Express Pharma (Vol.13, No.13) May 1-15, 2018

CONTENTS

AN ADVANCING SPHERE

Vol.13 No.13 May 1-15, 2018 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty

Rising levels of COPD, including asthma are driving a lot of innovations in inhalers with an aim to improve the overall effective management of these diseases | P12

BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Chief Designer Prasad Tate Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar

MARKET

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FDD CONCLAVE 2018

BIOSIMILARS SUMMIT INDIA 2018 IDMA-APA PHARMACEUTICAL ANALYSTS’ CONVENTION

MANAGEMENT

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PHARMA FORMULATORS DIVERGE ON STRATEGY FOR NON-PRESCRIPTION BUSINESSES: INDRA REPORT

Senior Artist Rakesh Sharma Digital Team Viraj Mehta (Head of Internet ) Dhaval Das (Web Developer) Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East

RESEARCH

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VERSEON PRESENTS ANTICANCER DRUG CANDIDATES TARGETING MULTIDRUG RESISTANT CANCERS

Marketing Team Rajesh Bhatkal Ambuj Kumar Ajanta Sengupta E Mujahid Nirav Mistry

Scheduling & Coordination Santosh Lokare CIRCULATION Circulation Team Mohan Varadkar

PHARMA LIFE

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PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia

PHARMA ALLY

INDIA’S ROBUST GROWTH TO BOOST EMPLOYMENT OPPORTUNITIES IN 2018: MICHAEL PAGE INDIA

Automation solutions for PHARMA industry www.br-automation.com

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EDITOR’S NOTE

Lessons from Orchid Pharma’s story

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fter a long wait, the Ministry of Chemicals & Fertilizers, Department of Pharmaceuticals has formed a task force to build a roadmap for the Active Pharmaceutical Ingredients (API) segment. But the 3-page office memo dated April 18 is already too late for some API manufacturers.

Take the case of Chennai-based Orchid Pharma, which has a total debt of `3,200 crores as per its annual report for 2016-17. The company was a prominent player in injectables and APIs, both capital intensive areas. With margins decreasing thanks to cheaper APIs from countries like China, Orchid Pharma faced shrinking revenues. Unable to pay back its loans, Orchid Pharma’s creditors demanded debt restructuring as well as means to recover their dues.

On August 23 last year, the Chennai Bench of the National Company Law Tribunal (NCLT), admitted a petition filed by one of its largest lenders, Laxmi Vilas Bank, for commencement of the Corporate Insolvency Resolution Process (CIRP).

Orchid Pharma's bankruptcy proceedings attracted a lot of interest as it would be a good fit for many of its peers. The main attraction are its manufacturing facilities, namely two API facilities and three formulation sites in India, all of which reportedly have MHRA and FDA approvals. By October, companies like Aurobindo Pharma, Dr Reddy's Laboratories, Piramal Group and Lupin were reportedly interested suitors for Orchid Pharma including some PE players like KKR though these companies declined to confirm their interest.

While DRL and Aurobindo had dropped out by this February, other names cropped up, like PE Blackstone which was one of four financial entities interested in the deal. Six pharma companies filed expressions of interest with Strides Shasun, Gland Pharma, and Nectar Lifesciences reportedly part of this list. On April 24, Orchid's lenders rejected an offer from Union Quimico, subsidiary of Hyderabad-based Vivimed Labs as too low and called for a second round of bids. Orchid Pharma's fate is not uncommon, with many smaller players already out of the picture.

The talk of reviving India's beleaguered API sector has unfortunately remained just that for at least two years. (Read our Sept 2016 editorial: http://www.expressbpd.com/pharma/editorsnote/reviving-apis/376805/) The April 18 memo also does not inspire too much hope of a speedy solution.

Recognising the obvious, that ‘there is still scope for further integration along the value chain in terms of manufacturing of APls and R&D where the country is importing essential APIs’, the memo states, ‘there is need for concerted efforts to harness the opportunities in the sector’. It goes on to

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The task force on APIs is too late to rescue Orchid Pharma but will hopefully prevent more API makers from burning out

constitute yet another task force of 12 officials, chaired by the Minister of State, Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers.

The redeeming fact is that the task force is inter-ministerial, bringing together senior policy makers from the Department of Commerce, Department of Industrial Policy & Promotion, Ministry of Health & Family Welfare (MoH&FW), Ministry of Environment, Forest & Climate Change, Department of Health Research, Department of Science & Technology, Department of Biotechnology, as well as institutions like the Council of Scientific & Industrial Research, and the Drugs Controller General of India, Central Drugs Standard Control Organization. With all concerned ministries on one task force, one hopes that they will all finally be on the same page.

This is crucial since the past has seen a tug-ofwar between ministries. For instance, while the DIPP, whose mandate is to promote the sector, would like industry-friendly policies, the Ministry of Environment would flag pollution concerns and the MoH&FW, CDSCO would highlight quality and patient safety issues.

Recognising the importance of getting industry on board, the task force may co-opt one member each from associations like IDMA, IPA, BDMA, OPPI (of the rank of CEO) as well as experts from the private sector, other government departments/ ministries as required. One hope that such associations are made part of the process sooner rather than later, to avoid further delay. There have been many proposals for the revival of API manufacturing. However, what is needed now is a balanced and nuanced policy.

The areas of focus span R&D, acquisition and commercialisation, application and adoption in specific sectors, development of the industry, regulatory framework, and lastly, potential impact on industry, job creation, investments, contribution to the economy, technology infusion, exports, integration with value chains. The task force may also study global practices and interact with relevant stakeholders as required. While these terms are vague, can we hope that our policy makers study China's policies and practices for APIs first?

Orchid Pharma’s dreams to dust story has many lessons for API manufacturers and policy makers.

One hopes that the task force does not 'start at the beginning' but takes off from previous efforts. The task force is too late to rescue Orchid Pharma but will hopefully prevent more API makers from burning out. But, time is running out.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET PRE EVENTS

FDD CONCLAVE 2018 to be held in Hyderarabad It seeks to provide a platform for formulation development scientists to gain applicable applicable insights on technologies and innovations in a rapidly evolving segment

A

ccording to a recent report from rating agency ICRA, R&D spends of top domestic companies moderated to 8.6 per cent during 9mFY2018 but are expected to remain at 8.48.6 per cent. There will be a growing focus both on regulated markets and complex molecules/therapy segments such as injectables, inhalers, dermatology, controlled-release substances and bio-similars.

With a projected moderation in R&D spends, it becomes all the more imperative that formulation and drug delivery scientists sharpen their skills and keep up to date to remain flexible to evolving market demands.

Expanding Horizons of FDD Research:

Embracing Complexity The main role of an R&D formulation and drug delivery scientist is to research, develop and optimise product formulations to fulfill the company's market strategy.

However, a crucial part of this role is to ensure these formulations adhere to regulatory mandates for patient safety, efficacy and quality.

Meeting internal expectations of a differentiated product as well as fulfilling external mandates is thus the balancing act that FDD scientists have to perfect.

A third factor is time.

FDD scientists are often working against time, keeping in mind the competitive nature of the pharma sector.

Delays could mean a loss of market share while poor quality could

mean batch recalls and loss of reputation.

Which is why the Indian Express (P) Ltd and Express Pharma, India's leading Pharma Business Magazine,

launched the Formulation and Drug Delivery Conclave (FDD Conclave) in June 2017, with the message: Staying Ahead of the Curve.

FDD Conclave 2017 had insightful sessions on Ensur-

ing Successful Development of Complex Generics, regulatory perspective of Lipids as Excipients in Pharmaceutical Formulations, Advances in Film Coating Technology, Dry Enteric Coatings as a Superior Polymer Technology to Meet Emerging Drug Delivery Demands, and panel discussions touching pertinent issues like FDD strategies to increase compliance in special population segments, and the need to expand India's FDD talent pool.

FDD, in its second edition, will take a deeper dive into evolving regulations which are fundamental to the FDD scientist's role one of the key gatekeepers of a company's future reputation and market leadership.

Some proposed topics: ◗ Product Development Through Integrated Project Management ◗ 505(b)2: Avenues for Development ◗ Regulatory Pathways for Specialty Generics ◗ Impact of Brexit on EU submissions ◗ The Potential of Specialised Injectables ◗ Advances in Powder Processing Technologies

Contact Rajesh Bhatkal T: 09821313917 Email: rajesh.bhatkal@ expressindia.com Vinita Hasija T: 09820590053 vinita.hassija@expressindia.com

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Mumbai to host Biosimilars Summit India 2018 Practical strategies and tactics for pharma and biopharma companies will be discussed with industry experts on development, manufacturing to commercialisation BIOSIMILARS SUMMIT India 2018, slated to be held from from May 10-11, 2018 in Mumbai, is a global platform that lays out the roadmap moving beyond theory to discuss the practical strategies and tactics, for pharma, biopharma companies to succeed in the global biosimilar market. Discussions will be held with industry experts on development, manufacturing to commercialisation – the current landscape, legal, regulatory, funding, challenges, market access strategy, business models and how

to get to market.

Topics which will be discussed during the event are: ◗ Current global biosimilar landscape and policy updates ◗ Opportunities – Business & Investment models ◗ Bioanalytics and interchangability ◗ Legal considerations and market access and commercialisation ◗ Case Studies – from development to market ◗ Biosimilar product portfolios and business strategies

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It aims to create a roadmap for pharma, biopharma firms to succeed in global biosimilar market

◗ Clinical Studies – Pharmacovigilance challenges ◗ Biosimilar manufacturing and latest technologies Who should attend?

Chief Executives, Directors Vice Presidents, Department Head, Leaders and Managers specialising in: ◗ Biopharma/Biotherapeutics ◗ Legal Affairs, Intellectual Property ◗ Health Economics, Pricing and Reimbursement ◗ Research and Development, Formulation ◗ Process Control and

Analytical Technologies, Analytical Characterisation ◗ Pharmacovigilance, Drug Safety & Risk Management ◗ Regulatory Compliance, Quality Affairs/Quality Control ◗ Business Operations, Scientific Affairs, Commercial Affairs ◗ Portfolio Management, R&D, Business Development Contact Rahul Sharma BD Manager rahul.sharma@biotrains.com T: +91 989 272 9885

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MARKET

IDMAto organise IDMA-APA Pharmaceutical Analysts Convention This year's theme in its 20th edition is ‘Best Practices For World Class Generics’ INDIAN DRUG Manufacturers’ Association (IDMA) is organising the 20th IDMA–APA Pharmaceutical Analysts’ Convention (PAC) 2018 across 18-19th May, 2018 in Mumbai. PAC is IDMA's flagship event that focusses on quality, technical, production and regulatory affairs personnel every year, since 1997. This year's theme is ‘Best Practices for World Class Generics’.

It is a platform for eminent technical personnel from the Indian pharma industry, research, academic and regulatory affairs to converge and interact on various recent developments. Senior CDSCO and FDA officials are also expected to attend the event this year along with regulatory authorities from Africa, Russia,

The convention will provide hands-on information regarding global requirements in the field of quality management and regulatory compliance the US, etc.

Some important topics which will be covered at the convention are:

BEST PRACTICES IN PHARMA DEVELOPMENT ◗ Formulations/Analytical & Life Cycle Management

BEST PRACTICES IN

MANUFACTURING OPERATIONS ◗ Containment and handling of Potent Products & Compounds ◗ Current practices in Aseptic Manufacturing ◗ Evaluation Techniques for Containments

BEST PRACTICES IN LABORATORY

◗ Challenges in Testing Primary packaging – Indian Pharmacopoeia 2018 ◗ Challenges in Testing Primary Packaging – US Pharmacopeia ◗ Bridging in-vivo and in-vitro Testing

BEST PRACTICES IN SUPPLY CHAIN ◗ Serialisation for Global Supply Chain ◗ Anti – Counterfeiting Measures The convention will allow delegates to receive hands-on information regarding global requirements in the field of quality management and regulatory compliance. At this workshop, eminent technical personnel from the Indian pharmal industry, research, academic and regulatory affairs will

converge and get together to interact on the various issues and challenges faced by the Industry. It is designed to attract all those involved in: ◗ Pharmaceutical Industry ◗ API, Excipients and Intermediates Manufacturers ◗ Biopharma Industry ◗ Government Laboratories ◗ Equipment Manufacturers ◗ Biotechnology industry ◗ Research Institutions ◗ R&D Machine Manufacturers ◗ Nutraceutical Industry ◗ Academic Institutions ◗ CROs Contact IDMA T: +91-22-24944624/24974308 Fax: +91-22-24950723 Email: admin@idmaindia.com Website: www.idma-assn.org

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IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express (P) Ltd. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications. We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

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MARKET EVENT BRIEFS 8

iPHEX 2018

IPHEX 2018 Date: May 8-10, 2018 Venue: Pragati Maidan Summary: iPHEX 2018 will bring together the drugs, pharma and healthcare industry – all under one roof.

The event will be organised by Pharmexcil and supported by Ministry of Commerce and Industry, Department of Commerce, Government of India.

400 overseas buyers from focus areas are being invited to participate in the exhibition.

Contact Mumbai TV Industrial Estate,

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Biosimilars Summit India 2018

Unit No 211, 2nd Floor, 248-A, S K Ahire Marg, Worli, Mumbai – 400030 T: 91 22 24938750 F: 91 22 24938822

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Formulation Development and Drug Delivery (FDD) Conclave 2018

strategy, business models and how to get to market.

Contact Website: http://biosimilars. biotrains.com

FDD CONCLAVE 2018 BIOSIMILARS SUMMIT INDIA 2018 Date: May 10-11, 2018 Venue: Mumbai Summary: Discussions will be held with industry experts on development, manufacturing to commercialisation – the current landscape, legal, regulatory, funding, challenges, market access

To subscribe: bpd.subscription@expressindia.com

Date: 15-16 June, 2018 Venue: Novotel Airport, Hyderabad Summary: Organised the Indian Express (P) Ltd and Express Pharma, India's leading Pharma Business Magazine, Formulation and Drug Delivery (FDD) Conclave is the platform for technologies, innovations

and applicable insights in a rapidly evolving segment. In its second edition, it takes a deeper dive into evolving regulations which are fundamental to the FDD scientist's role one of the key gatekeepers of a company's future reputation and market leadership.

Contact Rajesh Bhatkal T: 09821313917 Email: rajesh.bhatkal@ expressindia.com Vinita Hasija T: 09820590053 vinita.hassija@expressindia.com

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Global Pack 2018

GLOBAL PACK 2018 Date: 23-25 November, 2018 Venue: Labhganga Exhibition Centre, Indore, MP Summary: GLOBAL PACK 2018 is an International Trade Exhibition & Tech Summit for the packaging material, machinery and ancillary industry. Organised by Integrral Business Exhibitions & Media in association with SIES School of Packaging, it is being designed to serve as a platform for the packaging and printing industry, both in terms of business and technical content.

Contact Email: info@ibem-india.com

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cover )

Rising levels of COPD, including asthma are driving a lot of innovations in inhalers with an aim to improve the overall effective management of these diseases

By Swati Rana

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(

C

hronic Obstructive Pulmonary Disease (COPD) was the fifth leading cause of death in 2002 and will become the third leading cause of death across the globe by 2030, according to WHO. Moreover, its incidence is expected to increase in the coming years due to higher smoking prevalence and ageing populations in many countries. The increase in COPD is one of the major growth drivers of pulmonary drug delivery market. According to markets and markets report, global pulmonary drug delivery market is projected to reach $52.37 billion by 2021 from $36.10 billion in 2016, at a CAGR of 6.5 per cent during the forecast period. The report stated that the growth in this market is mainly driven by rising incidences of respiratory diseases such as COPD, asthma, and cystic fibrosis, increasing preference of pulmonary route of drug delivery and increasing technological developments in the form of smart/digital inhalers.

Although medication and treatment for COPD and asthma are available in oral, injectable dosage forms as well, inhaled therapy is preferred globally, because of the high drug concentration which can be achieved locally within the lungs, with reduced risk of systemic side effects. Global clinical guidelines issued by the Global Initiative for Asthma (GINA) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommend that persistent, moderate-to-severe asthma and COPD at high risk of exacerbations be treated with a combination therapy of inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA), administered via an inhaler. The guidelines also recognise that this therapy is best administered in a fixed-dose combination (FDC) from a single inhaler, rather than from two separate

THE MAIN FOCUS

We need to have smart inhalers which should be able to resolve clinical problems/challenges - how much of drug has entered the lung in the first place.

Children having drug through device may be labelled as a sick child therefore adequate care needs to be taken to make the device attractive Vinod Kumar Arora Principal Advisor, Institute of Good Manufacturing Practices India

We are witnessing innovation of drugs that are long acting and novel devices that improve adherence to treatment. New device engineering that now enables a combination of two drugs in a single inhalation and reduces device resistance that allow patients to take the medicine with ease are some of the other innovations that have a positive impact on treatment and better control of asthma symptoms A Vaidheesh Managing Director, GSK Pharmaceuticals India

The success of inhalation therapies hinges on multiple factors and involve multiple stakeholders including healthcare practitioners (HCPs), the patient, the drug product(s) coupled with the inhaler(s) selected in relation to the disease and patient abilities and preferences Pierre Carlotti VP, Strategic Marketing, Aptar Pharma

inhalers. This is demonstrated by reduced adherence and increased discontinuation rates in patients using multiple inhalers versus those using FDC devices. Thus, inhalers remain a major part of asthma treatment.

Trends in inhalers Currently, inhalers can be divided into three categories nebulisers, pressurised metered dose inhalers (pMDI) and dry powder inhalers (DPI).

Within and between these categories the inhalers differ in

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effectiveness of drug delivery and ease of use.

Explaining the role of each category, Vinod Kumar Arora, Principal Advisor, Institute of Good Manufacturing Practices India says, "The route of pulmonary drug delivery offer advantages such as reduced dosage of drug, less adverse reaction and rapid onset of action. Most nebulised formulations fall into two categories solution containing a drug that is typically dissolved in saline (or occasionally in another solvent or cosolvent with alcohol)

or drug suspension containing a drug that is not soluble in saline or another solvent. In pMDI, the drug is either suspended or dissolved in a propellant that is pressurised. Release of metered volume of drug in propellant through a control valve causes a high velocity aerosol with expansion and evaporation of propellant.

DPI's combine powder technology with device design in order to disperse dry particles as an aerosol in the patient inspiratory air flow. Therefore, a balance between the design of an

inhaler device, drug formulation and the inspiratory flow rate of patient is required."

Another recent trend in applications of pulmonary drug delivery include insulin by aerosol (Afrezza marketed by Mannkind, US), anxiety (Loxapine- marketed by Alexza Pharma), treatment of migraine (DihydroergotamineNDA submitted by Allergen, Zolmitriptan - Phase 1), Breakthrough pain management (Morphine/Fentanyl in Phase 2

by Aradigm), Parkinson's disease (Levodopa in Phase 3

by Acorda Ther), nicotine aerosol for smoking cessation (AERx nicotine in Phase 2 by Aradigm), aerosols for angina, aerosol vaccination and inhaled drug delivery for tuberculosis therapy. Nanoparticles (NPs) are also effective targeted drug delivery systems because of their non-invasive approach and lesser bioavailability in the systemic circulation.

The India scenario However, the scenario in India is completely different. A Vaidheesh - MD, GSK Pharmaceuticals India informs, “Though inhalers are considered by global guidelines as the preferred treatment for asthma, almost 70 per cent of asthma patients in India are still on oral formulations - one of the reasons for this is a strong perception against use of inhalers. Even for the smaller cohort of patients who use inhalers, it is a common observation shared by physicians that patients may not be using their inhalers correctly.

Most of the patients may not even be aware that their asthma is not well controlled despite being on medication.�

According to National Center for Biotechnology (NCBI) reports, current pMDI and DPI inhalers require a complex administration procedure involving several steps like dose loading, inhaler priming, and breathing management in order to ensure maximal

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cover ) benefit of the medication.

These steps require that patients display great dexterity and coordination. Failure to follow the instructions may lead to inhalation errors, some of which reduce, or prevent entirely, deposition of the medication in the lungs.

Arora says, "Currently there are around 300 million asthma and COPD sufferers rely on inhalation devices for effective delivery of their medication. However, using an inhaler is not easy as it takes skill and practice, whatever the design of device to ensure that inhalation and device actuation is synchronised, allowing the correct dose to be taken. To date focus has been on medications, the device design and optimising how both work together in the hand of patients who themselves are a diverse and varied group."

Vaidheesh also believes that inhalation drug delivery, is very crucial part in treatment of asthma but comes with lots of complexities. In order to have a correct dose delivered at the intended site, the doctor needs to recommend a device specific to the needs of the patient.

Though Indian asthmatics use inhalers such as controllers and relievers, a majority still prefer taking pills for asthma

A brighter future However, Arora is also optimistic about the future of inhaler technologies. He says, “The future of inhalation therapy is bright as there exists a medical needs who currently have inadequate treatment options. Key drivers for growth of the global pulmonary drug delivery is rising prevalence of respiratory chronic such as tuberculosis, bronchitis and chronic obstructive pulmonary disease, increasing demand for non-invasive methods, technological advancements such as smart inhaler, increase in smoking, increasing geriatrics population, and change in lifestyle. However, regulatory approvals and patent expiration of blockbuster drugs may

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issues that some asthma patients experience with pMDIs. Another approach contributing to reinforcing ease-ofuse and compliance is device feedbacks typically answered by a few key questions: is my device ready-to-use? Did I take my dose properly? When do I need to refill my prescription?

To answer the latter question, Aptar Pharma offer a range of robust and legible dose counters or dose indicators. Finally, digital health offers a variety of solutions that help tremendously to improve patient compliance and reduce the gap.” c-Prohaler

c-BAI

Photo Courtesy: Aptar Pharma hinder growth of the global market.”

Arora also says, “More patients are now open to taking dry powder inhalers which are considered as the cornerstone of treatment for asthma.

Though we have world class dry powder inhalers in India, battling the perception against inhalers and also ensuring the right technique is used during treatment are the biggest challenges faced by the respiratory segment. Incorrect inhalation technique is particularly common among older people and those with reduced inspiratory flow rate. Indeed, most patients with COPD are unable to use a pMDI or DPI correctly. Common errors include inadequate coordination of inspiration and actuation, and inability to achieve a sufficient inspiratory flow rate.”

Role of innovation Briefing on the innovation in inhalers, Arora says, “With many players in the race to be first to market with inhaled insulin technology innovations developed rapidly. The initial pioneering focus was to develop new highly efficient devices for powder dispersion that used external energy supply to form the aerosols. Later sophisticated particle engineering strategies emerged al-

lowing for the use of simpler and less expensive DPI with superior performance. The improved inhalation technologies -AERx system combined breath control features with a disposable nozzle that produced nearly monodisperse droplets ideal for alveolar deposition that practically eliminated deposition in the oropharangeal region and thus achieved intra subject variability equivalent or superior to SC injection.”

According to Vaidheesh, a lot of research goes behind improving drug and delivery systems in inhalers to improve patient compliance and keep the steps of usage of the device as simplistic as possible.

He says, “We are also witnessing the innovation of drugs that are long acting and novel devices that improve adherence to the treatment. New device engineering that now enables a combination of two drugs in a single inhalation and reduces device resistance that allows patients to take the medicine with ease are some of the other innovations that have a positive impact on treatment and better control of asthma symptoms.”

Pierre Carlotti, VP, Strategic Marketing, Aptar Pharma, opines that the success of inhalation therapies hinges

on multiple factors and involve multiple stakeholders including healthcare practitioners (HCPs), the patient, the drug product(s) coupled with the inhaler(s) selected in relation to the disease and patient abilities and preferences. It is a complex equation in which the patient-drug-device represents the corner stone. Unfortunately, for asthma it is reported that up to 60 per cent of patients fail to take their medication properly. The medical, social, and economic burden associated with non-compliance is tremendous.

Speaking on the innovation done by Aptar, Carlotti, says, “At Aptar Pharma, a major portion of our device innovation effort is oriented towards reducing the gap. One way to address the issue is to optimise existing devices and/or create novel devices that are easierto-teach and to-use such as Prohaler, one of our DPI platforms, that requires only one simple step before inhalation and after inhalation. We have verified the usability of Prohaler in partnership with hospitals clinicians and asthma and COPD patients. The development of simple though efficient Breath-Actuated Inhalers (BAIs) represents another innovative approach to resolve the hand-lung coordination

Moving towards smart inhalers Smart inhalers function in the same way as regular inhalers to deliver medication, but it includes technology for patients and health professionals to track inhaler use. Smart inhalers contain sensors attach to existing inhalers and record when somebody's medication is taken. Smart inhalers use Bluetooth technology to paired wirelessly with a smartphone, tablet, or computer. The market for digital dose inhalers for asthma and COPD will be worth $3.56 billion in 2024, according to a new prediction from Grand View Research.

Increasing investment in research and development of advanced devices, collaborations and partnerships, and technological advancements in smart inhalers are expected to boost the growth of the market in coming years.

According to Smart Inhalers Market Research Report - Global Forecast to 2022, Globally North America is the largest market for Smart Inhalers which is anticipated to reach $888.4 million by 2023.

Europe is the second-largest market in 2016 which is valued at $57.4 million. Furthermore Asia-Pacific market is expected to be the fastest growing market and is projected to grow at a CAGR of 55.3 per cent during the forecast period from 2016-2022.

However, Arora believes

( that certain measures have to taken to make smart inhalers more palatable in India. He says, “We need to have smart inhalers which should be able to resolve the clinical problem/challenge - how much of the drug has entered the lung in the first place. Children having drug through device may be labelled as a sick child therefore adequate care needs to be taken to make the device attractive...

With the rise of wearable devices and activity tracking could smart devices be tethered to a mobile phone through a specially designed app? If patients were not using the device correctly or had forgotten to take their medication could this information be gathered and feedback/reminder mechanism to improve usage? Another opportunity area could be use of biometrics to improve security - safe delivery of the correct drug to the correct individual.”

Carlotti informs that they have already made several moves in this direction, “Several years ago, Aptar Pharma began developing digital health solutions. More recently, we partnered with Propeller Health to develop the first integrated connected pMDI. Aptar Pharma believe connected inhalers and digital health are significant contributors to improving patient compliance issues. Current trends will see mobile phone ownership grow to 70 per cent by 2019 (even higher in developed countries) which means more people will have access to data-driven mobile technology.”

Going forward A digital health approach will help to identify the target patient populations with the highest levels of non-adherence.

By effectively targeting challenging patients and providing them with precise information and prompts to take medication, greater levels of patient engagement and improved dose adherence can be expected, and therefore

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improved health outcomes.

It is also anticipated that smart inhalers will help create a supportive, informed and transparent ecosystem whereby the patient, the

healthcare provider and the pharma company will have real-time access to information that will significantly help improve adherence for the patient. In the short term, it will

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MANAGEMENT

Pharma formulators diverge on strategy for non-prescription businesses: IndRa Report Indian formulators seeking growth amid divestment plans by global formulators

I

ndia Ratings and Research (Ind-Ra) expects Indian formulators to continue to make investments to grow their domestic non-prescription business through organic and inorganic routes. This would be driven by the need to further diversify the domestic prescription business and strong fundamentals. This strategy is in sharp contrast to some global majors looking for strategic alternatives to exit their mature consumer health business.

Investments by Indian formulators are likely to be in consumer healthcare and wellness products, apart from the traditional over the counter (OTC) product categories through new launches, brand extensions and switches from prescription products.

Global MNCs preparing for strategic alternatives: Since 2H17, global majors such as Merck and Pfizer have announced a potential full or partial sale of their consumer health business as well as strategic partnerships for accelerating deleveraging and to focus on the core prescription business.

However, potential buyers are opting out of the transactions on account of low single-digit growth globally and elevated valuations which will lead to a higher proportion of debt in the funding mix. GlaxoSmithKline’s buyout of its stake in the joint venture with Novartis International and the potential sale of consumer healthcare nutrition products to fund the same indicate early signs of consolidation in the consumer healthcare space. The non-prescription business includes products in categories such as analgesics, cough, cold & allergy, dermatological, gastrointestinal and lifestyle OTCs such as vitamins, minerals & nutritional supple-

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CONSUMER BUSINESSES OF GLOBAL MAJORS

ments and dental products. For global majors these businesses contribute 5-25 per cent to their total revenues, with emerging markets contributing 25-50 per cent from the non-prescription businesses.

Strong growth levers for domestic non-prescription market: According to Business

Monitor International (BMI), India’s non-prescription or OTC market contributes around 14.5 per cent to the total pharmaceutical sales and is expected to grow to $4.2 billion at a CAGR of 8.8 per cent over 2017-2022. The growth is likely to be driven by limited household affordability for frequent clinical visits, convenience of direct purchase

and growing preference for selfmedication for minor ailments.

Furthermore, the growth rate in the OTC segment is expected to be among the high growing Asian peers and would continue to outperform the growth rates in developed geographies.

Indian formulators’ growing focus on OTC businesses: Over

the years, Indian formulators have steadily increased presence in the OTC and consumer segments through organic and inorganic routes, to diversify their domestic generic prescription businesses, while leveraging the established distribution network and sales force of the prescription business. However, the current scale

and profitability in the OTC segment are rather insignificant to the overall business risk profile of majority of Indian formulators. Indian formulators Cipla (Cipla Health) and Cadila Healthcare (Zydus Wellness) have explored spin-offs into separate entities (but continue to hold controlling stake) to allow this business to charter its own course and tap into the growing health and wellness consciousness among the urban population. This has also attracted investments from private equity players to support incremental growth.

Large Indian formulators have expressed aspirations to build sustainable businesses with a turnover of `10.0 billion15.0 billion over the medium term to long term. The agency believes Indian formulators will ramp-up presence in the non-prescription business through investments in consumer healthcare and wellness products, apart from the traditional OTC product categories, through brand extensions and new launches. Furthermore, the agency believes the non-prescription business to contribute a solid 15-20 per cent to domestic revenues over the next five years.

nasal decongestant segment have continued to exhibit above-

market growth, the inability to recover from flat-to-low single-

digit growth of some leading multivitamin and antacid

brands in the trailing 12 months may be a cause of concern.

Selective interest by Indian formulators for acquisitions: There is a likelihood of selective interest among Indian formulators in the event of a potential sale of select established brands by global majors. The global consumer portfolios under review by Merck and Pfizer also include key common brands in the Indian OTC space for antacids, pain management, probiotic food supplements, depilatory creams and vitamins as well as select prescription brands in cough and cold and other therapeutic segments included as an incentive to the proposed sale process.

The mature brands in these portfolios contribute 20-50 per cent to India’s revenues, dominated by leadership positions in vitamins, antacids and expectorant/nasal decongestant subsegments. While the brands in haematinics and expectorant/

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MANAGEMENT Switch from prescription to OTCs: Indian formulators have also explored re-launch of prescription products in the OTC avatar such as Sun Pharmaceu-

tical’s Suncros (dermatology), Glenmark Pharmaceuticals’s Kwitz (nicotine gum) and the most recent launch of Lupin’s Softovav (laxative). This strat-

egy is likely to support lifecycle extension for prescription products albeit at a lower price point.

Anti-addiction, laxatives, UV protection categories are likely

to see incremental interest from other players.

Traditionally, the potential for abuse and adverse effects due to inadequate label instructions have restrained approval for proposed switches. However, the Indian government in September 2017 announced its plans to expand the basket of OTC medicines by adding around 100 new drugs to the OTC drug list. While the regulation is positive in terms of formalisation of a regulatory pathway, well-managed pricing, product differentiation, product positioning, engaging advertising and retail strategy of formulators pursuing the switch will determine profitability.

Regulatory interventions such as the ban on fixed dose combinations (March 2016) also have had a disruptive impact on the sale of some of the largestselling OTC brands sold by Indian and global formulators in India. These included Piramal Enterprises Ltd’s Saridon, Procter & Gamble Hygiene & Health Care’s Vicks Action 500 Extra and Reckitt Benckiser (India) Ltd.’s D’Cold. Although formulators have launched brand extensions without the banned combinations and have gradually recouped sales lost due to the ban, similar adverse regulatory actions may serve as hurdles to the OTC growth story.

Divergent dynamics from prescription products: The OTC segment is different from the broader prescription pharma space, as it has several nuances which are uncharacteristic in nature. These include lesser regulatory restrictions such as the inclusion in the national list of essential medicines that affect the pricing of products in the prescription pharma space, ability to grow brands by advertisement and promotion activities and effective communication, multiple avenues to enhance portfolio breadth by the addition of nutraceuticals, wellness FMCG and other segments and high propensity to

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grow brands in other geographies. However despite regulatory harmonisation, competitive elements such as significant investments in media campaigns for enhancing consumer appeal or brand recall to drive in-store visibility for user base retention are hurdles to grow sales and profitability.

A consumer business generally takes about three years to break-even to single-digit EBITDA margins, because of the significant investments required for distribution and sales force; post which, a positive operating leverage coupled with incremental product launches should enable the business to generate mid-teen margins. Established products in the wellness categories can have higher operating margins.

Large Indian formulators with demonstrated brand building capabilities and established distribution network can breakeven faster and achieve profitability early. The margin and return profile of an optimised non-prescription business is structurally better than an acute prescription portfolio but may significantly be lower than for a chronic prescription portfolio.

FMCG players to maintain upper hand in consumer healthcare: The agency does not expect Indian formulators to outwork established FMCG players in the consumer products arena. Indian FMCG players have demonstrated the ability to develop strong local market knowledge with innovative approaches to gain deep consumer insights, leading to a large diversified portfolio across several product categories and economies of scale to aggressively price products However, the product overlap is likely to be only in certain categories where formulators are likely to have a competitive edge due to better brand pull over FMCG players or portfolio gaps not adequately addressed by FMCG players.

MANAGEMENT

Achieving paperless IEC Office,the digital way Sudhir Patel, Chief Operation and Co-founder, Quinary Clinical Research, in this white paper, discusses the concepts and methods to achieve a paperless Ethics Committee submission by automating and eliminating paper forms as well as applications from the processes that currently require such documents to be completed

AN ARTICLE published in June 30, 1975 clearly described “The Office of the Future” which touted the concept of a fully automated office without paper. However currently it seems that instead of eliminating paper we actually have more of it due to the fact that the promise of a paperless office has only been partially realised and much more should be done to fully understand, implement and adopt this system.

There are many definitions of ‘paperless’ but the implied meaning is for a given process or function to be able to function without relying on paper as an input or output. Paper is used to capture data (in the form of forms, applications, surveys, contracts, etc.) in order to transport the data to a person operating the process that relies on the data. Paper is also used to output data, reports and charts to share with people who make decisions in regards to the process.

Being truly paperless is mainly aimed at being “paper-lessened” or “less papered” 1.

The aim of achieving paperless systems that improve data capture and management led to several developments in clinical research during the

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MANAGEMENT recent years that eventually led to major changes to existing procedures. However, going paperless is still considered to be in the best interests of clinical research organisations (CROs)/Independent Ethic committees(IECs)/Institutional Review Boards (IRBs) to remain competitive because a paperless clinical trial would lead to a consistent and streamlined framework. All major regulatory authorities like FDA, EMEA etc. also advocate adoption of technology to increase the efficiency; hence the adoption of this framework should be the goal of any organisation involved in clinical research.

The local regulatory DCG(I) has also implemented online submission process through SUGAM portal to scrutinise the applications through e-Governance. Implementation of SUGAM portal has brought simplicity, transparency, reliability, accountability, timeliness and also simplified ease of business. It is the project of national importance that directly reflects the Government’s Digital India initiatives and is a major influence in bringing reforms in the Indian pharma industry2.

According to the global survey performed by Veeva Systems in 2015 on use of paperless TMF: annual CRO report; more than 57 per cent of CROs reported improved audit- and inspectionreadiness as a result of adopting electronic Trial Master Files (eTMFs). Majority of them specifically cited a reduction in missing documents (92 per cent); misfiled documents (89 per cent); duplicate documents (86 per cent); incomplete documents and/or missing signatures (84 per cent); and expired documents (81 per cent)3. Development of a paperless system which is impregnable, adaptable and durable is always considered as a stumbling block due to several major concerns including interoperability.

While, the increasing cost pressures and complexities of clinical research demand organisations to become more efficient at adopting paperless systems4.

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TABLE 1: BENEFITS OF USING EIECS AGAINST THE CURRENT IECS FRAMEWORK Current IECs

eIECs

Paper based process

Online process

Tedious tracking process

Easy tracking

ROUTING AND STORAGE COSTS Expensive to file and store.Team personnel must look at a document (usually more than once) and decide where it needs to go. Over time, the document must be routed to various people and eventually into storage.

Storage costsvary but one must also factor in the energy and time of the personnel to maintain lists of stored documents and the time it takes to retrieve stored documents.

Much easier to file since electronic documents need to be saved only once and can be stored on high-capacity media for archiving.

LOCATING LOST DOCUMENTS Team personnel must spend time to locate lost documents (sometimes hours or even days); if a document has been filed in the wrong client folder, it may never be located.

Easier to locate using document search index software

SHARING AND COLLABORATING Personnel must spend time to copy and distribute the documents.

Easily distributed with each reviewer working on the same document.

Messages and communication can be easily compiled and centralized

REMOTE ACCESS Must be copied and shipped to remote locations – more energy is expended to file the copy at the remote location.Traveling personnel do not have access to documents unless the documents were copied ahead of time.

Available to all users with proper security across the Internet.

BACKUP/DISASTER RECOVERY Can be destroyed by fire, theft, water, and other natural disasters – once destroyed the documents are impossible to restore without a copy.

Can be easily backed up,copied,archived and transported off-site.Electronic copies take up little physical space and can be restored in little time.

REUSING PAST WORK (BRIEF BANKING) All documents must be searched tediously to find the document with the needed language.

It is easy and quick to search and locate documents.

TRAINING NEW STAFF Confusing folder structures increase amount of time needed to bring new personnel up to speed – the consequence: more errors during the training stage for new personnel.

New personnel are easily trained and quickly pick up the online application process.

ARCHIVING DOCUMENT CURRENT IECS

EIECS

Tedious process with respect to hard file.

Easy process with eIEC

THE CURRENT STATE OF IECs vs eIECs Independent Ethics Committees (IECs) play a key role in the oversight of clinical trials. The current functioning of IECs mainly involve

significant amount of paperwork, increasing the routing and storage costs; traceability issues; delays in sharing and collaborating the documents; difficulties in sharing the files across remote locations; risk

of backup and disaster recovery; lack of quick access to the documents; archival problems and extensive time in training the new personnel. The QCR helps IECs to resolve these difficulties and attain the

dream of being paperless by aiding to perform work without printing a single sheet of paper. The benefits of using Electronic Independent Ethics Committees (eIECs) against the current system of

MANAGEMENT IECs are discussed below in table 1.

HOW TO ACHIEVE A PAPERLESS IEC – CHALLENGES The tools and methods to go paperless have been around for years however only few people have built the expertise in using these tools and methods. More importantly, few companies have the resources to attempt automation with their own resources.

The initial approach to going paperless is three steps for IECs: 1) Recognising cost savings from eliminating paper. Without the right incentive, no organisation can choose to evolve.

2) Looking for systems that can eliminate the paper or reduce the need for paper in the first place.

3) Partnering with a company who can provide the infrastructure, technology and service to deliver on the promise of a paperless office.

However, the challenge with eliminating paperwork is also two-fold - most IECs have found it difficult to assess the cost savings that can be recouped and the technology for automating paperwork is not obvious to most and often implemented poorly. Therefore, it is important to consider certain methodologies and technologies during initial approach for implementing a plan to go paperless5.

Methodologies There are two main methodologies to going paperless.

They include: Systemic Approach: Any system that fully automates a process and displaces the paper originally used will take IECs paperless for that specific process. To ensure it remain fully paperless, it is important to seek and to eliminate the need to print documents that are output by the new system.

Forms platform approach: If the process requires print-perfect documents (even if IECs are not going to print them) then the best method for automating forms is to use a platform technology that inte-

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grates the data to and from your system with the forms in use. This approach is the most effective and easy to maintain when multiple documents need to be automated.

Technologies The best technology to use while being paperless is the Adobe® PDF standard. PDF,

which stands for Portable Document Format, has become the de-facto standard for displaying documents that display and print the same on virtually every computer. Since the early 1990’s Adobe has evangelized the Adobe Reader product to ensure that the majority of computers have a PDF-reader on it. As a stan-

dard, PDF enables companies to secure their documents and enable features such as interactivity, form fields for data capture, dynamic links to external systems and digital signatures (plus many more features).

THE FUTURE IMAGINED eIECs

With eIECs, the operator simply needs a terminal computer to work. The IEC by implementing and adopting eIEC, not only result in being paperless but also aid in: ◗ Eliminating waste: It seems that every company wants to be eco-friendlier. Going with eIEC results in less or almost no printing which means less

MANAGEMENT toner, ink and paper. It also means less transportation, fewer chemical bi-products in the production of toner and less material filling landfills and thus eliminating the waste. ◗ Implementing digital signature: One of the largest impediments to going paperless is the need for ink or ‘wet’ signatures on paper. A wet signature has been ingrained in our society and culture for hundreds of years as the way to verify that someone is committed to the transaction written on the paper. ◗ Increasing productivity: eIECs would save significant amount of time for ethics committee team, support staff, etc. ultimately, allowing them to spend more time to review proposals and increase productivity by 10-30 per cent.

Implementing eIECs would

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With elimination of past roadblocks of limited technology, signatures and expertise to implement, coupled with a return-on-investment, achieving a paperless office is completely possible with eIEC allow easy access of data electronically rather than manually which would increase accuracy, lower costs, reduce data management time and improve productivity5. ◗ Regulatory compliance issues require IECs to keep accurate records, provide thorough documentation on various aspects of clinical trials.

They also require to appropriately handle personally identifiable information. Information on paper tends to be easily misplaced, or simply left lying

around enabling access to the unauthorised personnel thus resulting in security issues1. eIEC helps in reducing these security risks by secured password system and limiting how much information an IEC member can take out the front door.

CONCLUSION Although a paperless office has been promised for over 30 years, it hasn’t been delivered until now. With elimination of past roadblocks of limited

technology, signatures and expertise to implement, coupled with a return-on-investment that is now easy to understand, achieving a paperless office is completely possible with eIEC and to go digital.

REFERENCES 1. François Ragnet; The “Less Paper” Office: How to Reduce Costs, Enhance Security and be a Better Global Citizen; Available from: https://www.xerox.com/downloads/usa/en/t/TL_ whitepaper_less_paper_office_Fr

ancois_Ragnet.pdf; Accessed on: 27th February 2018.

2. e-governance SUGAM Portal; Centre for development of advance computing: https://cdac.in/index.aspx?id=st_ egov_sugam_a; Accessed on: 25th March 2018.

3. Mike Burton, director of CRO Alliances, Veeva Systems; White Paper: Survey Signals Contract Research Organizations Driving A Digital Revolution; Clinical Leader; October 20, 2015.

4. Gupta SK. Paperless clinical trials: Myth or reality? Indian Journal of Pharmacology.

2015;47(4):349-353. doi:10.4103/0253-7613.161247.

5. Paperless clinical trials SCORR Marketing and Applied Clinical Trials; Available From:file:///C:/Users/Bharath/D esktop/SCORR_ACT_PaperlessClinicalTrials-Survey Report2016.pdf; Accessed on: 04th April 2018

RESEARCH UPDATE

Verseon presents anticancer drug candidates targeting multidrug resistant cancers Verseon’s drug candidates target cancer cells by inhibiting the protein tubulin, which leads to cell cycle arrest

V

erseon presented new preclinical studies on its anticancer drug candidates at the American Association for Cancer Research (AACR) annual meeting. The data show that Verseon’s drug candidates are potent against a range of cancer cell lines, including those that exhibit multidrug resistance. While chemotherapy remains the first line of treatment against most cancers, many tumours develop resistance to chemotherapy agents

over time, limiting their efficacy.

A common way for cancer cells to render drugs ineffective is by triggering an overproduction of transporter proteins (efflux pumps) that expel many chemicals, including chemotherapeutics. Verseon’s drug candidates target cancer cells by inhibiting the protein tubulin, which leads to cell cycle arrest. While marketed chemotherapies such as doxorubicin, paclitaxel, and vincristine show up to 2,000-fold reduced potency in cell lines

overexpressing major efflux pumps (MDR1, MRP1, and BCRP), Verseon’s drug candidates are only weakly affected by these transporters (typically less than 2-fold). In addition, cells can become resistant to tubulintargeting chemotherapy drugs by overexpression of ß-III tubulin, but again Verseon’s drug candidates are unaffected.

Verseon also presented pharmacokinetic data for one of its tubulin inhibitors, which show that the candidate is suitable for infu-

sion, a standard mode of administration for chemotherapeutics. The candidate was also well tolerated in a preclinical repeat-dosing study. “We are very encouraged by these preclinical results,” said Dr Sivaraja, who presented the results at the AACR. “Multidrug resistance is one of the main reasons why chemotherapies fail.

The insensitivity of our compounds to the major transporters and to the overexpression of ß-III tubulin may help us

address the need for a more effective, precise therapy.”

Verseon uses a computer-driven drug discovery platform embedded in a comprehensive chemistry and biology workflow to design new drug candidates for a wide range of diseases.

In addition to the oncology programme, the company currently has drug programmes in anticoagulation, diabetic macular edema, and hereditary angioedema.

EP News Bureau

HelperbyTherapeutics announces phase 1 results demonstrating multiple benefits of its unique combination antibiotic therapy HELPERBY Therapeutics presented data at European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) announcing Phase I results on tolerability, pharmacokinetics, pharmacodynamics and efficacy of AZT and colistin both alone and as a combined therapy, against multidrug resistant Enterobacteriaceae (CRE), a serious drug resistant pathogen.

Helperby also presented preclinical data which shows that

AZT is active against carbapenem and colistin resistant Enterobacteriaceae. AZT is a DNA chain terminator and represents a new class of antibacterial agent against the most resistant Gram-negative bacteria.

Further data were presented showing the combination to be active in animal models.

The significance of these data is that the WHO Critical Priority Gram-negative Carbapenem Resistant bacterial pathogens will contribute to the

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10 million deaths which are predicted worldwide by 2050 from treatment-resistant infections.

The combination provides antibiotic enhancement with a low dose of colistin, which is safe and tolerable in humans as demonstrated by the phase 1 results, and so avoids the risk of renal toxicity associated with colistin in higher doses.

Helperby’s new class of ARB antibiotic therapy is one of only a handful of drug candidates that WHO has identified as in devel-

opment to tackle the three WHO Critical Priority pathogens; carbapenem-resistant enterobacteriaceae (CRE), carbapenemresistant acinetobacter (CRAB) and carbapenem-resistant pseudomonas aeruginosa (CRPA).

“Our unique approach of combining antimicrobial resistance breakers such as azidothymidine with existing antibiotics has the potential to reach the market with a new class of effective antibiotic ther-

apy in three to five years,” said Professor Coates, founder and CSO, Helperby Therapeutics.

Dennis Molnar, CEO, Helperby said, “It’s well established that combination therapies prevent the emergence of resistance, and Helperby’s combination technique has the potential to extend the life of lastresort antibiotics which are under huge threat from the accelerating emergence of antimicrobial resistance.”

EP News Bureau

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PHARMA ALLY I N T E R V I E W

‘You name a complex geography; we have a Fabtech story’ Fabtech, a transnational company, has been providing start-to-finish engineering solutions for pharma and biotech companies all over the world, including some very difficult regions like Syria. Aasif Ahsan Khan, Life Engineer & MD, Fabtech shares his company vision and learnings from working in diverse geographies, in an interaction with Lakshmipriya Nair Fabtech's website states, 'Let's make medicines affordable together.' Can you explain how you make this vision possible?

We call ourselves Life Engineers. The work we do to build pharma capability indirectly gives doctors, researchers, lab techs and pharmacists vital tools they need to save lives.

Millions of people across the world die every year from diseases that are both treatable and preventable. Entire families and even villages are sometimes wiped out. Even when the drugs are available, often the cost of treatment is beyond the reach of people at greatest risk.

There is a lot of debate about how big pharma monopolies are responsible, but honestly, the problem is so much more complicated. Investments in research and responsibilities to shareholders often dictate the cost of medicine, even the life-saving variety. It's not ideal, but it is the reality. International bodies like WHO do incredible work to bring affordable drugs to at-risk populations, but it isn't enough.

I believe that the only way to make medicines more affordable and accessible to everyone is to build indigenous pharma capability.

If we make it simple to share technology, if we build indigenous manufacturing capability, we can enable developing and underdeveloped countries across the world to be self-sufficient. They will have the resources they need to contain local disease patterns through indigenous production, to save lives, to bring down the cost of healthcare. Very simply, this is the ethos of life engineering and Fabtech's purpose as an organisation.

How can Fabtech help life sciences companies' accelerate their growth and optimise costs?

Companies the world over are looking to find economies within their existing markets and find opportunities to expand into new ones. We work with customers in 53 countries. We have a network of over a thousand customers, relationships we have built and nurtured over the last 18 years, and we can leverage these relationships to bring out synergies for our customers. We work with Indian companies to explore new business opportunities in pharmaceutical and biotech manufacturing across the world. We support them to overcome manufacturing challenges in these new geographies.

Say a customer wants to expand into a new market, one where Fabtech already has an established base, we can help them facilitate this expansion. We know the lay of the land, the culture, the challenges. We know which companies in those markets are looking to expand their product portfolio with the right technology.

With our start-to-finish (turnkey) project solutions, we can help them manage and minimise their risk. Our emphasis on controlling every stage of the project management cycle in-house ensures we

24 EXPRESS PHARMA May 1-15, 2018

can deliver beyond expectations on every project – whether flexibility, operability or cost optimisations. It is literally the best of all worlds.

How do you partner firms across the globe in building their pharma and biotech capabilities?

Our presence in emerging geographies gives us the ability to help our customers build pharma and biotech capability right from market mapping to product selection to tech transfer, arranging the tech transfer, design and build, commissioning, installation, support to commercialisation.

Plus, we have the huge differentiating benefit of an equipment manufacturing base in India for air, water and process. Our partnerships with European pharma engineering companies allow us to offer solutions that are an ideal mix of state-of-the-art technology and economical pricing. We do about 40 projects a year around the world; our closest competitor does two. This allows us to leverage volumes and deliver economies without compromising on technology or performance.

Can you share some interesting examples of working in countries with different socioeconomic and political conditions?

You name a complex geography; we have a Fabtech story. Syria, particularly, is

close to my heart, because we were born there. Our first project came from Syria. At the time Syria was nowhere on the development map. Just about everything was imported. From that very first project in Syria, we went on to build most of the country's pharma manufacturing capability. We have seen their pharma industry grow from two companies to 75.

When the war hit, most of the companies active in Syria exited. We were the only company to leave our local installation team in place to support our clients. Our guys went beyond the brief and helped even non-customers move expensive equipment and machinery to safer areas.

We have built Ranbaxy's plant in Nigeria. Nigeria is not only a complicated terrain, but security is a prime concern there. We ensure not only project deliverables but also provided logistics support and security for material and teams onsite. Not one screw went missing and not one worker suffered any injuries.

Afghanistan is another market we have supported.

Recently, our team was there hours after the mosque blast in Herat which killed 120 people.

We had our people stationed in Iraq for a long time to support customers.

We seek challenges because we seem to be built for them.

We are drawn to situations that seem impossible. We call

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ourselves a war team. And with good reason.

What are the lessons learned from working in difficult conditions? How have you been applying it other contexts?

For one thing, whatever the conditions we work hard to build excellent relationships with our customers. This goes a long way to understanding their needs and responding to them.

Early on in our history, we realised that you could not deliver projects of this magnitude just sitting in your office in India flying in and out when something goes wrong.

There are several challenges you have to deal with - culture, language, security, regulations.

There are nuances only a local can understand. We consciously and deliberately set out to create local project teams. Having a local presence not only gives clients a sense of comfort - they know you aren't a fly-by-night operation, and it helps us assess risks more accurately and manage projects more efficiently.

We can deliver savings to our customers not just on cost but time and effort wherever possible - technical, logistics or even customs clearance.

Reliving customers of these coordination hassles is the most significant strength we possess, and this comes from our local presence.

We know we can manage projects anywhere in the world

because we have consistently delivered them in impossible conditions. There are others who have tried and failed, and we've gone in and bailed their customers out. What we do may seem easy, but very few have the discipline, the endurance and the courage it takes to make what we do a reality.

What are the factors which will drive the future trends in pharma?

I think five factors will drive change in the pharma landscape.

One, emerging markets are going to increasingly influence global strategy for the pharmaceutical industry.

Increasing spending power in these markets means they cannot be ignored.

Two, there will be more conversations about drug access and affordability driven by the social climate.

Companies will be increasingly compelled to offer data that shows why their expensive medications are worth the premium.

Three, companies will collaborate a lot more, driven by necessity and to stay competitive.

Four, digital is changing the life sciences landscape Amazon just made their entry in the US healthcare space and the industry is going to have to evolve to this reality if they want to stay current.

And five, and this is a big one; the industry will be forever

altered by the millennial and post-millennial generations of entrepreneurs and business leaders. These are people who have grown up in a digital era.

They don't see countries on a map; they see a world united by technology. Big players who live by conventional strategies will need to rethink their approach.

How is Fabtech poised to drive these trends and leverage the growth potential and opportunities that would arise?

Fabtech has one of the youngest demographics in the industry.

More than two-thirds of our people are millennials.

Generation Z or post-millennials have started joining our ranks. Both generations bring a brave new perspective of the world to our thinking, our strategy and our operations.

We will continue to strengthen our relationships with our customers and support them through all their goals and challenges.

Customers will continue to benefit from our single window approach to all their capability building needs from tech transfer to equipment supply and support to commercialisation. We will continue to evolve our operational capabilities with greater control on each element of our operations as well as the whole, so our customers do not have to worry about a thing. lakshmipriya.nair@expressindia.com

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May 1-15, 2018

PHARMA ALLY VENDOR NEWS

Honeywell’s new visualisation technology increases productivity for batch operations Experion batch provides operators with improved visibility, simplified maintenance and faster validation HONEYWELL PROCESS Solutions (HPS) introduced a control technology solution that increases productivity for batch operations and speed-tomarket of batch products by allowing operators to 'look ahead' into their processes and see an intuitive and comprehensive timeline of every task required to complete a product batch.

Honeywell’s Experion Batch, uses patent-pending visualisation technology to provide batch automation processes with the benefits of distributed control capability.

This approach provides operators with insights into upcoming events or potential delays, which make it easier for them to conduct multiple tasks, take appropriate actions sooner and adjust next steps accordingly.

It also makes operations less critically dependent on individual operator experience, which

Experion Batch is designed for industries such as pharma, speciality chemical and food processing, where manufacturers are challenged to increase operator efficiency and product quality while using fewer resources to reduce costs will help manufacturers overcome skill gaps at a time when more veteran operators are retiring.

“Many operators currently say they don’t have enough visibility into their batch processes,” said Matthias Maaz, HPS director of pharma and speciality chemicals. “Not knowing what tasks are coming when or being unable to foresee delays can lead to reduced production. Experion Batch

solves this issue and allows operators to do more with less.”

Experion Batch is designed for industries such as pharma, speciality chemical and food processing, where manufacturers are challenged to increase operator efficiency and product quality while using fewer resources to reduce costs. The technology simplifies ongoing maintenance by eliminating the need for a centralised, dedicated batch server. This

provides added benefit to customers by enablingengineering and maintenance personnel to take a unit controller out of service without affecting other units. Experion Batch also allows plants to easily and quickly transition from recipe testing to execution while reducing testing and validation efforts, and it is aligned with international batch standards ISA S88 and IEC 61512-1.

“Industries using batch

software management solutions are characterised by increasingly complex production processes, more multiproduct lines and increasing numbers of recipes,” said Janice Abel, Principal Consultant, ARC Advisory Group.

“Product innovation and speed to market are vital to the success of these manufacturers. The trend for batch manufacturing is toward realtime manufacturing, which requires closer coordination between the batch and control system software and sensors, and improved operator visibility into the process. Any solution that can improve visibility into what has happened, what is happening now, and how the operator can anticipate subsequent actions should be of high value to batch manufacturers.”

EP News Bureau

Crane’s new Saunders HC4 aseptic diaphragm valve factory comes up in Satara Customers and industry stakeholders will participate in a day-long event complete with a tour of the new plant and visit Maher Home for disadvantaged children CRANE CHEMPHARMA & Energy, Saunders a business of Crane Co and provider of fluid handling solutions worldwide, announced the inauguration of its newest location, an aseptic diaphragm valve factory in Satara, India. To celebrate, Crane has invited customers

26 EXPRESS PHARMA May 1-15, 2018

and industry stakeholders to participate in a day-long event complete with a tour of the new plant to be held on May 10, 2018. Built within the same complex as two other Crane factories, one for Saunders Industrial Diaphragm Valves and another for CentreLine

Butterfly Valves, the new facility will be 100 per cent dedicated to Saunders HC4 aseptic diaphragm valves and actuators. In addition to touring the new plant, attendees will also take part in a groundbreaking ceremony for the Crane-sponsored Maher Home

for disadvantaged children.

“Crane ChemPharma & Energy, known for its charitable works around the world, has a deep-rooted history in India,” said Hari Jinaga, President, Crane India. “With factory locations in Pune and Satara, and 14 regional sales of-

fices located across the country, we wanted to ensure that we are also supporting the local community, and we are so pleased to be able to bring the new Maher Home for Disadvantaged Children to Satara to help in that effort.”

EP News Bureau

PHARMA ALLY PRODUCTS

Gandhi rolling shutters - Quality engineered GANDHI AUTOMATIONS, India’s No. 1 Entrance Automation & Loading Bay Equipment Company, is the only manufacturer of rolling shutters certified to ISO 9001: 2015, ISO 14001: 2015, BS OHSAS 18001: 2007 quality management system. This has resulted in the implementation of continuous improvement in personnel training, production, inspection, equipment calibration, machinery maintenance, logistics and customer relations. The product engineering team uses the latest software combined with technologically advanced machinery to offer to the customer a well-engineered product. Over years of meticulously working on the design, fabrication and installation, Gandhi Automations has developed technical expertise in manufacturing various kinds of automated rolling shutters.

The research and development team, with its extensive know-how and experience, are able to produce specific types of rolling shutters unique to certain sites and client requirements. A consistent quality product has thus become the hallmark of Gandhi Automations' manufacturing process right through installation to after sales service.

Gandhi rolling shutters are ideal for situations where side room is at a premium and security is required. The rolling shutters require very little headroom above the structural opening. They combine strength with elegance along with durability and are designed for both external and internal applications.

Gandhi Rolling Shutters are fabricated of interlocking galvanised insulated and non-insulated, stainless steel, patented aluminum profiles and patented MS rolling grills.

Each of the rolling shutters

is designed to the clients specifications conforming to IS 6248 and solidly constructed to promote trouble-free operation and long life.

Gandhi rolling shutters fit openings to a maximum width of 30,000 mm and height of 40,000 mm with an endless array of options to satisfy both aesthetic considerations as well as working requirement.

To subscribe: bpd.subscription@expressindia.com

Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064, India Off: +91 22 66720200 / 66720300(200 lines) Fax: +91 22 66720201 Email : sales@geapl.co.in Website: www.geapl.co.in

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May 1-15, 2018

PHARMA ALLY VALUE ADD

New Bosch GKF 720 capsule filling machine to be presented at ACHEMA2018 It promises highest safety containment for highly potent pharmaceuticals and meets OEB5 requirements BOSCH PACKAGING Technology will present fast high-precision capsule filling machine for small batches at ACHEMA 2018.

Thanks to the specially designed platform for a fully automated washable containment process, the new GKF 720 ensures efficient and resourcesaving processing for all types of hard capsules.

“The system has been specially tailored to the demands of manufacturers of highly potent solid pharmaceuticals,” says Benedict KleineKoenig, Product Manager, Bosch Packaging Technology. “During the development, the focus was on satisfying their high safety requirements, as well as process precision and stability. The OEB5 containment ensures the highest protection for the operator, machine and product, while its minimal water requirements, 100 per cent defective capsule detection and compact design translate into additional cost savings.”

Building on many years of experience with the 702 ProTect and 1700 HiProTect series, the GFK 720 completes the Bosch containment portfolio with an output of 720 capsules per minute. Washable containment with minimal water consumption In the first cleaning stage of the GKF 720, the components that come into contact with the product are automatically cleaned from above with 200 millilitres of water, binding the highly potent residual dust. In the second stage, the processing area is manually flushed with ten litres of water maximum, quickly and completely ridding it of any product residue. The specially designed tabletop and the new

28 EXPRESS PHARMA May 1-15, 2018

dosing stations make sure that no water penetrates the machine room during cleaning.

“Thanks to the reduced water consumption, the machine can be operated independently from the customer’s water system without a separate water connection,” explains KleineKoenig.

Integrated 100 per cent weight control for pellets and micro-dosed powders The GKF 720 is designed for processing powders, pellets and tablets. For pellets and microdosed powders in particular, it features a patented, automatic height adjusting pellet station and a manually height-adjustable dosing disk. Together with the Net Weight Detection System (NWDS) and the integrated gravimetric check weigher, these features allow consistent in-process control (IPC). The regular adjustment of dosed amounts via IPC ensures a stable, capacitive measuring process throughout the production cycle. ”Depending on the product properties, the NWDS can achieve and constantly maintain a high measurement capacity – with a relative standard deviation of less than one per cent,” says KleineKoenig. Highly modular for quick product changes The GKF 720 is equipped with an extremely flexible plug-and-play station, which supports rapid switching, for instance from pellets to powders.

“For our customers, the growing trend toward dosing different solids in small batches of capsules means frequent product changeovers at relatively short intervals,” says Kleine-Koenig. “The machine’s

modular design offers them the highest possible flexibility: the system can be converted in less than five minutes. Moreover, the exchange of the modules is so simple and fail safe that even an inexperienced operator can do it.”

Extended service portfolio supports with process optimisations Customers can also take advantage of an extended range of services for the GKF 720.

In addition to operator training and the proven after-sales services, Bosch also offers an Engineering Pharmaceutical Service (EPS) for process optimisation. Here, Bosch experts share their extensive product expertise, for example in dosing difficult products.

Contact details Benedict Kleine-Koenig phone: +49 162 4096205 www.boschpackaging.com

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We care for your health DIGESTIVE AIDS ü Alpha amylase / fungal diastase / fungal amylase ü Alpha galactosidase ü Bacterial alpha amylase ü Bromelain ü Hemicellulase ü Lactase ü Lipase ü Ox bile ü Papain ü Pepsin ü Pancreatin ü Protease (acid / alkali)

ANTI-INFLAMMATORY ENZYMES ü Serratiopeptidase ü Peptizyme (enteric coated serratiopeptidase granules) ü Trypsin Chymotrypsin mix (6:1)

PROBIOTICS ü Saccharomyces boulardii ü Lactic acid bacillus ü Bacillus Subtilis ü Lactobacillus Plantarum.

BIOCATALYSTS ü Addzyme Liquid ü Addzyme Powder ü Addzyme Immobilized

CIRCULATORY HEALTH ü Nattokinase

ADVANCED ENZYME TECHNOLOGIES LTD. Sun-Magnetica, ‘A’ Wing, 5th Floor, LIC Service Road, Louiswadi, Thane (W) 400 604 Tel: +91-22-4170 3200 | Fax: +91-22-2583 5159 Email: info@advancedenzymes.com | www.advancedenzymes.com

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• All products are custom made & available in 304, 316 & 316L Quality with optional Matt & Mirror finish.

• We undertake the side work of Cladding of Machinery & others.

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S.S. CABINET FOR MULTIMILL SIEVES

S.S. WRITING DESK WITH DRAWERS

S.S. II CHANGE CROSS OVER BENCH

Contact: Mr. Kiran Shah / Mr. Chirag Shah

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OFFICE: F-823, VEENA SANTOOR BLDG., NEAR PAWANDHAM, BEHIND 'D' MART, MAHAVIR NAGAR EXTN. ROAD, BORIVALI (W), MUMBAI-400092. TELEFAX: 28197068 / 3082 MOBILE: 98200 54453. Email: info@pharmaequipments.com URL: www.pharmaequipments.com WORKS: W6, OM SAI COMMERCIAL COMPLEX, GODDEO ROAD, NEAR EKVIRA GAS GODOWN, BHAYENDER (EAST), THANE - 401 105 TEL: 2819 3082

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PVC RIGID FILM FOR BLISTER FORMING

TRIPLEX LAMINATE

US FDA Type III DMF: 032495

US FDA Type III DMF: 032497

ALU ALU LAMINATE

PVdC COATED PVC FILM

US FDA Type III DMF: 032494

US FDA Type III DMF: 032496

EMERGING AS THE MOST PREFERRED PRIMARY PACKAGING SOLUTIONS PROVIDER FOR THE PHARMA INDUSTRY. CALENDER

Uniworth Enterprises LLP with it's location at Ahmedabad, INDIA, is ideally suited to cater efficiently to the Indian market and with ICD facility and excellent connectivity by road to Nhava Sheva port, Mumbai, can also service the export market with minimum time lag between production and export.

Ÿ Dust Free & Fully Air Conditioned Factory Ÿ Fully Equipped Analytical Lab

SLITTER COATING LINE

Ÿ Producing 60 Micron PVC Film by Direct

Calendering without Stretching. Ÿ ISO 9001:2015 & ISO 15378:2017

Manufacturing site Ÿ 29000 Sq. Mtr. of Manufacturing Area

LAMINATOR

Ÿ 6000 Sq. Mtr. Built-up Area

WE PACKAGE GOOD HEALTH. Corp. Off: 804, Siddhi Vinayak Tower B off. S.G. Highway, Makarba, Ahmedabad -380051 Factory: Chharodi - Sanand (Gujarat) +91 -9726430369 / 7433966038 info@uniworthllp.com • www.uniworthllp.com EXPRESS PHARMA

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BCAP

Autoclavable & Sterile Disposable Goggles Clear view Autoclavable Panoramic Thermoplastic rubber Body Goggles With 40 Autoclave Cycles, Can Be Worn Over Eyeglass With Grid For Marking Autoclaving Goggles

BCAG

BCAH

Clearview Autoclavable Silicon Rubber Goggles With 40 Autoclave Cycle, Can Be Worn Over Eyeglass

BVGS

Cleaview Autoclavable GogglesWith 40 Autoclave With Grid For Marking Autoclaving Goggles

Grid

Bioclean Vijon Sterile Single Use Goggles

Grid For Marking Autoclaving

June Range of Products for free download look for JUNE4GMP

June Enterprises Pvt. Ltd. | www.june4gmp.com quality@june4gmp.com | 022-27787913

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ISO 9001 - 2015 CertiďŹ ed Company

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BUSINESS AVENUES CLEANROOM WIPES

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OSMOMETER 3250

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June Range of Products for free download look for JUNE4GMP

Milk Cryoscopes Available

127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India

Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in

LABORATORY EQUIPMENTS

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Incubator Shaker

REMI SALES & ENGINEERING LTD. Remi House, 3rd Floor, 11 Cama Industrial Estate, Walbhat Road, Goregaon (East), Mumbai - 400 063. India Tel: +91 22 4058 9888 / 2685 1998 Fax: +91 22 4058 9890 E-mail: sales@remilabworld.com l Website: ww.remilabword.com

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May 1-15, 2018

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Supported by

TM

INDIAN PHARMA EXPO & Business usiness Excellence Excellence Awards Aw ards 2018 7th, 8th & 9th August

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www.kesarcontrol.com

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Humidity Chamber

Cold Chamber

Service Network all over INDIA Mfg. Unit : B/8, Karma Industrial Estate, Nr. Trikampura Patiya, Vatva, Ahmedabad - 382445. Gujarat, INDIA. Tele : 079 - 25890727

Mobile : 09427613646 Email : service@kesarcontrol.com

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Do you know about weights calibration?

METTLER TOLEDO is the world's leading manufacturer of weighing instruments and significant supplier of weights, weights sets and related weight calibration services.

· · ·

Accurately calibrated weights are at the base of accurate weighing results.

Balances should always be checked with reference weights you can rely on and trust.

The Calibration Services cover the reporting of convention mass, expanded uncertainty and traceability in accordance with ISO/IEC 17025:2005 requirements.

Mettler-Toledo India Pvt. Ltd. introducing Mass Calibration Laboratory(MCL) for calibration of weights/ weight box.

Benefits:

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Accredited by NABL with accreditation certificate no. CC-2523 MCL meet or exceed ISO/IEC 17025, FDA, GMP and requirements of nuclear industry.

Reference Standard weights with expanded uncertainty (1/5th) of MPE of E1 accuracy class of weights.

Door to door logistic service with insurance on transit damage

For more on Weights Calibration Services Call Toll free No. 1800 22 08884 / 1800 10 28460 Mail us at sales.mtin@mt.com

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PHARMA LIFE

India’s robust growth to boost employment opportunities in 2018: Michael Page India Surge in demand for professionals in pharma and other key sectors

M

ichael Page, a recruitment consultancy has released its India Salary Benchmark 2018 report. The research explores and evaluates the growth across several industries in the Indian markets, the evolution of these sectors and the consequent increase in hiring activity.

The India Salary Bench-

2017, talent acquisition also witnessed an uptick across several sectors. With the Indian government constantly pushing reforms to receive economic growth through proactive measures, Michael Page India is anticipating these optimistic trends to continue across the key sectors.”

India’s economic landscape is a dynamic one, assisted by

With the Indian government constantly pushing reforms to receive economic growth through proactive measures, Michael Page India is anticipating these optimistic trends to continue across the key sectors. mark 2018 report, focusses on multiple sectors such as sales and marketing, legal, digital, engineering, marketing as well as supply chain and procurement of various industry like pharma, medical devices, life sciences, building material, consumer goods etc.

The report stated that India’s progressive economy has created demand for highly-specialised job roles which require skilled professionals. This includes digital marketing heads, head of taxation with GST implementation experience, compliance specialists as well as engineering experts in Cloud, Full Stack, AI and UI/UX. On his insights, Nicolas Dumoulin, MD, Michael Page India says, “Bolstered by the economic growth observed in

44 EXPRESS PHARMA May 1-15, 2018

regulatory adjustments and drives including the Goods and Services Tax (GST) and the Make in India project from the Government of India.

Encouraged by a positive economic setting, India’s employment scenario is anticipated to expand, supporting the country’s robust economic growth. The World Bank forecasts that India’s GDP growth will be 7 per cent for 2017-2018 – a positive sign for Michael Page business. Michael Page anticipates large-tosteady hiring activities within these spaces in the year ahead.

Excerpts from the report which display the current salary range in key job roles within top companies in pharma, medical devices and life science sectors.

REGD.WITH RNI NO. MAHENG/2005/21398, POSTAL REGD. NO. MCS/164/2016 – 18, PUBLISHED ON 5TH / 20TH EVERY FORTNIGHT, POSTED ON 5TH, 6TH, 7TH & 20TH, 21ST, 22ND OF EVERY FORTNIGHT POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE, MUMBAI – 400001

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