Express Pharma (Vol.12, No.15) June 1-15, 2017

VOL. 12 NO. 15 PAGES 82

www.expresspharmaonline.com

Market

Express Pharma to host FDD Conclave in Hyderabad

IT@Pharma

Robotic process automation: A tool to curb costs

1-15 JUNE 2017, ` 40

CONTENTS MARKET

Vol.12 No.15 June 1-15, 2017 Chairman of the Board

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Viveck Goenka Sr Vice President-BPD

EXPRESS PHARMA TO HOST FDD CONCLAVE IN HYDERABAD

Neil Viegas

20

Editor Viveka Roychowdhury* Chief of Product Harit Mohanty

21

BUREAUS Mumbai Usha Sharma, Raelene Kambli,

PHARMA PRO&PACK EXPO 2017 TO BE HELD IN HYDERABAD GENERICISATION EVOKES FIERCE DEBATE AT THIRD EDITION OF VANTAGE POINT

Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Senior Designer

TAKING THE GREEN PATH Express Pharma analyses efforts to make formulation development and drug discovery process more sustainable and environment-friendly | P30

MANAGEMENT

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Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma, Vivek Chitrakar

RESEARCH

P16: PRE EVENT CPhI’s 6th Annual Innopack Pharma Confex to be held in Mumbai

FIRST-IN-CLASS INNOVATION A KEY STRATEGY FOR PHARMA COMPANIES IN A HARSH MARKET ENVIRONMENT: GBI RESEARCH

IT @ PHARMA

Photo Editor Sandeep Patil

P34: INSIGHT

MARKETING

Thinking beyond medicines and products

Regional Heads Prabhas Jha - North

P37: INTERVIEW

Harit Mohanty - West

‘We are collaborating with pharma companies worldwide to adopt eco-friendly methods’

Kailash Purohit – South Debnarayan Dutta - East Marketing Team Ajanta Sengupta

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Ambuj Kumar E Mujahid

P49: VENDOR NEWS

Mathen Mathew

Merck launches off-the-shelf cell culture media for perfusion processes

Nirav Mistry

45

CELGENE LEUKAEMIA DRUG EXTENDS SURVIVAL IN EARLY STAGE TRIAL

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BRISTOL-MYERS NASH DRUG REDUCES LIVER FAT IN MIDSTAGE STUDY

Rajesh Bhatkal PRODUCTION General Manager BR Tipnis Manager

P51: PRODUCTS BOGE KOMPRESSOREN extends EO range of scroll compressors

Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

PFIZER DRUG FROM MEDIVATION DEAL SHOWS PROMISE IN BREAST CANCER: STUDY

47

ROBOTIC PROCESS AUTOMATION: A TOOL TO CURB COSTS

Express Pharma® Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18.

Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at 2nd floor, Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

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June 1-15, 2017

EDITOR’S NOTE

Towards sustainbility

A

s pharma companies in India gear up to implement the GST from July 1, there were the usual complaints that not enough was done for the sector. We will be closely tracking the finer nuances of GST’s impact on the sector as companies move into actual implementation post June 1, watch out for more coverage in the June 16-30 issue.

Over the past few years, Express Pharma has dedicated the first issue of June to a World Environment Day special. It is our effort to take stock of how pharma companies in India are moving towards being more environmentally friendly and sustainable. In this issue, we focus on the green measures taken by Glenmark Pharma and Fourrts Laboratories.

Solution providers to pharma companies too are on the same path. For instance, Lindstrom, reportedly the largest workwear rental company in India, recycles its products. Caliber Technologies urges companies to move to paperless labs. Similarly, Ideal Cures offers ecofriendly excipients which reduce the use of organic solvents in the coating process.

The 2017 Global Packaging Trends report highlighted how consumer focus on wellness, environmental impact and macroeconomic factors such as the growth of the middle class creating more disposable income are shaping the global packaging market. Customers across all sectors including pharma, are demanding minimal and less packaging waste while increases in the price of virgin materials are also driving demand for recycled materials. The report also predicts that as companies increasingly focus on sustainability, there will be growing demand for more energy-efficient machines, as companies seek to reduce their carbon footprint as well as energy costs.

Pharma companies have realised that while the upfront investment in green technologies may pinch in the short term, the long-term RoI is assured. Sustainability measures achieve the twin benefits of reducing operating costs while simultaneously meeting environmental goals.

Hence there is an increasing move towards sustainable practices. With India as a signatory to the UN Sustainable Development Goals (SDGs), they really have no choice.

Global pharma companies like Abbvie, Allergan, Astra Zeneca, Baxter, Bayer, Biogen, Boehringer Ingelheim, BMS, Catalent, GSK,

14 EXPRESS PHARMA June 1-15, 2017

Sustainability measures achieve the twin benefits of reducing operating costs while simultaneously meeting environmental goals

Johnson & Johnson, Eli Lily, Mallinckrodt, Merck, Novartis, Novo Nordisk, Pfizer, Shire, Takeda, Teva & West are part of the Pharma Supply Chain Initiative (PSCI), which aims to create better social, economic, health, safety and environmental outcomes for all those involved in the pharma supply chain. PSCI in association with partners like the ACS Green Chemistry Institute and Green ChemisTree Foundation organise industry meets to encourage innovation while catalysing the integration of green chemistry and green engineering in the pharma industry. The activities of the roundtable reflect its members' shared belief that the pursuit of green chemistry and engineering is imperative for business and environmental sustainability.

Strategic insights like the need to incorporate sustainability into all development and innovation activities would reap dividends in years to come.

The most recent meets supported by the PSCI was last February in Hyderabad and Visakhapatnam, two cities with a high concentration of pharma manufacturing plants.

The choice of venue was very apt, as the growth of the pharma sector in this region has unfortunately been at the cost of the environment and human life. On May 2, two workers died and four were injured in a fire at Azico Biophore, and active pharmaceutical ingredient (API) manufacturing unit at Jawaharlal Nehru Pharma City (JNPC) at Parawada, about 50 km from Visakhapatnam.

The same company had had its licence suspended by the Andhra Pradesh Pollution Control Board last October for not adhering to norms on waste disposal. The order was revoked a few months later after ensuring compliance of norms, according to reports in the media.

But in spite of these incidents, most major pharma companies in India seem to be well on the green path. In fact, experts at the World Resources Institute India suggest that with the sector's expertise in managing indoor air quality in manufacturing areas, industry leaders can drive similar best practices, learnings and collaborative engagement on ambient air quality management as well. While this might seem a huge leap today, especially in the light of the Azico Biophore incident, there is always room for hope.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET PRE EVENT

CPhI’s 6th Annual Innopack Pharma Confex to be held in Mumbai Professionals from the pharmaceutical packaging industry will congregate, network, exchange ideas and knowledge, form alliances and shape the future of the pharma packaging industry

C

PhI Conferences, a division of UBM India, has announced the 6th Annual Innopack Pharma Confex. The event will be held in Mumbai from June 1-2, 2017. The Confex promises to be the biggest platform for professionals from the pharmaceutical packaging industry to congregate, network, exchange ideas and knowledge, form alliances and shape the future of the pharma packaging industry, all under one roof.

This year, Rita A Teaotia, Honourable Secretary, Department of Commerce, Ministry of Commerce & Industry, Government of India, will inaugurate the Confex and share her views on the evolution of the Indian pharma industry. The key note sessions over the two-day conference will be delivered by Dr K Bangarurajan, Deputy Drugs Con-

The conference will be followed by the second edition of The India Packaging Awards in association with Accupack as title partner. The awards will recognise excellence and innovation in the packaging industry and celebrate the thinkers and creators who break new grounds in packaging

troller (India), Central Drugs Standard Control Organization (CDSCO), Dr NC Saha, Director and Principal Executive Officer, Indian Institute of Packaging and Chakravarthi AVPS, MD, Ecobliss India.

Discussions will be held on the growth, regulations and future of pharma packaging.

The confex will also see participation from eminent speakers such as Prof BK

Karna, Director, Packaging Clinic & Research Institute (PCRI), Neelam Lalwani, Director- Packaging Development, Dr Reddy's Laboratories; Prasad Satam, Head – Packaging Development (GM), Aurobindo Pharma; Prabir Das, Vice President, Mylan; Barun Dey, Director Packaging Development, Dr Reddy's Laboratories, Manish Bajaj, Vice President - India

Business,Dr Reddy's Laboratories, Anahita Karande, Sr Manager - Packaging Development Cell, Alembic Pharmaceutical, Pradeep Dhargalkar, Head of Packaging Development, Unichem Laboratories, and many more sharing their perspective about the various aspects to packaging in the pharma industry.

InnoPack Pharma has already established itself as a

premiere platform for Pharma Packaging Innovations. Last year, the 5 th edition attracted above 650 delegates from across the country over two action packed days.

The conference will be followed by the second edition of The India Packaging Awards in association with Accupack as title partner. The awards will recognise excellence and innovation in the packaging industry and celebrate the thinkers and creators who break new grounds in packaging.

The evening will witness the industry champions coming under a unique umbrella to cheer the inspiring masterminds and will comprise presentations, exclusive product launches, entertainment acts, along with the awards and recognition ceremony.

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This allows cost-effective manufacturing by avoiding container handling including empty container transport and storage, washing, and sterilization. The BFS process enables unique container designs and even insert of additional components such as valves, applicators or adapters; fill-volumes range from 0,1 ml to more than 1000 ml. More information on blow-fill-seal technology and your personal contact partner can be found on our website. www.rommelag.com

MARKET

Express Pharma to host FDD Conclave in Hyderabad Showcasing India's formulation and drug delivery skills, the FDD Conclave is a platform for leading industry professionals to gain the latest learnings, case studies, regulatory insights, and innovative technologies they seek in a rapidly evolving industry segment THE INDIAN Express (P) and Express Pharma, India’s leading pharma business magazine are organising Formulation Development & Drug Delivery Conclave (FDD). To be held on June 16-17, 2017 at the Novotel, Airport in Hyderabad, for the 100+ leading professionals in attendance, this is the platform for the technologies, innovations and applicable insights they seek in a rapidly evolving segment.

Opportunities galore As per the February 2017 IBEF report, India is the largest exporter of formulations in terms

of volume, with 14 per cent market share and 12th in terms of value. The domestic market is currently valued at $11.2 billion, with double-digit growth expected over the next five years.

On the biosimilars side, with an annual growth rate of 30 per cent, the domestic market is expected to scale $40 billion by 2030. Formulation research and development is sure to increase in tandem, with the government planning to allocate $70 million for local players to develop biosimilars.

What’s more, Indian pharma companies currently spend 8-11 per cent of total

turnover on R&D, and the February IBEF report also predicts an increase in R&D spend, which includes formulation R&D, as players try to differentiate themselves by investing heavily in R&D efforts and the development of new drugs.

There is no doubt that drug development and formulation is also a crucial part of India’s drug delivery devices market (estimated at $5.28 billion and expected to touch $14.69 billion by end 2020). Currently dominated by injectables, the sector is also seeing promising work in transdermal, ocular, implantable,

oral, nasal, topic and pulmonary drug delivery devices.

Staying ahead of the curve Adding to this is the possibility of tapping new patient segments, creating branding strategies around innovative drug delivery approaches and meeting evolving regulations.

Be it in the discovery and development of new, better medicines or improving existing ones, there is clearly a need for the knowledge of executable strategies and leading-edge technologies.

Come this June, for the 100+

leading professionals in attendance, the two day event will help: ◗ Showcase their formulation and drug delivery skills ◗ Gain access to solution providers with cutting edge delivery technologies ◗ Capture leadership insights from formulation research gurus ◗ Present case studies of innovative formulation research and drug delivery projects ◗ Discuss regulatory insights comparing device/product registration in different geographies EP News Bureau

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MARKET

PHARMAPro&Pack Expo 2017 to be held in Hyderabad The exhibition which is to held from 21-23, September, 2017 offers immense business opportunities to national and international pharma buyers as well as machinery manufacturers PHARMA PRO&PACK Expo 2017 co-located with IndiaLAb Expo 2017 / Analytica Anacon 2017 will be held between 21-23, September, 2017 at HiTEX, Hyderabad, India.

It is expected that more than 450+ exhibitors will be participating and around 18,000 trade visitors and serious buyers will attend the exhibitions.

India is said to be the next ‘Pharma Capital’ of the world. With stringent regulatory environment within the country, pharmaceutical companies are meeting the highest quality standards which are at par with international regulatory standards. Meeting high standards of quality is only possible with a robust pharma processing and packaging machinery system as well as its ancillaries available at the doorsteps for the Indian pharma manufacturers at a highly competitive cost.

According to Rattan Singhania, Trustee, Indian Pharma Machinery Manufacturers’ Association (IPMMA), PHARMA Pro&Pack Expo exhibitions creates numerous business opportuni-

ties for Indian pharma machinery manufacturers within the country as well as in the overseas markets, due to the vast number of trade visitors who visited the shows from India and abroad. The

tant roles to nurture the domestic business of pharma machineries and lab equipment manufacturers. It encourages solution providers to grow their business in a fair and transparent trade-

The exhibition remains a healthy trade domain for every exhibiting company with equal opportunity of growth and meets all the trade attendees at the show exhibition also provides a strong business platform to even a smallest entrepreneur to display his technical skills to national and international pharma buyers. Moreover, the exhibition remains a healthy trade domain for every exhibiting company with equal opportunity of growth and meets all the trade attendees at the show.

Such international trade events happening at our doorsteps play most impor-

ecology. With the launch of this exhibition, PHARMA Pro&Pack Expo in its first year (the year 2013) emerged as the largest most resourceful Indian pharma machinery exhibition in this sub-continen. Over period of time, it scaled up to accommodate more number of national and international pharma machinery manufacturers and solution providers in bigger way, added Singhania.

Looking to the response to the previous editions of PHARMA Pro&Pack Expo exhibitions from the industry, Mahendra Mehta, President, IPMMA and CEO, Parle Global Technologies said, “The 2017 edition of PHARMA Pro&Pack Expo will be the fifth edition, which would be beneficial in line with the Make-in-India programme initiated by the current government. At the same time, it is very interesting to have foreign buyers alongside the national buyers inspecting our products.”

Speaking about the quality of products made by Indian pharma machine manufacturers, Mehta informed that seeing is believing and when you showcase and demonstrate the working of your products to buyers at the show, the product speaks for itself. As far as the quality of the exhibit machines are concerned, there are distinct improvements over the past editions of the show.

The exhibitors have also turned more responsive when compared with the past editions.

EP News Bureau

PharmaTech Expo 2017 to be held in Ahmedabad The event to held from August 3-5,2017 THE SIXTH edition of PharmaTech Expo 2017, an International Exhibition on Pharma Machinery, Lab & Packaging Equipment is scheduled on 3-5, August 2017 at Gujarat University Convention Centre, Ahmedabad, Gujarat.

The three day long event is

20 EXPRESS PHARMA June 1-15, 2017

an important platform for showcasing the latest innovation and technologies throughout all phases of the product lifecycle, focusing pharma manufacturing and processing technology, pharmaceutical systems and services.

According to industry estimates approximately

35-40 per cent of India's pharmaceutical machinery is produced in Gujarat. This strong growth prospects of the pharma exports segment and growing demand from the domestic market, will further fuel the growth in the overall pharma machinery sector.

Experts are of the opinion

that there is a strong local and global opportunity for Gujarat in the manufacturing of pharma machinery, given its strong and well-established engineering sector.

Express Pharma is the media partner for the event.

NPME 2017 to be held in Lagos, Nigeria 4TH NIGERIA Pharma Manufacturers Expo 2017 (NPME 2017), an international exhibition on pharmaceutical industry, will be held at Lagos, Nigeria from 30-31 August to 1 September, 2017. The expo will attract more than 150 exhibiting companies and nearly 3,500 pharma trade professionals from Nigeria, Ghana, Mali, Chad, Cameroon, EQ Guinea, Central African Republic, Senegal, The Gambia, Ivory Coast, Niger, Burkina Faso, Benin amongst others.

NPME 2017 is being jointly organised by the Pharmaceutical Manufacturers Group of Manufacturers’ Association of Nigeria (PMG-MAN) and GPE EXPO. NPME 2017 will provide an unique platform to showcase pharma processing machineries (tablet/ capsule/ liquid/ injectables/ ointment/ dry syrup), packaging machineries, packaging materials and consumables, API, bulk drugs, additives, excipients, pharma finished products, formulations lab reagents, glassware and equipment, analytical, R&D equipment and biotech instruments, environment control equipment and services, utilities products and services, turn-key contractors, project consultants etc.

EP News Bureau

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MARKET POST EVENT

Genericisation evokes fierce debate at third edition of Vantage Point Panelists divided on the impact of the push for generics, many laud the intent but remain sceptical of consequences

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Partnered by Wellness Forever, the event was held at Sofitel in Mumbai. An eminent panel deliberated on the implications and possibilities of the Centre’s push towards genericisation of pharma brands, in a very interesting and insightful session, moderated by Dr Milind Antani, Head, Pharma and Life Sciences, Nishith Desai Associates.

The panel comprised Dr Amar Jesani, Editor, IJME; Dr Jayesh Lele, National Secretary – IMA Board of India; Milind Mangle, Internationally Certified Coach and Consultant, Angle Consultancy & Services; Vaijanath Eknath Jagushte, Treasurer, Chairman of Legal Affairs Committee —AIOCD & MSCDA and Treasurer of MSCDA; Priti Mohile, Managing Director, MediaMedic Communications; Dr KS Sharma, PG Committee Member, Medical Council of India MCI and Director Academic Tata

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Drew out the panelists to share their views candidly and discuss the ramifications of a mandate to prescribe only generic names of drugs Dr Milind Antani Head, Pharma and Life Sciences, Nishith Desai Associates

He said that if there was political will and collaboration between stakeholders, then genericisation could indeed be a panacea and create significant positive impact for patients Dr Amar Jesani Editor, IJME

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June 1-15, 2017

He opined that quality can be a concern in such a scenario as the industry and medical fraternity is illequipped to deal with genericisation Dr Jayesh Lele National Secretary – IMA Board of India

He stated that though the intention was to introduce a panacea to many problems faced by healthcare industry today, inadvertently opened a Pandora’s Box Milind Mangle Internationally Certified Coach and Consultant, Angle Consultancy & Services

She threw light on how marketing and PR would change in times of genericisation and its effect on patients Priti Mohile Managing Director, MediaMedic Communications

MARKET

Industry representatives were openly critical of genericisation. They viewed the move with disfavour and highlighted various pitfalls which would arise if genericisation became the law. Do all generic medicines give the same results as their branded counterparts?

Hospital; Daara Patel, Secretary General, IDMA; and Dr Suleiman Merchant, Dean, Lokmanya Tilak Municipal General Hospital and Medical College.

Dr Antani drew out the panelists to share their views candidly and discuss the ramifications of a mandate to prescribe only generic names of drugs. He steered the debate to touch upon lesser discussed points and look at the issue in a more detailed manner. He also threw light on many legal aspects of the issue and explained the various grey areas to give more clarity on the same. Dr Antani, in the course of his moderation, quipped that the Indian lifesciences industry is facing a challenge between choosing what is ethical and what is legal.

Industry representatives were openly critical of genericisation. They viewed the move with disfavour and highlighted various pitfalls which would arise if genericisation became

the law. Do all generic medicines give the same results as their branded counterparts? Are enough generic medicines available in market? While focusing on price, how do we not lose sight of quality? These were some of the questions posed by experts and veterans during the debate.

At the same time, there were panelists like Dr Jesani who was totally in favour of prescribing generics. He outlined the various advantages in terms of access and affordability of medicines. He said that if there was political will and collaboration between stakeholders, then genericisation could indeed be a panacea and create significant positive impact for patients. At the same time he admitted that there is a need to have better monitoring mechanisms in place to ensure effective implementation of the government’s push towards generics.

Opining that genericisation is a populist move, Dr Lele questioned the preparedness of the government to

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EXPRESS PHARMA

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June 1-15, 2017

MARKET implement it effectively. He said that quality can be a concern in such a scenario as the industry and medical fraternity is ill-equipped to deal with genericisation. He lauded the intent of the government but expressed reservations about effective implementation of the move.

Mangle pointed out that this is a very multi-faceted issue and would have widereaching implications. He explained the rationale of the government behind pushing generics and stated that though the intention was to introduce a panacea to many problems faced by healthcare industry today, inadvertently opened a Pandora’s Box. He said that our public and other stakeholders are still uninformed about various issues and hence not ready for a step like genericisation. He pointed out the various complexities arising from the move and said that lack of accountability is one of the major concerns in this situation.

Mohile was in favour of genericisation but she too had doubts about the step being successful in achieving its

He lauded Jan Aushadhi as a good initiative to make medicines available but recommended strengthening it

He pointed out to various grey areas which may prevent the move from being a beneficial one

Vaijanath Eknath Jagushte

PG Committee Member, Medical Council of India MCI and Director Academic Tata Hospital

Treasurer, Chairman of Legal Affairs Committee – AIOCD & MSCDA

He claimed that the industry would support the government if they come up with better strategies to serve the masses

Said that until the right standards, infrastructure and regulations are put into place, genericisation will not be successful

Daara Patel,

Dr Suleiman Merchant

Dr KS Sharma Secretary General, IDMA

Dean, Lokmanya Tilak Municipal General Hospital and Medical College

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24 EXPRESS PHARMA June 1-15, 2017

MARKET Dr Antani steered the debate to touch upon lesser discussed points and look at the issue in a more detailed manner.

He also threw light on many legal aspects of the issue and explained the various grey areas to give more clarity on the same objective. As a communication specialist, she threw light on how marketing and PR would change in times of genericisation and its effect on patients. She also said that information about quality will become paramount in future.

Jagusthe expressed concerns about ensuring quality and said that it is a premature move. He pointed out that there is no standardisation in India as far as quality is concerned. He opined that unless quality is assured through proper regulations and infrastructure, enforcing prescription of only generics is not a good decision. He lauded Jan Aushadhi as a good initiative to make medicines available but recommended strengthening it with better economic policies to make it sustainable and extend its reach.

Dr Sharma gave instances of how genericisation can fail in implementation and raised concerns about quality, accountability and efficacy. He said that the government’s intention to nullify the nexus between the medical fraternity and pharma companies might not really succeed as the wrongdoers might find ways to circumvent the move and continue with the malpractices. He also pointed out to various grey areas which may prevent the move from being a beneficial one, for instance, crosspathy practitioners do not have to adhere to these guidelines.

Patel was emphatic that ‘generics only’ is a decision which will not serve any objective. He stated that other measures to reduce prices might be more effectual and claimed that the industry would support the government if they come up with better strategies to serve the masses. He recommended slashing taxes of essential medicines as a measure to reduce prices of drugs.

Quality was a concern raised by Dr Merchant as well. He said that until the right standards, infrastructure and regulations are put into place to determine the efficiency and efficacy of drugs in India, genericisation will not be successful. He was also of the

opinion that it is an idea whose time has not arrived yet.

Thus, the panel was divided in its opinion about government’s decision to promote generic medicines. The panel discussion was followed by a Q&A session. Viveka Roychoudhury, Editor, Express Pharma & Healthcare posed the first question. She asked whether seminars held for associations help in maintaining the quality of medicines and in educating patients to take a good decision? To which Patel responded that they have already got an approval to add a topic on generic medicines to the existing seminars.

SR Vaidya, Chairman, SME committee, IDMA, suggested that there must be seminars held on quality of excipients as they constitute 95 per cent of the drug. He insisted on making pharmacovigilance activities mandatory which can increase the quality standards of generics.

Deepak Paliwal, External Advisor, GSK, London, connected with the audience and panelists through Skype. He was in favour of the government's move and threw light on a pilot project in the state of Andhra Pradesh where pharmacists are prescribing generics for past three years. He further clarified the government's motive behind mandating writing the generic name in capital letter is to ensure more readability among patients and pharmacists.

Akash Rajpal, MD and CEO of Ekohealth Management Consutants, raised a set of legal questions related to the liabilities of doctors while prescribing medicines. He asked, “Is a doctor liable when s/he prescribes a branded medicine of their choice and something goes wrong? Also, if the doctor is not liable in this case, then how can s/he be responsible when s/he prescribes a generic medicine? Are there any drugs available at pharmacies that are not FDA approved?”

Mangle replied saying that as of now, doctors can be held accountable for the various brands they prescribe.

While prescribing generics, the

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EXPRESS PHARMA

25

June 1-15, 2017

MARKET patient might not know who to hold responsible as the liability might keep shifting among various stakeholders.

Further on, the panelists highlighted the importance of bio-equivalence studies and the need for standardisation to build trust. On the contrary, Dr Jesani raised a point that in case of substandard drugs, the manufacturers are to be held liable and the regulators like CDSCO should be more attentive towards any spurious drugs available in the market. He also suggested that more investments need to be made in order to bring each company under their surveillance.

Sripad Desai, Americares, inquired that even if doctors prescribe a generic medicine, will the pharmacists be able to dispense branded ones? The panelists expressed that substitution is against the law and there is a need to take a few learnings from the US where unique codes are allotted to each formulation.

Payal Laad, Professor, Community Medicine, Sion Hospital, referred to Bangladesh's drug model and asked what can be the takeaways for India. Patel, informed that the Indian state of Rajasthan has a similar policy but, there are few hurdles faced while extrapolating these schemes across India.

Dr Gopal Dabade, President of Drug Action Forum of Karnataka asked whether generic medicines can be available at affordable prices, to which the panelists responded that there is an urgent need to tackle the nexus between manufacturers, doctors, and chemists for patients' benefit.

The event came to close with the panelists unanimously agreeing that patients’ well-being should be safeguarded at all costs. Therefore, before the government mandates generication of medicines, they need to put in place the required processes to ensure that quality generic medicines are made accessible for all. mansha.gagneja@expressindia.com lakshmipriya.nair@expressindia.com

26 EXPRESS PHARMA June 1-15, 2017

EVENT BRIEF EVENT BRIEF AUGUST TO SEPTEMBER-2017 3

PharmaTech Expo 2017

PHARMATECH EXPO 2017 Date: August 3-5, 2017 Venue: Gujarat University Convention Centre, Ahmedabad, Gujarat Summary: The 6th Edition of PharmaTech Expo 2017 will be Gujarat’s largest pharma expo and will be concurrently held with ‘Labtec’ & ‘Track & Trace’ Expo 2017. The focus will be on pharma machinery and equipment manufacturing

21

India Lab Expo 2017/ analytica Anacon India

sector and pharma packaging. More than 150 exhibitors from across the country participated in last year’s event.

Ahmedabad - 380009 P: +91-79-27540493/ +91-79-40306340

Contact details PharmaTechnologyIndex. com A Division of KNS Group 701 - 702, Corporate House, Opp Dinesh Hall, Income Tax, Ashram Road,

INDIA LAB EXPO 2017/ ANALYTICA ANACON INDIA

To subscribe: bpd.subscription@expressindia.com

Date: September 21-23, 2017 Venue: Hitex, Hyderabad Summary: India Lab expo, India’s largest exhibition on laboratory, scientific,

analytical and biotechnology sector will see international as well as Indian manufacturers and distributors.

Decision makers from sectors like hospitals, diagnostic labs, oil and petroleum, chemical, cosmetics and government departments will meet at the tradeshow. The event will be supported by Ministry of Science &

Techn-ology, Government of India.

Contact details MMI India INIZIO 507 & 508, 5 th Floor, Cardinal Gracias Road, Opp P&G building, Chakala, Andheri (E), Mumbai - 400099 Tel : +91 22 42554710 Mob: +91 9820668393 Fax: +91 22 42554719 info@mmi-india.in

EXPRESS PHARMA

27

June 1-15, 2017

MARKET GROWTH TRACKER

IPM registers ` 9893 crores in April 2017 Globally amongst the top market, India has moved a position up and is ranked ninth

28 EXPRESS PHARMA June 1-15, 2017

TOP 150 COMPANY SNAPSHOT IPM value – Rs. 9,893 crores (6.0% Growth) Month April 2017 Value (Rs. Crs)

564

6

Rank 41 - 60

670

7

Rank 61 - 100

638

6

Rank 101- 150

% Gwth

43

24,637

3

9

2

6

10

21

7

10

11,883

12

4

350

% MS

49,295

4

10

Rank 31 - 40

Value (Rs. Crs)

7

21

1,014

IPM value – Rs. 114,937 crores (9.0% Growth) MAT April 2017

% Gwth

43

2,088

Rank 11 - 20

Rank 21 - 30

% MS

4,269

Rank 1 - 10

6,359

6

7,599

7

7,495

7

8

13

10

5

4

4,125

12

Top 10 companies constitute ~ 43% share of IPM on MAT and Month basis.

The top 150 companies continue to account for 97% of IPM on MAT and month basis. ● For both MAT and month,Top 20 companies contribute to 64% ● Growth of the top companies slowed down, highest growth is in the companies ranked between 31-40 Source: QuintilesIMS TSA & SSA, April 2017 ● ●

TOP 40 BRANDS

GLYCOMET-GP(U S V)

34

LANTUS(SANOFI*)

32

Top 1-10

34

JANUMET(MSD*)

0.38

17

38

SPASMO-PROXYVON +(WOCKHARDT*)

0.53

9

53

Value (Rs. Crs)

% MS

0.35

41

0.34

57

0.32

22

NOVOMIX(ABBOTT*)

29

7

0.29

LIV-52(HIMALAYA)

28

8

0.29

DEXORANGE(FRANCO)

27

13

0.28

GALVUS MET(NOVARTIS*)

26

AUGMENTIN(GSK*)

25

-4 8

%Growth of Top 10 brands in April’17 over April’16 is 16%

PREVENAR-13(PFIZER*)

24

BETADINE(WIN)

24

THYRONORM(ABBOTT*)

24

BECOSULES(PFIZER*)

23

FORACORT(CIPLA)

23

VOVERAN(NOVARTIS*)

23

ACILOC(CADILA)

23

MONOCEF(ARISTO*)

22

CLAVAM(ALKEM*)

21

%Growth of 11-20 brands in April’17 over April’16 is 0.5%

Mi t d

ti

t b th t

20

SHELCAL(TORRENT)

20

VOLINI(SUN*)

20

ZINETAC(GSK*)

19

PAN(ALKEM*)

19

BETNOVATE-C(GSK*)

18

BETNOVATE-N(GSK*)

18

ULTRACET(JANSSEN)

18

GLIMESTAR-M(MANKIND)

18

43

% MS

0 5 -16

8 5 -13

JALRA-M(U S V)

18

0.25

CALPOL(GSK*)

17

0.24

ROSUVAS(SUN*)

17

LEVIPIL(SUN*)

17

ZINCOVIT(APEX)

16

TELMA(GLENMARK)

16

GLUCONORM-G(LUPIN)

16

0.23 0.23 0.23

2

0.23

-11

0.22

0

d ith

0.21

0.21

SEROFLO(CIPLA)

16

PANDERM+(MACLEODS)

16

GEMER(SUN*)

16

%Growth of 31-40 brands in April’17 over April’16 is 2%

MS f

0 5%

0.20

8

0.20

-9

0.20

2

0.19

-5

0.19

30

0.19

19

0.18 0.18

22

0.18

149

Ø14

0.25

0.24

% MS

26

Value (Rs. Crs)

Mixtard continues to be the top brand with a MS of ~0.5% ● Glimestar-M,Janumet, Duphaston& Spasmo Proxyvon + have shown phenomenal growths in April’17 ● Other brands with remarkable growth are Lantus, Pan D, Betnovate, Ultracet and Gluconorm-G Source: QuintilesIMS TSA & SSA, April 2017 ●

% Growth

-3

%Growth of 21-30 brands in April’17 over April’16 is 14%

Ø0

b

PAN-D(ALKEM*)

0.26

Ø 16

24

20

% Growth

Value (Rs. Crs) DUPHASTON(ABBOTT*)

ELECTRAL(FDC)

0.26

Top 31-40

MIXTARD(ABBOTT*)

% Growth

Top 21-30

Value (Rs. Crs)

Top 11-20

THE INDIAN Pharmaceutical Market (IPM) was valued at ` 9893 crores in the month of April 2017. First time in last three years, IPM has recorded a very slow growth of six per cent in April 2017. Even MAT April 2017 has seen the slowest single digit growth of 9.04 per cent as compared to strong double digit growths over last couple of years.

While the industry witnesses a recent challenge of generic prescription regulation in India at prescriber level, GST has been making rounds at the distributor level. With the current level of clarity on GST implementation, there has been an overall slowdown in stockists purchases for the month of April 2017 which is assumed to be one of the reasons for an overall slow IPM growth for the month.

Top 10 companies continue to hold 43 per cent share indicating the fragmented nature of IPM. Whilst the Top 10 companies reflected a collective growth of seven per cent for the month, the next level of companies in the 11-20 and 2130 bracket grew slower at four per cent and three per cent respectively. Seven of the top 10 companies grew faster than the market. Lupin with 15 per cent growth was the fastest growing company in the top 10 for the month.

Six of the top 11-20 companies reflected better growth than the market with Torrent and Glenmark growing at double digit while Pfizer (-12 per cent), Novartis (-6 per cent) and Cadila (-6 per cent) showed negative growth.

Though there is an overall slowdown in growths for the month, Top 10 brands of IPM valued at ` 326 crores have shown a strong 16 per cent growth over last year. Mixtard and Glycomet-GP continues to maintain at number one and two positions respectively.

While Novomix and Aug-

% MS %Growth

12 -6

0.18 0.17 0.17

9 17 0

0.17 0.17 0.17

-12

21 12

0.16 0.16 0.16

-31

19

Ø2

0.16

MARKET mentin have lost their rank from fifth and seventh position to sixth and tenth respectively, we see a good rank jump for Spasmo-Proxyvon to number three position owing to consistent 40 per cent+ growths since couple of months. Janumet is the fastest growing brand amongst top 10 brands of IPM for the month. We do see a subdued growths for the next rung of brands (Rank 11-20) at 0.2 per cent which has contributed to overall slowdown for the month. Amongst the next league, Glimestar-M, Duphaston, Lantus, Pan D, Betnovate, Ultracet and Gluconorm-G have shown phenomenal growths in April 2017.

Domestic players account for 78 per cent of the market in April 2017 and grew slightly better than the market with a growth of 6.9 per cent while MNCs reflected a very slow growth of 3.3 per cent for the month. However, the largest MNC, Abbott grew slightly better than the market for the month with a seven per cent growth while GSK reflected a double digit growth of 10 per cent. However, other top five companies like Pfizer and Novartis have recorded a high negative growths of (-12 per cent) and (6 per cent) respectively which is pulling down the overall growth for MNC companies.

While acute therapies continue to hold a massive share of IPM with a 64 per cent contribution to the total market, the chronic TAs grew at a comparatively higher pace than IPM at 8.7 per cent. However, in comparison to last year, growth rates for both the TAs have been slower with more impact seen for Chronic TA which grew at healthy 11.3 per cent in April 2016. The Top 5 therapy areas have contributed massive growths of 15.2 per cent with three therapeutic classes from anti-diabetic therapies crossing `500 crore mark and growing at a very healthy growth rate of 20.3 per cent in April 2017.

Cardiac therapy and GI constitute the largest market share in IPM occupying 12 per cent share each. Anti-diabetics and derma registered a growth of around 17 per cent and 14 per

THERAPY TRENDS Value (Rs Crores) IPM

MS %

Gastro Intestinal

1,139

12

Anti-infectives

1,118

11

10 8 14 8

8 -8

6

5

498

7

4

6

607

Gynaec.

17 5

7

657

Neuro / CNS

5

7

724

Respiratory

16

-1

8

774

Derma

7

8

796

Pain / Analgesics

7

10

944

Vitamins / Minerals / Nutrients

7

5

12

1,204

Anti Diabetic

6

100

9,893

Cardiac

Growth% (Prev. Month)

Growth % (SPLY)

5

3

8

Ophthal / Otologicals

210

2

11

Urology

181

2

11

Vaccines

176

2

Hormones

155

2

Oncology

137

1

10 8

7

4 7

-4 -11

-3

Cardiac therapy and GI constitute the largest market share in IPM occupying 12% share each Anti Diabetics & Derma registered a growth of around 17% and 14% respectively for the same period last year â—? Respiratory and Onco market have de-grown by 8% and 3% respectively, while rest of the therapies grew over previous month.

Source: QuintilesIMS TSA & SSA, April 2017 Source: â—? â—?

cent respectively for the same period last year. Respiratory and oncology market have degrown by eight per cent and three per cent respectively, while rest of the therapies grew over previous month.

Cardiac therapy area, the number one therapy for the month, clocking a revenue of ` 1143 crores with a growth rate of 5.3 per cent was almost half as compared to previous year growth of 9.8 per cent. The top molecules of this segment, Atorvastatin and Telmisartan have reflected de-growth of -16 per cent and -4 per cent respectively due to impact of regulatory price reduction. However, Telmisartan recorded robust volume growth of 12.1 per cent for the month. Rosuvastatin continued to reflect strong value at 8.1 per cent but recorded a lesser volume growth of 3.4 per cent. The growth in cardiac therapy area was mainly pulled down by plain molecules which showed a combined growth of one per cent in comparison to combinations which grew at 12 per cent, especially Telmisartan and combination recording a growth of 17 per cent in April 2017.

Owing to subdued growths

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in last couple of months anti-infective therapy has slipped to number three slot for the month with a value of ` 1118.1 crores and -0.6 per cent growth rate, the only therapy area in top 10 to reflect a negative growth for the month. This degrowth is largely because of Ceftriaxine injectables (-15 per cent) and Cefixime oral solids (-9 per cent), Piperacillin + Tazobactam (-5 per cent) and Azithromycin oral solids (-6 per cent) amongst the Top 10.

Gastrointestinals moves to be the second largest therapy area for the month garnering a revenue of ` 1139 crores with a growth rate at par with IPM at 6.9 per cent. With 60 per cent contribution from combination molecules driving a higher growth of 8.2 per cent Pantoprazole + Domperidone has shown a very healthy 14 per cent growth for the month. Dicycloverine Hydrochloride + Paracetamol + Tramadol Hydrochloride also has shown a very impressive growth of 34.6 per cent amongst the top molecules.

Anti-diabetics continued to be the number four ranked therapy area in IPM for the month of April 2017 growing at 17.4 per cent over SPLY. DPP4

inhibitors remains at the top category in the anti-diabetic therapy area with Sitagliptin and combination contributing 33 per cent of the category by value. Vildagliptin and combination reflected de-growth in value (-2 per cent) as well as a negative volume growth (-10.3 per cent) for the month.

Teneligliptin and combination has reflected a robust growth (113 per cent) as well as have a share of 21 per cent in the segment.

Dermatology, the second fastest growing therapy area in IPM clocked a growth of 14.4 per cent SPLY with a value of ` 724.5 crores. Emollients continues to be the largest sub category with a 14.5 per cent growth while itraconazole remains to be the fastest growing molecule at 92 per cent growth for the month with major contribution from new introductions in this segment. Luliconazole amongst the newer entrants has made an entry amongst the Top 15 molecules in dermatology with 15 crore value for the month.

Neurology with a value of ` 606 crores reflected a six per cent growth for the month over SPLY, Levetiracetam continued to be the largest molecule

in the space clocking a value of ` 44 crores with a 12 per cent growth for the month. Except Escitalopram and Clonazepam which reflects a negative growth for the month, all other molecules in Top 10 are collectively showing a healthy 11 per cent growth over last year. The highest growth of 27 per cent is witnessed for Pregabalin + Mecobalamin and other combination.

Global (March 2017) The global pharma market is valued at $1007 billion degrowing at -3.6 per cent. The US continues to dominate the market with 42 per cent market share with growth of 27.3 per cent.

Amongst the top market, India has moved a position up and is ranked ninth. The only markets de-growing in the top markets are Spain and Russia; wherein Venezuela and China has shown more than 50 per cent growth.

(QuintilesIMS is a leading global information and technology services company providing end-to-end solutions to the life sciences and healthcare industry)

EXPRESS PHARMA

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June 1-15, 2017

cover )

30 EXPRESS PHARMA June 1-15, 2017

(

THE MAIN FOCUS

Express Pharma analyses efforts to make the formulation development and drug discovery process more sustainable and environment-friendly

+

LEADING THE PACK PG 32

THINKING BEYOND MEDICINES AND PRODUCTS PG 34

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'WE ARE COLLABORATING WITH PHARMA COMPANIES WORLDWIDE TO ADOPT ECO-FRIENDLY METHODS' PG 37

THE MONSTER IN YOUR LABORATORY PG 38

OPERATIONAL EXCELLENCE WITH SUSTAINABILITY: LESSONS FROM LINDSTRÖM PG40

EXPRESS PHARMA

31

June 1-15, 2017

cover )

Leading the pack Kanish Malik, President, Operations, Glenmark Pharmaceuticals and SV Veerramani, Founder and Chairman, Fourrts India, explain the philosophy behind their sustainability efforts.

By Usha Sharma

Implementing the 3Rs principle Eleven of our manufacturing facilities are ISO 14001:2004 certified, while five facilities are OHSAS 18001:2007 certified. Our facilities are approved by regulatory bodies such as the US FDA, MHRA UK, WHO-GMP, Canadian TPD, South African MCC and ANVISA of Brazil.

We endeavour to continually take initiatives broadly pertaining to the following areas: decreasing water footprint, reducing our emissions, increasing the energy efficiency of our operations and efficient waste management. In addition to this, we have aligned our commitment to provide a safe working environment to all our employees, which apart from meeting the moral and legal obligations, also leads to enhanced productivity and workplace satisfaction.

Glenmark has taken a number of initiatives to reduce the amount of freshwater drawn and waste water discharged by our facilities. We have imbibed the principle of 3R’s (Reduce, Reuse, Recycle), which has helped us reduce our specific water consumption year after year.

Reducing stress on natural sources of water, adopting a less carbon intensive path We recycle about 98 per cent of the waste water generated at our facilities.

Collectively, all these initiatives have helped us save more than 215 million litres of water during the FY 2015-16.

In order to reduce the stress on natural sources of water, we have built rain water harvesting structures at our facilities in Goa, Taloja and Mahape, and set up groundwater recharging systems at Indore, Nalagarh and Baddi.

We have adopted a new high pressure water cleaning system that reduces the water consumption for equipment cleaning by more than 40 per cent. By shifting to plate heat exchanger for the generation of hot water and by capturing the steam

32 EXPRESS PHARMA June 1-15, 2017

WE HAVE ALIGNED OUR COMMITMENT TO PROVIDE A SAFE WORKING ENVIRONMENT TO ALL OUR EMPLOYEES

KANISH MALIK President Operations - Glenmark Pharmaceuticals

condensate, we have been able to reduce the water required for the process by 20 per cent.

We have installed waste water recovery systems at our plants in Dahej, Ankleshwar, Aurangabad and Mohol, which has brought down our fresh water requirement. Our state-of-the-art systems employ technologies like Reverse Osmosis (RO), Multiple Effect Evaporator (MEE) and Agitated Thin Film Drier (ATFD). The recovered water is used for flushing, gardening, boilers and cooling towers. Currently, we are in the process of installing these technologies at our Kurkumbh plant and have established it as a norm for all our future plants.

Goa plant

As part of our environmental responsibility, we continually identify opportunities for adopting a less carbon intensive path as we grow as a company. This is being done by adopting a two pronged strategy. Firstly, we have begun to diversify our energy mix by including low or no carbon emitting sources such as biodiesel, solar and hydro power. Secondly, we continually upgrade our equipment and processes to the latest energy efficient systems, thereby bringing down our specific energy requirement. More than 10 per cent of our electricity demand in the reporting year was met by electricity from renewable sources like solar and hydro power. After successfully introducing

the biodiesel-based boiler at our Nashik plant, we extended this project to our Mohol and Kurkumbh plants, thereby substituting a total of 435.4 kl of High Speed Diesel (HSD) with biodiesel.

Implementation time consuming, challenging in the short term but desirable and beneficial to society in the long term Implementation is a time consuming process, but as an environmentally conscious drug manufacturing company, we strongly feel that adopting green initiatives is the right thing to do and it is the new way forward. We strive to fulfil our mission of enriching lives of our employees, our neighbourhoods, the global community and the future generations. In short term one may find this approach challenging but in the long term it is desirable and beneficial to the society at large.

Three major benefits of sustainability strategy Water Conservation ◗ We saved 215 million litres of water through our water conservation efforts.

It roughly amounts to annual drinking water requirement of more than 1,17,000 people in rural India.

Electricity conservation ◗ Around 5300 Megawatt-Hours saved, which can light up more than 55,000 rural households for one year Waste management ◗ 110 metric tonne co-processed which is equivalent to more than 18,000 trees planted ◗ More than 3.6 per cent of our electricity demand in the reporting year was met by electricity from renewable sources like solar and hydro power ◗ A total of 435.4 kl of HSD was substituted with biodiesel at our Nashik, Mohol and Kurkumbh plants.

( Sustainability measures being implemented Wind Power At Fourrts, wind power is utilised for plant operation. Fourrts has entered into strategic equity participation with an organisation engaged in the generation of power using wind mills.

This organisation is also exploring the possibility of generating power using solar energy. And soon Fourrts will be using power generated from replenishable energy sources only. Apart from cost advantage of about 25 per cent, we derive the satisfaction of participating in the national interest of conserving energy.

THE MAIN FOCUS

WE CONTINUALLY IDENTIFY OPPORTUNITIES FOR ADOPTING A LESS CARBON INTENSIVE PATH

Scrubber The flying dust generated from the process are captured into scrubber which ensures the dust generated is completely sent to ETP by water spray technique which is inbuilt with machines.

Noise control

SVVEERRAMANI Chairman and Managing Director Fourrts India

The machines installed at Fourrts are state-of-the-art and environment friendly. The processing machines have silencers and acoustic insulation in-built.

Stack monitoring Flue gases from the boiler and generator are periodically monitored to prevent air pollution.

ETP and STP Fourrts has set up state-of-the-art Effluent Treatment Plant (ETP) to treat the waste generated in the formulation process. It is a zero discharge effluent treatment plant. The Sewage Treatment Plant (STP) treated water is utilised for gardening purpose. The ETP treated water is utilised for cooling tower and boiler and RO reject water is sent for mechanical evaporation and salt is collected in the solar panel.

reduce power consumption.

system is that energy source is renewable and using natural refrigerant namely water, which does not harm the atmosphere like TFC or substitutes. In this system, the usage of convention power consumption is reduced substantially by ` 5.5 per TR (Ton of refrig-

eration). The bleed air from AHUs is filtered through 0.3µ HEPA filters to protect the environment. We use LED/CFL light fittings for reduce power consumption. All machineries and utility motors are running with Variable Frequency Drive (VFD) to

Three major benefits of sustainability strategy ◗ Power saving ◗ Prevention of land pollution ◗ Prevention of air pollution u.sharma@expressindia.com

Strategically planned rain water harvesting to increase ground water table level In Fourrts, sub-surface water recovery is done by laying natural water conserving system beneath the building foundation in order to avoid seepage of water inside the building during rainy season. The sub-surface water generated through this system is collected in sumps and utilised for cooling purpose. In strategic location, rain water harvesting is done to increase the ground water table.

Conservation of energy For all heat requirements, Fourrts has set up boiler using non-fossil fuels like agro wastes instead petroleum products like furnace oil which is highly polluting.

The use of boiler for heat requirements saves cost and reduces dependency on conventional power from electricity board. By installing indigenously designed bio-reactor the steam-fuel ratio is improved and the soot discharge into atmosphere is minimal.

Fourrts GMP WHO Plant at Kelambakkam

Air Handling Units (AHUs) In Fourrts, AHUs function in a very environment-friendly manner by using replenishable energy for cooling. Fourrts has set up heating and cooling system for its HVAC by adopting vapour absorption system. The advantage of this

UK MHRA Plant at Venkatamangalam

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EXPRESS PHARMA

33

June 1-15, 2017

cover ) INSIGHT

Thinking beyond medicines and products Vivek P Adhia, Strategy Head – Climate, WRI India, Tanvi Bongale, Sr Project Associate, Climate, WRI India, Shruti Karkhedkar, Air Quality Intern, WRI India, elaborate on how the pharma industry can drive innovation beyond core areas to minimise environmental impact especially on air quality, and in turn support improved human health

VIVEK P ADHIA, Strategy Head – Climate, WRI India

TANVI BONGALE, Sr Project Associate, Climate, WRI India

SHRUTI KARKHEDKAR, Air Quality Intern, WRI India

A

ir pollution is increasingly being recognised as a serious human health issue for India, and with exponential growth in industrialisation, cities and infrastructure – this warrants immediate cohesive national action. As a

34 EXPRESS PHARMA June 1-15, 2017

background, local air pollutants are those substances when emitted in the atmosphere – that continue to exist over and above the natural physical diffusion, chemical elimination and biological purification to have a direct or in-

direct effect on human health.

Typically, four major pollutants are said to have maximum impact viz. sulphur dioxide (SOx), nitrogen oxides (NOx) and particulate matter (PM10 and PM2.5). Health related standards providing guidelines on

safe concentration levels of these pollutants have been established based on various public health studies, meant to provide a means to benchmark and ascertain environmental impact on the local air quality front. Consistently across the

last few years, it is found that more than 85 per cent of the global population lives in areas exceeding these safe guidelines – which results in acute public health and livelihood impacts.

For emerging economies, low and middle income countries and other groups that include India and China – about 99 per cent of the population lives in vulnerable areas. Further, as per the outdoor air pollution in cities database of World Health Organization (WHO), 10 of the 20 most polluted cities (in terms of PM2.5) are in India, with most regions across the Indo-Gangetic plains topping the list as can be seen from the adjoining chart.

Multiple causes, contributing to deteriorating air quality including mobile sources (transport), area sources (waste burning, cook stoves, suspended dust of construction and industrial activity) and stationary sources such as power plants, and diesel generators have resulted in severe and acute health impacts. Air pollution related deaths have in a short time jumped into the topfive causes within the country (as seen in the chart titled, Acting now is inevitable). This also reflects the broader situation globally, with both indoor and

(

THE MAIN FOCUS

outdoor air pollution responsible for nearly seven million deaths, making it the world’s largest single environmental health risk.

While there is a major realisation on the growing threat of air pollution, the pace of response and corrective action needs to be accelerated. The Environment (Protection) Act, 1986 and The Air (Prevention and Control of Pollution) Act, 1981 assign the responsibility for controlling air pollution in India to the Ministry of Environment, Forests and Climate Change (MoEFCC), the Central Pollution Control Board (CPCB) and the State Pollution Control Boards (SPCBs). Over

quality monitoring network, setting National Ambient Air Quality Standards (NAAQS), designating critically polluted areas and placing moratoriums on environmental clearances based on the Comprehensive Environmental Pollution Index (CEPI), requiring Environmental Impact Assessments (EIA) to be completed prior to project approvals, imposition of pollution cesses, launch of an Air Quality Index (AQI), and various public awareness programmes. The purpose, impact, ease of implementation and cost-effectiveness of each measure is very varied; as is the clarity on the role they should play in the future, along

agement for the country. While the current and ongoing policy instruments are being refreshed in view of the urgency on actions that are needed, industry can play a tremendous role on environmental leadership.

The role of Indian Industry in addressing growing levels of air pollution within the country cannot be understated, considering that it is not just the part of the problem, but an integral part of the solution as well.

Corporations have realised that, they can gain competitive advantage by managing ecological variables through application of air quality ‘control measures’ and ‘environmental

and improved communitycum-stakeholder engagement.

As widely understood, the pharmaceutical industry manufactures various classes of products including analgesics, antidepressants, anti-hypertensives, antibiotics, steroids, hormones etc. During some of these manufacturing processes effluents, wastes and air emissions associated with the production for the same are known to impact human health and environment. More specifically, sources of air pollutants in the pharma industry revolve around use of volatile solvents in the chemical synthesis process, formulation process and during product recovery

the last three decades, these and other agencies have employed a portfolio of measures to control air pollution including, among others, promulgating industry-specific emission standards, establishing an air

with other instruments that have not been tried previously in India (emissions trading markets to cite one example for purpose of illustration), in a well-designed and enforced framework for air quality man-

technologies’. With wide-scale penetration of environmental technologies, often gives a competitive impetus to businesses and supports cost savings, improved productivity, compliance with ongoing regulations

operations. In an equipmentspecific context major air emissions might be attributed to operations of process reactors, distillation units, centrifuges, storage tanks or pill drying ovens. Pollutants from these

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likely include fine, dry, light particulate emissions that might be agglomerative or hygroscopic, and typically reduced/controlled with the help of scrubbers or condensers.

Additionally, material substitution (mainly in tablet coating operations) and controlling bulk storage air emissions using dust collectors (that rework the dust back to the product), optimising fossil fuel combustion, use of dedicated vent condensers, maintaining nitrogen purge rates etc. are also some of the control measures used for managing indoor and outdoor air quality. Additionally, air emissions from pill coating, mixing operations and ethylene oxide sterilisation processes as well as halogenated, VOC and HAP streams are controlled through technologies like regenerative thermal oxidisers, concentrators, catalytic oxidisers, thermal recuperative and direct fired thermal oxidizers.

In terms of regulatory guidelines in the form of policy instruments, industry environmental emission standards hold the key for governing the air emissions. While there are a host of standards for various segments, processes and industry’s – particularly for the pharma manufacturing and formulation sector – air pollution related emission norms broadly cover emissions from incinerators when it comes to stack emissions. Additionally, the norms for captive power production, say via independent units or by use of back-up diesel generators, are more or less comparable to the generic industry emission standards.

The Indian pharma industry can play a leadership role, and engage on environmental parameters so as to front-end the affirmative action that large corporations can play in combating air pollution. Progressive companies in this space already endorse a comprehensive outlook on adopting tangible control measures and environmental technologies.

Some of the equipment, control measures and technologies can be outlined below;

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cover ) Concentrator It is an adsorption system which concentrates large volume, low concentration process exhaust into a much smaller, highly concentrated air stream. A cartridge style concentrator or a rotor wheel removes the emissions through adsorption onto a substrate.

This treats 90 per cent of the total air volume which can be released in the atmosphere.

The remaining 10 per cent is used as desorption air by heating it to high temperatures.

This process transports adsorbed toxins to the desorption section. The organic compounds then get desorbed by an absorptive media in a low volume heated air stream. This air stream is then processed by an oxidiser. It has been observed that an integrated system with a concentrator and an oxidiser saves costs for low concentration air streams due to its low operating costs. At high concentration levels it can also provide adsorption energy to the concentrator.

Oxidisers Various technology options can be clustered into the broader group of oxidisers as can be seen below; ◗ CATOX or catalytic Recuperative Oxidiser: For processes that emit Hazardous Air Pollutants (HAPs), Volatile Organic Compounds (VOCs) as well as emissions that have odours.

This process uses catalysts to reduce the temperature for oxidation. The emissions enter a metal heat exchanger where it is heated progressively and finally reaches the combustion chamber. Here, the pollutants are converted to carbon dioxide, water vapour and heat under an exothermic reaction.

There are savings with respect to operating costs due since the heat exchanger reduces the need for auxillary fuel requirement. ◗ Regenerative Thermal Oxidiser: Air emissions including VOCs and HAPs enter the oxidiser and are preheated in the energy recovery chamber. As the air stream moves towards

36 EXPRESS PHARMA June 1-15, 2017

Considering its inherent expertise on technologically superior indoor air quality management practices, pharma industries now are in a position to expand this awareness in the form of peer engagement and knowledge sharing with other industrial sectors and groups the combustion chamber it heats progressively over ceramic media bed. In the combustion chamber the air stream is oxidised and later cooled over a media bed. This process also saves cost through energy recovery in the oxidiser. ◗ Thermal recuperative oxidiser: The preheated air stream is treated in a shell and tube style heat exchanger. Oxidation takes place at very high temperatures and the reaction is exothermic. Pollutants get converted to carbon dioxide and water vapour and heat. In the shell section of the heat exchanger the hot treated air stream enters to release energy for preheating the incoming air. ◗ Direct fired thermal oxidiser: Air emissions which have high concentration of pollutants (HAPs and VOCs) are controlled with this technology.

The burner oxidizes the VOCs and HAPs giving out clean air.

Scrubbers Scrubbers help in eliminating particulate as well as gaseous pollutants from air emissions from pharma industry emissions. Pollutants are primarily captured with the help of water media. In the pharma industry many acids are stored in the form of aqueous solutions in tanks that can emit hazardous gases which need treatment.

Wet scrubbers are most common approaches for improving the overall air quality that is being handled in the pharma plants. Certain processes release emissions with a very large concentration of VOCs. Treatment might become expensive and hence the emis-

sions are first treated in a wet scrubber stripping the emissions that dissolve in water. Following broader classification for scrubbers could be looked at for facilitating improved air quality; ◗ Fume and gas wet scrubbers: These are used for removal of gaseous and particulate matter with the help of water and other liquid media. ◗ High efficiency dry scrubber: For the removal of aerosol mist, hydrochloric acid, sulfuric acid, nitric acid and chromic acid with minimum consumption of water the high efficiency dry scrubber is used. ◗ NOx Control Wet Scrubbers: NOx emissions are controlled by virtue of high efficiency wet oxidation or reduction method.

A 99% efficiency can be achieved on total NOx removal and elimination of red/brown NOx exhaust plume.

Dust collectors Dust in pharma industry is typically generated by a variety of unit operations including crushing, milling, screening, mixing, pelletising, dispensing, granulating, blending, drying, compressing, coating, weighing, batching, micromisation, sampling and packaging. While previously done for product recovery, the air quality and emission considerations have now taken centre-stage and major companies are focusing heavily on improving the dust collection efficiencies. A typical dust collector system is designed for large volumes of dust and comprises a blower, dust filter, a filter-cleaning system, and a dust receptacle or dust removal system.

Types of dust collector systems ◗ Bin vent: A stream of compressed air enters the top of each filter element in the compressed air blast. The airstream is expanded by the regulator resulting in the dropin pressure and its direction is reversed due to which the dust in the emissions is removed and it settles at the bottom. ◗ Cartridge dust collector: The cartridge dust collector comprises top box, middle box, bottom box, soot cleaning system, dust relief device, blow device, control system. The air emission stream enters the middle cylinder from the bottom. Due to the inertial collision and sedimentation the larger particulate matter settle in the bottom box. The collector has porous cylindrical metal cartridges which are lined with filtering media on the two ends. One of the ends is sealed while the other acts like an outlet for clean air. Cartridge collectors use perforated metal cartridges that are cylindrical shaped and open on one or both ends lined with a pleated non-woven filtering media.

Once installed, one end of the cartridge is sealed off and the open end is used for the clean exhaust. Similar to a baghouse, the gas stream is forced through the outside of the cartridge to the inside where it then exits back into the system.

These are also useful tools for airflow cleaning. However, the downside would be their maintenance. It would be costly to buy new cartridges for the filters every so often. ◗ HEPA Filtration System

(High Efficiency Particulate Air filters): HEPA filters effectively trap bacteria and viruses.

When the air stream passes through an HEPA filter it comes across the folds of the pleated filter media that splits the air stream in numerous air streams. This helps in trapping particles that are larger than the pore size of the media. This primary collection mechanism is called impaction and acts on particles greater than 1.0 micron. Small particles start moving from areas of higher concentration to lower concentration and settles on media fibres.

So, while the current focus on air pollution and ambient air quality management is critical considering the overall challenge on health impacts, the pharma industry can build in a cohesive approach here. Typically, strong air quality management measures and best practices in the indoor context (for manufacturing operations) have been prime. Similar best practices, learnings and collaborative engagement can be driven by industry leaders on ambient air quality management as well.

Considering its inherent expertise on technologically superior indoor air quality management practices, pharma industries now are in a position to expand this awareness in the form of peer engagement and knowledge sharing with other industrial sectors and groups. The technological options and control measures outlined above are indicative (and not all-inclusive), sectoral leaders can engage further with technology providers via independent platforms on air quality management driven across state and regional entities to access additional inputs on the economic feasibility and applicability across specific instances.

Pharma industries also have inherently strong monitoring and measurement frameworks for indoor air quality, concentration of key components, air composition etc. and these could be replicated to also communicate more actively on the ambient and stack emissions aspects.

(

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I N T E R V I E W

'We are collaborating with pharma companies worldwide to adopt eco-friendly methods' Over the years, Ideal Cures’ R&D department has helped pharma companies to adopt ecofriendly methods and increase productivity. Its recent INSTACOAT 4G is a new addition in this range. Suresh Pareek, MD, Ideal Cures, divulges more to Usha Sharma Tell us more about Ideal Cures’ recent launch, Instacoat EHP 250.

Instacoat E-series was launched by the company to support the pharmaceutical industry in its endeavour to remove use of organic solvents in the coating process, reduce energy consumption thereby having an overall effect of reduction in carbon footprint.

Instacoat EHP 250 is soluble in water and is a product which is used at 25 per cent reconstitution, which means that one takes 25 kg of Instacoat EHP 250 material and 75 kg of water, as compared to the other products available in the market, which requires six to 10 times the water. It effectively means that the need of carcinogenic organic materials is completely eliminated as well the energy required in evaporating solvents is saved. By using Instacoat EHP 250, customers have been able to reduce coating time by 50-60 per cent. In fact, few customers have been able to eliminate the need to purchase additional coating equipment and save the cost of a lot of infrastructure investments.

How has Ideal Cures helped pharma companies adopt eco-friendly measures to increase their productivity?

We collaborate with pharma companies worldwide in their endeavour to adopt eco-

friendly methods and increase productivity by providing necessary technical support, including helping them with their batches on production as well as organising training seminars for them. EHP 250 and EMB are the products developed for this purpose. In fact, it has always been the endeavour of our company’s R&D department to help pharma companies adopt ecofriendly methods and the recent INSTACOAT 4G is a new addition in that regard.

Give an update on Instacoat 4G and tell us about the company's plan for wet dispersion units?

INSTACOAT 4G is the fourth generation coating system launched to increase the productivity and adoption of eco-friendly methods for pharma companies. 4G works at 35 per cent reconstitution, which means it has 35 per cent solid content and 65 per cent water. It was specifically developed due to industry demand for continuous coating machines, which have 30 to 50 spray guns needed for immediate drying and film formation. The product has been effectively commercialised with customers in Europe using continuous coaters of O’Hara and Thomas Engineering.

There are about 32 pharma manufacturing plants in Sikkim. To help them reduce risks in the supply chain, we set up a manufacturing plant in Sikkim and started production. Ideal Cures is the first excipient company to start a manufacturing facility in Sikkim.

How can pharma companies reduce risks in the supply chain?

GST is finally coming into effect from July 1. Are you optimistic about the move?

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Has the Sikkim unit started commercial production?

The Sikkim unit started commercial production in March 2017 and is presently catering to customers in Sikkim. The current installed capacity is 75 metric ton per month single shift, with space for further expansion. The Sikkim unit will produce the full range of INSTACOAT coating systems, ESPHERES and some speciality products.

In general, introduction of GST is a right initiative and reform needed in the country.

There may be initial hiccups for some duration in the understanding of the reform.

This will ultimately make all the states competitive.

Introduction of GST would lead to streamlining of the compliance level across the country, simplify the taxation structure and its effect may vary according to the industry.

Overall, I am very optimistic by this move and change brought in by the government.

Will there be shortage of medicines in the market due to implementation of GST? In my view, there may be temporary shortages of not only medicines but in general all commodities across industries as the new law has to be understood and complied with. It make take the initial few months to understand the process and compliance, but production should continue because the shortage would not only affect manufacturers but consumers as well. Simultaneously, efforts may be made to exhaust existing finished goods before June 30. A seller would like to sell and a purchaser would like to delay the purchase, which may ultimately lead to shortage.

Could you throw some light on the recent investment by TA Associates in Ideal Cures?

The company will be able to benefit by having TA as a share-holder in the long run, by way of getting TA’s expertise and association with pharma industries worldwide.

Apart from this, the company would have the necessary support in its expansion plans in market place as well as setting up new plants.

Tell us about the company's plans for the current fiscal?

Last year, Ideal Cures opened its US office by getting Dr Kamlesh Oza on board. This year, the company would like to further expand its US operations and is actively looking at increasing the customer base. For this, we have also participated in CPhI, North America for the first time. We are also working towards providing the necessary support to pharma companies to achieve higher production levels in the sugar coating segment. To support this, we have launched new products like INSTACOAT SFC (Sugar Fast Coating) and CFC (Chewable Fast coating).

Some more products are in the pipeline, which will be introduced in the current fiscal. We also have on board Mike Easterbrook as Chief Technical Officer, who will provide support for customer training programmes as well as in development of new products and technologies. u.sharma@expressindia.com

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cover) INSIGHT

The monster in your laboratory Sekhar Surabhi, CEO and President at Caliber Technologies, insists on paperless automation and recommends a shift to a completely automated, paperless laboratory

I

t is eating up your time and effort. It is resulting in a compromise on your efficiency. It is taking up all your space. It is putting you under huge risk of data loss and noncompliance. It is putting you under huge risks. To add to all this, it is making you falter in front of your auditor. There is a monster in your laboratory. Paper!

Though environment is one of the lesser considered factors while addressing pharma challenges, a simple web search will tell you how paper is affecting the environment. Collectively known as paper pollution, it is causing deforestation, air pollution, water pollution and to some extent, damaging the planet.

Due to the increased usage of paper, paper mills have begun to contribute all the more to the world’s pollution. The production of paper itself contributes to most of this pollution, leave aside the over-usage and consequent wastage of resources after said production. An interesting fact I came across recently is that the pulp and paper industry is fifth in the list of worldwide largest consumers of energy, thus taking up four per cent of the world’s energy usage. As the worldwide consumption increases year after year, this paper pollution continues to be a threat to the environment. To sum up, paper usage is hurting the greenness of the planet. Laboratories that use piles and piles of paper are ending up wasting the opportunity to make a difference to the planet by continuing to use paper even while superior paperless automation options are readily available in the market.

Having said that, my case is

38 EXPRESS PHARMA June 1-15, 2017

quality control laboratories are due to improper controls or such controls being circumvented.

These issues generally happen in paper-based quality management and many of such issues are consequentially solved and enforced in the automated systems.

Data security and sanctity

not just about the environment.

It is for your laboratory. Paper is not doing any good for your laboratory either. It is affecting your time, efforts, efficiency, quality, data security, data sanctity and unarguably, regulatory compliance.

Time and effort Constant dependence on paper for recording analytical testing and associated tasks is resulting in a laboratory that is unable to function at its highest capacity.

26 per cent of the precious time of lab personnel is getting wasted in writing and re-writing transcriptions. Having to fill in the same details manually over and over again, and physically passing around sheets of paper for approvals seems archaic.

With transcription of the data from lab books or instruments, manual calculation verification, data review and approval, most of the supervisor’s time is

wasted in verification, which has no value addition from him/ her to the system. This results in a sheer wastage of efforts and time.

Efficiency In a world that changes every second, compromising on efficiency is not a negotiation. The law of ‘Survival of the Fittest’ applies to everybody and is a wellknown fact known. Being your best comes from using the best resources and applying the best efforts into making a truly excellent product. Upgrading to technology and building more opportunities to do better is an endeavour every business must envision. With paper, your processes continue to eat up the efficiency of your laboratory. Reworks and re-checks caused by manual errors become a hindrance to productivity and in turn, your laboratory’s efficiency gets affected. In an automated

world, efficiency is a natural outcome, not an effort.

Quality The foundation for quality in GMP has been the 4M Rule Man, Machine, Method and Material. It is the fundamental rule of GLP (Good Laboratory Practices) that if these four resources are controlled and used in the way they need to be used, quality of the analytical testing is assured, thereby assuring the end quality/safety of the medicine supplied. Controlled resources are a direct result of a mixture of many processes done right qualified analyst to perform specific tests assigned to him/her, calibrated status maintained instruments, testing method for the analysis being performed and all associated material like chemicals, volumetric solutions, standards, columns, micro cultures, etc. More than 29 per cent of the non-compliances found in

Data security and sanctity is also one of the major concerns with paper. Storage of crucial laboratory information on paper, which is open to the risks of damage and loss, is a burden that a laboratory must carry in the absence of technological intervention.

Data archival, preservation and retrieval is least optimum with paper. Also, with humans at the other end of this piece of paper, errors and even frauds, are a risk that an organisation must be willing to take. Manipulation or error could thereafter result in multiple issues which may affect the quality of the product, regulatory compliance, and even your profitability. How much can all this cost you is a calculation that I know you can make better.

With an automated system, all information is stored in a system at one place and can be retrieved whenever needed. Only authorised persons can access data and every movement in your data can be easily tracked. A smooth audit trail is made which makes it effortless to point out an error or manipulation. An automated system can provide the kind of security that paper just cannot.

Regulatory compliance Risk of non-compliance could be one of the biggest risks in

( pharma. Even if you are willing to ignore the effects of paper as argued above, regulatory compliance is an aspect a laboratory can absolutely not afford to compromise on.

ALCOA - recent guidelines for data reliability and integrity, issued by UK MHRA and US FDA is one of the prime drivers for automation in order to achieve compliance. Every piece of lab information/action recorded should comply to 'Assignable, Legible, Contemporaneous, Original, Attested copy.'

Also, with FDA insisting on electronic filings and audits, it is imperative that your laboratory shifts to an automated setting.

It must also be noted that amongst the 483s published, 69 per cent are due to non-compliance from QC. A further drill

down shows that these pertain to procedures, controls, transcription errors, etc. A paperless system is a much easier way to control these issues. Automating procedures, workflows and documentation will result in significantly lesser need for review and supervision.

This will also drastically bring down audit comments with respect to errors and procedural irregularities.

With stringent rules from different regulatory bodies, it is crucial that your entire working system is robust. Systems must be designed in a way that these regulations are met by default, hence ruling out the need to revisit each procedure to ascertain if they meet the conditions put forward the by these regulatory bodies.

A completely automated, 100 per cent paperless laboratory Quite perceptibly, taking the leap to completely get rid of paper is intimidating to a laboratory of any size. However, a company envisioned this and approached us in 2014 asking for a completely paperless laboratory. While most of our counterparts offer only partial automation, this client asked us for a 100 per cent paperless laboratory.

We took up the challenge. The solution was a scalable, hosted and integrated solution ensuring high data integrity and data sanctity. Hence, we implemented our LIMS (CaliberLIMS) – Laboratory Information Management System in their laboratories across India.

The result was a 100 per cent

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paperless laboratory (first of its kind) with complete automation of every task, minimum scope for human intervention and zero dependence on paper. All processes were made completely automated. For example, this system facilitated sample logins and sample registrations with complete automation and controls; sample results approval and certificates could be generated online; label printing and barcoding was programmed within the system; online review process by multiple levels of supervisors was made possible; etc. This solution was designed in a way that the laboratory adhered to international quality standards like GLP, GMP, 21 CFR Part 11, and 17025. All systems and instruments were integrated with our software to en-

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sure smooth flow of processes.

In addition to this, our solution came with a built-in ELN – Electronic Lab Notebook. As a result, the audit observations drastically came down, and it improved the efficiency manifold, also creating a secure database for all laboratory decisions and processes. All this was possible by making a definitive resolve to go paperless.

Automation is not just a trend to follow, it is indeed a real need – and it is undoubtedly achievable. So, get rid of that monster in your laboratory.

I urge you, not just for the sake of the planet, but for the sake of your own time, efforts, efficiency, data, risks, and compliance, make the shift to a completely automated, paperless laboratory.

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cover ) CASE STUDY

Operational excellence with sustainability: Lessons from Lindström Lindström, which provides rental workwear solutions for the pharmaceutical sector has adopted various environmentally-friendly ways to achieve significant cost benefits, reveals its recently released Sustainability Report 2016. Excerpts from the report Effective use of textiles throughout their lifecycle Renting textiles is a wastefree solution for the customers, since the responsibility for purchasing, maintenance, storing and disposal is handled at Lindström.

The company purchases over two million kilogrammes of textiles per year. Therefore, with an aim to prolong the lifespan of a textile and to reduce the amount of textile waste, the company orders only on demand and designs textiles that is easy to repair.

It focuses on the profitable reuse of textile waste - easier said than done. Reportedly, the company withdraws about a million kilogrammes of textiles per year, when rental textiles, such as workwear, hotel linens, and restaurant table cloths reach the end of their cycle. The aim is to increase the utilisation of textiles to 90 per cent by 2020. One solution that the company deploys is taking part in the Relooping Fashion project organised by VTT (Technical Research Centre of Finland). The aim is to find a solution to handling textile waste. With a mechanism for dissolving cellulose fiber developed by VTT, used cotton clothing is dissolved in this project and the residue fiber is then processed to new fiber for the textile industry.

Effective laundry, clean laundry The company also adopts var-

40 EXPRESS PHARMA June 1-15, 2017

VISION GOALS AND RESULTS We’ll act responsibly and eliminate all unnecessary business.This gives us control over our actions and their eff ect on people and the environment.

of water.

Water savings: Water is recycled in different washing cycles. The used rinse water can be re-used as the wash water for the next batch. Clean water is used for rinsing, and the company monitors the end result and the quality of the wash water. The cleanest water comes from laundering hotel textiles and the dirtiest comes from mats and industrial towels.

Fuel savings: The same truck transports the fresh textiles back to the client and at the same time picks up new dirty laundry. Clean and dirty textiles are kept separate

Responsible products and purchasing

We monitor the responsibility of the supply chain with uniform reporting and in accordance with purchasing strategy.We’ll assess our suppliers and enter the results of those evaluations into our supply database. Further, we’ll audit our suppliers within the realm of our regular supplier auditing program.The outcome of audits will be documented in the AMT (Audit Management Tool) system.

Source: Lindström

ious measures while washing and repairing textiles to become a more sustainable organisation.

Short distances: The laundry facilities are located close to industrial areas to reduce textile transportation. The distribution routes are optimised

all the time and the distribution trucks' used capacity high is kept high.

Sorting: The clothes are sorted by dirtiness and colour to ensure the right washing programme. In the industrial washing process, clothes are disinfected.

Energy savings: Most of the energy used in the laundry is used to heat up the wash water and to finish off. Collecting heat from the wash water and the tumble drier air improves energy effectiveness. Also the heat from the wash water can be used to heat the next batch

Lindström demonstrates that responsible products and purchasing is a part of sustainability. The company buys products needed in abundance mainly from Asia and Africa. Local manufacturers from Europe and Asia serve small-scale needs. Long-term relationships with responsible partners is a strategy to enable sustainability and responsibility.

Mutual understanding minimises risks: Understanding suppliers' working conditions, and compliance with environmental and ethical principles with regular audits and visits. Lindstrom classifies its suppliers by the risks involved in suppliers and supplier countries and also by the importance of goods. They

( made a country risk analysis last year to evaluate, for instance, the state of official inspection, human rights issues, use of child labour, and corruption by the supplier country. In addition, they have made an individual risk analysis for all their most important suppliers. The monitoring and reporting of the supplier chain constantly helps the company stay up to date with what’s happening globally and whether agreed issues are followed up on.

Assessing country risks: Lindstrom assesses the following risks involved in their operations: ◗ salary and energy expenses ◗ political change ◗ culture ◗ crime and piracy ◗ government officials' behaviour and corruption ◗ legislature ◗ the climate and infrastructure ◗ health and safety It assesses the probability of risks in their supplier countries and the effects of those to their business. A strategy to safeguard themselves from those risks is also put into place. If the risk level is found to be too high, the company doesn't purchase supplies from the country in question.

THE MAIN FOCUS

WE USE OUR TEXTILES UNTIL THEYARE UNUSABLE BEFORE WE ORDER NEW ONES

Safety at work The company is responsible for employees’ health and safety.

The most effective way to increase safety is to prevent accidents and monitor risks. The most common accident situations for Lindströmers are while commuting to and from work and while moving a trolley or a mat grid at a laundry. The most notable occupational hazards are linked to ergonomics, noise, vibration, and exposure to chemicals. An important means to prevent such accidents and occupational hazards is to monitor safety risks. The company encourages its staff to always report on their findings. They organise initiatives like monthly safety walks at service centers

Source: Lindström

to monitor the safety and risks of the premises together. The challenges are the different ways of registering accidents in different countries and cultures, which results in an in-

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ability to compare the safety at work accident figures among subsidiaries. Moreover, the cost effects of sick leaves and absences are notable but not yet recognised by all the

managers.

Thus, Lindström adopts myriad measures to make its main operations more sustainable which in turn has also resulted in significant

cost savings in the long run.

It shows by example that strategic adoption of sustainability measures can help an organisation achieve operational excellence.

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MANAGEMENT REPORTS

First-in-class innovation a key strategy for pharma companies in a harsh market environment: GBI Research The report also mentions that a product entering into clinical development has a 72 per cent likelihood of failing to reach the market across any of the indications for which it is in development

F

ewer than two in 10 medicines exceed the average pharmaceutical R&D cost required to bring a drug to market when the risks of failure to reach market approval are factored in, according to business intelligence provider GBI Research.

The company’s latest report states that, across the pharma industry, a product entering into clinical development has a 72 per cent likelihood of failing to reach the market across any of the indications for which it is in development. On top of this, it is widely understood that bring-

42 EXPRESS PHARMA June 1-15, 2017

ing drugs to market is becoming increasingly expensive.

Dominic Trewartha, Managing Analyst, GBI Research, explains, “The growth in drug development costs has been attributed to higher failure rates for drugs tested in clinical trials. Additionally, a range of factors are thought to have increased clinical trial costs, including increased trial complexity, larger average trial sizes, higher costs of inputs from the medical sector, and increased targeting of chronic and degenerative diseases.”

“Overall, these higher costs appear to stem from an

increased clinical failure rate and emphasis on proving superiority over comparator drugs in healthcare technology assessments, as well as an increasing level of sophistication from payers when assessing the cost-effectiveness of drugs. The additional trials needed to provide adequate evidence of a drug’s efficacy have significantly added to the cost of development,” Trewartha said.

Due to growing R&D costs and the limited lifecycles of patented drug products, it is imperative that pharma companies maximise annual product revenue following market

approval and maximise the lifecycles of their drugs, primarily by minimising the impact of generic entry.

Trewartha continues, “First-in-class innovation is a key strategy that companies have been employing to achieve these imperatives.

Over recent decades, in addition to an increase in the yearly number of new chemical entity approvals by the FDA, the number of first-inclass products also increased.

Indeed, the proportion of first-in-class approvals has increased steadily each year since 1994.”

EP News Bureau

Haematological cancers pharma pipeline one of the strongest within oncology: GBI Research THE HAEMATOLOGICAL cancers pipeline, which covers leukaemia, lymphoma and myeloma, is the largest within the oncology therapy area of pharmaceuticals, with 1,474 programmes in active development and a total of 477 first-in-class pipeline programmes, according to business intelligence provider GBI Research.

The company’s latest report states that cytokine signalling targets make up the greatest proportion of pipeline and first-in-class programmes, followed in both instances by kinases. These two target categories are intrinsically linked with components of immune response, and are responsible for the majority of targets, in part due to the nature of haematological cancers and their action on immune cells.

Callum Dew, Associate Analyst, GBI Research, explains, “As these disorders affect the immune cells within the blood and bone marrow, there is a high degree of pathophysiological crossover between the separate types of malignancy within haematological cancers, so it is not uncommon for products being developed for this therapy area to be tested across multiple indications.”

With regard to individual molecular targets in the pipeline, 27.3 per cent are first-in-class, which is a greater proportion than the industry average.

EP News Bureau

Global immunology market to surpass $75 bn by 2022 despite patent expirations According to GBI research, the large immunology pipeline consists of 2,054 products in active development, almost 100 of which are in Phase III THE GLOBAL immunology market, which covers autoimmune diseases such as rheumatoid arthritis, psoriasis, lupus, and ankylosing spondylitis, is set to rise from $57.7 billion in 2015 to $75.4 billion by 2022, representing a compound annual growth rate of almost four per cent, according to business intelligence provider GBI Research.

The company’s latest report states that disease-modifying anti-rheumatic drugs – a highly genericised class of systematic

small molecule based agents – are used in the first-line treatment of immunological disorders. However, as these therapies often fail to elicit an adequate long-term response, a large second-line therapy segment has emerged in these markets, which began with the approval of Remicade (infliximab) and Enbrel (etanercept) in 1998.

This segment consists largely of premium systemic monoclonal antibodies (mAbs), which have been highly commercially successful over the past decade.

Qaisrah Khalid, Analyst, GBI Research, explains, “Although the patents for many of these mAbs have either already expired or are due to expire during the forecast period, the market is expected to experience continued growth due to practical and regulatory barriers to entry for biosimilars that are not present for small molecule generics, and a moderately strong late-stage pipeline.”

The large immunology pipeline consists of 2,054 products in active development, al-

most 100 of which are in Phase III. Although none of the products in the late-stage pipeline are expected to achieve the same levels of success as the mAbs currently in the market, GBI Research believes the more competitive landscape will enable a number of candidates to generate strong annual revenues during the forecast period, such as sarilumab and baricitinib.

Khalid continues, “A range of companies are actively involved in the development or market-

ing of immunology products, including a large proportion of top 20 pharma firms such as AbbVie, Johnson & Johnson, Roche, Amgen and Pfizer. Despite the fact that many of the approaching patent expiries – especially that of Humira (adalimumab), marketed by AbbVie, and Remicade, marketed by Johnson & Johnson – will affect these players directly, they are anticipated to maintain their high market shares in the area.”

EP News Bureau

Growth hormone deficiency market to grow steadily, surpassing $2 bn by 2026 According to a report by GlobalData, major drivers of this growth include the launch of long-acting growth hormones, improved adherence to and compliance with the use of these growth hormones THE GLOBAL growth hormone deficiency (GHD) space, which covers the seven major markets of the US, France, Germany, Italy, Spain, the UK, and Japan, is set to rise from around $1.42 billion in 2016 to $2.08 billion by 2026, representing a steady compound annual growth rate (CAGR) of 3.9 per cent, according to research and consulting firm GlobalData.

The company’s latest report states that major drivers of this growth include the launch of long-acting growth hormones, improved adherence to and compliance with the use of these growth hormones, and increased awareness of the disease within the medical profession.

Edit Kovalcsik, Healthcare

GlobalData believes that these long-acting growth hormones will eventually replace daily growth hormones, and will capture more than half of the latter’s patient share by the end of the forecast period Analyst, GlobalData, explains, “Patient compliance with daily growth hormone drugs has been a long-standing issue in the GHD treatment landscape, and remains the greatest unmet need in the market. This unmet need has given a major thrust to innovation in the treatment space, with pharmaceutical companies focusing heavily on developing easier

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delivery options for patients.

“Currently, a dominant trend in the GHD market is the development of long-acting growth hormone drugs that can be administered weekly or biweekly in comparison to currently marketed daily growth hormones. In fact, all four of the late-stage pipeline drugs and two out of three drugs in early-stage development for

GHD are long-acting.”

GlobalData believes that these long-acting growth hormones will eventually replace daily growth hormones, and will capture more than half of the latter’s patient share by the end of the forecast period.

Among them, Pfizer/OPKO’s Lagova (hGH-CTP), Versartis’ somavaratan, and Novo Nordisk’s somapacitan will be

the highest revenue earners by the end of the forecast period.

Kovalcsik continues, “Following the launch of new longacting therapies, the level of need for new drugs will be low in the GHD market. Indeed, environmental unmet needs, such as earlier diagnosis, disease awareness, and physician education, are of greater priority in the GHD field than designing a new drug.

“The efficacy of the growth hormones is often reduced by non-compliance or non-adherence to the daily injection regimen. In this way, developers should continue focusing on improving delivery options and frequency of administration of growth hormones.”

EP News Bureau

EXPRESS PHARMA

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RESEARCH UPDATES

Pfizer drug from Medivation deal shows promise in breast cancer: Study Common adverse side effects included anaemia and low blood platelet and white blood cell count

A

breast cancer drug that Pfizer acquired with its $14 billion purchase of Medivation showed promising anti-tumour activity following prior treatments and a modest ability to hold the disease in check, according to data from a mid-stage study released recently.

The drug, talazoparib, belongs to a class of medicines called PARP inhibitors which may induce tumour cell death.

PARP inhibitors have shown promise in ovarian and breast cancers.

The Phase II study tested the drug in women with advanced breast cancer who had heredi-

tary mutations of the BRCA1/2 genes. That is the type of mutation that led actress Angelina Jolie to have preventive breast removal surgery due to her increased risk of cancer.

Talazoparib led to significant tumour shrinkage in 21 per cent of the 48 patients in the study's first group, whose disease had progressed following platinumbased chemo therapy treatment.

Significant tumour shrinkage, or overall response rate, was seen in 37 per cent of a second group of 35 patients who had received at least three prior regimens of non-platinum chemotherapy.

Median progression-free sur-

vival, or the time until disease worsening after talazoparib treatment, was four months in the first group and 5.6 months in the second group. Overall survival data was not yet available.

Common adverse side effects

included anaemia and low blood platelet and white blood cell count. Three patients, or four per cent, discontinued treatment due to side effects.

The data, included in a brief summary of the study to be presented next month at the American Society of Clinical Oncology meeting in Chicago, may not represent the final results.

BRCA mutations account for more than 50 per cent of hereditary breast cancers, and up to 65 per cent of those who inherit the mutations will develop breast cancer, often much younger than is typical for the disease.

While gaining the blockbuster prostate cancer drug

Xtandi was the prime reason for the Medivation acquisition last year, Pfizer has extensive plans for talazoparib.

It has begun enrolling patients for a larger Phase III breast cancer study and sees potential for the drug against several other types of cancer, including ovarian, gastric and small cell lung cancer, in combination with other treatments such as immunotherapies. “The programme for talazoparib includes broad and competitive development plans in multiple tumours,� said Maria Koehler, Vice President of Strategy for Oncology, Pfizer Reuters

Keytruda improves survival for bladder cancer patients The company is currently enrolling patients in a phase three trial of Keytruda, combined with chemotherapy, as an initial treatment for bladder cancer PIVOTAL TRIAL results for Merck & Co's immunotherapy drug Keytruda show that it lengthened survival by three months, or nearly 40 per cent, for patients with advanced bladder cancer who had stopped responding to chemotherapy.

The data, to be presented next month at a meeting of the American Society of Clinical Oncology, follow recent announcement that rival drug Tecentriq, from Roche Holding, did not improve survival when used as a second-line treatment for bladder cancer in a trial.

The Merck drug is awaiting US Food and Drug Administration approval, but Tecentriq

44 EXPRESS PHARMA June 1-15, 2017

was approved by the agency last year, contingent on verification of its clinical benefit.

Roche, in an emailed statement, said it plans to discuss the data with health authorities but did not disclose the timing for the discussions. According to the FDA approval letter, the company has until December to submit the full trial data to the agency.

Merck filed in February for FDA approval of Keytruda for both initial and secondary treatment of advanced urothelial cancer, the most common type of bladder cancer.

Keytruda is already approved for treating melanoma, lung cancer, head and neck cancer

and Hodgkin lymphoma.

Merck announced in October that the second-line bladder cancer study met its main goal and was stopped early. The company is currently enrolling patients in a phase three trial of Keytruda, combined with chemotherapy, as an initial treatment for bladder cancer.

In addition to Tecentriq's approval for bladder cancer patients whose disease has stopped responding to chemotherapy, the FDA last month approved the Roche drug as an initial treatment for people with a specific type of advanced bladder cancer and in people whose cancer progressed despite at least one

prior platinum-containing chemotherapy.

The agency has also granted contingent approval to AstraZeneca's Imfinzi, BristolMyers Squibb’s Opdivo and Bavencio, developed by Pfizer's and Merck, as second-line bladder cancer treatments.

All five drugs are part of a new class of treatments designed to unleash the body's immune system to fight cancer by interfering with proteins known as PD-1 or PD-L1 that help malignant cells evade immune attack.

Merck said data from an open-label Phase 3 trial of 542 advanced bladder cancer patients showed median survival

of 10.3 months for Keytruda patients and 7.4 months for patients given second-line chemotherapy. The study's median follow-up was 18.5 months.

After 18 months, 36 per cent of Keytruda patients were alive, compared with 20.5 per cent of chemotherapy patients, according to research published by ASCO. The study did not detect a difference in the length of time patients lived without their disease getting worse.

Severe side effects were reported in 16.5 per cent of the Keytruda patients, compared with nearly half of the chemotherapy group.

Reuters

Celgene leukaemia drug extends survival in early stage trial The Celgene drug works by transforming leukaemia cells in the bone marrow into normal mature white blood cells NEARLY 20 per cent of patients with an aggressive form of leukaemia experienced complete remission along with prolonged survival from treatment with an experimental Celgene Corp drug, according to data from an early-stage study released recently.

The drug, enasidenib, delivered high overall response rates in patients with acute myeloid leukemia (AML) whose disease had relapsed following prior treatments.

Available data from 176 patients showed 40.3 per cent responded to the treatment, with 19.3 per cent achieving complete remission.

Median overall survival for relapsed AML patients was 9.3 months and rose to

19.7 months among those who experienced complete remission.

Patients in the trial had run out of treatment options and would have been expected to live only about three or four months, said Dr Eytan Stein from Memorial Sloan Kettering Cancer Center in New York, who led the study.

Stein called the early results extremely promising.

"For patients who have a limited life expectancy, this is a fantastic new treatment that in many people will hopefully extend their lives," Stein said.

Unlike chemotherapy that kills cancer cells, the Celgene drug works by transforming leukaemia cells in the bone marrow into normal mature white blood cells.

The data was included in a brief summary of the Phase I study that will be presented next month at the American Society of Clinical Oncology meeting in Chicago.

In addition to the complete remissions, enasidenib led to complete remission with incomplete return to normal blood cell count in 6.4 per cent of patients and partial remission in 6.3 per cent

of patients.

In a dose escalation portion of the study, maximum tolerated dose was not reached at doses up to 650 milligrams daily. The 100 mg daily dose was chosen for the study going forward.

Researchers reported that the drug was well tolerated with no serious adverse side effects of concern.

AML, a fast-growing cancer of the blood and bone marrow, is one of the most common adult leukaemias diagnosed in about 15,000 Americans each year.

Stein said he was looking forward to further enasidenib studies "so we can get this therapy to our patients as soon as possible."

Reuters

Weight loss tied to lower risk of knee joint degeneration There were also changes in the menisci, crescent-shaped pads that protect and cushion the joint OVERWEIGHT AND obese people who shed a lot of excess pounds may have less damage in their knee joints than their counterparts who don’t lose weight, a recent study suggests.

While previous research has linked obesity to an increased risk of joint disease and cartilage damage in the knees, the current study underscores how weight loss may help minimise this risk.

Researchers followed 640 obese and overweight patients for four years. By the end of the study, participants who lost more than 10 per cent of their weight were 66 per cent less likely than people who didn’t lose any weight to show progression in the deterioration of their knee joint cartilage.

People who shed five per cent to 10 per cent of their weight were also less likely to have progression in knee joint damage, but the difference

wasn’t big enough to rule out the possibility that it was due to chance.

“Our study shows that a lifestyle intervention such as weight loss can slow the process of knee joint degeneration in patients at risk for and with osteoarthritis and therefore may slow the worsening of symptoms such as pain and disability, said lead study author Dr Alexandra Gersing of the University of California, San Francisco.

“The more weight loss the patients achieved, the greater the benefits were, even if they remained obese after losing weight,” Gersing said by email.

Osteoarthritis is the most common joint disease in the US, affecting more than half of people 75 and older, researchers note in the journal Radiology.

Compared with people at normal weight, obese women are nearly four times more likely to

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develop knee osteoarthritis, while obese men have five times the risk.

At the start of the study, participants were 63 years old, on average, and typically very overweight or obese. Most of them had either minimal or moderate damage to the knee joint, based on magnetic resonance imaging (MRI) exams.

Four years later, roughly half of the participants were at about the same weight as when they started. Another 238 people lost between five per cent

and 10 per cent of their weight and 82 participants lost more than 10 per cent of their weight.

Not only did the researchers find that weight loss slowed cartilage degeneration, they also saw changes in the menisci, crescent-shaped pads that protect and cushion the joint.

The study wasn’t a controlled experiment designed to prove that weight loss prevents knee joint damage or osteoarthritis.

Limitations of the study include the lack of data on weightloss methods participants used, which may have influenced what happened with their knee joints, the authors note.

Even so, the study offers fresh evidence of how weight loss may benefit the knee joints, said Dr Leena Sharma, director of the Multidisciplinary Clinical Research Center in Rheumatology at Northwestern University Feinberg School of Medicine in

Chicago.

“This study uniquely gets at the benefits of weight loss on specific tissue abnormalities in knee osteoarthritis and convincingly demonstrates the benefit of weight loss on the course of this common condition,” Sharma, who wasn’t involved in the study, said by email.

It should also encourage patients to consider the benefits of even a little bit of weight loss,” said Dr Kent Kwoh, Director of the University of Arizona Arthritis Center in Tucson.

“Losing weight can help overweight and obese patients protect their knees and keep their arthritis from getting worse,” Kwoh, who wasn’t involved in the study, said by email. “At this point in time, joint damage cannot be reversed; we can only keep it from getting worse.”

Reuters

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RESEARCH

Bristol-Myers NASH drug reduces liver fat in midstage study The Bristol drug also led to improvements in cholesterol and triglycerides, researchers reported BRISTOL-MYERS Squibb Co said its lead experimental drug for non-alcoholic steatohepatitis, or NASH, significantly reduced liver fat versus placebo, according to data from a mid-stage trial presented at a recently held medical meeting.

NASH, a progressive fatty liver disease tied to obesity and diabetes, afflicts about five per cent of the population and is poised to become the leading cause of liver transplants. Many companies are developing drugs for the complex disease for which there are no approved treatments.

The 16-week, 74-patient trial tested the subcutaneously-injected drug, BMS-986036, at two dosing regimens versus placebo in adults whose NASH was confirmed by liver biopsy. Both the 10 mg dose given daily and a 20 mg once-a-week injection met the main goal of significantly re-

ducing liver fat.

Liver fat was reduced 6.8 per cent with the daily injections and

5.2 per cent for the weekly dose compared with 1.3 per cent for placebo.

In addition, the Bristol-Myers drug reduced biomarkers for fibrosis, the scarring that can lead to cirrhosis, cancer and liver failure, as well as measures of liver stiffness and enzymes indicative of liver injury, data showed.

“These data suggest that BMS-986036 may be effective in patients with NASH, many of whom will experience disease progression due to the lack of available treatment options,” Dr Arun Sanyal, the study's primary investigator from Virginia Commonwealth University in Richmond, said in a statement.

"The results of this study show that BMS-986036 had beneficial effects on three important components in the treatment of NASH: liver fat, liver injury and fibrosis," said Sanyal, a leader in the field who presented the data at the European Association for the Study of the Liver (EASL)

conference in Amsterdam.

The drug is a pegylated, or long acting, version of a natural human hormone called fibroblast growth factor 21, a regulator of metabolism believed to be effective because of the varied metabolic drivers of the disease.

The Bristol drug also led to improvements in cholesterol and triglycerides, researchers reported. At least one NASH drug further along in development from another company led to a rise in ‘bad’ LDL cholesterol, which caused some concern.

There were no deaths, serious side effects or discontinuation due to adverse side effects reported among patients who received the Bristol drug. The most frequently reported side effects were diarrhoea, nausea and frequent bowel movements, none of which were considered severe, the company said.

Reuters

Eating tree nuts may cut risk that colon cancer will return: Study All of the patients in the study had received surgery and chemotherapy to treat their colon cancers COLON CANCER survivors who ate at least two ounces (57 grams) of tree nuts a week — roughly 48 almonds or 36 cashews — were significantly less likely to have their cancer return or to die from their cancer than those who did not eat nuts, US researchers said.

The finding by Dr Temidayo Fadelu of Dana-Farber Cancer Institute in Boston and colleagues is the latest to suggest a health benefit from nut consumption.

The researchers analysed a questionnaire about dietary intake from a clinical trial of 826 patients with stage III colon cancer - a stage in which the cancer has spread to nearby lymph

46 EXPRESS PHARMA June 1-15, 2017

nodes but not other parts of the body.

All of the patients in the study had received surgery and chemotherapy to treat their colon cancers.

People who reported that they ate more than two ounces of tree nuts per week - about 19 per cent of the study participants - had a 42 per cent lower chance of cancer recurrence and a 57 per cent lower chance of death than those who did not eat nuts.

The benefit applied only to tree nuts and not peanuts or peanut butters, said Fadelu, whose study was released in advance of the upcoming American Society of Clinical Oncology

(ASCO) meeting to be held early next month in Chicago.

That may be because peanuts are legumes, which may have a different metabolic composition than tree nuts, Fadelu

said.

“This study shows that something as simple as eating tree nuts may make a difference in a patient's long-term survival,” ASCO President Daniel Hayes

said in a statement.

Hayes said basic healthy eating is often overlooked by doctors and their patients in cancer care.

The team focussed on nut consumption because prior studies have shown that eating nuts can reduce the risk of obesity and diabetes - factors that also influence the risk of recurrence and death from colon cancer. Fadelu said further studies should look at whether tree nuts are associated with better health outcomes at other stages of colon cancer. The study was funded by the National Cancer Institute, the National Institutes of Health and Pfizer.

Reuters

IT@PHARMA INSIGHT

Robotic process automation: Atool to curb costs Sanjay Koshatwar, Executive Vice President, Pharma & Life Sciences, Incedo, highlights the potential of robotic process automation to usher efficiency, profits and regulatory control in the pharma industry

T

he pharmaceutical industry is going through a tough phase as research costs have hit the roof over the last few years, along with increasing regulatory controls. The healthcare industry has observed a multi fold rise in the cost of life-saving drugs, which puts pharma firms in a tough spot. The recent drug price hearing held at US this month publicly shamed drug companies, adding to the tremendous pressure to bring new drugs into the market profitably.

Challenges along the traditional path Currently, pharma firms are looking for innovative ways to close the gap between growing R&D costs and profits, while facing the challenge

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June 1-15, 2017

IT@PHARMA of rising regulatory control, testing, securing approval and bringing new drugs to the market efficiently.

So far, most changes which aimed at reducing costs and increasing efficiency was done through centralisation and standardisation of processes.

However, in some cases, standardisation can also mean compromising on the organisation's capability to react quickly to changes. Choosing between the lesser of the evils isn't an option and presents a challenge for most enterprises today.

Most of the established pharma firms are re-evaluating their business models as well as their operations. These requirements involve too many man hours to handle continuous and repetitive manual processes as many of the business processes associated with clinical trials, clinical data management are outsourced.

The pharma business is known to be a process-oriented industry. There are many standard operating procedures like Master Data Management, Drug safety reporting and clinical data management. For about 20 years, pharma firms have been outsourcing these processes to lower cost countries and it helped in curbing costs for a while. However, cost arbitrage which came from outsourcing doesn’t hold a competitive edge any more, thus compelling the industry to use automation. Besides, many clinical processes in practice today are still people intensive. This means a high volume of staff get busy in ensuring efficiency, profits and regulatory control when it can be done by machines in a shorter time.

Advent of RPA Replacing the human element with Robotic Process Automation (RPA) can be a potential game changer. Many of us have heard the term RPA but industry didn’t fully understand its potential. It is sometimes misinterpreted due to the absence of robots. Rather, RPA software is a powerful tool which is capable of performing manual, time-con-

48 EXPRESS PHARMA June 1-15, 2017

Replacing the human element with Robotic Process Automation (RPA) can be a potential game changer suming, repetitive tasks efficiently at lower costs, when compared to other automation solutions available in the market today.

For those who are not familiar with RPA, it is an application of technology which allows employees to configure a ‘robot’, or a computer software which can capture data from existing applications within the organisation to process a transaction, operate with the data, generate an appropriate response and communicate with other digital systems - all this without any human intervention. This technology is transforming the way we work traditionally, and it is set to change the way we know work processes over the decade.

Enterprises must constantly evolve to keep efficiency high and new opportunities flowing. RPA can bring down the need for people based processes significantly, and it can improve speed, accuracy and compliance – all this at a reduced cost to the pharma firm. It helps in saving costs by eliminating manual labour and reducing the wait time.

The potential applicability of RPA is widespread and spans across industries such as BFSI, retail, pharma and other data intensive sectors.

Since RPA is relevant to almost every process associated with clinical research, pharma firms are prime candidates for RPA since the solution is ideally suited to any process that can be defined and consistently executed with minimal variation.

RPA in pharma With RPA, the pharma firm applies digital robots to perform repetitive tasks in a high volume which earlier robbed the organisation of human hours. RPA can ensure consistency in data entry, quality

control and regulatory control and is suitable for any domain or any function where there is a repetitive process. For instance today we manually validate NPI/SLN numbers of HCP/HCO for those records where MDM could not match, it takes approximately 15 to 30 minutes. Meanwhile, a robot can be trained to open an email, attachments on the email such as exception report in Excel, validate information, request any detail that is missing by navigating to relevant websites, fill the data and send an email to the manager. All this happens in less than a minute and can be designed to run parallelly.

mented in a matter of days.

Potential areas for application RPA adoption is currently in its nascent stage within the pharma industry. Broadly, pharma firms can benefit from RPA in the following areas. ◗ Clinical development: RPA can cut processing time for clinical data management, site management, site payment processing, clinical data quality check and relevant actions, master data management, data stewardship etc. RPA is primarily helpful with email processes, validation of an employee, approval-integration with HR, contract management system etc.

How does RPA help?

All businesses are beginning to recognise the importance of RPA. Mainly, they see that implementing RPA in pharma firms offers an advantage of speed, auto audit trail and improved accuracy, eliminating human errors. Every process is required to be traceable and accountable; and while designing automation, we have experienced process optimisation in most cases. RPA bots can be deployed in parallel to scale up the surge almost instantaneously using cloud. One of the major advantages of RPA projects is that it does not initiate long IT integration project.

Implementation of RPA projects can be led by business operation. In our experience, most of these projects can be delivered in 8-10 weeks and benefit from RPA. A key advantage of RPA over other automation technologies is its drag-and-drop functionality. Unlike traditional automation tools, RPA solutions can be easily implemented and it can be effortlessly integrated with existing systems. It also eliminates the need for programming or coding. Consequently, RPA can be imple-

◗ Commercial operations: RPA can be applied into functions like sales force effectiveness, Aggregate Spend Reporting, Marketing Fulfilment, Chargeback and Rebate Processing, Account Payable etc.

It also helps in master data management. Most pharma firms get their data from third party providers, but the data quality isn’t the best available.

RPA can enrich the collected data and cut down from the process of third party aggregation. ◗ Rebate processing/chargeback processing: This is a commercial process where the pharma firm pays back rebate to the wholesaler and requires many integrations. In most companies, there’s still an element of manual processes involved, which can be significantly reduced with RPA. For instance, when a wholesaler submits a rebate, there is a defined timeline. RPA removes the manual process from the system and saves integration costs. Different enterprises are in various stages of RPA integration currently – some are focusing on fully auto-

mated systems, and some on semi-automated ones. RPA is very valuable from an organisational perspective as it can save integration costs to a large extent, sometimes even by millions. ◗ Regulatory submissions: During regulatory submission process, a lot of time and effort gets invested in quality check. RPA can apply Optical Character Recognition (OCR) and related technologies to automate this process.

What to look out for in your RPA solution?

When you look for an RPA solution or a service provider, you must check whether the solution can ensure security, scalability, and ability to integrate flexibly with third party technologies. Besides, it must also be easy to use from a user’s perspective. A quality RPA system should be functional from both, the technical and the end user’s stand point.

As an organisation, a decision maker may feel that one is more important and adapt your system accordingly. However, both sides should come into play and it should always be considered in the selection process.

Additionally, it is vital to have clarity and discuss right at the beginning what your desired outcome is, and what your business requirements are. The way you partner with your service provider can have a definitive impact on the project. In the end, your verdict on which RPA product is right for you also depends on various factors which are unique to your business.

Earlier, it was predicted that the robotic technology will grow to a $1.3 trillion industry. It is now estimated that the current growth rate would surpass the predictions.

Though RPA hasn’t completely replaced mainstream processes yet, it is gradually enabling pharma firms to focus on bringing safe and effective drugs to market at a lower cost by helping to address some of the key administrative tasks. It’s only a matter of time before the FDA is convinced that robots can do exactly what humans are doing today.

PHARMA ALLY VENDOR NEWS

Merck launches off-the-shelf cell culture media for perfusion processes Customers will be able to achieve a more optimal output than they would using conventional batch or fed-batch processes

M

erck took a significant step towards increasing manufacturing flexibility and enabling higher productivity with the launch of the EX-CELL Advanced HD Perfusion Medium. This first offthe shelf, high-density cell culture media supports perfusion processes at low perfusion rates, increasing production yield and speed to clinic.

Biomanufacturers are mov-

ing toward perfusion processes, the next generation in manufacturing, as they seek to cut costs while increasing quality and efficiency. Perfusion processes, however, require a new type of medium. Merck’s EX-CELL Advanced HD Perfusion Medium meets 'next-gen' manufacturing requirements, allowing customers to achieve a more optimal output than they would using conventional batch or

fed-batch processes.

“This launch is a major milestone on the road to truly enabling next generation processing,” said Udit Batra, Member of the Merck Executive Board and CEO, Life Science. “The benefits of perfusion technology include increased cost efficiency, decreased risk and enhanced manufacturing flexibility- ultimately advancing our customers’ production capabilities and increas-

ing access to therapies for people worldwide.”

A benefit of perfusion processing is higher protein yields, compared with fed-batch, which has been the primary mammalian cell cultivation mode for biopharma manufacturing over the past few decades. Perfusion technology is compatible with small portable plants and can be used with many drug types over a range of production

scales.

Merck’s EX-CELL Advanced HD Perfusion Medium is the most recent addition to the company’s EX-CELL Advanced product line, which offers increased performance, streamlines regulatory compliance and provides the supply chain security needed in today’s evolving biopharmaceutical environment.

EP News Bureau

Werum IT Solutions bags Frost & Sullivan Global Technology Leadership Award Award recognises Werum’s advanced PAS-X manufacturing execution system for improving manufacturing processes throughout pharmaceutical and biotechnology industries WERUM IT Solutions received the Frost & Sullivan Global Technology Leadership Award for Industrial Automation Solutions in Pharma and Biotech at the recently held PAS-X User Group Meeting, which took place in Morristown, NJ. As the most functional, comprehensive manufacturing execution system (MES) on the market, Werum’s PAS-X MES solution enhances the operational efficiency of pharmaceutical and biotechnology manufacturers’ businesses, increases their productivity, and aids in regulatory compliance.

The award recognises the sizable research and development spends dedicated to innovation, their crucial importance to the industry, and the

resulting positive impact on brand perception.

“With its flagship product PAS-X, Werum IT Solutions is the world’s leading supplier of MES and manufacturing IT solutions dedicated to the pharma and biopharma industries,” says Tonya M Fowler, Director of Americas, Europe, and Africa, Best Practices, Frost & Sullivan. “The company also supports enterprise manufacturing intelligence, an advanced integration of the automation layer, and superior interfacing technologies, in line with the Industrial Internet of Things and Industrie 4.0 trends.”

The annual gatherings in Europe and the US bring together a global network of pharma and biopharma profes-

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sionals to exchange ideas for best practices and discuss emerging industry trends and challenges. Owing to these proactive measures, the majority of the world’s top 30 pharmaceutical and biotechnology companies – as well as many regional and mid-sized manufacturers – use the PAS-X MES software.

“For its continuous investment and focus on leveraging technology to drive customer value and business impact, we are pleased to present Werum IT Solutions with the 2017 Global Technology Leadership Award for Industrial Automation Solutions in Pharma and Biotech,” Fowler said.

Rüdiger Schlierenkämper, CEO, Werum IT Solutions GmbH said, “Earning the pres-

tigious Frost & Sullivan Technology Leadership Award is a tremendous achievement for which we thank our customers.

We will continue to pave the way to the future of pharma manufacturing while addressing the challenges of our customers and actively developing new solutions under the Industrial Internet of Things and Pharma 4.0 concepts.”

Werum’s MES solution comprises the PAS-X software, pre-configured content, and a full set of services. Through standardised interfaces, the software integrates all related IT and production systems such as enterprise resource planning (ERP), laboratory information management system (LIMS), and distributed control system (DCS). This inte-

gration allows the company to offer seamless information exchange, data integrity, and higher performance.

Among other challenges, the growing demand to replicate manufacturing plants and facilities and the need to minimise costs associated with production downtime have led pharma and biotech manufacturers to seek cost-effective, off-the-shelf MES solutions to navigate complex environments and increase overall manufacturing efficiency, productivity, and visibility.

Werum’s PAS-X MES solution meets these challenges, and also addresses requirements for cloud-based initiatives, industrial mobility, and Big Data analytics.

EP News Bureau

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PHARMA ALLY

Thermo Scientific CW3 Cell Washer to boost laboratory performance New Thermo Scientific blood cell washer enhances reliability, ease of use and sample safety A NEW automated, high-performance cell washer has been specifically designed to enable precise, thorough, reproducible and rapid blood cell washing of up to 24 tubes in a three-minute run.

Fully automated, the Thermo Scientific CW3 Cell Washer has been uniquely engineered to combine the benefits of efficient performance with user-friendly design and safe operation. Users can select one of the pre-set programmes that have been designed to run in automatic mode, accelerate blood cell washing cycles and achieve significant time savings, while allowing for maximum ease of use and sample safety.

“Effective blood cell washing is extremely important in the removal of plasma and unwanted antibodies to ensure that patients will not be affected by adverse health ef-

The CW3 Cell Washer has been designed to achieve optimal corpuscle dryness by allowing users to pre-set the desired decanting speed. At the same time, corpuscle washing is improved via the optional overflow method fects and that blood-transfused products will retain all of their beneficial attributes,” said Hugh Tansey, global product director, centrifugation, Thermo Fisher Scientific. “To address this issue, we’ve developed a novel cell washer to help clinical, hospital and serological laboratories, as well as blood bank and transfusion centres, fulfill their fundamental mission to promote the well-being of pa-

tients.”

The CW3 Cell Washer has been designed to achieve optimal corpuscle dryness by allowing users to pre-set the desired decanting speed. At the same time, corpuscle washing is improved via the optional overflow method. For washing, tubes swing at a fixed positive angle to sediment cells rapidly at the bottom of the tube, whereas when decanting, the rotor holds tubes at a

Mukund Turakhia of Neelikon bags the UAA - ICT Distinguished Alumnus Award The award was in recognition toTurakhia‘s contributions in developing food, drug and cosmetic dyes as well as fluorescent dyes manufacturing in India NEELIKON RECENTLY announced that Mukund Turakhia, Founder and Managing Director, Neelikon was presented the 'UAA - ICT Distinguished Alumnus Award’ (Entrepreneur Category) for the year 2017-2018. The award was presented at the Foundation Day Celebrations of the UDCT Alumni Association (UAA), on 12, May, 2017 at the Institute of Chemical Technology (ICT) in Mumbai.

The award was in recogni-

50 EXPRESS PHARMA June 1-15, 2017

tion toTurakhia‘s more than 50 years contribution to the Indian dyestuff industry and specifically to his pioneering role in developing food, drug and cosmetic dyes as well as fluorescent dyes manufacturing in India.

Turakhia is an alumni (19621966) of ICT which was founded in 1933 as a University Department of Chemical Technology (UDCT) of the University of Mumbai.

ICT is considered to be one of the best post-graduate institutes

in India. The international surveys conducted by Professor Jude Sommerfeld of Georgia Institute of Technology for the 5year period during 2007-2011 described ICT as the best chemical engineering institute in India on the basis of number of research papers published. Besides, it was ranked fourth in the world after MIT, Delaware University and Georgia Tech. The Institute has produced more than 500 first generation entrepreneurs and academicians.

slightly negative angle and the saline is decanted centrifugally. The result is optimised pelleting performance.

Furthermore, the flexibility to use 12- or 24-place rotors and standardised, repeatable procedures enables the instrument to adapt to the processes and protocols already in place within the lab.

Built with sample safety in mind, the compact CW3 Cell

Washer features an automatic alert mechanism that informs users about low or disrupted saline levels and when a run is complete. A view port on top of the unit facilitates quick calibration, while the saline distributor is mounted directly on top of the rotor to reduce the risk of cross-contamination. The new washer is also equipped with tube racks bearing red and blue number labeling for easy sample balancing. In addition, when closed-monitoring of the washing process is required, the system can be operated manually to allow for cells that need to be washed stepby-step. As a low maintenance instrument, the CW3 Cell Washer includes easy-tochange pump tubing and an easy-to-remove catch basin, rotor and rotating bowl.

EP News Bureau

Moreschi Doors opens facility in Hyderabad EUROPE-BASED Moreschi Doors, which is into manufacturing of industrial doors has set up its base in Hyderabad.

Its Group company MoreschiSrl, Italy, has 50 years of experience in manufacturing industrial doors. All manufacturing machineries are imported from Europe and all the technicians have been trained in Italy.

Moreschi Asia will manufacture industrial folding doors, industrial sliding doors, rapid roll up doors and rapid fold up doors, insulated rolling shutters.

The products are used in the following: Air craft hangars, automobile industry, engineering industry, food industry, healthcare, industrial production areas, logistics, pharmaceuticals, service stations, ship industries, ware houses.

Contact details Moreschi Manufacturing Plant Plot No:10-A, I,D,A, Bollaram, Near Miyapur, Hyderabad 502 325 phone +91 40 32921226 fax +91 8458 279790

PHARMA ALLY PRODUCTS

BOGE KOMPRESSOREN extends EO range of scroll compressors BOGE KOMPRESSOREN has extended its EO range of scroll compressors to ensure full protection from contamination: the new EO 11 produces oil-free compressed air in the 11 kW performance segment. This means BOGE now covers the full performance range from 5.5 kW to 22 kW. The EO series is available with one to four compressor stages. Alternatively, in the upgrade-ready version, the EO 11 can be retrofitted with a third compressor stage. The EO 11 can also be ordered with an integrated or separate refrigerant compressed air dryer, mounted on a container or as a double or multiple system. Its compact design combined with operation at a minimum of 59 dB(A) means there is no problem installing the system next to the workplace.

BOGE’s eccentric oil-free (EO) compressors meet the requirements of oil-free compressed air for sensitive applications. The recipe for success here is the scroll compressor technology which operates without oil lubrication: The aluminium spirals in the compressor chamber interlock but do not touch. The resulting compressed air is pulsation-free and absolutely free of oil. In the medical sector, such as dental practices and clinics, pure compressed air protects the health of patients while preventing the contamination of highly sensitive equipment.

Up to four compressors can be installed in the housing of the compressor to ensure flexible adaptation to the compressed air demand. At 10 bar the EO se-

ries can cover delivery rates from 490 l/min to 1,960 l/min, while at 8 bar the supply of compressed air ranges from 620 l/min to 2,480 l/min. Featuring a modular design, the EO series can be ordered with an integrated or separate refrigerant compressed air dryer, mounted

on a container or as a double or multiple system. Like the EO 17, the new EO 11 is available as an upgrade version. This enables the two-stage compressor to be extended to include a third compressor stage or an integrated refrigerant dryer. The system comes with the electrical system required here, thereby offering users flexible options for retrofitting. The machine features an optimised space-saving design, as EO system solutions are no wider than a standard doorway.

In conjunction with its quiet operation – minimum 59 dB(A) – the compressor is perfect for installation next to a workstation.

BOGE's control system, focus control 2.0, can regulate up to four EO scroll compressors horizontally with base load switching, thus ensuring

efficient control for as many as 16 compressor units. And when maintenance is required, users benefit from unrestricted operation of the compressed air system. Durability and efficiency are backed up by a two-stage cooling concept. A primary surface cooler systematically cools down the compressed air along with an aftercooler in stainless steel. The pressure dew point for delta t is approximately 8 K. Contact details Franklin Comforter Jayakaran, Country Manager BOGE India #216, Third Link Street Nehru Nagar Industrial Area, Kottivakkam, Chennai - 600041 Tel: +91 44 4359 3454 Fax: +91 44 4359 3452 E-mail: fc.jayakaran@boge.com www.boge.com/en

Cole-Parmer launches ThinTouch line of gloves COLE-PARMER, a leading global source of laboratory and industrial products, equipment, and supplies since 1955, has introduced its ThinTouch line of gloves. The gloves are perfectly engineered for strength and dexterity.

Traditional disposable gloves provide protection for only short periods of time and typically have a thicker, sturdier design for long lasting protection.

Cole-Parmer ThinTouch gloves not only offer high levels of protection for longer time but its unique ‘Touch and Feel’ experience due to optimised tactile sensitivity makes it a perfect glove for varied applications. These gloves are perfectly engineered for strength and dexterity. Its ergonomic design is

manufactured using an advanced elastic thin-film formulation for supreme sensitivity, excellent comfort and maximum protection.

Cole-Parmer’s ThinTouch line of gloves include Nitrile and Latex Gloves. ThinTouch Nitrile Gloves and ThinTouchPROtect Nitrile Gloves ColeParmer are the first two launched products from the range.

ThinTouch Nitrile Gloves 9.5” are the Next-Gen Best-inClass Nitrile Gloves for applications involving small parts or operations demanding speedy handling. It’s high tensile strength, exceptional protection and unique ‘Touch and Feel’ experience makes this glove the Best-in-Class. These latex- and powder-free gloves have low-particulates to

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Carmustine and ThioTepa.

They have been tested as powder free gloves as per ASTM D6124 minimising occurrence of powder related complication such as irritant contact dermatitis. Not just protection, these gloves provide a conformable feel to the user-especially when worn over a long period. prevent glove-related work contamination. In addition, these gloves meet ASTM D 6319, ASTM D 6124, EN 455-1, EN 455-2, ISO 9001 / ISO EN 13485 performance standards.

ThinTouchPROtect Nitrile Gloves are ideal for use in chemotherapy drug production area and provide proven barrier protection from bacteria, viruses and chemicals.

These 12" non-sterile gloves

are tested against 29 chemotherapy drugs as per ASTM D6978-05 and offers a high level of protection against these drugs. These gloves have an advanced composition with higher breakthrough time of 127.5 minutes against Carmustine (3.3 mg/ml) and 240 minutes against ThioTepa (10.0 mg/ml) under standard test conditions - clearing it for use with

Vinita Singh Marketing Manager Cole-Parmer India403, A-Wing, Delphi Hiranandani Business Park, Powai Mumbai 400 076, India Tel: +91-22-61394410 (Direct)+91-22-61394444 (Board)+91-8828126093 (Mobile)Fax: +91-22-61394422 vinita.singh@coleparmer.in www.coleparmer.in

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PHARMA ALLY VALUE ADD

Exploring versatility of excipients in solubility enhancement Geetanjali Laghate and Dr Heeshma Shah, Technical Services Department, Signet Chemical Corporation, Mumbai, give an insight of various excipients and strategies that can be used for solubility enhancement by using different techniques THE PHARMACEUTICAL industry is facing enormous challenges in formulating poorly soluble active pharmaceutical ingredients (APIs) including new chemical entities (NCE) which are approved and under development. These molecules possess poor physicochemical properties like low aqueous solubility and low permeability both of which lead to poor bioavailability [1,2]. Scientists are therefore focusing on developing formulation strategies for increasing the therapeutic effectiveness of these molecules via an appropriate selection of excipients. Various excipients and strategies that can be used for solubility enhancement by using different techniques are elaborated [3,4] .

Solvents / co-solvents The addition of a water-miscible or partially miscible organic solvent /co-solvent, is one of the most common and effective ways to increase solubility of poorly soluble molecules which are generally weak electrolytes, highly crystalline and lipophilic in nature. Co-solvents act by decreasing the interfacial tension between aqueous solution and lipophilic solute to facilitate solubilisation[5]. Some cosolvents extensively used in marketed formulations are propylene glycol (Kollisolv PG), low molecular weight polyethylene glycols (Kollisolv PEG 300 and 400), polyoxyl castor oil derivatives (Kolliphor EL and ELP), glycerin, medium chain triglycerides (Kollisolv MCT 70), long chain triglycerides like corn oil and olive oil,

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dmimethyl sulfoxide, ethanol, etc. Although a simple and quick approach, precautions need to be taken while using cosolvents to avoid precipitation of the solute on exposure to aqueous media and biological fluids.

Solubilisers: Surface active agents or surfactants are amphiphilic molecules having a polar head group and non-polar tail. The head group can be cationic, anionic or non-ionic in nature. They function by lowering the surface tension and improve the dissolution of lipophilic, poorly soluble APIs. Beyond a specific concentration known as the critical micelle concentration (CMC), the surfactant molecules self assemble to form aggregates known as micelles. Drug molecules get entrapped within these micelles which in turn increases their solubility.

The CMC for most surfactants is very low. For non-ionic

surfactants it is in the range of 10-5 mol/L. The CMC is slightly higher for ionic surfactants and micelle formation is difficult due to electrostatic repulsion between the charged polar groups and is in the range of 103 mol/L. Non-ionic surfactants are the ones which are mostly used for formulation development. Notable examples found in marketed formulations are polyoxly 35 castor oil (Kolliphor EL), polyoxyl 40 hydrogenated castor oil (Kolliphor RH 40), polyoxyl-15-hydroxystearate (Kolliphor HS 15), Poloxamers (Kolliphor P 188, Kolliphor P 407 , Kolliphor P 124), D-alphatocopherol polyethylene glycol 1000 succinate (Kolliphor TPGS), Polysorbates (Kolliphor PS 60, Kolliphor Ps 80), sorbitan mono oleate (Span 60, Span 80), etc. Apart from facilitating dissolution by micellar solubilisation, surfactants also play an important role in stabilising suspensions, formation of micromulsions and self emulsi-

fying drug delivery systems [6].

Microemulsions are thermodynamically stable, transparent, low viscosity, isotropic dispersions consisting of oil and water stabilised by an interfacial film of surfactant molecule in conjunction with a co-surfactant. Water soluble, water insoluble and amphiphilic drugs can be incorporated in these systems. Self emulsifying and self micoremulsifying drug delivery systems (SEDDS and SMEDDS) are isotropic solutions of oil and surfactant which form oil in water microemulsions on mild agitation in the presence of water. Poorly soluble drugs can be dissolved in the oil surfactant mixture which is known as a pre-concentrate. On oral administration they behave as microemulsion and enhance the bioavailability of the API. Examples of oils used in the formulation of microemulsions, SEDDS and SMEDDS are caprylic/capric triglycerides (Capryol), polyglycolysed glycerides (Labrafil and Labrasol), medium chain triglycerides, (Kollisolv MCT) etc. [7,8] These oils are used along with the surfactants listed above. Another way of enhancing the solubility of poorly soluble drugs is by formulation of liposomes. They are closed spherical vesicles composed of outer lipid bilayer membranes and an inner aqueous core with an overall diameter of < 100 microns. They can be produced from cholesterol, non-toxic surfactants, sphingolipids, long chain fatty acids and phospholipids like hydrogenated soya phosphatidiyl

choline (HSPC), Distearoylglycero phosphoethanolamine (DSPE), Dipalmitoylglycerophosphoglycerol sodium salt (DPPG, Na), MPEG-ylated phospholipids like MPEGDSPE [9,10].

To summarise, due to the ease of availability and relatively non-toxic nature as compared to organic co-solvents, solubilisers were and still are the most widely used excipients for solubility enhancement.

Complexation: Cyclodextrins are cyclic (a-1,4)-linked oligosaccharides of a-D-glucopyranose comprising of a hydrophobic central cavity to accommodate the drug molecule to form an inclusion complex and hydrophilic outer surface.

They are classified as a, ß or ? corresponding to 6, 7 or 8 glucopyranose units. Out of these, ß-cyclodextrins (ß-CD) are widely preferred in the industry. They act by making the drug available at the surface of the biological membranes from where it partitions without interfering with the lipid bilayer thereby making the drug bioavailable. In addition to the natural cyclodextrins, two synthetic water soluble derivatives i.e. hydroxypropyl ß-cyclodextrin (HP ß-CD) and sulfobutylether- ß-cyclodextrin sodium salt have generated interest due to the advantages of greater solubility, tolerability and safety. Though ß-CD and HP ß-CD are less toxic as compared to surfactants and cosolvents, the limitation of this technique is that the drug

PHARMA ALLY needs to have the ability to form complexes which may not be possible in some cases. [11,12] Solid dispersions: The stable form of a drug molecule is crystalline in nature and poses problems in solubilisation due to its high lattice energy. On the other hand, the disorderly/irregular amorphous form offers an advantage over crystalline forms with respect to solubility inspite of its poor physical and chemical stability. New techniques that render the amorphous form stable are becoming increasingly popular; can be achieved either by making the API amorphous or by formulating an amorphous delivery system. For both approaches, solid dispersion technology is used extensively. These are systems where one component is homogenously dispersed in a carrier matrix (which is usually polymeric and often amorphous) and when the whole system appears to be in a solid state. They can be formulated primarily by two methods viz. melting method and solvent evaporation by using processes like spray drying, spray congealing, spray layering and hot melt extrusion among others. Amorphous solid dispersions can be stabilised if the 'freezing effect' is sufficient due to a high glass transition temperature of the

Scientists are focusing on developing formulation strategies for increasing the therapeutic effectiveness of these molecules via an appropriate selection of excipients system or, better, by interaction such as hydrogen bonding formation between the dispersed drug and the polymeric or amorphous carrier. When exposed to the aqueous GI environment these systems produce supersaturated solutions to achieve optimum release.

Commonly used matrix formers are homopolymers, copolymers, amphiphilic copolymers.

These may be used in combination with solubilisers and plasticisers. Notable examples of matrix formers are polyvinyl pyrrolidone- poly vinyl acetate (Kollidon VA 64), Hypromellose acetate succinate (AQOAT), Hypromellose (Pharmacoat), povidones (Kollidon 30, Kollidon 90F), polyvinyl caprolactum-polyvinyl acetate-polyethylene glycol graft co-polymer (Soluplus), Polymethyl methacrylates. These polymers can be used alone or in combination with one or more surfactants like Poloxamers (Kolliphor P 188, Kolliphor P 407), polyethylene glycols (Kollisolv

PEG 300 and 400), and Vitamin E polyethylene glycol succinate (Kolliphor TPGS). The concept of solid dispersions has been applied to many marketed formulations and has resulted in clinical benefits by increasing the bioavailability poorly soluble API [13,14,15].

Conclusion Understanding the rate limiting step in oral absorption is important in the selection of appropriate excipients and designing formulation approaches which are simple and cost effective. A combination of good science and good judgment help in overcoming the challenge posed by poorly soluble drugs and meeting stringent development timelines.

References 1. Shah SS, et al. Preclinical Formulations: Insight, Strategies, and Practical Considerations.

AAPS PharmSciTech 2004; 15(5); 1307-1323.

2. Kawabata Y, et al. Formula-

tion design for poorly water-soluble drugs based on biopharmaceutics classification system: Basic approaches and practical applications. International Journal of Pharmaceutics 2011; 420; 1– 10.

3. Herting MG, et al. Investigation of solubilization efficacy using a high throughput robot. In: Reintjes T, ed. Solubility Enhancement with BASF Polymers, Germany: BASF SE, 2011: 53-63.

4. Narang A. Problem dissolved?

– ensuring improved bioavailability. World Pharmaceutical Frontiers. 2014.

5. Kalepu S, et al. Insoluble drug delivery strategies: review of recent advances and business prospect. Acta Pharmaceutica Sinica B 2015; 5(5); 442-453.

6. Koltzenburg S. Formulation of problem drugs- and they are all problem drugs. In: Reintjes T, ed.

Solubility Enhancement with BASF Polymers, Germany: BASF SE, 2011: 9-26.

7. Bajaj H, et al. Bioavailability enhancement: A review. Interna-

tional Journal of Pharma and Bio Sciences 2011; 2(2); 202-214.

8. Strickley RG. Solubilizing excipients in oral and injectable formulations. Pharmaceutical Research 2004; 21(2); 201-229.

9. Jing L, et al. Review on phospholipids and their main applications in drug delivery systems.

Asian Journal of Pharmaceutical Sciences 2015; 10; 81-98.

10. Technical Brochure of Synthetic phospholipids and other synthetic lipids. Switzerland: Corden Pharma Switzerland LLC, 2011.

11. Rasheed A, et al. Cyclodextrins as drug carrier molecule: a review. Scientia Pharmaceutica 2008; 76; 567-598.

12. Technical Brochure of Kleptose: Betacyclodextrins and hydroxypropyl betacyclodextrins.

France: Roquette Freres S.A, 2006.

13. Huang Y, et al. Fundamental aspects of solid dispersion technology for poorly soluble drugs.

Acta Pharmaceutica Sinica B 2014; 4(1); 18-25.

14. Introduction to solid dispersions. In: Kotler K, Karl M, Gryczke A, eds. Hot Melt Extrusion with BASF Polymers, Germany: BASF SE, 2012: 10-18.

15. Introduction to hot melt extrusion for pharmaceuticals. In: Kotler K, Karl M, Gryczke A, eds. Hot Melt Extrusion with BASF Polymers, Germany: BASF SE, 2012: 19-34.

Ami Polymer: Sealing expert in silicone Vinay Pandey, Rubber Technologist, Ami Polymer, gives an outlook about silicone rubber used for healthcare products in pharma and biotech applications POLYMER INDUSTRIES have been serving the pharmaceutical industry through various polymeric product compositions to meet critical requirements of food, pharma and biotech industries. Silicone resin formulations very easily meets with FDA and USP requirements with ultra low extractable and leachable properties.

Silicone rubber is the most widely used polymer in pharma and biotech industries due to its inherent properties

like biocompatibility and inertness to cells/human tissues.

Every product puts a demand on the material used, but none so more than the medical industry. In terms of meeting both the regulatory requirement and performance, the answer is thermosetting Liquid Silicone Rubber (LSR).

Overview of silicone rubber chemistry Silicone rubber is chemically known as PDMS (Polydimethylsiloxane). It contains

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VINAY PANDEY, B- Tech Rubber Technologist, Ami Polymer

Si-O Backbone Structure in polymeric chain, which is responsible for its superior performance as mentioned below: ◗ Flexibility at lower temperature up to - 80°C ◗ High heat resistance up to 250°C. ◗ Greater weather and oxidative resistance ◗ Key properties of product made of silicone resin Silicone resin is translucent polymer widely preferred for pharma industry because of below reasons:

◗ Non-reactive and inert to biological tissues/ cells ◗ Excellent biocompatibility ◗ Smooth surfaces tend to prevent contamination of fluid on its surface ◗ Easy to clean and sterilise by any standard sterilisation process. ◗ Free from toxic ingredients ◗ Free of phthalate and bisphenol content ◗ Low level of extractable compare to any other polymers ◗ Excellent flexibility to facilitate dynamic applications

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PHARMA ALLY (Peristaltic Pump) ◗ Translucent compare to other rubbers to visualise flow of material

Types of available silicone rubber Based on chemistry of Cure Mechanism, there are two types of silicone rubber available as stated below. ◗ Peroxide Cured Silicone Rubber ◗ Platinum Cured Silicone Rubber

Understanding peroxide cured silicone rubber While processing of Silicone Resin, catalyst is added to strengthen its physical properties. When peroxide catalyst is used for processing, it is called as peroxide cured silicone rubber. Most common catalyst is DCP (Dicumyl Peroxide).

The peroxide curing process leaves behind by-products in the form of volatile organic acids. To remove byproducts, Peroxide Grade Silicone products are treated in Tray Drier (hot air circulating oven) at 200°C for three to four hours.

This treatment is called post curing process, which eliminates the by-products by converting it into gaseous form. But still, ineffective post curing process may lead to leaching of by-products in food contact and medical applications.

Understanding platinum cured silicone rubber Platinum complex-based catalyst is added in Silicone Resin while it’s processing. Chemically it is known as addition reaction. There is no generation of any kind of by-products in platinum curing system of silicones.

Prevention of by-product generation makes it safe to use in critical application of food, pharma and biotech industries.

Advantages of platinum cured silicone products over peroxide cured silicone products ◗ Superior transparency to see visibility of fluid flow transfer ◗ Free of by-products and odour

54 EXPRESS PHARMA June 1-15, 2017

◗ Smooth surface resists stickiness of transfer fluid. It prevents contamination and bacterial growth. ◗ Better physical properties like tensile strength, tear resistance. ◗ By-product free silicone resin contains low level of extractable and leachable enhances its usage of critical product transfer in pharma and biotech industry

◗ Maintains physical characteristics in storage condition of long period enhance its shelf life. Doesn’t turn yellowish during prolonged storage period

Contact details 319, Mahesh Industrial Estate, Opp. Silver Park, Mira-Bhayander Road, Mira Road (East), Mumbai - 401104.

Maharashtra.

INDIATel.: +91-22-28555 107 / 631 / 914 Cell : +91-9223 411 447 / 9223 290 931 / 943 E-mail : info@amipolymer.com Web : www.amipolymer.com

PHARMA ALLY

Overview of ICP-MS market in India Increasing demand from applied markets and requirement to comply with the revised regulatory norms are creating awareness on elemental analysis in India. M Jagadish Naidu, Business Manager for inorganic product line, PerkinElmer India, throws more light on the same INDIA ELEMENTAL analysis market is segmented on the basis of types, technologies and applications. New international GMP and GDP certification, proposed revision from regulatory bodies like USP, ICH, EN etc and growing food safety / Environment safety concerns are major factors driving the demand for elemental analysis in India. Notable advancements took place across techniques such as Inductively Coupled Plasma Spectrometry (ICP), Inductively Coupled Plasma Mass Spectrometry (ICP-MS), and Atomic Absorption Spectrometry (AAS) to meet the needs of rapidly evolving industry challenges across applications. Increasing demand from applied markets, and requirement to comply with the revised regulatory norms are creating awareness on elemental analysis in India.

ICP-MS broadly finds applications in the following markets: ◗ Life sciences – Pharma ◗ Food and beverage testing ◗ Environment testing ◗ Geology ◗ Others (Chemical, oil and gas, and cosmetics industries)

Major growth drivers for ICPMS in India ◗ Pharmaceuticals: The Indian pharmaceutical market is the third largest in terms of volume and 13 th largest in terms of value#. Branded generics dominate the pharma market, constituting

With the advent of recent changes implemented by international regulatory bodies for constraining inorganic impurities in pharma and drug products, there has been a demand for this technique across pharma drug product manufacturing cycle nearly 70 to 80 per cent of the market. Indian generics accounting for 20 per cent of global exports in terms of volume. The Indian pharma market increased at a CAGR of 17.46 per cent in 2015 from $6 billion in 2005 and is expected to expand at a CAGR of 15.92 per cent to $ 55 billion by 2020. India is likely to be among the top three pharma markets by incremental

growth and sixth largest market globally in absolute size.

With the advent of recent changes implemented by the European Pharmacopoeia (EP), the United States Pharmacopoeia (USP) and other international regulatory bodies for constraining inorganic impurities in pharma and drug products, there has been a demand for this technique across pharma drug product

Market – US $M

manufacturing cycle .

The general chapter specifies limits for the amounts of elemental impurities in drug products. Elemental impurities include catalysts and environmental contaminants that may be present in drug substances, excipients, or drug products. These impurities may occur naturally, be added intentionally, or be introduced inadvertently (e.g.,

by interactions with processing equipment and the container closure system).

The USP Convention has announced the establishment of an implementation date of January 1, 2018 for General Chapters <232> Elemental Impurities—Limits and <2232> Elemental Contaminants in dietary supplements in USP’s compendia of public standards. This will provide a huge opportunity for the ICPMS business growth in India. ◗ Food: India food sector has emerged as a high-growth and high-profit sector due to its immense potential for value addition, particularly within the food processing industry.

The Indian food processing industry accounts for 32 per cent of the country’s total food

Expected growth – US$M

Technology

2013

2014

2015

2016

CGR- 13-16

2017

2018

2019

ICPMS

6

6

7

7

4.9%

10

12

14

2020

Notable players in Indian ICPMS elemental analyzer market include ●PerkinElmer,Inc ● Agilent Technologies,Inc. ●Thermo Fisher Scientific, Inc. ●HORIBA, Ltd. ●Shimadzu Corporation ●Analytik Jena.

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June 1-15, 2017

PHARMA ALLY

market, one of the largest industries in India and is expected to grow at a CAGR of 11 per cent by 2018.

One of the drivers behind India’s growth in food market is its government support towards irrigation, power, fertilizer, which boosts production for many exported crops. Indian government is taking all necessary actions to harmonise India regulations with standards of international agencies to drive exports. Key regulatory bodies that govern the food safety standards in India are Food Safety and Standard Authority of India, Ministry of Food processing industries & Agriculture and processed foods export development authority.

Elemental analysis in food products has become mandatory due to environmental pollution caused by human agencies leading to adverse health concerns. Hence, food quality monitoring has become a basic necessity for the government and manufacturers.

ICPMS technology exhibits the versatility to screen varied food products for trace elemental contaminants and understand the source of contamination. ◗ Academia and research The research ecosystem in

56 EXPRESS PHARMA June 1-15, 2017

has recently been developed that virtually stops the formation of many of these harmful species before they enter the mass analyser. Complex secondary reactions and collisions take place, which generate many undesirable interfering species.

If these species were not eliminated or rejected, they could potentially lead to additional spectral interferences.

Basically two approaches are used to reject the products of these unwanted interactions: ◗ Discrimination by kinetic energy ◗ Discrimination by mass.

Collision/reaction cells have given a new lease on life to quadrupole mass analysers used in ICP-MS. They have enhanced its performance and flexibility and most definitely opened up the technique to more-demanding applications that were previously beyond its capabilities.

ICPMS Hyphenation technique

Application

GC-ICPMS

Speciation

LC-ICPMS

Speciation

FFF- SP- ICPMS

Nano particle characterization

Advanced techniques

(Few of the commercially available speciation techniques are as above.)

India presents a significant opportunity due to its intellectual capital available in the country. Government of India has taken several steps to promote the R&D sector in India and announced plans to establish National Institution to Transforming India (NITI) to increase involvement of entrepreneurs, researchers to foster scientific innovations Research in India used to be carried out by few of the major institutes / universities.

Government of India is encouraging government private collaborations to enhance research across disciplines.

Currently only 25 per cent of the universities undertake research activities and this is going to double by 2020. ◗ Others: While pharma, food and academia will continue to be the major markets for ICPMS in India, we will also continue to have

opportunities across chemical and environment, HPI etc.

Introduction Inductively coupled plasma mass spectrometry (ICP-MS) is a very sensitive elemental analysis technique capable of analysing wide variety of sample types. This technique is reviewed as an alternative nuclear analytical technique for the determination of radioisotopes, the latest development and advancements in utilisation of collision and reaction cells offers unrivaled flexibility for solving difficult applications. In this technique, the ionised sample created by the plasma is drawn into the intake for a mass spectrometer. This forms the basis of ICP-MS technology, which generally requires liquid or dissolved samples. For solids, glow discharge or laser ablation can be used to produce ions, performance by eliminating mass

interferences.

Trends : Recently ICP-MS has become a favoured technique for the fast and accurate determination of trace and ultra-trace elements in many matrices due to its low sample consumption, high sensitivity, excellent precision, and potential for multi-element analysis.

However, isobaric and polyatomic interferences can significantly affect the accuracy of ICP-MS analyses, especially for radioisotopes.

Suppression of these interferences has been the subject of many studies. Although there are ways to minimise these interferences — including correction equations, cool plasma technology, and matrix separation — they cannot be completely eliminated.

Interferences A new approach called collision/reaction cell technology

The use of inductively coupled plasma mass spectrometry (ICP-MS) coupled with separation techniques for the purpose of elemental speciation has gained a lot of attention across applications.

Speciation is defined as the ability to measure multiple forms of the same element, the various forms can be differences in oxidation state or other atoms associated with the element of interest.

Elemental speciation analysis has only developed during the last two decades with the evolution of instrumental detection powers coupled with the knowledge that speciation leads to a better understanding of elements in our environment.

Reference [1] Strategic Directions International, Inc. Market Forecast (2012-2016).

[2] Markets and Markets –( June-2015) .

[3] Center for Single Nanoparticle, Single Cell, and Single Molecule Monitoring (CS3M), Missouri [4] Spectroscopy online

PHARMA ALLY

Intelligent formulation optimisation Michael Caves, India Business Development Manager, Malvern Instruments, elaborates on how viscosity measurements if carried out over an appropriate range can be highly informative

VISCOMETRY HAS been a mainstream technique for formulation, but those leading the way have long since transitioned to the broader capabilities of rheometry. The choices associated with replacing your ageing viscometer may, therefore, be a long way from like-for-like. Here we provide insight to support an upto-date assessment of the value of upgrading.

A standard rotational viscometer is an efficient tool for measuring viscosity, at a single point or across a moderate range of shear conditions.

However, viscosity is far from being the only parameter that can usefully be measured to determine product performance, or indeed commercial appeal. Other defining rheological properties include: viscoelasticity; yield stress; thixotropy; and tackiness. Rotational rheometry extends access to the comprehensive measurement of all of these parameters and in so doing has the potential to deliver significant value to formulators. In simple terms, the capabilities of a rotational rheometer allow formulators to develop a detailed understanding of performance across all the changing

Figure 1: With a rotational rheometer it is possible to extend the flow curve across a much wider shear rate range to understand how a product will behave under all the conditions encountered during routine use

Figure 2: Oscillatory test data across a range of frequencies indicates whether a sample will behave as a visco-elastic solid, as a gel or as a viscoelastic liquid

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PHARMA ALLY conditions to which a product may be subjected, during manufacture and use.

Complete flow curve measurement Viscosity measurements remain the most widespread rheological analysis and if carried out over an appropriate range can be highly informative. Non-Newtonian materials either shear thin i.e. exhibit lower viscosity at higher shear rates, or, less commonly, shear thicken, meaning that viscosity increases with applied shear rate. Generating a flow curve - a plot of viscosity as a function of shear rate – over a representative shear rate is therefore a valuable core strategy for formulation studies. A particular strength of rheometers, relative to viscometers is that they enable measurement across a broader shear rate range, in particular at the extremely low shear rates associated with storage, and can therefore provide insight into long-term product stability (Figure 1).

The majority of viscosity measurements involve the application of a rotational shear force or rate, but rheometers, by enabling the precise control of normal force and the

Looking ahead

The capabilities of a rotational rheometer allow formulators to develop a detailed understanding of performance across all the changing conditions to which a product may be subjected, during manufacture and use

gap between upper and lower geometries, also provide the means to carry out axial testing, a technique that is inaccessible with a standard rotational viscometer.

This permits pull away or tack testing – to quantify stickiness and squeeze flow measurements – to extend flow curve measurement for samples with high solids loadings which can fracture during standard viscosity testing.

Probing viscoelasticity A further primary difference between viscometers and rheometers is that the latter permit oscillatory testing. As the term suggests, oscillatory testing involves subjecting the sample to a relatively small shear force, or displacement, applied in the form of a sinusoidal wave. It therefore calls

for bi-directional movement of the upper geometry, relative to the lower, a feature uniquely associated with rotational rheometers. This testing is usually performed in the Linear Viscoelastic Region (LVR) where stress-strain is linearly dependent and the microstructure remains intact. Oscillatory testing probes the viscoelasticity of a material – the extent to which it exhibits viscous (liquid-like) or elastic (solid-like) behaviour, or indeed transitions between the two under different conditions. Key test variables are the frequency of oscillation (v), which correlates with the timescale over which deformation is carried out (t ˜ 1/v), and temperature, which is similarly tailored to reflect in-use conditions. The metrics measured include the com-

plex modulus, G*, which indicates total material stiffness and which can be broken down in to its elastic and viscous moduli, G’ and G’’ by utilising the phase angle or phase difference, c, between the applied stress and measured strain.

Oscillatory testing supports the development of a microstructural fingerprint that provides insight into important aspects of product performance such as stability by identifying conditions under which structure develops in the product (Figure 2). It can also quantify characteristics such as spreadability, as a function of temperature for example, and provides textural information by quantifying stiffness (via G*) and springiness (via phase angle).

In recent decades formulation has transformed from black art to advanced science, a process that continues as productive analytical strategies emerge. Formulating to fully meet consumer expectations is vital for commercial success and there is intense time pressure on formulation and reformulation programmes.

By offering enhanced sensitivity, and a wider range of test capabilities, rotational rheometers answer far more fully to current formulation requirements than traditional viscometers, more effectively supporting a knowledge-led approach to product development.

Upgrading to a rotational rheometer can therefore pay significant dividends in the form of faster, more secure formulation and, ultimately, competitive product performance.

Contact details Malvern Aimil Instruments Naimex House, A-8 Mohan Co-operative Industrial Estate, Mathura Road, New Delhi – 110044 Tel: 011-30810244 Fax: 011-26950011 Email: delhi@aimil.com

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PHARMA LIFE OBITUARY

MR Shahstri,Ex Director,DCA, Gujarat,passes away He took keen interest in the development of pharmaceutical industry and amendments in the Drugs & Cosmetic Act

M

R Shahstri, Ex Director of Drugs Control Administration, Gujarat,recently passed away at the age of 97. He joined Baroda Drug Laboratory under DCA as Jr Scientific Analyst in November, 1947. Later on, he was promoted as the Sr Scientific Officer in August, 1961 and as

Joint Director (Testing) in June, 1971.

Shahstri was promoted as Director of DCA, Gujarat as the third Director of DCA, Gujarat. During his tenure as Director, DCA from February, 1975 to August, 1978, he exhibited excellent acumen as a drug regulator and adminis-

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trator. He took keen interest in the development of pharmaceutical industry and amendments in the Drugs & Cosmetic Act. Even after his retirement, he was actively participating in mega events of Indian Pharmaceutical Congress (IPC). Even after 30 years of retirement, he

visited FDCA Office at Gandhinagar and shared his experience with FDCA officers. He graced the inaugural function of new office of Assistant Commissioner, FDCA, Vadodara and blessed the new generation FDCA officers in June2016.

EP News Bureau

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