Express Pharma (Vol.13, No.2) November 16-30, 2017

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CONTENTS Vol.13 No.2 November 16-30, 2017 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas

Express Pharma, DuPont organise discussion on probiotics

Editor Viveka Roychowdhury*

New Delhi Prathiba Raju

29 Discussions focussed on the potential and challenges of making probiotic products part of the Indian consumer’s lifestyle | 16

DESIGN Bivash Barua

P31: INTERVIEW

Asst. Art Director Pravin Temble

‘We strive to change the way medical treatment is practised across the world’

Chief Designer Prasad Tate

Dr Sanjeev Saxena Founder and CEO, POC Medical Systems

Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma Photo Editor Sandeep Patil

P33: INTERVIEW

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

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

CPHI & P-MEC INDIA TO BE HELD IN MUMBAI FROM NOV 27-30, 2017

Sanjiv Navangul MD, Janssen India

Dr Anil Koul Director, CSIR-IMTECH

We have to work together through multi-sector partnerships and collaborations to tackle TB

IS IT TOO EARLY TO TALK OF GLOBAL HEALTH?

RESEARCH

35

National Design Editor

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

15

MANAGEMENT

Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana

MARKET

FDA APPROVES GILEAD CANCER GENE THERAPY

PHARMA TECHNOLOGY REVIEW

36

TRANSFORMING LIFE SCIENCES WITH AI AND AUTOMATIONS

39

CPHI WORLDWIDE ANNOUNCES WINNERS FOR ITS 14TH PHARMA AWARDS

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

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

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

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EXPRESS PHARMA

11

November 16-30, 2017

EDITOR’S NOTE

Who’s next, after Torrent-Unichem?

A

fter a search that reportedly lasted a decade, Unichem Laboratories finally settled on Torrent Pharma as the best choice to sell its domestic branded formulations business in India and Nepal. While the acquirer strengthens its focus on the domestic market, the seller gets to flex its wings overseas. Unichem CMD Prakash Mody plans to return half of the `3600crore to his stakeholders. The rest will be his war chest for acquisitions, to improve existing manufacturing, marketing and R&D facilities. He plans to spotlight complex biologics and specialised generics as part of a rejigged overseas strategy, with a special focus on the US. PM Modi has already apparently ‘identified specific opportunities and niches which we can potentially capitalise on,’ clearly indicating that he is ready for his next innings and is not going to walk away into the pharma sunset.

Post the deal, Torrent jumps up the rankings in India’s ` 1.14 trillion pharma market: from 13th to 5th in secondary sales according to IMS, while AIOCD moves the Ahmedabad based company from 13th to 8th position. Torrent's market share goes from 2.4 per cent to 3.4 per cent. As Torrent Pharma’s Chairman Samir Mehta put it, approximately 3000 plus employees will be added to Torrent Parivaar, and the company gets access to an additional 2,100 stockists across India.

The deal also marks Torrent’s entry into the lucrative Indian OTC market, thanks to Unichem’s Unienzyme.

Torrent has had five acquisitions in the Indian market, so it seems to have perfected the art of absorbing acquired assets. But, it won’t be smooth sailing. Past mega mergers like the Sun PharmaRanbaxy deal faced some friction from the latter's field force, symptomatic of a clash of cultures and compensation scales.

On paper, Torrent bags brands worth `200 crore, while market share in cardiology, CNS, and GI therapies segments will rise a few percentage points.

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12 EXPRESS PHARMA November 16-30, 2017

While Torrent strengthens its focus on the domestic market, Unichem will get to flex its wings overseas

But, Torrent could find itself in the same position as Abbott post the 2010 acquisition of Piramal Healthcare's branded generics business. Abbott did gain a few big brands, but a long tail of smaller ones as well. Most brands acquired from Unichem are older generation molecules, all of which have tough competition from the same molecule as well as nextgeneration products. Thus, the scope for price hikes is not very high. An HDFC Securities report on the deal cautions that the benefits will not be immediate but will be visible over a period of time by increasing medical representative (MR) productivity (which is ` 2.7 lakhs/MR for Unichem versus a much higher ` 6 lakhs/MR for Torrent) and cross-selling (2,100 additional stockists). Additionally, the analyst points out that this acquisition will largely be funded by debt (` 30-32 billion), as Torrent’s internal accruals are not very strong, which would in turn negatively impact earnings for the next two years.

But on the positive side, the deal will increase contribution of Torrent's domestic business in both top-line and EBITDA to 44 per cent and 55 per cent respectively (which pre-acquisition were 36 per cent and 48 per cent). The enhanced business mix will in time ensure sustainability of future cash flows.

The buzz is, there are many companies like Unichem who are prime acquisition targets, either for lack of a succession plan or interest of the next generation in the pharma business. For such companies, Unichem’s Mody is the best example of how building and nurturing brands pays off in the long run. In fact, now that he has the finance to chase his dream in global markets, it will certainly not take him seven decades to achieve critical mass. We wish him all the best!

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET PRE EVENT

CPhI & P-MEC India to be held in Mumbai from Nov 27-30,2017 The 3rd Pre-Connect Congress 2017 is scheduled on November 27, 2017

C

PhI & P-MEC India will be held at two venues in Mumbai. The exhibition at MMRDA Grounds, BKC in Mumbai will be held from November 27-29 and Bombay Exhibition Centre from November 28-30, 2017. The event will be a perfect place for companies to pick up on the latest trends and innovations the market has to offer.

CPhI India will bring in pharma professionals from all over the world to Mumbai and will facilitate initiating and closing business deals. The exhibition will showcase high-quality pharma machinery and equipment. Key decision makers in pharmaceutical industry from over 95 countries will converge where visitors can network in one of the world's fastest growing pharma markets.

The 3rd Pre-Connect Congress 2017 is scheduled on November 27, 2017 at Hotel Westin Garden City, Mumbai. The forum will see a congregation of renowned leaders who have headed large pharma organisations and propelled them to reach new heights of success.

Driven by powerful content and unmatched speaker profiles, the forum promises to provide a unique opportunity to bring all key stakeholders in the pharma industry on a single platform to discuss, deliberate and share their thoughts on achieving the next phase of growth.

EP News Bureau

EXPRESS PHARMA

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November 16-30, 2017

MARKET POST EVENT

Express Pharma,DuPont organise discussion on probiotics Discussions focussed on the potential as well as challenges of making probiotic products part of the Indian consumer’s lifestyle Mansha Gagneja Mumbai AS THE world battles superbugs, lifestyle and chronic diseases on one side and rising healthcare costs on the other, the role of a sound immune system takes on great significance.

Thus, as healthcare moves from curative to preventive, the trend towards consuming supplements to support and enhance our immune system will only get stronger. Answering this need, is the rapid growth of functional foods and supplement products such as probiotics which contribute to improved digestive and immune health addressing health challenges ranging from diarrhoea to upper-respiratory tract illnesses (URTI) such as common cold and atopic eczema. According to EuroMonitor, probiotics is the fastest growing ingredient in the global food supplement market.

The Promise and Power of Probiotics Recognising the significance of probiotics in health management and disease prevention, Express Pharma in association with DuPont recently organised a round table discussion on ‘The Promise and Power of Probiotics,’ which addressed the nascent industry of probiotics while analysing the challenges. The discussion was moderated by Viveka Roychowdhury, Editor, Express Pharma and Parth Patel, Business Director, South Asia, DuPont Nutrition & Health.

The event held in Mumbai saw experts from sectors including academia, research

16

EXPRESS PHARMA

November 16-30, 2017

(L-R) Subham Ray, Head Product Development, Technology & QA, Future Consumer; Amit Srivastava, BU Head, Dr Reddy’s Laboratories; Dr Nikhil Bangale, Sr Manager Medical Affairs, Nestle Nutrition India; Bharat Jhaver, CEO, Tablets India and Ankit Kochhar, Marketing, ITC Foods

Dr B Sesikeran, Former Director, National Institute of Nutrition, ICMR

(L-R) Dr Jasvir Singh, Regulatory, Scientific & Government Affairs Leader - South Asia, DuPont Nutrition & Health; Dr TSR Murali, Chief R&D Officer, Mother Dairy; Dr JB Prajapati, Principal and Dean, SMC College of Dairy Science; Dr B Sesikeran, Former Director, National Institute of Nutrition (ICMR) and Dr Nandan Joshi, Head: Health & Nutrition Science, Danone

Amit Srivastava, BU Head, Dr Reddy’s Laboratories

(L-R) Parth Patel, Business Director, South Asia, DuPont Nutrition & Health and Viveka Roychowdhury, Editor, Express Pharma

Dr TSR Murali, Chief R&D Officer, Mother Dairy

MARKET and sectors spanning food and pharmaceuticals, to share their perspectives and experiences on the science, research as well as the market presence and potential of probiotics in India.

The participants included Dr B Sesikeran, Former Director, National Institute of Nutrition (ICMR); Bharat Jhaver,

Ankit Kochhar, Marketing, ITC Foods

The event held in Mumbai saw experts from sectors including academia, research and industry CEO, Tablets India; Amit Srivastava, BU Head, Dr Reddy's Laboratories; Dr TSR Murali, Chief R&D Officer, Mother Dairy; Dr Jasvir Singh, Regulatory, Scientific & Government Affairs Leader - South Asia, DuPont Nutrition & Health; Dr Nandan Joshi, Head: Health & Nutrition Science, Danone; Dr Nikhil Bangale, Sr Manager Medical Affairs, Nestle Nutrition India; Ankit Kochhar, Marketing, ITC Foods; Subham Ray, Head Product Development, Technology & QA, Future Consumer and Dr JB Prajapati, Principal and Dean,

EXPRESS PHARMA

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November 16-30, 2017

SMC College of Dairy Science.

The key questions addressed during the round table discussion ranged from the definitions of probiotics as per regulators, the positioning in different markets across the world and how early players in India have modulated their goto-market strategies based on consumer research. Partici-

pants discussed the possible evolution of the Indian market from the existing mix of doctor prescribed probiotics and limited fermented products to a more diverse offering of foods and supplements that could be part of an everyday Indian diet.

The need for industry to build awareness about the rele-

vance of probiotics for preventive healthcare was highlighted. While identifying the roadblocks that could hinder the growth of this segment, stakeholders also look at ways to come together to overcome them. Participants shared insights on the mindset barriers of consumers in India that need to be addressed. Given

the increasing interest in probiotics category, wherein there have been new launches ,the participants discussed ways to ensure that probiotic products backed by scientific evidence and real benefits break through the clutter and win the trust of Indian consumers.

Patel summarised the discussion by listing a few key

MARKET pointers that were raised during the round table and on which all panelists aligned upon. These included 1. Probiotics are useful and documented, yet a lot of work needs to be done to promote efficacy.

2. The probiotics industry will grow if the regulations evolve in harmony with global norms.

3. Education and awareness among healthcare professionals and consumers need to be broadened leveraging the power of technology.

4. Strong clinical evidence will help build trust among consumers.

5. Tackling challenges of infrastructure related to cold chain, etc will help the market to grow.

6. Research and marketing of prebiotics should also be promoted.

7. Innovation should be the key to develop various probiotic food formats. Educating consumers about these unique formats will help in increasing awareness.

8. Probiotics is straddling two worlds: medicine and food.

The critical aspect to focus on is to tap wellness more positively from a food angle. The notion that food is the best medicine has to be propagated.

A few takeaways by the panellists ◗ Dr Jasvir Singh, Regulatory, Scientific & Government Affairs Leader - South Asia, DuPont Nutrition & Health: The role of a regulator in pro-

18

EXPRESS PHARMA

November 16-30, 2017

Bharat Jhaver, CEO, Tablets India

Dr Nandan Joshi, Head: Health & Nutrition Science, Danone

Subham Ray, Head Product Development, Technology & QA, Future Consumer

Dr Jasvir Singh, Regulatory, Scientific & Government Affairs Leader - South Asia, DuPont Nutrition & Health

Dr JB Prajapati, Principal and Dean, SMC College of Dairy Science

Dr Nikhil Bangale, Sr Manager Medical Affairs, Nestle Nutrition India

biotics space is going to be extremely integral. We already have nutraceutical regulations which cover probiotics, but as it is in the initial stage it needs to be made more stringent to promote good practices. We need to build more specificity so that the benefits can be proven and the products can

become part of the approved list. ◗ Dr TSR Murali, Chief R&D Officer, Mother Dairy: There is a need to educate the consumers about the richness and goodness about probiotics. ◗ Dr JB Prajapati, Principal and Dean, SMC College of Dairy Science: Strengthen the

relations of industry and academia to promote research in probiotics and to increase governance about it. Also, we need education on probiotics at every level, from primary to professionals. ◗ Dr B Sesikeran, Former Director, National Institute of Nutrition (ICMR): We need to

be modest in one's claims on probiotics as it can be a supplement to either food or drugs.

We need to generate evidence if there are any gaps and to concentrate more on prebiotics. ◗ Dr Nandan Joshi, Head: Health & Nutrition Science, Danone: We need to bring credibility in the industry and educate consumers to make probiotics a lifestyle choice. ◗ Subham Ray, Head Product Development, Technology & QA, Future Consumer: We need to create a strong link between the industry, academia and the consumers. ◗ Amit Srivastava, BU Head, Dr Reddy's Laboratories: Speaking as a pharmaceutical company, we need to educate and enable doctors on the foundation of outcomes to be promoted as an adjuvant and not as a therapy. ◗ Dr Nikhil Bangale, Sr Manager Medical Affairs, Nestle Nutrition India: Education is certainly going to be instrumental in disseminating the importance of probiotics starting right from the grass root level for consumers and HCPs. Drawing simplistic and practical analogies would ensure effective education. Putting forth claims backed by data would be crucial. ◗ Bharat Jhaver, CEO, Tablets India: We need continuous education for consumers as well as the doctor fraternity. Word of mouth can also be great to spread awareness. mansha.gagneja@expressindia.com

MARKET GROWTH TRACKER

IPM clocks ` 115,578 crores in Sept 2017 Anti-infective therapy clocked ` 1481 crores while the gastro intestinal therapy has maintained its third position in IPM over last many months and clocked ` 1088 crores THE INDIAN Pharmaceutical Market (IPM) clocked ` 115,578 crores of which the retail sector was valued at ` 97,406 crores as of MAT September 2017 with a growth of 5 per cent over last year. While looking at the growth over SPLY, IPM showed a subdued growth of 3 per cent whereas retail showed a slightly better growth of 4 per cent.

Top 10 companies continued to dominate with a 43 per cent share in the IPM but have grown slightly slower than the

IPM with a growth of 3 per cent over SPLY. While the top 11-20 companies showed a very slow growth of 1 per cent over SPLY, 21-30 ranked companies remained stagnant and showed no growth.

While Sun Pharma has maintained its leadership in terms of value, Mankind (9 per cent) and Intas (10 per cent) have shown the fastest growth among the Top 10 on month basis. Lupin showed highest growth of 10 per cent on MAT level. While Zydus Cadila (-1

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per cent) was the only company among Top 10 to de-grow on MAT level, on month level only Alkem (-1 per cent) showed de-growth. Many companies in 11-20 bracket showed negative growth with Pfizer (10 per cent) continuing to degrow the most. However, in the same segment companies like Aristo, Torrent, Sanofi, Dr Reddy’s and Glenmark grew positively at both MAT and month level.

Top 10 brands in the IPM clocked a combined valued at

` 340 crores for the month of September 2017 grew at 9 per cent over SPLY. The growth is mainly due to brands like four brands namely Augmentin (28 per cent), Lantus (26 per cent), Spasmo-Proxyvon+ (37 per cent) and Liv-52 (17 per cent) all of which showed a strong double digit growth. Both No.1 brand Mixtard (-1 per cent) and second ranked brand Monocef (-6 per cent) showed de-growth and were the only two brands among top 10 not to grow positively. Augmentin

continued its revived growth with 28 per cent growth over SPLY and gained two ranks to become number three in IPM. A major change in the list of top 10 brands list as compared to August 2017 is exit of Novomix whose place is taken

by Spasmo-Proxyvon+ which gained seven places to be ranked sixth. While Mixtard maintained its top position, Glycomet-GP and Lantus lost two positions each to give the No 2 and No. 3 position to Monocef and Augmentin.

EXPRESS PHARMA

19

November 16-30, 2017

MARKET Brands ranked 11-20 grew much slower at combined growth of 2 per cent where brands like Novomix (-3 per cent), Clavam (-10 per cent), Thyronorm (-5 per cent) etc. showed major de-growth. Only Prevenar-13 (15 per cent), Foracort (10 per cent) and Shelcal (24 per cent) showed a healthy double digit growth.

Indian companies further increased their dominance in the IPM by increasing their share to 80 per cent for the month of August 2017 and grew slightly better than the IPM with a growth of 4 per cent over SPLY. MNCs, however, showed a slower growth at 2 per cent and lost share 1per cent. While Top Indian company Sun Pharma grew only at 1 per cent and slower than IPM, number one MNC Abbott (3 per cent) recorded a like to like growth with the IPM. While many of the top 10 MNCs showed de-growth over SPLY, Pfizer (-10 per cent) and Janssen (-12 per cent) recorded double digit negative growth which has brought down the overall growth of MNCs. Among Indian companies only Alkem (-1per cent) showed degrowth while all other top 10 Indian companies grew positively for the month of September 2017 with Intas Pharma (10 per cent) registering the highest growth.

Chronic therapy, with a growth of 6 per cent, grew three times faster than acute therapy (2 per cent) for the month of September 2017.

Even though acute therapy continues to be larger in size it has lost share as compared to September 2016 and come down by 1 per cent to 67 per cent share in IPM. Anti-infectives maintained its top position for the second consecutive month and was valued at ` 1481 crores making it the largest therapy for the month of September but with a de-growth of -4per cent. Cardiac (5 per cent) continued to be second with a slightly better growth than the IPM. For the second consecutive month Derma (17 per cent) registered a much better growth than anti-diabetic therapy (10 per cent) and was the fastest growing Top 10 therapy in IPM. Cough prepa-

20 EXPRESS PHARMA November 16-30, 2017

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

AugustMonth

Month Growth %

MAT August

MAT growth %

Global pharma market

88,918

2.2

1,091,612

4.2

US

35,493

2.8

452,346

2.3

China

6,809

4.3

77,142

1

Japan

6,479

-6.1

76,926

-2.8

Germany

3,720

8.6

41,199

2.2

France

2,829

9.2

33,238

0.8

Italy

2,304

10.6

28,877

0.6

Brazil

2,288

12.4

24,631

26.1

Uk

1,990

2.5

22,678

-10.3

Canada

1,844

8.3

20,084

4.7

Spain

1,758

9.8

20,947

-0.6

India

1,562

9.4

15,974

6

Australia

1,166

-7.1

12,927

5.8

Russia

1,147

17.5

14,721

27.1

Korea

766

4.8

8809

8.3

TABLE 2: INDIAN COMPANIES’ MARKET SIZE IN THE GLOBAL MARKET All values in Million USD

August Month

Month Growth %

MAT August

MAT growth %

Global pharma market for Indian companies

3,588

7.7

39,324

4.6

Sun Pharma

448

-2.9

5,428

2.4

Lupin Laboratories

329

-3.6

4,112

5.1

Dr Reddys Lab

239

-1.3

3,019

-0.7

Zydus Cadila

237

26

2,196

1.6

Cipla

223

22.2

2,326

25.2

Aurobindo

219

24.4

2,293

-3

Torrent

201

13

2,209

12.2

Intas

201

19.7

2,198

17.1

Glenmark Pharm

157

-0.5

1,828

2.4

Mankind Pharma

123

14.4

1,188

6.3

ration ethicals was the largest therapeutic class 4 segment with a value of ` 185 crores and low growth of just 1 per cent for the month. Only two of the top 10 TC-4s Ceftriaxone Injectables (-12 per cent) and Cefixime Oral Solids (-11 per cent) recorded a de-growth for the month.

Anti-infective therapy clocked ` 1481 crores for the month of September and continued to show de-growth (-4 per cent). However, on month basis it has continued to show revival after some mediocre performance till July 2017 which has led to its demotion to rank two in IPM behind cardiac. While most of the Top 10 molecules continued to degrow, Meropenam (9 per cent) and Amikacin (13 per cent) continued their growth. Also, for the first time in many months Cefuroxime Oral Solids (9 per cent) also showed growth over SPLY. Amoxycillin and Clavulanic Acid Solids continued to be the top molecule in the therapy with a value of ` 122 crores and zero per cent growth for the month of September 2017. Top 10 brands also continued to show de-growth including number one brand Monocef (-6 per cent), however, brands like Augmentin (28 per cent), Ceftum (31 per cent) and Mikacin (21 per cent) grew strongly.

Cardiac therapy continued to be the second ranked therapy in IPM clocking a revenue of ` 1161 crores and a growth rate of 5 per cent as compared to SPLY. The therapy is mainly driven by the growth of combinations (9 per cent) which is growing three times faster than plain molecules (3 per cent) and combinations have also shown increase in share over SPLY. Atorvastatin regained its top spot as the largest molecule with a value of ` 63 crores but continues to de-grow (-10 per cent). Rosuvastatin on the other hand continued to grow positively (4 per cent) but slower than the therapy. Cilnidipine was the fastest growing molecule among Top 10 while Atenolol + Amlodipine (12 per cent) and Amlodipine + Telmisartan (13 per cent) also grew in double digits. All Top 10 brands except Clexane (-9

MARKET per cent) showed strong growth especially MinipressXL (43 per cent), Cilacar (34 per cent), Nitrocontin (30 per cent) and Brilinta (31 per cent) showing growth of more than 30 per cent.

Gastro intestinal therapy has maintained its third position in IPM over last many months and clocked ` 1088 crores for the month and a subdued growth of 2 per cent which is slower than the IPM. For the first time in many months one of the top 10 molecules Ranitidine Oral Solids (7 per cent) registered degrowth while remaining top molecules showed a positive growth with the largest molecule Pantoprazole + Domperidome growing at 8 per cent. Other Dicyclo Combination was the fastest growing molecule among Top 10 with a strong growth of 32 per cent over SPLY. Bacillus Clausii continued to show growth (32 per cent) but its value trend has seen a decline in last two months. Spasmo-Proxyvon+ (37 per cent) maintained its top position for the second consecutive month and also entered into the top 10 brands of IPM for the month of September 2017. Among top 10 brands Aciloc (-10 per cent), Rantac (-2 per cent), Pantocid (-6 per cent) and Duphalac (-6 per cent) were a few brands to show negative growth.

Anti-diabetics clocked revenue of ` 918 crores for the month of September 2017, which grew in double digits (10

OVERVIEW OF IPM

● IPM was valued at ` 115,578 crores and the retail sector was valued at ` 97,406 crores as of MAT Sep’17 ● On a MAT level, IPM has grown by 4.2 per cent at TSA and 4.6 per cent at SSA. On month,TSA has grown by 3.4 per cent and SSA has grown by4.5 per cent

SNAPSHOT OF TOP 150 COMPANIES

● Top 10 companies constitute ~ 43 per cent share of IPM on MAT and Month basis. ● The top 150 companies continue to account for 97 per cent of IPM on MAT and month basis. ● For both MAT and month,Top 20 companies contribute to ~64 per cent ● On a MAT basis, highest growth can been seen in the companies ranked between 31-40

per cent) over SPLY. However, its growth is much lesser as compared to usual 15 per cent+ growth seen over the last many months. This is mainly due to many top molecules like Glimepiride + Metformin (8 per cent), Inter + Fast Acting Insulin (7 per cent) etc. showed a single digit growth over SPLY along with de-growth Metformin (-4 per cent).

Among DPP4 Inhibitor molecules Teneligliptin and Combination recorded a strong growth of 45 per cent over SPLY while Sitagliptin (-2per cent) was the only molecule top show de-growth. SGLT-2 Inhibitors continued to be the most progressive segment in the therapy with an 85 per cent growth over SPLY. Two of the Top 10 brands of the therapy Mixtard (-1 per cent) and Novomix (-3 per cent) which are insulins have recorded degrowth while other Top brands like Lantus (26 per cent), JalraM (21 per cent) and Istamet (15 per cent) showed strong double digit growth.

Dermatology for the second consecutive month grew faster than anti-diabetes with a growth of 17 per cent over SPLY. It clocked a revenue of ` 806 crores and was ranked eighth in the IPM for the month of September 2017.

Emollients remains the largest sub category within the therapy with a strong growth of 15 per cent. Most of the Top 10 molecules showed a strong double digit growth of which Luliconazole (211 per cent)

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EXPRESS PHARMA

21

November 16-30, 2017

MARKET grew the strongest along with Itracoazole (75 per cent) and Clobetasole+ Ofloxacin +Ornidazole + Terbinafine (91 per cent) also showing strong growths. However, two molecules in Top 10 showed degrowth which are Beclomethsone + Neomycin + Clotrimazole Combination (-6 per cent) and Terbinafine (-1 per cent). While number one brand Betadine (0 per cent) showed stagnancy in growth 8 per cent, other top 10 brands like Panderm+ (103per cent), T-Bact (119 per cent) and ITMac (98 per cent) recorded a tremendous growths.

TRENDS IN ACUTE AND CHRONIC THERAPIES

Global (August 2017) The global pharma market is valued at $ 1091 billion growing at 4.2 per cent. The US continues to dominate the market with 40 per cent market share with growth of 2.8 per cent.

Amongst the top market, India has notched up and is ranked 11th. Only market in the top markets with more than 10 per cent growth are Russia, Brazil and Italy. Japan and Australia are the only de-growing top markets as per August 2017 data.

● Acute therapies continue to dominate the market constituting 67 per cent of the IPM while chronic therapies have grown more for the month. ● The top TC4 in the IPM is Cough Prep. Ethicals with the a value growth of only 1 per cent

Indian companies hold 4 per cent share in the global market as per August 2017

data. For the month of August 2017, the IPM showed growth and among Top 10 companies,

only Cipla and Aurobindo showed more than 20 per cent growth. Top 10 companies con-

tribute to 66.4 per cent market share among Indian companies in the global market.

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cover )

By Swati Rana

24 EXPRESS PHARMA November 16-30, 2017

(

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THE MAIN FOCUS

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cover ) Q

uality assurance (QA) in pharmaceuticals is a wide concept covering all matters that individually or collectively influence the quality of a product. It ensures that pharma products are of certain required quality for their intended use. QA is also a part in pharmacovigilance (PV), which is concerned with identifying the hazards associated with pharma products and with minimising the risk of any harm to patients. A robust PV QA department in place can increase the overall growth of the pharma company. Global players like the US and the EU have made rapid and far reaching progress, whereas, Indian pharma industry is lagging behind. Indian mid segment/ generic pharma companies started late with their PV set ups and few of the companies are still contemplating. With the newly drafted Good Pharmacovigilance Practice (GPVP) guidelines for Indian pharma industry by Central Drugs Standard Control Organization (CDSCO), it is expected that PVQA in India would be more heard of and/or practiced, in India in the near future.

Is quality assurance system in place?

The quality of medicine has been a major concern in the pharma industry. There has been a growing awareness on the significance of quality of pharma products. QA plays an important role in the development of products and services in pharma and biotech, as part of GMPs (Good Manufacturing Practices).

Dr J Vijay Venkatraman, MD and CEO, Oviya MedSafe, speaking on the concept of QA in pharma industry says, “There is no doubt that the pharma industry is growing by leaps and bounds. However, I feel that the domain of QA and its capability to augment the industry’s success is not wellunderstood. Rather, the rest of

26 EXPRESS PHARMA November 16-30, 2017

The greatest challenge is finding suitable auditors for PV QA. It is not enough to convert a former GCP auditor to a GVP one without providing them sometime in a PV operations role Dr Sameer Thapar, Global Pharmacovigilance Director, Oracle Health Sciences Consulting

A very stricter /stringent oversight by the Regulatory Authority and demand for GXP compliance alone would ensure standard quality medicine in the market. The presence of sub standard, adulterated /spurious medicines in the market is well known Moin Don, President and CEO, PVCON

PV QA departments, on an average, are prepared to cope with favourable outcomes only. There is an unreasonable fear of negative outcomes and due to it, a professional approach to put up Corrective And Preventive Actions (CAPAs) is lacking Dr J Vijay Venkatraman, MD and CEO, Oviya MedSafe

A robust pharmacovigilance system needs to be rigorously followed by all pharmaceutical industries. We need to have an integrated approach for developing a robust Pharmacovigilance system. As such the pharma industries and the regulatory authority must work together for patient safety Dr V Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission

Quality Assurance in PV is still in its infancy stage, it will soon become an integral part of the PV process. As expectations of the regulators keep increasing, industry has to step up and match the expectations if they want to stay relevant in the industry Dr Ranjana Pathak, Global Head, Cipla

the industry tends to consider that adherence to quality norms lessens their speed and cost-effectiveness, without realising that having a robust QA department in place will be the first step to protect the organisation and in turn the whole industry in the long run.”

Unfortunately, the term QA is considered with regulatory compliance. While QA deals with regulatory compliance, compliance is just a part of QA. If QA activities are performed as a mere compliance exercise, the purpose of QA is defeated. Another problem is that the needs of QA departments are often treated as low priority and are the first to get impacted during cost-cutting initiatives.

Explaining the current scenario of PV QA, Dr Venkatraman further says, “QA plays a very important role especially in PV. However, PV QA departments, on an average, are prepared to cope with favourable outcomes only.

There is an unreasonable fear of negative outcomes and due to it, a professional approach to put up Corrective And Preventive Actions (CAPAs) is lacking. Added to it is the fact that QA is seen not as a ‘need to have’ part of the process but as a ‘good to have’ one. Having said so, the awareness of these findings is much better than before and I feel it can only bring us more progress.”

Dr Ranjana Pathak, Global Head, Cipla believes, “QA in PV is still in its infancy stage.

It will soon become an integral part of the PV process. As expectations of the regulators keep increasing, the industry has to step up and match the expectations if they want to stay relevant in the industry.”

Moin Don, President and CEO, PVCON says, “QA is a very broad field, encompassing all GXP (GMP,GLP.GCP, GVP,GDP etc.) domains. While QA has been always an evolving and dynamic science, I would like to restrict myself to my area of expertise that is PV

( and GPvP. The Indian generic pharma companies always (erroneously) considered PV obligations to be responsibility of multinational innovative companies. In addition, the PV set up has been always considered as ‘Cost centre’ without ‘Return On Investmant (ROI) by the senior management and never got the type of support, it required.”

PV practice Recently, the health ministry has mandated pharma companies to set up PV department to monitor the safety and quality of authorised pharma products. The Pharmacovigilance Programme of India (PvPI) has been very successful in bringing about a sea change in the PV scenario in India. Due to PvPI, India became the seventh largest contributor to the Uppsala Monitoring Centre's (UMC) drug safety database (Vigibase). But, what was more important was that PvPI demonstrated appreciable quality in terms of completeness of the Individual Case Safety Reports (ICSRs) reported to UMC (0.94 out of 1).

In fact, PvPI has a separate quality review panel in addition to the signal review panel and core training panel.

“PvPI has recently launched the Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAH) of Pharma Products in India which has a dedicated module for quality management system. It provides exhaustive information on PvPI’s expectation in terms of quality from a MAH. Moreover, PvPI conducts skill development programmes for their staff as well as for interested professionals which is a very important step towards better QA of drugs in India,” says Dr Venkatraman.

“PV in some countries is making in roads and hence not fully understood. However, PV is essential to ensure the safety of the patient particularly in relation with adverse events of a drug/device on the patient. PV is also going to ensure better

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and long standing usage of a particular drug on an uncontrolled environment with and without co morbidities etc,” says Dr Pathak.

Speaking on the various initiative taken by PvPI, Don

says, “To the credit of PvPI, it must be said that with more than 200 AMCs throughout India, and various initiatives taken, PV is reaching to people/places which was earlier not thought of. The implemen-

THE MAIN FOCUS

tation of GPVP guidelines would not only strengthen the PVQA but would also add to the understanding and realisation of MAHs about their ultimate responsibility towards patients’ safety and well being

which of course can be achieved through overall robust QA system.”

Challenges Today’s pharma business is generally global. Hence, hav-

cover ) ing locally acceptable standards alone will not guarantee growth of a concerned organisation. However, there are problems in living up to global standards because there is considerable variation in the standards followed in one region as opposed to another.

“Having a QA system that will serve as a ‘Common Minimum Programme’ in terms of global compliance and therefore global quality. This is one of the primary challenges. In the context of PV, a significant challenge is that there is a lack of expertise in differentiating Product Quality Complaints (PQCs) from Adverse Events (AEs) or Lack of Efficacy (LoE) cases. This is one area where proper understanding of PV and having a proper PV QA system in place will have a direct positive impact on the overall quality of a pharma product manufactured or marketed by a given company.

This is a priority area that deserves the attention of the top managements in pharma,” says Dr Venkatraman.

According to Dr Sameer Thapar, Global Pharmacovigilance Director, Oracle Health Sciences Consulting, the greatest challenge is finding suitable auditors for PV QA. It is not enough to convert a former GCP auditor to a GVP one without providing them sometime in a PV operations role. He says, “PV is a

28 EXPRESS PHARMA November 16-30, 2017

Today’s pharma business is generally global.

Hence, having locally acceptable standards alone will not guarantee growth of a concerned organisation. However, there are problems in living up to global standards because there is considerable variation in the standards followed in one region as opposed to another process-based domain, where one task can be repeated but with a slight variation each time. Take for instance, the Medical Review function. It is rendering a consistent judgement on subjective criteria.

Two judgements may have the same end result, but could be derived from two differing viewpoints. Also, in this process-based domain, checklists, such as ones used for other GXP audits, rarely are beneficial. There are many governing factors on operational decisions, from appeasing regulations to nuances brought by previous external inspections. It is mandatory for anyone entering the PV QA area to realise these criteria and to spent time in or around the operational analytics to fully be able to render a good GVP audit.”

Speaking from the PvPI perspective, which also plays an important role in the qual-

ity assurance of the medicine and what are the challenges faced by the sector, Dr V Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission says, “Lack of skilled PV manpower is a major challenge faced by the pharma industry. In line with Prime Minister’s Kaushal Vikas Yojana (PMKVY), Indian Pharmacopoeia Commission has started a skill development programme on 'Basics and Regulatory Aspects of Pharmacovigilance.'” Thus skilled manpower can be utilised for the establishment of a sustainable PV system in pharma industries.

“There are numerous challenges in the industry, from trained people up to clarity with regulations and everything in between. Today’s consumer is much more savvy, they expect more from the manufacturers and technology often is ahead of regula-

tion, for example novel therapies (growing skin, organs etc), the regulations have not been developed as yet,” says Dr Pathak.

Required measures “A robust PV system needs to be rigorously followed by the pharma industry. We need to have an integrated approach to develop a robust PV system. The pharma industry and regulatory authority must work together for patient safety,” suggested Dr Kalaiselvan.

According to Don, a very stricter /stringent oversight by the regulatory authority and demand for GXP compliance alone would ensure standard quality medicine in the market. Presence of sub standard, adulterated /spurious medicines in the market is well known. With access to advanced technology and processes, this nefarious activ-

ity can be significantly curbed given the political will, that is required.

Dr Venkatraman, says, “Quality has to be ensured right from the stage of BA/BE studies in case of a generic product and from the stage of clinical trials in the case of an innovative drug. While clinical trials are quite well-regulated, BA/BE studies are still riddled with questions on their reliability. We may recall that this has led to product withdrawals following analyses of BA/BE data by foreign regulators. Similarly, GMP deviations keep getting identified during regulatory inspections.

Therefore, the focus on quality research and quality manufacturing has to be improved.”

He also suggested that doctors and other healthcare professionals need to be motivated to report PQCs and/or AEs without hesitation so that the real adverse effect load of any drug in India can be assessed.

With the launch of the PV Guidance Document for MAHs in India which is to be effective from January 2018, the industry now has a higher level of commitment to patient safety in the form of a governmental obligation. Enforcing rules with proper conduct of PV audits and inspections will be the next level in augmenting patient safety in India. swati.rana@expressindia.com

MANAGEMENT INSIGHT

Is it too early to talk of global health?

Global ill-health can render even health-secure nations vulnerable in a seamless world. An insight

by Bharathi Ghanashyam, Founder & Editor, Journalists against TB

www.glatt.com

Process & Plant Engineering

TWO MAJOR international health conferences were held in the past few months where some of the best brains from across the world converged to share the latest research and significant achievements in the healthcare sector. In these conferences, global health also came up for discussion. It was exciting to be part of the discussions as it held out hope that ‘health for all’ across the world, might soon become a reality.

Ironically, at the same time, in Jharkhand, in India, there were reports of people dying of hunger because their Aadhaar Cards were not linked to their ration cards. This meant they did not get their monthly quota of subsidised food-grains from the public distribution system (PDS). To state the obvious, food is a vital and indeed the most basic requisite for health. Juxtaposed against the discussions on global health, the hunger deaths were stark reminders of how far we are from achieving global health, and how many obstacles were yet to be overcome. That there are still people in the world who are denied access to a very basic resource such as food highlighted the inequities that can render any discussions on global health empty rhetoric.

But let’s begin at the beginning.

Equity and otherwise The most commonly accepted definition of global health is the

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November 16-30, 2017

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MANAGEMENT “…health of populations in the global context; it has been defined as "the area of study, research and practice that places a priority on improving health and achieving equity in health for all people worldwide…” – Koplan JP, Bond TC, Merson MH, et al. (June 2009).

Definitions notwithstanding, in place of equity in health, we have two realities – one for the developed and another for the developing world. It begins with birth, continues into life and living, and ends with death. In place of health for all, what we have is actually a patchy, uneven and even unjust palette.

We begin with equity which we cannot take credit for; it is the order of the Universe - every living being - plant, animal or human, goes through the cycle of birth, life and death. The inequities begin after that. Developed countries, having achieved health for all are finding ways to conquer diseases like cancer, or finding ways to enable better

quality of lives for ageing populations because they are living longer. Developing nations are still struggling to gain victory over vector borne and water borne diseases, and other basic issues such as safe drinking water and food for all.

Through the life cycle It begins with birth – there are countries in the world where it is possible for every woman, regardless of whether she is living with diabetes, hypertension, HIV or cancer, can dream of safe motherhood because the medical system guarantees them access to the best healthcare. In others, even otherwise healthy women often don’t survive childbirth simply because they did not have access to quality care. The world is a safe place for babies born in the developed world, and an obstacleridden place for babies in developing countries, where they have to defy great odds to live beyond their fifth year.

Life for those in developing countries is a struggle all the way. Shelter, assured livelihoods, adequate nutrition and primary healthcare, which constitute the requisites for a healthy and productive life are a dream for large sections of developing countries. Little wonder than that end of life too is fraught with inequity.

Pessimism or hard talk?

This piece might be painting a grim picture, but it is important to recognise that while global health is a good goal to aspire to, it is difficult to achieve. It takes a lot more than coming together to discuss it.

Why does this situation exist? Why do some countries make such good progress while other leave large sections of their people behind? Is it size? Is it huge populations belonging to hugely varying economic strata?

If yes, then it confounds because theories abound about the ease of working to scale. Why is that

not applicable to health?

In a somewhat conceptual, even philosophical article such as this, it might be out of place to talk figures and data. But the answers might just lie in allocation of resources, percentage of GDP and political will. Inequities exist here too – while there are countries which invest as much as 11 per cent of GDP or more on health, there are countries which spend as little as 2 per cent, and grudgingly at that.

Little wonder then that global health is proving hard to achieve.

What mechanisms do we have in place to change the situation? It is yet another anomaly that for an issue as vital as health, we have soft options to bring the world together. With an issue that concerns the wellbeing of millions of people we only have declarations, pledges, commitments etc. etc. There are absolutely no actions that can put errant nations on the carpet. By the same yardstick,

we show collective paranoia while policing nations that supposedly (or in reality), build or stock nuclear weapons. We impose sanctions and isolate these nations to keep them in check, when in reality it is not nuclear war but disease that will kill more people.

In conclusion, global ‘illhealth’ is a bigger worry than the lack of global health. Because global ill-health can render even health-secure nations vulnerable in a seamless world.

TB is a classic example. The refugee situations across the world, people travelling across borders on business and holidays provide an ideal situation for the disease to spread. No country is really safe in this context and it is only ‘global health’ in the real sense than can help. The cost of not getting tough on health is too high.

So the discussions that have begun are relevant and timely.

They need to be amplified and converted to action.

REPORT

The global negative pressure wound therapy market set to reach $1.3 bn in 2024 According to GlobalData, NPWT market growth will be driven primarily by increasing awareness of the technique and its various applications THE GLOBAL negative pressure wound therapy (NPWT) market, valued at $1.2bn in 2017, is expanding at a Compound Annual Growth Rate (CAGR) of 2.1 per cent and is forecast to reach $1.3 bn in 2024, according to GlobalData, a leading data and analytics company. Disposable NPWT devices are expected to increase at a CAGR of 8.3 per cent during the forecast period.

The company’s research reveals that NPWT market growth will be driven primarily by increasing awareness of the technique and its various applications. Stand-alone devices are expected to see steady sales in the global market, due to the higher availability of clinical

30 EXPRESS PHARMA November 16-30, 2017

data demonstrating their efficacy; however, portable devices

are expected to see relatively fast growth due to an increas-

ing patient preference for lightweight, discreet NPWT devices.

NPWT, sometimes referred to as topical negative pressure therapy or vacuum-assisted wound closure, is an advanced wound management technology that is being used in the treatment of both acute and chronic wounds. The treatment uses a vacuum suction device coupled with a wound dressing to promote wound healing and closure, as well as draw bacteria and foreign debris from the wound.

Disposable, or single-use, NPWT devices represent an emerging technology in this space that is expected to see rapid adoption in all countries

where they are launched. The adoption of these disposable devices will be primarily driven by their drastically reduced costs and expanding indications, including surgical incisions.

A spokesperson from the GlobalData Healthcare Analyst team, commented, “Despite the high cost associated with NPWT, physicians recognise the clinical benefits that it can provide over conventional techniques. As the education of physicians improves and they gain access to more robust clinical data, the outlook for the NPWT market looks strong, with room for further product improvement with next-generation devices and accessories.”

EP News Bureau

RESEARCH I N T E R V I E W

‘We strive to change the way medical treatment is practised across the world’ Dr Sanjeev Saxena, Founder and CEO, POC Medical Systems in an interaction with Viveka Roychowdhury, gives information about low cost tests to screen various cancers, which will be launched in the Indian market shortly

Point-of-care testing (POCT) is very common in management of blood glucose levels as part of diabetes care. What are the other disease conditions that are now being or could be managed with such diagnostic platforms?

We are currently focussing on launching ‘MammoAlert’ for breast cancer screening.

However, going ahead, we expect to develop such early screening and low-cost tests for other cancers like prostate, ovarian, cervical, lung, liver etc.

Further, we also expect to develop tests for cardiac screening and infectious diseases like TB, typhoid, dengue, STDs, ebola etc.

What is the science behind POC Medical Systems' MammoAlert and the Pandora CDx microfluidicsbased platform?

The Pandora CDx developed

by POC Medical Systems is a microfluidic platform for rapid, point-of-care serum testing. It is based on a unique, low cost disposable microfluidic disk. The platform is very simple and easy-to-use system.

MammoAlert is the first product based on this technology. This portable breast cancer screening test, which runs on Pandora CDx technology, uses a few drops of blood from a finger prick to generate results in 20 minutes. It uses multiple cancer markers for high accuracy.

In India, we are also looking at different market sectors namely government through NGOs, door-to-door screenings, private sectors for CSR initiatives, certified diagnostic labs etc Simply put, An instrument which is the size of a CD player: 1. A microfluidics disk, where the reaction takes place between the blood and the reagents 2. The chemistry which consists of various reagents already prepared and loaded on the disk, so no human interaction is required in the field except for loading of blood 3. The software which records and analyses the data that can be accessible from any location to a doctor and a report automatically post the test.

So, the instrument which is called the Pandora CDx (runs on rechargeable batteries) that can be taken to any village or in any neighbourhood or can be run in any lab or doctor’s office with minimal training.

The way it works is as

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follows: ◗ The technician or operator enters patient’s information on a tablet ◗ Pricks the patients finger with a lancet ◗ Applies the blood to the inlet in the disc where the blood has to be inserted ◗ Selects the test and presses ‘Enter’ ◗ The test is then performed on its own and the results are displayed and displayed/ printed within 20 minutes.

The disk is then removed from the Pandora CDx and disposed ◗ All the results are maintained on cloud for further research and reference So, you have microfluidic channels where you have the antibodies already conjugated on beads and pre-loaded into these micro channels. When we put in a drop of blood, it attaches to that and incubates

very quickly because we are dealing with very small samples. It then migrates to another chamber which has a separation median so that the HPLC equivalent is done right there. Because the disk is spinning at a high rpm, the separation takes place right there and blood cells get separated out. At the end of the chamber, you have detection of the fluorescence.

Everything that you are doing outside, you are doing in this little disk itself. That is why you are able to automate the whole process, and you do not need any trained personnel to do it.

How can POCT as a diagnostic domain, be applied in a viable and sustainable manner, to improve public health, especially in resource poor countries like India where access to medical care is

poor? What is the business model to make it viable for companies like POC Medical Systems, which also have to meet investors’ expectations?

I agree, that for a huge country like India, the health accessibility (physical, economical, technological) is the biggest roadblock. It has been proved that existing technologies for breast cancer screening/ detection (mammography) in India has limitations, e.g. geographic inaccessibility, inconvenient, long test-to-result-time, high cost, requirement of trained personnel, and high false positive rate, personal discomforts, etc.

As per WHO statistics, every seven-minute one woman succumbs to breast cancer in India, and if we want to fight this dreadful disease, we need to adopt a disruptive technology like POCT. We, at

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RESEARCH POC have internalised the vision to change the way cancer is perceived across the world, we would like to ‘kill the fear of cancer’ by early screening/ detection.

Second biggest challenge is low awareness level. We are planning various public education activities to reach out to the masses. Various awareness initiatives like group activities, seminars, workshops are being planned out which will not only be targeted at the women audience but also their family members, so that everyone is made aware of the grave situation and the possible solution. The idea is to provide low-cost solutions to those, who need it the most.

We strive to change the way medical treatment is practised across the world, moving it away from symptom-based treatment to diagnostic/data-based treatments. We are confident of achieving our end goals i.e. ‘erasing fear of cancer’, as early detection means better cure rates. We will also take help of NGO’s and government bodies to reach the masses.

Business model As mentioned in the last paragraph, we cannot achieve this herculean task without the help of government bodies,

NGOs and corporates. We will concentrate on one state at a time and have approached state governments for their support and participation.

Which disease conditions has POCT been applied to in a public health setting?

As mentioned above, we are about to launch our test for breast cancer screening in a couple of months. However, going ahead, we expect to develop low cost tests for other cancers like prostate, ovarian, cervical, lung, liver etc.

Further, we expect to also develop tests for cardiac screening and infectious diseases like TB, typhoid, dengue, STDs, Ebola etc. In time, we also expect to develop tests for water-borne pathogens and food tests.

These will all be low cost tests, which will be affordable to all strata of society.

What has been the response to MammoAlert since it’s unveiling in India in March 2018? Is it available outside the MoH&FW's scheme?

After unveiling, POC team concentrated its efforts on procurement of quality certifications and clinical validation studies.

With respect to availability of the product, we are still in

We will concentrate on one state at a time and have approached state govts for their support and participation discussions with various state authorities and will be able to give details of the same at the time of launch.

What is the cost per test per woman? What are the funding strategies?

Each CD is equipped to test 10 samples and POC is planning to offer these tests in the Indian market at a very affordable cost. The final costings are yet to be reached, but we believe that we will be about 1/5th the cost of mammography.

What is the status regarding the validation studies in India?

In addition to earlier conducted

clinical studies in the US, with support of world renowned breast cancer expert, Dr Raghuram Pillarisetti, we are conducting clinical validation studies at following study centres across India: 1. KIMS Hospitals - Andhra Pradesh 2. Amrita Institute of Medical Sciences and Research Centre - Kochi, Kerala 3. Basvatarakam Indo American Cancer Hospital and Research Institute Hyderabad 4. HCG MULTI Specialty Hospital HCG Cancer Center Ahmedabad 5. Manipal Hospital Bengaluru 6. Maulana Azad Medical College University of Delhi & Associated Lok Nayak Hospital - New Delhi 7. Tata Medical Center – Kolkata What are the regulatory certifications necessary for such diagnostic platforms?

Where does MammoAlert currently figure in terms of certifications etc?

In India, the regulatory path for IVD devices is guided under non-invasive devices and the Pandora CDx falls under this category.

However, we have already acquired a CE certification from Europe. CE marking on a

product indicates to all authorities that the product is in compliance with essential health and safety requirements of all directives that apply to the product and also the requirement needed for commercialisation in India.

What kind of tie ups are you looking for to improve the impact of MammoAlert in India? Which are the other resource strained countries and communities that your company is targeting to launch the test?

We are about to launch Pandora CDx technology in a couple of months. In India, we are also looking at different market sectors namely government through NGOs, door-to-door screenings, private sectors for CSR initiatives, certified diagnostic labs etc.

Over the period, this product will also be made available to other countries in Africa, China, Europe and the US. The product has already generated huge interest from all over the world. As a matter of fact, every day we receive emails from countries like Africa and Europe asking when the system will be available in their countries. viveka.r@expressindia.com

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EXPRESS PHARMA

November 16-30, 2017

Email your contribution to: The Editor, Express Pharma, Business Publications Division,

The Indian Express (P) Ltd, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021.

Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 viveka.r@expressindia.com

RESEARCH I N T E R V I E W

We have to work together through multi-sector partnerships and collaborations to tackle TB Johnson & Johnson (J&J) recently entered into a partnership with the Institute of Microbial Technology (IMTECH), part of the Council of Scientific and Industrial Research (CSIR), to accelerate the discovery of innovative new treatments for tuberculosis (TB). Sanjiv Navangul, MD, Janssen India and Dr Anil Koul, Director, CSIR-IMTECH, give more details about the project and its objectives, in an interaction with Lakshmipriya Nair The WHO Global report released in 2016 places India at the centre of the global TB crisis with an estimate of 2.8 million patients. How will J&J’s MoU with CSIR-IMTECH help forge a tool to deactivate this ticking time bomb?

Under the Memorandum of Understanding, scientists from Johnson & Johnson’s global public health team will work closely with scientists from CSIR-IMTECH, on a research and development programme to explore potentially more effective, safer, all-oral treatment regimens to tackle multidrugresistant TB (MDR-TB), as well as new molecular entities to treat all tuberculosis (TB) patients.

Can you give us more details on the role of the stakeholders in this project?

Dr Anil Koul: IMTECH has world class TB research including state of art facilities. J&J has been involved in TB research for past 17 years and been successful in bringing new drug to patient of MDR-TB, Bedaquiline, which has been approved in 45 countries till date, including India which is home to more than quarter of the global TB

population. By bringing the best of India TB drug discovery scientists, with a global team of expertise in pre-clinical and clinical drug development at J&J, we aim to deliver on national strategic goal of ‘Ending TB by 2025.’

CSIR-IMTECH as a potential discovery R&D partner can provide expertise in areas of bacterial energy metabolism - which is the target of combo therapy and all four targets work on the idea of synergistic combinations using bedaquiline as backbone. Johnson & Johnson will provide its broad preclinical and clinical development resources and experience. MDR-TB is a global threat and we are committed to develop new drugs and solution for treatment of this dreaded disease including in patients with HIV where this drug regimen will be compatible with all HIV medications. No drug-drug interactions are envisaged at this moment either with known HIV drugs are drugs against diabetes.

This partnership aims to explore a treatment regimen to tackle MDR-TB. How it would help India achieve its goal of ending TB by 2025? How close are we towards the discovery of

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November 16-30, 2017

RESEARCH innovative new treatments for TB? TB remains a significant challenge to India. While we have made great advances in recent years with the approval of new TB medicines, we realise that eliminating TB will require significant additional R&D into new drugs that could allow us to create novel combinations of shorter, more effective, safer, and all oral treatment regimens for MDR-TB. By bringing together some of India’s brightest minds with our scientists, Johnson & Johnson’s partnership with CSIR-IMTECH will help advance the potential of Indian science and help accelerate the discovery of innovative new treatments for TB. The partnership will work on four new drugs to develop a universal regimen for TB. We hope the first human trials will commence in 2019.

It has been over a month since the MoU was signed. Can you give us an update on the progress of this partnership?

Can you give us some details on the investment on this project and its deployment?

We are exchanging detailed discovery plans and identifying roles and responsibilities. In the coming weeks, a delegation from of Janssen scientists will be joining their colleagues at IMTECH to have a face to face kick off of the collaboration.

As a company which has a wide experience in TB research and development, can you tell us about the major strides that we have made in this sphere till date?

The partnership with CSIRIMTECH builds on nearly 20 years of TB research and development by Johnson & Johnson, which led to the approval of bedaquiline, the first new TB medicine in nearly 50 years, and adds to existing partnerships at central and state levels in India to increase awareness, diagnosis and care, and broaden access to bedaquiline.

In March 2016, Janssen India and the Revised National Tuberculosis Control Program announced a Conditional Access Program (CAP) to

34 EXPRESS PHARMA November 16-30, 2017

The partnership will work on four new drugs to develop a universal regimen for TB; we hope the first human trials will commence in 2019

We aim for an universal, oral and HIV compatible new drug regimen. The idea is to work on synergistic combination of drugs with bedaquiline

SANJIV NAVANGUL MD, Janssen India

DR ANIL KOUL Director, CSIR-IMTECH

provide bedaquiline free-ofcharge for 600 patients across six sites in India. In April 2017, it was confirmed that the CAP would be expanded to additional TB patients across 156 sites.

What are the gaps in the current TB regiment that the project aims to plug?

Dr Anil Koul:We aim for an universal, oral and HIV compatible new drug regimen.

The idea is to work on synergistic combination of drugs with bedaquiline. This

potential collaboration aims to develop a completely new drug regimen for TB with: 1. University treatment regimen, that can be used for treatment irrespective of background resistance profile and eliminates the need for drug -resistance testing, 2. A significantly shorter treatment duration, 3. An all oral combo therapy and that removes injectable and reduces pill burden, 4. Better safety profile.

What are the major

challenges and roadblocks that hinder TB research in India? What are the concerted steps needed to boost research and build on the existing knowledge base?

Dr Anil Koul: TB is a complex disease and we have a responsibility to work together through multi-sector partnerships and collaborations in the TB community to tackle this challenge. The Indian scientific community excels at early-stage research. We need to complement these

strengths and bridge more concretely between discovery research and translational medicine development processes. This can be done through targeted capability building and a strengthened clinical research infrastructure.

We hope our collaboration will build on early-stage research excellence in India and maximise expertise and resources from both the public and private sector to develop new, effective treatments for this deadly disease. lakshmipriya.nair@expressindia.com

RESEARCH UPDATES

FDAapproves Gilead cancer gene therapy Gilead’s Yescarta, to be administered just once to each patient, would cost $373,000 US REGULATORS approved a new therapy for a type of lymphoma, which was developed by Gilead Science’s Kite Pharma, marking the second approval for this potentially revolutionary approach to fighting cancer.

The Food and Drug Administration approved the gene therapy, to be sold under the name Yescarta, to treat adults with large B-cell lymphoma, a type of non-Hodgkin lymphoma, who have failed

to respond to other treatments.

Gilead, which recently acquired Kite Pharma, said the list price for Yescarta, which is to be administered just once to each patient, would be $373,000.

The price is well below that of the first drug in this new class – Novartis' $475,000 Kymriah. The Novartis gene therapy was approved in August for Bcell acute lymphoblastic leukemia, the most common form of childhood cancer in the US. Both are chimeric antigen receptor Tcell therapies, or CAR-Ts, which reprogramme the body’s own immune cells to recognise and attack malignant cells.

The high price of CAR-Ts is igniting a new debate over the rising cost of prescription drugs. Novartis said it would

charge for Kymriah only if patients responded within a month of the treatment, but Gilead is not following suit.

“We are in ongoing and active discussions with payers, and we have communicated our openness to considering different solutions that improve patient access,” Gilead spokeswoman Amy Flood said.

She said the price was set following extensive research with both government agencies that reimburse for drug costs and private insurers, and cancer centres.

Jefferies analyst Michael Yee said Yescarta could generate sales of up to $250 million in 2018. Gilead said about 7,500 lymphoma patients each year in the US would be eligible for CAR-T therapy.

The American Cancer Society estimates that 72,240 people will be diagnosed with non-Hodgkins lymphoma this year and 20,140 people will die from it. This type of lymphoma accounts for about 4 per cent of all cancers in the US. Potentially curative CAR-T therapies are poised to revolutionise blood cancer treatment, offering therapies tailored to the individual patient.

The treatments are made from a patient’s own infection-fighting cells. They are extracted, genetically engineered to recognise cancer cells, and infused back into the patient, where they form an army to attack and destroy malignant cells, potentially for years.

“Gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer,” FDA Commissioner Scott Gottlieb said in a statement. In a pivotal clinical trial of more than 100 adults, 51 per cent of patients treated with Yescarta achieved complete remission, far higher than what is typical with current standard-of-care treatments.

Reuters

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November 16-30, 2017

PHARMA TECHNOLOGY REVIEW INSIGHT

Transforming life sciences with AI and automations Dr Sameer Thapar, Global Pharmacovigilance Director, Oracle Health Sciences Consulting, talks about the need to deploy technology to improve efficiency in the lifesciences sector

M

any previously labour intensive functions in healthcare and life sciences are now becoming commoditised with the aid of technology. Digitisation of data elements is allowing health professionals to utilise technology to assist in the management of activities.

Deploying a database is the first step to raise the level of efficiency that a healthcare organisation experiences from baseline. Most solutions today have the means to raise the standards of efficiency within the organisation. This is done when workflow best practices and automation configurations are implemented in line with the deployment.

The result of these implementations is to transform the organisation beyond the realm of industry best practices.

There are new tools available to healthcare professionals to overcome the increasing demands that they face on resources and budgets in the management of routine activities, such as implementations of automation, use of intelligent bots and data mining tools. These are just few of the more commonly deployed from the list of known technology. All can immediately be leveraged to elevate the organisation from operating at an industry best level to a transformational one.

Automation is the buzzword of this year but in-depth understanding of the components that make up automated processes is not known well. Automation is simply ap-

36 EXPRESS PHARMA November 16-30, 2017

plying rule-based algorithms to tasks. If a task is repetitive and non-changing, then it is a good candidate for automation. Automation is an excellent modality for data mining activities. Big Data has the challenge of discovery of pertinent elements. Up till recent advanced in big data mining using automation, it has been a laborious task to sieve through the records using various algorithms at each pass through. Automation is sometimes used interchangeably with Artificial Intelligence (AI) and this is not accurate.

As mentioned, automation is rule based whereas artificial intelligence is machine learning. AI is allowing the computer, database, or machine to process and deploy algorithms as it sees fit. The machine is 'fed' data and 'learns' from it. It then applies this learning to other similar tasks. If it experiences an outlier, a piece of anomalous data, it deploys a best fit for that, therefore an 'intelligence'. According to Forrester Research i, investment in Artificial Intelligence (AI) is expected to triple this year.

Tech giants such as Google, Microsoft and Amazon are already tapping the potential of machine learning with inventions like Home, Cortana and Alexa.

In order for AI to operate well, it needs to mine data at an exponential rate. Large data sets in the trillions of bytes have to pass through the AI machine for it to grasp and

formulate its rules and algorithms. For healthcare and life sciences domain, the need for real-time data mining is crucial. It is not advantageous in these domains to shift through data elements as a backlog activity. Actionable insight is always on elements being generated in the present. However, this has been constrained by technology and labour requirements. But if technology could be upgraded along with the near elimination of labour resources, we would have an automated data mining system.

Such a system is in its early stages at the FDA. The FDA Data Mining Council (DMC) was formed in 2007. The DMC is collaborative and explores methods and best practices recom-

mended by experts from other federal agencies, industry, and academia—all of whom have analogous experience in knowledge discovery through various data mining approaches.ii The council serves as a forum for FDA scientists to share their experiences and challenges in analysing data contained in the vast databases the FDA maintains, as well as to discuss new methods for such analyses. The FDA currently receives approximately two million adverse event, use error, and product complaint reports each year from consumers, healthcare professionals, manufacturers, and others.

Since the early 1990’s, FDA has advocated data mining to the industry in an effort to

better understand the signals within the safety data. Now, FDA data mining experts have expanded their attention to adding more sophisticated data mining methods and applying data mining to other types of product safety-related FDA and non-FDA databases.

The Proportional Reporting Ratio (PRR) is the foundational concept for many disproportionality methods.

However, because this method does not adjust for small observed or expected numbers of reports of the productevent pair of interest, other more advanced statistical methods are employed, such as the Multi-Item Gamma Poisson Shrinker (MGPS), which produces Empirical Bayesian Geometric Mean (EGBM) scores iii. Several FDA Centres including CDER, CBER, and CFSAN, use the MGPS algorithm for their routine surveillance activities. Various commercially available software programs generate PRR and/or EBGM scores.

CDER has applied Empirica Study to analyse drug clinical trial data in either new drug applications or supplemental applications. Empirica study interfaces with data that conforms to the standardised Study Data Tabulation Model (SDTM) of the Clinical Data Interchange Standards Consortium (CDISC) data standards to create a wide set of automatically generated analytical outputs and tailor-made,

Several pharma companies are now experimenting with the tools of automation and artificial intelligence, such as bots, which are outside the purview of current regulations

reusable tables and graphs. These outputs have helped reviewers to more efficiently analyse potential safety issues in clinical trial data of drugs approved by the FDA. The FDA notes the benefits of data mining with these tools in the areas of standard processes (because data mining is automated, the outputs are statistically objective and devoid of manual analyses), simultaneous analysis (across an entire database at once), efficiency (analyses computed in minutes), and the benefits of automated signal investigations (transparency with audit trails, drill-down capability, observation of signals over time, and study of a product in populations). These tools are in the early stages of the automation efforts at the FDA. However, the FDA operates in a regulated environment. Several pharmaceutical companies are now experimenting with the tools of automation and artificial intelligence, such as bots, which are outside the purview of current regulations. Chatbots, or bots as they are simply known, are assisting with routine tasks such as getting weather updates, flight messages, booking hotels, and now, answering simple health inquiries from physicians.

Merck-Sharpe-Dome (MSD) Italy has launched the MSD Salute Bot in 2016. The first focus has been the immuno-oncology and soon to come there will be many more areas. The Bot is running on Facebook Messenger. From the MSD prospective physicians are digital consumers looking for relevant information for their professional activity iv. Some key factors like the increase of media availability, mobile devices penetration and the decrease of time available, are resulting in a reduction of time spent navigating and searching on the web. Only available to registered physicians at this time, the Bot has interacted with hundreds during the 2016 winter holidays.

Bots are the first layer of accessi-

ble and deployable AI that encompasses natural language processing (NLP) on the general lexicon. Anyone can deploy a Bot via online free tools and building kits. As of now, Bots are the for the outreach activities and do not decipher well the complicated medical lexicons. Currently, the Bot, no matter how strong the AI or NLP element, could not replace the human interaction for in-depth conversations on health, disease diagnosis, or exploratory conversations with the health professional. Its aim is different, and that is to relieve the health professional from answering the routine questions. Bots are best when utilised for social media outreach activities and fare extremely well in instances requiring a customer service orientation.

Yet, technology is advancing and these tools will as well. New processing power in chip technology, coupled with advances in algorithmic analysis will yield better tools for the healthcare and life sciences industries. AI, NLP, Bots, automation, machine learning and data mining are not new.

They have been used in other industries such as manufacturing, customer service, and finance. Now progress in these other industries and the elimination of the requirement for extensive resources has caught on with the health sciences. As new adopters of these technological advances share their experiences, the entire health and life sciences industry will benefit, having access to a new set of tools to transform itself.

References i. https://www.forbes.com/sites/gilpress/2016/11/01/forrester-predictsinvestment-in-artificial-intelligencewill-grow-300-in-2017/#3350400d5509 Accessed 29Oct2017 ii. Data Mining at FDA, Hesha J. Duggirala. 2016 Accessed 29Oct2017 iii. Oracle Empirica Manual 2015 iv.http://www.impossibleminds.com/p ortfolio-item/msd/Accessed 30Oct2017

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November 16-30, 2017

PHARMA TECHNOLOGY REVIEW VENDOR NEWS

Gandhi Automations bags recognition at Express Logistics & Supply Chain Leadership Awards 2017 Samir Gandhi, MD, Gandhi Automations, received the award for his outstanding contribution serving the industry with commitment, expertise, integrity and passion GANDHI AUTOMATIONS bagged dual awards for Best-InClass Loading Bay Equipment Company and Exemplary Leadership Award. Samir Gandhi, MD, Gandhi Automations, received the award for his outstanding contribution serving the industry with commitment, expertise, integrity and passion.

The Express Logistics & Supply Chain Leadership Awards 2017 was held at 11th Express Logistics & Supply Chain Conclave in Mumbai.

On receiving the award, Samir Gandhi, MD, Gandhi Automations, expressed, “Gandhi Automations is glad to serve the industry and stand tall as a trusted partner for past 21 years into entrance automation and loading bay equipment. We continue to evolve and deliver the best to our customers.”

With 70 per cent market share and more than 100,000 installations globally, Gandhi Automations is recognised as pioneers in delivering solutions for entrance automation and

loading bay equipment in India.

The company specialises in designing, manufacturing and installing customised entrance automation systems and loading bay equipment products comply with the highest safety standards accompanied with

reliability and energy efficiency.

It is an astute leadership and expertise of Directors Samir Gandhi and Kartik Gandhi, who passionately drives their commitment to quality and further towards customers by exceeding all ex-

pectations. Gandhi Automations invested strategically into R&D, factory and warehouse further reinforced with European collaboration and technology since two decades delivering innovative and creative engineered products.

Lastly, the conclave, in its 11th edition touched numerous topics on digitisation, challenges, best practices, regulations, global trends, procurement, automation and equipment.

EP News Bureau

Waters Corporation appoints Chris O’Connell Elected as Chairman Doug Berthiaume to retire as Chairman of the Board of Waters Corporation WATERS CORPORATION announced that Douglas A Berthiaume will retire as Chairman of the Board of Directors of the Company, effective December 31, 2017. The Board of Directors has elected Christopher J O’Connell, President and CEO, as its new Chairman effective

38 EXPRESS PHARMA November 16-30, 2017

January 1, 2018.

Thomas P Salice will continue to serve as the company's independent lead director.

Commenting on the announcement, Berthiaume said, “It has been my pleasure to serve as both an executive and non-executive Chairman of the Board of Directors of Waters.

Two years ago, upon my retirement as Chief Executive Officer, Chris O'Connell assumed the CEO position and has successfully guided the company to new levels of growth and profitability. I am pleased to once again pass the torch to Chris as he assumes the additional role of Chairman of the

Board in addition to his service as CEO of the company.”

“I am honoured to have been elected as Waters' new Chairman of the Board of Directors," said Christopher J O'Connell. "For 20 years as an independent public company, Waters' success was guided by Doug Berthiaume's visionary

leadership. I am truly grateful to Doug for his strong support of me and the Waters team over the past two years. Speaking on behalf of all Waters employees worldwide, I wish Doug the very best as he completes his transition to retirement."

EP News Bureau

PHARMA TECHNOLOGY REVIEW

CPhI Worldwide announces th winners for its 14 Pharma awards 19 winners chosen from 200 entries,received from nearly 30 countries worldwide CPHI WORLDWIDE, organised by UBM, has announced the winners of the prestigious 2017 CPhI Pharma Awards in Frankfurt. The awards celebrate and recognise pharmaceutical excellence, and strongly encourage companies that are committed to participate in the growing and evolving pharma industry.

In the ‘API Development’ category, the winner was Cambrex’s new, efficient synthesis of Ospemifene – which uses standard plant equipment and requires only two synthetic steps and one recrystallisation, minimising waste and use of solvents.

Orbis Biosciences was given the ‘Formulation’ award for Orbis’ Optimum technology for oral drug products, which has the ability to create microcapsules with uniform shell thickness that contain pH responsive polymers for targeted delivery approaches for a broad range of active ingredients.

The ‘Excipients’ award has been presented to Colorcon for the Opadry QX, Quick and Flexible film coating. This product reduces preparation and production times, and ensures coating process efficiency and cost savings in all types of equipment, from traditional to continuous coating.

MJR PharmJet triumphed in the ‘Manufacturing Technology and Equipment’ category with the MicroJet Reactor technology, making it possible to produce of a wide range of particle sizes with combination of process parameters from 10 nm up to 20 µm.

In the category of ‘Bioprocessing’, Capsugel was successful with the Modular Automated Sampling Technology (MAST) platform. MAST allows direct transfer of aseptically collected bioreactor samples to analytical devices, providing rapid, reliable data for superior bioprocess guidance.

1CryoBio was granted the

The awards celebrate and recognise pharma excellence, and strongly encourage companies that are committed to participate in the growing and evolving pharma industry ‘Analysis, Testing, and Quality Control’ award for FlexiQuot, the world’s first dividable cryotube, which is revolutionising sample collection, storage and handling for liquid sample long term storage products.

Out of over 20 entries, Perlen was triumphant in the ‘Drug Delivery Devices’ category with its Single Use Inhaler (DPI) Perlamed-BLISTair (R).

The SideActuationDevice by Aero Pump won in the category ‘Packaging’ for its metered dosing pump, which ensures a strict dose accuracy over the whole life cycle of the product, only one defined drop per actuation, independent of the filling volume of the bottle.

The award for ‘Supply Chain, Logistics, and Distribution’ has been given to TraceLink for its series of real-time information sharing applications to connect the entire pharma supply chain on an interoperable network, facilitating a new era of real-time information sharing that will transform how the industry provides care to patients.

Crystec was granted the ‘Contract Services and Outsourcing’ award for its modified supercritical anti-solvent (mSAS) technology, a singlestep, high yielding and readily scalable process to generate dry, free flowing particles, designed to meet a target product profile and optimise drug delivery.

Piramal Pharma Solutions was selected as the winner in the

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‘Regulatory Procedures and Compliance’ award category thanks to its unique approach to meeting and exceeding global regulatory standards. One approach unique to Piramal is to take the best learnings from other industries and apply these to the pharma industry. The company is very customer focussed and has introduced new quality improvement tools including QUEST, an organisation-wide ownership campaign, with perpetual audit readiness at sites maintained though tools such as vSENSOR and vPREDICT. Pharma5 achieved the award for ‘Corporate Social Responsibility’ for its Hepatitis project in Morocco. After the success of the new generation drug against Hepatitis C, Pharma5 is now launching the first treatment of Hepatitis B in Morocco.

Richard Chin, MD, Founder and CEO, Kindred Biosciences, has been awarded the prestigious ‘CEO of the Year’ award.

KindredBio is a biopharmaceutical company focussed on saving and improving the lives of pets.

BenevolentAI, the global leader in the development and application of AI for scientific innovation, was granted the award for ‘Pharma Company of the Year (SME)’. BenevolentAI has proven its technology by applying it to human biology and has made significant progress in accelerating drug development,

particularly in reference to ALS. AptarGroup’s internal Landfill Free certification programme has been selected as the winner of the ‘Sustainability Initiative of the Year’ category for promoting process efficiencies and the conservation of natural resources in a global setting.

Rachana Overseas was awarded in the ‘Excellence in Pharma: Export Promotion’ category, while Pronova emerged as the winner of the ‘OTC’ category.

Within ‘Patient Centricity’, ERT was victorious with the innovative digital health network, TARGET My Hives, which helps patients actively take control of their condition through stronger engagement with physicians, patient association groups and others affected by chronic urticaria.

Recognised for its expertise in device R&D, Biocorp received the ‘IT, mHealth & Digitilisation’ award. Biocorp has incorporated software development capacities to develop connected drug delivery systems, and a range of add-ons and smart sensors for existing drug delivery devices.

Tara Dougal, Acting Head of Content – Pharma, UBM EMEA, added, “The staggering number of entries for this year’s CPhI Pharma Awards was a surprise to everyone, and the judges worked diligently to assess each individual submission on its own merit. As a result of the growing appreciation for the overall prestige and value of the award, we had to great new categories to fully cover the bredth of attendee innovations at CPhI Worldwide.”

The judges commented that this year we had an extremely high standard of entry and all of the finalists would have been worthy winners. So on behalf of CPhI Worldwide and UBM, I would like to commend all of the finalists and offer my warmest congratulations to this year’s outstanding winners.”

EP News Bureau

Lonza’s MODA software release enables companies to meet updated regulatory guidance LONZA’S MODA-EM Version 3.3 software enables microbiology Quality Control (QC) laboratories to comply with new regulatory guidelines. QC facilities have to manage the daily challenges of QC monitoring while meeting changing regulatory compliance mandates.

Lonza's latest software release meets these evolving challenges with additional features focussing on data integrity, data visibility and data review.

MODA Version 3.3 delivers improved workflow with better analytics and reporting than ever before. Complete with a streamlined implementation and a risk-based validation solution, this software is the paperless solution for QC laboratories.

“It is essential for QC laboratories to be able to readily adapt to changing regulatory guidance. To aid this compliance MODA Version 3.3 features a new, fully searchable audit trail that lets scientists easily track changes made through a sample’s lifecycle,” said Sinéad Cowman, EU Business Development Manager, Lonza Informatics. “The paperless efficiency features save time on many everyday activities, such as settling plate exposure times, organism identification and master data management and review.”

The new software has been designed to meet end user requirements and features enhanced scheduling and calendar capabilities for simplified sample management. It also offers web-based dashboards so that metrics and results can be accessed from anywhere with an internet connection.

EP News Bureau

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November 16-30, 2017

PHARMA TECHNOLOGY REVIEW PRODUCT

Clean room high speed doors, an integral part of pharma manufacturing facility BETTER QUALITY or better yield is the primary reason for investing in a cleanroom space. Numerous manufacturing facilities now require a controlled environment in which you limit the amount of dust and dirt in area of 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. You need to know the requirement for your 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 one chooses 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 be quick enough to isolate the outside environment and internal facility.

At Gandhi Automations, we provide clean room high speed doors specifically designed for above purpose. The clean room high speed doors are best suited for facilities where controlled environment is needed. The opening and closing of door is quick enough to separate outside environment and internal facility.

High speed clean room

40 EXPRESS PHARMA November 16-30, 2017

doors designed by Gandhi Automations 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 66720201Email: sales@geapl.co.in Website: www.geapl.co.in

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EXPRESS PHARMA

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November 16-30, 2017

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TM

S.S. PALLET

S.S. ANTIVIBRATION TABLE S.S. FIX / REV STOOL / CHAIR TM

S.S. CABINET FOR BLISTER S.S. LOCKER S.S. VISITOR CHANGE PART / STRIP CH PART / FOR KEEPING APPRON CABINET POLYBAG STREET GARMENT

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

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

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S.S. CABINET FOR MULTIMILL SIEVES

S.S. WRITING DESK WITH DRAWERS

S.S. II CHANGE CROSS OVER BENCH

Contact: Mr. Kiran Shah / Mr. Chirag Shah

S.S. DIES & PUNCHES CABINET

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

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introduce

An Enterprise Providing Professional Value of Optimized Technology Name Source : Advantage + Technology + Praxis + Practice

From Technique for Humanity

From Zero Base to Innovation

Breakthrough the existing frame, users-centered and innovative new product

Optimized Technology

28-30 Nov 2017, BEC, Mumbai Visit us : Booth No.: N52, Hall No.: 5

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

1st Indian Company to launch “PLC Based” Control System.

Tablet Press

Capsule Filling F Series

P Series

GSM Technology: SMS Mobile Alert.

“Best Service in its Class”. Acclaimed by our Proud Customers.

Our World Class & World Renowned Equipment I

Walk-In Humidity Chambers.

I

BOD Incubators.

I

Humidity Chambers.

I

Bacteriological Incubators.

I

Walk-In Cold Chambers

I

Photostability Chambers.

I

Cold Chambers.

I

Deep Freezers.

I

Walk-In Incubators.

I

Ovens.

Mack Pharmatech Pvt Ltd. B-48, Malegaon MIDC, Sinnar, Dist. Nashik, Pin - 422 113, Maharashtra, India

+91 2551230877

+91 2551230877

sales@mackpharmatech.com

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November 16-30, 2017

www.mackpharmatech.com

service@mackpharmatech.com

Sejong Coater

Sejong FBD

C Series

D Series

Source Genuine Sejong Spares from Allpharm Alone Save your high tech machines from Non OEM, Spurious parts

A 404, Rajeshri Accord, Teli Galli Cross Lane, Andheri (East), Mumbai - 400 069 Tel: +91 97691 99633 Email: mail@allpharm.in Web: www.allpharm.in

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OSMOMETER 3250

LABORATORY EQUIPMENTS

Lab Stirrers Hot Plate Magnetic Stirrers

Walk-in chamber

Refrigerated Centrifuge Deep freezer

Laboratory Centrifuge

Single Door Refrigerator

Cyclomixer

Mini Rotary Shakers

Incubator Shaker

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

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

VISIT US @ Multiple Products Under One Roof HALL #5, STALL #N‐36 28TH ‐ 30TH NOV, 2017 BOMBAY EXHIBITION CENTER, MUMBAI, INDIA.

Imavac™ - Silicone Hose reinforced with SS 316 helical wire

for Food & Bio-Pharma Industries

07TH ‐ 12TH FEB, 2018 GANDHINAGAR, AHMEDABAD, GUJARAT. INDIA

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

Imaprene™ - Thermoplastic Elastomer Tube (TPE)

We are specialized in manufacturing Platinum Cured Silicone Tubes, Braided Hoses, Inflatable Seals / Gaskets and customized polymer solution for food, medical and pharmaceutical industries application.

®

Imavacfit - Silicone hose reinforced with Polyester Braiding and SS 316 helical wire

Silicone Inflatable Seals & Gaskets

TM

Ami Polymer Pvt. Ltd.

www.amipolymer.com

“Sealing Expert in Silicone” An ISO 9001:2008/14001:2004/18001:2007 & Clean Room Certified Co. DMF #26201 accredited by USFDA

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November 16-30, 2017

mktg@amipolymer.com EXPRESS PHARMA

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Goggles & Writing Accessories For Cleanroom

u

ble vaila nch A w No Lau n lean Bioc g Versio fo Anti-

11X14EPAd02

Sterile Pen & Marker

u

S S Writing Pad & S S Pen With Chain

u

Cleanroom Vinyl Sterile Tape 1/2”, 1” & 2”

Clear view Autoclavable Panoramic Thermoplastic rubber Body Goggles With Can Be Worn Over Eyeglass With Grid For Marking Autoclaving Goggles

Cleaview Autoclavable Goggles With 40 Autoclave With Grid For Marking Autoclaving Goggles

50

Cleanroom Paper & Pad (Autoclavable)

u

40 Autoclave Cycles u

u

BCAG

u

BCAP

u

Grid For Marking Autoclaving

Grid

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

November 16-30, 2017

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US $4 Billion well diversiďŹ ed Group

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Leading Nirtogen Plant manufacturer for more than 30 years

Turnkey supplies to Pharma Sector and other industrial segments such as Chemical, Power, Metallurgical and Food - where we have sustained majority market share consistently and established ourselves as market leaders and amongst the largest and best-of-breed air and gas treatment systems company around the world.

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To Advertise in

Business Avenues www.kesarcontrol.com

www.kesarcontrol.com

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

Please Contact: ■ Mumbai: Rajesh Bhatkal 09821313017 ■ Ahmedabad: Nirav Mistry 09586424033 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai ■ Bangalore: Kailash Purohit +91 9552537922 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580

Mobile : 09427613646 Email : service@kesarcontrol.com

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November 16-30, 2017

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Laboratory Glass Syringes

®

GLASS SYRINGES Chromatography Consumables

• 0.25ml,0.5ml,1ml, 2ml, 3ml, 5ml, 10ml,20ml, 30ml, 50ml & 100ml

CERTIFIED VIALS, CAPS, SEPTAS

Metal Luer Lock Tip

Metal Luer Slip Tip

Glass Luer Slip Tip

FILLING SYRINGES • 2ml, 5ml,10ml, 20ml, 30ml,50ml & 100ml Wide Mouth Glass Tip

3/8 UNF Thread Tip

1/4 UNF Thread Tip

Open Barrel

CONTROL GLASS SYRINGE Range: • HPLC Vials (1.5ml / 1.8ml / 2ml) - 9mm, 8-425, 11mm (crimp & snap) • 4ml - 13mm • GC Vial, 20mm - 10ml / 20ml • Vial Inserts, Shell Vials • EPA Vials - 20ml - 60ml • Storage Vials 2ml -60ml

GAS TIGHT SYRINGES • 5ML,10ML, & 25ML • Gas chromatography • Zero Dead Volume for Syringe pumps • 60 mm Stroke Glass Tip Fixed Needle

• 2ml, 5ml & 10ml • 3 Ring offers better grip while use in Laboratory for Filteration • Calibration Certificate On Request

PRESSURE LABORATORY GLASS SYRINGE • 2ml, 5ml,10ml, 20ml, 30ml, 50ml & 100ml • Tested upto 43.50 PSI • Certificate given with each syringe • Graduation starting from 0.02ml

SELF REFILLING SYRINGE

Teflon luer lock

• 0.5ml, 1ml, 2ml & 5ml • Repititive Dispensing Of Preset Volumes • Feed Tube Set, Vial Holder Set • Fully Autoclavable • SS Piston, Glass Barrel, No O-ring

3/8 UNF Thread Nut

CAPILLARIES

• TLC,ETE,etc.

(Manufactorer & Exporters Since 1964)

Top Syringe Compound, W.E. Highway, Pandurang Wadi, Mira Road (East), Thane 401 104. INDIA Tel: +91 9769175036 Email id: sales@top-syringe.com Website: www.top-syringe.com

Experiment With The Truth Wiper Type Sight Glass

Certified ISO 9001: 2008

DIN 100 Light Glass LED

Swastik Associates Shed No. 1, 2 & 3, Sr. No. 30/7, Behind Dran Company, Dhayari-Pune 411041 Phone : 020 24690268 / 24690041, 9923124949 / 9028716622, 9028716222 Email : sale1swastik@gmail.com swastikpune1@gmail.com

Our other product details u

SS Fittings

u

SS Valves Manual & Pneumatic

u

SS Filters

u

SS Pumps: Centrifugal, Self Priming & Shear Pump

u

SS Powder Blender

u

SS Steam & Water Mixing Station

u

Drain Trap

Sight Glass Flange with LED

A BENCHMARK FOR

QUALITY SOLUTIONS

LED Bush

STABILITY CHAMBER

WALK-IN STABILITY CHAMBER

4W / 15W / 20W / 24W

PRODUCT RANGE l

Manhole Round Dia 450

Manhole Pressure Type

Manhole Elliptical

AUTOCLAVE-WINGNUT

l l l l l

Autoclave BOD Incubator Bacteriological Incubator Cooling Incubator Deep Freezer Hot Air Oven

l l l l l l

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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November 16-30, 2017

B.O.D INCUBATOR

www. a. ldindi oswor com

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2

Designers, Engineers & Manufacturers of Machinery & Filteration Equipments for:

es Decad ies. ustr Over d In to ice of serv ing Stronger Grow t & Integrity us with Tr

Pharmaceuticals, Packaging, Chemicals, Food, Beverages, Distilleries, Breweries, Paints, Food, Oils & Consumers

MAJOR PRODUCTS MANUFACTURED AT UNIPACK Linear Vial/Bottle Washing Machines Sizes: vials 2ml to 100 ml & Bottles 15 ml to 500 ml Scramblers/Unscramblers Sizes:24” dia, 36” dia. 48” dia 60” dia Hydraulic Loading Platforms Inspection Tables Loading and unloading Conveyors Liquid Filling, Rubber Stoppering & aluminium Cap sealing Machines for Vials Powder Filling, Rubber Stoppering & aluminium Cap sealing Machines for Vials

Sterlity Testing Units in S.S. Sizes: Single Place, Three Place & Six Place Plate and Frame Type Filter press in SS Size: 20 cm X 20 cm, 40 cm X 40 cm, 60 cm X 60 cm, 100 cm X 100 cm Zero hold up/Sparkler Filter press Size : 600 LPH to 15500 LPH Sterile Pressure and Storage Vessels Size : 10 ltrs to 500 ltrs Membrabe Filter Holders (Size: 293 mm, 142mm, 90mm) Inline Filter Holders (Size:47mm, 25mm, 13mm) Basket/Bag/Catridges Filters

We Supply different sizes of Filter Sheets and Filter Modules of Major International Brands

Our Achievements: Over 2500 installations of our major products manufactured in-house are supplied to all Leading Companies in India & Multinationals abroad

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