Express Pharma 16-31 July, 2013

VOL .8 NO.18 PAGES 68

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Market The Lanka effect Management Drugs no more Packaging Special Cold chain ‘pack’age

16-31 JULY, 2013, ` 40

V O L 8 . N O . 1 8 J U LY 1 6 - 3 1 , 2 0 1 3

CONTENTS

Chairman of the Board Viveck Goenka

Drugs

Editor Viveka Roychowdhury* BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap

eDetailing: The future for pharma communication?

MARKETING Deputy General Manager Harit Mohanty Senior Manager Rajesh Bhatkal PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Asst. Manager - Scheduling & Coordination Arvind Mane

PAGE 28

RESEARCH ‘Our products are safe for juvenile diabetics as well as pregnant, lactating and

NO MORE

Delhi Shalini Gupta

MANAGEMENT

nursing mothers’

PAGE 30

Shorter and cheaper drug trials in pipeline with new research

PAGE 31

PACKAGING SPECIAL Cold chain ‘pack’age

PAGE 32

‘Pharma packaging segment will provide significant growth opportunities in the future’

PAGE 34

Deputy Art Director Surajit Patro

PHARMA ALLY

Chief Designer Pravin Temble

‘Our experience in India over the past 20 years has been quite phenomenal’

Senior Graphic Designer Rushikesh Konka Photo Editor Sandeep Patil

headaches

Layout Rakesh Sharma

Sotax Group shifts Asia-Pacific

C I R C U L AT I O N Circulation Team Mohan Varadkar

The Lanka Effect

PAGE 36

headquarters

MARKET ‘HPV screening mkt seems to be growing in excess of 20% annually’

Copyright @ 2011 The Indian Express 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.

Venus bags Japanese patent for Elores

PAGE 14

DTAB recommends changes to compensation guidelines for clinical trials CDSCO allows re-printing / re-labelling of scheduled formulations

PAGE 17

Growth opportunities intact but managing industry challenges remains key for pharma sector: ICRA

PAGE 37

PHARMA LIFE

PAGE 9

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15 RNI Regn. No.MAHENG/2005/21398 Printed for the proprietors,The Indian Express Limited 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.

July 16-31, 2013

PAGE 35

Remote monitoring: A cure for maintenance

PAGE 16

Kelly Services releases whitepaper titled ‘The Indian Workforce Today’

PAGE 63

Dr Rabinder Buttar, Founder and CEO, ClinTec International receives award

PAGE 64

PAGE 18

Unichem chalks out expansion plans post Mylan deal

PAGE 19

Suven Life secures two product patents for their NCEs in Japan and the US

PAGE 20 PAGE 21

M&A activity in pharma sector focuses on strengthening respiratory portfolio

PAGE 22

Bangalore INDIA NANO focus: Drug delivery and healthcare

PAGE 23

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EXPRESS PHARMA

5

EDITOR’S NOTE Wooing Indian pharma back

REGULATORS IN INDIA WILL NEED TO MOVE MUCH FASTER TO CUT THE RED TAPE AND BRING BACK THE ‘FEEL GOOD’ FACTOR IN INDIAN PHARMA

6 EXPRESS PHARMA

Stringent regulations and ever increasing approval timelines are hampering the India pharma story, though recent recommendations on the compensation guidelines show that the regulators are trying to accommodate at least some of industry’s concerns.

Similarly, the Foreign Investment Promotion Board (FIPB) has cleared foreign direct investment (FDI) in seven brownfield proposals. But will this convince industry players that things will improve enough?

In India’s latest tryst with compensation guidelines for clinical trial-related injury and death, the Drug Technical Advisory Board (DTAB) has made various suggestions/clarifications at a meeting in May. They reveal some surprising recommendations. (See story: DTAB recommends changes to compensation g'lines for clinical trials; http://bit.ly/1afGBTa).

Patient groups may not approve some of the Board’s recommendations. One example is the DTAB’s view that compensation need not be paid if the trial participant dies or is injured due to the failure of the investigational product since ‘the trial is conducted with the objective of assessing the therapeutic effect of the drug along with safety.’

Similarly, the DTAB has recommended that the trial participant should be provided free medical management only in case the injury is related to the trial, otherwise this could be seen as ‘inducement’. The term ‘related to the trial’ is nebulous and gives rise to dispute: an accident is obviously not ‘trial-related’ but a slip or a fall could be related to the trial medication though proving it could be difficult.

Industry has in general welcomed the fact that the minutes of the DTAB meeting show that the authorities are at least discussing the topic but seems cautious of hoping for too much, too soon. Ever since the guidelines were released on January 30, industry associations and individual pharma companies have tried to reason with the regulator that certain clauses

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needed clarifications. There were dire predictions that GSR53(E), the offending gazette notification, would be the death knell of clinical research in India and in time, would set back the country's pharma industry as well.

In fact, the exodus of Indian pharma companies and talent to greener pastures has already started, claims a survey conducted between March-June this year by The Associated Chambers of Commerce and Industry of India (ASSOCHAM). The survey, based on interviews with around 250 top industry hands, from five top pharma hubs of the country (Andhra Pradesh, Gujarat, Karnataka, Maharashtra and Tamil Nadu) blamed prolonged approval timelines and restrictive regulations as reasons to shift operations to more accommodating countries in South Asia. Countries like Cambodia, Korea, Philippines, Singapore, Thailand, Vietnam and others, are reportedly ‘wooing India’s R&D industry’ with ‘sops and transparent regulations’ says the ASSOCHAM survey. Getting permissions/approvals for trials or marketing drugs takes more than 12-15 months in India while the US FDA, EU and Singapore issue such approvals within a month's time, points out the survey.

Sri Lanka, the topic of our cover story in this issue, is another country set to benefit from the decreasing incentive for pharma companies in India. With tax sops in SEZs set to expire, Indian pharma companies are looking at the island nation as the next frontier.

But, with other Asian nations like Singapore and China moving in quickly, pharma companies from India will have to be much more aggressive and exploit ancient cultural ties with the island nation. Similarly, regulators in India will need to move much faster to bring back the ‘feel good’ factor. Wooing back Indian pharma will prove much harder once they taste success overseas.

Viveka Roychowdhury viveka.r@expressindia.com

July 16-31, 2013

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MARKET

W H AT ’ S INSIDE

THE BUSINESS OF PHARMACEUTICALS

‘HPV screening mkt seems to be growing in excess of 20% annually’ PG 14 DTAB recommends changes to compensation guidelines for clinical trials PG 16 CDSCO allows re-printing/re-labelling of scheduled formulations PG 17 Growth opportunities intact but managing industry challenges remains key for pharma sector: ICRA PG 18 Unichem chalks out expansion plans post Mylan deal PG 19 Suven Life secures two product patents for their NCEs in Japan and the US PG 20 Venus bags Japanese patent for Elores PG 21 M&A activity in pharma sector focuses on strengthening respiratory portfolio PG 22 Bangalore INDIA NANO focus: Drug delivery and healthcare PG 23

MANAGEMENT 25 RESEARCH 30 PHARMA PACKAGING 32 PHARMA ALLY 35 PHARMA LIFE 63 July 16-31, 2013

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EXPRESS PHARMA

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HITESH GAJARIA, Partner KPMG

T There are more than 100 pharmaceutical players from India with strong business links in Sri Lanka. It is predicted that the number will continue to grow as more companies start considering Sri Lanka as a preferred gateway for pharma exports.

This business sentiment has been ably supported by governments on both sides of the Palk Strait. For example, Anand Sharma, Union Minister of Commerce and Industry, recently announced a tie up with the Sri Lankan government to build a pharma manufacturing hub in the island nation, expected to be ready by next year.

Commenting on this announcement, Hitesh Gajaria, Partner KPMG says, “This initiative will not only boost bilateral trade between the countries but will also help Sri Lanka’s pharma landscape evolve and gain some global exposure too.”

Officials from Bal Pharma, an Indian pharma company with a 15-year long presence in the island nation and in fact a recipient of merit awards from the State Pharmaceuticals Corporation of Sri Lanka in June 2012 and in early 2000 too have seen the situation evolve over the years. Archana Dubey-Mitra, Associate Vice President API and Exports, Bal Pharma comments, “There has been a big move by the Sri Lankan Government to strengthen the local pharma industry. The government's spending on the healthcare sector is continuously increasing and this trend aims to provide medical aide free to the people. Various reforms such as tax relief to the private sector and the infusion of more investments towards the healthcare sector in the budget will pave the

10

EXPRESS PHARMA

ARCHANA DUBEYMITRA Associate Vice President API and Exports, Bal Pharma

DR E SANEESH Research Analyst, Business and Financial Services Healthcare, Frost & Sullivan

Indian pharma companies will find it cheaper to export products to Sri Lanka in light of this policy.

While this move will put pressure on the domestic industry in Sri Lanka

The two countries have similar culture hence acceptance of the products should be high. We must target to capture above 30 per cent market share due to our reach reach to the entire island

The low per capita expenditure on medicines and proposed drug price control policy would be a concern/ restraint for the growth of the local market

future growth path. The Government is also providing opportunities for many Indian companies for joint ventures (JVs) and greenfield projects.

The Sri Lankan Government is in the process to strengthen their regulation to have better quality checks. Overall the Government is providing good support to boost this sector.”

This support has fructified into various agreements recently signed between the two nations. “The signing of the Comprehensive Economic Partnership Agreement (CEPA) will make the current economic engagement more prolific by bringing more investment and services in Sri Lanka. The Indian Government has also clarified that they are not seeking reciprocity in relations with Sri Lanka and will help the latter set up a pharma hub in the country,” informs Gajaria.

have to be registered with the CDDA after fulfilling the regulatory requirements specified by the CDDA before they can be imported into or marketed in the country.

Dr E Saneesh, Research Analyst, Business and Financial Services Healthcare, Frost & Sullivan gives further details of existing schemes introduced by the Sri Lankan Government. He says, “The Government of Sri Lanka has allowed the pharma sector in the country to be amongst the ‘Strategic Import Replacement Sectors’ and has lowered the minimum investment required, making the sector eligible for various schemes under the new tax regime. Under this scheme, the new enterprises are eligible for a five-year tax holiday, a concessionary tax rate post that period and the enterprises looking at expansion are eligible for concessionary tax rate.” These sops demonstrate the seriousness of the Sri Lankan Government to boost pharma companies and help Indian pharma companies expand their businesses by utilising existing opportunities.

In 2011, the Sri Lankan Government announced in its budget that pharma products would be exempt from port and airport levies. The Sri Lankan government offers a fiscal incentive package encompassing tax holidays of 10 years or more and customs duty exemptions engaged in export-oriented activities operating within specially desig-

nated Export Processing Zones operated under the directions of the Board of Investment (formerly known as the Greater Colombo Economic Commission).

In addition, the signing of the CEPA will further incentivise Indian players to look at Sri Lanka as a possible investment destination. Dubey Mitra feels, “This will not only be of interest to Indian companies but all companies exporting their products to Sri Lanka.

The landing cost will definitely decrease but the competition will certainly rise and more companies will be attracted.”

Gajaria spells out compelling reasons why Indian pharma companies should consider having business operations in Sri Lanka instead of SEZs in India commenting, “In India, the SEZ units in Baddi and Solan have become saturated and are losing their sheen in terms of tax holidays and other incentives.

In light of the demand for Indian generics globally, India is in need of cost effective manufacturing hubs. Sri Lanka could be a prospective destination for Indian companies to set up their manufacturing hubs, provided they are able to obtain the requisite US FDA site approvals.”

He continues, “Indian pharma companies will find it cheaper to export products to Sri Lanka in light of this policy. While this move will put pressure on the domestic industry in Sri Lanka which will have to compete with

Regulations with attractive features Gajaria informs, “The duration taken for registration of a new product can vary depending on the compliance with the stringent documentation requirements and procedures followed by the Cosmetics, Devices and Drugs Authority (CDDA).” The CDDA is the island natIon's equivalent of the CDSCO and is monitored by the body appointed by the Ministry of Health of Sri Lanka. The CDDA regulates both locally manufactured as well as imported products and all products in these categories www.expresspharmaonline.com

July 16-31, 2013

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unethical practices in Sri Lanka.

Saneesh says, “To counter the recent entry of sub-standard drugs into the market, the Sri Lankan Government has announced quality enforcement measures such as, revision of the qualifying process for manufacturers and labeling requirements in local languages. The price of drugs

is market based and is determined by the producers.

However, the Government has proposed a National Drug Policy to control the price of the drugs.”

Business potential Market analysts and industry sources attest to the untapped potential of this opportunity. In 2012 the phar-

ma market in Sri Lanka was between $450 milllion to $480 million and is expected to grow at a compound annual growth rate (CAGR) of 10 to 15 per cent by 2015. Of this pie, nearly 20 per cent is contributed by local manufacturers, while imports make up the rest. India ranks third in pharma imports to Sri Lanka.

Of the more than 300 manu-

www.aptar.com/pharma

July 16-31, 2013

EN AT

VA

TED

T APP

ROVE

D

EM

E MARK

Quality with no causalities According to a PIB release issued on May 7, 2012 there were reports in the Sri Lankan media alleging supply of low quality drugs by Indian exporters. There were other reports alleging suspension of some Indian companies by the Government of Sri Lanka for violation of tender terms.

Discussions were held by concerned authorities in Sri Lankan Government by the High Commission of India in the Sri Lanka as also during the visit of Health Ministers of Sri Lanka to New Delhi during July-August, 2011 wherein the need for clear technical specifications in the tendering process was stressed so as to prevent entry of sub-standard and low quality drugs in the Sri Lankan market.

The PIB release also mentioned that no report on banning of any Indian drug manufacturer has come to the notice of the Government of India. Drugs and pharma products are exported only after meeting stringent regulatory requirements prescribed by the regulatory authorities in various countries. Besides, Indian exporters have to comply with quality norms prescribed for the manufacturing of drugs and pharma in India

by Drug Controller General of India (DCGI) under Drugs and Cosmetics Act. Any reported violation is viewed seriously and is dealt with as per prescribed procedure under Drugs and Cosmetics Act. To avoid quality issues in the finished products and focus more on consumer friendly features the Sri Lankan Government has taken serious efforts to restrict

facturers in Sri Lanka, the top 10 companies comprise more than a third of the market share.

Speaking about Indian players Dubey-Mitra says, “There are many pharma companies well established in the region. Sun Pharma has done phenomenally well while companies like DRL, Cipla, and Micro Labs have

P

cheaper drugs, it will incentivise manufacturers to look at Sri Lanka as an export destination for formulations and APIs.” Comparing the business trends in the two territories, Dubey-Mitra avers, “Indian pharma companies can be more aggressive and increase their presence as the trends in both the markets are very similar. Indian players have relatively easier access to the region, as well as economical products with quality and therefore it should be advantageous to have a better presence. Moreover, the two countries have similar culture hence acceptance of the products should be high. We must target to capture above 30 per cent market share due to our reach to the entire island.”

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EXPRESS PHARMA

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established themselves too.

Bal Pharma is one of the prominent suppliers to the Sri Lankan Government and has been getting merit awards.”

According to the World Health Organization, in Sri Lanka, cardiovascular diseases account for approximately 30 per cent of the deaths, while cancer accounts for nine per cent followed by respiratory diseases (nine per cent) and diabetes (four per cent).

Ranbaxy has a significant RANK

presence in the anti-infective, cardiovascular, dermatology, asthma, and diabetes therapeutics. “These therapeutic areas would have immense business potential for Indian players should they choose to look at Sri Lanka as a prospective market,” analyses Gajaria.

As with other geographies, Non Communicable Diseases (NCDs) are on the rise in Sri Lanka. According to recent data published by World Bank’s Human Development

CORPORATIONS

MAT ~ 03/2013 TOTAL MARKET

Network, NCDs account for around 90 per cent of diseases in the Sri Lankan population.

The island nation is characterised as a generics-driven market majorly focused on alimentary and metabolism segments with the highest growth coming from the cardiovascular therapeutic area.

Concurring with these figures, Saneesh predicts, “Cardiovascular diseases contribute more than 30 per cent to the mortality, followed by

cancer and diabetes. The NCDs are expected to drive the pharma market in Sri Lanka.” Other promising therapeutic segments are the nervous system while the derma range seems to be a lucrative option as well.

Gajaria points out, “Originator brands, which have grown by 16 per cent from 2010, have been lately outpaced by generics, which have grown at a rate of 19 per cent in the same period. The

MAT ~ 03/2013

MAT ~ 03/2012

MAT ~ 03/2011

MAT ~ 03/2010

MAT ~ 03/2009

SL Rs 000

SL Rs 000

SL Rs 000

SL Rs 000

SL Rs 000

28,697,715

25,284,244

22,915,411

19,104,590

16,156,728

1

CIPLA

2,208,524

1,973,623

2,007,381

1,589,977

1,162,793

2

GLAXOSMITHKLINE

1,892,761

1,761,415

1,687,671

1,467,361

1,323,326

3

ZYDUS CADILA*

1,805,932

1,388,618

1,118,439

896,579

793,308

4

SUN PHARMA

980,001

833,373

704,245

564,429

468,244

5

TORRENT PHARMA

789,227

695,780

589,767

503,478

436,275

6

ASTRON

630,262

539,453

474,656

391,268

338,131

7

MEAD JOHNSON NUTR.

625,987

521,800

450,759

350,201

276,829

8

USV

621,520

458,385

386,864

334,829

270,483

9

RANBAXY

618,922

571,878

553,949

539,195

445,700

10

ABBOTT

544,654

501,864

614,254

597,985

483,601

11

KALBE GROUP

535,782

423,270

387,486

341,257

276,527

12

MICRO LABS

531,613

506,982

437,202

373,484

317,691

13

ASTRAZENECA

507,593

434,581

387,023

348,811

291,536

14

GETZ PHARMA

453,121

356,229

288,998

214,433

157,680

15

SANOFI AVENTIS

399,017

346,302

312,382

260,415

214,197

16

NOVO NORDISK

379,875

279,654

254,007

197,259

181,942

17

ALLERGAN

378,679

347,272

276,757

199,618

161,512

18

E. MERCK

374,977

316,390 284,178

230,242

167,081

19

GLENMARK

352,356

340,096

310,664

234,138

219,887

20

DR. REDDYS LAB

351,356

296,182

254,971

234,748

192,409

Source : IMS Health, Sri Lanka Pharmaceutical Audit (SLPA), March 2013

Table 1

RANKINGS 12M

BRAND

CORP

QTR TOTAL MARKET

1

1

AUGMENTIN

GLAXOSMITHKLINE

2

4

SUSTAGEN

MEAD JOHNSON NUTR.

3

2

ZAART

Cipla

4

3

GLYCOMET

USV

5

6

SEROFLO

Cipla

6

7

ATORVA

ZYDUS CADILA

7

5

MIXTARD HM 30/70

Novo Nordisk

8

8

PANADOL

GSK

9

9

DIAMICRON

LLS

10

10

FORACORT

Cipla

11

12

T4

BAG

12

11

SERETIDE

GSK

13

13

GLUCOPHAGE

Merck Marker

14

16

ENHANCIN

Ranbaxy

15

17

ZINNAT

GSK

Source : IMS Health, Sri Lanka Pharmaceutical Audit (SLPA), March 2013

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July 16-31, 2013

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generics market share has grown considerably over the last few years and presently represents close to ~66 per cent of the total market.”

According to the IMS Health, over a 12 month period ending march 2013, GSK's Augmentin was the top selling brand with Indian companies like Cipla, USV, Ranbaxy, Zydus Cadila.... also featuring the top 15 brands. (Refer to IMS Table 1 )

catering to 15-20 per cent of the total demand), Sri Lanka is currently left with no option but to import these products from their neighbours. This is an opportunity, which most Indian pharma manufacturers are pursuing and encashing.

Therefore growth is a given.”

She recalls that earlier, the regulatory guidelines were too stringent and it was easy to

register or renew (marketing licenses). But since last year, changes have been introduced making CDDA more stringent, primarily due to many back to back complaints regarding imported pharma goods. She opines that Indian companies have a good regulatory back up and will therefore always find it easy to register.

The authorised regulatory

bodies of both the countries have shown a sustained interest and are targeting to register robust growth, which will help interested Indian pharma companies, both newcomers as well as existing players, grow much faster. These initiatives are an assurance of the commitment of both governments and Indian companies are sure to be feeling relieved,

especially in the light of changes in the island nation's regulatory procedures.

Its early days to monitor the progress on collaborations like the pharma manufacturing hub announced by India's Union Minister of Commerce and Industry but it sure looks like a win-win for both nations. u.sharma@expressindia.com

Indo – Sri Lanka business relation According to Gajaria, Sri Lanka recorded a $ 9,313 million trade deficit in 2012, a 4.1 per cent year on year decline .

However, the pharma industry in Sri Lanka is on the brink of growth, with the prospect of relatively inexpensive labour and the proximity to India. It is predicted that Sri Lanka's negative pharma trade balance is expected to widen over the next five years.

Sri Lanka's negative balance of trade is only going to increase in the coming years, with the increasing incidence of NCDs driving demand in the pharma market.

“The negative trade balance is primarily due to the limited local industry though the (Sri Lankan) Government is encouraging local manufacturers. However the gap is too high to meet total demand.

This is definitely not a cause of concern to the Indian players working or keen to enter this market. In fact, Sri Lanka can serve well as an efficient manufacturing hub for India,” feels Dubey-Mitra Spelling out both, the opportunities as well as the risks of this situation, Saneesh remarks, “A decline in imports without simultaneous increase in local production will have a detrimental effect on healthcare in the country. This scenario should be of strategic interest to the Indian companies looking for investments in the Sri Lankan pharma sector. However, the low per capita expenditure on medicines and proposed drug price control policy would be a concern/restraint for the growth of the local market,” Dubey-Mitra too comes to the same conclusions saying, “The overall situation looks promising as there has been an increase in the consumption driven by increased spending on healthcare and focus on healthcare by the Government. Given the very limited number of local pharma manufacturers (only six July 16-31, 2013

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‘HPV screening market seems to be growing in excess of 20 per cent annually’ IncellDx, an US-based molecular diagnostic company recently launched HPV Oncotect, a first of its kind molecular diagnostic test for the detection of oncogenic HPV E6, E7 mRNA in India in association with Delhi-based CureHealth Diagnostics. Shalini Gupta finds out more in an interview with Lowell Gruman, Executive Director, IncellDx and Dr Dinesh Gupta, Director, CureHealth Diagnostics How do you look at the Indian diagnostics market?

What are the opportunities and challenges?

Lowell Gruman (LG): Diagnostic screening is beginning to gain importance in India as more and more people are becoming aware that early treatment is often a good indicator of successful treatment. For example, highly specific screening assays, such as HPV OncoTect, identify actual disease rather than the risk of or predisposition to disease.

However, the market for such assays in India is, for all intents and purposes, in its infancy. While India's medical training infrastructure continues to add increasing numbers of highly-qualified professionals to its healthcare delivery programme, there are large segments of the population that remain underserved. For companies like ours, with novel, high-performance technology, India represents an opportunity to reach into and beyond the current footprint of standard health-

care delivery at a fraction of the cost associated with early stage cancer detection.

We are mindful that we are not alone in seeing India as an attractive growth opportunity.

Dinesh Gupta (DG): The Indian diagnostics market is largely skewed and unorganised. There are only a few large players with extensive networking of collection centres, engaged with run-ofthe-mill services. Technical promotion is weak. Gullible patients undergo lab tests at a rapid frequency and repeat testing requests. While the routine clinical market is growing at a CAGR of 9 to 10 per cent, molecular testing market is at above 25 per cent. There are immense opportunities to promote molecular point-of-care procedures. The biggest challenge is to enhance awareness among common people, including that of cancer prevention procedures.

How does IncellDx distinguish itself from its competitors?

INTERVIEW

Lowell Gruman, Executive Director, IncellDx

Dr Dinesh Gupta, Director, CureHealth Diagnostics

LG: IncellDx is at the cutting edge of new developments in molecular diagnostics, as our technology quantifies intracellular target biomarker activity while retaining the morphology of each cell, allowing critical cellcycle analysis and determination of the nuclear cytoplasmic ratio. Competitively, companies must push the performance boundaries that currently exist: introducing an assay that produces the same result as the next test in a different manner is no longer good enough.

DG: Market is evolving to a large extent by introducing the newer generation of tests in cancer and sexually transmittable diseases. There are not many competitors in this area, technology development companies like IncellDx are working around developing multi-parameter single test services that potentially could detect more than one STD in a single assay.

tend to grow the current market, year-on-year the growth metrics don't carry much meaning unless seen in the broadest of senses. That being said, HPV screening market in all its forms seems to be growing in excess of 20 per cent annually.

DG: Out of 100 women globally acquring new infection, 33 are from India and half of them die due to lack of treatment. Every third woman newly diagnosed with cervical cancer is Indian. Lack of awareness on cervical cancer prevention, no insurance reimbursement cover for preventive diagnostics and a lack of clear understanding/consensus among policy makers for cancer detection programmes are a few challenges. Few state governments have already introduced universal screening for cervical and breast cancers, a PPP in this area will be rolled out soon.

What is India's cervical cancer burden? By how much is HPV screening market growing?

LG: The politics of the disease will generally drive a different answer to your question in every country, and each healthcare system should determine the priorities within the scope of its own resources. That being said, early stage cancer detection is on everyone's list of priorities. And because technological step-changes

14

EXPRESS PHARMA

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What is the market size for HPV screening? What are the drawbacks of current HPV tests and what advantages does the new test offer? Is it designed to function in low resource settings?

DG: Nearly 10 million women out of 150 million in the age group of 25 to 59 could best benefit from screening at least once in three to five years. The current HPV test only detects presence of HPV infection while missing on harmful July 16-31, 2013

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HPV infection that can potentially lead to cancer development. With HPV infection so common among sexually active women, identifying any HPV infection is clinically no good. From a doctor's point of view, despite being a sophisticated molecular test, it helps handle biological specimen without having to isolate or purify viral DNA while identifying the correct location of HPV infection in women’s genitalia. Yes, it is designated for better use in the low resource setting too, provided one bears in the mind that disease treatment costs many thousands of bucks with poor survival rate too, and that you do not need to repeat the test at a rapid frequency. The test also has a negative prediction over several years, so one saves money on needless procedures like repeated pap tests, colposcopies, biopsies and so forth. The incremental costs for disease prevention are far lesser than disease treatment.

states in India have already begun rolling out programmes in the public domain. Since the incidence of both CA, CX as well as BRCA is highest in our population, we estimate over a million tests market for any screening procedures.

However, the current BRCA screening tests are insufficient, lack sensitivity.

Most diseases are detected in advanced stages where treatment failure is high and consequent deaths are imminent. We wish to change this scenario.

Companion diagnostics are the cornerstone of personalised medicine. Does Incell have any tests along these lines or plans to introduce

such tests?

LG: IncellDx technology is ideally suited for use in companion diagnostics for pharma therapies, particularly newly-developed therapies that must hurdle increasingly higher performance metrics to achieve regulatory approval. We are working on several projects at the moment with strategic phar-

ma partners and will be announcing these later this year. A non-invasive, early stage breast cancer screening assay is under development at the moment. Once the assay has been fully confirmed and validated we would not hesitate to make it available to hospitals and reference laboratories in India. shalini.g@expressindia.com

Reliable.

Simple.

Affordable.

What should be the parameters of a good HPV test?

LG:The performance of any assay should ultimately be determined by its clinical usefulness. The best assays are both highly sensitive and highly specific, and are able to inform the clinician with a strong argument for either treating or not treating a patient.

DG: A good HPV test should have ● high sensitivity >96 per cent (disease pick up rate- very high) ● high specificity >90 per cent (pick up women with no disease as normal) ● high correlation with clinical identification of precancer disease ● high reproducibility (positive as positive on repeat testing) ● affordable cost as a screening test ● results easy to interprete

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How big is the molecular oncology testing market in India?

DG: Of the nearly $ 650 million Indian diagnostic market, molecular oncology contributes to nearly seven per cent. This is a market in transition in India. We have just begun to accept liquid cytology or VIA/VILI as potential screening tools.

Our government recognises the importance of CA, CX screening; in a way that few July 16-31, 2013

www.expresspharmaonline.com

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COMPANY WATCH DTAB recommends changes to compensation guidelines for clinical trials Proposed changes take cognisance of industry concerns Viveka Roychowdhury Mumbai ompanies involved in clinical trials in the country could finally have some clarity on the much debated compensation guidelines issued in January this year.

The minutes of the 63rd meeting of the Drug Technical Advisory Board (DTAB), held on May 16 in FDA Bhavan, New Delhi, reveal that the DTAB has recommended modifications and clarifications.

These are based on the opinions of the Technical Committee, which has been receiving the views of individual industry stakeholders, associations like Indian Society for Clinical Research (ISCR), Federation of Indian Chambers of Commerce and Industry (FICCI), as well as drugs manufacturers associations over the past few months.

In January 2013, the Ministry of Health and Family

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Welfare (MoH&FW) spelled out guidelines for the grant of compensation in the case of injury or death during clinical trials with the release of a new rule 122 DAB to the Drugs and Cosmetics Rules, 1945 Additionally, an APPENDIX XII was added to Schedule Y laying out the procedures for examination of SAEs and compensations to be paid when clinical trial related injury or death occurred during a clinical trial. Broadly speaking, the minutes of the May 16, 2013 show that DTAB seems to be trying for a balancing act. Its recommendations have accommodated industry suggestions on some issues, like amending a clause to specify that free medical management is to be provided only in case the injury is due to clinical trial related activities, and dropping sub-rule (5) of rule 122 Clause (c) effectively agreeing to industry’s viewpoint that compensation is not justified in case of death/injury due to failure of

investigational product as that there is always a possibility that the investigational product may fail to provide intended therapeutic effect.

Similarly, DTAB agrees to justification for use of a placebo and thus recommends a modification in clause (d) of sub Rule (5) as well as extending timelines for reporting Serious Adverse Events (SAEs) but has stood firm on certain guidelines related to allocation of responsibility by investigators and sponsors.

So also, the Board has not gone along with the Technical Committee’s opinion that a change should be made in sub rule 5 clause (b) and has stood firm that the sponsor has to compensate for injury/death due to violation of approved protocol, scientific misconduct and negligence by the investigator as investigators are identified and are under contract of the sponsor for conduct of the study.

Similarly there was no relaxation in the requirement of sponsors or their representatives to pay compensation

www.expresspharmaonline.com

within 30 days of receiving the order from Drug Controller General of India (DCGI).

Calling this discussion on compensation in the minutes of the DTAB meeting as “an encouraging development”, Suneela Thatte, President, ISCR says, “ISCR is glad that the regulatory bodies are addressing the concerns of all stakeholders. Collaboration, transparency and open dialogue are important to ensure the progress of the industry, while securing the rights and safety of patients.”

Dr Arun Bhat, President, ClinInvent Research, points out that these are as yet only recommendations of the DTAB and it will take time to actually amend the January notification. But he points out that the DTAB has not just suggested modifications and clarifications to existing rules and clauses but also recommended inclusion of a new qualifying clause to clause (2) of rule 122 DAB which specifies that “in case there is no permanent injury, the quantum of compensation shall be commensu-

rate with the inconvenience, loss of wages, transportation.”

Bhat predicts that this could be a cause for concern as there could be many claims for compensation under this newly proposed sub-rule, should it be passed. Proving that a temporary injury was not related to the trial could be difficult. Also, there is need for further clarification on how ‘quantum of compensation’ is to be determined as well as maybe a formula to work out what is ‘commensurate with the inconvenience, loss of wages, transportation.’

Harking back to previous statements by ISCR, Thatte cautioned,” The current compensation rules make the continuing conduct of high quality, scientifically valid clinical trials in India virtually impossible, negatively impacting the availability of scientific data to assess the benefits and risks of medicine for the Indian population. We believe that all of these contentious rules need to be addressed with equal priority and emphasis.” viveka.r@expressindia.com

July 16-31, 2013

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CDSCO allows re-printing / re-labelling of scheduled formulations Will help pharma cos adhere to 45-day deadline Usha Sharma-Mumbai

NPPA is in the process of fixing ceiling prices of scheduled formulations and manufacturers need to ensure that formulation

packs of these drugs available in the market reflect the new prices, inclusive of local taxes as applicable, within 45 days from the date of the

notification.

The recent CDSCO circular brings transparency into the system and officially allows pharma companies to reprint/ re-

label the concerned medicine packs without violating Rule 104 A of the Drugs and Cosmetic Act. u.sharma@expressindia.com

harmaceutical companies are now allowed to re-print / re-label medicine packs impacted by the recent price revisions ordered by the national drug pricing authority. A recently posted Central Drugs Standard Control Organization (CDSCO) circular clarifies that the Drugs Controller General of India (DCGI) has no objection to the relabelling/re-printing of such packs and given the scale of the activity, has decided to ‘take the practical approach to expedite the printing of price so that the benefits of

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A CDSCO CIRCULAR CLARIFIES THAT THE DCGI HAS NO OBJECTION TO THE RE-LABELLING/ RE-PRINTING OF SUCH PACKS price reduction can be passed on to the consumers.’

This permission seems to be the result of a representation from the Organisation of Pharmaceutical Producers of India (OPPI) which requested CDSCO to issue clarifications on this issue after the National Pharmaceutical Pricing Authority (NPPA) released revised drug prices under the Drugs (Prices Control) Order (DPCO) 2013.

Tapan Ray, Director General, OPPI said, “There was an issue over section 104 A of Drugs and Cosmetic Acts, which does not allow any kind of relabelling / re- printing on the products without an approval from the State Drug Controller of India. We requested the DCGI to issue an order so it becomes official and not violate the law.

This solves the problem but there are still other major issues that the industry is facing.”

July 16-31, 2013

www.expresspharmaonline.com

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Growth opportunities intact but managing industry challenges remains key for pharma sector: ICRA Expects 10-12 per cent growth for domestic formulation industry in 2013-14 ccording to ICRA, despite the high-base of the previous year, the Indian pharmaceutical industry would continue to experience strong growth in the near-term, however, there would be some moderation in the growth trajectory.

Principally, the generic opportunities in the US will continue to drive revenue growth for the Indian pharma companies.

This would be an outcome of a) the sizeable generic opportunity (drugs with brand value of $80 billion are expected to face generic competition) over the next four to five years, b) strong product pipeline of pending ANDAs with high increasing proportion of complex generics and c) market share improvement given the relatively small base (share of leading Indian companies is less than 10 per cent in the US generics space). In addition, acquisitions by Indian companies to add technical capabilities and focus on strengthening branded business (albeit on a small scale) are also likely to drive growth going forward as companies feel the need to diversify.

While growth momentum in the domestic formulation industry slowed down in 2012-13 owing to a confluence of reasons (discussed above), ICRA believes that the industry would revert to its long-term growth trajectory in the medium-term as structural growth drivers continue to remain impervious.

The growth momentum has picked-up over the past few months and with pricing policy related matters behind us, ICRA expects the industry to

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revert to a growth of 10-12 per cent in 2013-14. The impact of new DPCO though expected to be limited, could also get offset by volume expansion and efforts of industry participants to take price hike in rest of the portfolio.

In Europe, the performance of Indian companies improved in 2012-13 in comparison to the prior year led by primarily new product launches which helped to offset the impact of pricing pressure. However, given the pace of healthcare reforms and the way competitive landscape is changing in Europe, ICRA believes that the performance of generic companies would remain contingent on new product introductions. As many of the European markets are gradually shifting character from being ‘branded generic’ to ‘un-branded generic’ and from being ‘physician-influenced’ to ‘pay or-influenced, a re-look at business plans also appears to be a common theme across companies.

Generics companies are increasingly focusing on expanding presence in relatively under-penetrated markets (i.e. France, Spain and Italy), branded generic markets of East Europe and niche areas like complex generics, OTCs etc. In general, Indian pharma companies generate a relatively lower share of revenues from Europe with profitability also subdued compared to other markets.

In addition the US generics, emerging markets present one of the most promising growth opportunities for Indian pharma companies.

As growth prospects normalise in developed markets, companies are increasingly focusing on emerging markets through portfolio expansion, alliances or JVs and

WHILE GROWTH MOMENTUM IN THE DOMESTIC FORMULATION INDUSTRY SLOWED DOWN IN 2012-13 OWING TO A CONFLUENCE OF REASONS, ICRA BELIEVES THAT THE INDUSTRY WOULD REVERT TO ITS LONG-TERM GROWTH TRAJECTORY IN THE MEDIUM-TERM AS STRUCTURAL GROWTH DRIVERS CONTINUE TO REMAIN IMPERVIOUS 18

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acquisitions, says ICRA. According to ICRA, given the distinct nature of some of the markets being tapped, managing regulatory hurdles (i.e. delays in receiving approvals in Brazil, healthcare reforms in Russia) and execution however remains the key. Indian companies though have an inherent advantage given their experience with ‘branded generics’ in India. Amongst new frontiers, evolving generic market in Japan (world’s second largest pharma market with only 23 per cent generic penetration) and biosimilars provide alternative growth prospects for Indian companies. While product filings and approvals will be gradual in Japan, hurdles in biosimilars could be multi-fold, stemming from higher R&D outlay for clinical trials and uncertainties related to pathway for regulatory approvals.

In 2012-13, operating profitability indicators of the pharma companies remained fairly stable in comparison to the prior year led by strong scale-up in the US generics business on back of high margin FTF opportunities and favourable foreign exchange environment.

Steady growth momentum in some of the branded generic emerging markets also aided to the earnings profiles.

Overall, margin pressures were limited to few companies and lack of new product introductions in the US, higher expenditure on R&D, onetime charges related to the implementation of Generic Drug User Fee Amendments (GDUFA) and increase in manpower costs were the most common factors. We believe that the margins of Indian pharma companies are currently sensitive to broadly four key factors – a) the implementation of the new pricing policy in India, b) relatively lower proportion of blockbuster generic opportunities in the US in CY 2013 compared to CY 2011 and CY 2012, c) expectation of increasing R&D spending and d) evolving regulatory reforms across many of the emerging markets which may impact margins. The sharp volatility in foreign exchange and the recent depreciation

of rupee vis-à-vis the US dollar will also have influencing role to play given the dependence on international markets. That said, company specific factors would, however, continue to impact earnings profile and quality of product pipeline with higher share of limited competition launches will be the single most differentiating factor. Earnings of companies with debt profile skewed in favour of foreign exchange borrowings would be exposed to MTM losses.

Investments in R&D and acquisitions are expected to gain momentum in Indian pharma industry. Over the years, the Indian pharma companies have developed capabilties to target complex segments like injectables, inhalers, ophthalmics and even biosimilars. Given the increasing focus on these segments, pharma companies have been investing a higher proportion of their sales in R&D activities over the past few years and have guided to spend even higher amounts as they continue to broaden their product portfolio of complex compounds. ICRA believes that there three key drivers for higher R&D spending by Indian companies – a) increased pace of product filings in the US and Europe, b) focus on complex generics, some of which require clinical trials to demonstrate basic safety and efficacy and c) investments in developing biosimilars for emerging markets and eventually for developed markets.

In addition, ICRA expects in-organic investments to also gain momentum in the medium-term as companies plan to create stronger presence in emerging markets and build expertise in select therapy areas. In particular, fast-growing branded generics markets in South-East Asia, Latin America and even some of the markets in East Europe will be of interest to Indian companies. Besides, marketentry driven acquisitions, we also expect investments to add technical capabilities in selected therapy areas or delivery systems to also continue going forward in view of increasing focus on complex generics.

EP News Bureau–Mumbai July 16-31, 2013

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Unichem chalks out expansion plans post Mylan deal To set up up a new manufacturing facility in Goa Usha Sharma - Mumbai umbai-based Unichem Laboratories (Unichem) plans to use sale proceeds of its Madhya Pradesh (MP) formulation facility to expand existing facilities in other locations as well as set up a new manufacturing plant in Goa. Construction work on the new facility in Goa is likely to begin

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THE DEAL BETWEEN US-BASED MYLAN LABORATORIES AND UNICHEM,WORTH `160.50 CRORES,WAS RECENTLY CLEARED BY THE COMPETITION COMMISSION OF INDIA. AT PRESENT, UNICHEM HAS SEVEN MANUFACTURING FACILITIES IN INDIA

July 16-31, 2013

in the next two to three months.

The deal between US based Mylan Laboratories and Unichem, worth `160.50 crores, was recently cleared by the Competition Commission of India (CCI). At present, Unichem has seven manufacturing facilities in India; two for APIs and the remaining for fixed dose forms (FDFs).

Giving further details, Rakesh Parikh, Vice President – Finance, Unichem said, “As targeted early this year, we are in line with the schedule. Both companies have almost received all required approvals from their respective ends.

Now, we are awaiting final approval from MP’s SEZ authority.”

Spelling out the management’s plans post the deal, he said,“We owe dues to the Income Tax Department, which we would like to pay off first. The rest will be spent on our existing API facilities and also to build up a new manu-

www.expresspharmaonline.com

facturing facility in Goa. We also plan to expand our existing research and development (R&D) facility in Goa.” Justifying the company’s decision to sell the MP formulation facility he said, “When we were allotted land from the MP SEZ authority in 2007, the core aim of this facility was to target the developed market. However, US registration used to then take 12-18 months; today this has been extended to 33 months. Secondly, the US authorities have since introduced generic user fees which amount to almost Rs one crore per individual facility. Finally, around two years back, the Finance Ministry exempted SEZ profit in maximum alternate tax.”

Giving Mylan’s takeway from the deal, Nina Devlin, Vice President, Global Communications Mylan said, “The (Mylan) facility has a capacity of approximately two billion tablets and capsules,

providing Mylan with a meaningful expansion of its oral solid dosage (OSD) capacity in line with the company’s stated strategy to double its OSD manufacturing capacity over the next several years.”

Mylan has 11 manufacturing facilities of which eight facilities are used for the manufacture of Active Pharmaceutical Ingredients (API); two facilities for FDFs; and one facility for injectibles.

The company also has two dedicated R&D facilities in India.

Unichem is present in over 30 countries, with more than 300 registrations filed for emerging as well as existing markets. “We have filed 28 ANDAs and plan to file one to two every quarter for the next two years. During 2013, we have touched revenues of `1080 crores. We also target to do business in the US and other developed markets,“ added Parikh. u.sharma@expressindia.com

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Suven Life secures two product patents for their NCEs in Japan and US With these new patents Suven has a total of six granted patents from Japan and, 12 granted product patents from the US uven Life Sciences announced that the grant of one product patent from Japan (5139512) and one product patent from the US (8318725) is corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases and these patents are valid through 2028 and 2029.

The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, Attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Parkinson and Schizophrenia.

With these new patents, Suven has a total of six granted patents from Japan and, 12 granted product patents from the US. These granted patents are exclusive intellectual property of Suven and are achieved through the internal discovery research efforts. Products out of these

S

inventions may be out-licensed at various phases of clinical development like at Phase-I or Phase-II. “We are pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally,” says Venkat Jasti, Chief Executive Officer, Suven.

Suven Life Science is a biopharmaceutical company focused on discovering, developing and commercialising novel pharmaceutical products, which are first in class or best in class CNS therapies through the use of GPCR targets.

The company has 12 internally-discovered therapeutic drug candidates currently in pre-clinical stage of development targeting conditions such as ADHD, dementia, depression, Huntington’s disease, Parkinson’s disease and obesity in addition to developmental candidate SUVN-502 for Alzheimer's disease and Schizophrenia.

EP News Bureau–Mumbai

Mylan in distribution agreement with Zyomyx Under the terms of the distribution and supply agreement, Zyomyx will supply the POC CD4 test to Mylan ylan has entered into an exclusive agreement with Zyomyx for the rights to distribute Zyomyx’s proprietary point-of-care (POC) CD4 T-cell count test in the developing world. CD4 count testing is a critical diagnostic component in treating HIV/AIDS, as medical professionals refer to a patient’s CD4 count to determine when to begin and/or alter HIV treatment. As part of the agreement, Mylan also has made a strategic equity investment in Zyomyx.

Under the terms of the distribution and supply agreement, Zyomyx will supply the POC CD4 test to Mylan, and Mylan will pay development and commercial milestones and a share of profits to Zyomyx for the exclusive rights to distribute the POC CD4 test in Africa; Asia (excluding Japan and South Korea but including (without limitation) Russia, Central Asia and the Middle East); CEE; CIS; South America and Central America (including Mexico); and the Caribbean Islands.

Further, simultaneous with the execution of the distribution and supply agreement, Mylan made a strategic equity investment in Zyomyx and entered into an agreement with the Bill & Melinda Gates Foundation to provide improved and affordable CD4 testing access to patients in high burden HIV countries. All other terms of the agreements are confidential.

The Zyomyx POC CD4 test is currently in final stages of development and is expected to be launched in the near-

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term, pending applicable regulatory approvals. Mylan expects to distribute the portable, easy-to-use, low-cost test in the developing world alongside its broad portfolio of high quality, affordable generic antiretroviral (ARV) drugs in order to improve access to and guide HIV/AIDS treatment in resource-limited settings. To complement the exclusive agreement with Zyomyx, Mylan also announced that it has signed a Global Access Commitment with the Bill & Melinda Gates Foundation, an investor in Zyomyx. Mylan has committed to ensuring that the Zyomyx POC CD4 technology can be made available and accessible at a reasonable price in high burden HIV countries. Increasing access to affordable and effective health interventions for those in need is a priority for the foundation.

Rajiv Malik, President, Mylan added, “Zyomyx’s CD4 test is a revolutionary technology that couldn’t come at a better time. The World Health Organization’s revised antiretroviral treatment guidelines increase the number of people living with HIV and eligible for treatment to close to 26 million, and pregnant women are now advised to start treatment as soon as they test positive. The more quickly patients can receive CD4 testing, the more quickly they can access life-saving medicine. Mylan’s investment in Zyomyx is just one step in our efforts to support the goal of universal access to HIV/AIDS treatment.”

EP News Bureau–Mumbai July 16-31, 2013

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Venus bags Japanese patent for Elores It is expected to launch Elores in Japan by the end of 2015 enus Medicine Research Centre (VMRC), the research and development (R&D) wing of Venus Remedies has been granted a patent for Elores, an antibiotic found effective against carbapenemase-resistant enterococci bacteria, by the Japanese Patent Office. It is expected to launch Elores in Japan by the end of 2015.

Dr Manu Chaudhary, Joint Managing Director, Venus Remedies and Director (Research), VMRC said, “This unique antibiotic adjuvant entity creates a synergistic effect due to its activity on multi-drug resistant extended spectrum beta lactamase and metallo beta lactamase (ESBL/MBL) producing gram negative bacteria. It prevents the development as well as the spread of bacterial resistance from one species to another.

Clinical studies on more than 1,000 patients have indicated an over 30 per cent reduction in cost of therapy as compared to conventional therapies.”

Elores was recently recognised as the best innovation of 2013 by a team of experts from Stanford Business School, US, IC2 University of Texas, Austin, US and Lockheed

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Martin Foundation in collaboration with the union department of science and technology under the Indo-US joint science and technology innovation programme, 2013. It has also been selected among the top eight technologies to be commercialised in the US. “Elores is a product with proven potential.

The Japanese patent has given us exclusivity for the product in one of the world's most important and lucrative healthcare markets up to 2025.

Venus has already filed the common technical document with the European Union (EU) and is on the verge of getting MA grant for the product.

Since EU and Japan have an understanding on the regulatory front, the product can be made available in the Japanese market within no time after receiving the MA grant from EU,” said Chaudhary.

Venus has received patents for this product from 46 countries, including the US, Australia, New Zealand, Russia, South Africa, South Korea, India and all major economies, including EU constituents.

EP News Bureau–Mumbai

Glenmark Generics receives approval for Rizatriptan Benzoate tabs According to IMS Health for the 12-month period ending March 2013, Rizatriptan ODT achieved sales of $263 million lenmark Generics announced that the United States Food and Drug Administration (US FDA) has granted final approval for Rizatriptan Benzoate orally disintegrating tablets, its generic version of Merck’s Maxalt MLT tablets. The company will commence shipping immediately.

The approval is for the 5 mg and 10 mg of Rizatriptan ODT. According to IMS Health for the 12-month period ending March 2013,

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July 16-31, 2013

Rizatriptan ODT achieved sales of $263 million.

Glenmark’s current portfolio consists of 87 products authorised for distribution in the US marketplace and 53 ANDA’s pending approval with the US FDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

EP News Bureau–Mumbai www.expresspharmaonline.com

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M&A activity in pharma sector focuses on strengthening respiratory portfolio Decreases in both volume and value terms, when compared to the average of previous six months Figure: M&A (including private equity) trend analysis

Source:

Top M&A deals (Jun 2013) Rank Date

&A activity in the pharmaceutical sector was focused on strengthening respiratory product pipeline as lung diseases like chronic obstructive pulmonary disease (COPD) continues to increase worldwide and is predicted to be the third leading cause of death by 2020. According to World Health Organization (WHO), total deaths from COPD are projected to increase by more than 30 per cent in the next 10 years.

In line with the above trend, UK-based AstraZeneca acquired Pearl Therapeutics, a US-based developer of inhaled small-molecule therapeutics for respiratory disease, for approximately $1.1 billion. This acquisition will enable AstraZeneca to offer further distinctive treatment options across the full spectrum of COPD and asthma to patients and physicians.

This transaction will give AstraZeneca access to PT003, a potential new treatment for COPD, currently in late-stage development, and inhaler and formulation technology that provides a platform for future combination products.

In another key deal, Israel-based Teva Pharmaceutical Industries agreed to acquire MicroDose Therapeutx, a USbased pharmaceutical and drug delivery company, for approximately $165 million. With this transaction, Teva is taking a significant step towards expanding its respiratory pipeline.

With this acquisition, Teva will gain access to MicroDose’s proprietary technology, including its multi-dose dry powder nebulizer device, which requires no preparation and can be administered in less than 30 seconds.

MicroDose’s current pipeline is anchored by MDT-637 for Respiratory Syncytial Virus (RSV) infection, which prevents viral replication and delivered via MicroDose’s technology.

M&A activity in the pharma sector decreased in both volume and value terms, when compared to the average of previous six months (Dec 2012 – May 2013). According to Datamonitor's Medtrack database, the pharma sector recorded 31 M&A transactions in Jun 2013, against the previous six months’ average of 32.8 transactions. In value terms, the sector recorded deals worth $2.7 billion against the previous six months’ average of $5 billion.

The Indian pharma sector witnessed no deals during Jun 2013, against the average of one deal over the previous six months.

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Target

Acquirer

Deal value ($m)

1

06/27/13

Pearl Therapeutics, Inc. (US)

AstraZeneca PLC (GB)

1150

2

06/17/13

Aragon Pharmaceuticals, Inc. (US)

Johnson & Johnson (US)

1000

3

06/17/13

MicroDose Therapeutx, Inc. (US)

Teva Pharmaceutical Industries, Ltd. (IL)

165

4

06/17/13

Fera Pharmaceuticals, LLC – product portfolio (US) Perrigo Company (US)

129

5

06/05/13

Plastiape S.p.A. (IT)

PM & Partners S.P.A (IT)

92.81

6

06/17/13

Boda Pharmaceutical Co., Ltd. (CN)

Zhuhai Rongding Equity Investment Partnership L.P. (CN) 65

7

06/04/13

Isconova AB (SE)

Novavax, Inc. (US)

29.6

8

06/25/13

Cross Pharma AB (SE)

Medivir AB (SE)

18.58

9

06/18/13

Thallion Pharmaceuticals, Inc. (CA)

BELLUS Health Inc. (CA)

13.76

10

06/06/13

Novartis AG - Syntometrine (CH)

Alliance Pharmaceuticals Limited (GB)

11.8

Source:

Figure: Venture financing trend analysis

Venture Funding Companies in the pharma sector raised $218.9 million during Jun 2013, against the previous six months’ average of $215.1 million. In terms of volume, the sector recorded 19 venture funded deals, when compared to the previous six months’ average of 19.3 transactions.

Notes and definitions Source:

Top venture financing deals (Jun 2013) Rank Date

Target

Investors

Deal value ($m)

1

06/04/13

Akebia Therapeutics, Inc. (US)

Satter Investment Management, LLC; Novo A/S; Novartis Venture Funds; Kearny Venture Partners; Venture Investors LLC; Athenian Venture Partners; Triathlon Medical Ventures; AgeChem Venture Fund, L.P; Sigvion Capital Fund

41

2

06/11/13

Dermira, Inc. (US)

Maruho Co., Ltd.; Bay City Capital LLC; New Enterprise Associates, Inc.; Canaan Partners

35

3

06/27/13

Heptares Therapeutics, Ltd. (GB)

The Stanley Family Foundation; Clarus Ventures, LLC; Takeda Ventures, Inc

21

4

06/21/13

3-V Biosciences, Inc. (US)

Kleiner Perkins Caufield & Byers; New Enterprise Associates, Inc.

20

5

06/26/13

Complix NV (BE)

Edmond de Rothschild Investment Partners; Gimv NV; Biotech Fund Flanders; LRM; Omnes Capital; Vesalius BioCapital Partners S.a.r.l ; Gemma Frisius Fund K.U.Leuven; TrustCapital NV; PMV-Vinnof; Baekeland Fund I NV; Centre de Recherche Public de la Sante; Undisclosed Investors

15.74

Medtrack is a comprehensive, fully integrated, global biomedical database providing information on companies, products, patents, deals, venture financing, and epidemiology. It is a live database, constantly updated with news, milestones, trial information, etc. Medtrack’s unmatched coverage is supported by a user-friendly, highly dynamic set of decision support tools and analytics. In-house analysts and researchers add key insights and conclusions to provide you with the primary and secondary information you need. Key uses of the database include competitive intelligence, target identification, screen potential licensing and investment opportunities, patent assessments, product due diligence, royalty valuations, and developmental benchmarking.

Definitions: 1.Deal value trend is based on transactions where associate values have been disclosed.

2.Trend analysis excludes rumored and terminated deals.

3.Value and volume analysis excludes private equity exits.

For more information, visit us at www.medtrack.com

Source:

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PRE EVENT Bangalore INDIA NANO focus: Drug delivery and healthcare 6th edition of the event to be held from December 4-6, 2013 he 6th edition of Bangalore INDIA NANO will be held from December 4-6, 2013 at Hotel The Lalit Ashok, Bangalore.

The focal theme for the event is 'Nano Horizons.' The nanotechnology event will feature an exhibition and conference sessions which will be reportedly addressed by internationally acclaimed speakers and experts discussing a range of issues pertaining to research, technology development, skills requirement, institutions, risks issues, regulatory and governance structure, Investment and collaborations between academia, R&D and industry.

It will also feature a preconference tutorial session on December 4, 2013 for the delegates which will offer a preview on latest trends of nanotechnology. The trade show will include displays and presentations on innovative technologies, vendor displays, product demonstrations, a pavilion for institutes of national importance and nano mission pavilion.

From this year, a special award by Prof CNR Rao and Mrs Rao will be presented to an eminent scientist. The focus areas of the event are advanced materials, energy, electronics and NEMS, agriculture, drug delivery and health care, safe drinking water and textiles. Over hundred leading international and Indian companies are expected to participate in Bangalore INDIA NANO 2013.

International delegations are expected from the US, the UK, Japan, Korea, China, Singapore, Germany, Switzerland and Australia for the event. A special early bird offer is on for delegates registering for the conference until August 2013.

Bangalore INDIA NANO National Award would be presented during the event to a distinguished personality for significant achievements in the field of nanotechnology.

The selection would be done by a special jury under the

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Chairmanship of Prof CNR Rao. India Nanotech Innovation Award recognises the nanotechnology enabled innovations in areas like medicine, electronics, materials, agriculture and biotech by an organisation / individual which would bring in path breaking change in the nanotech sector. Entries are invited for India Nanotech Innovation Award.

A special programme 'Nano for the Young' is also being organised in the event.

Students from various engineering, medical and bio-tech colleges across Bangalore can attend this special session.

Over 500 graduate students are expected to attend this exciting session.

Bangalore INDIA NANO 2013 will also feature a ´Poster Session´ providing a unique opportunity for scientists and researchers to share their innovations and research in nanoscience and nanotechnology with industry, research institutes and venture capitalists.

ISN Prasad, Principal Secretary to Government, Dept of Information Technology, Biotechnology and Science & Technology, Government of Karnataka, said, “The nanotechnology event has assumed a larger role for the industry and gained significance importance globally. Hence, we are proud to rechristen the event as Bangalore INDIA NANO. Over the years, the event has become very important to all the stakeholders. The event has grown steadily since its inception in 2007.

“Bangalore INDIA NANO has always enabled experts, scientists, researchers, industry and start-ups to meet and exchange notes on tomorrow's nanotechnology. The annual event will be a congregation of academia, research and industry featuring inspiring talks, high quality research papers and a platform to showcase innovative and ground breaking nano-applications. India and more specifically Karnataka will be a major influencer in the field of Nanotechnology in the next couple of years,” he said.

EP News Bureau-Mumbai www.expresspharmaonline.com

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Noppen Conference & Exhibition to host 2nd Annual India Pharmaceutical Summit Event to be held in Mumbai on October 10-11, 2013

oppen Conference & Exhibition is hosting the 2nd Annual India Pharmaceutical Summit on October 10 and 11 at Novotel (Juhu) in Mumbai. Some of the major issues to be addressed at the event are: Techniques for expanding into emerging economies like Africa, Middle East and Asia; Understanding the regula-

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tions and compliance issues for the US and EU markets; Exploring the latest trends in pharmaceutical packaging; Overview of the expanding generic drug sector in India; How can domestic pharma companies successfully establish a cold chain infrastructure.

The summit will give the delegates access to network-

ing sessions, panel discussions, one-to-one business meetings where the manufacturers can meet the top leaders and potential clients and an opportunity to showcase latest equipments and technology.

There has been an amazing progress in the Indian pharma industry in the recent years. The industry has

emerged as one of the most attractive markets globally as it continues to grow and outperform the global industry, especially markets such as US and European Union (EU). It has been forecasted by the experts that by 2020, this market will touch $74 billion sales whereas it current sales stand at $11 billion.

EP News Bureau - Mumbai

try; nutraceutical industry; microbiological industry; Government laboratories; research institutions; academic institutions; business consulting companies; contract manufacturing organisations; contract research organisations; R&D equipment/machine manufacturers; supply chain management; API, excipients and intermediates manufacturers and CROs. Heads of strategy and business development, R&D, regulatory affairs; analytical development laboratory; quality control/assurance; production; packaging; purchase; exports; medical affairs; pharmacology and toxicology; outsourcing; supply chain; pharma product development; logistics and clinical research services are likely to attend the convention

bring pharma professionals from all over the world to Mumbai and facilitates initiating and closing business deals.

Take this opportunity to showcase your products and services while enhancing your brand at South Asia’s leading pharma industry event.

EVENT BRIEF Pharmac India 2013 Date: September 5-7, 2013 Venue: Hitex, Hyderabad Summary: Pharmac India 2013 is 4th International pharma machinery, equipment, bulk drugs, API and material exhibition is going to be held in Hyderabad, Hitex. It has successfully brought together manufacturers and buyers on a common platform and contributed substantially towards the growth of the industry.

Pharmac India 2013 is jointly organised by Orbit Exhibitions and IDMA (GSB) and actively supported by BDMA and CIPI. Contact details: Varsha Surve Manager - Exhibitions Orbitz Exhibitions 101, Navyug Industrial Estate, TJ Road, Siwree (W) Mumbai - 400015 Mob: 9322037955 Email: info@pharmacindia.com

industry is growing an annual rate of whopping 84 per cent.

Clinical Trials Asia Summit is a platform for key stake holders to engage and critically analyse the road map for further growth towards establishing sustainable leadership of India in global clinical trials scenario.

Contact details: Tikenderjit Singh Makkar Dy. Mktg. Manager - India Fleming Gulf 605, City Tower Boat Club Road Pune - 411001 Maharashtra (India) Tel: (020) 67276403 Fax: (020) 6607 0061 Email: tikenderjit.singh@fleminggulf.com Website: www.fleminggulf.com URL: http://www.fleminggulf.com/co nferenceview/Clinical-TrialsAsia-Summit-/485

2nd Annual India Pharmaceutical Summit Date: October 10 - 11, 2013

Clinical Trials Asia Summit Date: September 26-27, 2013 Venue: Hyderabad Summary: Clinical trials are being conducted globally however outsourcing them to emerging economies like India provides competitive advantages in terms of lower operational costs and faster conduction of clinical trials. India has a steady supply of patients and medical facilities for conducting clinical trials at very competitive proposition. The Indian pharma industry is growing at the annual rate of 11 per cent while the clinical research

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Venue: Novotel (Juhu), Mumbai Summary: Noppen Conference & Exhibition is hosting the 2nd Annual India Pharmaceutical Summit. Some of the major issues to be addressed at the event are: Techniques for expanding into emerging economies like Africa, Middle East and Asia; Understanding the regulations and compliance issues for the US and EU markets; Exploring the latest trends in Pharmaceutical Packaging; Overview of the expanding Generic Drug Sector in India; How can domestic pharmaceutical companies successfully establish a cold chain infrastructure.

The summit will give the delegates access to networking sessions, panel discussions, one-toone business meetings where the manufacturers can meet the top leaders and potential clients and an opportunity to showcase latest equipments and technology.

Contact details: Samantha Dasgupta Regional Marketing Manager Tel: (080) 4333 4012 Email: Samantha@blr.noppen.com.cn

16th PAC-2013 Date: September 27 - 28, 2013 Venue: Hotel Hyatt Regency, Sahar Airport Road, Mumbai Summary: Indian Drug Manufacturers’ Association (IDMA) and Association of Pharmaceutical Analysts (APA) have announced the 16th Pharmaceutical Analysts’ Convention (PAC) 2013. The main theme for this year’s convention is ‘Generics The Game Changer’. Dr B Suresh, Vice Chancellor, JSS University, Mysore and President, Pharmacy Council of India New Delhi will be the Chief Guest. Experts in analysis, research, academia and regulatory spheres from the Indian pharmaceutical industry, will converge and get-together to interact on various recent developments. The convention will be held in order to update and exceed the current regulatory requirement and sciencebased systems approach in pharma industry. The convention is designed to cater to all those involved in: pharma industry; biopharmaceutical industry; biotechnology induswww.expresspharmaonline.com

Contact details: Prachi,Sr Manager Publications & PR,IDMA 102-B, 'A' Wing, Poonam Chambers Dr Annie Besant Road, Worli Mumbai - 400018 Tel: (022) 24944624/ 24974308 (Extn. 103) Mob: 9867634383 Email: ppr@idmaindia.com/ prach17@gmail.com Website: www.idma-assn.org

CPhI India Date: December 3-5, 2013 Venue: Bombay Exhibition Centre, Mumbai

Contact details: Chaitali Patil UBM India,Times Square Unit No 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol, Andheri (East) Mumbai - 400 059 T +91 22 61727162 F +91 22 61727273 E chaitali.patil@ubm.com

65th IPC, 2013 Date: December 20-22, 2013 Venue: Amity University, Noida Summary: Indian Pharmacy Graduates' Association will host 65th IPC, 2013. The event will be organised by Indian Pharmaceutical Congress Association. The academic partner for the event is Amity University, Noida.

Contact details: Dr Arun Garg General Secretary-IPGA Director-PDM College of Pharmacy, Bahadurgarh, Haryana Mob: 09416056213

Summary: Reflecting the continued growth in the API, generics, fine chemicals and bio-pharmaceuticals industries on the Indian sub-continent, CPhI India and related pharma services events saw an increase in visitors and exhibitors. CPhI India will July 16-31, 2013

MANAGEMENT INSIGHT FOR MANAGING PHARMA

Treated as drugs for long under the Drugs and Cosmetics Act, the fate of medical devices seems to be headed for a turnaround with whispers of the new bill to be soon put up before the cabinet. The industry has been long advocating for such a change even as it contemplates the implications this transition will bring.

Shalini Gupta finds out more

eDetailing: The future for pharma communication? PG 28

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E Even as the European Commission is in the throes of tightening rules for the approval of medical devices following a series of health scandals, a move that has hit a political deadlock, India, it seems to have realised the growing importance of regulation in this sector as momentum is building to introduce the new medical device bill in the Parliament. Reports indicate that the Health Ministry has sent a note proposing the new bill to the Cabinet Secretary for approval of the Union Cabinet.

The bill that would replace the earlier Drugs and Cosmetic Act of is expected to lay down separate provisions for Medical Devices including a separate definition of them, their risk-based classification

V SASHI KUMAR

RAJIV NATH

AJAY PITRE

Managing Director, Phoenix Medical Systems

Forum Coordinator, Association of Indian Medical Device Industry (AIMED)

Managing Director, Sushrut-Adler Group

With other countries, including Brazil, Russia, China and Turkey, having established regulatory systems, this bill has come none too early in India.

The importance of the bill resides in the need to safeguard the welfare of India's large population while reducing malpractices

After the bill on Regulation of Medical Devices and Patient Safety is passed by a National Regulatory Authority under the Ministry of Health, the current CDSCO's role could be enlarged with more autonomy and renamed as the Indian Healthcare Regulatory Authority

Extensive recruitment and internal training are no doubt necessary by the regulatory authorities to create an organisation that can suitably regulate the industry in an appropriate manner with the objective of creating a vibrant domestic industry that can hold its head high on the world stage

for regulatory control, Clinical Trials on Medical Devices, Conformity Assessment Procedures, Penal provisions, etc. This is in stark opposition to the scenario today wherein medical devices are treated as drugs. The situation is unlike in the US and EU which have separate pathways for medical devices and pharmaceuticals.

import, sale and manufacture under Section 3(b) (iv) of the D&C Act. Thus, from time to time any device which is intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified by the Central Government by notification in the Official Gazette is considered as a drug under the D&C Act. Giving a background on how devices ended up as drugs under the earlier act, Ajay Pitre, Managing Director, Sushrut Adler Group, explains, “Both the regulators and the industry were overtaken by events that moved rather abruptly (in 2006) wherein the need to regulate with immediate effect was forced on the government and it chose to notify selected 'Medical Devices' as 'Drugs' as an expedient route. This was a fundamental mistake – a fact not only evident by studying the global understanding on this subject but also a realisation by our regulators as of date.” It is to be noted that even though the domestic industry has been struggling to get its feet on the ground, over 75 per cent of medical devices sold in India are imported. India is one of the top three emerging markets for international medical device companies with newer

companies entering the market every year. The new bill would also increase compliance w.r.t design, manufacturing, packaging, labelling, import, sale, use, and disposal requirements for companies wishing to import devices into India or manufacture products locally while also expanding the list of products requiring registration.

Stressing on a special focus on internationally harmonised affordable regulations, Dr A Didar Singh, Secretary General, FICCI, says, “Post marketing surveillance and adverse event reporting could be a more optimum solution for monitoring safe and effective performance than doing clinical trials on products well established for usage and safety in other countries. This will not only ensure the quality of devices manufactured or imported into India as well as provide the required impetus for local manufacturers to export medical devices.”

Regulation in India when it comes to medical devices has been restricted to reviewing of documentation and certifications of 'imported' products leaving the domestic industry largely unregulated.

The lack of clarity on the implementation of the regulation, the application of the inappropriate drug law and the non-uniformity of

Righting a wrong?

It was in 2006 that the Ministry of Science and Technology proposed the Medical Devices Regulation Bill (MDRB) in order to put in place stringent laws related to medical devices and establish the Medical Device Regulatory Authority of India (MDRA). The proposal was aimed at establishing and maintaining a national system of controls for the quality, safety and availability of medical devices in India.

However, the bill is pending legislative action since then. Prior to 2005, only medical devices such as disposable hypodermic syringes, tubal rings, condoms, metered dose inhalers, were required to be registered in India when the Ministry of Health and Family Welfare (MoHFW) further notified 10 sterile devices (“Notified Medical Devices”) to be considered as drugs and consequently regulated their

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DR A DIDAR SINGH Secretary General, FICCI

Post marketing surveillance and adverse event reporting could be a more optimum solution for monitoring safe and effective performance than doing clinical trials on products well established for usage and safety in other countries understanding of the industry at the Central and State regulator levels has led to some rather piquant situations, Pitre adds. Thus domestic companies have been left to fend for themselves, and some have been setting standards of excellence and even meeting regulatory requirements of other countries.

Chips in V Sashi Kumar, Managing Director, Phoenix Medical Systems, a company which has set its own standards high, at par with international standards with many of its products having qualified for the CE mark and been awarded US FDA 510k certification. “Safety and efficacious treatment are frequently sacrificed on the altar of cheapness. With other countries, including Brazil, Russia, China and Turkey, having established regulatory systems, this bill has come none too early in India. The importance of the bill resides in the need to safeguard the welfare of India's large population while reducing malpractices and encouraging genuine manufacturers.” Even Sushrut-Adler’s recent acquisition by Smith and Nephew is a testament to the fact that such companies are at par with their international counterparts and better are recognised for their world class products. However, it is up to the regulators to empower indigenous manufacturers while creating a level playing field for all parties involved.

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The way forward In a final draft of the guidelines on medical devices, the Drug Technical Advisory Board (DTAB) recommended strict implementation of Indian Conformity Assessment Certificate (ICAC) for the medical devices manufactured, imported and marketed on Indian market under Schedule M III of Drugs & Cosmetics Rules 1945 while classifying them into Class A, B, C & D as per their level and intended use. All such devices sold in India (except for custom made devices, meant for a particular patient use) should, as a general rule, bear the Indian Conformity Assessment Certificate mark (ICAC) to indicate their conformity with the provisions of this schedule. The new Bill is expected to bring all medical devices sold in India under the purview of the government agency charged with regulating medical devices: the Central Licensing Approval Authority (CLAA) under the CDSCO. For the moment, however, the CLAA only requires certain categories of devices that have been the subject of notifications in the Official Gazette of India (21 device categories in total) to register with the CDSCO. Apart from the notification issued in 2005, in March last year, the Government upon the recommendation of the DCGI and examination by the Expert Committee, has further confirmed 11 devices such as Spinal needle, Insulin syringes, three way stop cock as an accessory of I.V. Cannula/Catheter/Perfusion Set, Introducer sheath, Cochlear implant, Close wound drainage set, AV fistula needle, Extension line as an accessory of Infusion set, ANGO kit/PTCA/ Cath Lab kit, Measure volume set and Flow regulator as an accessory of Infusion set as drugs.

FICCI recommends a single regulatory authority with sufficient resources allocated to it for effective implementation and monitoring of the regulatory framework alongwith a thorough and careful interlinking of various Govt Ministries/Departments (like CDSCO, MoH&FW, DEITYMCIT, DoT-MCIT, BIS, DGFT, AERB and more) presently involved in Governance of Medical devices.

Elucidating the role of CDSCO and the future ahead, www.expresspharmaonline.com

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Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AIMED) says, “ After the bill on Regulation of Medical Devices and Patient Safety is passed by a National Regulatory Authority under the Ministry of Health, the current CDSCO's role could be enlarged with more autonomy and renamed as the Indian Healthcare Regulatory Authority with decentralized Divisions for Drugs, Cosmetics, Medical Devices and Diagnostics.”

He also advocates sharing of regulatory controls given the vast diversity of technologies and varying risk profile of Medical Devices with a National Regulator for Policy, Licensing & Registration of Manufacturers/Importers/Exp orters for enabling a single window and harmonized controls; Utilization of CAB's ( Conformity Assessment Bodies) for delegating the task of factory audits of Indian and Overseas Manufacturers for

Compliance to Good Manufacturing Practices/ Quality Management Systems and the State Regulatory Authority for Licensing and Registration of Traders Distributors/Dealers/Wareho using Sub Contractors /

Retailers etc for regulating Logistics and Sales. This would require minimal increase in employment by the Governemnt and is the Regulatory Model being used in Europe, Canada, Australia, New Zealand with even the

US and Japan reviewing the same, he adds.

The regulatory agency needs to set up suitable and capable infrastructure and staffing with the qualifications, skills and capabilities appropriate to regulate devices that are primarily engineering products used in critical health related applications.

“Extensive recruitment and internal training are no doubt necessary by the regulatory authorities to create an organisation that can suitably regulate the industry in an appropriate manner with the objective of creating a vibrant domestic industry that can hold its head high on the world stage and earn recognition for quality and innovation,” exhorts Pitre.

Singh strongly feels that due opportunity must be provided to stakeholders for commenting on the Bill and give inputs and suggestions on the same through a formal discussion mechanism."To ensure

availability of care for the patients, it is imperative that a suitable transition time be provided to import / manufacture medical devices & equipments in India. Moreover as the implementation of new set of regulations will take some time, industry seeks interim guidelines and implementation plan for the new guidelines from regulators till the new regulations are fully in place."

As we await the bill and its ramifications, lets mull on what Serge Bernasconi, Chief Executive, Eucomed, the European medical technology industry association was quoted as saying on the current situation in the EU, “We need to address the weaknesses of this system to make it even safer for patients without delaying access to safe, life-saving medical devices and without stifling innovation.” Perhaps this is the way forward for India as well. shalini.g@expressindia.com

DIGITAL DOSE eDetailing: The future for pharma communication?

Dinesh Chindarkar, Co-founder, MediaMedic Communications elucidates about eDetailing – where technology and graphics, married with rich content, come to the rescue of mundane communication etailing has always been the backbone of doctors’ communication with the pharma industry for over the last three to four decades. This print tool, though has undergone quality improvements in terms of its content, visual appeal, some added gimmicks etc; all these have been valueadds within the box. Nothing has challenged it so far.

With healthcare providers (HCPs) getting increasingly busy, the print communication gets poor attention with hardly five to 10 per cent of the total message delivered at times.

Many a times, the doctor says that he has seen the

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detailer over and over again and asks the sales representative to just name the brand and/or leave samples and move on. All the cumulative hard work of the brand manager, marketing manager and the sales representative goes for a toss when the doctor does that. This also affects the sales person’s psyche and morale because of which his work gets adversely affected. A major complaint of the field people, including managers, is that they cannot talk beyond the brand name and one or two points; just because they had a bad experience with the doctor not being receptive or not allowing them to speak more.

Within the current scenario, isn’t the doctor justified to refuse him? Isn’t the medical representative justified in insisting on finishing his detailing after waiting for so long? Is the communication tool incomplete or lackwww.expresspharmaonline.com

ing something interesting to convey its message?

Welcome to the era of eDetailing – where technology and graphics, married with rich content, come to the rescue of the mundane communication!

With the advent of technology, video content, graphics, motion and interactivity, and newer digital tools are challenging this visual aid and redefining communication. This version of detailing adds an ‘e’ of electronic to it, making it completely different from the current mode of communication. A different form of eDetailing is one where communication is sent to doctors on the PC without a personal interaction. But we are talking of eDetailing in the context where the electronic detailing aid is used by the sales rep in person-to-person call.

The objective of having a

rich, content – driven conversation with the doctor, so as to discuss about newer medical advances, sharing updated information and help him make the right decision for prescription can be achieved using eDetailing.

All this can be done weaving the brand within the conversation rather than the brand dominating the communication.

With a range of devices available from the high end iPads to lower end tablets, one can choose the right one based on the needs and budgets.

However, the biggest two challenges in eDetailing are: 1. Approach and understanding of technology 2. Changing mindsets and training people eDetailing is not just digitising communication. A lot of pharma companies today have moved to converting their existing content of the July 16-31, 2013

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visual aid into a presentation format and this they feel is using digital technology. No it is not! Digital medium is a medium by itself and each media has its own nuances, advantages and disadvantages, their own strengths and weaknesses. One has to build up on the strength and minimise weaknesses, just like with people. If the MR makes a powerpoint presentation to a doctor using the visual aid, how is it different from using a print media?

This is just like repackaging the radio and listening to it on a TV. Will that really be utilising the key advantages that a television offers?

The approach to the content has to be radically different. What does digital media really offer? It gives an incredible video streaming experience, rich graphics, interactive animations, the technology of touch, audio effects, navigational framework etc. All of these have now to be utilised keeping in mind the key messaging that we need to convey to our TG. Instructional design forms the basis of any eDetailing project and forms

the core of building communication. There are various approaches to eDetailing based on the category in which one is operating, the nature of the brand, the amount of science available in it and the level of HCPs‘ understanding around it.

Considering today’s limitations of time, a MR should be able to set up the story easily before he meets the doctor and deliver the key message within the anticipated time.

If the MR is able to deal with this efficiently, the whole communication can be effective. If he can break the same story in different parts and present to the doctor during different visits he can create one strong message going to the doctor. Another critical advantage of eDetailing is in equipping the MR to answer variety of queries through handy information capsules.

In eDetailing there is also a possibility of creating an analytics back-end, wherein key things can be recorded, like which doctor has seen the story, spent how much time on which part, where the interaction was maximum etc. This data can be

collated real time and based on that feedback can be given. Taking eDetailing to a new level, the MR can connect the doctor to the medical team in his office through his device and get any queries sorted out. Also, he can encourage and involve the doctor in the interactive presentation through guided questions and lead him into conversation. Another advantage of eDetailing is compiling all data in an interactive form, where the MR can open up a product manual to showcase references or showcase a latest CME video to get across an important point. Patientcentric case-studies, interactive CMEs, lead-in medical cases etc can make a doctor completely involved in the communication process. Any interesting data can be shared with the doctor there and then or could be requested for with a follow-up.

Though all this sounds like a dream after four decades of mundane detailing, there are certain hurdles that one needs to overcome.

The hurdles with using the right technology which

works all the time is critical.

The connectivity, bandwidth, actual model of detailing, the software used and the interface of promotion are all critical in making the technology stronger.

Even if the technology is good it is critical to train your people, especially unlearning old things, which is difficult. People are resistant to change. With a long history of regular detailing, it is really difficult to change the typical ‘senior management mindset’. To bring them out of their comfort zone is a challenge for the industry.

Companies need to do a thorough training – both on the mental front to encourage them for usage and on the usability front to make them tech-savvy. It is critical to take rational decisions knowing the internal limitations, rather than copying someone. If there is a clear understanding of technology with a simple vision, one can have a convinced internal buy-in. It should be understood by all stakeholders that the idea is more important and bigger than the technology!

Industry insights ndian pharma industry is one of the fastest growing markets, registering a consistent double digit growth. This is fuelled by a burgeoning middle class population, robust economy and increase in lifestyle diseases.

In recent times, diminishing returns due to lack of differentiation, stringent regulatory environment and limited market access have pulled down this growth. Another major challenge is capability building. Traditional model of ‘product detailing’ is met by a huge resistance from doctors. This significantly impacts the confidence of the modest sales representative. New avenues in the form of media, distribution, promotion to enhance customer engagement therefore represent the next big opportunity. The conventional visual aid has ceased to aid both the doctor in conveying the ‘right’ marketing message as well as the medical representative as it is perceived as a ritual for any sales call. The time for a versatile gadget to replace this ritual is now.

We have a long way to travel from ‘detailing to discussion’ and add value to the call measuring in one to two minutes. In a fragmented

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market dominated by hundreds and thousands of branded generics, the task of increasing the in-clinic share of voice for the brand is the core objective for any marketer.

Closed Loop Marketing (CLM) represents a method to address these needs. Our medical representative is successful in initiating a CLM by making a sales call. However, the time to deliver the marketing message has reduced significantly as most of the e-savvy HCPs are already updated with the latest development in the medical field before our friend proudly walks in his chamber to present the ‘latest’ study in a particular disease or a particular molecule. This is due to the explosion in the social media space.

This results in a rapidly diminishing return on a sales call.

A recent PwC research shows that 20 per cent of clinicians refuse a sales call. Any day on the field, from our own experience, the difference between planned and actual calls will corroborate this. In this changing environment, there is a need to shift from product centric approach to customer centric approach thereby aligning marketing campaigns based on needs and interests of cus-

tomers. Understanding customer needs calls for an in-depth customer profiling and segmenting them to tailor a targeted sales and marketing strategy. The message may be conveyed with the sales representative who can be equipped with interactive tools, as well as other channels like social media and community portals. Finally a loop back into marketing with real time feedback serves as a tool and resource for content development. This helps the marketer to measure the effectiveness of the campaign. He should look at adding value beyond the pill.

To develop this framework which helps the marketer update the content with minimum lag, digital is the only route. Leaders in this space will have to build social authority to drive change. We need to keep in mind that doctors and patients have adapted to social media faster than pharma companies and with the increasing penetration of smart phones and improving spectrum bandwidth, this is heading for an exponential rise.

There is an increasing pressure on pharma companies on containing the SG&A to deliver the same results. This will lead to an increas-

www.expresspharmaonline.com

Manish Bhagat, Chief Manager - Strategic marketing, Abbott Healthcare ing spend in digital as a media.

According to Ernst & Young, in Pharma 3.0, balancing the free-form messaging of social media, with the control, consistency and mass reach of traditional (Sales Rep) media, can offer the best of both worlds. The need to reduce cost + need to improve access + need to enhance quality of interaction + the need to reach new customer groups = need for change in pharma.

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RESEARCH EXPERTISE FOR DRUG DEVELOPMENT

New research could lead to shorter and cheaper drug trials PG 31

‘Our products are safe for juvenile diabetics as well as pregnant, lactating and nursing mothers’ Recently, DSK Nutrition Research Centre has launched two new products for diabetes which do not contain any artificial sweeteners. Dr Sharad Kasarle, Director in DSK Nutrition Research Centre share more details about the newly introduced products and about research pipelines, to Usha Sharma Tell us about the company’s inception and its ongoing activities?

DSK Nutrition Research Centre is inspired by dedication and passion in well documented scientific research, power of technology, real values and wealth of nature. It is constantly striving for innovative and specialised nutrition therapies with great sensory attributes for consumers of all ages. These exciting health foods will help prevent the onset of lifestyle disorders like obesity, diabetes, stress, heart and brain health. It’s all about right and adequate clinical nutrition and replenishing the nutritional deficiencies through tasty food product formulations.

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After a six-year research, DSK Nutrition Research Centre has developed natural medicinal products for diabetes. Tell us more about them?

These are a range of authentic diabetic nutrition and herbal nutrition products developed through scientific and clinical research using food technology, bio-analytical and SBT technology.

The products are as follows: A) Herbal Oral Therapy (Insulin like effect) – This is very powerful for hyperglycaemic patients to lower the blood glucose naturally.

B) Diabetic Medical Nutrition – The product contains authentic nutraceuticals, micronutrients and herbal derivatives for healthy blood glucose, blood cholesterol and fat management.

The product is natural and is devoid of any side effects and toxic elements.

These products do not contain any chemical/artificial preservatives, colours and additives which are harmful.

What is the USP of these products?

The products (A&B) are safe for juvenile diabetics as well as pregnant, lactating and nursing mothers.

Where were the clinical trials conducted? Did you find any variation in study reports from country to country?

DSK Nutrition Research Centre has initiated the clinical trials (Product A & B) and carried the the research at various centres in Hyderabad, Mumbai and Chennai. The research took almost six years for completion and it was conducted under my observation.

Which technology did you use in developing the product?

We have used food technology with SBT and medicinal herbalism for product A & B. How will this product fare in comparison to other existing products in the market?

Our Diabetic Medical Nutrition product is unique, developed with the help of advanced technology of SBT, which modulates sensory buds and creates the best of medicinal nutritional values.

With regard to this product, which factors play an important role in the case of chronic diabetes disease?

Our product Herbal Oral Therapy gives the lowest glycaemic index and the ability to maintain healthy blood sugar levels as well as HbA1c levels, making it the ideal nutrition solution for diabetics.

How are artificial sweeteners harmful for the human body? Are there any ways to overcome this problem?

Artificial sweeteners are chemicals and their longterm safety profiles on www.expresspharmaonline.com

INTERVIEW

humans are still not known.

They are slowly being proven as toxic and carcinogenic, hence even regulatory bodies like FDA, FSSAI etc. enforces warning declaration on the food packs ‘Not recommended for children’. Their safety is questionable for pregnant mothers as well. Moreover, these artificial sweeteners use harmful bulking agents like dextrose/glucose, maltodextrins, which sometimes have even higher glycaemic index than sugar. Their administration should be carefully monitored.

Do you think your latest discovery for diabetes will offer remedial measures?

As far as Herbal Oral Therapy is concerned, the discovery has specially been focussed at the healthy management of blood sugar profile, healthy maintenance of glycosylated haemoglobin HbA1C and healthy maintenance of cholesterol levels; which are very important for diabetics to prevent further complications of diabetes such as cardiovascular diseases, retinopathy, neuropathy, stroke, stress, fatigue and so on. Diabetic Medical Nutrition is a product that is nutritious, healthy and naturally free from sugar, with great taste as an advantage and is available in many exciting formats like creamy vegetable soups, fruits and vegetable products like jellies, jams, marmalades, juices, beverages, soluble fibre sprinklers, etc.

How many products are in the pipeline and when will they be launched in the Indian market?

We have developed a range of speciality medical nutrition and nutraceutical products with well documented scientific research and credentials; which are as follows:

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Obesity nutrition for weight management ■ Cardio nutrition for the healthy management of cholesterol and triglycerides ■ Cardio nutrition for improving healthy circulation and maintain health of cardiac muscles ■ Diabetes nutrition for healthy blood glucose and HbA1C management.

■ Cancer nutrition ■ Immunity enhancement through medical nutrition ■ Treating chronic constipation and colon cleansing through herbaceuticals ■ Neurodegenerative disorders like depression, anxiety, loss of memory and concentration, neuropathy through nutraceuticals ■ Insomnia and sleep apnea management through medico nutritionals ■ Paediatric nutrition ■ Nutrition for new born infants and pregnant lactating and nursing mothers Nearly more than 150 formulations in medical nutrition and functional foods have been researched and developed. u.sharma@expressindia.com July 16-31, 2013

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CLINICAL UPDATES Shorter and cheaper drug trials in pipeline with new research Chicago Booth professor suggests adaptive model that could save lives with quicker results

n an effort to save lives and money in the expensive healthcare field, a University of Chicago Booth School of Business professor and a Ph.D. student have devised a way to expedite the trial phase of pharmaceuticals development.

John R Birge, Jerry W and Carol Lee Levin Professor of Operations Management, and Vishal Ahuja, a Ph.D. student, wrote their results in 'Fully Adaptive Designs for Clinical Trials: Simultaneous Learning from Multiple Patients,' a working paper that they are revising for publication.

The researchers see a possible way to shorten clinical trials, which have increased in

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length by 70 per cent from 1995 to 2005, while the cost for a single trial has surged to as much as $100 million. Birge and Ahuja hope to change the status quo which is based on an agrarian model from the 1920s that was used to analyse crop yields to a more responsive method.

Though the research must still move from mathematical model to reality, which would require FDA approval after the paper is published, the researchers, when studying data from a 2008 trial on stents that were used to treat stroke patients, detected the potential of adaptive trials to save time, money and lives over traditional trials.

Birge and Ahuja found that, had the trial used their model, 17 failures could have been prevented. In the traditional study, which involved 451 patients, participants who received the stent were more than twice as likely to have a second stroke or die as those who received conventional treatments. Five people who received the stents died, and 46 trial participants had experienced a stroke or died within 30 days of receiving treatment.

The research currently works best with diseases and treatments when effects reveal themselves quickly, says Elbert Huang, Director of the University of Chicago’s Centre

for Translational and Policy Research of Chronic Diseases, and works less well when effects manifest themselves more slowly, as with diabetes.

Birge and Ahuja are working to address that challenge, and are studying doctors who treat diabetes to understand how they determine the best sequences of treatments to offer patients. They are using data from a large, governmentfunded study that Huang is overseeing, which is investigating what drugs doctors have prescribed for roughly 500,000 diabetes patients treated through the US Department of Veterans Affairs.

EP News Bureau - Mumbai

RESEARCH UPDATES Hepatitis B virus control, identifying proteins in mutation management Researchers at Kanazawa University Graduate School of Medical Science used an avian counterpart for HBV duck HBV (DHBV) to investigate the role of the host factor UNG in viral hypermutation in cccDNA

July 16-31, 2013

esearchers at Kanazawa University Graduate School of Medical Science in Japan have determined how APOBEC proteins mediate hypermutations that inhibit viral replication. They also identify the host factor protein UNG that can repair these mutations.

The hepatitis B virus (HBV) is a primary cause of chronic liver disease. So far the persistence of the virus has not been fully explained.

Recently researchers showed that a group of proteins – apolipoprotein B mRNA editing catalytic polypeptide (APOBEC) proteins – were found to inhibit replication of the virus but the exact mechanism remained a mystery.

Now researchers at Kanazawa University Graduate School of Medical Science in Japan have determined how APOBEC proteins mediate hypermutations that inhibit viral replication.

They also identify the host fac-

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tor protein UNG that can repair these mutations.

The HBV genome form is converted into stable covalently closed circular DNA (cccDNA) in the nuclei of liver tissue cells when they are infected. As the authors point out, “cccDNA is not targeted by anti-HBV drugs and thus enables the re-establishment of viral replication after cessation of antiviral therapy.”

However, the lack of an experimental system that can produce cccDNA in sufficient quantities for investigation has limited what is known about the host factors that control cccDNA. Masamichi Muramatsu and colleagues at Kanazawa University Graduate School of Medical Science used an avian counterpart for HBV – duck HBV (DHBV) – to investigate the role of the host factor UNG in viral hypermutation in cccDNA. DHBV shares many similarities with HBV with an www.expresspharmaonline.com

(Source: Kanagawa University, Japan, Organization of Frontier Science and Innovation)

important advantage for experimental investigation; it reproduces cccDNA more efficiently.

Transfection experiments showed that cccDNA hypermutation was enhanced on UNG inhibition in APOBEC3G expressing cells, resulting in a significant decrease in viral production. “We speculate that the balance between

AID/APOBECs and UNG activities on mutation frequency decides the consequence to hepadnaviruses: deleterious mutations vs. diversification,” suggest the researchers. Their future research will look into the possible role of APOBECs and factors like UNG in the emergence of drug-resistant mutants of HBV and DHBV. (ResearchSEA - Asia Research News) EXPRESS PHARMA

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‘Pharma packaging segment will provide significant growth opportunities in the future’ PG 34

PACKAGING S P E C I A L Cold chain ‘pack’age Packaging of cold chain pharma products is one of the most critical activities for both pharma and packaging industry. Sachin Jagdale reports on the advancements in this evolving sphere

O Over the years, forms and characteristics of medicines have evolved continuously and so have the packaging requirements for them. The changing appearances and characteristics of medicines have kept packaging solution providers on their toes. May it be vaccines, different types of proteins or antibodies, each of these have their own set of temperature requirements. To package such temperature sensitive medicines in a manner that would preserve their integrity and make them suitable for cold chain logistics is a prime concern for pharma packaging solution providers.

Trends in cold chain packaging

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Success of a cold chain is largely dependent on the way the pharma product has been packed. Cold chain environment can interfere with the properties of improperly packed medicines. Vishal Sharma, Cofounder and Director, Vienni Training and Consulting LLP, explains why the packaging of cold chain pharma products are getting increasing attention. He says, “A cold chain is a temperature controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range. It is used to help extend and ensure the shelf life of drug products. Historically, cold chain is maintained by vaccine

manufacturers in India, but with novel therapies, like stem cells, r-protein and monoclonal antibodies coming aboard, packaging of cold chain products have received a phenomenal impetus. Biologics and pharma companies are getting increasingly aware about the importance of cold chain maintenance and the challenges associated with it.”

While explaining recent trends in such packaging, Sharma adds, “Recently I came across a product, by an Indian company, that is for clinical trial and needs more than -1900C for storage, which is previously not thought of and the most current packaging solutions does not work. The current trends belong to investments in ultra-low temperature storages, space optimisation and ensure that there is an excellent track-andtrace mechanism.

Innovation and energy saving technologies are in the pipeline with many organisations, since low volume shipments, especially in clinical trials, also need cold chain distribution.”

Scientific advances in the pharma industry have made cold chain pharma products not only more effective and but also complex.

Fortunately, to safeguard these products their packaging has also improved over the years.

Sharad Dahatonde, General Manager, Biotechnology, Elder Pharmaceuticals, says, “Packaging requirements for the cold chain pharma products have evolved significantly from dry-ice packaging to refrigerated trucks/cars. There is good availability of gel packs, insulated shipping containers, phase change materials and temperature monitors to ensure that thermal control is maintained throughout the cold chain shipping, handling and storage process.” www.expresspharmaonline.com

Cold chain pharma products are moved over land, air and sea. So approved packaging materials are necessary to ensure their safety.

Suresh Ganapuram, Packaging Development, Torrent Pharmaceuticals, Research Center, talks about a few more aspects of cold chain pharma product packaging. He says, “Although most developments in coldchain packaging focus on conductive systems, new high-performance convection systems are worth considering. One relies on polyurethane-foam insulation to keep shipments cold longer than would be possible with polystyrene foam.

This higher insulation factor reduces the amount of dry ice or gel packs needed to protect the payload and may

allow shippers to switch from overnight delivery to more economical two or three-day service. High durability means the foam insulation can be reused.”

Challenges Managing cold chain pharma products was never a cake walk for the medicine manufacturers. As far as packaging solution providers are concerned they always have to engage most recent technology to ensure optimum standards of packaging.

Sharma opines, “More and more Indian pharma companies are exporting out of India, thus adding newer challenges in maintaining the cold chain. Apart from more regulated markets, Indian drug export is July 16-31, 2013

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steadily growing in less regulated regions too. Imagine a vaccine or a drug that is delivered to sub-Saharan Africa, and which needs cold chain maintenance. The challenges with such products are not only time and temperature excursions or logistics, but also with respect to active infiltration and theft.”

Sharma adds, “Managing cold chain at clinical sites is another challenge which companies are working on.

Indian clinical research market is growing and more often than not the clinical sites are at remote places from the manufacturing site, in some cases outside India too. Here packaging and logistics have to be carefully deliberated upon, the failure here is not the inventory cost, but the cost of delayed R&D, which in some cases can go up to years.”

As described earlier, technology is the key factor while developing packaging solutions for the cold chain pharma products. However, technology needs money and to keep the cost under control is also a major challenge.

Sharma elaborates, “Logistics and packaging cost is of course another challenge which needs to be addressed. Often primary, secondary and tertiary packaging is designed to maintain cold chain and 'data loggers' are used to record and observe time and temperature during transit, long hauls etc.

Cost optimisation using local hubbing and packaging, which works excellently for other cold chain products like agricultural produce may not work for drug product, thus increasing the cost.”

According to Suresh

July 16-31, 2013

VISHAL SHARMA

SHARAD DAHATONDE

SURESH GANAPURAM

Co-founder and Director, Vienni Training and Consulting LLP

General Manager, Biotechnology, Elder Pharmaceuticals

Packaging Development, Torrent Pharmaceuticals, Research Center

With novel therapies, like stem cells, r-protein and monoclonal antibodies coming aboard, packaging of cold chain products have received a phenomenal impetus

Packaging requirements for the cold chain pharma products have evolved significantly from dry-ice packaging to refrigerated trucks/cars

Although most developments in cold-chain packaging focus on conductive systems, new high-performance convection systems are worth considering

Ganapuram, for many frozen shipments, dry ice has been the refrigerant of choice. He adds, “However, it may alter the pH of some drugs, and many carriers consider it a hazardous material because it can cause burns and requires special handling during packing and unpacking. Dry ice also emits carbon dioxide.”

drugs in the market.

Moreover, the molecules of the drugs are becoming more complex (therefore potentially unstable), and regulatory authorities around the globe are demanding a greater degree of proof concerning drugs identity, strength, quality and purity.”

Dahatonde explains by giving an example. He says, “In case of Menaquinone manufacturing, due to product stability issue, the purification and packaging process need to have dark conditions after the fermentation process. The finished product is light sensitive and need to be packed in special quality, black plastic bags and containers to retain their efficacy.”

Medicinal Products through the Transportation Environment'. With PDA chapter recently functional in India, we see a lot of knowledge sharing and learning possibilities,” informs Sharma. However, he cautions that the technology is available but, keeping up-todate is a challenge due to lack of guidance and enforcement in the local scenario.

Manufacturing precautions Packaging aspects are taken into consideration right from the manufacturing stage. Even more so for cold chain pharma products.

Dahatonde explains, “All pharma and biotech executives are working very hard to manufacture best quality cold chain pharma products and always keep the packaging aspect in mind to provide the accurate quality for their

www.expresspharmaonline.com

Technologically sound Though maintaining cold chain is a tough task, according to Sharma, the Indian players are in a position to offer world class services in this category. He strongly feels that the Indian packaging development organisations are keeping themselves abreast to face the challenges.

“There is a lot of collaboration happening between Indian organisations and multinational companies. A lot of good work is done and a lot more needs to be done, as the paradigm is shifting every day, with new challenges emerging. Parenteral Drugs Association (PDA) came up with a comprehensive guideline for cold chain maintenance in their Technical Report 39 (Revised 2007) 'PDA Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature Sensitive

Innovative future Sharma informs about some of the key developments in the pharma packaging sector. “Utilising Quality

by Design (QbD) concept is gaining fast momentum in packaging development for cold chain products, and we see a lot of novel products/concepts coming in near future,” says Sharma.

He expects that the innovative products that are at the top of the dosage forms pyramid will necessitate novel packaging and distribution methodologies, which in turn will turn the wheels of innovation in the cold-chain management quicker and smarter.

With the rise in number of biologics' companies in India, the cold chain pharma products have also started becoming more visible in the medicine market. Moreover, packaging solution providers have also responded positively to these developments by offering requisite packaging solutions. It is to be expected that these moves by the packaging companies would contribute in enhancing their credibility globally and usher in more progress in the sector. sachin.jagdale@expressindia.com EXPRESS PHARMA

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‘Pharma packaging segment will provide significant growth opportunities in the future’ Oaktree Capital has acquired a stake in Cogent Glass. Ashok Sudan, Chief Executive Officer, SGD and Board Member, Cogent Glass divulges details of this deal and predicts that the pharma packaging segment will continue to grow and play a significant role in the company’s growth, in conversation with Usha Sharma Oaktree Capital acquired nearly 60 per cent stake in Cogent Glass and plan to invest `200 crores in the company. Tell us about the strategies for the investment?

The strategy is to establish Cogent Glass as a leading supplier of type 1 moulded and tubing glass for the pharma industry in India and, furthermore to develop it as a global supplier focussed on regulated markets.

SGD, another firm in which Oaktree Capital has made an investment, has signed an agreement with Cogent Glass. Can you reveal more about the terms and conditions of the agreement?

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INTERVIEW The agreement calls for technology exchange between Cogent and SGD. In addition, it calls for SGD to provide assistance and advice in the areas of production and industrial management, sales, marketing, financial management and control.

Why is an LA-based investment firm, Oaktree investing in a pharma packaging firm?

Oaktree has several investments in the packaging field including its investment in SGD, which is a global leader in pharma packaging. Oaktree believes that the pharma packaging segment will provide significant growth opportunities in the future.

Will this deal help Cogent Glass to access SGD market and vice versa?

Cogent and SGD will cooperate first in developing the Indian market for type 1 pharma glass and then jointly leverage opportunities for export.

How large is the Indian packaging market and out of three different type glass manufacturing which other area you are targeting to explore and why?

The Cogent plant is focused on the niche of type I glass, which is the highest

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quality glass for pharma, used specifically for products that need to be packaged in highly neutral glass.

Do they have plans to bring this global technology to India?

The cooperation agreement calls for a mutual exchange of technology in the moulded glass and tubing glass areas.

Is this development restricted to the AsiaPacific market or is it for the global market?

There are no geographical restrictions in the agreement, though the primary focus will be the rapidly growing pharma market in India.

Cogent is a three-years old company and isn’t it too early to take such a bold step. Tell us why you chose this way to grow?

Cogent Glass has a world-class plant with some of the best glass-making technology in the world. It also has employees with a high level of technical competence. Making type 1 glass is a very complex operation with very high quality requirements and we believe that this plant will be the standard for manufacturing this type of glass, not only in India, but in the world.

Tell us about the shareholding pattern after the stakes owned by Oaktree

capital?

At closing Oaktree became the majority shareholder of Cogent with approximately a 60 per cent share of the equity.

Will the employees of the Cogent Glass get affected by this deal?

No, there will be no change in the existing pattern.

Presently, how many people are associated with Cogent Glass, and are there any possibilities of increasing this headcount in the near future?

The Cogent head-count will continue to grow as the business ramps up.

Recently, the company started up a world-class plant in Addakal, near Hyderabad to produce high quality moulded type I glass vials as well as tubular glass vials and ampoules for the pharma industry, and the plan is to fill up the capacity of this plant as quickly as possible and to expand capacity as the need arises.

Tell us the market potential of glass vials in the India and how much business have you captured in the Indian market?

The market for glass vials in India is growing at a double-digit rate. Cogent is just starting production but hopes to capture a significant share of this market. u.sharma@expressindia.com

July 16-31, 2013

PHARMA ALLY ‘Our experience in India over the past 20 years has been quite phenomenal’ Sigma Aldrich has consolidated its position in the Indian market and is now making inroads into the Indian pharma and healthcare industry. Sunil Punjabi - Deputy Managing Director, India, shares his vision for Sigma Aldrich India with M Neelam Kachhap Why is India an important destination for SigmaAldrich?

India is a key destination for all global companies like Sigma Aldrich. Being one of the fastest growing economies in the world, the country’s R&D and manufacturing activities are significantly expanding to cater to both local and global requirements.

This provides opportunities for us to support and make both our customers and us successful through expanding our footprints in India. In addition, we are leveraging India's advantage by providing support to our global operations through our shared services centre in Bangalore. The talent pool available in India is another key reason for high importance of India as an important destination for Sigma Aldrich.

Tell us about your business interests in India.

We actively promote our corporate flagship product line under brands Sigma (Life science), Aldrich (Chemistry), Fluka & Supelco (Analytical), SAFC (manufacturing customers in life science and hi-tech industry) to our customers in research, applied and commercial markets.

India has an enormous potential and we have a robust plan to continue our focus in India on small scale manufacturing, R&D, packaging and distribution. In addition, we will actively seek opportunities in expansion of channel distribution of scientific products and solutions which includes our recent agreements for distribution with Corning Axygen, GE Whatman and in the past with Corning Life Science. We also have global shared services centre in India to support operations globally within Sigma Aldrich to achieve July 16-31, 2013

operational excellence.

What is the size of these markets and what percentage is served by SigmaAldrich?

We believe the market size is around $ 400-500 million in the space we operate and we are a significant player in the market.

Sigma-Aldrich has been in India for 20 years, how has the experience been?

Our experience in India over the past 20 years has been quite phenomenal. We are very pleased with it. From a modest liaison and branch office status in 1992-94, we expanded our operations through our Customs bonded warehouse in 1999 to support our customers pan-India. We added oligonucleotide manufacturing facility in 2004 and moved to our own 10 acre sprawling campus in 2006 which houses manufacturing, R&D, packaging and distribution facilities.

In addition, we have our global shared services operations working out of a dedicated facility in Bangalore to support our global operations.

How has the Indian market evolved in the past 20 years?

Prior to 1992, most of the R&D work was carried out in government-funded research institutions and universities.

However, with economic liberalisation in 1991, there has been accelerated expansion of R&D labs in both private and public sectors.

Manufacturing sector grew at a significant rate over the last two decades to support both local and global requirements. This further helped expansion of R&D to support it. More and more global companies have expanded their R&D and manufacturing

units in India in last two decades.

The globalisation of Indian R&D and manufacturing market has helped in making it more competitive and achieve operational excellence to remain relevant in this challenging global environment. Sigma Aldrich caters to customers in both R&D and manufacturing; it has evolved itself to support changes in both these sectors by bringing both global and local solutions to support its customer base. Companies in our space have had to come up with innovative solutions like customs bonded warehouse etc. to provide for the dynamic requirements of its customers. Sigma Aldrich has been pioneer in bringing solutions to market to remain always ahead in the curve to support its customer needs.

What are the new trends in this market?

The key trend we see in the market is about focus on competencies rather than cost.

Market opportunities and development of product to meet local needs is the buzz word rather than just localising the existing product. Customer desires and needs are the drivers for research and development and manufacturing rather than government incentives. The focus has moved to catering for both local and global requirements to sustain and grow business.

Tell us about your expansion plans in India.

We have,over the last few years, expanded our warehouse, global shared service centre and services and capabilities in our small scale manufacturing set up in Bangalore.

We will further evaluate expansion and scale up of our manufacturing activity in India to support our local and global customers. We will continue to enhance the capabilities and scaling of our global shared services over the years to support our global operations.

What is the staff strength of Sigma-Aldrich in India? www.expresspharmaonline.com

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Remote monitoring: A cure for maintenance headaches PG 36 Sotax Group shifts Asia-Pacific headquarters PG 37 Thermo Fisher Scientific launches ‘Tribrid’ LC-MS PG 38

Would you be hiring new talent?

Currently, we have more than 325 staff members in India and expect to increase the headcount to more than 500 in the next few years.

Which new products would you be launching in future?

Our focus is going to be more customer-centric and our offerings to be launched in the future will be aligned to customers in research, applied and SAFC commercial segments like life science and Hitech. We are working on a robust product pipeline in analytical and life science range to bring to market over next few years. We have also launched the Vetec Brand Lab Essential range of product line to offer value and reliability.

We will be expanding this range over the next few years to cater to the requirement of scientists for their everyday research use.

What is Sigma-Aldrich’s focus for future?

Sigma Aldrich’s focus will continue on driving innovation and expanding into new markets by leveraging our core scientific strengths: analytical chemistry, biology and chemistry-materials science. Our initiatives will enhance our position in the areas we know best for our customers in research, applied and commercial markets. mneelam.kachhap@expressindia.com

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VALUE ADD Remote monitoring: A cure for maintenance headaches Continuous online monitoring systems give industrial firms access to real-time production data that can help improve preventive maintenance and business decision-making. Jon Furniss, Global Product Manager, Rockwell Automation elaborates hysicians and production facilities are alike in many ways. Every day, medical professionals are expected to evaluate and treat patients, bringing the sickest of people back to health. Like doctors examine their patients, production facilities must constantly assess their machines, monitoring them to ensure they’re in good health and restoring them to it when they’re not. Often, physicians must make decisions with less-than-ideal information. In the past, the same has been true for production facilities when it comes to plant-floor data.

Luckily, that’s no longer the case. The information needed to diagnose, treat and even predict the health of plant-floor equipment is now little more than an Internet connection away. By tapping into continuous, online monitoring systems, production facilities and OEMs can remotely access real-time production data from their machines and systems.

Everything from key product measurements such as switch temperatures, CPU usage, and

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flow rates, to faults and alarms and higher-level production trends can be collected, monitored and analysed around the clock and around the globe.

Frequently, medical professionals see the symptoms of a problem, but diagnosing the cause and determining the best treatment option is complex. For production facilities, the comprehensive view offered by remote access to plant-floor data makes it possible to do what so many doctors only dream of doing — diagnosing the cause of problems and applying the best solution to fix them, all without leaving the comforts of home.

With that in mind, let’s look at few of the symptoms many production facilities are suffering from, and examine some options that will provide relief.

Symptom: My IT staff is too lean to monitor all my machines and processes properly Treatment: See a specialist The proliferation of network technology on the plant floor practically mandates collaboration between IT and production — a change that has drastically altered the roles of professionals in both areas. Not only has the scope of their responsibilities evolved, but the technology that these professionals must manage has become increasingly complex.

Along with myriad other responsibilities, the IT staff often is tasked with monitoring complicated and interconnected processes and machines.

Unfortunately, these individuals often don’t have the training, time or skill set it takes to make sure these systems are optimised.

In addition, because IT professionals often aren’t solely focused on production, they lack understanding when it comes to the urgency of production-related issues.

Outside production, a server crash may result in a printer or email outage and the expectation is that it will be addressed within a few www.expresspharmaonline.com

hours. Inconvenience is generally the largest consequence of such events. But in production facilities, downtime is lost profit, and responses must be activated in minutes, not hours.

While IT professionals often are stretched too thin to understand and address complex production issues properly, OEMs and other automation experts specialise in this area. They possess a deep knowledge of plant-floor technologies and understand the many intricacies of how systems affect production.

Thanks to advancements in remote monitoring technology, taking advantage of this expertise is easier than ever before. Through secure Internet connections, automation professionals can help troubleshoot plant-floor issues, discover trends and identify process improvements. They also can be alerted to all changes in processes and machines, so they can identify and respond to warning signs quickly — usually within minutes — and work to correct them.

Symptom: I never have enough time for maintenance Treatment: Change your lifestyle Most people don’t go to the doctor very often, and when they do, something is already wrong. They don’t make time for regular checkups even though the majority of medical professionals would say it’s the key to identifying and solving problems early. In general, production facilities intuitively know the same goes for preventive maintenance activities. In reality, however, it’s often just as difficult to make the time for preventive maintenance on machines as it is to visit the doctor for that annual physical.

Remote monitoring can help change the status quo when it comes to maintenance. Allowing remote access to machine data enables OEMs and other automation professionals to access plant-

floor data and perform a variety of support and maintenance activities — from suggesting overall infrastructure health improvements to monitoring individual process tags.

Regular preventive maintenance is particularly important because superficial problems with processes and machines can be indicators of more substantial issues. For example, when a pump isn’t performing well, the problem often can be traced to a faulty pump seal. However, this failure frequently is symptomatic of another, more serious problem, such as misalignment or overpressure. By proactively monitoring the right machine conditions and operating data, specialists can remotely identify causes and correct them before they become catastrophic issues.

Symptom: I don’t know what’s happening at my plant in Asia Treatment: Go remote As production becomes increasingly global, more and more companies are spreading their operations abroad. Often, this distance comes with a price: decreased access.

Companies with factories in China, oil rigs in the Gulf of Mexico, pipelines in the Canadian Rockies, and locations in a variety of other remote places often have limited, if any, access to their machines — not to mention the production data they generate. For most, lack of access means maintenance and repairs are costly, time-consuming and sometimes dangerous. What’s more, lack of insight to data makes it nearly impossible to make process improvements.

In the past, production facilities have tried to establish access to remote locations by creating a VPN connection — an activity that is time-consuming and complex. But once this connection is set up, plant managers still have to conduct the monitoring themselves, which leads to the same expertise and Continued on Pg 37 July 16-31, 2013

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VENDOR NEWS Sotax Group shifts Asia-Pacific headquarters Acquires Dr Schleuniger Pharmatron for $15 million

Usha Sharma - Mumbai otax Group has relocated its Asia-Pacific headquarters from China to Mumbai, India effective July 1, 2013. The entire Asia business of Sotax will be managed by Mumbai office.

Jean-Lois Raton, Head of Business Unit Asia – Pacific, Sotax Group reasoned about relocating the headquarters and said, “In China we do not have companies to sell our products directly, however, in India we deal with companies directly. And India has more potential than China.

To continue our business in China, we will be following dealer model.”

The company is involved in the development and manufacturing of equipment for dissolution testing, automated sample preparation and physical testing of pharma dosage forms. With a global network of service engineers,

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it is being preferred for the installation, maintenance, repair and qualification services for its Sotax and Zymark brand products.

The company has also acquired Swiss-based firm Dr Schleuniger Pharmatron for $15 million. It has raised the required funds partially from internal accruals and from term loans.

Commenting on recent development in Mumbai, Raton commented, “This development will extend our business further. It will give our clients a complete range of solutions under one roof. We will be asking Pharmatron to develop ‘Made in India’ installation solution specifically for Indian companies. We are also looking for more acquisitions from India.”

“With hundreds of tablet hardness testers installed at all leading pharma companies in India since 1997 and a

proven track record of more than 20,000 testers in the market, Dr Schleuniger Pharmatron hardness testers are renowned for their reliability and repeatable precision all over the world. In India we have limited reach but after the recent development, we will certainly grow many fold,” said Holger Herrmann, Vice President Sales and Marketing, Dr Schleuniger Pharmatron.

“The Sotax Group's acquisition of Dr Schleuniger Pharmatron at this juncture is the right strategy and will strengthen the Sotax leadership position as the provider of pharma testing globally.

In India, Dr Schleuniger Pharmatron is the number one choice for most leading pharma manufacturing companies for testing of tablets.

Sotax India shall capitalise on this opportunity and further strengthen our market share in this segment in the coming

years,” mentioned Dr L Ramaswamy, Managing Director, Sotax India.

The company also offers SPS Pharma Services (CRO), contract research lab dedicated to dissolution testing research and integrated the Zymark automation product line. It is also planning to set up a high quality contract research laboratory for dissolution testing in Mumbai.

It is likely that commercial operations will begin before December 2013. “This new lab will be a subsidiary of SPS and will be a unique facility in the Asia. India has low cost margin and more reach with quality, that's why we have identified India as a destination for setting up a lab,” said Ramaswamy.

The turn over of Sotax group is now $55 million and the company expect to touch around $60 millionn. u.sharma@expressindia.com

DKSH opens offices in Mumbai DKSH has recently established strategic partnerships for India with blue-chip chemical manufacturers Clariant, Wacker and Synthomer to provide tailored market expansion services KSH Business Unit Performance Materials, a leading speciality chemicals distributor and provider of market expansion services for performance materials, has strengthened its presence in Asia by expanding its infrastructure in India.

DKSH has moved into brand-new offices in Mumbai – larger than 1,000 square metres. Both state-of-

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Remote monitoring Continued from Pg 36 effectiveness problems that production facilities are experiencing in locations where access isn’t an issue.

Fortunately, today’s remote monitoring solutions present a different alternative.

In fact, they were designed July 16-31, 2013

with this sort of global accessibility in mind. Remote access technologies make it easy for global production facilities to access their facilities and equipment regardless of location. Working with specialists trained to monitor these facilities can save additional time

the-art innovation centres, one for the personal care and the other for the food and beverage industry, will be upgraded and reopened within the next months.

Mario Preissler, Head Business Unit Performance Materials, DKSH says, “The new premises in the ‘Fantree Building’ finally unify all teams and facilities under one roof: sales, technical, sourcing and R&D staff.”

In addition, DKSH has recently established strategic partnerships for India with blue-chip chemical manufacturers Clariant, Wacker and Synthomer to provide tailored market expansion serv-

ices while offering comprehensive distribution opportunities for their products in the Indian market. For Clariant, DKSH will represent the complete range of ingredients for cosmetic and home care formulations. The collaboration with Wacker focuses on personal care, silicones and food ingredients.

Synthomer, one of the world’s leading producers of emulsion polymers for coatings, construction chemicals and adhesives, will now have its products made available through the extensive DKSH network in India.

DKSH leverages on a capillary distribution network

and local market expertise in India. Through seven sales offices in the major industrial centres of Ahmedabad, Bangalore, Kolkata, Chennai, Mumbai, New Delhi and Secunderabad, the company is serving over 2,000 customers in the coatings, construction, cosmetics, food and beverage, pharma and plastics industries within India.

The new partnerships will reportedly strengthen DKSH’s market position in India while contributing incrementally to the Group’s overall earnings and profitability over time.

and money.

In the past, for example, if a medium-voltage drive in a remote location went down, the production facility would need to wait for spare parts to arrive, and call upon a trained technician wearing appropriate personal protective equipment (PPE) to open the drive

and service it. With remote monitoring, specialists monitor the drive and receive warnings when the temperature increases or the current has risen too high. Upon receiving these alarms, specialists can access the drive and repair the issue before it becomes a catastrophic event — all without

ever opening the cabinet.

This proactivity and responsiveness, along with the ability to pass monitoring responsibilities to the specialists who know it best, minimises downtime and can bring significant productivity savings — and that’s just what the doctor ordered.

www.expresspharmaonline.com

EP News Bureau - Mumbai

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PRODUCTS Thermo Fisher Scientific launches ‘Tribrid’ LC-MS T hermo Fisher Scientific has introduced Thermo Scientific Orbitrap Fusion Tribrid liquid chromatographymass spectrometry (LC-MS) system, combining its three mass analysers –quadrupole, Orbitrap and linear ion trap – in a novel ‘Tribrid’ architecture that offers unprecedented depth of analysis of complex biological samples.

One way the Orbitrap Fusion system can address throughput challenges is through tandem mass tags (TMT).

This technique enables mass spectrometers to determine relative quantification of proteins in multiple samples simultaneously. The

significantly greater sensitivity than was previously possible. New TMT reagents are also available from Thermo Fisher, allowing comprehensive, simultaneous analysis of up to 10 samples.

At the heart of the Orbitrap Fusion LC-MS is a configuration of three different mass analysers that work together to raise analytical performance to new levels and enable completely new experimental methods: A quadrupole for precursor selection at isolation widths down to 0.4 amu for excellent sensitivity and selectivity; An ultra-high-field Orbitrap offering resolution in excess of

Thermo Scientific Orbitrap Fusion Tribrid LC-MS (r) with Thermo Scientific Dionex UltiMate 3000 Series UJPLC

Orbitrap Fusion instrument dramatically increases depth and quality of data compared to previous tools to make TMT results far better. The new platform takes advantage of MS3 selectivity to improve quantitative accuracy, and can collect twice as many MS3 scans per unit time, at

450,000 and scan rates up to 15 Hz for unsurpassed selectivity and speed of analysis; An ion routing multipole followed by dual-pressure linear ion trap providing MSn HCD, CID and ETD fragmentations and fast, sensitive mass analysis with scan rates of up to 20 Hz. Synchronous precursor

selection enhances the instrument’s signal-to-noise ratio.

This Tribrid configuration enables users to positively identify larger numbers of low-abundance proteins faster than previously possible with existing commercial instruments. Its unique architecture enables simultaneous precursor isolation, fragmentation, and data acquisition in both the Orbitrap and linear ion trap mass analysers. More high-quality data can be collected compared to existing instruments, expanding the range of possible experiments.

The ability to choose between fragmentation modes at any stage of MSn analysis with detection by the Orbitrap or linear ion trap analyser makes possible a range of novel experiments to achieve a new level of structural information from metabolites, glycans, posttranslational modifications and sequence polymorphisms.

In typical metabolomics experiments, scientists frequently encounter unknowns along with target compounds.

To identify the unknowns, the sample must be rerun on an LC-linear ion trap instrument to obtain MSn data. But it is difficult to match chromatography retention time on the second run, introducing substantial uncertainty. With its unique three mass analyser configuration, however, the new Orbitrap Fusion Tribrid LC-MS addresses this problem, offering users the ability to transform many small molecule experiments by conclusively identifying unknowns as they are encountered.

New intelligent software

on the Orbitrap Fusion LC-MS provides Dynamic Scan Management (DSM), a capability that automatically adjusts scan parameters as experiments are running to achieve optimal results.

The Orbitrap Fusion system features a novel, easy-touse drag and drop method editor that removes most of the guesswork from setting up complex methods. This is part of a comprehensive suite of MS software that supports the platform’s unprecedented usability. It includes: Thermo Scientific Freestyle software, a new data visualisation tool that also facilitates rapid method development and data quality assessment; Thermo Scientific Proteome Discoverer, a comprehensive software application for protein identification; Thermo Scientific Compound Discoverer software, used to perform small molecule structural identification in a wide range of applications; Thermo Scientific SIEVE software for differential quantitative analysis of proteomic and small molecule samples; mzCloud software, a novel mass spectral database that supports identification and structural elucidation of unknowns.

Contact details: Stuart Matlow Public Relations Manager Chromatography and Mass Spectrometry Thermo Fisher Scientific 355 River Oaks Parkway San Jose, CA 95134 (408) 965-6408 office (415) 407-5474 mobile stu.matlow@thermofisher.com www.thermofisher.com

Eppendorf launches 5.0 mL Centrifuge Tubes and Plastic Cuvettes Eppendorf Tubes 5.0 mL When working with samples between 2 and 5 mL, researchers often have no choice but to use tubes that are really designed for larger volumes, typically 15 mL conical screw cap tubes. The new Eppendorf Tube 5.0 mL now provides the ‘missing link’ for such samples, delivering a high-quality solution for volumes up to 5 mL. These new tubes feature a practical and convenient snap cap for

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single-hand operation and a compact conical design, removing the contamination risks associated with manipulating small volumes in large tubes.

Eppendorf Tubes 5.0 mL are designed for safe and stable centrifugation up to 25.000 x g, eliminating the risk of sample loss when using rapid protocols. A new polypropylene material provides high transparency and minimizes leaching for safe www.expresspharmaonline.com

and reproducible assay data.

Introduction of 5.0 mL tubes will lead to 60 per cent reduction in plastic waste!

Lowry, etc.), determining optical density of bacterial cultures (OD600 methods) and kinetic and flourescence measurements.

Eppendorf Vis Cuvettes The Eppendorf Vis Cuvettes are disposable cuvettes made of clear plastic with a light transmission of 300 nm to 900 nm. The visible cuvettes are perfect tool for applications outside the UV range, for example, colorimetric protein assays (Bradford,

Contact details: M Anthoni Jai Kumar Eppendorf India Chennai Tel: +91 44 421 11 314 Fax: +91 44 421 87 405 email: anthoni.jk@eppendorf.co.in website: www.eppendorf.co.in July 16-31, 2013

Breathe again

Good Morning Density!

By the time you will read this advertisement, the DMA 500 Digital Density Meter from Anton Paar would have: 4 4 4 4 4 4 4 4 4

Filled the sample Controlled temperature with an accuracy of 0.3°C Automatically checked for filling errors via the FillingCheckTM Applied a viscosity correction factor Reported Density/Specific Gravity with a repeatability of 0.0002 g/cm3 Calculated the concentration* Ensured full traceability by storing a picture of the measuring cell Exported the data wirelessly to a PC Printed the result via a Bluetooth printer

. . . And will be ready to measure the next sample!

DMA 500. It’s that simple

*For Binary Solutions

Anton Paar India Pvt. Ltd. Tel: + 91 - 124 - 4361057 Fax: + 91 - 124 - 4361058 info.in@anton-paar.com www.anton-paar.com

Join pharma professionals from all over the world to network and do business with pharma machinery, equipment and technology suppliers @ P-MEC India 2013!

Pharma Machinery, Equipment & Technology

3-5 December 2013 Bombay Exhibition Centre, Mumbai, India P-MEC India is part of the largest and most comprehensive pharmaceutical industry event in South Asia. Focused on pharmaceutical machinery, equipment, ingredients, outsourcing and bio-solutions, this is your ultimate one stop pharma shop!

As the pharma industry is increasingly looking towards India to source low cost, high quality pharma solutions, P-MEC India and co-located events provide the perfect place to initiate and explore partnerships with key pharma companies from India and abroad.

www.pmec-india.com

Co-located with:

P-MEC is an excellent platform to see the latest products in action. Most of us would like to see the machine performance live and P-MEC is the best place to see the product and thus facilitates the decision making process.

Hitesh Doshi, Indeus Life Sciences Pvt. Ltd.

This event is an excellent opportunity to keep abreast with new developments in the pharma industry.

Dr Prakash U.Tahiliani, Prime Ever Ayurvedic Research Laboratories

Organised By:

Express Pharma Business Avenues

July 16-31, 2013

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Express Pharma Business Avenues We care for your family . . .

Anti-Inflammatory Enzymes Serratiopeptidase Peptizyme (enteric coated serratiopeptidase granules) Trypsin Chymotrypsin mix ( 6:1)

Probiotics Saccharomyces boulardii Lactic acid basillus sporogenous

Circulatory Health Nattokinase

Bio Catalysts Immobilized Cal B

Digestive Aids Alpha amylase / fungal diastase / fungal amylase Alpha galactosidase Bacterial alpha amylase Bromelain Hemicellulase Lactase Lipase Ox bile

Papain Pepsin Pancreatin Protease ( acid / alkali)

Advanced Enzyme Technologies Limited Sun Magnetica, 'A' wing, 5th Floor, Accolade Galaxy, LIC Service Road, Louiswadi, Thane(W) - 400604, India Tel: +91 22 41703200, Fax: +91 22 25835159 • E-mail : info@enzymeindia.com • Website: www.enzymeindia.com

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Non-GMO ISO CERTIFICATION

GOTS CERTIFICATION

Products

WHO cGMP

FDA

July 16-31, 2013

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July 16-31, 2013

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Product Range Horizontal Plate Filter Press Plate & Frame Filter Press Bag Filter Cartridge Filter Single Plate Filter Holder Basket Filter Rotary Spray Ball Recess Plate Filter Press

Parksan Filters Pvt. Ltd.

103, Laxmi Industrial Estate, Navghar, Vasai Road (East), Dist. Thane - 401 210, India Tel : +91 250 239 1904 Mob : +91 98338 83114 Email : sales@parksanfilters.com Web : www.parksanfilters.com parksan@vsnl.net

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July 16-31, 2013

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BRK Instruments India LLP Blister Pack Integrity Test.

Transdermal Delivery Systems

Spreadability Of Creams

Consistency Of Moisturizing Cream

PHARMACEUTICAL APPLICATION SCOPE OF CT-3 TEXTURE ANALYZER

Ø

Empty Capsule Loop Tensile Test

Ø

Tensile Test Of Polymer Gelatin Films

Ø

Blister Packaging Integrity Test

Ø

Transdermal Patch Consistency Test In Ndds

Ø

Alginateraft Strength

Ø

Resilience Of Films

Ø

Adhesiveness Of Films, Patches, Creams

Ø

Gel Strength / Bloom Test

Ø

Spreadability Of Creams, Gels, Solution, Shampoo Etc

Ø

Extrusion Tests

Ø

Tablet Bilayer Shear Test

Ø

Tablet Coating

Advanced Application Laboratory

Ø

Tablet Swelling Characterization

Ø

Muco Adhesion Of Buocal Tablets / Films / Gels

ANM House, Plot No. A-141, Road No. 23, Wagle Industrial Area, Thane (W) 400 604. INDIA Tel.: 91-22 - 6614 1666 | Fax: 91-22 - 6614 1678 Email: info@brkindia.net URL: www.brkindia.net | www.brookfieldengineering.com

viscosity 46

Bilayer Tablets (shear Force Measurement) Soft / Hard Gelatin Capsule Brittleness Test.

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texture

rheology www.expresspharmaonline.com

powder

on-line July 16-31, 2013

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Express Pharma Business Avenues SILICONE TRANSPARENT TUBING F O R H I G H P U R I T Y AP P L I C AT I ONS

DMF NO: 26710

1 1 1 1 1 1 1 1 1 1 1 1 1

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US FDA regulations CFR 177.2600 for contact with food USP class VI requirements European Pharmacopoeia 3.1.9 Animal derivative free Imported state of the art machine ed Highly advanced auto-curing system rtifi e C Excellent heat resistance (-50째C to 250째C) m nroo Clea Odourless Completely nontoxic Repeatedly autoclavable No leaching of particles Does not support bacteria growth Retains elasticity even after prolonged use

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July 16-31, 2013

Express Pharma Business Avenues

THE UNITED ENGINEERING COMPANY

UNITED “AFS-10” HI – SPEED AUTOMATIC AMPOULE FILLING AND SEALING MACHINE

UNITED “SAL” FULLY AUTOMATIC SELF ADHESIVE VERTICAL BOTTLE LABELING MACHINE FOR ROUND / OVAL / FLAT BOTTLE(SINGLE / BOTH SIDE LABELLING)

OUTPUT: 15000 to 18000 Ampoules/Hour RANGE : 1 ml. – 10 ml.

OUTPUT – 3000 to 12000 Bottles/Hour (Output depends on Bottle size & Label size)

Salient Features : n

n

Salient Features :

In feed of empty washed and sterilized ampoules with the help of conveyor or S.S.

n

Hopper and S.S. Tray.

n

Automatic collection of filled and sealed ampoules in erect position.

n

Vertical & Horizontal adjustment of label applicator and label position to handle

n

Both sides labelling machine is available for flat bottles.

Same machine can handle round and flat bottles with minimum change parts.

n

Individual No Ampoule No Fill Arrangement.

n

S.S. 316 L syringe with rotary valve with a single volume adjuster.

Accurate Label Placement.

Label dispensing with Servo Motor and Servo Drive for better accuracy. different size of bottles by means of Hand wheel.

n

A.C frequency drive & geared motor.

n

n

Fully PLC controlled with touch screen & HMI.

n

n

Machine body fabricated with Stainless Steel 304 quality.

n

Machine body is fabricated with S.S. 304 Structure & Cover.

n

Easy change over with minimum setting time for different size of ampoules.

n

Easy Change Over.

Fully PLC controlled touch screen with HMI & AC Frequency Drive.

“UNITED” PROUDLY INTRODUCES MOST COMPACT HI-SPEED ONLINE VIAL WASHING MACHINE WITH ULTRASONIC WASH AND PLC SYSTEM MODEL – “OL-VW-12”

UNITED HI-PRO “ ARBW” AUTOMATIC ROTARY BOTTLE WASHING MACHINE

CAPACITY - 5ml. to 30ml. Round Vials.

OUTPUT - 10000 to 14000 Round Vials/Hour

CAPACITY - 10ml. to 1000ml. Round Bottles.

OUTPUT - 4800 to 8400 Bottles /Hour.

n

Salient Features : n Most Compact Design.

No Bottle No Washing. n Machine supplied with 2 pumps for two different media of water fitted with filter and s. s. housing. n Conveyor driven by separate motor with AC Frequency Drive n The washing area is covered with acrylic sheet. n All pipes connected to water are as per GMP standard. n Machine can be used for air/water cleaning or even combine cleaning. n Versatile machine used for Glass/PET/HDPE bottles of different shape and size with additional change parts. n Easy change over with variable size. n Automatic loading and unloading of bottles. n After washing the bottles are directly fed to the filling machine without any hand touch. n Machine will stop automatically in case of bottle jammed at out feed. n

Salient Features : Most Compact Design.

n

PLC with HMI and AC Frequency Drive.

n

Minimum change parts.

n

Entire machine and contact parts with water & air are made of S.S. 316.

n

Alarms for Low Pressure of Recycled Water, DM, WFI & Compressed Air.

THE UNITED ENGINEERING COMPANY 132, Damji Shamji Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai 400 093.

Phone : +91-22-2687 6919 ● Fax : +91-22-2687 6676 ● E-mail : uec.mum2@mtnl.net.in Head Office : 35A, Hazra Road, Kolkata-700 029 (INDIA) ● Phone : +91-33-2475 9744.

Fax : +91-33-2475 7727 ● E-mail : uec@cal2.vsnl.net.in

July 16-31, 2013

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Innovation is our culture…

Preclinical Toxicology Services: Single dose (Acute ) toxicity studies Repeated dose (14, 28, 90 & 180 Days) toxicity studies • Skin, Eye Irritation / corrosion • Skin Sensitization • Pharmacokinetic studies on Beagle dogs • LD50 and maximum tolerated dose • Immunotoxicity • Genotoxicity Studies • •

Test Systems: • Mouse (Balb-C, Swiss-Albino, C57, Diabetic) • Rat (Sprague Dawley, Wistar) • Rabbit (New Zealand White, Non albino) • Guinea Pig (Hartley) • Canine (Beagle Dogs)

Quality in our genes…

Pharmacopoeial Services: (Accredited by NABL for ISO/IEC 17025:2005)

• • • • • • • •

Pyrogen Testing Abnormal Toxicity Undue Toxicity Bioassays Systemic Injection Test Intracutaneous Test Implantation Test Eye Irritation Test

Facility Infrastructure: Individually Ventilated Cages Designed as per GLP/ AAALAC Independent facility for Rats, Mice Rabbits and Beagle Dogs • Ultra modern Histopathology lab • Safety alarms/call to scientists • Online Recording of Observations • • •

SERVICES Formulation Development.

Microbiological Studies.

Biological Studies.

Pre Clinical Studies.

Analytical Research.

Bio-equivalence Studies.

Clinical Trials.

Dossier Preparation.

Preclinical Pharmacopoeial Services.

ACCREDITATIONS USFDA registered cGMP control testing laboratory.

DSIR approved R & D Centre.

Drugs Controller General of India (DCGI).

NABL accreditation for Chemical, Biological Medical Testing, Bioanalytical & Mechanical.

Recognized by Bureau of Indian Standards.

Drugs Control Administration (A.P).

Department of Biotechnology approved Institutional Bio-Safety Committee (IBSC).

NABL for ISO/IEC 17025:2005.

!"! $!%!&'('%" )*!+",+'- ,% ./012 324. !*' 5'-,&%'5 "6 '%-7*' "6"!8 ,%"'&*,"9: -'+7*,"9 !%5 ;!-"'-" *'"*,'<!8=

ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH

SIPRA LABS LIMITED Industrial Estate, Sanathnagar, Hyderabad – 500 018.

Industrial Estate, Sanathnagar, Hyderabad – 500 018.

Tel: 040-23802000, Fax: 040-23802005 Email:sipra@sipralabs.com web: www.sipralabs.com July 16-31, 2013

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Manufacturers of Pharmaceutical Machinery

39/2A, Purna Das Road, Kolkata - 700 029. Gram : Techpharma. Tel : 91 33 2464 4568 / 0457 7253 Fax : 91 33 2464 7254. Email : mails2neomachine@gmail.com, neocota@sify.com Website : www.neocota.com, www.neomachine.in Mumbai : 91 22 2261 4088, Chennai : 91 44 2432 2243 / 2432 8128, Delhi : 91 11 2546 0255

July 16-31, 2013

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CLEANING, SANITISING EQUIPMENTS CLEAN ROOM ACCESSORIES ASEPTIC PIPING , PW / WFI DISTRIBUTION LOOPS

Floor Drain Traps

Hand Sanitiser

Water Saver Cleaninng Nozzles(self-rotating) Nozzles

Shoe Cover Dispenser

Foot Sanitiser

Split Butterfly Valve

Pendents(Service Shafts) CIP/ SIP MODULE We also design & manufacture # IBC Washing/ Drying Modules # Containers/ Glass Ware Wash Modules # FBD Bag Washing/ Drying Modules # Cannisters Washing Modules # Drums Washing Modules

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Wash Down Hose Station

SIP MODULE

8/B, Surat Singh Est ,SV Rd, Jogeshwari(W), Mumbai-400102 Tel; 022-26797941 Telefax:022-26798066 Cell: 9869231815 email: iewi@mtnl.net.in website : www.iewi.net

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Top Tank / Reactor Sampler

Flush Bottom valve July 16-31, 2013

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SURVEY Kelly Services releases whitepaper titled ‘The Indian Workforce Today’ The study gives an insight on the impact of quality of education in career growth

elly Services, a leading staffing firm released its whitepaper titled ‘The Indian Workforce Today’, which gives an insight on the impact of quality of education in career growth. It gives a detailed summary of the Indian education system and its direct role in creating a brand value of an individual.

India has an advantage of the world’s largest youth population. Around 400 million people are in the age bracket of 25-35 years. This makes India a potential future supplier of skilled workforce. In order to produce a globally competitive workforce the Indian education system needs a renaissance of sorts.

On the contrary, Indian technical institutes have consistently managed to meet demand globally. A large numbers of Indian scientists are working in prestigious research institutions around the world, doctors from India are some of the most celebrated around the globe and the contribution of the Indian workforce to the

K

global IT industry. Kamal Karanth, Managing Director, Kelly Services India said, “It’s widely seen that professionals from certain branded institutes have an edge in gaining entry to many marquee companies. Branding has become an important tool for colleges or Business schools to stay ahead of the curve by clearly communicating this differentiation to students as their USP.” The inevitable role of the private sector behind the unprecedented growth in the higher education segment will lead to battles for market share between established players, and exposing incumbents. To deal with these changes the role of branding has become extremely important as educational institutes use branding as a tool to meet the sustainable changes in the near future.

According to the study, 57 per cent respondents believe that the brand reputation of educational institute play an important role while job place-

ment. College brand plays an important role during initial five years of one’s career; in exploring new opportunities and sustaining in the corporate sector because till then the employers perceive employees to be superior due to the college brand, provided the expectation are fulfilled.

Karanth further adds, “Education in a branded institution is a key factor, but it’s not a means of sustainability alone. Meritocratic organisations also take note of the employers one has worked for when they recruit senior candidates. The reality is that education in a branded institution and good tenures in reputed employers is a potent combination in professionals rise in career today

Other key findings of the survey include: ●

●

32.7 per cent respondents believe price to be the key factor while considering selection of an education institute/college 36 per cent respondents

●

●

●

find previous work experience with alumni as a major factor which would classify an educational institute vis-à-vis its brand image Respondents believe that the role of college brand (76 per cent) and education (52 per cent) are significant at the junior level, while at mid level domain expertise has more weight (72 per cent) for career growth Almost 72 per cent of toppaid CEOs in India are from the branded colleges either from India or abroad. This statement is also validated by the survey result where 62 per cent of respondents agree that the alumni of branded institutes have proven themselves in the corporate world throughout their career.

Employers prefer to offer 10 per cent–20 per cent more in terms of remuneration compared to a non-branded college pass out.

EP News Bureau – Mumbai

AWARDS Swiss Garnier bags Emerging India Awards 2013 Received award in life sciences category; Awards organised by ICICI Bank and powered

by CRISIL

July 16-31, 2013

wiss Garnier has received the Emerging India Awards – 2013 in the life sciences category (Pharmaceuticals & Chemicals). The awards were organised by ICICI Bank and powered by CRISIL. The function was presided by NR Narayana Murthy, Founder, Executive Chairman of Infosys.

Swiss Garnier Life Sciences, a leading manufacturer of pharma and neutraceutical products in India, commenced its commercial production in 2006. The

S

turnover of the last financial year 2012-2013 reached R `143 crores from `17 crores during the fiscal year 20062007.

The promoters, Managing Director MS Theivendran, a www.expresspharmaonline.com

BTech Graduate in Chemical Engineering from Madras University with an experience of over 20 years; as well as T Rethinavalli, Director, co-promoter, a dynamic women entrepreneur, credit this growth to the dedicated efforts of their employees and valued support received from customers.

Swiss Garnier as a contract manufacturing company are engaged in selling technology / manufacturing formulations from their Mehatpur facility to

multi-national companies like PepsiCo, Merck, Abbott Healthcare, Ranbaxy, DRL and for the leading Indian pharma players like Lupin, Intas Pharmaceuticals, Unichem Laboratories, Alembic Pharmaceuticals, Mankind Pharma, Karnataka Antibiotics, Biocon, Fourrts (India), Glenmark Pharmaceuticals, Wockhardt, F r a n c o - I n d i a n Pharmaceuticals, Emcure Pharmaceuticals, Zuventus Healthcare.

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Dr Rabinder Buttar, Founder and CEO, ClinTec International receives award Named Deloitte Female Entrepreneur of the Year at Scottish Business Awards 2013

r Rabinder Buttar, Founder and Chief Executive Officer, ClinTec International, has won ‘Female Entrepreneur of the Year’ award at the Scottish Business Awards 2013 held recently at the Edinburgh International Conference Centre.

The awards, which are the largest and most prestigious of their kind in the UK, were attended by dignitaries such as President Bill Clinton, Scotland’s First Minister Alex Salmond, and representatives from 1600 businesses.

Buttar said, “Winning this award is a great recognition of the work the team and I do in supporting the pharmaceutical industry in developing novel medicines for the treatment of major diseases such as cancer and diabetes.

As a company, ClinTec has grown substantially since it was founded in 1997, and it is always an honour to win awards such as this. I feel it

D

reflects the work we do and the achievements that we have generated to date from management right through to the work delivered on the ground for our international clients.”

The winning of the award

by Buttar marks an important week for ClinTec, which concludes with exhibiting at the 49th Annual DIA Meeting in Boston. The conference, the largest of its kind in the pharma industry, is being used by the company to formally launch its Masters in International Clinical Research and Technology to the American market, as well as highlighting the company’s new full service offering for the MENA region.

As the founder of ClinTec International, Buttar has seen her clinical research organisation expand into over 40 countries in the space of 17 years, and the company is now ranked as one of the eminent CROs in a

variety of key markets across the globe, including the burgeoning Middle East and North Africa (MENA) Region. The company, which is a majority woman-owned business, was founded by Buttar in 1997, and can now

count ten of the world’s top pharma companies as clients, as well as having a diverse and multicultural workforce which holds key staff in 43 countries worldwide.

EP News Bureau – Mumbai

Suresh G Kare’s completes 50 glorious years of visionary leadership at Indoco Kare’s visionary leadership has been instrumental in achievements of many significant milestones for the company uresh G Kare, Chairman, Indoco Remedies has completed 50 years of visionary leadership. He took the reins of Indoco Remedies 50 years ago, i.e on July 2, 1963 at the age of 24. His visionary leadership has been instrumental in achievements of many significant milestones for the company during these 50 glorious years.

Born in Margao-Goa on January 9, 1939, he is blessed with his father’s principles and mother’s values. He completed his school education in Goa and university education in Mumbai. Thereafter, he joined his father’s business of marketing pharmaceutical in Goa and then moved to Mumbai as the Managing Director of Indoco Remedies.

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Under his able guidance, the company progressed steadily with a strong presence in the Indian pharma market and is well recognised as a reliable source for products and services to generic companies across the globe.

Over a period of time, Kare has created an impressive manufacturing base consisting of eight facilities spread across India.

Kare’s administrative and organisational capabilities, his persistent efforts, astute decision making and creativity have all been responsible for taking Indoco to greater heights. The way in which he expanded the company by investing in infrastructure, marketing activities, and strategically tapping opportunities across the globe, is an inspiring story for young entrepreneurs.

For 50 long years, Kare has ceaselessly strived for the development and progress of www.expresspharmaonline.com

the company and the pharma industry. Kare has been the past President of the Indian Drug Manufacturers’ Association (IDMA) and an active member of the Indian Pharmaceutical Association (IPA). Through these organisations he has represented the pharma industry on many government committees.

Kare is associated with many social, cultural and educational institutions in Mumbai and Goa. He is the President of The Goa Hindu Association’s Sneha Mandir, a modern home for the aged at Bandora-Goa and the Managing Trustee of ‘SureshKare Indoco Foundation’, a charitable trust established to promote higher education and social upliftment to deserving students.

Recently Kare has been honoured with the 'Udyog Shree Jeevan Gaurav Sanman' (Lifetime Achievement Award) for his

noteworthy contribution to business and industry. In the past, Kare has received various awards such as ‘Pharma Business and Technology Excellence Award 2004’, Lifetime Achievement Award

by Pharma Summit Mumbai, ‘Saraswat Chaitanya Gaurav Award’ by Saraswat Prakashan, ‘Jeevan Gaurav Puraskar’ by Unnayan, a social organisation, ‘Best Industrialist-2011 Award’ by Lokmat Goa and ‘Lifetime Achievement Award’ by The Goa State Industries Association. He is also the first recipient of ‘Lifetime Achievement Award’ instituted by the Maharashtra Chamber of Commerce.

In 2011, ‘Karenama’ a book on the life of Kare was released. The book has short stories and incidents in his life that moulded his personality and made him the visionary that he is today.

EP News Bureau – Mumbai July 16-31, 2013

REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE.