Express Pharma (Vol.12, No.24) October 16-31, 2017 by Indian Express

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CONTENTS Vol.12 No.24 October 16-31, 2017 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas

IDMA, NSF UK launch advanced programme in pharma quality management First batch with 39 pharma professionals starts at Bengaluru’s Acharya College | 15

Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble

P12: PRE EVENT

Chief Designer Prasad Tate

Express Pharma to host first edition of Pharma CXO Summit in Goa

Senior Designer Rekha Bisht

P41: INTERVIEW

Graphics Designer Gauri Deorukhkar

‘These molecules can be future blockbuster drugs for the treatment of glioma’

Senior Artist Rakesh Sharma Photo Editor Sandeep Patil

Dr Mayur Yergeri, Associate Dean and Professor, SPPSPTM, SVKM’s NMIMSDeemed to be University

MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East

P46: INTERVIEW

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

‘Technology will play a significant role in helping maintain physical and mental wellbeing’ Jitender Sandhu, Director, M2M Modules – Indico and ASEAN Region

PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Santosh Lokare CIRCULATION Circulation Team Mohan Varadkar

MANAGEMENT

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EXPRESS PHARMA

October 16-31, 2017

EDITOR’S NOTE

Balancing volumes with value

hen the going gets tough, the tough get going. This adage could well describe the beleaguered pharma exporters of India. Hoping for faster approvals and better volumes from semi-regulated markets, companies decided to exit or reduce exposure to regulated markets. However, after a few good years, the strategy seems to be unravelling. A seven-year trend analysis of Indian pharma formulation exports to semi-regulated markets by India Ratings and Research (Ind-Ra) says weak economic and political conditions in Africa and currency volatility in Latin America (LATAM) are likely to weigh on the consumption of pharma formulations. In FY17, semi-regulated markets made up 44.9 per cent of India’s pharma exports. Most Indian exporters are now forced to rationalise their presence among semi-regulated markets as well, avoiding markets where risks outweigh opportunities. According to the Ind-Ra report, which includes finished formulations and excludes bulk drugs and intermediates, these companies are now placing high importance on margins and cash flow security over volumes, given the present challenging currency environment. There are some positives midst this gloom. Exports to other Asian peers were on a stable footing (up 13.9 per cent YoY), driven by a stable demand. Exports to Middle East rebounded (33.4 per cent yoy) in FY17 on the back of improving economic conditions, political stability in non Gulf Cooperation Council Middle Eastern countries and increasing mandatory insurance in Gulf Cooperation Council (GCC) countries. However, the Ind-Ra report warns of regional challenges. Exports to Asian markets are on a low base and these are price sensitive markets.

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10 EXPRESS PHARMA October 16-31, 2017

While political and economic headwinds are unpredictable and volatile, it is important to future proof systems and processes so that they are responsive to such trends

Similarly, the affluence of the GCC nations, with the ability to pay, is offset by the dependence on oil exports. Though the CIS market is showing some recovery, Indian exporters remain cautious even about Russia, the largest export market for India among CIS countries. The Ind-Ra report points out that Russia could present a high value opportunity as there is a higher ability to purchase without aid programmes, in contrast to countries like Africa, which are dependent on internationally funded initiatives by agencies such as WHO. Indian companies are key suppliers to these programmes but funding for these initiatives is drying up, adding to the uncertainty. Though the Ind-Ra report believes that despite the export underperformance, the longterm fundamentals of semi-regulated markets remain intact, exporters will need to track these variables very closely and be flexible enough to change course and strategy. With exports key to the very survival of the Indian pharma sector, companies are tracking every trend and regulation that will impact their overseas performance. Which is why Express Pharma's first Pharma CXO Summit will focus on track and trace systems, a regulatory requirement for exports to most markets. Scheduled for November 9-10, in Goa, the Summit will help exporters discuss ways to expand their exports in a sustainable manner. While political and economic headwinds are unpredictable at best and volatile at worst, it is important to future proof systems and processes so that they are responsive to such trends. We hope that the Pharma CXO Summit will be a strong step in this direction. For more details, see our website: http://www.expressbpd.com/pharma/cxo-summit-2017 VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET PRE EVENTS

Express Pharma to host first edition of Pharma CXO Summit in Goa To be held in association with Optel Group, this year’s theme for the event is,‘Beyond 2017 – Leveraging global traceability for sustainable business and growth’

erialisation, combined with track and trace mechanisms, are being seen as an important solution to ensure that substandard or counterfeit medicines are discovered and recalled from global markets. Over 40 countries across the globe are already implementing or set to enforce track & trace and serialisation mandates by 2018. Indian companies too are realising that it is strategic business sense to make traceability the cornerstone of sustainable fu-

ture growth. Therefore, the Pharma CXO Summit, organised by Express Pharma and the Indian Express Group, will bring together leading pharma CEOs, COOs and Division Heads who are leading the way for Indian pharma exports the world over to share their learnings and experiences on implementing serialisation. The conference will present insights from regulators and policy makers, as well as case studies from the early adopters

of traceability technologies. The case studies will be both from global as well as Indian experts who have headed serialisation strategies in their companies. Some of the broad topics which would be covered at the conference are: ◗ Leveraging global traceability for sustainable business and growth ◗ Learning from serialisation stalwarts: Global case studies ◗ Serialisation strategies for biologics

◗ Serialisation strategies for pharmaceuticals ◗ Serialisation strategies for CMOs ◗ Opportunities and challenges in India’s serialisation journey The other highlights at the event will be: Express Pharma Excellence in Exports Awards: It seeks to recognise the untiring efforts of pharma exporters. It will acknowledge and celebrate the resounding successes of Indian pharma companies, and the vi-

tal roles they have played in establishing India as a leading export destination. The Express Pharma CXO Handbook: It will feature interviews, in-depth articles and strategies that Indian pharma exporters have adopted to create an unassailable edge and leading positions. While some have chosen to excel in a particular category, others have crafted their geographical footprint with great care. EP News Bureau

ISPE to organise Europe Pharma Pharmac India 4.0 Conference in Italy 2017 to be held in The conference will focus on preparing the pharma and biopharma industry for a full transition to an end-to-end integrated computerised system throughout the manufacturing process THE INTERNATIONAL Society for Pharmaceutical Engineering (ISPE) with its Italy Affiliate will organise Europe Pharma 4.0 Conference in Verona, Italy from November 23-24, 2017. The conference will focus on preparing the pharma and biopharma industry for a full transition to an end-to-end integrated computerised system throughout the manufacturing process. The two-day event will feature an education programme focussed on core topics, including automation, analytics, end-to-end integration, and workforce 4.0. Attendees will gain insight into a new world of

EXPRESS PHARMA

October 16-31, 2017

manufacturing, engaging in dialogue with peer groups and senior industry leaders, and learning new manufacturing applications, models, and solutions. The introduction of advance automation and the increasing interconnectivity of Industry 4.0 is not only revolutionising the pharma industry, but also introducing many new challenges and production roadblocks. “Shifting the paradigm to Pharma 4.0 and focusing on the issues specifically surrounding pharma priorities will lead to improvements in productivity, quality, and security of the supply chain,”

said John Bournas, CEO and President, ISPE. The ISPE 2017 Europe Pharma 4.0 Conference stems from the ISPE Europe Affiliates’ newly founded special interest group (SIG): ‘From Industry 4.0 to Pharma 4.0.’ The Pharma 4.0 SIG started discussions around the issues that the new ‘automation’ factors are causing in the pharma production chain. Their goal is to specify and differentiate Pharma 4.0 from the common ‘Industry 4.0’ concept, with the focus on maturity level models integrated in the programme. EP News Bureau

Ahmedabad

INDIAN DRUG Manufacturers' Association (IDMA) and Orbit Exhibitions will organise Pharmac India 2017 at Gujarat University Exhibition Hall, Ahmedabad from November 7-9, 2017. The event will bring together pharmaceutical manufacturers, bulk drug manufacturers, api manufacturers, pharmaceutical formulators, merchant exporters, contract manufacturers, bio technology companies, pharma distributors, govt suppliers/liaison agents and regulatory bodies. Exhibitor’s profile include pharmaceutical packaging, pharmaceutical machinery, pharmaceutical refrigeration, pharmaceutical logistics, pharmaceutical software, API manufacturers, bulk drugs manufacturers, pumps and valves, labelling and printing coatings, safety equipment, R&D lab equipment and clean room technology. EP News Bureau

MARKET POST EVENT

IDMA,NSF UK launch advanced programme in pharma quality management First batch with 39 pharma professionals starts at Bengaluru’s Acharya College IN A bid to address the dearth of globally certified pharma quality professionals based out of India, IDMA has collaborated with UK-based NSF Health Sciences to offer a customised course. Speaking at the launch on World Pharmacy Day on September 25, Chief Guest Dr Sharanprakash Patil, Minister for Medical Education, Government of Karnataka appreciated the initiative by IDMA and mentioned that the global

training programme will help take Indian pharma sector to new heights. In a video address, Sudhanshu Pandey, Jt Secretary, Department of Commerce said that this programme is a much needed one. While Indian pharma has been successful, he spoke of the many challenges that the industry is facing of late. He felt that this programme will fill the gaps and train Indian pharma professionals to the level of global

professionals. He assured the audience that the batch size would increase and that he would visit during the course to get feedback. He wished the delegates success with the course. Pegged as the first ever international education programme, the ‘Advanced Program in Pharmaceutical Quality Management’ (APPQM), includes five intensive modules each of four days duration scheduled every

eight weeks. Each module will be assessed through a written examination. Successful candidates will be awarded an internationally recognised certification from NSF and IDMA. The course participants comprised employees from companies such as Ajanta Pharma (with as many as four entrants), Astral SteriTech, Aurobindo Pharma, Cipla, Emil Pharmaceuticals, Encube Ethicals, Eucare, FDC,

Fourrts Labs, Galentic Pharma, Gland Pharma, INGA Laboratories, Leben Life Sciences, Medopharm, Micro Labs, Mylan Laboratories, S Kent Healthcare, Shanta Biotech, Softgel Healthcare, Steril-Gene Lifesciences, Strides Shasun, Sun Pharma, Swiss Garnier, USV and Zim Laboratories. With a course fee of `8 lakhs plus 18 per cent GST, not including travel and stay, the price would make most

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EXPRESS PHARMA

October 16-31, 2017

MARKET managements hesitate. Except for the fact that it would probably cost a lot more to sponsor a candidate for a similar course in the open market. Daara Patel, Secretary General, IDMA indicated that most companies have decided to leverage this course as a talent appreciation and retention strategy, carefully choosing the candidates and ensuring that they are most likely to stay and contribute to the company.

Why APPQM? SM Mudda, Project Director, APPQM and Director Global Strategy (Technical), Micro Labs, who has played a major role in conceptualising and tweaking the course for India, gave the welcome address, and explained why IDMA, which as an association generally restricts itself to representing industry issues to the government, decided to involve itself with quality education and certification programme. Indian pharma has grappled with recurring surprises like import alerts, product recalls, insufficient documentation etc which had a far reaching negative impact on the industry’s perception with global regulators. In the course of engagement with industry, government and regulatory agencies, it became evident that an industry-level response in educating the key personnel in global quality system is necessary. In several surveys conducted, the companies said that the shortage of skilled staff was a major worry. Mudda said that there was a need for adopting a systems approach and to link the three dots of GMP, quality systems and quality culture through the education of second level quality leadership. The aim of the programme offered by IDMA therefore is to improve the compliance ability of the industry and secondly, improve trust and credibility globally and promote Brand India Pharma by introducing change agents for quality excellence in the industry.

So what’s different? Explaining the ‘why’ of such a

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October 16-31, 2017

Dr Sharanprakash Patil lighting the lamp and also seen are SM Mudda, Martin Lush, Daara Patel and J Jayaseelan

Delegates during the inauguration function

MARKET programme, Martin Lush, Global VP, NSF Health Sciences, who is spearheading this course along with Mudda, strongly emphasised that the industry needs to keep the patient at the centre of their business and balance profits and efficiency, legacy and reputation, with customer service. Looking for the reasons why the Indian cricket team is currently number one in test cricket, he said it was because they got the basics right, consistently. He referred to the various events, like Trump, Brexit, global warming, etc due to which it is ‘not business as usual.’ He advised Indian pharma companies to ‘educate for the future, not the past,’ quoting author Jim Collins. Explaining the philosophy behind the course and their teaching methods, Lush said

In the course of engagement with industry, government and regulatory agencies, it became evident that an industry-level response in educating the key personnel in global quality system is necessary that the aim was to ‘transform the way people think about quality, change the hearts and behaviours, so that they can change their company and the industry.’ Individuals who enrol for this course would move from CAPA (Corrective Action, Preventive Action) to PACA (Preventive Action, Correc-

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October 16-31, 2017

tive Action). As he pointed out, preventive action rather than corrective action has proved to be cheaper in the long run. Lush also thanked Mudda for his vision, passion and resiliency in organising and getting this programme to India and as a mark of respect for the untiring efforts taken

by him, conferred the certification of APPQM 2017-18 on him by offering a symbolic mortar and pestle offered to QPs in the UK. In a video address, Dr Ajaz Hussain, Insight Advice & Solutions, built on the reason why the course will build on Brand India Pharma. He said the ‘ostrich syndrome,’ of

burying the head in the sand when threatened, of denying the presence of a problem, is holding back India’s pharma quality in the 21st century. He linked the ability to adopt to quality systems to adult human development and exhorted the participants to use the APPQM course to develop their order of consciousness

to at least fourth order to create a self-authored mind. Dr B Suresh, Vice Chancellor, JSS University, Mysore spoke about the importance of companies investing in their human resources. His perspective was that without knowledge advancement, it will be a challenge to continue the innovation which defines

MARKET and differentiates this sector and each company. As he put it, “Industry should hire people who are firstly, knowledgeable and they should be ready to pay for them. And secondly, is the individual capable of continuing to learn and think beyond.” Other dignitaries on the dias like J Jayaseelan, Chairman, Tamil Nadu, Puducherry, and Kerala state board, IDMA, BT Khanapure, Drug Controller, Karnataka, CDSCO, too added their appreciation of the course. Rajsekhar, Asst Drug Controller, CDSCO, Karnataka on behalf of DCG(I), wished the participants all the best.

The C-suite perspective Dushyant Patel, MD, Astral Steritech, who has two employees registered for the course, said that the programme has the potential to change the approach to quality and hoped that it would train “quality leaders to not only perform to perfection but also to perform under pressure.” Mehul Shah, Founder and MD, Encube Ethicals, who also has two employees in the

The course in progress

Feedback from delegates I would like to thank you very much for spearheading and organising this wonderful workshop. As I was deliberating on today’s learnings, for the first time I realised that this was a unique experience. Truly it was about education and learning and not training. Swapna Ajit Encube Ethicals

This shows the excellent planning and tremendous efforts by NSF and IDMA teams for entire programme” Soni Biren Sun Pharma

Had a great time, got many concepts cleared, learnt new things, got to know many, shared old memories, cooled the chimp brain a bit, got away from daily chorus, brain stormed in groups, saw the advantages of team. Now looking forward to module 2 Yogesh Gole Emil Pharmaceuticals

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October 16-31, 2017

Thanks a lot, Martin for compiling all the sheets and tasks in the form of presentation with descriptive notes for our benefits. This will help us to take forward within the organisation and educate all my colleagues in the same way we learnt and simplify all the complexities within the system. Also, thank you and Rob for all your guidance and taking us through the basics, realities and challenges. Thanks to Mudda sir for arranging the programme and support/guidance during the programme. Looking forward to meet one and all in the next module.

I believe that there is not one but many interesting things about this programme 1) Teaching techniques which help to grasp so much in such subtle ways. 2) The programmes has given a totally new angle to my views of pharma industry and where I fit in. 3) The approaches that we are being educated like influencing behaviour, simplification of systems, risk-based decision making- will have positive influence on me throughout my life

Trupti Bhagat Astral Steri Tech

Manan Shah Executive Director, Leben Lifesciences

Thank you very much to you, IDMA team, Lush and Rob. The course was really designed well to suite our current requirement. It will definitely help all the participants to make positive difference in our day to day working in our organisations. Thanks once again for the initiative and the efforts of one and all

At the outset, please accept my sincere appreciation for having designed and organised the most advanced learning programme at Bengaluru in association with NSF

Dr Shashikant Shinde Mylan Labs

S Sridharan Managing Director, Eucare Pharmaceuticals

MARKET course, shared his thoughts on the current status of the industry and where this programme comes in. “Most are talking of T(rump) and B(rexit). But it’s more than that. Effective valuation of generics has reduced by one third on the last one year. Industry is compressed due to pricing, competition, regulatory pressures. Up to now, the relationship between the three pillars of the industry, (patients, doctors and regulators), were driven by faith. The knowledge gap between patients and doctors is reducing and expectations from the industry have increased in terms of providing cost effective solutions. Today, he pointed out that the industry is becoming like any other average industry with average profits. He warned that investment priorities, locally and globally, have changed. Derating of the industry is happening and consequently a decline in the business of equipment/ instrument suppliers of the industry. Under these circumstances, the need to build capability of our people to simplify work processes and institutionalising the global best practices is the need of the hour, Shah added. He quoted Deming and stated that 94 per cent of the business problems could be solved by adopting a system and riskbased approach. The APPQM will build the capability of our technical staff in designing and implementing a robust pharma quality system. This education will help companies to achieve the objective of right first time in their operations, focus on patient welfare and be more innovative and cost effective, Shah concluded.

Module 1: A great learning experience The four-day Module 1 saw active participation of all delegates through several working groups that resulted in learning of key quality system elements through group discussions and case studies. The topics covered included creative and critical thinking, problem solving and crisis management, risk-based

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October 16-31, 2017

decision making, accelerated learning, simplification of processes and SOPs and performing well under pressure. The 39 professionals whose companies sponsored them for the course, have probably realised that this is far from another ‘chalk-andtalk’ course. Participants left with proj-

ects that needed to be implemented at their workplaces and will present the results at the end of the course. The mix of theory with hands on work is a key aspect of the learn-bydoing feature which will make them change leaders at their workplaces. The participants were good mix of juniors as well

as senior pharma professionals, as well as nine applicants who are second generation pharma entrepreneurs, some without a pharma background. Mudda commented that the perspectives coming from this sub group add a management/owner’s view point, which takes the discussion beyond the technical into

aspects of corporate policies. A summary of the learnings was presented in the form of flip charts and posts and a progressive story board of learning was displayed in the class room. The story boards along with descriptive notes were also shared with the delegates. EP News Bureau

MARKET EVENT BRIEF PHARMAC INDIA 2017 Date: November 7-9, 2017 Venue: Gujarat University Exhibition Hall, Ahmedabad Summary: Indian Drug Manufacturers’ Association (IDMA) and Orbit Exhibitions will organise Pharmac India 2017, which will see pharmaceutical manufacturers, bulk drug manufacturers, API manufacturers, pharmaceutical formulators, merchant exporters, contract manufacturers, bio technology companies, pharma distributors, govt suppliers/liaison agents and regulatory bodies come together.

export destination. The Express Pharma CXO Handbook will feature interviews, in-depth articles

and strategies that Indian pharma exporters have adopted to create an unassailable edge and leading

positions. While some have chosen to excel in a particular category, others have crafted their geographical footprint

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Contact details Varsha Surve Orbit Exhibitions Email: info@ pharmacindia.com Phone: +91 9322037955 Dr RS Joshi Indian Drug Manufacturer’s Association (IDMA-GSB) Email: idmagsb@gmail.com Phone: +91 (0) 79 26406680

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Date: November 9-10, 2017 Venue: Goa Summary: Pharma CXO Summit, organised by Express Pharma and the Indian Express Group, will bring together leading pharma CEOs, COOs and division heads who are leading the way for Indian pharma exports the world over to share their learnings and experiences on implementing serialisation. The conference will present insights from regulators and policy makers, as well as case studies from the early adopters of traceability technologies. The other highlights at the event will be: Express Pharma Excellence in Exports Awards: It seeks to recognise the untiring efforts of pharma exporters. It will acknowledge and celebrate the resounding successes of Indian pharma companies, and the vital roles they have played in establishing India as a leading

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October 16-31, 2017

MARKET GROWTH TRACKER

IPM clocks ` 115,202 crores in August 2017 Anti-infective therapy was valued at ` 1,454 crores and was the only therapy in top 10,other than respiratory to register a negative growth THE INDIAN Pharmaceutical Market (IPM) clocked ` 115,202 crores of which the retail sector was valued at ` 196,997 crores as of MAT August 2017 with a growth of 5 per cent over last year. Also on a monthly basis, retail has shown an improvement with a growth of 6 per cent while the entire IPM has shown a growth of 5 per cent over same period last year (SPLY). Top 10 companies maintained 43 per cent of share in the IPM and these top companies have grown at par with the IPM by growing at 5 per cent SPLY. The top 150 companies continued to account for 97 per cent of IPM on MAT and month basis whereas Top 20 companies also maintained a share of 64 per cent in both MAT and month level. Lupin continues to be the fastest growing company among the Top 10 on MAT basis whereas on month basis Intas grew the fastest. Except Zydus Cadila all the Top 10 companies showed positive growth on MAT. Most of the companies in 11-20 bracket have an improvement as compared to July 2017 and have shown positive growth for the month apart from Aristo, Pfizer and Dr Reddys Lab which reflected a negative growth. Torrent Pharma and USV have grown in double digits while Emcure has shown 0 per cent growth. Top 10 brands in the IPM showed revival in growth where these brands valued at ` 348 crores for the month of August 2017 showed a combined growth of 8 per cent over SPLY. The growth would have been in double digit had it not been for a -24 per cent degrowth of Monocef which is the fourth largest brand in IPM. While top 2 brands Mixtard (7 per cent) and Glycomet-GP (6 per cent) showed

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October 16-31, 2017

TABLE 1: PHARMA MARKET SIZE IN MILLION $ USD BY COUNTRY All values in Million USD

July Month

Month Growth per cent

MAT July

MAT growth per cent

Global pharma market

85184

1.8

1086589

4.5

34321

2.4

448502

1.8

China

6345

3.5

76859

1.3

Japan

5993

-6.4

77346

-0.7

Germany

3632

7.3

40904

2.6

France

2899

7.6

33090

1.1

Italy

2572

7.1

28591

0.4

Brazil

2145

11.2

24391

27.6

1942

4.9

22660

-10.7

Spain

1831

5.1

20790

-0.8

Canada

1754

14.1

19904

4.8

India

1318

-3.6

15887

6.8

Russia

1136

28.5

14555

26.9

Australia

1048

-6.4

13013

9.7

Korea

739

7.4

8774

9.7

TABLE 2: INDIAN COMPANIESâ&#x20AC;&#x2122; MARKET SIZE IN THE GLOBAL MARKET All values in Million USD

July Month

Month Growth per cent

MAT July

MAT growth per cent

Global Pharma Mkt

85184

1.8

1086589

4.5

SUN PHARMA

405

-11.9

5433

LUPIN LABORATORIES

294

-10.2

4126

8.2

DR REDDYS LAB

218

-8

3006

-1.3

CIPLA

194

20.5

2285

25.4

TORRENT

190

9.4

2187

12.2

AUROBINDO

184

2227

-5

ZYDUS CADILA

175

2145

-0.2

INTAS

142

-11.5

2136

15.1

GLENMARK PHARM

138

-8.2

1826

3.5

MANKIND PHARMA

102

-3.2

1177

6.9

MARKET a decent growth, other top 10 brands like Lantus (35 per cent), Janumet (13 per cent) and Dexorange (12 per cent) and Liv52 (24 per cent) have shown a double digit growth. The biggest positive change was for Augmentin which grew at 14 per cent as compared to negative growths over last few months. A major change in the list of top 10 brands as compared to July 2017 is exit of Galvus-Met and Thyronorm whose place is taken by Liv52 and Monocef. Also, Janumet lost two positions to be ranked sixth and lost its place in top 5 brands. Brands ranked 11-20 grew slower at combined growth of 6 per cent and were valued at ` 263 crores. While Brands like Galvus-Met (23 per cent) and Spasmo-Proxyvon+ (18 per cent) registered a strong growth, others like Clavam (12 per cent) and Thyronorm (4 per cent) showed a negative growth resulting in pulling down of overall growth of the segment. Indian companies continued their dominance in the IPM with a share of 79 per cent for the month of August 2017 and grew at par with the IPM with a growth of 5 per cent. MNCs also grew alike at 5 per cent and maintained their share of 21 per cent in the IPM. No. 1 MNC Abbott (8 per cent) recorded a growth better than the IPM whereas 2 of the top 10 MNCs, Pfizer (-8 per cent) and AstraZeneca (-4 per cent) showed a negative growth for the month. Top Indian company Sun Pharma showed a growth of 5 per cent with the IPM and except Aristo Pharma (-2 per cent) all other top 10 Indian companies grew positively for the month of August 2017 with only Intas Pharma registering a double digit growth of 11 per cent. Chronic therapy, with a growth of 10 per cent, grew five times faster than acute therapy which registered a growth of 2 per cent for the month of August 2017. However, acute therapy continues to be larger in size with a 67 per cent share in IPM. Antiinfectives regained the top position for the first time since

IPM OVERVIEW

IPM was valued at ` 115,202 crores and the retail sector was valued at ` 96,997 crores as of MATAug 2017 TSA and SSA both have grown by 5 per cent at MAT ● On month,TSA has grown by 6 per cent and SSA has grown by 6 per cent Source: QuintilesIMS TSA & SSA, Aug 2017 ● ●

TOP 40 BRANDS

Mixtard continues to be the top brand with a MS of ~0.5% Flu season has been favorable for Influvac which has grown remarkably by 343% in Aug 2017 ● Other brands with remarkable growth are Panderm +, Lantus, Shelcal, and Phesnedyl Cough Source: QuintilesIMS TSA & SSA, Aug 2017 ● ●

November 2016 and was valued at ` 1,454 crores making it the largest therapy for the month of August with a growth of -9 per cent. Cardiac slipped to second position but

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registered a strong growth of 9 per cent on SPLY. For the first time anti-diabetic therapy (16 per cent) was not the fastest growing therapy in IPM and instead it was derma

which clocked the highest growth at 21 per cent for the month of August 2017. Therapies like vaccines (16 per cent), urology (10 per cent), oncology (13 per cent), he-

patoprotectives (13 per cent) and antivirals (12 per cent) also registered a double digit growth. DPP IV Inhibitors and Combination continued to be the top ranked therapeutic

EXPRESS PHARMA

October 16-31, 2017

MARKET class 4 segment with a value of ` 221 crores and a strong growth of 21 per cent for the month. Only two of the top 10 TC-4s Cough Preparation Ethicals (-11 per cent) and Ceftriaxone Injectables (-23 per cent) recorded a negative growth for the month. Anti-infective therapy was valued at ` 1,454 crores and was the only therapy in top 10, other than respiratory to register a negative growth (-9 per cent). It is because of such high negative growth of the largest therapy that IPM’s overall growth could not touch double digit even after nine therapies registering a growth of more than 10 per cent. However, value wise it has shown a revival as compared to last six months. While most of the Top 10 molecules have shown negative growth, specific hospital focussed molecules like Meropenem (7 per cent) and Amikacin (9 per cent) have shown strong growths. Amoxycillin and Clavulanic Acid Solids was valued at ` 120 crores with a growth of 6 per cent is the biggest molecule in the therapy. While most top 10 brands including the No. 1 brand Monocef (-24 per cent) registered a negative growth, there are three brands – Augmentin (14 per cent), Mikacin (14 per cent) and Ceftum (19 per cent) which not only grew positively but also recorded a double digit growth. Cardiac therapy lost its top position and slipped to be the second ranked therapy in IPM clocking a revenue of ` 1,227 crores and a growth rate of 9 per cent as compared to SPLY. Combinations with a growth of 14 per cent continue to drive growth in this therapy whereas single molecules which contribute 58 per cent of the revenue are growing at a slow pace of 6 per cent. Rosuvastatin with a value of ` 65 crores is the top molecule in the therapy and has shown a growth of 8 per cent over SPLY. Single molecules like Atorvastatin (-10 per cent), Enoxaparin (-2 per cent) and Amlodipine (10 per cent) are the only ones in Top 10 to have shown negative growth. Telmisartan Combina-

24 EXPRESS PHARMA October 16-31, 2017

ACUTE AND CHRONIC THERAPY TRENDS

Acute therapies continue to dominate the market constituting 67% of the IPM The top TC4 in the IPM is DPP4 Inhibitor & Comb with the a value growth of 21% Source: QuintilesIMS TSA & SSA, Aug 2017 ● ●

THERAPY TRENDS

Anti Infectives constitutes the largest market share in IPM occupying 13 per cent Anti Diabetics registered the highest growth of around 21 per cent for the same period last year ● Anti Infectives and Respiratory market have grown by 37 per cent and 36 per cent over previous month Source: QuintilesIMS TSA & SSA, Aug 2017 ● ●

tions have registered a whopping combined growth of 18 per cent of which Top 3 molecules like Telmisartan + HCT (11 per cent), Telmisartan + Amlodipine (18 per cent) and Telmisar-

tan + Metoprolol (29 per cent) have all shown robust growth. Five of the Top 10 brands Ecosprin-AV (25 per cent), Minipress-XL (20 per cent), Cilacar (39 per cent), Nitrocon-

tin (32 per cent) and Dytor (30 per cent) have recorded a growth of more than 20 per cent. Gastro intestinal therapy continued to be the third

largest therapy in IPM with a value of ` 1,167 crores for the month and a growth of 5 per cent which is at par with the IPM. All top 10 molecules in the therapy registered a

MARKET positive growth with the largest molecule Pantoprazole + Domperidome showing a double digit growth of 10 per cent. Bacillus Clausii continued to show progress with 20 per cent growth over SPLY. Other top molecules which showed strong growths are Milk of Magnesia and Combination (21 per cent), Esomeprazole + Domperidome (23 per cent) and Other Dicyclomine combinations (15 per cent). Spasmo-Proxyvon+ displaced Pan to become the top brand in the therapy and showed a robust growth of 18 per cent for the month of August 2017. Among top 10 brands only Aciloc (-4 per cent) showed a negative growth. Anti-diabetics maintained its fourth position in the IPM clocking a value of ` 975 crores and also continues to grow strongly with a growth of 16 per cent at both MAT and month basis. All top molecules showed a strong double digit growth over SPLY except for 0 per cent growth for Metformin and 6 per cent for Metformin + Gliclazide. While DPP4 Inhibitors (` 215 crores) continued to be the largest segment in the therapy, SGLT-2 Inhibitors continued to be the most progressive segment with growth for the month recorded at 103 per cent over SPLY. Six of the Top 10 brands of the therapy have recorded a double digit growth with Lantus (35 per cent) showing the highest growth. Only Zoryl-M (-2 per cent) and Trajenta (-5 per cent) showed a negative growth among Top 3 brands of the therapy. For the first time dermatology overtook anti-diabetes in terms of growth and became the fastest growing therapy in IPM for the month of August 2017. Dermatology clocked a revenue of ` 828 crores and a strong growth of 21 per cent for the month of August 2017. Emollients remains the largest sub category within the therapy which registered a growth at 21 per cent. Seven of top 10 molecules showed a strong double digit growth of which Luliconazole (282 per cent) grew the strongest. The second

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October 16-31, 2017

largest molecule Itraconazole also continued its progression with a tremendous growth of 81 per cent over SPLY. While No 1 brand Betadine grew at 8 per cent, other top 15 brands like Panderm+ (114 per cent), IT-Mac (113 per cent), Lulifin (109 per cent) and Candiforce (55 per cent) recorded a tremendous growths.

Global pharma The global pharma market is valued at $1086 billion growing at 4.5 per cent. The US continues to dominate the market with 40.3 per cent market share with growth of 2.4 per cent in July 2017. Amongst the top market, India has notched up and is ranked 11th. Top markets with

more than 10 per cent growth are Brazil, Canada and Russia. Venezuela has moved out from the top markets globally due to the high level of currency fluctuations in the month of July 2017 as per the MIDAS IMS data. Indian companies hold 3.6 per cent share in the global market as per July 2017 data.

For the month of July 2017, the IPM showed degrowth. Cipla is the only Indian company which has shown more than 20 per cent and above growth in the month of July 2017 globally. Sun Pharma, Lupin and Intas have shown degrowth of more than 10 per cent in the month of July 2017 as per global market.

cover )

The global push for traceability to quell counterfeiting and raise quality standards have opened up myriad growth avenues for Indiaâ&#x20AC;&#x2122;s pharma packaging equipment industry By Swati Rana

26 EXPRESS PHARMA October 16-31, 2017

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INSIDE

PACKED WITH POTENTIAL

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OPPORTUNITIES CALLING

INTV: PRAKASH CHANDRAJOSHI, SECRETARY GENERAL, PACE

EXPRESS PHARMA

October 16-31, 2017

cover )

28 EXPRESS PHARMA October 16-31, 2017

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EXPRESS PHARMA

October 16-31, 2017

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Opportunities calling The pharma packaging equipment market is on a growth curve, spurred by the need to comply with stringent global regulations and counter the threat of counterfeit medicines. By Swati Rana

he global emphasis on the implementation of traceability solutions to reduce counterfeiting of pharma products has led to the growth of pharma packaging equipment market as well. Most of the countries are planning to make serialisation mandatory. For instance, the

US is set to implement Drug Supply Chain Security Act (DSCSA) by November 27, 2018. Likewise, the Falsified Medicines Directive (Delegated Act 2016/161) requires all packaging in the pharma sector in the EU to bear an individual serial number by February. 2019. The implemen-

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tation of serialisation globally has created opportunities as well as challenges for the pharma packaging industry. As the fourth largest manufacturer of medicines in the world, India too has to meet the growing demand for medications and to deliver them in safe, patient-centric ways that

meet the needs of the various populations they serve. As a leading exporter of generic medicines, India has to comply with global regulations. Hence, pharma companies need partners who can offer innovative packaging solutions that cater to changing requirements globally.

A flourishing segment The growing demand for pharmaceuticals coupled with increased emphasis on product packaging is expected to drive the global pharma packaging market to reach $158.8 billion by 2025 from $77.65 billion in 2016, according to a new report by Grand View Research.

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October 16-31, 2017

cover )

It is important to combine global knowledge and local manufacturing expertise to leverage lean production processes and build on an optimised supply chain Rahul Dev VP, Datwyler India

The rising number of mergers, acquisitions, and an increasing number of collaborations and partnerships are some of the trends that have been observed in global pharma packaging equipment market Sunil Nirmale Domestic Sales, ACG Engineering business

32 EXPRESS PHARMA October 16-31, 2017

Highlighting the huge growth potential of the pharma packaging market, Shaunak J Dave, MD and CEO, Optel Group, India, VP – Asia says, “Pharma packaging market volume is expected to grow at $90 billion globally, registering a growth rate of eight per cent, with the US, Western Europe and Japan contributing to 60 per cent of this market. Asia Pacific region is expected to reach 33 per cent in 2025 due to the growing demand of pharma and presence of large number of plastic and other packaging raw material manufacturers.” He further points out that the growth of the pharma industry offers a big opportunity to the Indian pharma packaging market as well. It is estimated that pharma packaging industry in India will be worth of $2.6 billion by 2020.

Pharma packaging equipment market: Opportunities and challenges This, in turn, has also opened up growth avenues for the pharma packaging equipment market. As per a MarketsandMarkets report, the global pharma packaging equipment market is estimated to grow at a CAGR of 6.8 per cent from 2017 to 2022 to reach $8.24 billion approximately by 2022. It states, “The growth of the market can be attributed to factors such as cost containment in pharma R&D, growth in funding for generics and biopharma research, and technological advancements in labelling and serialisations solutions. The development of production lines for small batch size and research purposes, growing fo-

cus of pharma manufacturers to cut operational costs, and rising emphasis on labelling and serialisation for anti-counterfeiting of drugs are the key trends in the market. ” Counterfeit pharma products are a major threat to the pharma industry’s progress, as global pharma counterfeit industry is estimated at $75 to $200 billion (which is 8 per cent to 15 per cent of total world’s pharma products). Innovative secured packaging material (covert/ overt features) and an efficient packaging process shall help to minimise the problem along with serialisation, authentication and tamper evident compliances. Therefore, as Dave points out, it is a big opportunity for pharma packaging sector as 80 per cent of all drug packaging units are to be serialised worldwide over the next seven years. In 2016 and 2017, the biggest noticeable trend observed by industry experts is impact of ‘Global Track and Trace i.e. Serialisation and Tamper Evident Regulations.’ This subject has attracted industry’s attention at every recent global packaging event. Similarly, rising incidence of diseases, and innovations in drug delivery techniques are some of the other factors driving the growth for global pharma packaging equipment market. In addition, increasing generic and contract manufacturing activities are expected to drive the market for pharma packaging equipment in Asian countries, especially in India and China. “Companies involved in pharma

The packaging industry requires understanding handling potent/ toxic products and providing assured containment system. With the change in the regulation it is also important that the data integrity especially for the detection / rejection systems are used KD Datar Director, Technolutions Projects

It is a big opportunity for pharma packaging sector as 80 per cent of all drug packaging units to be serialised worldwide over the next seven years Shaunak J Dave MD & CEO, Optel Group, India, VP – Asia

( packaging have been involved in saving operational cost. In addition, rising number of mergers and acquisitions, new product launches and an increasing number of collabora-

The stringent tracking norms of the pharma industry globally is a trend to move towards automation of the packaging lines. Earlier the primary packaging industry was moving fast and now event the secondary packaging equipment are being upgraded to meet the international standards Ajay Mehra Director, ACE Technologies

tions and partnerships are some of the trends that have been observed in global pharma packaging equipment market,” informs Sunil Nirmale – Domestic Sales, ACG Engineering Business.

An urgent need Thus, the growth potential in this segment is immense. However, the players need to be geared to leverage the opportunities effectively. As Rahul Dev, VP, Datwyler India points out, “The pharma and healthcare market is

EXPRESS PHARMA

October 16-31, 2017

continuously confronted with changes and challenges, which are directly linked to the changing needs of state-of-theart healthcare. It is important to combine global knowledge

and local manufacturing expertise to leverage lean production processes and build on an optimised supply chain. ” Pharma packaging can be a vital element is ensuring an ef-

THE MAIN FOCUS

fective supply system. To provide safety and quality of packaging for pharma products and comply with global norms, pharma packaging equipment nowadays

have to be automated and integrated. At the same time, flexibility in packaging lines and process is also important. “Due to non-uniformity of various serialisation

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cover ) regulations, packaging lines and machinery need to be flexible enough to meet those regulations and it poses significant challenges for India, being a global manufacturing hub of generics. Everywhere else in the world, the manufacturing scenario is being changed from dedicated packaging lines which required less changeover to flexible packaging lines with frequent change over. This change is to respond to diverse market demands in a quicker way. Industry 4.0 and integrated supply chain will drive the packaging technology and processes in near future,” informs Dave. Speaking on the challenges faced by the equipment manufacturers, Ajay Mehra, Director, ACE Technologies says, “Many companies are suffering from data management issues which are getting more and more complex and not easy to manage by humans only, hence a growth of the automation in the packaging industry is foreseen in our industry. He further said, “The challenges

being faced by the manufacturers is the lack of clear understanding of the parameters that need to be captured to make the software self reliant. As usual though we have the technical capability we always follow the innovators and limit our development to the tech-

nology available with the market leaders only.” KD Datar, Director, Technolutions Projects also opines that the packaging industry requires understanding of handling potent/toxic products and providing assured containment system. With the change in the

regulations it is also important that data integrity, especially for the detection/rejection systems are used.

What does the future behold? The pharma packaging equipment market is expected to

grow sizeably. However, the focus will be towards accelerated adoption of packaging technology, advanced systems for key functions such as checking/coding, tracking etc. Datar is of view that new packaging components and systems; automation with

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34 EXPRESS PHARMA October 16-31, 2017

( focus on detections/tracking; advanced systems for packaging materials; flexibility of handling various types of materials and more importantly, medium to high and very high speed compatibility and packaging machines for handling potent/ toxic products will be the future trends in pharma packaging equipment. Reiterating this, Mehra says, “The stringent tracking norms of the pharma industry globally is a sign to move towards automation of packaging lines. Earlier, the primary packaging industry was moving fast and now even the secondary packaging equipment are being upgraded to meet international standards.” Dave mentions that technologies such as direct printing of 2D data matrix code or human readable on tablet/ capsules by laser and serialisation of primary packaging like vials and primary unit dosage (blister pocket) is gaining popularity in advanced countries. Nirmale states, “Manufacturers are continuously challenged to increase output and improve efficiency, as well as inspection accuracy, placing their main focus on fully automated solutions. Large-scale production of generics will increasingly be relocated to the emerging markets, calling for durable and highly productive machines. To maintain and improve a plant’s overall equipment effectiveness, aftermarket services are becoming more and more important. A processing and packaging specialist who wants to keep pace with the industry needs to offer comprehensive consulting services all over the globe.” Fortunately, the players have taken note of the opportunities and is geared to optimise them. Mehra informs, “Labelling challenges, along with serialisation are the demand for the future of innovative pharma packaging equipment and Ace Technologies have tied up with companies like Sea Vision who are one of the pioneers of serialisation and

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October 16-31, 2017

have now set their eyes on the Indian market. As the company deals with the global leaders of packaging both in terms of primary packaging and secondary packaging. It has the full range of equipment to offer the latest

trends in the field of packaging under one roof.” Similarly, the Optel Group is serving the global pharma industry with its sophisticated vision and high speed image processing technology to check

THE MAIN FOCUS

product, packaging and printing integrity on the pharma packaging containers. Dave says, “Since 2004, it offers track and trace solutions globally and has achieved number one position with 25.7 per cent

global market share according to MarketsandMarkets’ recently published survey.” Thus, the packaging equipment industry is on a growth trajectory. swati.rana@expressindia.com

cover ) I N T E R V I E W

The outlook for PET bottles is bright PET Packaging Association For Clean Environment (PACE) and National Chemical Laboratory (NCL), Pune have recently conducted a research study to understand the scenario of PET bottle consumption in India. Prakash Chandra Joshi - Secretary General, PACE presents the key highlights of the report, in an interaction with Usha Sharma Tell us about the findings of the report released by National Chemical Laboratory on PET bottles. According to the report, how many PET bottles have been recycled by the pharma sector? The report initiated by PET Packaging Association For Clean Environment (PACE) was to understand the PET recycling scenario in the country. PACE requested National Chemical Laboratory (NCL), Pune to undertake a research study to map the recycling landscape of post consumer PET bottles in India. The project team studied various working of recycling system, value chain, price point; people engaged in recycling PET, process used to develop a robust understanding of the underlying issues in recycling. Almost 900 K tonnes of PET material was used in India in 2016 and it is established that almost 65 per cent to 70 per cent of the post consumer PET bottles are being recycled in 45 organised recycling facilities. PET bottles are being used for packaging of products like cough syrup, antacid, multi vitamin, food supplements. The PET material is free of Bisphenol-A, endocrine disruptive chemicals and is permitted by Indian Drugs & Cosmetic Act, Indian Pharmacopoeia and BIS. It is estimated that around 80 K tonnes of PET material is being used for pharma which is around nine per cent of the total material used. Many of

36 EXPRESS PHARMA October 16-31, 2017

the PET bottles use amber colour to improve the UV resistance of the bottle. It is estimated that 60 per cent of these bottles are recovered and used for making black fibre. It is further concluded from the study that PET bottles used in pharma take around 18 months from the time filled with products to reach recycling stream. Give us a brief report of the ongoing activities of PACE? PACE is an industry association to facilitate the framing, development and dissemination of best practices related to PET manufacturing, recycling. Incorporated on March 3, 2015, PACE promotes environmentally-friendly packaging, improving its quality, environmentally safe and friendly PET packaging for beverages and food and pharmaceutical products. PACE is presently engaged with various centres of excellences like National Chemical Laboratory, Pune; Indian Institute of Technology, Delhi; Indian Institute of Packaging, Mumbai; Institute of Chemical Technology, Mumbai; Central Food Technological Research Institute, Mysore, to research and study the health aspects, life cycle assessment and mapping of recycling landscape related to PET bottles under Indian conditions. It is expected that the outcome of the research will be a valuable source of information for the benefit of various stakeholders

including government and regulatory agencies. How many sector members are part of PACE and what are the criteria to become a member of the association? We have members consisting of raw material producers, processors, brand owners and recyclers covering the full value chain of the industry. The membership is of two types. They are subscriber members who participate in the management of the association and the other is called associate members who are entitled to access the resources being build by PACE and taken care of their interest as industry member. How did you execute the project? And what was your learning? Which new

projects do you plan to execute? Anything in particular for the pharma sector? If we talk about the methodology, a combination of site visits, interviews, literature survey was used for this study. The project team visited PET waste collection, sorting centres, PET waste traders and PET recycling units spread across the country, and have interviewed over four dozen vendors, traders, recyclers who are engaged in this business, and have interviewed industry experts, experts from trade organisations, PET manufacturers, bottlers, NGOs etc. NCL have used the existing (and emerging) literature in this fieldâ&#x20AC;&#x201D; reports, analysis, journal articles, market data, government data etc. to aid our analysis and understand the overall picture and present that through this report and a dedicated website. The draft report is available in the website named www. petrecycling.in From the learning perspective, there are various ways in which recycling of PET bottles impacts society. First and the most obvious ways is the reduction of the total solid waste that ends up in landfills, thus creating enormous strain on the overall ecosystem. Without recycling of PET bottles, much of this would either end up in landfills or used for generating energy by incineration etc. But the conversion of PET bottles into marketable items puts them

back in consumption cycle again. PACE is studying all the aspects of the PET bottle industry covering the health and recycling on ongoing basis. It will continue to invest its resources to research, study and innovate to ensure that PET remains a material of choice for packaging of beverages, food, pharma and personal hygiene products in circular manner with no cost to environment in close consultations with all stakeholders including government and regulators. What is the consumption of PET bottles in the pharma sector and how has it grown in the last two to three years? Tell us the issues faced by PET manufactures and how to overcome the challenges? It is estimated that 80,00085,000 tonnes of PET was used by the pharma sector. Various sizes of PET bottles which are used in pharma sector are mentioned below: Sl. No.

Capacity (OFC) ML

Weight GMS

8-10

10-12

120

12-14

250

23-25

The market has been growing at 8-10 per cent YTY basis. It is expected that it will continue to grow at the same rate for next three to five years.

( PET bottle manufacturers have been adding capacity as per the requirement of the industry. These bottles conform to various BIS standards and manufactured and packed in class 10,000 environment to ensure the quality of packaging. Some of major BIS Standards applicable for PET Bottles for pharma sector are: ◗ 1987- 12252 PET and PBT for safe use in contact with foodstuffs, pharma and drinking water ◗ 1998- 9845 Determination of overall migration of containers of plastic materials intended to come in contact with foodstuffs, pharma and drinking water

◗ 1999- 10171 Guidelines of suitability of plastics for food packaging ◗ 2014- 9833 Pigments and colorants in plastics for contact with Foodstuffs, Pharma & Drinking water Why should PET bottles be preferred against glass bottles? PET is hygienic, strong and resistant to attack by microorganisms, does not react with foods or beverages and will not biologically degrade. Its safety for food and beverage use is recognised by health authorities around the world. But unlike glass, PET is extremely lightweight, simple to transport and won't break, which is why it's preferred for

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packaging many foods and beverages. Also, glass bottles if not manufactured properly have the tendency to delaminate in the content if kept for long time. PET bottles do not exhibit any such tendency. It is possible to transport 30,000 of 100ML PET bottles in a truck against only 18,000 bottles of glass. This reduces the transport cost and environmental impact.Plastic and glass are both recyclable, but since glass can only be recycled and turned into more glass, it limits its options. On the other hand, since plastic does not loses its integrity, it can be recycled into a number of products from carpet filling to plastic lumber and so on. How are PET bottles more

THE MAIN FOCUS

environment friendly in comparison to glass? PET is well known for its clarity, making it a lightweight, non-breakable alternative to glass and other plastic resins. Consumers are increasingly interested in authentic, 'real food' offerings and transparent PET supports this trend. PET is a remarkably energy-efficient packaging material, with an environmental impact that compares very favourably to glass, aluminum and other container materials. Although PET's feed stocks are derived from crude oil and natural gas, approximately 40 per cent of that energy is trapped within the PET polymer for recapture and reuse every time PET is recycled. And because PET is

very strong yet lightweight, it allows more product to be delivered with less packaging, less weight and less fuel for transport. These factors help explain why life cycle studies of PET have consistently shown it to be a highly sustainable material with a positive environmental profile. The outlook for PET bottles in bright in line with growth of the products approved and accepted for using such packaging. The cough syrup, suspensions, antacids, multivitamins are estimated to grow at 10-12 per cent on YTY basis. This means that 10,00012,000 tonnes per year will need to be processed into bottles to meet the packaging demand of the pharma sector. u.sharma@expressindia.com

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October 16-31, 2017

MANAGEMENT INSIGHT

Consolidated FDI policy 2017 - Implications on pharmaceuticals and healthcare sector Rabindra Jhunjhunwala, Partner, Khaitan & Co and Sameer Sah, Associate Partner, Khaitan & Co share their insights on various aspects of the consolidated FDI policy 2017 and the impact of the life sciences sector

ver since the government introduced the concept of the Consolidated Foreign Direct Investment policy circular (the Consolidated FDI Policy), it has been one of the most sought-after documents expressing government policy. Not only does it have far-reaching ramifications on the inflow of foreign direct investment in India, it also represents an effort by the administration to gradually simplify and promote ease of reviewing and understanding regulations relating to doing business in India. Initial versions of the Consolidated FDI policy were released in two parts, one in April and the other in October with a sunset period of six months. Gradually, the government has done away with the concept of introducing two such circulars in a year, and now the government introduces only one such circular. The timing of course has become slightly stretched from April as is usual, to August in 2017. The latest version of the Consolidated FDI Policy was issued on August 28, 2017. This version consolidates all the changes that have taken place on the FDI policy by way of press notes, standard operating procedures, etc., over the last one year or so.

Pharmaceuticals and healthcare Sector Specifically, for the pharma and healthcare sector, the Consolidated FDI Policy essentially consolidates the various pronouncements over the last 12 months and as such does not create new stipulations. Some of the relevant changes from

38 EXPRESS PHARMA October 16-31, 2017

Despite the relaxation described in point 1 above, an investor should be mindful that the much debated non-compete restrictions will still continue to apply to all foreign investments, except of course where prior approval from the government is obtained based on â&#x20AC;&#x2DC;special circumstances.â&#x20AC;&#x2122;

Rabindra Jhunjhunwala

the last version of the FDI policy are highlighted below: 1. FDI up to 74 per cent permitted under automatic route: Under the erstwhile FDI policy, FDI in brownfield pharma investment proposals required prior government approval. However, in June 2016, the government had relaxed this requirement to specify that FDI was permitted under the automatic route without any government approval up to 74 per cent, and for investment being 74 per cent and above, government approval would be required. This change from June 2016 has been included into the Consolidated FDI policy. 2. Non-compete restrictions:

3. Conditionalities: Additionally, conditions which were typically imposed by the government through the approval process (namely, maintenance of production levels of essential medicines, R&D expenses on essential medicines, etc.) will nevertheless continue to apply to all brownfield investment proposals notwithstanding the relaxation mentioned in point 1 above, and will be enforced on a self-declaration basis. 4. Asset transfers: It is debatable whether asset transfers/business transfers involving a purchaser being an Indian company having more than 74 per cent FDI would be transactions that required prior government approval. Based on the past practice of the government, and the policy stance adopted by the government, one would lean in favour of classifying such transactions as approval

proval will have to be sought. Therefore, for MNC whollyowned subsidiaries in India, it would be relevant to assess what is the additional FDI brought into the company post the last round of approvals before raising any future funds from shareholders by way of FDI.

Sameer Sah

route transactions. 5. Additional FDI in the same entity: The erstwhile FDI policy had clarified that if approval had been obtained for a particular foreign ownership percentage or for fresh investments into a whollyowned subsidiary, in that situation prior approval would not be required for additional investments provided the foreign equity percentage is maintained. However, the latest version of the Consolidated FDI policy has clarified that the additional investment that can be brought in without prior approval would be capped at a cumulative aggregate amount of ` 5000 crores. Above this amount, prior ap-

The Consolidated FDI policyhave far-reaching ramifications on the inflow of FDI in India. It represents an effort by the administration to gradually simplify and promote ease of reviewing and understanding regulations relating to doing business in India

6. Process for government approval: As a part of the budget speech for 2017-18, the Finance Minister had announced that the FIPB would be abolished. This was done in June 2017 and certain standard operating procedures were published to clarify how such matters would be dealt with going forward. The details of the standard operating procedure, to the extent relevant, have been incorporated into the Consolidated FDI policy. Specifically, for the pharma sector, the approval would now be given by the Department of Pharmaceuticals, which is a part of the Ministry of Chemicals and Fertilisers. The process will be managed by this department along with the Department of Industrial Policy and Promotion which is a part of the Ministry of Commerce and Industry. There are additional generic changes to the Consolidated FDI Policy which may also have relevance to the healthcare and pharma sectors. These include, reference to permissibility of deferred consideration structures in transactions, relaxations pertaining to FDI in start-ups, permissibility to capitalise pre-incorporation expenses, etc.

REPORTS

Type II diabetes market in SE Asia set to experience strong growth According to GBI Research, the type II diabetes market will hit $2.9 billion by 2023 THE SOUTH-EAST Asian Type II Diabetes Mellitus (T2DM) market, which includes South Korea, Singapore, Taiwan, Malaysia, the Philippines, Thailand, Vietnam and Indonesia, will rise from $1.92 billion in 2016 to $2.96 billion by 2023, at a compound annual growth rate (CARG) of 6.3 per cent, according to business intelligence provider GBI Research. The company’s latest report ‘Type 2 Diabetes Mellitus Therapeutics in South-East Asia Markets to 2023 - Increasing Usage of Newer Therapies and Expanding Treatment Population to Encourage Robust Growth’ reveals that there has been a steep rise in T2DM cases across the eight SouthEast Asian markets over the past decade. This can be attributed to a variety of factors, including changing lifestyle habits and aging populations. However, the drug treatment rate remains relatively low due to the asymptomatic nature of the disease, the availability of alternative treatment options such as traditional medicines and the recommendation of lifestyle modifications as the first-line therapy. Gautam Arora, Healthcare Analyst, GBI Research, explains, “Unmet needs related to patient convenience and ease of use will be significantly addressed over the forecast period. Higher levels of innovation are apparent in the early-stage pipeline, which may lead to considerable improvements beyond the existing range of products, in terms of safety and efficacy over the long term.” The late-stage pipeline contains a high proportion of products from established drug classes, with improved

dosing regimens and administration routes compared with currently marketed products. These are Novo Nordisk’s NN-9535 and OG-217SC, which are GLP-1 agonists; Pfizer’s ertugliflozin and Theracos's bexagliflozin, which are SGLT-2 inhibitors; Sanofi’s sotagliflozin, which is dual SGLT-1 and SGLT-2 inhibitor and Merck’s omarigliptin, which is a DPP-4 inhibitor. Of these products, GBI Research believes that OG-217SC, being a firstto-market oral formulation in the GLP1 class of drug, has the most potential to change the treatment paradigm due to its improved administration route compared to other drugs in the same class. In terms of recently approved therapeutics, GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors have already achieved strong market uptake and are all expected to increase their market share over the forecast period. In comparison with many previously marketed therapies, these new products provide improved weight control and lowered hypoglycemia risk. Arora added, “In countries such as Thailand, Indonesia, and Vietnam, where affordability is a limiting factor, metformin – a low-cost generic drug – will maintain its pivotal role in the T2DM treatment algorithm. Due to its well-characterised safety and efficacy profiles, wide availability and low cost, metformin will continue to be prescribed as the first-line pharmacotherapy and also remain the favoured option for use in combination therapies.”

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EP News Bureau

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October 16-31, 2017

MANAGEMENT

Osteoarthritis 7MM market set Global respiratory to be worth $3.5 bn by 2026 market to be worth The OA pipeline is rapidly evolving due to improved understanding of the disease’s pathophysiology and recent biomarker development THE OSTEOARTHRITIS (OA) market is expected to increase from $1.6 billion in 2016 to $3.5 billion by 2026 in the seven major markets (7MM), at a compound annual growth rate (CAGR) of 8.1 per cent, according to GlobalData. The company’s latest report: ‘OpportunityAnalyzer: Osteoarthritis Opportunity Analysis and Forecasts to 2026’ reveals that this rapid market growth will be driven by a rise in the aging population and the launch of novel biologic therapies priced at a substantial premium to the generics and smallmolecule therapies. The OA market is largely genericised and no product is anticipated to lose patent protection during the forecast period. At the end of 2026, the US will continue to dominate the OA market as its share of sales increases further from its current 68.2 per cent to 75 per cent across the 7MM, while the 5EU and Japan will account for around 15 per cent and 10 per cent of sales, respectively. The higher sales numbers for the US can be attributed to a large OA population, which will continue to grow to over 274 million by 2026, as well as a higher than anticipated high annual cost of therapy (ACOT) of biologic analgesics including Pfizer’s tanezumab and Regeneron’s fasinumab as well as DMOADs including TissueGene’s Invossa and Samumed’s SM04690, in the US market. The OA pipeline is rapidly evolving thanks to improved understanding of the disease’s pathophysiology and recent biomarker development. Current R&D strategies in OA are characterised by a trend towards developing new analgesics with novel MOAs and drugs with disease-modifying effect, reflecting market de-

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mand for these therapies. Analgesics with innovative MOAs — including anti-nerve growth factors (anti-NGFs), a new class of opioids (CR845), an intra-articular formulation of capsaicin (CNTX-4975), and improved and novel formulations of marketed therapies (Zilretta, SI-613, and X-0002)—continue to be studied in clinical trials. In addition, with developments in biomarkers and magnetic resonance imaging (MRI) techniques, several potential DMOADs are now in development. These drugs include a small molecule therapy, SM04690, and two cell-based DMOADs, Invossa and ReJoin. Maria Sudul, Healthcare Analyst, GlobalData commented, ‘‘The OA market provides an abundance of opportunities for the development of novel analgesics and DMOADs. OA is considered a heterogeneous disease and as such, distinct OA patient populations exist and therapies targeting these subgroups are much needed. We anticipate that with the rapid evolution of OA pipeline products, the OA market landscape will change radically over the next 20 years.’’ Current treatments for OA are symptomatic therapies that aim to provide pain relief and improve function as well as offer a disease-modifying effect; however, available treatment modalities have limited therapeutic effect, and more than half of OA patients are unable to achieve adequate pain relief with any of the current treatments. OA is also primarily a disease associated with aging and elderly patients often have other comorbid conditions alongside OA, such as diabetes or hypertension. As a result of this, many treatment modalities currently available for OA are

often contraindicated in these patients. Sudul continued, ‘‘We anticipate that clinical unmet need in the OA market will remain largely unfulfilled over the forecast period. There is a pressing need for alternative analgesics with the ability to adequately address pain in OA patients at all severity levels. In addition, OA is considered a heterogeneous disease due to its complicated pathophysiology and unclear etiology. As such, distinct OA patient populations exist and therapies targeting these subgroups are much needed. There also remains a need for therapies that simultaneously address the OA and comorbidities a patient may have.’’ The current OA therapy landscape offers a large opportunity for pharmaceutical companies to develop drugs with new MOAs and disease-modifying effects including novel analgesics with the ability to adequately address all severity levels of OA-associated pain. A novel class of analgesics, antiNGFs, under development for OA pain among other indications, is expected to provide an attractive treatment option for moderate-to-severe knee and hip OA patients. In GlobalData’s competitive assessment of the late-stage OA pipeline, antiNGFs, especially Pfizer’s tanezumab, emerged as the most clinically and commercially attractive analgesic treatment option. Sudul added, ‘‘Anti-NGFs are likely to become the most attractive new treatment option, especially for moderate and severe patients. We also believe that anti-NGFs will provide a commercial advantage over DMOADs as they face lessdaunting reimbursement barriers.’’ EP News Bureau

$41.3 bn by 2023

According to GBI Research, patent expirations of the commercially successful Advair, Symbicort, Ventolin and Spiriva will allow generics to enter the market THE GLOBAL marketplace for respiratory diseases across the seven major pharmaceutical markets (7MM) is projected to exceed $41.3 billion in sales by 2023, at a compound annual growth rate (CAGR) of 4.2 per cent from 2016–2023, according to business intelligence provider GBI Research. The company’s latest report: ‘Global Respiratory Drugs Market to 2023 – A Changing Therapeutic Landscape as Key Patents Expire and Biologics, Targeted Therapies and CFTR Modulators for Asthma and Cystic Fibrosis Treatment Emerge as Market Growth Drivers’ reveals that market growth will be sustained by the approval of new biologics and targeted therapies, particularly for the treatment of asthma and cystic fibrosis. The patent expirations of the commercially successful Advair, Symbicort, Ventolin and Spiriva will allow generics to enter the market, but the impact of these expirations on market growth will be offset by the approval of new products, extended patents of drug delivery devices and the difficulty in manufacturing such devices. The presence of biologics in the pipeline is growing, which reflects the recent market trend, particularly in asthma, for targeted biologics aimed at specific patient sub-types. Examples of such therapies include the recent approvals Nucala and Cinqair, which supplement a market traditionally dominated by commercially successful small molecules. This trend appears to be continuing in the development landscape, with biologics also being developed for other respiratory disorder indi-

cations. Mark Needham, Associate Analyst, GBI commented, ‘‘Many companies are developing highly targeted biologics and mAbs aimed at specific patient sub-types, with the hope of benefiting previously underserved patients and generating strong revenues. Biologics are also less prone to generic erosion following the expiration of patents as they are more difficult to replicate.” Another factor driving market growth is the rise of CFTR modulating therapies for the treatment of the rare disease, cystic fibrosis. These are considered disease-modifying therapies that treat the underlying cause of the disease and have generated substantial revenue in a market that has been traditionally dominated by symptomatic treatments. There are currently just two marketed CFTR modulating therapies; however they are anticipated to generate over $4 billion collectively by 2023. Despite the innovation and shift towards more targeted therapies within asthma, chronic obstructive pulmonary disease (COPD) and cystic fibrosis, the report highlights a lack of treatment options and small late-stage pipeline for idiopathic pulmonary fibrosis (IPF). Needham added, ‘‘There is a significant unmet need in the treatment of IPF, a disease with a median survival time ranging from 2.5 to 3.5 years. This report provides a detailed analysis of the pipeline and clinical trial landscape to inform future decision making.’’ EP News Bureau

RESEARCH I N T E R V I E W

‘These molecules can be future blockbuster drugs for the treatment of glioma’ Dr Mayur Yergeri, Associate Dean and Professor, SPPSPTM, SVKM’s NMIMSDeemed to be University, has developed a new series of cancer molecules and the research findings have not shown any toxicity on normal cells. To put these drugs into clinical trials, he is trying to procure more funds from private including venture capitalists. Dr Yergeri shares the research outcomes and his plans for molecules commercialisation, in an interaction with Usha Sharma Tell us about the research findings of the new series of cancer molecules? How advanced will these molecules be? Where have these research papers published? I am one of the few scientists in the world who has worked on a chemical moiety called Acridone. I have been working on this molecule for more than two decades. From our studies, we have come to know that these molecules are found to be cytotoxic in breast cancer, lung cancer, ovarian cancer cell lines whereas the drugs are highly cytotoxic in glioma cell lines. The results have proved that these molecules which are lipophilic have shown 100 times more cytotoxicity than the presently used drug Temozolomide. Some of the results have been published in the prestigious European Journal of Medicinal Chemistry recently. How can new drug molecules work effectively by combining with other cancer drugs? We have carried out studies of combining these drugs with Doxorubicin and studies have shown that these drugs have been found to exhibit synergism and they increase

the cytotoxicity by almost 10 times in breast cancer cell lines. The concentration of molecules used for this study was based on IC25 concentration. We found these molecules to be very potent in sensitive breast cancer cell lines as well as in resistance cell lines also. So, I can say that these molecules can potentiate the

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RESEARCH activity of presently used drug Doxorubicin. Will AC2, AC7 and AC26 be developed as potent anticancer molecules for chemotherapy for the treatment of glioma? Definitely, these molecules have been found to be highly cytotoxic in sensitive U87 glioma cell lines and the resistant T-98 glioma cell lines. The molecules have shown 100 times more cytotoxicity than the presently used drug Temozolomide and is the only drug available for treatment of glioma. Every year four people in two lakh population are affected from glioma. These molecules can be future block buster drugs for the treatment of glioma. Moreover, they will be from India. I am desperately trying to commercialise these molecules towards clinical studies and trying to have my own start up for taking these molecules towards phase I clinical studies. I have received

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some funding but it is not enough. I am trying to attract more funding and I am also open to funds from venture capitalists. I want these molecules to be taken towards clinical side as early as possible so that the benefits for the treatment of glioma is given to patients. As India lags behind in new drug discovery, bringing these molecules into the market and over riding the regulatory norms will be a huge challenge for me. Tell us about the partnership with Dr GJ Peters of VU University Medical Centre, Amsterdam, Netherlands. How is the partnership progressing? I know Dr GJ Peters for more than 10 years and I have been collaborating with him since 2006. I worked with him as a BOYSCAST Fellow (Postdoc) for a year and we published more than five research papers in highly reputed medicinal chemistry and

cancer journals. Dr GJ Peters is one of the few scientists in the world who has worked on reversing drug resistance in cancer cells and it was path breaking for me to know so many things in treatment of cancer, especially related to treatment of drug resistance in cancer. This field needs high support as people die of cancer due to drug resistance as the drugs fail to kill the cancer cells. I also had the opportunity to use so many new cancer related equipment in his lab. I was lucky as I got another opportunity to work with him as a collaborator on a sabbatical from 2015 to 2016 and the studies I carried out during this time and the major outcome being these hit molecules. I am thankful to him for hosting me for a year. We did carry out a lot of mechanistic studies also which we will publishing soon in another medicinal chemistry based journal.

Which type of cancer cells are likely to be destroyed? Do these molecules destroy good cells? As discussed earlier that the molecules are cytotoxic against breast cancer, lung cancer, ovarian but highly potent against glioma cell lines as these drugs were designed keeping in view the lipophilic character and these drugs are able to cross the blood brain barrier and the results have shown that these molecules can future block buster drugs for the treatment of glioma. These molecules have been tested on normal cells to the level 75 ÎźM and they have not showed any toxicity on normal cells. In which form will these molecules be available for treatment? Are there any side effects from these molecules? I have not worked on formulations aspects as yet so I canâ&#x20AC;&#x2122;t comment on these

aspects. As I have been funded by the Department of Health Research, I will try to check the side effects of these molecules as the funding has been on these aspects. We will come to know the actual side effects only after testing these molecules in patients. I expect the same kind of side effects as other anti-cancer drugs being used clinically. Are you working on any other research molecule as well? Right now I am focussing on these molecules for taking them towards clinical side and trying to find funding for my start up and I have approached various funding agencies, I hope I will be funded for this. I am also working on nano formulations which are being exploited for treatment of lung cancer and I am on the verge of filing patents for these products. u.sharma@expressindia.com

RESEARCH UPDATES

Trial data suggests new typhoid shot could halve infection rate The vaccine developed by Bharat Biotech could also be used safely in babies

A NEW typhoid vaccine developed by privately-held Bharat Biotech proved safe and highly immunogenic in a study and could be used to prevent millions of infections if it succeeds in final-stage clinical trials, researchers said. Typhoid fever affects between 12 and 20 million people worldwide in regions where the quality of water and sanitation is low, particularly in south Asia and sub-Saharan Africa. Around one in 100 cases is deadly, and about 3 per cent of those infected become chronic carriers of the disease. Results of a mid-stage trial of the vaccine, a so-called Vi-conjugate shot which, its developers say, could also be used safely in babies, showed it was able to prevent half of those vaccinated from developing typhoid when they were exposed to it. “Our study provides further evidence to support the development of Viconjugate vaccines as a control measure to reduce the burden of typhoid fever,” said Andrew Pollard of Oxford University’s vaccine group, who co-led the trial. Experts say that while children are particularly susceptible to typhoid, no vaccine has yet been licensed for worldwide use in babies under 24 months old. This study, published in The Lancet medical journal, was conducted in 112

adult volunteers and used a ‘controlled human infection model.’ Volunteers are randomly assigned to be given either the experimental vaccine or a control one, and then deliberately exposed to the pathogen. Participants are closely monitored and treated for infection afterwards. Studies like this have been used in the development of various vaccines, including shots against cholera, since they are a fast and clear way to assess whether a vaccine works. Nicholas Feasted, an expert at the Liverpool School of Tropical Medicine in Britain, and Myron Levine of the University of Maryland in the US, said in The Lancet that the trial’s results had been “awaited with much anticipation” by global health experts keen to tackle typhoid in endemic areas. The World Health Organization’s expert panel on vaccines is due next month to consider whether to recommend Vi-conjugate vaccines to prevent typhoid. Once the WHO’s recommendations have been made, the Global Alliance for Vaccines and Immunisation, which helps fund vaccines at lower prices for poor countries, will decide whether or not it can finance the shots.

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Reuters

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RESEARCH

Zika vaccine shows promise in early human trial Inovio-GeneOne shot is a synthetic vaccine made by reproducing sections of the Zika virus genome in a lab

DNA-based Zika vaccine from Inovio Pharmaceuticals and South Korea’s GeneOne Life Science induced anti-Zika immune responses in an early stage human trial, US researchers reported. Unlike conventional vaccines, which often use inactivated or killed versions of a virus, the Inovio-GeneOne shot is a synthetic vaccine made by reproducing sections of the Zika virus genome in a lab, and then loading them onto a ring of genetic material called a plasmid. This vaccine is then injected beneath the skin and followed up with a device that generates

electrical impulses, creating small pores in cells that allow the DNA to pass into cells. After three doses of the Zika vaccine known as GLS-5700, all 40 healthy volunteers in the study developed Zika-specific antibodies. “Everybody made antibodies,” said Dr Pablo Tebas, an infectious disease expert at the University of Pennsylvania who led the study. To see if these antibodies could be protective against the virus, blood from immunised study participants was injected into mice who were then exposed to Zika. Animals that had

received the Zika-specific antibodies were protected. “When we gave mice serum from the same people before they got the vaccine, they were not protected. The mice died,” Tebas said. Tebas said the study shows how nimble synthetic DNA vaccines can be, noting that it took just seven months from the time the vaccine was first designed until the start of the clinical trial. “This technique of making DNA vaccines is very fast,” he said. More testing will be needed to show the vaccine is effective at protecting people from Zika,

and that could prove challenging given that the once explosive epidemic has slowed and there are few large populations now at risk for Zika infection. Last month, Sanofi ended development efforts on its Zika

vaccine, based on an inactivated or killed Zika virus. Takeda Pharmaceutical Co is still working on a Zika vaccine using this approach. Reuters

Eli Lilly wins US approval for breast cancer drug Verzenio belongs to a newer class of oral medicines called CDK 4/6 inhibitors that block cancer cells’ ability to divide and proliferate THE US Food and Drug Administration said it approved an Eli Lilly and Co drug to treat advanced breast cancer that has progressed following prior treatment. The drug, abemaciclib, which will be sold under the brand name Verzenio, will carry a list price before any discounts or rebates of about $10,948 per month, Lilly said. Verzenio belongs to a newer class of oral medicines called CDK 4/6 inhibitors that block cancer cells’ ability to divide and proliferate. It will compete with Pfizer's Ibrance and Kisqali from Novartis. “Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike other drugs in the class, it can be given as a stand-alone treatment to patients who were previously treated with endocrine therapy and chemotherapy,” Richard Pazdur, Head of oncology drug evaluation, FDA, said in a statement. Lilly said Verzenio will be available

44 EXPRESS PHARMA October 16-31, 2017

in the US by the end of October. Under a special savings card programme, the company said eligible commercially in-

sured patients may obtain the first three months of therapy free, then pay no more than $10 per month for up to 12

months. Lilly, in an emailed statement, said it will work with insurers, health systems and providers to ensure patient access to the treatment. In a pivotal clinical trial, abemaciclib when added to standard therapy reduced the risk of disease progression by 46 per cent. It also led to significant tumour shrinkage in 59 per cent of patients compared with 44 per cent of those who received endocrine drugs alone in the study. It was approved for adults who have hormone receptor HR-positive, HER2negative advanced or metastatic breast cancer that has progressed after endocrine therapy that alters a patient’s hormones, the FDA said. An estimated 252,710 women will be diagnosed with breast cancer this year, and 40,610 will die of the disease, according to the National Institutes of Health. About 72 per cent of patients with breast cancer have tumours that are HR-positive and HER2-negative. Reuters

RESEARCH

Psoriasis patients face increased risk of heart attacks and death The longer people had lived with psoriasis,the more inflammation they had in their blood vessels PEOPLE WITH psoriasis, a chronic inflammatory disease, may be more likely than others to experience heart attacks and strokes at least in part because inflammation damages their vascular system, a recent study suggests. The longer people had lived with psoriasis, the more inflammation they had in their blood vessels, the analysis of imaging tests for 190 psoriasis patients found. While these imaging tests didn’t connect vascular inflammation to an increased risk of heart attacks and strokes, researchers also examined data on roughly 87,000 Danish adults with psoriasis and another 4.2 million people without the condition. They found each year people lived with psoriasis was associated with a 1 per cent increase in the future risk of cardiovascular events like heart attacks and strokes. “It has been suspected that longterm exposure to low-grade systemic inflammation may increase the risk of cardiovascular events, but the effect of disease duration on the relationship between psoriasis and cardiovascular disease has been unclear,” said lead study author Dr Alexander Egeberg of Gentofte Hospital in Copenhagen. The inflammation in psoriasis is very similar to, and in many cases can overlap with, the inflammatory processes that contribute to hardening of the arteries, or atherosclerosis, Egeberg said. Even though plenty of previous research has linked psoriasis to heart disease, the current results offer fresh evidence that living longer with systemic inflammation can increase the risk of heart attacks and strokes even for psoriasis patients who don’t have other risk factors for heart disease such as smoking, diabetes or advanced age, Egeberg added. All of the patients in the imaging portion of the study had mild to moderate psoriasis. On average, they were around 54 years old and had been living with psoriasis for roughly eight years. The duration of psoriasis was asso-

ciated with increased vascular inflammation even after accounting for traditional risk factors for cardiovascular disease such as smoking and a family history of heart attack or stroke. In the separate analysis of the Danish population, researchers followed people for an average of almost five years. During this period, 152,122 people without psoriasis had major events like a heart attack or stroke, which translates into about eight people out of every 1,000 in the population each year. Over that same time, 4,472 people with psoriasis had major events like a heart attack or stroke, which translates into about 11 people out of every 1,000 in the population each year. One limitation of the study is that researchers lacked data for the Danish population on other factors that influence cardiovascular health such as obesity and exercise habits, the authors note in the Journal of the American Academy of Dermatology. Even so, patients should be aware that psoriasis can make cardiovascular problems more likely, said Dr Lawrence Eichenfield of Rady Children’s Hospital and the University of California, San Diego. “There is some evidence that certain systemic medications that treat psoriasis potentially decrease the inflammation and can decrease the psoriasis-associated cardiovascular risks,” Eichenfield, who wasn’t involved in the study, said by email. “The psoriasis treatment options should be discussed with a dermatologist.” Reuters

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IT@PHARMA I N T E R V I E W

‘Technology will play a significant role in helping maintain physical and mental wellbeing’ Technology is bringing about a growing convergence between life sciences and healthcare to benefit the patients, especially for special population such as the geriatrics. A good instance is Onkol, a Mhealth solution which can bring in all the stakeholders on a common platform to improve elderly care. Jitender Sandhu, Director, M2M Modules – Indico and ASEAN Region, talks about the growing role of IoT-enabled solutions in improving patient adherence to medicines and more, in an interaction with Lakshmipriya Nair How has advancements in digital health and technology-enabled care helped enhance support and care of elderly? How do they help in ensuring a better quality of life and encourage self-management? Many of us can attest how fortunate we are to have parents and grandparents living to a grand old age. And what’s been more impressive, is that we’ve been able to help those we love extend their independence longer than ever before. This will become crucial in the decades ahead as the elderly population is predicted to double globally by 2030. And to adapt smoothly to this demographic shift, technology will play a significant role in helping maintain physical and mental wellbeing. The elderly can have different levels of ability and having connected technology is a great balancing effect. Internet-of-Things (IoT) comes as a great help in this regard, where a variety of connected devices can help the care takers to be aware about health stats of an elderly in real-time. Take the Gemalto mHealth hub for example – this smart hub connects an elderly to their family and caregivers keeping them informed of their vital signs and emergency response situation. It is aimed at helping the user live a safe, independent life

46 EXPRESS PHARMA October 16-31, 2017

within the comforts of their home. Old age affects patients’ ability to manage their own medicines, resulting in adverse reactions to drugs, non-compliance and drug wastage. Medicines management is therefore a pivotal issue in geriatric care. How will Gemalto’s and Onkol’s collaboration help tackle this issue? OnKöl's mHealth solution powered by Gemalto’s M2M module helps user’s medical devices communicate with the OnKöl via voice call, Bluetooth, USB, Wi-Fi, ZigBee, and even physical wired connections. The devices share readings securely including medication reminders on a regular basis, so that the user doesn’t miss any dosage; and it can also correspondingly notify selected people about status of dosage – missed/ taken. By notifying family members, proper action can be taken swiftly and they can come in the frontline of the issue if things turn into an emergency. What are the benefits that caregivers accrue through this kind of technologyenabled solution? How does it minimise errors and improve patient adherence to medicines? The mHealth hub can ease the pressure on family members to always be present as they

How have you tried to overcome this barrier in Onkol’s solution? How is it designed for ease-of-use with optimal effectiveness? As mentioned earlier the solution is designed for simplicity, which is supreme given complexity and requirements of the ‘age in place individuals.’ The awardwinning hub removes barriers to technology adoption and encourages engagement without intimidation. In fact, it is a first-in-its-kind solution that is much easier, less invasive way to stay connected to someone we care about. juggle with their daily routine and busy careers. Moreover, the idea is to streamline health management so that the user can go on living a normal life at home. It is very important that any health solution targeted at the elderly is convenient and secure. If it isn’t user-friendly and intuitive, a device is unlikely to become part of the daily routine. Keeping that in mind all our IoT solutions including this one, are designed right from the start with the enduser in the centre. And for something as important as health, that’s essential. This solution is simple, doesn’t require any outside installer and works straight out of the box. Generally, adoption of technology is a challenge among the older populace.

Your module encrypts and sends information to OnKöl platform for caregivers. Have you considered partnerships with pharma players to use this data to improve drugs and medications for the elderly (without compromising patient’s confidentiality)? We think the data transmitted by the connected devices, if studied by pharma companies without including personal data can help in improving understanding of nutrition, but again the usage of data is subject to user discretion. Gemalto espouses the use of encryption technologies to protect critical data while holding consumer privacy at the paramount level because consumer’s trust is very important to us. We will do everything to maintain the

effectiveness of the security tools necessary to keep information safe and secure. What are the unique opportunities for growth in India’s healthcare and pharma IT segments? How are you positioned to leverage them? A large part of India’s population remains underserved when it comes to healthcare due to several reasons – remote location, accessibility, mobility of medical professionals etc. IoT-enabled healthcare services can help ease many of these hindrances by integrating secure communication capabilities into patient care which can help deliver a superior quality of medical attention, remotely. We are well positioned to address this segment and we believe gradually we will see higher uptake of secure, IoT enabled healthcare solutions. Any other significant developments you foresee? Hospital automation is another big requirement for the health sector. One of the applications will be tracking of small and big medical devices within the hospital. These will be IoT-connected devices which will be tracked to protect against theft as well immediate tracking in case of need. lakshmipriya.nair@expressindia.com

PHARMA ALLY VENDOR NEWS

Applied DNAand Videojet enter strategic partnership To offer new security print platform to diverse commercial ecosystems

ideojet Technologies has entered into a strategic partnership with Applied DNA Sciences. Applied DNA and Videojet have collaborated in the design of co-branded Applied DNA SigNature molecular-tagged Videojet inks, and a co-branded printer that electronically restricts the use of ink cartridges to only those that contain SigNature DNA inks. The relationship brings the potential to empower the tagging of countless commercial items, all of which are candidates for a CertainT licensing agreement, enabling traceability along the entire supply chain. Integrating the technologies from both companies creates a world-class solution that will be offered to the many industries in which both companies are already engaged. The 345,000-install base of Videojet printers, which code and mark well over ten billion products each day, is a testament to the power of continuous inkjet printing (CIJ) technology. The initial offering utilises the newly released Videojet 1860 printer, which will be co-branded with Applied DNA, along with co-branded Videojet inks that will incorporate Applied DNA's unique SigNature molecular tag into each individual ink cartridge. The SigNature-enabled inks will be brand-specific, enabling each brand to tag, test and track their products from source to shelf under a CertainT platform. Gaining this additional traceability, transparency and ultimately trust between value chain partners will allow brands to offer a new level of certainty to their customers that the products they are buying are authentic. The initial rollout of co-branded SigNature molecular tagged inks includes an aerospace-approved ink. This durable black ink was chosen to qualify first, due to its specific application and use in US military and aerospace industry for unique identifier (UID) tags, for an array of critical components spanning several

The initial rollout of SigNature molecular tagged inks includes an aerospaceapproved ink Federal Supply Groups (FSGs). Initial qualification testing, confirming that the molecular tagged ink does not impact printer uptime or operation, was performed under Applied DNA’s first Rapid Innovation Fund (RIF) contract awarded by the Office of the Secretary of Defense. In addition to critical FSG items, this ink is most commonly used as a date/lot code marking solution for food, tobacco, coffee, baby, health and personal care. “We are excited to team with Videojet to bring this combined solution to market and offer a broad range of companies a definitive method to support their brand protection strategies. This is a significant opportunity to increase the universe of SigNature-tagged items, increase our market share and broadly secure the supply chains of complex commercial ecosystems through the use of our CertainT platform,” stated Dr James Hayward, President and CEO, Applied DNA. “Applied DNA’s SigNature molecular tags and CertainT platform complements Videojet marking and coding solutions, allowing us to offer a new secure ink option, adding to our robust portfolio of brand protection and industrial track and trace offerings that are used across many commercial industries,” said Fred Susi, Videojet VP of Business and Product Planning. EP News Bureau

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LANXESS India continues its CSR thrust in Nagda

Gerresheimer presents Perfect Gx Elite vials at CPhI Worldwide

Signs agreement to support Government College, Nagda with e-learning tools

The intelligent software detects the defects in a few fractions of a second

AS PART of its corporate social responsibility initiative, LANXESS India, the leading speciality chemicals company, has asserted its commitment for technological intervention in educational empowerment by setting up e-learning tools in Government College, Nagda, Madhya Pradesh. This project is in line with LANXESS’ vision of a digital future and also finds resonance with the current government’s focus on creating a digitally empowered nation. While the privileged/privately-run educational institutions have made the most of the available technology, students from the state-run municipal institutions seem to be losing out, primarily due to the financial inability to procure tech-based

THE GX Elite vials have-set new standards for type 1 borosilicate glass vials. They are the result of comprehensive optimisation measures in the conversion process, which have focussed on designing out the risk to create product flaws during production including the removal of all glass-to-glass contact beginning with the tubing material all the way through final packaging. Gerresheimer will be showcasing Gx Elite vials at booth D02 in Hall 4.2 at CPhI Worldwide in Frankfurt (Germany) from October 24 to 26, 2017. “Our Gx Elite vials are setting new standards when it comes to quality,” says Jens Heymann, Senior VP, Europe & Asia Tubular Glass, Gerresheimer, underlining the ma-

learning tools. LANXESS has sought to play a key role to fulfil this gap by providing such infrastructure to underprivileged educational institutions and give an equal opportunity to students. LANXESS India, in a ceremony held at Civil Hospital, Nagda in the presence of Dilip Singh Shekhawat, Member of Legislative Assembly, Neelanjan Banerjee, Senior Executive Director, LANXESS India, Sanjay Singh, Site Head, Nagda, LANXESS India and other esteemed dignitaries from the state and local administration, formalised the agreement with the State Arts, Science & Commerce College of Nagda to support the institution with seven interactive e-learning tools at a cost of around ` 1,500,000.

At the same function, LANXESS India also presented a cheque of ` 1,000,000 to the Nagda Civil Hospital authorities as part of its three-year long commitment to contribute towards the upgradation of the existing facilities and infrastructure of the hospital. The local authorities along with the hospital management presented to LANXESS the need of a sonography machine as the patients, especially, women had to travel long distances to get such basic tests done. The machine is expected to be installed at the hospital by the end of this year. The Civil hospital has undertaken the responsibility to operate and maintain the sonography machine. EP News Bureau

jor difference that avoiding glass-to-glass contact in the production process can have on vial quality. The inspection systems, for one, are developed in house and form part of a closeknit testing system that ensures the highest precision and quality assurance in line with the latest standards. Complete with five HD cameras, the Gx G3 inspection system makes sure that cosmetic defects are identified reliably, for instance. The intelligent software detects and classifies the defects in a few fractions of a second, while the Gx RHOC system ensures dimensional quality with three HD matrix cameras on each side and a hypercentric ID camera. EP News Bureau

PRODUCTS

Sanner to showcase comprehensive portfolio of desiccant packaging solutions at CPhI India SANNER, MANUFACTURER of highquality primary plastic packaging and medical devices, will showcase a comprehensive portfolio of desiccant packaging solutions at CPhI India from November 27-30, 2017. After founding its new subsidiary Sanner of India and expanding warehouse capacities at its site in Pune, the company now underlines the successful extension of activities in India. In November, pharma experts from around the world meet at CPhI India. For Sanner, market leader for desiccant packaging, the show is a good opportunity to showcase its comprehensive portfolio. Sanner has been providing the Indian market with high-quality desiccant packaging solutions for many years. In 2016, the establishment of Sanner of India marked an important milestone. Recently,

48 EXPRESS PHARMA October 16-31, 2017

combine the advantages of conventional desiccant capsules and canisters and ensure exceptional stability. As of 2018, the innovative AdCap capsules will also be available with activated carbon. The distinct shape of both solutions prevents potential confusion with tablets or capsules and thus the risk of accidental ingestion. AdCap and AdPack comply with all global requirements for contact with food and drugs.

a new warehouse was added to the site in Pune, enabling Sanner to supply its customers all over India directly and on short notice. Apart from integrated desiccants, Sanner also provides customers with dif-

ferent drop-in solutions: AdPack consists of highly permeable desiccant sachets. Their flexible, lint-free Tyvek material combines barrier protection, durability and breathability with high moisture adsorption. The AdCap desiccant capsules

Contact details Commha Consulting GmbH & Co. KG Annette Crowther Poststraße 48 69115 Heidelberg Germany Tel. +49 (0)6221 18779-27 Fax +49 (0)6221 18779-11 sanner@commhaconsulting.com

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Clean room high speed doors a necessity DOES YOUR business plan include the development of an area in your plant for clean manufacturing? Better quality or better yield is the primary reason for investing in a cleanroom space. It goes straight to your bottom line. Numerous manufacturing facilities now require a controlled environment in which the amount of dust and dirt is limited in the area of the manufacturing. Medical instrument manufacturing and packaging, electronics and computer manufacturing, food preparation and some military applications are but a few of the instances that have strict requirements for maintaining a clean environment. One needs to know the requirement for specific product or process. Clean rooms have become integral part of pharma manufacturing facilities.

One of the most important aspects of cleanrooms is the doors which is chosen for cleanroom facility. Time for which door is open will play a critical factor in avoiding dust, outside temperature, humidity etc. Opening and closure of door has to quick enough to isolate the outside environment and internal facility. Gandhi Automations provide clean room high speed doors specifically designed for above purpose. clean room high speed doors are best suited for facilities where controlled environment is required. The opening and closing of door is quick enough to separate outside environment and internal facility. High speed clean room doors designed by Gandhi Automation are engineered carefully with feature below:◗ Concept of low air permeability in pressurised rooms with positive and negative air pressure

◗ Designed to fit inside the columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with transparent PVC horizontal sections or vision windows ◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h Δ 50 PA . ◗ Control device enclosure in Stainless Steel SS 316 Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064 Off: +91 22 66720200 / 66720300 (200 Lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website: www.geapl.co.in

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New PEGylation reagents available from Gelest GELEST HAS introduced a unique range of dual-function poly(ethylene glycol) (PEG) reagents that enable new approaches to PEGylation for bioconjugates, reduction of surface biofouling and formation of polymeriseable vesicles for drug transport. These 'first of a kind' materials are heterobifunctional materials with an amine at one terminus and a choice of two different species at the other. One species can undergo radical reactions and the second can undergo hydrolytic condensation. In addition to reacting directly with appropriate functionality of drug or protein substrates, these materials

The new polymeriseable PEG materials have the potential to form polymeriseable vesicles, stabilising PEGylated drugs or acting as comonomers for microencapsulated drug delivery. The polymerisation can proceed by either free radical organic polymerization or hydrolysiscondensation siloxane polymerisation. The motif below depicts PEGylation of a bioactive substance and the benefits of the PEGylation with a PEG terminated by styryl and amine functionality. It also shows potential pathways for both stabilised vesicle formation by polymerisation and pH-

have the potential to undergo polymerisation. PEGylation, the formation of a conjugate of a protein, peptide, drug or other bioactive material by linking it with one or more PEG chains, in many instances imparts desirable properties to a biomolecule: increased solubility, resistance to metabolic degradation and reduced immunogenicity.

responsive release of the bioactive. Contact details Henryk Bik Briechle-Fernandez Marketing Services, 265 Industrial Way West, Ste. 7 Eatontown, NJ 07724-2213 Phone: 732-982-8213 Fax: 732-982-8223 henryk.bik@bfmarketing.com www.bfmarketing.com

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HP-TLC fingerprint: Apicture is worth a thousand words! Dr Saikat Mallick, Asst Lab Manager, Anchrom Enterprises India, gives an insight on HP-TLC Fingerprint, which has been newly introduced regulation for chromatogram evaluation, of complex and variable natural products CHROMATOGRAPHY methods are extremely popular for separation and quantification of components in mixtures, as well as for their identification when coupled with a MS detector. Particularly so, in synthetic chemistry labs where a lot of information is available on the inputs in terms of identity, purity, impurities etc. and a reasonable prediction can be made about the output. Identifying a pure component in synthetic chemistry samples is not difficult, today. With 'articles of botanical origin' like herbal extracts and medicines, foods, neutraceuticals, essential oils, spices, vegetable oils etc etc. the analysis requirements are very different. Here, one has to certify authenticity and non-adulteration (purity) of a 'sample' containing numerous and unknown components, without knowing the components! Just stating a sample name e.g. Ashwgandha is not enough because there are so many variables inherent in the 'Ashwagandha sample' such as which part of the plant, age, storage, geographical origin, altitude, species, sub-species, chemotype, phenotype etc. Then there is the method of extraction or trituration or treatment (eg. Shodhan or purification as in Ayurveda) etc. which too can alter the phytochemical composition of the 'botanical sample.' With so many variables, that too in a complex matrix, the simplest and best approach for identification of a single botanical material for quality control is to have a

50 EXPRESS PHARMA October 16-31, 2017

'Botanical Reference Material' (BRM) and then compare its HP-TLC fingerprint, with the sample. If there are e.g. six varieties of saffron, then there would be 6 saffron BRMs and 6 HP-TLC fingerprints viz. Saffron (Iran), Saffron (Spain), Saffron (Kashmir) etc. These fingerprints could confirm e.g. if the premium label 'Kashmir' saffron is genuine or cheap Iranian saffron. About 50 samples of saffron could be checked for identity and adulteration in a day, at a very nominal cost, using HP-TLC. No other chromatography method gives any visual information about the sample. Leave alone a 'fingerprint.' 'HP-TLC fingerprint' is a visual representation of the phy-

tochemical composition obtained by the technique of High Performance Thin Layer Chromatography (HP-TLC). One does not need to know the names of the phytochemicals present! So called 'markers' i.e. components whose presence has been previously identified, have no role in fingerprint identification which is the primary test for identification of an article of botanical origin. Inorganic samples like 'bhasma' cannot be HP-TLC fingerprinted. Here is an example of HP-TLC fingerprint. The number, distance, colour and intensity of all bands in a sample is its fingerprint. HP-TLC fingerprint is very easy to obtain by the simple

HP-TLC technique, at a low cost with high throughput. A modern s/w controlled HPTLC can fingerprint dozens of different samples per day. Software control is a must because HP-TLC is performed using five independent steps, using five stand alone instruments. Only with the common controlling link i.e. modern HPTLC software, regulatory and cGLP requirements can be complied with. Pure substances may be chromatographed on same plate during fingerprinting for System Suitability Test. The industrial quality images can be used for quantification or far better quantification can be achieved by scanning densitometry. Evalu-

THE NUMBER, DISTANCE, COLOUR AND INTENSITY OF ALL BANDS IN A SAMPLE IS ITS FINGERPRINT

Figure 4-15: HPTLC fingerprints of hawthorn species (Crataegus leaf and flowers). MP: ethyl acetate, methanol, formic acid, water (50:3:3:6) D: Natural Products reagent, UV 366nm. Tracks 1 and 7, C. Laevigata; tracks 2 to 5, C. monogyna (4, strongly fermented sample); track 6, standards (with increasing Rf: rutin, vitexin – 2”- O-rhamnoside, chlorogenic, hyperoside, vitexin); track 8, C. laevigata, “Punicea”; track 9, C. x macrocarpa; track 10, C.azarolus; track 11, C.pentagyna. Ref: HPTLC Analysis of Medicinal Plants by Dr Reich

ation of reference fingerprint vs sample’s fingerprint must be done on same computer display only and in no other way. The fingerprint is ideally used in botanical quality control of individual materials. In case of formulations, the fingerprint cannot be, often, related to the raw materials used. But checking batch to batch consistency, stability testing is possible. Fingerprints are also useful to monitor changes of in-process materials, particularly in those Ayurvedic preparations, with complex preparations. To sum up, HP-TLC Fingerprint is a newly introduced regulation for chromatogram evaluation, of complex and variable natural products, by comparing the phytochemical composition represented in photographic image form, for the primary purpose of identification and secondary purpose of detecting adulteration and dilution of materials of botanical origin. This is a very recent development and will become a very commonly used procedure in the next few years, in the botanical (herbal and food) industries. Further reading ◗ HPTLC for Analysis of Medicinal Plants by Dr Reich (ISBN 3-13-141601-7/ ISBN 978-3-13-141601-8) ◗ USP Chapters 202, 203, 1064, 2251 ◗ PhEur Chapter 2.8.25 ◗ WHO Expert Committee on specifications for Pharma Preparations (Report 51) Contact details hptlc@anchrom.in

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Preserve the patients’eyes,not the drug PRESERVATIVES are necessary evils in the conventional three piece multi dose eye drop vial, as the ambient non-sterile as well as the left over drop exposed to ambience environment renters in the vial from the same path as that of the drug flow path contaminating the liquid inside. Preservatives are added, as mandated, to prevent the growth of microbial contaminants and biodegradation in the formulations. Thus, preservatives have become a key component in ophthalmic formulations to keep the sterility of the product, widely used preservatives are: ◗ Benzalkonium chloride (BAC/BAK), ◗ Stabilised Oxychloro Complex (SOC) ◗ SofZia Though preservatives help keep the formulation sterile over the course of multiple uses, various studies have proved that preservatives used in long term therapy induces ocular toxicity and causes harmful effects to your eyes such as Tear film instability, Conjunctival inflammation, Ocular discomfort, Corneal Surface impairment and more mentioned in Table 1. Novelia,’ a technology from France, brought in India for the first time by Kilitch Healthcare India Limited, is the solution that provides the benefits of the medication without the ill effects of any preservatives. The state-of-the-art patented pure flow technology prevents bacterial contamination and avoids the need of preservatives in the formulation. Benefits major of these preservative-free multi dose formulations are listed in Table 2. Working of the preservative free system in can be better understood correlating the below process shown in Table 3. On squeezing the bottle the liquid flows out of the bottle through a defined path

TABLE 1

CONJUMCTIVAL CHANGES

OCULAR SURFACE CHANGES

EPILHELIAL CHANGES

OCULAR DISCOMFORT

CORNEAL SUFACE IMPAIRMENT

TEAR FILM INSLABILILY

HISTOLOGICAL CHANGES

CONJUNCTIVAL INFLAMMATION

Owing to the potential adverse effects of ophthalmic preservatives, there is an increasing need for preservative-free ophthalmic products among the consumers

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TABLE 2

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PHARMA ALLY dispensing uniform dosage (❏) Contaminated air (❏) or contaminated liquid from atmosphere cannot flow back into the bottle due to the presence of non-return valve in the nozzle. (❏) Air compensation happens by entry of ambient air or liquid from ambient atmosphere through the aperture provided on the side of the bottle, through the continous silicon membrane which allows only gases to flow through, arresting the microbes. (❏) The functioning of the system can be summarised in a nutshell in four simple steps as mentioned in Table 4. In Novelia bottles main functions are achieved by Valve system: which opens to deliver accurate drop and closes to avoid any backflow Venting system: which allows only the filtered sterile air to enter the device after drop delivery due to the presence of silicone membrane.

position of drug content due to microbial growth. In traditional eye dropper bottle, as external ambient non-sterile air comes in contact with the drug, inducing microbial growth, preservatives are added. It is myth to say that preservatives help to keep the drop efficacy.

In Novelia technology does the efficacy of the product remains same even after one month of opening the cap? In Novelia technology, ambiant non sterile air passes through the homogenous silicone mem-

wasted?

Novelia bottles demonstrating that the different technical functions of Novelia are able to protect content against contamination brane, blocking any potential bacteria and only allowing gasses to flow through, hence the product remains sterile and efficient all throughout its shelf life even after opening. Preservatives have no effect

on efficacy of drug, so drops even after one month will be sterile and as efficient as first drop.

Does the residual drop on the tip of the bottle get

In Novelia technology during instillation even if there is a residual drop remaining on the tip of the bottle, it does not get wasted for the following reasons: ◗ On closing of the bottle with the cap, the drop remains sterile as the inner surface of the cap and the top of the bottle contains silver ions which avoids any bacteria growth ◗ When it is squeezed for a second time, this residual drop will be part of the new drop. Contact details info@kilitchhealthare.com

TABLE 3

Major challenge test done to prove the ability of above functions: ◗ To challenge the valve system tightness to micro organisms with vaccum in the container. ◗ To challenge the ability of venting system to protect content against contamination ingress. ◗ To challenge the ability of Novelia bottle to keep the contents sterile even after repetative contact of the tip of the device with contamination. ◗ To challenge the ability to keep contents sterile during a three-month treatment and to check that Novelia bottles has the same functioning after three months of use. ◗ To challenge the compatability between the Novelia silicon parts and our formulations.

Conclusion Novelia bottles pass in all the above challenge test, demonstrating that the different technical functions of Novelia are able to protect content against contamination. FAQs Does preservative help to keep the drop efficacy? Preservatives are added to formulations to prevent decom-

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TABLE 4

Functioning of the Preservative-free system in a nutshell

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With high performance comes design freedom. A choice of 9 RAL colors to go with your brand image.

You demand. We fulfill. Bangalore I Delhi I Guwahati I Hyderabad I Jammu I Kolkata I Mumbai I Vadodara I Sales@labguard.biz I www.labguard.biz Call National Hotline - 022 65650606

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The Reagent Racks featuring in this image is not a standard LabGuard product.

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WHAT IS HP-TLC FINGERPRINT? PHYTOCHEMICAL CONTENT REPRESENTED BY IMAGE(S) HP-TLC Fingerprint is a simple, rapid, low cost, yet a powerful, easy-tounderstand pharmacopeial technique, with innumerable applications in herbal extracts, medicines, foods, neutraceuticals, functional foods. In all these samples, the raw materials are very complex and variable but no problem for HP-TLC fingerprint analysis. Extraction of material of botanical origin for fingerprint analysis: 100mg sample in 1ml methanol. Sonicate for 15mins. Centrifuge. Use supernatant.

Sample Application Pattern On Plate:

70mm

Chromatogram Development: 33% RH, develop 70mm, 20min chamber saturation, paper lining, dry vertically

UV 254nm

UV 366nm

1st Indian Company to launch “CE” approaved equipment. Visible Derivatised

Visible

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Evaluation: BRM vs Sample

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BRM Sample Fail (less no. of bands)

BRM Sample Pass (identical bands)

BRM Sample Fail (one band extra)

HP-TLC Fingerprint evaluation i.e. comparison between Botanical Reference Material fingerprint and sample(s) for Rf, colour and intensity of bands, using GLP compliant auditable data. Less or more no. of bands means adulteration or substitution and fails the sample. Otherwise identical to BRM, but weaker bands indicate dilution.

HP-TLC Specialist! EXPRESS PHARMA

For live demo, details & free training: hptlc@anchrom.in 9833830899/9833830898

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NEW AS 200 BASIC, DIGIT CA & CONTROL Vibratory Sieve Shakers

Particle Size Analysis with EasySieveÂ® Software and CFR 21 Compliance EasySieve, the software for particle size analyses, exceeds manual evaluation in many aspects. n Automatic registration, evaluation and administration of measurement data n Measurement protocol inaccordance with standards n EasySieve CFR offers compliance with FDA 21 CFR Part 11 P REM I U M QUA L IT Y MA DE I N GE R MAN Y

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28-30 November 2017, Bombay Exhibition Centre Mumbai, India

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Imavac™ - Silicone Hose reinforced with SS 316 helical wire

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Imawrap® - Silicone Hose reinforced with Polyester Fabric & SS 316 helical wire

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KILITCH HEALTHCARE INDIA LTD. Avoid the

Harmful Side Effects of Preservatives

India’s first ever Preservative Free Ophthalmic Manufacturing Facility Widely accepted by Ophthalmologist

Patented Pure Flow Technology For contract manufacturing contact: Kilitch Healthcare India Ltd. 902/B Godrej Colesium, Behind Everad Nagar, Near Priyadarshani Cirlce, Sion (East), Mumbai – 400022. Tel. : 022 6137 2222 Mr. Divya Mehta : +91 9819724957 www.kilitchhealthcare.com info@kilitchhealthcare.com

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BCAG

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Sight Glass Flange with LED

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Multi-branch Manifold u

Grid

June Enterprises Pvt. Ltd. l www.june4gmp.com info@june4gmp.com l 9930359528

October 16-31, 2017

BCAP

Grid For Marking Autoclaving

Contact Details: Wadala Shree Ram Indl. Estate, Unit No. C-32, 3rd Floor, G. D. Ambekar Marg, Wadala, Mumbai - 400 031, Maharashtra India. Phone: +91 22 4356 0400 Fax: +91 22 4356 0425 Email: pharma@shahbros.com

www.shahbros.com EXPRESS PHARMA

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Experiment With The Truth Certified ISO 9001: 2008

A BENCHMARK FOR

QUALITY SOLUTIONS

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Muffle Furnace Photo Stability Chamber Pharma Refrigerator Stability Chamber Vacuum Oven Walk-in Stability Chamber

Osworld Scientific Equipments Pvt. Ltd.

B-44, New Empire Industrial Premises, Kondivita, J. B. Nagar, Andheri (East), Mumbai - 400 059. India Tel.: +91-22-28320880 / 28390487 E-mail: info@osworldindia.com

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Top Features CARTS FOR STERILE & OSD APPLICATION

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cleaning agents. Steam heating arrangement for effective cleaning. Rotary spray arm at the top and bottom of chamber for external cleaning. Internal cleaning via nozzles on Loading Carts. Effective HEPA ltered drying system. 21 CFR Part II compliant control system. Batch printing for process documentation and validation.

Steam Sterilizer Closure Processing Systems Hot Water Spray Sterilizers Steam Air Sterilizers Dry Heat Sterilizers W Stills Pure Steam Generators Ethylene Oxide Sterilizers

Machinfabrik Industries Pvt. Ltd.

October 16-31, 2017

MACHINFABRIK INDUSTRIES PVT. LTD. R - 89 / 90, Rabale, MIDC., Thane Belapur Road, Navi Mumbai - 400701, India www.machinfabrik.com | sales@machinfabrik.com | 91-22-6736 8200

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www.kesarcontrol.com

Humidity Chamber

Cold Chamber

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

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October 16-31, 2017

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OSMOMETER 3250

Milk Cryoscopes Available

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

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

October 16-31, 2017

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Developing and Optimising Advanced Materials Formulation Optimisation

Process Control

Quality Control

Malvern’s Gel Permeation Chromatography (GPC) solutions give complete characterisation of the structure and molecular weight of polymers.

PANalytical X-Ray Flourescence (XRF) Technology gives rapid identification of contaminants, allowing efficient process optimisation.

Accurate and precise measurements of particle size and shape using Laser Diffraction and Static Image Analysis gives confidence in the quality of your product.

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www.aimil.com

www.panalytical.com

October 16-31, 2017

Aimil/Ad/A&I/17-18/10/40

Visit us at: P-MEC 2017 • Hall No : 5 • Stall No : N18 Date: 28-30 Nov, 2017 Venue: BC&EC, Goregaon Mumbai

PHARMA LIFE CAMPUS BEAT

HK College of Pharmacy organises two-day intercollege scientific programme Students from various pharmacy colleges participated in poster presentation competition

K College of Pharmacy, Jogeshwari (W), Mumbai, recently organised two days intercollege scientific programme. One-day national seminar was organised on the theme- ‘Innovations and Advancements in Natural Products and Drug discovery’ along with poster competition. The chief guest, Dr Anisha Pargal, Director, Global Clinical Science & Operations R&D, Hindustan Unilever, Mumbai, mentioned in her key note address about the importance of natural product discoveries in the plant world, market trends in natural products as drug and opportunities provided by natural products over synthetic products. Scientific sessions were preceded with topics like ‘Venoms as a Potential Future Drug’ by Dr Mrunal Ghag Sawant, Scientific Officer, Haffkine Insti-

tute, Mumbai. ‘Evidence- based Evaluation of Rhododendron arboretum as An Estrogenic Agent’ by Dr Sunita Shailajan, Head, Department of Botany, Ramanarain Ruia Autonomus College, Mumbai. Challenges in Research on Natural Products by Dr Renuka Munshi, Head In Charge, Department of Clinical Pharmacology, TN Medical College & BYL Nair Hospital,

Mumbai. Students from various pharmacy colleges participated in poster presentation competition. This include Allana College of Pharmacy, Pune; VIVA Institute of Pharmacy, Virar; Vispute College of Pharmacy, Panvel; Kalsekar Institute of Pharmacy, Panvel; IDEAL College of Pharmacy, Kalyan; VES College of Pharmacy, Chembur;

Oriental College of Pharmacy, Sanpada; SNDT Women’s University's CU Shah College of Pharmacy, Santacruz and HK College of Pharmacy, Jogeshwari. There were a total 67 posters for the competition from different categories of pharmacy field. The evaluation of posters was done in two rounds by experts of each category. Poster evaluators were Dr Swati Patil, Department of Pharmacognosy and Dr Mrunal Sanaye, Department of Pharmacology from KM Kundnani College of Pharmacy, Mumbai; Dr Tabassum Khan, Department of Pharmaceutical Chemistry from Dr Bhanuben Nanavati College of Pharmacy, Mumbai; Bhagyashri Joshi, Department of Pharmaceutics from MET Institute of Pharmacy. 9th Scientific Day named as

TechCrunch was also organised. The chief guest of the day was Dr Rajan Verma, Director, Formulation, and Development, Abbott Pharmaceuticals, who shared a few words of experiences with students. Different competitions like model making, innovative product packaging, debate and pharma quiz were arranged. Students from HK College of Pharmacy and other colleges like CU Shah College of Pharmacy, Santacruz (W), Mumbai and VIVA Institute of Pharmacy, Virar (E), Mumbai participated enthusiastically in different competitions. There were a total of 21 groups in innovative product packaging competition, 36 groups in pharma quiz competition, 12 groups in debate competition, and 16 groups in model making competitions. EP News Bureau

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October 16-31, 2017

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