Express Pharma (Vol.11, No.9) March 1-15, 2016

VOL. 11 NO. 9 PAGES 48

www.expresspharmaonline.com

Market Genuine cos would not be harassed, black sheep should not be spared: Thakur Kaul Singh, Health Minister, HP 1-15 MARCH 2016,` 40

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CONTENTS MARKET Vol.11 No.9 MARCH 1-15, 2016 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

09

Bengaluru Neelam M Kachhap DESIGN National Art Director Bivash Barua Asst. Art Director Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Designer Rekha Bisht Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Harit Mohanty - West & East

RESEARCH

WAITING TO IPO? Will the bullish response to last year’s IPOs in the pharma and healthcare sector spur more companies to test the market in 2016?

Will these hopefuls succeed in timing their IPOs just right?

Or is this just hype and hope? | P18 P28: INTERVIEW

P29: INTERVIEW

‘The US office will play a key role in establishment of new contacts and customers in Latin America’

‘Mass Spectrometry helps in better understanding of diseases like Alzheimer’s and Parkinson’s’

Manager Bhadresh Valia

P30: INTERVIEW

P42: INTERVIEW

Scheduling & Coordination Ashish Anchan

‘The role we play is more of an enabler’

‘We are planning to set up shop in the Americas in a very unique way’

Marketing Team Rajesh Bhatkal Ambuj Kumar E Mujahid Arun J Debnarayan Dutta Ajanta Sengupta Nirav Mistry PRODUCTION General Manager B R Tipnis

CIRCULATION Circulation Team Mohan Varadkar

GENUINE COS WOULD NOT BE HARASSED, BLACK SHEEP SHOULD NOT BE SPARED: THAKUR KAUL SINGH, HEALTH MINISTER, HP

23

GASTRIC REFLUX DRUGS MAY BE TIED TO DEMENTIA RISK

24

STUDY SUGGESTS ZIKA CAN CROSS PLACENTA, ADDS TO MICROCEPHALY LINK

25

TESTOSTERONE THERAPY IMPROVES LIBIDO BUT NOT VITALITY IN OLDER MEN

Express Pharma® Regd. with RNI No. MAHENG/2005/21398,Postal Regd. No. MCS/164/2016 – 18. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2016. 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.

EDITOR’S NOTE

Public health: In need of Nari Shakti A

s we mark yet another Women’s Day this March, here are some sobering words from Sanghita Bhattacharyya, Senior Public Health Specialist at the Public Health Foundation of India, which sums up the situation very well: “Beyond a narrow elite, there is little sign in India that women themselves are becoming more active in managing their health and well-being.

Public health policy has paid limited attention to the well-being of women beyond their reproductive years. This in itself is a manifestation of gendered expectations, where even decision makers have not looked at women beyond their roles as mothers and care givers.”

She was speaking at the Global Consumer Health Debate 2016, held at Merck's global headquarters, as part of an international panel of academics, public health specialists, NGO leaders and business experts. The topic of discussion was ways to close the gap between the future vision of women's health and well-being and the current reality in countries across the globe.

Public health policy plays a central role in health, but it is seldom understood that improving the health and well being of women in a family also has great health benefits to the entire family because it is the women who are the custodians of their family's health. Educating women on healthy practices therefore means that she would be the best person to educate her family.

Improving health and well being of women has great benefits because women are the custodians of their family’s health

Which is why Express Healthcare, our sister publication, will be organising a public health policy focussed summit, Healthcare Sabha, in Hyderabad from March 4-6 with support from the National Health Mission. (For more details, see http://healthcaresabha.financialexpress.com/) While investors seem to be more than interested to invest in pharma and healthcare IPOs (See cover story of the March 1-15, 2016 issue: Waiting to IPO?, pages 18-20), the public health sector needs investment of effort, expertise and efficiency from both policy exerts as well as industry gurus to ensure optimal utilisation of resources, be it funding or human talent. Do catch our forthcoming issue with the post event coverage of Healthcare Sabha, where public health experts will discuss financing models, use of ICT, frugal innovation, skilling programmes and PPPs, all through the lens of public healthcare in India.

While pharma IPOs may well turn out to be the flavour of 2016, quality issues could derail the entire industry’s prospects. Regulators from India, the US, the UK and the EU at Indian Pharmaceutical Alliance’s Indian Pharmaceutical Forum 2016, stressed the importance of making quality excellence the next frontier. When market competitors like Lupin, Sun Pharma, Dr Reddy’s Laboratories, and Zydus Cadila join forces to tackle a common problem, there is hope that this time, we will breach this frontier as well.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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March 1-15, 2016

MARKET PRE EVENT

Express Healthcare to host first edition of Healthcare Sabha at Hyderabad Central and state-level policymakers would congregate at the event to deliberate on cohesive, unified and innovative ways to achieve the vision of the National Health Mission

IN KEEPING with the objectives of the National Health Mission pertaining to ‘Universal Access to Equitable, Affordable and Quality Healthcare Services’, The Indian Express Group and Express Healthcare are organising Healthcare Sabha 2016 – The National Thought Leadership Forum on Public Healthcare.

The first edition of Healthcare Sabha will be held from March 4-6, 2016 at Hyderabad Marriott Hotel and Convention Center. The forum will deliberate on cohesive, unified and innovative ways to achieve the vision of the National Health Mission.

Key subjects at the forum would include ◗ Models of financing public healthcare to aid the masses ◗ Usage of ICT in the public healthcare delivery model ◗ The role of frugal innovations in medical technology ◗ Skill enhancement programmes to bridge the workforce deficit ◗ The expanding role of NGOs’, Foundations’ and corporate hospitals’ outreach programmes The event will also host the Express Public Health Awards honouring the visionaries, innovators, and game changers from public healthcare.

Public Health Foundation of India (PHFI) will be the Knowledge Partner to the Awards. Dr K Srinath Reddy, Founder and President, PHFI, is the Chairperson of the jury.

8

EXPRESS PHARMA

March 1-15, 2016

The categories for the Express Public Health Awards 2016 will be as follows: ◗ Express Public Health Award to the Most Efficient State/Institution in management of: This category aims to recognise and acknowledge state governments which have been the most proactive and efficient in initiating public health programmes and utilising public funds to meet the population’s health needs. The jury would take into account the scope and impact of the project in terms of size of population covered, etc., defined measurable outcomes. The sub-categories in this segment are: ■ Infectious diseases ■ Non-communicable diseases ■ Reproductive, Maternal, Neonatal, Child and Adolescent Health ■ Excellence in Public Health Service Delivery (in terms of covering greater population and increased range of services through the health system) ■ Innovation in Financing for Health ■ Innovation in increasing affordable access to medicines, vaccines, medical products and technology ■ Innovations in health information systems for population health assessment/quality improvement/increasing transparency and accountability ■ Innovations in human resource for health ■ Excellence in leadership, stewardship and governance

■ Healthcare for elderly and differently-abled people ◗ Express Public Health Award for Most Effective Health Technology Systems: This category aims to recognise and celebrate the work of states and institutions which have deployed technology to improve efficiency and access to quality, affordable healthcare services.

The sub-categories in this segment are: ■ Health Information Management and Systems (HIMS) ■ Telemedicine/teleradiology ■ Health helpline ■ Affordable lifesaving technology ■ Wearable health devices

at the state level ◗ Express Public Health Award to the Most Effective Public Private Partnership in: This award celebrates state governments which have managed successful, sustained partnerships with the private sector ■ Healthcare infrastructure ■ Diagnostics ■ Human resource for health ◗ Express Public Health Award to the Most Effective Healthcare NGO: This category aims to recognise

and celebrate the work of registered NGOs which have contributed to identifying and solving healthcare challenges on a local, regional or national level for a minimum of five years. Nominations will be evaluated on the outcomes and scope of their work. The sub categories will comprise: ■ Healthcare for rural poor/ urban poor/migrant population ■ Tribal health issues ■ Social empowerment models ■ Women and child health

◗ Lifetime Achievement Award for Contribution in Public Health: It would recognise and celebrate yeoman service in public health, either through their NGOs or through their efforts to support public health causes.

Nominations for this category can be made by individuals other than the nominee. ◗ Express Public Health Award for Contribution by a Private Healthcare Practitioner towards Public Health: This award aims to recognise and appreciate outstanding contribution of a private healthcare practitioner towards public health causes and initiatives, bridging the private-public divide.

For more information on the event log on to www. healthcaresabha.in

POST EVENT

Genuine cos would not be harassed,black sheep should not be spared: Thakur Kaul Singh,Health Minister,HP A ring side view of The North India Pharma Manufacturers Conclave, which saw a free exchange of views between senior regulators from both state and centre, and top manufacturers from Baddi’s pharma hub

PHARMACEUTICAL companies from the North zone put up an impressive show of strength at the recently held North India Pharma Manufacturers Conclave. Presented by the Indian Drug Manufacturers Association (IDMA), Federation of Pharmaceutical Entrepreneurs (FOPE) and Express Pharma, the two-day conference and exhibition was held at Baddi, Himachal Pradesh (HP), which has evolved into one of the country’s biggest pharma manufacturing hubs.

The event brought together senior government officials from the centre and HP, IDMA and FOPE delegates comprising large to mid-sized pharma manufacturers. Leading Indian and international pharma equipment providers took the opportunity to showcase their products and services to a captive audience at the co-located exhibition.

The event started with the

EXPRESS PHARMA

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March 1-15, 2016

MARKET inauguration and tour of the exhibition by the Chief Guest Thakur Kaul Singh, Health Minister, HP and other senior regulatory officials from the centre and state.

Calling to attention the forum, BR Sikri, co-chairman, FOPE commenced the day’s proceedings by calling on Viveka Roychowdhury, Editor, Express Pharma to welcome the delegates. Wishing the delegates a fruitful two-days of networking, she also congratulated FOPE on completing a decade of service to the cause of MSME pharma companies, especially in the North region, and expressed confidence that they would continue their mission in the next decade as well.

In his address to the delegates, SV Veerramani, President, Indian Drug Manufacturers Association, thanked Express Pharma for taking the initiative to organise the event.

In an overview of recent policy decisions, he advised SME players to not consider themselves at a disadvantage as they had already reached a level where they were at a substantial advantage. New players on the other hand, would have to grapple with getting as many as 41 approvals to start a manufacturing unit and set up infrastructure from scratch, giving established players a lead of around three years, which they should utilise judiciously.

Industry’s wish list RC Juneja, Chairman, FOPE amplified the concerns of pharma manufacturers, emphasising that his company, Mankind Pharma and others, had made HP a pharma manufacturing hub, saying, “HP has given a lot to the pharma industry and vice versa.”

He stressed that the pharma sector is an employment generator but also needs support from the centre and states. He flagged issues like the increase in fees, loss of tax holiday status, etc. He suggested that on long drawn out issues like fixed dose combinations (FDCs), the government needs to find a solution so that no more money is spent on legal fees.

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EXPRESS PHARMA

March 1-15, 2016

... and regulator’s (yard)stick Countering many of the issues raised by Juneja, Navneet Marwaha, Drug Controller, HP raised cheers from the audience when he assured them that the state was, is and will be committed to producing safe and quality medicines. He thanked the companies who had chosen to make HP a pharma hub stating that eight of the top 10 pharma companies had manufacturing plants in the state.

Taking a firm stand, he said, “Cooperation would be given (to pharma companies) provided they manufacture quality drugs and keep away from making those which can be misused/abused as this is a social cause.“ Representing the Centre’s view, KB Agarwal, Additional Secretary, Ministry of Health & Family Welfare, Govt of India expressed his privilege to be present at such a gathering and gave an overview of the various actions being taken to increase the ease of doing business and to create an enabling environment. On a lighter note, taking a dig at the former speaker, but in tune with his message, he opined that the designation of 'Drug Controller' should be changed as it reflected negativism. He suggested that today’s reality is that the role requires a facilitator, comparing the role of a Drug Controller to that of a parent, who would always be disliked by children during the growing years. Only to be remembered more favourably in the later years, when the realisation will dawn that the control and discipline of the parent/regulator contributed to the success.

As the Chief Guest of the inaugural session, Thakur Kaul Singh, Health Minister, HP, stole the show, with his heartfelt appreciation of the organisers for organising such an event as well as the delegates for putting his state on the map as an established pharma hub.

Reminding the audience that every third drug in the country was produced in HP, he expressed the hope that many more such events would

MARKET be organised so that the Ministry and industry could work together for the betterment of the nation.

He reiterated that the HP government was committed to the manufacturing of quality drugs and assured the assembled manufacturers that they would get a patient hearing, as per the rules of law. Since he holds dual charge of the law ministry, it was only expected that he would send a warning note, saying, “The value of the human being is more than that of the pharma industry. Genuine manufacturers would not be harassed but black sheep should not be spared. There will be no compromise on quality but manufacturers should aim for quantity with quality.”

He advised pharma SMEs to focus on regional markets and niche products pointing

out that 90 per cent of HP lives in the villages and thus affordable medicine is the goal. He also sought the assurance of manufacturers that 70 per cent of employees of their units based in HP should be Himachali. Signing off, he said that as HP was dev bhoomi, the pharma industry would continue to receive blessings in the‚ ‘abode of the gods.’

Giving the Vote of Thanks, Daara Patel, President , IDMA thanked Sikri for all his efforts towards making the event a success, “for perfecting the ‘art of asking’ on behalf of the SME pharma sector” and for being a very effective sutradhaar of the morning’s session.

The afternoon session had technical sessions by pharma companies and exhibitors.

Manoj Kumar, Head QA, Abbott informed the delegates of the latest revisions in GMP

regulations. This was followed by presentations from exhibitors on products and services which would help growing manufacturers scale up smoothly, while taking care of their compliance needs.

While Jatin Bali, Assistant Manager, SSP informed the audience about process and zero liquid discharge technologies for pharma industries.

Ashok Desikan, Director Business Development, India & Saarc, Tyco Fire & Safety followed up with a presentation, complete with videos on actual usage, on integrated solutions to enhance fire safety and security in the pharma segment‘ Manish Mohindra, AVP – North Region, Domino Printech India’s session on coding solutions for product identification and serialisation was very interesting considering

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EXPRESS PHARMA

11

March 1-15, 2016

MARKET the recent move towards serialisation at all three levels of packaging.

The last technical session was on designing a GMP facility and monitoring the shop floor by Prakash Jha, Medicamen Biotech.

The presentations were followed by a live wire panel discussion on recent regulatory moves which have the industry up in arms. This session included topics like DPCO/margin capping on generic-generic and branded - generic drug act amendments including licence fee hike /FDC/GST etc. The concerns were ably articulated by industry representatives like Juneja, Veeramani, Sikri, DC Jain, Chairman, Akums Drugs & Pharmaceuticals while Dr AK Pradhan, Deputy, DCG(I), Agarwal and Marwaha fielded the queries with the regulators’ perspective.

On FDCs Industry experts at the event expressed serious concern about the chronic problem of FDCs which is hanging fire for almost nine years. They opined that they needed to go to court frequently and get relief. There are cases in Chennai, Haryana, HP and Nagpur High Courts and matter is becoming complicated day by day.

It was further deliberated that the court case of 294 FDCs pending in Chennai High Court since the last nine years had not been resolved and if that was the trend the industry representatives were anxious about the fate of more than 7000 applications.

Industry stalwarts like Sikri was a key person to take the lead to discuss this issue with Pradhan. He further mentioned that in the first sub committee of 294 FDCs, stake holders were members of that committee but for the latest FDCs, stakeholders are not involved.

Pradhan clarified that this committee is totally of experts and even CDSCO representatives have not been involved in this committee. Therefore, the question of industry involvement does not arise. However, he assured the gathering that due diligence will be main-

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March 1-15, 2016

MARKET tained, industry will be given enough opportunity and government is seriously working to resolve this at the earliest taking patient's safety into consideration.

On DPCO Industry representatives made the point that in the last year, each official had a different interpretation of the DPCO 2013 Act, leading to implementation in 'different draconian' ways.

For example, the manufacturers alleged that if a mistake concerning a few paise was made, the concerned official could end up misrepresenting the case and award a huge penalty going into crores of rupees. This would force the manufacturer to resort to legal action and ultimately resulting in harassment.

Besides this, manufacturers opined that retrospective pricing in schedule products was impractical, again leading to litigation and being a great bottle neck for the SSI segment.

Similarly, industry representatives explained how the capping of margins is a retrogressive step. Few companies do not want to have a team of field force whose expenses amounts to 30-40 per cent of sales.

This too is not a fixed amount, due to various labour laws and union problem.

Manufacturers pass on margins to the distribution channel to avoid all other expenses and labour problems. By capping margins the industry will be eliminated completely thus closing down manufacturers and lessening of employment in factories. This would in turn lead to a shortage of NLEM and other medicines in tier II and III areas.

Moreover, the proposal to cap margins in dosage form of tab and liquid per bottle and ointment, eye drops etc per pack has no rationale.

Representatives stressed that all the above issues impact the survival of the SSI and MSME segment and the government must act to save this section of the industry.

Impact of GST Industry experts like Jain from Akums also highlighted how GST would be detrimental to the pharma companies in excise free zones, where they opine that the industry has survived because of MRP (Maximum retail Price)-based excise duty structure. After implementation of GST. It will be levied on sales value of i.e. on transaction value and not on MRP less abatement. Like other

states, excise free zones will take input tax credit and pay applicable GST. It is doubtful that the government will give a refund even for value added tax; and even if refund is allowed, it would be a cumbersome procedure. Marketing companies would expect adjustment of possible refund from contract manufacturers in advance, whereas refunds would take time thus would affect the cash flow of the manufacturers.

As per Para 3.9 of the first discussion paper on 'Goods & Services in India' circulated by the Government of India in November 2009, exemptions and remissions under Special Industrial Area Schemes would continue up to legitimate expiry time both for the centre and the state; and these will be converted into cash refund scheme, after collection of taxes.

Promises given by Government of India under the new Industrial policy dated 07.01.2013 read with Excise Notifications 49 & 50 dated 10.06.2003 and as affirmed by Para 3.9 of First discussion paper on 'Goods & Services in India' are missing in 'Goods & Services Tax Bill, 2016' submitted by Government of India in the form of 'Model GST Law.' Refund Mechanism provided under 'Model GST Law' also does not provide any system of refund for excise free zones; though government officials orally still assure for such refunds.

These experts opine that IDMA and FOPE must make representation to the government to ensure that the benefits are incorporated into the new enactment. Once the old Acts are repealed without a saving clause in clear words in GST, the government will be helpless to give any benefit even through a notification.

Presently, the excise duty rate on raw materials (API) is 12.5 per cent and excise duty rate on pharmaceutical formulations (medicines) is six per cent. If the government categorises APIs under ‘standard’ GST Rate say 18 per cent and medicines under ‘Merit’ GST Rate say 12 per cent; then both the exporters and pharma manufacturers may have to put their shutter down and close their business. Exporters have been representing; and is the need of the industry that input tax rates and output tax rates are same.

The vote of thanks was given by Vinod Gupta, Co Chairman - FOPE & Vice Chairman - HDMA and Chairman - Meridian Medicare.

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EP News Bureau-Mumbai

EXPRESS PHARMA

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March 1-15, 2016

MARKET GROWTH TRACKER

IPM clocks ` 8014 crore in January 2016 Nine therapies have outgrown the IPM growth THE INDIAN Pharma Market (IPM) clocked ` 8014 crores in January 2016 and has grown at 9.1 per cent.

Amongst the top 10, Mankind grew by 26.8 per cent, Lupin by 13.4 per cent and Macleods at 12.7 per cent.

Amongst the top 50 corporate, Bharat Serums had the highest growth of 34.8 per cent followed by Hetero at 29 per cent and Mankind at 26.8 per cent. 23 corporates have shown growths of more than 10 per cent amongst the top 50. Amongst the 11-20 ranked corporates, Alembic had the highest growth of 23 per cent followed by Aristo at 17.3 per cent and Glenmark at 16.3 per cent.

Amongst the 21-30 ranked corporates, FDC had the highest growth at 14.2 per cent followed by Cadila at 11.3 per cent and Novartis at 10 per cent. Amongst the 31-40 ranked corporates, Bharat Serums grew at 34.8 per cent followed by Hetero at 29 per cent and JBCPL at 13.5 per cent. Amongst the 41-50 ranked corporate, Troikaa has the highest growth at 21.5 per cent followed by Wallace* at 16.6 per cent and Systopic at 15.8 per cent.

Amongst the 51-60 ranked corporates, Boehringer Ingelheim grew at 49.5 per cent followed by Corona at 32.4 per cent and Centaur at 24.2 per cent. Amongst the 61-70 ranked corporates, RPG grew at 25.2 per cent followed by Geno which grew at 12 per cent and East India at 11.8 per cent. Amongst the 71-80 ranked corporates, Samarth grew at 21.3 per cent followed

by Shreya at 20.2 per cent and Walter Bushnell at 18.2per cent. Amongst the 81-90 ranked corporates, Galpha grew at 49.2 per cent followed

by Veritaz at 40.5 per cent fol-

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EXPRESS PHARMA

March 1-15, 2016

WITH BONUS UNITS AT FULLVALUE Val in Crs CORPORATE

Rank MAT

MAT Jan-16 MTH

IPM

Jan-15

Jan-16

Val (Cr)

MS%

GR%

Val (Cr)

Val (Cr)

MS%

GR%

96954

100.00

14.0

7348

8014

100.00

9.1

Sun + Ranbaxy

1

1

8526

8.79

13.6

675

726

9.06

7.6

Abbott + Abbott HC + Novo

2

2

5980

6.17

13.5

479

485

6.05

1.1

Cipla

3

3

4848

5.00

16.2

375

419

5.23

11.6

Zydus + Biochem

4

4

4029

4.16

11.4

314

330

4.11

5.1

Mankind

5

5

3587

3.70

19.1

243

308

3.85

26.8

Lupin

6

6

3362

3.47

17.8

246

279

3.48

13.4

Alkem + Cachet + Indchemie

7

7

3360

3.47

11.8

240

266

3.32

10.7

Glaxo

8

8

3189

3.29

6.4

243

258

3.22

6.1

Pfizer

9

10

2860

2.95

11.8

245

236

2.95

-3.4

Macleods

10

9

2809

2.90

14.7

215

242

3.02

12.7

Intas

11

11

2728

2.81

23.5

200

229

2.85

14.5

Emcure + Zuventus

12

13

2545

2.62

10.0

199

203

2.53

1.9

Aristo

13

14

2419

2.50

17.8

161

189

2.36

17.3

Sanofi India

14

15

2359

2.43

12.2

200

185

2.31

-7.3

Glenmark

15

12

2314

2.39

24.9

175

203

2.54

16.3

Torrent

16

16

2254

2.32

19.1

172

185

2.31

7.4

Dr. Reddys

17

17

2229

2.30

16.6

164

181

2.26

10.3

USV

18

18

1924

1.98

18.5

150

169

2.11

12.7

Micro + Bal

19

19

1855

1.91

12.9

133

155

1.93

16.0

Alembic

20

20

1351

1.39

19.2

97

120

1.50

23.0

Wockhardt

21

21

1319

1.36

32.2

101

111

1.38

9.9

Novartis

22

22

1267

1.31

9.2

98

108

1.35

10.0

Ipca

23

23

1249

1.29

8.0

89

98

1.22

9.1

MSD + Fulford + Organon

24

24

1003

1.03

21.8

74

78

0.97

5.3

FDC

25

25

944

0.97

12.5

66

76

0.95

14.2

Unichem

26

26

893

0.92

10.9

72

76

0.94

5.3

Cadila

27

28

725

0.75

8.1

52

58

0.72

11.3

Himalaya

28

27

717

0.74

8.9

54

59

0.73

9.3

Indoco Remedies

29

29

686

0.71

6.4

54

57

0.71

5.5

MARKET lowed by Dabur at 30.9 per cent. Amongst the 91-100 ranked corporate, Ozone grew at 30.2 per cent followed by Serum Institute at 25.9 per cent and Gland at 22.8 per cent.

The 100th biggest corporate was Gland Pharma and 150 th biggest corporate was Claris in the IPM. MSD has entered the ` 1000-crore club, Dey’s Medical, Ozone, Johnson & Johnson entered the ` 100crore club, Medo Pharma and La Renon entered the ` 50crore club on MAT Basis.

Indian companies have grown at 11.4 per cent versus 1.5 per cent for MNCs in January 2016. Amongst the top 50 in MNCs, Merck grew at 11.9 per cent followed by Novartis at 10 per cent and GSK at 6.1 per cent. Under the nonNLEM category Indian companies grew at 12.4 per cent whereas MNCs grew at 1.1 per cent.

The NLEM containing molecules market grew at 5.3 per cent whereas the nonDPCO market grew by 9.8 per cent and Non-Sch Para 19 Market at 6.4 per cent resulting in an overall growth of 9.1 per cent for January 2016.

NLEM and Non - NLEM Category showed unit growth at 4.3 per cent and 2.5 per cent respectively.

Nine therapies have outgrown the IPM growth. Respiratory market grew at 17.8 per cent, gastrointestinal market grew at 11.7 per cent, pain and analgesics market grew at 8.1 per cent whereas anti-infectives grew at 11.9 per cent.

The anti-diabetic market grew at 9.4 per cent and cardiac at 7.3 per cent in chronic business. Derma market grew by 9 per cent and urology market at 4.1 per cent. Antimalarials de-grew at 20.1 per cent.

13 regions have outgrown the IPM growth. The Odisha market grew the highest at 20 per cent followed by Jharkhand at 19.4 per cent and Bihar at 19.3 per cent. The Tamil Nadu market grew at 1.7 per cent and two regions had negative growth in January 2016.

Amoxycillin + Clavulanic acid market grew at 16.4 per

Val in Crs Super Group IPM ANTI-INFECTIVES CARDIAC GASTRO INTESTINAL VITAMINS / MINERALS / NUTRIENTS ANTI DIABETIC RESPIRATORY PAIN / ANALGESICS NEURO / CNS DERMA GYNAECOLOGICAL HORMONES VACCINES ANTI-NEOPLASTICS OPHTHAL BLOOD RELATED UROLOGY OTHERS ANTI MALARIALS STOMATOLOGICALS SEX STIMULANTS / REJUVENATORS

cent and Glimepiride + Metformin Market grew at 8.8 per cent. The markets of paracetamol grew at 28.4 per cent, Atorvastatin 1.3 per cent, Probiotic Microbes at 28.2 per cent, Cefixime 7.1 per cent, Pantoprazole 14.9 per cent, Montelukast + Levocetrizine at 15.3 per cent, Glimepiride + Metformin + Pioglitazone at 9.8 per cent, Vitamin-D at 19.4 per cent, Hydroquinone + Mometasone + Tretinoin at -9 per cent, Voglibose + Metformin + Glimepiride at 30.7 per cent, Rosuvastatin at 12.6 per cent, protein supplements at 11.4 per cent, Azithromycin at 17.1 per cent, calcium carbonate + Vit D3 market at 0.8 per cent, Paracetamol + Phenylephrine + Chlorpheniramine at 15.2 per cent, Meropenem at 45.1 per cent, Montelukast + Fexofenadine at 36.9 per cent. The 50 th biggest market is Sildenafil and 100th biggest market is Cefalexin.

Mixtard leads the pack with ` 31 crores followed by Corex at ` 29 crores, Glycomet GP & Augmentin at ` 28 crores for January 2016.

Few Brands who have gained ranks include Aciloc RD (+94), Electral Powder (+68), Unwanted Kit (+64), Rotarix (+47), Meronem (+43), Duolin (+39), Betnesol (+30), Rabipur

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MAT Jan 16 VAL IN CRS 96954 14858 12099 11363 8664 7817 7685 6692 5954 5800 4723 1641 1678 1561 1401 1102 1050 1054 548 393 537

Month Jan-16 GR% 14.0 10.2 14.3 16.1 11.0 22.7 15.1 12.3 14.8 16.8 11.1 12.0 16.6 10.0 13.2 15.3 17.6 25.0 -0.3 7.0 13.4

VAL IN CRS 8014 1194 1042 899 671 665 745 528 515 488 374 142 125 116 111 86 83 96 28 32 49

GR% 9.1 11.9 7.3 11.7 5.9 9.4 17.8 8.1 10.6 9.0 3.1 9.3 -9.6 -8.5 7.0 11.0 4.1 33.7 -20.1 2.2 3.8

STATEMENT ABOUT OWNERSHIP AND OTHER PARTICULARS OF EXPRESS PHARMA, MUMBAI, AS REQUIRED UNDER RULE 8 OF THE REGISTRATION OF NEWSPAPERS (CENTRAL) RULES, 1956 FORM - IV (SEE RULE 8) 1. Place of Publication 2. Periodicity of its publication 3. Printer's Name Whether citizen of India Address 4. Publisher's Name Whether citizen of India Address 5. Editor's name Whether citizen of India Address 6. Name and address of individuals who own the newspaper AND Shareholders holding more than One per cent of the total capital

: 2nd Floor, Express Towers, Nariman Point, Mumbai-400 021 : FORTNIGHTLY : Ms. Vaidehi Thakar : Yes : 2nd Floor, Express Towers, Nariman Point,Mumbai-400 021 : Ms. Vaidehi Thakar : Yes : 2nd Floor, Express Towers, Nariman Point,Mumbai-400 021 : Ms. Viveka Roychowdhury : Yes : 1st Floor, Express Towers, Nariman Point,Mumbai-400 021 : The Indian Express (P) Ltd. 2nd Floor, Express Towers, Nariman Point, Mumbai 400021 : Indian Express Holdings & Entp Private Limited.

2nd Floor, Express Towers, Nariman Point, Mumbai 400021 : Mr. Viveck Goenka & Mr. Anant Goenka 2nd Floor, Express Towers, Nariman Point Mumbai 400021 : Mr. Shekhar Gupta & Mrs. Neelam Jolly C-6/53, Safdarjung Development Area New Delhi 110 016

I, VAIDEHI THAKAR., hereby declare that the particulars given above are true and to the best of my knowledge and belief.

Date : 1/3/2016

sd/VAIDEHI THAKAR Publisher

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MARKET (+28), Vertin (+27), Jalra M (+26), Ultracet, Betnovate N (+23), Deriphyllin (+21), Sapsmoproxyvon Plus (+20), Monocef –O (+18), Trajenta (+17)< Budecort (+16), Betnovate C , Dolo (+15), Levipil (+14), Voveran, Pamderm Plus, Telma, Rosuvas, Ascoril Plus (+13), Pan, Calpol, Thyronorm, Januvia, Azithral (+12), Janumet (+11), Telma H, Pantocid D SR (+10), TaximO, Moxikind CV, Gluconorm-G (+9), GalvusMet, Susten, Rantac, Pantop (+8), Clavam, Sinarest (+4) amongst top 100 brands over January 2015.

Mero (+182), Finecef (+151), Lobate GM (+107), Zerodol SP, Pipzo (+88), Enterogermina (+87), Cilacar (+76), P (+75), Brilinta, Moxclav (+68), Grilinctus (+41), Bevon (+25) are few brands in 101-200 ranked brands. Few brands that have moved up ranks

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13 regions have outgrown the IPM growth.

The Odisha market grew the highest at 20 per cent followed by Jharkhand at 19.4 per cent and Bihar at 19.3 per cent. The Tamil Nadu market grew at 1.7 per cent and two regions had negative growth in January 2016

by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech. AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind AIOCD AWACS’ research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

Terminologies used fastest into Top 300 Brands are Ocid, Grafeel, Similac, Candiforce, Reditux, Anafortan, Mero. The 300 th biggest brand is Reditux from DRL. A total of 239 brands and 401 SKUs were launched in January 2016. The top new brands are Ledviclear, Sofab LP, Hepcinat LP. Three

brands were launched in Sofosbuvir + Ledipasavir category. Within the VMS category are Folyblend (Akesiss), Pforu (Galpha), Macgesia (Macleods), within anti-diabetic are Kmet Duo (Blue Cross), Glurest M (Alde Medi Impex), Satrvog GM ( Merck) and within respiratory, we see

Solitair (Blue Cross), Monokast FX, Monokast (TTK), Ebmont FX3 (MMC).

The biggest new launch by a MNC is Ledviclear in January 2016.

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted

MAT – Moving Annual Total MTH – Month Val (Cr) – Value in Crores MS per cent – Market Share in Percentage GR per cent – Growth in percentage.

For more information, visit http://www.aiocdawacs.com/

EVENT BRIEF MARCH 2016 - APRIL 2016 4

Healthcare Sabha 2016

HEALTHCARE SABHA 2016 Date: March 4-6, 2016 Venue: Marriott Hotel and Convention Center, Hyderabad Summary: In keeping with the objectives of the National Health Mission pertaining to ‘Universal Access to Equitable, Affordable and Quality Healthcare Services’, the Indian Express Group and Express Healthcare are organising Healthcare Sabha 2016 – The National Thought Leadership Forum on Public Healthcare.

Contact For Healthcare Sabha 2016 registrations: Shilpa Chaurasia The Indian Express 1st Floor, Express Towers, Nariman Point, Mumbai 400 021 Ph: 08879137185 Email: shilpaindianexpress@gmail.com Website: www.healthcaresabha.in

PHARMA PRO&PACK EXPO 2016 Date: April 27-29, 2016 Venue: Mumbai Exhibition Centre, Mumbai Summary: IPMMA and GPE Expo will organise PHARMA Pro&Pack Expo 2016. The exhibitors profile include: machineries and equipment: Pharma processing M/c (tablet, capsule, injectables, ointments, dry

27

PHARMA Pro&Pack Expo 2016

syrup powder) packaging machineries lab and biotech instruments, glassware, packaging materials, lab-wares and consumable, clean room and environment control products and services, utilities equipment and services, project consultants and turn key contractors.

Contact details PHARMA Pro&Pack Expo 2016 / Mumbai GPE Expo Global, 402-403, Abhijyot Square B/h Divya Bhaskar, SG Highway Ahmedabad 380 051 T: +91-79-40008233 / 40008253 E:mail@PharmaProPack.com W: www.PharmaProPack.com

DOP/PAO Leak Testing Air Flow Pattern (Smoke)Test

2ND EDITION OF ASIA LABEX Date: September 22-24, 2016 Venue: Gujarat University Convention & Exhibition Centre, Ahmedabad Summary: Asia Labex is a premiere exhibition and conference on laboratory, analytical, scientific, diagnostic, biotechnology, research and testing instruments and consumables. The exhibition will be organised by Fenza Exhibitons.

Contact details: Fenza Exhibitions Plot No 1, 2nd Floor, GT Karnal Road, Opposite PNB Bank, New Delhi – 110033

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cover )

WAITING TO IPO? Will the bullish response to last year's IPOs in the pharma and healthcare sector spur more companies to test the market in 2016? Will these hopefuls succeed in timing their IPOs just right? Or is this just hype and hope?

VIVEKA ROYCHOWDHURY

L

ast year’s IPOs of Syngene International and Alkem Laboratories in the pharmaceutical space and Dr Lal Path Labs and Narayana Hrudayalaya in the healthcare sector were pleasant surprises to say the least. All four IPOs did much better than others in the ring and many analysts predicted that 2016 would see many more such bids from pharmaceutical and healthcare enterprises.

The rationale was these favourable responses would finally encourage promoters and investors of companies said to be ripe for an IPO to take the plunge to book profits and exit, either partially or fully.

But other experts were not so impressed. They cautioned that just four successful IPOs were not enough to

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sway sentiment towards the sector and determine that it was finally getting its due from the market.

Across sectors, the numbers show that the urge to IPO seems to be picking up. According to a PTI report dated November 23, last year saw 40 companies filing their draft documents with SEBI to float IPOs, with 31 getting approval, including some pending from 2014. By November, 18 companies had launched IPOs and collectively raised nearly ` 11,000 crore, making 2015 the best in four years in terms of fund raising through initial share-sale programmes. In contrast, just six IPOs had hit the market in 2014, together garnering a mere ` 1,261 crore, while three firms had launched their public issues in 2013

to mobilise ` 1,284 crore.

The first good news specific to the pharma sector was that the IPO of Syngene International, Biocon’s contract research and manufacturing subsidiary was heavily oversubscribed, by as much as 32 per cent on the first day of the IPO itself. Perhaps more importantly, the stock continued to surge post IPO, even touching 45 per cent at one point of time.

The Alkem Laboratories IPO, slated to raise ` 1,350 crore, saw the issue subscribed 44 times, reportedly with the high net worth individual (HNI) category subscribed nearly 130 times. Similarly, the Dr Lal Path Labs’ IPO was oversubscribed 33 times. This time, the charge was led by institutional investors who report-

edly put in bids worth 63 times the allocated amount. These successes had a positive impact on the ` 613 crore IPO of Dr Devi Shetty’s Narayana Hrudayalaya.

The calm before the storm?

A quarter later, with the heat and dust settled, sentiments remain mixed. Munish Aggarwal, Director, Equirus Capital, a mid-size investment banking firm, remains upbeat, predicting that from the capital market perspective, this is possibly the best year in the last three to five years.

He supports his prediction with two reasons. Firstly, according to him, the pharma sector boasts of many high quality scaled-up businesses which are still private. He points out

(

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THE MAIN FOCUS

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cover ) Globally, healthcare is leading 2016 so far in the number of filings for equity offerings. In 2015, nine of the top 10 performing IPOs were in healthcare, but so were eight of the 10 worst performers for the year Mahesh Singhi Managing Director, Singhi Advisors

that many companies like Eris Lifesciences, Intas Pharma, Mankind Pharma and many others of a similar size and scale, have contemplated IPOs in the past but changed their plans because of an inactive IPO market.

“The successful IPOs of Syngene International, Alkem Laboratories and others have put to rest these concerns and some of these companies, especially those backed by PE firms, are expected to take advantage of this IPO window to raise capital or exit,” says Aggarwal.

And secondly, Aggarwal reasons that the demand slowdown in global as well as Indian markets will have a limited impact on this sector.

But in spite of his optimism, he too refrains from predicting exactly when we will see the next wave of pharma/healthcare IPOs.

Next in line

Pharma sector boasts of many high quality scaledup businesses which are still private. Companies like Eris Lifesciences, Intas Pharma, Mankind Pharma or many other of similar size and scale have contemplated IPOs in the past but changed their plans because of inactive IPO markets Munish Aggarwal, Director, Equirus Capital

20 EXPRESS PHARMA March 1-15, 2016

But how narrow or wide is the ‘IPO window’? This is the proverbial million dollar question, which plagues IPO aspirants. Besides the financial gains of an IPO, there is no doubt that the company gains brand visibility and attracts attention, both from existing as well as prospective clients. For instance, take the north-based New Delhi Centre For Sight, a chain of specialty eye care centres which filed its Draft Red Herring Prospectus (DHRP) in November last year. According to its DHRP, the company plans to use the funds generated to expand the footprint to Central and East India, as well as diversify its revenue streams by serving demand in medical tourism, expanding in pharmacy and optical sales and clinical research.

Mahesh Singhi, Managing Director, Singhi Advisors points out that companies to be tracked are Intas Pharma, Blue Cross, Advanced Enzyme Technologies and Thyrocare Technologies, who are most likely to hit the markets first as they have already filed their DRHP with SEBI or are planning to do so. Bangalore-

based Healthcare Global Enterprises (HCG) too received SEBI approval to float an IPO while Aster DM Healthcare is also said to be filing its IPO this year to fund its growth aspirations.

Singhi too says it is very difficult to give any time line since a major rout is ongoing in global capital markets including India, hinting that companies and bankers would want to wait for conditions to stabilise before hitting the market.

If priced right, these opportunities will be attractive for both retail and institutional investors reasons Aggarwal as the basic fundamentals driving this sentiment remain intact, namely, a relatively stable demand scenario, benign commodity prices and favourable currency movement.

Singhi too sees more demand for (IPOs of) pharma companies than companies in other sectors because as he points out, many IPOs like Just Dial, Inox Wind, Interglobe Aviation, Coffee Day Enterprises are now trading below IPO prices. He reasons that investors would want to go with stable businesses like pharma, which have very high entry barriers and (are) defensive businesses.

Singhi cites the size of the Indian pharma market (third largest in terms of volume and 13th largest in terms of value) and the growth potential as the major drivers. The Indian pharma industry is estimated to grow 20 per cent CAGR 2016-2020, and will touch ` 6 trillion by 2025. If it maintains this growth rate, it will outperform the global pharma industry, which is set to grow at an annual rate of five per cent between the same period.

Analysing the growth drivers, Singhi says, “This growth will be backed by increased exports and increasing consumer spending, rapid urbanisation, raising healthcare insurance among others to fire the growth in the domestic market. Going forward, better growth in domestic sales would also

depend on the ability of companies to align their product portfolio towards chronic therapies for diseases such as cardiovascular, anti-diabetes, anti-depressants and anticancers that are on the rise.”

In terms of investor mix, Singhi’s analysis is that retail investors (non HNI) have been largely keeping away from both the secondary and primary capital markets. He points out that the retail subscription in recent IPOs has been very low across sectors as compared to QIP portion, which got oversubscribed multiple times. He assumes that there will be heavy participation from institutional investors only in the case of pharma IPOs.

The flip side The numbers are familiar figures found in most industry reports but will these predictions turn into fact? On the flip side, Aggarwal lists three main factors which could derail the IPO dreams of pharma companies. Firstly, and not surprisingly, the increased regulatory risk in terms of increased FDA related litigation is a real worry.

As Singhi puts it, “Muted export revenue growth and stringent USFDA compliance requirements/ warnings may be the spoilsport for the pharma sector.” So though overall pharma exports are expected to grow at about five per cent, the recent increase in US FDA regulatory actions, including several warning letters and import alerts against Indian facilities of domestic companies on quality related issues, is likely to restrict growth of exports to the US. Volatile secondary markets and continued FII pullout from domestic markets and a flight to safety make up this trio of red flags, says Aggarwal.

Regulatory challenges top the list of global cues which could impact this trend followed by the shift from branded generics to pure generics as is witnessed in many European countries

which will lead to severe price cuts making brands redundant is another negative which could dim IPO prospects.

Thirdly, manufacturing costs across geographies are tending to become equal as pharma sourcing has become global in nature and this is diluting the manufacturing cost advantage that India enjoyed.

On the biologics side, the increasing use of biotech products pose challenges to synthetic products. On the other hand, entry into biosimilars in regulated market is still with a lot of hurdles, points out Aggarwal.

Singhi also highlights that the higher depreciation of emerging market currencies is also likely to impact export growth to semi-regulated markets. Many companies are in fact cutting back or pulling out of such volatile markets, looking to deploy resources in other territories.

According to Singhi, at a global level, the healthcare sector, (which includes pharma stocks), is leading 2016 so far in the number of filings for equity offerings.

But he also points to a sobering fact. “In 2015, nine of the top 10 performing IPOs were in healthcare, but so were eight of the 10 worst performers for the year. It is difficult for investors to determine which companies will do well.

Biotech companies, in particular, often have products that are still in development and not yet approved for sale when they file to go public,” he cautions.

In India, according to market estimates, almost ` 14,000 crore was raised across sectors from the markets last year, and this year, the figure is predicted to be more than three times, at around ` 50,000 crore. Some point out that it was a cashing out of PE investors rather than growth compulsions which led to most IPOs. But the IPO kitty looks tempting.

Whether it turns out to be an illusion or reality, only time will tell. viveka.r@expressindia.com

MANAGEMENT REPORT

India’s medical devices market will hit $17.6 bn by 2020: GlobalData The market will undergo significant changes, driven by mounting patient awareness of advancements in medical technology, and an aging population

IKA® Plant Systems Laboratory, Analytical and Process Technology Scale-up from Laboratory to Production achieved through consistent tip speeds and mixing tool geometries.

T

he medical devices space in India will see impressive expansion, rising from $10.4 billion in 2014 to reach $17.6 billion by 2020, representing a robust Compound Annual Growth Rate (CAGR) of 9.4 per cent, according to research and consulting firm GlobalData.

The company’s report states that although this market will not see the same level of growth as the pharmaceutical sector, it will still undergo significant changes, driven by mounting patient awareness of advancements in medical technology, and an aging population.

Adam Dion, Senior Industry Analyst, GlobalData says that India’s medical device market is one of the fastest-growing, thanks to the country’s strong economic growth and improving living standards.

In terms of current opportunities within the medical devices arena, ophthalmic devices take up the largest proportion of market share.

Dion notes that,“Johnson & Johnson Vision Care and Essilor International are the current market leaders in India’s ophthalmology devices space, but they face competition from several major players, such as Carl Zeiss, Bausch & Lomb (i.e.

Valeant), and Novartis’ Alcon subsidiary."

IKAworldwide

IKAworldwide /// #lookattheblue

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IKA® India Private Limited 814/475 · Survey No.129/1 · Mysore Road · Kengeri Bangalore - 560060 · Karnataka · India Tel. +91 80 26253 900 · Fax +91 80 26253 901 Hotline: 1800-42-555-444 info@ika.in · www.ika.com

EP News Bureau-Mumbai

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MANAGEMENT REPORT

CubeX maps health and wellness opportunity among Indian women Its report also captures all the trends and new launches in the Indian women health market

R

ealising the changing dynamics of the Indian OTC market, CubeX has updated its report â&#x20AC;&#x201D; 'Decoding the Better Half of India â&#x20AC;&#x201D; Mapping the Health and Wellness Opportunity among Indian Women (V2).' The new version of the report details this potential market opportunity which many marketers are still missing.

According to United Nations, Indiaâ&#x20AC;&#x2122;s female working population (age between 15-64 years) is expected to increase by 18 per cent between 2015 and 2030.

Growing income will fuel direct demand for health products.

Digital technology has further equipped consumers with access to global information.

Adoption of digital technology by women population has augmented the purchase power of these set of consumers. According to a survey conducted

by Google in 2014, one-third of total Indian population with Internet access are women. About

22 EXPRESS PHARMA March 1-15, 2016

32 per cent of younger women who do not use Internet are keen to use it soon and 46 per cent of non-users in the age group of 1829 years are likely to use Internet soon. This opens up a huge opportunity in digital marketing of OTC products. The survey further revealed that majority of women who use Internet have higher incomes.

The updated report captures all these trends and also the new launches in the Indian women health market, their success stories along with the case studies of global products. Further it encompasses health concerns and needs of women at different age groups, prevalence of women health conditions in India, market dynamics with respect to size and top brands in each category, opportunity areas and profiles of key market players with their marketing strategies for marketers to act beyond their usual marketing activities.

About 51.6 per cent of women

in India make their healthcare decisions (IJSS Vol. 2, 2013) and the trend is growing. However, there is still a dearth of appealing promotions and products attracting women consumers. Realising the increasing trend of women making informed medical choices, Revital Woman, Ostocalcium, Voltaren Gel, V Wash, Lactacyd, and Unwanted-21 are

few inspirational brands targeting women consumers through multichannel approaches. Furthermore, companies are launching new variants extending the product life cycle, thus sustaining themselves in this competitive market.

Innovative marketing plans engaging women and addressing their concerns precisely has

benefitted these brands. Creating a persuasive story and an emotional appeal with rational offering are vital elements in women centric marketing. For instance, V Wash launched in 2010 became a million dollar brand within a short span of time. Communicating intimate concerns of women in an effective manner and launching of variants (like VWash Wipes) with attractive packaging are the success factors of VWash.

Further, growing awareness among the female population is driving the market growth of feminine intimate care at a CAGR of 15 per cent (2010 2014).

Companies such as GSK, Sanofi, Glenmark, Emami and Sun Pharma (Ranbaxy) have capitalised on this growing opportunity through innovative marketing strategies. Some of these women centric companies have been also profiled in detail in the new version.

(CubeX is the Strategic Consulting and Business Intelligence division of Sorento Healthcare Communications)

RESEARCH

Gastric reflux drugs may be tied to dementia risk The drugs do carry an increased risk of kidney disease, fracture, low magnesium levels, gastrointestinal infections, Clostridium difficile infection and pneumonia REPEATED USE of a certain class of drugs for gastric reflux or peptic ulcers was linked with a higher risk for dementia among patients in Germany, researchers say. The drugs, known as proton pump inhibitors (PPIs), include lansoprazole (Prevacid), manufactured

by Novartis, as well as esomeprazole (Nexium) and omeprazole (Prilosec), both manufactured by AstraZeneca.

The current study can only provide a statistical association between PPI prescriptions and occurrence of dementia in the elderly. It can’t prove that PPIs actually cause dementia, said senior author Britta Haenisch of the German Center for Neurodegenerative Diseases in Bonn, Germany.

“In our analysis we focused on longterm regular PPI prescription for at least 18 months,” Haenisch said. The researchers examined medical records from 2004 through 2011 from more than 73,000 patients age 75 and older, mostly women. They classified 2,950 of those patients as regular PPI users, meaning they had at least one prescription for one of the drugs every four or five months over an 18-month period. During the study period, 29,510 people developed dementia.

Regular PPI users were 44 per cent more likely to develop dementia than those who were not receiving the drugs, the authors reported in JAMA Neurology.

The researchers couldn’t know

whether some of the people in the study were at increased risk for dementia to start with, Haenisch said.

PPI use and dementia may both be influenced by similar risk factors, Dr Lewis H Kuller of the University of Pittsburgh wrote in an editorial accompanying the results.

In the Women’s Health Initiative, for example, women who took PPIs were more often obese, had arthritis, and had poorer health generally than others, which may increase dementia risk, Kuller wrote.

The drugs do carry an increased risk of kidney disease, fracture, low magnesium levels, gastrointestinal infections, Clostridium difficile infection and pneumonia, Kuller said. Some PPIs are available without a prescription, but prescriptions are needed for long-term use, he said.

Some of the drugs may cross the blood-brain barrier and interact with brain enzymes, or they may be associated with vitamin B12 deficiency, which may promote neurological damage, she said. “Patients should take the drugs according to their doctor’s instructions,” Haenisch said. “To evaluate cause and effect relationships between long-term PPI use and possible effects on cognition in the elderly randomised, prospective clinical trials are needed.”

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Reuters

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RESEARCH

Study suggests Zika can cross placenta,adds to microcephaly link The women had symptoms of Zika infection — including fever, muscle pain and a rash — during their first trimester of pregnancy

IN WHAT experts describe as another piece of evidence linking Zika with the risk of birth defects, researchers reported finding the virus in the amniotic fluid of two pregnant women whose foetuses were diagnosed with microcephaly. In a study in the Lancet Infectious Diseases journal, the scientists said their finding suggests Zika virus can cross the placental barrier, but does not prove it causes microcephaly, a condition in which babies are born with abnormally small heads.

More research is needed to understand the link, they said. “This study cannot determine whether the Zika virus identified in these two cases was the cause of microcephaly in the babies,” said Ana de Filippis, the doctor who led the study at the Oswaldo Cruz Institute in Rio de Janeiro, Brazil.

"Until we understand the biological mechanism linking Zika virus to microcephaly, we cannot be certain that one causes the other." Many scientists believe Zika, a mosquito-borne disease that is currently sweeping through the Americas, may be a risk factor for microcephaly in newborns, as well as for a serious neurological disorder in adults called Guillain-Barre syndrome.

The World Health Organization has declared the Zika epidemic spreading from Brazil a global public health emergency and called for urgent studies to establish with its association with rising number of cases of suspected birth defects can be proven.

24 EXPRESS PHARMA March 1-15, 2016

The number of suspected cases of babies with microcephaly in Brazil in 2015 has increased 20-fold compared with previous years De Filippis' study noted that the number of suspected cases of babies with microcephaly in Brazil in 2015 has increased 20-fold compared with previous years. At the same time, Brazil is reporting high numbers of Zika

virus infections.

Babies born with microcephaly are at risk of incomplete brain development. The condition has previously been linked to a range of factors including genetic disorders, drug or chemical intox-

Zafgen obesity drug succeeds in mid-stage trial

ication, maternal malnutrition and infections with viruses or bacteria that can cross the placental barrier such as herpes, HIV, or other mosquito-borne viruses such as chikungunya. For this study, de Filippis' team investigated the cases of two women, aged 27 and 35, from Paraiba in northeastern Brazil.

The women had symptoms of Zika infection — including fever, muscle pain and a rash — during their first trimester of pregnancy.

Ultrasounds taken at approximately 22 weeks of pregnancy confirmed the foetuses had microcephaly.

The researchers took and analysed samples of amniotic fluid at 28 weeks of pregnancy. While the women's blood and urine samples tested negative for Zika, their amniotic fluid tested positive for the virus genome and for Zika antibodies. "Details of the Zika virus being identified directly in the amniotic fluid of a woman during her pregnancy suggest ... the virus could cross the placental barrier and potentially infect the foetus," de Filippis said. Jimmy Whitworth, a Zika expert and professor of international public health at the London School of Hygiene & Tropical Medicine, said the findings "strengthen the body of evidence" pointing to Zika as a cause of microcephaly in Brazil.

But he noted that while studies of this sort can show associations, they can't show direct causation.

ZAFGEN'S controversial obesity drug reduced the weight of overweight diabetic patients, the second trial success in as many months for the drug on which all tests have been halted since December after two patients died.

The company said patients given 1.8 mg and 1.2 mg doses of beloranib lost 12.7 and 13.5 per cent of their body weight, respectively, in a mid-stage study, while patients given a placebo only lost 3.1 per cent of their weight.

Analysts have said positive data from the trial would help Zafgen build a strong case to persuade the US Food and Drug Administration to allow it to restart tests. “A subsequent lifting of the clinical hold ... could send the stock near the $20 range,” RBC Capital Markets analyst said in a note.

The FDA asked Zafgen to halt all tests on beloranib in December after a second patient died during a trial. Obesity treatments have generally been plagued by safety concerns, particularly related to heart risk and birth defects, and several have been taken off the market. Last month, Zafgen said beloranib was successful in treating Prader-Willi syndrome (PWS), the most common genetic cause of life-threatening obesity, in a late-stage trial. Zafgen plans to present to the FDA data from both trials, conducted before the FDA stopped tests, and a proposal for a risk mitigation strategy for beloranib in PWS to resolve the complete clinical hold.

The company said it was working to better understand the potential impact of the drug on thrombosis. Both patient deaths associated with the treatment were related to blood clotting. In the latest trial, nine serious adverse events were identified in eight patients, including pulmonary embolism and deep vein thrombosis.

Reuters

Reuters

RESEARCH

Testosterone therapy improves libido but not vitality in older men MEN OVER 64 with low levels of testosterone saw modest improvements in libido and sexual activity when treated with a gel that contains the male hormone, according to US researchers.

The treatments did not significantly improve vitality or walking distance in people tested for those problems, according to the results in the New England Journal of Medicine. However, researchers did find that when they tested all 790 volunteers to search for improvements in walking and mood - even if men hadn't complained about problems in those areas - they saw significant improvement The participants were all at least 65 years old, and they all had unequivocally low testosterone concentrations.

"The results don't apply to others," chief author Dr Peter Snyder at the University of Pennsylvania in Philadelphia said. Altogether, the researchers tested the gel in seven different trials, and men could participate in more than one. The new report focuses on the trials that assessed the effect of testosterone gel on sexual function, physical function and vitality. Data on its effect on bones and cognitive function, and whether it causes anemia or heart problems, are still being analysed.

But Dr Abraham Morgentaler, director of Menâ&#x20AC;&#x2122;s Health Boston and a urologist on staff at Beth Israel Deaconess Medical Center, called the results "a game changer" that no longer allows critics of testosterone therapy to say the benefits of the treatment are unproven.

He is the author of the book "Testosterone for Life," which promotes the therapy.

Morgentaler said that such treatments probably cost $300 to $400 per month if not covered by health insurance.

Testosterone levels decrease with age and have been linked to declines in energy, sexual

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function and mobility. Past attempts to use testosterone treatment to reverse those

problems have produced inconsistent results. Nonetheless, 430 million testosterone pre-

scriptions were written in 2012 - often for middle-aged men - in part because of â&#x20AC;&#x2DC;Low Tâ&#x20AC;&#x2122; com-

mercials on television.

Reuters

RESEARCH

Regulus hep C combo drug Zika vaccine shows effective in mid-stage study promise in mice, lifting maker Inovio

Regulus enrolled 79 patients with chronic hepatitis C virus and 38 of these patients were being evaluated through eight weeks of follow up REGULUS THERAPEUTICS said interim mid-stage data for its hepatitis C combination drug showed it had the potential to sharply reduce the duration of the treatment to four weeks from 12 weeks. Regulus tested its injectable drug, RG101, separately with FDA-approved hepatitis C drugs such as Gilead Sciences’ Harvoni, Johnson & Johnson’s Olysio, and Bristol Myers Squibb’s Daklinza.

Jefferies analyst Brian Abrahams said Gilead’s hepatitis C drug sales may take a hit if Regulus's treatment turns out to be more effective in combination with drugs developed by its rivals. Gilead, with its two blockbuster drugs Harvoni and Sovaldi, has dominated the market for hepatitis C, which affects about 185 million people worldwide. Harvoni's total sales were $13.86 billion in 2015.

However, the company has been facing growing competition from rival treatments developed

by AbbVie and Merck. Wedbush securities analyst Liana Moussatos said she expected Regulus's

drug to be priced either in line or less than the oral pills. Regulus enrolled 79 patients with chronic hepatitis C virus and 38 of these patients were being evaluated

through eight weeks of follow up.

The data showed 97 per cent of these patients had a sustained reduction of the virus at eight weeks of the treatment.

Analysts called Regulus's interim data set impressive but cautioned that longer follow-up period would be needed to asses the drug's curative potential. Regulus said it expected to report 12week response data in the second quarter.

Most adverse events were mild to moderate though it appears there were two serious adverse events that required hospitalisation, one possibly occurred after dosing, Abrahams said.

Investors will be keen to know whether there will be any other adverse effects related to the treatment during the study, Cowen and Co analyst Eric Schmidt wrote in a note.

Reuters

FDA approves UCB's drug to treat epilepsy-related seizures The approval comes nearly two months after the European health regulators recommended approval of the drug, Briviact, in Europe THE US Food and Drug Administration (US FDA) approved Belgian drugmaker UCB SA's drug as an add-on therapy to treat partial seizures caused by epilepsy. The FDA approval comes nearly two months after the European health regulators recommended approval of the drug, Briviact, in Europe.

26 EXPRESS PHARMA March 1-15, 2016

Briviact has been approved for use in epileptic patients who are 16 years and older. The Belgian drugmaker has been active in epilepsy drug research and development for over 20 years and treating the disease forms an important plank of its business. Epilepsy is a chronic disorder of the brain characterised

by recurrent seizures, which are brief episodes of abnormal brain activity.

About 50 million people worldwide have epilepsy, making it one of the most common neurological diseases globally, according to the World Health Organization.

Reuters

The test will be next conducted on non-human primates and initiate clinical product manufacturing HOPES OF developing a vaccine against Zika took a small step forward as Inovio Pharmaceuticals said its experimental shot had induced a robust and durable response in mice.

At least 15 companies and academic groups are currently racing to develop Zika vaccines, according to the World Health Organization (WHO), spurred on by growing public concern over the virus sweeping across the Americas. Zika, whose symptoms include mild fever and rash, has been linked to brain damage in thousands of babies in Brazil, although the connection is not yet proven.

There is no proven treatment or vaccine for the disease, a close cousin of the viruses that cause dengue, chikungunya and West Nile fever.

Inovio said that mice given its vaccine showed the development of antibodies and generated a response from T-cells, which play an important role in immunising the body. "We will next test the vaccine in non-human primates and initiate clinical product manufacturing. We plan to initiate Phase I human testing of our Zika vaccine before the end of 2016," said Joseph Kim, Chief Executive Officer, Inovio.

Phase I is the first stage in a three-step process of testing new medicines and involves giving an experimental product to healthy volunteers. Inovio's DNAbased vaccine is being developed with South Korea's GeneOne Life Sciences and academic collaborators. One Canadian collaborator said

last month that vaccine testing on humans could begin as early as August.

Other organisations with relatively advanced Zika vaccine projects include India's Bharat Biotech, which said earlier this month that its experimental vaccine would start pre-clinical trials in animals imminently. The US National Institutes for Health is also working on another DNA vaccine, while France's Sanofi, which makes the world's first vaccine for dengue, said that it was launching a Zika project.

Despite the accelerated work programme, however, the WHO estimates it will still be at least 18 months before any Zika vaccines are ready to be tested in largescale clinical trials. Much remains unknown about Zika, including whether the virus actually causes microcephaly, a condition marked by an abnormally small head size in newborns, although the WHO believes the suspected link could be confirmed within weeks.

Brazil is investigating the potential link between Zika infections and more than 4,300 suspected microcephaly cases. An estimated 80 per cent of people with Zika have no symptoms, making it difficult for pregnant women to know whether they have been infected.

Experts say the developing of a useable preventative shot against the disease will not be simple, particularly due to concerns surrounding the safety of vaccinating pregnant women.

Reuters

PHARMA ALLY I N T E R V I E W

‘The US office will play a key role in establishment of new contacts and customers in Latin America’ Ideal Cures has recently opened a representative office in the US to augment its global reach to the Americas.

Suresh Pareek, Managing Director, Ideal Cures, speaks to Sachin Jagdale about the new venture in the US

What will be the key responsibilities of your newly opened US office?

The key responsibilities of our newly opened US office will be to expand our business footprint in the Americas by building an organisation to support customers in Canada, the US, Mexico and Latin America. Business development strategies from a global perspective will also be a key responsibility along with working closely with the head office in India and satellite offices in Europe and Israel.

Where in US has the office been opened?

The office is opened in the Greater Philadelphia Area.

What will be the employee strength?

Initially, we will recruit people to manage the application labs and then build a full-fledged manufacturing workforce, so we plan to start with a few people (three to five) and then expand to support the customers’ need and demand.

What are your current

28 EXPRESS PHARMA March 1-15, 2016

business figures in the US market? How will your US office help augment these figures?

We have many companies who are our customers in Asia and Europe but we are not supplying our products to these companies in the US. Once they are aware of our services in the US, they will start considering us seriously for their requirement in the US markets and this will eventually help in our growth.

The US office will further play a key role in establishment of new contacts and customers in the Latin American countries.

Ideal Cures has a welldeveloped market in Asia and Europe compared to the US market. Why so?

We first established ourselves firmly in India and neighbouring countries and then expanded to rest of the Middle East by establishing an office in Israel. Next, we targeted Europe where we already had a tech team and an application lab to support customers. It usually takes

three to five years of developmental activities and support to customers for getting a firm hold in the market. The Europe office started in 2009 and since it is well established now, we decided to expand to the Americas.

When do you plan to start construction of the manufacturing plant in the US? Which products will be manufactured in the new facility?

We expect to have manufacturing capabilities within the next two to three years with application lab support available within a year. Ideal cures will offer all its products to the industry, based on the regulatory climate in each country and will lead with our flagship Instacoat ready to use film coating systems.

Which markets will the US plant cater to?

The US plant will cater to both North and South America. sachin.jagdale@expressindia.com

PHARMA ALLY I N T E R V I E W

‘Mass Spectrometry helps in better understanding of diseases like Alzheimer’s and Parkinson’s’ Dr David Smith, course leader for MSc Biotechnology and senior lecturer in biochemistry, Sheffield Hallam University, UK talks about importance of mass spectrometry in the biotechnological research, in discussion with Sachin Jagdale

How the use of Mass Spectrometry Imaging (MSI) could reduce the need for animal testing in pre-clinical research projects?

Mass Spectrometry Imaging (MSI) allows thousands of molecules to be located within a sample or tissue. Using this technique, researchers no longer need to have knowledge of the important and relevant molecules before they conduct an experiment, making the experiment target free.

As a range of molecules are detected at once, one sample can provide a large amount of information that previously would have needed multiple samples. This, in itself, reduces the number of animals needed to conduct pre-clinical trials.

With MSI, if a new molecule becomes relevant later then the researcher can interrogate the original dataset without needing to repeat the experiment and, therefore, the testing. MSI can be used to observe the change in proteins across a tumour or the distribution of a drug in a tissue.

When coupled with tissue engineering and 3D cell culture methods, model systems can be made that closely mimic the animal models, such as living skin equivalents and cancer spheroids. These models allow the toxicity and effectiveness of drugs to be tested, in this case, without the need for animals to be used in any part of the testing process.

Kindly shed more light on Mass Spectrometry’s (MS) role in better understanding of diseases like Alzheimer’s and Parkinson’s.

One of the central theories about the development and progression of Alzheimer’s and Parkinson’s disease is that specific proteins and peptides come together in the brain to form a structure called amyloid. This is part of the so-called ‘amyloid cascade’ hypothesis. During the assembly of amyloid material, very small toxic structures are formed from these proteins and peptides called oligomers.

These oligomers, which are known to be able to kill brain cells, can be observed in cell culture, animal models and human samples. Mass spectrometry is ideally suited to observe these oligomers assembled in the test tube and ask questions such as what brings these structures together in the first place. Using this method, we can work out how big the oligomers are, what shape they form and crucially how we can prevent them from assembling — leading to Alzheimer's disease or Parkinson's disease — by the use of drugs.

What is your observation regarding MSc biotechnology curriculum which is being taught in Indian colleges?

I have limited experience of the MSc Biotechnology curriculum in Indian colleges. However, the teaching staff I have met, have first-hand knowledge of

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that students and staff are able to access the latest technology that enables world-class research and innovation. Those students who can graduate from an institution where they have been able to access industry-standard facilities will leave fully-prepared to begin their careers, without the need for further training.

biotechnology and its application in research and industry.

Use of MS is always an expensive affair for any Indian teaching institute. How to overcome this problem?

It is true that MS is expensive and technical. One solution might be for institutes to work together to set up regional centres where access to instruments and materials could be located. Such centres could all contribute to the purchase and running of the technology and allow access to researchers and students in a collaborative manner. Alternatively, students or staff can develop partnerships and agreements with organisations or institutions which do have access to these facilities.

India has no dearth of talented mathematicians, engineers and biotechnologists. But many of them prefer career abroad. What steps need to be taken to retain this talent?

Talented science, technology, engineering and maths (STEM) graduates will always go where they can find the most challenging and rewarding careers. The most passionate STEM graduates are often drawn by the opportunity to be innovative in their fields so countries which are developing and creating exciting opportunities in STEM industries should have no problem retaining the most talented graduates. Biotechnology is a major, growing industry and research area in India. According to the ‘Make In India’ campaign, the Indian biotech industry will grow at an average growth rate of around 30 per cent a year and reach $100 billion by 2025.

According to you, what are the improvement areas for the Indian biotechnology institutes?

In my experience, staff are well-trained and well-respected and already produce high quality research. It is important

Tell us about the development of innovative teaching methods in STEM. How to facilitate knowledge exchange between Indian and overseas biotechnology institutes?

International knowledge exchange occurs through conferences and social media. Many academics have an open and collaborative approach to knowledge exchange. Blogs are used to share teaching practices and ideas. Twitter chats such as #lthechat and #educhat are used to allow academics from all over the world to discuss teaching practices and issues in real time on a global stage.

Good use of technology encourages interaction and enthusiasm and when students are engaged then they want to participate and learn. The use of technology-enhanced learning is becoming more common at present. Students are using their smart phones in the classroom to interact with the tutors. This allows a deeper understanding to be gained and a strong rapport to build between student and tutor.

Videos and other digital materials are being used effectively in a ‘flipped classroom’ — a teaching technique in which video or online content is viewed by students at home, while class time is dedicated to active learning exercises and problem-based learning. Studies have shown that the use of different kinds of technology in the classroom have a positive impact on learning and attainment. sachin.jagdale@expressindia.com

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PHARMA ALLY I N T E R V I E W

‘The role we play is more of an enabler’ C-Square with its ability to create advance technology solutions has emerged as the leading solution provider of enterprise-resourceplanning (ERP) software & business intelligence (BI) tool for the pharmaceutical industry in India.

Sripal Bachawat, Director, C-Square, reveals more about the company's future prospects to Usha Sharma

Tell us about the ongoing activities of C-Square.

C-Square is a customerfocused and technologydriven company which provides various pharmaceutical companies a comprehensive solution that helps them increase their productivity and operational efficiency. As a software solution company, we have partnered with pharma manufacturers and distributors to help them manage the logistics and retail operations, including tracking the entire sales life cycle of pharma products, right from the manufacturer to the distributor, retailer and finally to the end consumer. The company also offers an effective sales force excellence tool to the pharma industry. It also focuses on value-added services such as business intelligence and analytics services, application development and maintenance, consulting and its BPO offerings. Some of the largest pharma companies in the country trust our software solution for their most complicated distribution tasks. We have over the years laid a strong

30 EXPRESS PHARMA March 1-15, 2016

foothold and customer base across various cities in India.

How Covenant PharmAssist and Cybix Info Systems came together and formed C-Square and what is its relevance?

Covenant PharmAssist was headed by Sripal Bachawat and Cybix Info Systems by Sajith T. Any software unless it is continuously improved upon, will gradually loose its relevance and die a natural death. Bachawat, who had the marketing rights to a supply chain automation software knew his limitations on the technology front, then partnered with Sajith for his expertise in the technology sector. It became even more relevant since Sajith was also operating in the pharma demand side automation in Cybix Info systems. The new company which was formed used the common alphabet ‘C’ and became C Square.

What services do you offer to the pharma companies and who are your major clients? And how much per cent business does it contribute to the company’s balance sheet?

PHARMA ALLY We offer software for C&F’s, C&A’s, super stockist, medical representatives, stockist, retail chains, standalone pharmacies, hospital pharmacies, online pharmacies back end activities etc.

Major players: Go4Plus: Hedge & Hedge, S H Pharmaceuticals, Lundbeck, Wings Bio tech, Ban labs, Anthem Bio Pharma, Laborate, AFD Labs GGSFA: Alkem, BlueCross, J B Chemicals, Hegde & Hedge, Hetero, Apex PharmAssist: Vardhman, Rajsons, Mahaveer Sales Corporation, Meher Distributors, Palepu Pharma, Power Pharma, Kasi Vishwanathan, Tara Medicos, Palod Distributors, Getwell Pharma, Varghese & Company, KN Mathew Group Retail chain: Emami Frank Ross, Wellness Forever, Noble Plus, Sanyog, Vardhman Health Specialities Standalone pharmacy: Cash Pharmacy, Avikova, Renuka Medicals, USA Dispendery, Balaji Medicals, Maruthi Medicals, People Medical. Susheel medicals, Sushant Medicals Hospital pharmacy: AIIMS, Narayana Hrudalaya, Essential Hospital, Nanavati Hospital, Chord Road Hospital Cyber Pharmacy: Zigy, Netmeds, Ezymeds, Pharmeasy, Emami Above all put together, 95 per cent + business represents from pharma industry Over a period of time, CSquare has become a recognised name in the ERP offering segment.

Elaborate in detail.

In the growing economy, business houses were moving beyond one roof and this needed a tech support.

C-Square understood this phenomenon very early and invested heavily in ensuring that tech should not be a bottle neck during growth phase. In an attempt to help distributed business houses, we ended developing one of the most comprehensive

Our solutions are aimed at the SME sector and offer security and features akin to the top of the line ERPs, giving great value for money. The cost of acquisition and the running costs are at a bare minimum. The personnel training cost is almost nil as these solutions are very intuitive and on the job training for a few days can make the operator proficient to handle day to day tasks

ERP solution for these kind of businesses.

Logistics play an important role in the pharma industry. What role do you play and how competitive is C-Square from its competitors?

Logistics is going through a radical change in the face of the implementation of GST. It is important in the pharma industry which can be tracked better because the industry is quite regulated.

The role we play is more of an enabler who offers solutions and empowers pharma organisations to efficiently execute their key business processes in the face of a dynamic market.

Our robust architecture, user-friendly tools, industryspecific functionality and highly customised end-toend solution, help simplify operations, boost productivity, and help companies increase their revenue.

Our solutions are aimed at the SME sector and offer security and features akin to the top of the line ERPs, giving great value for money.

The cost of acquisition and the running costs are at a bare minimum. Most importantly the personnel training cost is almost nil as these solutions are very intuitive and on the job training for a few days can make the operator proficient to handle day to day tasks.

Tell us about the company's

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in-house developed ERP specialised technology and its significant role in the pharma industry?

Ecogreen+ is retail business chain management solution and can centrally manage n number of stores. The system takes care of all the operations of retail chains including sales, purchase, order processing, sales returns (credit note), purchase returns (debit note), stock transfers (GDN and GRN) (Branch to Branch, Admin to Branch or Vice versa). It's a complete business solution which manages right from purchasing, selling, reconciliation, controlling to accounting aspects.

Ecogreen is a very powerful tool and takes care of all back-end activities of an online pharmacy.

Which new technologies are in the pipeline and how will it ease the business the Indian pharma industry?

C-Square’s focus is on mobility environment. Retail consumers today are texting, talking, communicating, buying, searching, watching videos and taking photographs all on their mobile devices. On the web front, by integrating their eCommerce strategies with the mobile environment, retailers and distributors are trying to leverage the mobile channel and add value to clicks from the web and bricks of physical stores. On the store front, in their quest

to make the customer instore experience a memorable one, retailers are once again turning to mobility solutions for checking in the customers as they enter the store, scanning products, receiving offers through mobile coupons, making payments, and producing digital receipts among a host of other features.

With an increasing number of retailers and distributors embracing mobility solutions, from instore to supply chain, from sales and marketing to decision making levels, CSquare is trying to empower all facets of the retail business.

Which new trends do you see in the market?

Nowadays, online pharmacies are playing a major role in today's market.

Also, new and small enterprises will play an important role in the growth of India's pharma sector at a domestic level.

With the government implementing track and trace technology to monitor all drug exporting firms, the Ministry of Commerce have been looking into newer technologies that will be deployed this year (2016).

Today, the industry is facing several challenges.

Mention two to three topics which needs immediate action and why?

The pharma industry in India

is extremely fragmented causing friction and an extremely volatile environment. Companies need to review their products on a periodic basis to ensure more products are made for customers.

Another area of concern is the low margin of profits for pharma companies because of the government's reforms, the drugs have to be priced at a lower cost to be sold to the public. The government should also consider funding pharma companies.

Also this affects the research and development of companies with low profits made. The investments would be even lower to develop newer products.

Tell us about the company's future plan.

Our company is a one-stop solution provider for our customers.

C-square has years of experience in developing cutting-edge applications and products for customers that are scalable and flexible to meet today's business challenges. We use industry standards and guidelines to augment our experience and ensure that every project we deliver is of the highest quality.

We are an ideal partner for companies looking to outsource their IT solutions.

Our ability in being a complete solutions provider eliminates the hassle of managing multiple vendors, logistics, and technological bottlenecks for our clients.

You can partner with us and transform your business to achieve your business goals.

Our customer-centric approach provides maximum value for investment and caters for the long-term benefits of our clients. ◗ C-Square is working on B2B Integration portal and in its beta launch – it has already processing 20K orders per day. ◗ Last mile visibility of tertiary sales to be made available to companies for deeper marketing focus u.sharma@expressindia.com

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PHARMA ALLY PRODUCTS

Sectional overhead doors launched by Gandhi Automations GANDHI AUTOMATIONS' Porto and Max Vista, automatic sectional overhead doors, the ideal solution for all industrial and commercial needs.

Porto: Porto sectional overhead doors are ideal for all industrial and logistics needs. The design and different solutions offered ensure the door to be aesthetically pleasing and perfectly suited to any architectural environment — from modern and traditional industrial buildings to fine commercial buildings. As these doors slide vertically, stopping in the proximity of the ceiling, they blend in with the architectural features of the building. Porto doors are built to ensure the highest ease and flexibility of use which, in turn ensures a quick, hassle free and accurate replacement of old doors.

Their compact size ensures more available space both inside and outside the premises. Depending on the structure of the building and the requirement a choice can be made from a standard lift, vertical lift, horizontal lift, low headroom or inclined lift.

Porto range consists of a wide series of track systems, panel

options and safety features. Special glazed doors provide excellent lighting and vision into the building where required.

Max Vista: Max Vista sectional overhead doors are ideal for industrial and commercial buildings. The doors are made with a combination of aluminium panels and transparent acrylic, grilled or meshed windows giving it a distinctive look and enhancing the look of a building. Max Vista Doors make the environment bright and pleasant to work in as it allows natural light to pass through the large clear areas.

Gandhi sectional overhead doors provide heat insulation

and sound proofing thus improving the working conditions on the premises and saving energy. The products are affixed with a CE mark making them reliable and safe.

● ●

●

Key features ● Reliable and low- noise operation. ● Extreme robustness. ● Safe operation in compliance with safety requirements. ● Design-oriented surfaces and optimum light solutions. ● Minimal bulk for more space indoors and outdoors ● Easy and practical to open and operate ● Energy savings and more

●

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comfort Bright indoor environment and attractive design Pre-painted, galvanised steel, sandwich panel, thickness 40 mm The gaskets, made of a special non ageing rubber, seal the perimeter of the door opening.

They produce a perfect seal, preventing water, air and dust infiltration Minimal bulk for more space indoors and outdoors Easy and practical to open and operate Energy savings and more comfort Bright indoor environment

●

● ● ●

and attractive design Sectional overhead doors can be customised as gas tight ripening room doors.

Opening - Closing speed = 0.2 - 0.4 m/s.

Sizes available : Width (max) = 15000 mm Height (max) =10000 mm

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

Bilcare saves chiller opex with HMX-PCU-F BILCARE, AN INNOVATION-LED solutions provider, is a global leader in the field of pharmaceutical packaging. Bilcare uses a range of specialty polymer films and aluminum foils to devise solid dosage pharma packaging materials. It operates out of nine different locations and has five R&D centres spread across Asia, Europe and the US. The company has a strong base of 2,500 customers across 50 countries.

The Rajgurunagar plant of Bilcare had set up a new triplex laminating line with a raw mate-

32 EXPRESS PHARMA March 1-15, 2016

rial storage area. As per the process requirement, the temperature inside the laminator plant room was to be maintained at 26 ± 0°c throughout the year with a RH level of 55 ± 5 per cent.To achieve this, 3 x 100 TR water cooled screw chillers are used with two Air Handling Units (AHUs) with chilled water coils, one with 26,000 CFM and the other with 13,000 CFM. During summer, the fresh air coming into the chilled water AHUs was at 40-45°c. This led to high TR load on the chillers, resulting in high operating ex-

penditure for these chillers. To reduce the operating cost of chillers, it was necessary to bring down the temperature of fresh air coming to the chiller.

Bilcare discussed the problem at length with the HMX team. On the basis of the weather data available and the TR load installed, HMX worked out a feasible solution for the company. It was suggested that two fresh air pre-cooling units HMX-PCU-F without blowers should be installed for the two chilled water AHUs. This would help in bringing down the tem-

penditure of the air conditioning system installed. Based on the recommendations, Bilcare opted for two HMX-PCU-F, which were installed and commissioned in September 2013.

perature substantially of the fresh air being taken in, thus reducing the TR load on the chilled water coils, which would in turn lower the operational ex-

Contact details ATE Enterprises (Business Unit: HMX) T-126, T Block, MIDC, Bhosari, Pune-411 026 Telephone: +91-20-30881100 Ext. 302 M:+91-9158308880 W: www.hmx.co.in / www.ateindia.com

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Two great brands come together under Charles River to provide an even stronger testing solution for our customers.

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OSMOMETER 3250

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PHARMA LIFE I N T E R V I E W

‘We are planning to set up shop in the Americas in a very unique way’ Ideal Cures has recently announced the opening of its representative office in the US. Dr Kamlesh Oza as the new President – Global Business Development will take charge of expanding the company’s global reach. Sanjiv Das finds out more on his vision for the company in an interview As the President – Global Business Development, Ideal Cures, what new ideas are you hoping to implement?

The ideas are around global business planning, new business development, M&A activities and leading actionable global and regional strategies to become the supplier of choice for the pharmaceutical and nutritional industries. We plan to increase the awareness of the most innovative set of products compared to our competitors by showcasing them globally. We will participate in industry events that we were not part of earlier such as Drug, Chemical & Associated Technologies Association (DCAT), ExcipientFest and American Association of Pharmaceutical Scientists (AAPS).

After three decades in an MNC , what was the driving factor which made you to shift to an Indiaheadquartered company?

Entrepreneurship, swift implementation of strategy and decision making.

How different is your current role from the previous one? What are the challenges you foresee?

In my previous roles I managed a region, then a strategic business unit (SBU) and finally a service along with global accounts. These were bits and pieces of the entire

42 EXPRESS PHARMA March 1-15, 2016

The challenges will be to be at the right place at the right time in setting up resources to support our business and it is dependent on how the pharma industry business and geography shapes up business. At Ideal Cures, I will manage the global business in its entirety with unrestricted consult with all functions such as sales, operations and technical services. The challenges will be to be at the right place at the right time in setting up resources to support our business and it is dependent on how the pharma industry business and geography shapes up.

As part of your new role, you are going to start an application lab and a manufacturing plant in the US. What are the new innovations you will be incorporating in this project?

We are planning to set up shop in the Americas in a very unique way so watch this space.

What will be your strategy to expand Ideal Cures’ global reach?

Ideal Cures has an energised work force, multiple excipact approved facilities and world class products that can be leveraged for the international market. Further, we will continue to invest in creating infrastructure to follow high concentration clusters of pharma facilities around the world. We will develop people, teams, portfolios and sales strategies to be at the cuttingedge of business, ensuring sustainable returns to customers, shareholders and employees.

What percentage of Ideal Cures’ revenues comes from overseas business? Which are the best performing markets?

From our perspective, we define overseas business as product moving directly out of India to a customer as well as that which is used for products made in India for the overseas market. So it’s not an

exact science on the split but we can say we have a very balanced split. Presently, the best performing markets are Europe and Asia.

What are the targets you have set for yourself in Ideal Cures?

The key target is to increase our market share globally.

What is going to be your strategy to achieve these targets?

Our strategy will be to increase awareness of Ideal Cures services and products by participating in global events. We will also like to showcase our innovative products such as Instacoat 4G, the most advanced film coating system, which can be reconstituted at 35 per cent solids and still have a low viscosity and is ideally suited for continuous coaters. sanjiv.das@expressindia.com

INSIGHT

Creating tomorrow’s pharma leaders In the second article of his series on pharma leaders, Amogh Deshmukh, Member, Key Leadership Team, DDI India, speaks on managing talent to meet pharma industry’s future business needs IN MY last article ‘Leadership challenges in the pharma sector and the way forward’ I argued how Indian pharma industry is poised for superlative growth and how availability of leaders may make or break this opportunity.

The Indian pharma market increased at a CAGR of 12.79 per cent in 2015 from $6 billion in 2005, and is expected to expand at a CAGR of 15.92 per cent to $55 billion by 2020 (Source:PwC, McKinsey, TechSciResearch).

The pharma industry has a lot of things going in its favour such as low cost of production coupled with strong policy support from the Government of India.

India’s competitiveness lies in its significant lower cost of production vis-à-vis the US and almost half of Europe.

The Government of India unveiled ‘Pharma Vision 2020’ with an aim to make India one of the top five pharma innovation hubs by 2020. The government intends to support the pharma industry through world class infrastructure, internationally competitive scientific manpower for pharma R&D, venture fund for research and various tax breaks. To enhance ease of doing business in India, the approval time for creation of new production facilities has been significantly reduced. The government has also allowed 100 per cent FDI under the automatic route in the drugs and pharma sector.

In order to leverage this growth opportunity, pharma companies have started making massive investments in training and development of their leaders. Unfortunately, while it is a

well-meaning step it is unlikely to yield positive return on investments or on stakeholders’ expectations.

Wondering why? Take a look at the results of a study of about 200 leaders from the pharma industry. Here is a summary of what we found: Leaders in the pharma sector excel in execution. They are good at building networks and ‘getting things done’. They demonstrate high result focus.

They are grounded in reality at the grass root level and are quick at decision making.

Strategic thinking came as an area of development across leaders in the pharma sector with only a few leaders demonstrating high degree of proficiency in it.

Pharma leaders particularly need to develop ‘other leaders’ across the length and breadth of the organisation while promoting a spirit of entrepreneurship, customer centricity and sound business acumen. So, given the above context what should the pharma CEOs should do?

I do not have a panacea for everything that ails the pharma sector but I am confident that the three steps explained below will help pharma organisations achieve success.

Make talent management a strategic priority Considering its impact on key organisational metrics like topline, bottom-line and everything in between, talent management is too important a function to be left to the human resources (HR) department alone and has to figure in the CEOs' list of priority.

Conventionally talent man-

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agement has been the domain of HR and the role of the CEO and COO was intermittent and distant. Two factors largely account for increased CEO involvement in the past few years: the shift in focus towards intangible assets such as talent, and increased board scrutiny in relation to both ethics and performance.

Jim Collins, author of Good To Great had this sound advice for CEOs, “Those who build great organisations make sure they have the right people on the bus, the wrong people off the bus, and the right people in the key seats before they figure out where to drive the bus. They always think first about who and then about what.”

The CEOs must start seeking answers to the following critical questions: ◗ What future challenges will leaders need to address? ◗ What kind of leaders do you need and how many? ◗ What knowledge, skills, experience, and personal attributes will be critical to their success?

Accelerated access to development In an ideal world, everyone will have equal access to development. Unfortunately, the world we live in is far from ideal — it is hyper competitive. The war for talent will only get more intensified when the growth in the pharma sector will demand more and more ready leaders while the supply of such leaders will be significantly lower than its demand. That would mean that organisations will not only have to constantly vie towards engaging and retaining their top talent but also attract top talent

from competition without losing much talent to them.

Let us get one thing straight – talent management is not a democracy. The key is to identify potential early and deploy a differentiated developmental journey for leaders that demonstrate potential to grow. Our best talent must have access to best in class development that prepares them for building readiness for future.

It’s easy to confuse performance, potential, and readiness, so it’s important to note the distinction between them. Performance is how someone is performing in their current role. Potential is someone’s likelihood for leadership growth. Readiness is someone’s fit with a specific role or job. Confusing these will lead to bad decisions about talent. For example, someone performing successfully in their current job, may not be ready for a role at the next level. Identifying someone with potential is only part of the equation—they may still not be ready for the role and will benefit from development to fill those readiness gaps.

Holding leaders accountable for succession planning Before you are a leader, success is all about growing yourself. When you become a leader, success is all about growing others —Jack Welch Succession planning is important. Therefore, it came as no surprise when Sun Pharmaceuticals founder Dilip Shanghvi in one of his media interviews revealed earlier this year that succession planning is ‘engaging his attention.’

AMOGH DESHMUKH, Member, Key Leadership Team, DDI India

Leaders indeed must be evaluated on their ability to create a strong succession pipeline.

To be fair, before leaders are asked to coach and develop leaders they should themselves be oriented and if need be provided assistance on how to go about coaching and developing others within their realm of influence.

The good news is ‘Coaching others’ is a learned behaviors’ and with practice and patience leaders can develop high degree of proficiency in it.

Creating talent pipeline is not a single programme or tool. It’s a process that provides both the right quantity and quality of leaders—in time—to step up and meet pressing business challenges.

As a first step, leaders need to ascertain current and future business drivers and design talent strategies accordingly. Overcoming different business challenges will need leaders to effectively demonstrate different behaviors.

Once leaders have ascertained the direction their business is set to take the next step is to define what success looks like for each level. The ask from a leader may vary significantly across businesses and levels; there cannot be a ‘one size fits all’ approach to succession planning.

Developing leaders presupposes checking for readiness of leaders. Assessing readiness not only helps you make accurate placement and promotion decisions, it also pinpoints each leader’s strengths and development needs thereby providing clear direction for targeted development.

EXPRESS PHARMA

43

March 1-15, 2016

PHARMA LIFE CAMPUS BEAT

KM Kundnani College of Pharmacy th celebrates 45 Annual Day A slew of activities were held to commemorate the event THE 45TH Annual Day of Principal KM Kundnani College of Pharmacy was recently celebrated at Watumull Institute, Worli, Mumbai. The chief guest for ‘Sunehre Din’ was Aditi Kare Panandikar, Managing Director, Indoco Remedies, Dr Pramod Patwardhan, Vice president GSK Asia, was the ‘Guest of Honour.’ Niranjan Hiranandani, President, Hyderabad (Sind) National Collegiate Board, presided over the function.

Ketan Dhamanaskar, General Manager, Zoetis was the ‘Alumnus Achiever of the Year’

and Panandikar was felicitated as ‘Distinguished Alumnus’.

The evening was rendered colourful with an extravaganza of entertainment in the form of slew of dances, plays, skits, orchestra and vocal performances.

The event was put together by students and staff under the able organisation of Nishita Shah, General Secretary, Dr Mrinal Sanaye, Assistant Professor and Cultural day Incharge and Dr Urmila Joshi, Principal.

EP News Bureau – Mumbai

(L-R) Dr Mrinal Sanaye, Ketan Dhamanaskar, Dr Pramod Patwardhan, Aditi Kare Panandikar, Dr Urmila Joshi and Nishita Shah

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