Website: www.toshniwal.net Pharma Bio World

press release Cadila Pharma Showcased Its Might at CPhI Frankfurt

Q2FY19. The EBDITA (including other income) came in at ` 20.82 Cr with margins at 24 percent. The PAT at ` 32.66 Cr as against ` 27.34 Cr in Q2FY19, includes recognition of deferred tax asset of ` 16.03 Cr in the current quarter.

The Board approved an interim dividend of 100 percent, i.e. ` 5/- per equity share.

The company also announced the opening of a wholly owned subsidiary in Germany to address the demand in the European market and be strategically located closer to customers across the European continent. This subsidiary would also manufacture value-added products like D3 500 feed grade, D3 100 feed grade, etc in Europe through third parties. These value-added products would typically be new variants utilizing third party resources in terms of plant, equipment, etc. This will strengthen Fermenta Biotech’s position in terms of quality, reach, and tap into new customers without any additional CAPEX.

Ahmedabad, India: Cadila Pharmaceuticals, one of the biggest pharma companies in India and known for innovation and quality, participated in the recently concluded CPhI Worldwide event held in Frankfurt, Germany.

CPhI is one of the biggest pharmaceutical industry buyer-seller meet where pharma stakeholders can come and interact to grow their business. Cadila’s International Formulations team and the Active Pharmaceutical Ingredient (API) team participated in the event where they talked about their products and expertise. Their products which are heavily based on research and development, got a great response from the buyers. The event was held from 5 to 7 November, 2019 in Messi, Frankfurt.

Leading Cadila’s International formulations team at the event, Mr Mahidhwaj Sisodia, Executive Vice President, International Business, said “We are excited to be at CPhI Frankfurt. We are very well poised to serve the growing finished formulations market across the globe. We met delegates from multiple countries and the feedback throughout has been very encouraging.”

The next CPhI event will be hosted in Delhi, India from 26 to 28 November, 2019 expecting to see multiple stakeholders attend the event.

Fermenta Biotech Ltd (formerly DIL Limited) Declared Interim Dividend and also Announced Launch of Backward Integration Project Mumbai, India: Fermenta Biotech Ltd (previously known as DIL Ltd) has recently announced results for the second quarter and first half of the current financial year, in a challenging global business environment. On a standalone basis for the quarter, the total revenue (including other income) stood at ` 85.98 Cr as against ` 130.56 Cr in Pharma Bio World

Commenting on the performance and merger, Mr. Krishna Datla, Managing Director, Fermenta Biotech Ltd said, “We are pleased to announce that The National Company Law Tribunal, Bench at Mumbai has approved the Scheme of Amalgamation between DIL Ltd, and Fermenta Biotech Ltd. This would bring overall efficiency in the running and management of the business. The merger has further strengthened our balance sheet and cash flows, which has enabled us to retire a significant part of long-term debt. The Company has announced an interim dividend of 100 percent and is well placed to implement and execute appropriate returns to the shareholders, with the bandwidth to undertake organic and inorganic growth plans.”

“As part of our ongoing efforts to be a fully integrated entity in the entire value chain of Vitamin D3 production and products, we are pleased to announce that our multi-synthesis plant at Dahej would start manufacturing cholesterol from wool grease soon. This will bring in self-sufficiency; de-risk us from vagaries as experienced in FY2015 apart from cost savings”, he added.

Revenue during H1FY20 was ` 170.09 crores as against ` 214.01 crores in H1FY19. The EBDITA margin was 28.4 percent in H1FY20 as against 35.3 percent in H1FY19. Revenues and margins were under pressure due to decline in prices of Vitamin D3 Animal Feed, a major outbreak of African swine fever in several Asian countries effected consumption which also led to the price decline. In addition, the technical issues faced by one of the largest Vitamin D3 customer of the Company at their production facility, continued to impact the revenue.

In a strategic backward integration move, the Board of Directors has decided to utilize the multi-synthesis plant at Dahej for manufacturing of Cholesterol, a key raw material, from wool grease. Production is expected to commence in Q4 FY20.

Expressing optimism about the future demand, Mr. Datla said, “Looking at the demand for Vitamin D3 backed by growing awareness, we believe that volumes will continue to grow at 15-20 percent CAGR over the next 5 years. We continue to look at avenues to monetise our real estate assets to strengthen our efforts towards transforming from being dependent on Vitamin D3 to a multi-vitamin and value-added ingredient based, Nutraceutical Company.”

November 2019 ► 47

press release Thermo Fisher Scientific Inaugurated 50Th Union World Conference on Lung State-of-the-Art Customer Solution Health Focused on the Prevention of Global Tuberculosis Epidemic Center in Mumbai

Paris, France; Hyderabad, India: The 50th Union World Conference on Lung Health happened in Hyderabad, opened with a call to end the emergency of the global tuberculosis (TB) epidemic, which is responsible for killing some 1.5 million people each year.

“Ending the TB emergency starts right here in India”, said José Luis Castro, Executive Director of The International Union against Tuberculosis and Lung Disease (The Union), convenor of the Union World Conference, which held for the first time in India in half a century.

The Indian government led by Prime Minister Narendra Modi has committed to eliminate TB in India by 2025, five years ahead of the official UN target.

Mumbai, India: Thermo Fisher Scientific Inc, the world leader in serving science, has recently announced the opening of its Customer Solution Center (CSC) in Mumbai. The facility will provide access to the company’s industry-leading offerings of analytical instrumentation, software, and consumables to showcase Thermo Fisher’s strong foothold in India.

“Our customers rely on us to provide advanced solutions and this center gives us the opportunity to demonstrate the depth of our capabilities and comprehensive offerings relevant to the pharmaceutical, healthcare, environmental, and industrial applications”, said Amit Chopra, Managing Director, Thermo Fisher Scientific, India and Middle East. He added, “It is an important milestone that will enable us to deliver greater value for our customers and continue to build on our industry-leading position”.

The state-of-the-art facility in Mumbai is equipped with innovations in liquid-gas-and-ion chromatography, mass spectrometry, trace element analysis, molecular spectroscopy, sample preparation, and a range of laboratory equipment and related consumables. The center is staffed with technical experts and will serve as a hub for conducting trainings and workshops, sample analysis, instrument demonstrations, and method development to help build capacity and expertise in the region.

“The announcement of our Customer Solution Center in Mumbai delivers on our commitment to bring advanced integrated solutions to the country,” said Mitch Kennedy, President, Chromatography and Mass Spectrometry, Thermo Fisher Scientific, US. “The center helps us continue to enable our customers to make India healthier, cleaner, and safer”.

With an ever-evolving industry landscape, the Customer Solution Center will focus on the development of next generation chromatography and mass spectrometry workflow solutions, where customers will be able to work with Thermo Fisher’s technical experts on method development, undergo training, and gain hands-on experience with the equipment.

48 ◄ November 2019

“One in four people in India are living with TB. So it is clear that we cannot end TB globally unless we end it in India. This is why it is so important to get behind the Indian government’s commitment to ending the epidemic”, concluded Castro.

The Union World Conference is the world’s largest gathering of clinicians, policy makers, public health managers, researchers and advocated working to end the suffering caused by lung disease, with a focus specifically on the challenges faced by low- and middleincome countries. Some 3,500 delegates from over 80 countries are expected to attend.

News announced yesterday that work on a vaccine trial is yielding encouraging progress is expected to be followed up at the conference this week with a dramatic reduction in the price of a key prevention drug and the announcement of a major clinical trial aimed at preventing multidrug-resistant TB (MDR-TB).

“We cannot end the TB emergency unless we dramatically scale up the prevention in those parts of the world where we are treating it;” said Dr Jamhoih Tonsing, Director of The Union’s South East Asia Office in New Delhi. “If we are to make inroads into the epidemic here in India and beyond we need to see a radical scale up of preventative therapy that can help to stop the TB transmission cycle.”

The Honourable Vice-President of India, Shri M. Venkaiah Naidu, will officially inaugurate the conference at the Opening Ceremony today.

Speakers at the opening ceremony will also include film and television actress Claire Forlani, Dr Ren Minghui, Assistant Director-General at the World Health Organization (WHO), senior representatives of the State of Telangana, and Nandita Venkatesan, a TB survivor, activist and journalist from Mumbai.

Yesterday, Tuesday 29 October, the conference hosted the inaugural Survivors Summit, which was attended by dozens of survivors of TB and other lung diseases from around the world.

The scale of the TB global health emergency has been acknowledged by the United Nations (UN), which held the inaugural High-Level Meeting on TB in New York last September, culminating in a Political Declaration signed by world leaders committed to ending TB by 2030.

Pharma Bio World

press release B&R Simplifies Automation Technology: Integrated Automation for Pharmaceutical Machinery and Plants

utilization. The APROL EnMon solution is used to collect relevant energy data and generate comprehensive reports for evaluation and interpretation – allowing users to considerably reduce energy costs.

APROL ConMon provides vibration monitoring and analysis based on key condition parameters calculated from acquired process data. It detects cases when service work might be needed and can therefore prevent unplanned system downtime. Together APROL PDA, EnMon, and ConMon help users achieve financial savings while strengthening their competitive edge.

Cytel to Hold Complex Innovative Trial Design Symposium

B&R's integrated automation solutions fulfill all of the requirements of the pharmaceutical industry.

Pune, Mumbai: B&R will be presenting its integrated automation solutions for pharmaceutical machinery and plants at P-MEC 2019 in Hall 10, Stall 10.B29 at India Expo Centre, Greater Noida, India from Tuesday, November 26, 2019 to Thursday, November 28, 2019.

B&R's scalable automation solutions fulfill all of the requirements of the pharmaceutical industry. FDA 21 CFR Part 11 regulations are essential in the pharmaceutical industry and place great importance on digital documentation. All hardware and software from B&R is fully compliant with FDA 21 CFR Part 11 regulations.

Many pharmaceutical products are small, lightweight, and delicate which makes them complex to handle position and move through production lines. Production processes like high-speed bottling and syringe filling, blister packaging, and labeling require intelligent product transport systems that work quickly, precisely, and safely. B&R has introduced a new generation of industrial transport technology that delivers key advantages for efficient production while simultaneously improving product quality. B&R's track-based transport systems ACOPOStrak and SuperTrak feature independent shuttles moved by permanent magnets along a long-stator linear motor track. Product movements are configured individually, including variable speed and acceleration as well as batch grouping and ungrouping. The dramatic increase in processing speed makes the lines more productive.

B&R will also be showcasing the first ever machine vision solution – including cameras, lighting and intelligent image processing algorithms – to be fully integrated into the automation landscape. From simple machine vision sensors to high-end smart cameras, B&R serves a broad spectrum of applications. Ready-made software components are available for creating applications with minimal new programming.

B&R's APROL process control system makes it possible to monitor all lines and plants constantly, helping to reduce maintenance costs and downtime. Moreover, it also optimizes asset availability and Pharma Bio World

Cambridge, UK: Cytel Inc, the leading global provider of innovative analytical software and consulting services to the life sciences industry, has announced the recent happening of their Complex Innovative Trial Design Symposium and East® Training from 6th to 7th November, 2019 at Alexion’s Headquarters in Boston, Massachusetts. The event has brought together industry-leading experts to discuss innovative solutions to pressing challenges including rare disease clinical trials.

Cytel has hosted the annual Complex Innovative Trial Design Symposium and East Training since 2011 to connect global thought leaders and innovators from the pharmaceutical industry in order to facilitate the exchange of ideas and reveal new insights on the latest developments in adaptive clinical trial designs. The event also played a key role in guiding the continual evolution of Cytel’s East platform, the industry-standard software for adaptive clinical trial design and analysis. The guest speakers were from Pfizer, Takeda, and Servier as well as statistical experts from Cytel, Alexion, and Axio.

This year’s symposium focused on overcoming the acute challenges associated with clinical trials for rare diseases, with an emphasis on – how innovative, adaptive clinical trial designs can be exploited to maximize trial efficiency, accommodate specialized data requirements, and enhance rare disease trial success rates. The latest insights and detailed case studies will be shared through a series of engaging presentations, and participants had the opportunity to actively participate in an East training session on day two.

Currently, rare diseases affected around 350 million patients worldwide, with 90 percent of rare diseases still without an approved therapy. In addition, scarce patient resources and lack of disease knowledge regarding the best endpoints and treatment effect size made clinical development for new and effective therapeutics for rare diseases especially difficult.

“In order to overcome the myriad of clinical trial pain points presented by rare diseases, we need to think creatively and adopt a knowledgesharing approach to the clinical development process,” said Yannis Jemiai, Chief Scientific Officer at Cytel. He added, “The symposium will offer a key space to facilitate peer-to-peer exchanges, ideation, and sharing of practical solutions. We are driving forward novel experimental designs and statistical approaches for better clinical outcomes in patients with rare disorders.”

November 2019 ► 49

press release SGLTPL Announced a Business Collaboration with Hakka Sangyo

Hyderabad, India: Standard Glass Lining Technology Pvt Ltd (SGLTPL), a leading manufacturer of chemical and pharmaceutical equipment is going to establish a new manufacturing location at JINNARAM, HYDERABAD with the investment ` 35 cr. Mr. Kundala Nageswara Rao, Managing Director of Standard Group has informed that it shall start commercial operations from the new location from the month of April 2020. Currently SGLTPL has two manufacturing units located in Jeedimetla, Hyderabad set-up with an investment of 35 Crores, manufactures reactors with capacity 63L to 20KL. With the opening of new manufacturing location SGLTPL expects to make about 200 Reactors every Month and also undertake production of vessels up to 32KL. SGLTPL has 400+ Clients and have supplied to customers in Oman, Turkey and Dubai. It has supplied 4000+ rectors till date. In 2018-2019 the Turnover of the company is ` 80 Cr and expects to do a turnover of ` 140 Cr in the Current Financial year.

SGLTPL announced a business collaboration with Japan’s pioneer in manufacturing of Glass Lined Equipment M/s. Hakko Sangyo Co Ltd in Nakatsu, Japan. With this collaboration SGLTPL shall launch Conductivity Glass Lined Reactors for the first time in India. With these reactors, the accidents that occur due to static Discharge would not happen. These would be in market from December 2019.

Along with Jeedimetla, the new branch will also manufacture the same. Even the Reactors with capacity 32,000 liters would also be manufactured in Jinnaram plant. So far SGLT has 400+ clients and 4000+ reactors have been supplied. Oman, Turkey and Dubai also have their clients. Very soon the equipments would be supplied to Russia as well.

GSK Candidate Vaccine Demonstrates Sustained Level of Protection against Active Pulmonary Tuberculosis London, UK: GSK and IAVI have recently reported that GSK’s M72/AS01E1 candidate vaccine significantly reduced the incidence 50 ◄ November 2019

of pulmonary tuberculosis disease (TB) in HIV-negative adults with latent TB infection2. These results demonstrate an overall vaccine efficacy of 50% during the three years after vaccination.

The candidate vaccine has an acceptable safety and reactogenicity profile. The final results are consistent with the primary analysis done after two years of follow-up and published in New England Journal of Medicine in September 2018.

TB is the leading cause of death through infectious disease worldwide and represents a significant public health threat with 1.5 million attributed deaths in 20183. It is estimated that one-quarter of the global population has latent TB infection, of whom approximately 10% will develop active pulmonary TB disease. Currently, multi-drug resistant strains of TB are emerging and spreading globally, and the only available TB vaccine, BCG, does not provide proven and consistent protection in adults in TB- endemic countries4. Without a more effective vaccine, it will not be possible to achieve the World Health Organization target of decreasing the number of new cases by 90 percent and the number of TB deaths by 95percent between 2015 and 2035.

Dr Thomas Breuer, Chief Medical Officer of GSK Vaccines, said: “These results demonstrate that for the first time in almost a century, the global community potentially has a new tool to help provide protection against TB. I want to thank our scientists for their dedicated effort and scientific innovation in developing this impactful vaccine candidate in partnership with IAVI and other key organisations.”

The trial was conducted in TB-endemic regions (Kenya, South Africa and Zambia) and involved 3,573 HIV-negative adults between the ages of 18 and 50 years. Participants who received two doses of either M72/ AS01E or placebo 30 days apart were followed for three years to detect evidence of pulmonary tuberculosis disease. In the final analysis, 13 participants in the vaccine group developed active pulmonary tuberculosis compared to 26 participants in the placebo group. Among participants who received the vaccine, an increased M72-specific immune response was sustained through three years.

Dr. Mark Feinberg, President and CEO of IAVI, said: “These final results show that M72/AS01E could be an important tool in the fight against pulmonary tuberculosis. While additional trials need to be conducted to confirm these findings in other populations, we have never before seen a vaccine that provides protection in adults who are already infected with the bacteria that cause tuberculosis.”

1 The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes 2 WHO, Latent tuberculosis infection: updated and consolidated guidelines for programmatic management, 2018 3 WHO, Global Tuberculosis Report, 2019 4 WHO, Weekly Epidemiological Record, 23 February 2019, vol.93 (pp73-96) : BCG vaccines, WHO position paper Pharma Bio World

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

For more information, please contact: Toshniwal Instruments (Madras) Pvt. Ltd. 267 Kilpauk Garden Road Chennai - 600 010. India Tel: +91 44 26448983 / 8558 Fax: +91 44 - 26441820 Email: sales@toshniwal.net

Fully-automatic Plate Shifter Filter Press In applications where the filter cake may not discharge immediately when shifting the plates due to adhesion to the filter cloth, a hydraulic bump mechanism is available as an attachment to the automatic plate shifter. When the bump option is included, the lift mechanism attached to the shifter carriage on one side of the filter press lifts the filter plate handle on that side of the press and drops it. The force of the filter plate handle impacting the side bar knocks the filter cake loose from the cloth.

An automatic plate shifter eliminates the need for operator intervention during filter cake discharge. It is used in PLC controls, to provide the highest level of filter press automation available.

An automatic plate shifter is desirable when there are multiple filter presses installed in one location, where operator contact with the filter cake is undesirable or where a dedicated operator is not available to shift each filter plate every time the filter press is opened.

The automatic plate shifter features continuously adaptive shifting speed to optimise filter cake discharge times. Shifter speed is varied throughout each plate shift to provide quick and smooth operation.

Automatic plate shifters can also be built with an automated filter cloth washer. Their design is the most compact and efficient on the market. It takes up a minimal amount of space above and around the filter press. It is designed with a variable speed drive so the cloth washer can run fast for a heavy rinse or more slowly for very soiled cloths.

The automatic plate shifter self-corrects crooked filter plates by pushing the plate stack back prior to shifting. If your filter cake is particularly sticky, the shifter speed can be increased to strengthen the pull of the shift.

For more information, please contact:

Thorat Filtration Pvt Ltd A-12, A-Building, 3 rd Floor Garni Indl Park Plot No: C-39/A, TTC Indl Area Pawane MIDC, Navi Mumbai 400 709 E-mail: info@thoratfiltration.com / sales@thoratfiltation.com

Pharma Bio World

November 2019 â&#x2013;ş 51

Planetary & High-speed Dispersion Blades The patented PowerMix combines a planetary blade and a high speed dispersion blade. Both agitators are in constant motion.

The planetary and the high speed disperser blades (PowerMix) rotate on their own axes and also rotate continuously around the vessel. The planetary blade feeds materials directly into the high shear zone of the orbiting high speed disperser. This combination of unique mixing actions combines to eliminate the need for multiple mixers that this one machine can accomplish.

Both agitators are independently variable speed to permit users to fine tune the speeds to the process at hand. The PowerMix is available in sizes from 1/2 through 750 gallons and can be supplied with many options such as vacuum/pressure, jacketed vessels, etc.

For more information, please contact: Ross Process Equipment Pvt Ltd Plot No: D-233/3, Chakan Indl Area Phase II, Village: Bhamboli, Tal: Khed Dist: Pune, Maharashtra 410 501 Tel: 02135-628400, 628401, 628402, 628403 E-mail: mail@rossmixers.com

Short Route to Optimum Drive Solutions Customers are guided through the order process step-by-step.

A wide range of search and sorting functions (eg, motor power, output speed, output torque) facilitate selection of the optimal drive technology. Thanks to the plausibility check, the product configurator in the myNORD customer portal only shows options which match the requirements that have already been entered.

Explanations of the configuration features can be displayed with information symbols. Online configuration and conformity checking of ATEX geared motors is also possible. There is also the option of configuring decentralised drive technology or control cabinet inverters. All configuration steps are carried out on a single screen.

All of the specifications which have been entered as well as the features which are still to be selected are clearly displayed in a box at the right hand side of the screen and are always in view. In addition, 3D models, outline drawings and dimensioned drawings can be generated for the configured drive solutions. Furthermore, customers can simply download the CAD data which has been created and integrate it directly into their CAD program. Even during configuration, all purchase prices are visible and on completion an offer can be called up and the order process triggered.

In the document centre the product documentation for the specific order can be downloaded in a wide variety of languages. Documents include operating and maintenance manuals or spare parts lists. The documents can be downloaded or conveniently forwarded as a link.

The team function enables joint access by all colleagues involved with drive technology within the company - not only to the configurations, but also to all other available data.

For more information, please contact:

NORD DRIVESYSTEMS Pvt Ltd 282/2 & 283/2, Plot No: 15, Village Mann Tal: Mulshi, Adj Hinjewadi MIDC Phase II Pune, Maharashtra 411 057 Tel: 020-39801217, Fax: 91-020-39801416 E-mail: monika.mishra@nord.com / pl.muthusekkar@nord.com

52 â&#x2014;&#x201E; November 2019

Pharma Bio World

Hydrofoil Impellers

Disk Impellers

These are most efficient axial flow impellers.

It is recommended for blending, solid suspension, heat transfer, etc. It provides max flow at minimum power. It is mostly available in three blade version. But different number and width of blade are also common in special applications. This is also called fabricated propeller.

For more information, please contact:

FEDA Inc B-37 Maruti Indl Estate Plot No: 59/1/2/3, Phase 1, GIDC Vatva Ahmedabad, Gujarat 382 445 E-mail: ashok@fedainc.com / reena@fedainc.com

Mostly used for gas dispersion application.

Curve blade (concave, parabolic, etc) disc can handle 2 to 6 times more gas than flat blade disk turbine.

Power drop between gassed and ungassed condition is very less than conventional flat blade disk impellers. Hence, it is preferred choice for gas dispersion applications, viz, fermentation, hydrogenation, oxidation, carbonisation, ethylation, etc.

For more information, please contact:

FEDA Inc B-37 Maruti Indl Estate Plot No: 59/1/2/3, Phase 1, GIDC Vatva Ahmedabad, Gujarat 382 445 E-mail: ashok@fedainc.com / reena@fedainc.com

Flaker Flakers which are also known as cooling drums are used for solidifying molten material. After processing on flakers, such materials can be obtained in the form of films or easily handled flakes which are suitable to further processing or packing into containers for transport.

A great advantage of flaker is that they offer a continuous process. The hot material is applied to the cooling drum by direct immersion into a trough, indirectly using doctor/applicator rolls, etc. The molten liquid is cooled after application on the cooling drum and after a partial revolution the cooled and solidified product is removed by a scraper in the form of flakes or film.

The cooling drum of the flaker is specially designed to provide an even cooling effect by having uniform and effective internal distribution. As a result, both high output and homogeneity of the product are possible. A variable speed drive arrangement enables adjustment of the drum speed for optimum performance.

Material of construction of wetted/contact parts can be SS, carbon steel hard chrome-plated or special metals such as Monel, Inconel, Hastealloy, etc. Optional include hood, rear scraper, flake breaker, flake conveyor, etc. Hood can be of SS, aluminium, FRP, etc.

For more information, please contact:

Tech-Mech Engineers A-227, 16 th A Road, Wagle Indl Estate Thane, Maharashtra 400 604 Tel: 022-25828749 Telefax: 91-022-25827883 E-mail: info@techmecheng.com techmecheng@gmail.com

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November 2019 â&#x2013;ş 53

Distillation Plant with Glass Reactor Ablaze offers customised distillation systems with jacketed glass reactor. It includes vapour column, condensers, reflux provision, phase separator, addition and receiver vessels, along with valves at suitable places and supporting metal structure. The units are supplemented with TCU (thermal control unit) for circulation in jacket of reactor.

For more information, please contact: Ablaze Export Inc E-52/4, Sardar Estate Ajwa Road, Vadodara, Gujarat 390 019 Tel: 0265-2570105 E-mail: info@ablazeexport.com

Mobile Skid Jet Mixer (Injector) The pump creates the pressure before the injector, by the change of section; the speed of the liquid is getting higher and creates a vacuum through the Venturi effect. This enables the mixture of the powder or a liquid with the conveyed liquid. When the inlet powder valve is open, the powder will be introduced particle by particle and directly dissolved into the liquid. The choice of the pump depends on the required transfer time as well as on the viscosity of the end-product.

For more information, please contact: Sawant Filtech Pvt Ltd 102/103 Ram Ashirwad Indl Estate Bldg No: 2, Ram Mandir Road Goregaon (W), Mumbai 400 104 Tel: 022-67251786, 26764171

Heating Cooling Systems for Multi-reactors The user can get closed repeatable temperature control in a wide temperature range can achieve -120 to 300 oC temperature control. Avoid replacement of traditional equipment and facilities, and the maintenance of jacket, the small fluid volume also ensure the rapid response of the control loop and the thermal reaction delay is small.

Built-in electric heating heat transfer oil auxiliary systems, which can automatically turn on the auxiliary heating system according to the demand to reduce the steam use pressure. It can achieve accurate energy saving by accurately matching the heat demand with fast operation.

Control the temperature of the whole reaction process through precise and fast calculation, and perform rapid response for the exothermic and endothermic reactions in the whole reaction process.

Reserve the standardised interface which can increase the heat source heat exchanged module according to actual needs.

Optionally controlling the reaction process temperature and single fluid heating temperature, and the temperature difference between the reaction process temperature and the thermal single fluid temperature is settable and controllable.

It can carry out recipe management and production process records.

For more information, please contact: ATR-ASAHI Process Systems (P) Ltd 668 GIDC, Makarpura, Vadodara Gujarat 390 010 E-mail: prosys@atrasahi.com

54 â&#x2014;&#x201E; November 2019

Pharma Bio World

Thermoplastic Elastomer Tube Imaprene pharma grade thermoplastic elastomer tubing designed for peristaltic pump transfer. Imaprene is opaque tubing especially known for its excellent flexibility and flex crack resistance.Imaprene is manufactured by using world class thermoplastic elastomer.

It is manufactured and packaged in dust-free environment of ISO 9001 QMS, ISO 14001 and OHSAS 18001 Certified facility. It has excellent chemical and solvent resistance (Ex IPA). It is superior flex crack resistance and durable for peristaltic pump application. It has smooth bore to ensure least contamination. It is non-toxic and nonhaemolytic.

For more information, please contact:

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

SS Cartridges SS cartridges are designed to overcome the temperature and chemical compatibility limitations of fabric or synthetic fibre media. This will offer high temperature resistance and can withstand high differential pressure. SS cartridges are offered in SS-304, SS-316 and SS-316 L material. These elements can be plain cylindrical or pleated configuration to increase filtration area. Normally all SS plated and cylindrical filters are supported with coarser filter media to ensure any dirt damages to main filtering media under process upsets. A bubble point tests can be done to certify that no opening larger than the specified pore size exist in product joints or seams. No media migration due to SS material. These elements can be backwashed and reused.

For more information, please contact:

National Card Board Mill Plot No: 140-2/B/2, GIDC Estate Dist: Baruch, Ankleshwar, Gujarat 393 002 Tel: 02646-252569, 222569 Fax: 91-02646-253002 E-mail: ncbmfilter@gmail.com

Brushless Slotted Motors for Surgical Applications Portescap offers a new line of standard prototype motors for surgical applications.

These 15 motors represent Portescap’s new SM Series of surgical motors designed to meet the demanding requirements for surgical devices at a more cost-effective price point. These motors have been optimized for Powered Staplers, large and small bone Orthopedic Tools, Arthroscopic Shavers, ENT Microdebriders and high speed Neuro Drill applications. They are also well-suited for traditional surgical tools, as well as for robotically assisted surgical devices and can be paired with a Portescap sterilizable controller for battery powered applications.

Portescap motors have the proven capability to deliver exceptional surgical results under the most demanding conditions. Portescap’s cost-effective SM motors have been designed and tested to withstand 500+ sterilization cycles. These small motors range in dia from 0.5-1.23 inches, speeds up to 97K RPM, and torques up to 17.5 oz-in.

They are lightweight with low noise and vibration to maximize tactile response and surgeon control in the most delicate of surgeries.

Standard prototypes are available within two weeks, enabling Portescap’s partners to begin testing quickly and shorten their time to market. Portescap’s R&D engineers are well-versed in medical device integration and are eager to collaborate – for partners needing custom solutions; Portescap can optimize a design to meet the exact requirements of the application.

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

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November 2019 ► 55

events diary BioPharma World Expo 2019 ( South )

14Th Biosimilars Congregation 2019

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

Date: 12 December 2019 Venue: Kohinoor Continental, Mumbai, India

About the event: BioPharma World Expo 2019 is the best platform for both Indian and international manufacturers/service providers/startups connected with pharma machinery, CRAMS, CROs/CMOs, packaging, logistics, exports, APIs, generics, biotech, regulatory affairs, etc . It offers a unique opportunity to meet, network, and establish business partnerships. The concurrent conference tracks would highlight latest technological developments, market trends, investment opportunities, and challenges facing the industry. The technical sessions would cover pharmaceutical technology, biosimilars, green chemistry, compliance, etc.

About the event: Biosimilars Congregation Conference intends to unite industry leaders to analyse advanced commercial developments & to identify successful management strategies for Biosimilars. It will discuss the biosimilar product development strategies for Indian Pharmaceutical companies, as the companies have started to look at biosimilars as a lucrative sector owing to the recent regulatory approvals and revenue generating opportunities.

For more information: https://chemtech-online.com/

For more information: https://www.virtueinsight.com/pharma/14th-Biosimilars-Congregation-2019/

Pharma IT Summit

Pharma CMI

Date: 5 December 2019 Venue: The Leela Mumbai, Mumbai, India

Date: 30 - 31 Jan 2020 Venue: Mumbai, India

About the event: Pharma Innovation & Technology Summit is one of the leading conferences themed on the current innovations & technology trends in the Pharma industry. It is one of the foremost industry event in this space which brings together the CIO community from the pharmaceutical industry. It features the world class speakers presenting their real life case studies through enlightening keynotes, in-depth panel discussions, interactive networking activities, thinks tanks, & round table discussions. The Pharma IT Summit also takes an opportunity to honour top IT leaders for delivering innovative solutions and bus their organization in an extraordinary manner.

About the event: Pharma CMI, India is a leading competitive and market intelligence conference, themed on Intelligently Driven Pharma Business. This event is relevant for seniorlevel Pharma, Biotech, and Device professionals. The conference will discuss about the latest updates and the most critical & relevant issues being faced by the competitive & market intelligence community. The conference is themed on driving the future of pharma business through competitive & market Intelligence. The conference aims to understand how the pharmaceutical & biotech companies’ marketing, competitive intelligence, strategy, and operational divisions are staying updated with accurate information about their competitors in today’s dynamic market to keep themselves ahead and to deliver business value. Pharma CMI also gives an opportunity to meet and network with industry thought leaders & peers within competitive intelligence industry in one location.

Highlights of the event: • Learn from thought-leaders, industry veterans as well as the upand-coming faces.

• Interact with industry experts to gain an insight of the industry.

• Explore areas of collaboration between the various stakeholders in the Pharmaceutical Industry.

For more information: https://pharmaitsummit.com/

56 ◄ November 2019

For more information: http://pharmacmi.com/

Pharma Bio World

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

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

The Antidote: Inside the World of New Pharma Author: Barry Werth Price: $ 30.00 No. of Pages: 448 pages Publisher: Simon & Schuster About the Book: This book is about a ground-breaking close-up of Vertex – an upstart pharma company. Here in this time-relevant book, the author Barry Werth has leveraged his experiential insights spanning more than two decades and explained the indispensable world of Big Pharma.

The book is about the rise of charismatic Joshua Boger after his leaving Merck, then America’s most admired business. The book takes the readers to the olden days and narrates a real-life story about founding a drugcompany, which eventually challenged industry giants and transformed health-care. The author described the tumultuous early days of the business, the bold endurance, and the eventual success.

FASTtrack: Pharmaceutical Compounding and Dispensing (FASTtrack Pharmacy) Author: Christopher A. Langley (Author), Dawn Belcher (Author) Price: ` 1,711.00 Pages: 217 Publisher: Pharmaceutical Press About the Book: This book has been designed to assist the students in understanding the key dosage forms encountered with extemporaneous dispensing. The book precisely focuses on the comprehensive take-away for the students through providing concise and bulleted information, key points, tips, and all-time important self-assessment sections. The content has been structured through various MCQs, case-studies, sample essay questions, and worked-out examples. It also includes the ultimate lecture notes and is a must-read for all pharmacy students. Readers can even now have an easy access to online videos demonstrating various dispensing procedures.

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November 2019 ► 57

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R.N.I. No.: MAHENG/2002/08502. Date of Publication: 26th of every month. Postal Registration No: MCS/207/2017-19 Posted at Patrika Channel Sorting Office, Mumbai 400001, on 27th of every month. Total Pages:- 60