Express Pharma July 1-15, 2014

VOL. 9 NO. 17 PAGES 74

www.expresspharmaonline.com

Market The Blockbuster goes bust?

Cover Story Restructuring infrastructure Management Hope against hope

1-15 JULY 2014,` 40

When excellence is your goal, partner with Ashland for world-class pharmaceutical technologies Ashland meets the needs of formulators by providing an unparalleled range of excipients and technologies, as well as longstanding polymer expertise and technical support from benchtop to commercialization for: • • • • •

Controlled-release formulations Drug solubilization Tablet film coating Tablet binding Tablet disintegration

® Registered trademark, Ashland or its subsidiaries, registered in various countries ™ Trademark, Ashland or its subsidiaries, registered in various countries * AquaSolve AS™ HPMCAD in the United Kingdom © 2013, Ashland AD-12529

Introducing Benecel™ DC HPMC for controlled-release formulations • Increased content uniformity • Improved flow over existing controlled-release and directly compressible grades • Lowered manufacturing costs • Reduced development time For more information, please contact your local Ashland Specialty Ingredients representative or visit us at ashland.com/benecel.

The Internet of Everything demands superhuman speed.

Explore the Unexplored with Cisco WLAN Technology

With continued growth of mobile data traffic, IT professionals need new Wireless technologies to provide employees and customers better applications, services and experiences.

Get the Cisco WLAN Edge - Broadest WLAN Portfolio in the Industry - Enterprise WLAN Leader per Gartner Magic Quadrant - Largest Customer-base in the WLAN Industry - Largest Development Team in the WLAN Industry

For more details, visit us at http://cs.co/JSI or Call us at 18001037723

TOMORROW starts here.

2014 Cisco Systems, Inc. All rights reserved

NEW Kinetex Biphenyl

Choose Your LC System

For Small Molecule Analysis

UHPLC

HPLC

Select Your Optimal Kinetex Particle ™

0

0

1

1

2

2

1

1

2

2

3

3

3

4

3

4

5

5

4

4

6

6

40

0

1

2

1

2

3

3

4 5

4

6

0

20

40 mAU

0

21433

2

2

3

3

5

4

6

Incredible UHPLC efficiency and performance gains

1

1

4

Kinetex 1.7 µm: 20 % higher efficiency than fully porous 1.7 µm columns

0

20

mAU

5 min

5 min

5 min

5 min

UHPLC

Kinetex 2.6 µm: Achieve sub-2 µm performance on HPLC and UHPLC systems

0

20

mAU

0

10

20

mAU

Four Kinetex particles give you full scalability HPLC

PA20010214_in

CONTENTS Vol.9 No.17 JULY 1-15, 2014 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Delhi Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble

MARKET

HOPE AGAINST HOPE The Modi-led Government will present its first General Budget on July 10. Representatives of pharmaceutical companies and industry associations put forth their wishlists hoping that unlike the past few years, the new government will fulfill their demands. | P34

Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma

P21: GROWTH TRACKER

Photo Editor Sandeep Patil

IPM registers `6636 crores in May 2014

MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West

P40: CLINICAL UPDATE

Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Yuvaraj Murali Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar

Bristol to test drugs with Gilead’s Sovaldi

42

‘ASHLAND ALREADY HAS MORE THAN $1 BN SALES COMING FROM THE ASIA PAC REGION’

44

CLARIANT INAUGURATES NEW INDIA HEADQUARTERS AT NAVI MUMBAI

45

NULEAP AND VENOSTIC IN AGREEMENT

P66: AWARD BMS's ‘The Pink Drive’ campaign bags bronze at Abby awards 2014

P67: FORUM Kelly Services India organises its first Life Science Xchange 2014 Summit in Mumbai

THE BLOCKBUSTER GOES BUST?

16

‘REGULATORY PLAYS A MAJOR ROLE IN SHAPING UP THE MARKET FOR INFECTIOUS DISEASE DIAGNOSTICS IN DEVELOPING WORLD’

18

CIPLA COLLABORATES WITH HETERO TO LAUNCH ITS SECOND BIOSIMILAR DRUG DARBEPOETIN ALFA

19

MERCK SERONO AND MERSANA TO DEVELOP ANTIBODY-DRUG CONJUGATES

20

ARVIND REMEDIES AND ADESH UNIVERSITY SIGN MOU

PHARMA ALLY

Piramal’s NCE research shares preclinical efficacy data for two promising molecules

P40: RESEARCH UPDATE

13

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. 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.

EDITOR’S NOTE

Wish upon on a star

N

arendra Modi's massive electoral mandate has unfortunately raised expectations; both from the man on the street as well as from CXOs in boardrooms. Many have seen in him the glimmer of hope that the first star in the night sky brings. And seem to have wished upon this star. Will NaMo and team live up to the expectations?

With this government set to present their first Union Budget in July, Express Pharma asked association chiefs as well as industry analysts to share their wish list. Some say that in the past few years, this annual project has turned out to be an exercise in futility, with the pharmaceutical sector getting far too little, in terms of financial incentives or visionary policy reform. Or so goes the grouse.

This year, the mood is more upbeat, though only slightly so. Expectations of a silver bullet have been some what tempered by the partial roll back of the proposed hike of rail fares but hope springs eternal. To get a feel of what tops the wish lists of association chiefs and industry analysts, see our feature: Hope against hope, (pages 34-39) Our cover story in the July 1-15 issue looks at another area where Prime Minister Modi seems determined to change the status quo: infrastructure. One of the points mentioned in BJP's election manifesto was 'robust physical and social infrastructure'. The 52-page document goes on to detail specific areas of intervention in the areas mentioned in the pledge. The manifesto has probably become the most studied document by industry honchos as they try to read between the lines and guesstimate the impact on their sectors.

Putting in place this infrastructure, both at the micro and macro level, has since become part of PM Modi’s 100-day agenda. Press reports seem to suggest that he sees the revival of Special Economic Zones (SEZs) as the ticket to generate employment as well as spur economic growth at the corporate level. (http://m.financialexpress.com/news/narendra-modiplans-booster-shot-for-sezs/1260163).

Infrastructure for the pharma sector needs a desperate facelift, to put it mildly. Our stories in the Infrastructure Special (pages 24-33) analyse

10

EXPRESS PHARMA

July 1-15, 2014

The suggestions put financial incentives at the top of the wish list,but once there is a will,there will be ways to work out a compromise

the issue from various perspectives.

Faced with decreasing margins in the past few years, most pharma companies have cut budgets for plant upgradation. This neglect has unfortunately resulted in a mindset that is far more detrimental to regulatory compliance than outdated machinery. The lead story 'Restructuring infrastructure' (pages 24-27) makes the point that though the fear of both reputation and revenue loss has of late spurred some capital expenditure on infrastructure upgradation, changing mindsets will take longer. Functional heads who have turned the blind eye so far to plant operators cutting corners, especially those that result in 'savings', will now have a hard time explaining why rules and guidances need to be followed, in both letter and spirit.

While there are no quick fixes for so deep seated a problem, there are a few steps that the PM can take which will at least give the sector some incentive to weed out the faulty practices and invest in change. ‘Clustering for comfort’ (pages 28-29) analyses how the proposed Cluster Development Programme for the Pharma Sector (CDP-PS), which is being presented as a better alternative to the SEZ model, can revive the sector albeit with a few more tweaks.

For instance, small and medium enterprises (SMEs) are acknowledged as the backbone of any sector and this is true of pharma as well. The BJP election manifesto does give SMEs their due. It considers the role of SME sector as crucial for the economic development of our country and goes on to mention some of the facilities which need to be provided for its development. Many of these resonate with the wish lists of pharma SMEs (Lending a helping hand, pages 30-33). As always, the suggestions put financial incentives at the top of the wish list, but once there is a will, there are always ways to work out a compromise.

Here’s hoping that unlike previous years, the pharma sector's hopes are not as fleeting as shooting star.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

H P LC CO LUM NS Offering unbeatable value for chromatographic performance, reproducibility, and quality, Waters Reliant™ HPLC Columns are chosen by scientists who require robust columns without compromise.

All Reliant HPLC Columns are manufactured using strict cGMP procedures and provide chromatographers the very best value and opportunity for success.

Contact us today for more information: E: reliantcolumns@waters.com

EXCEPTIONAL VALUE OUTSTANDING PERFORMANCE TRUSTED DEPENDABILITY

©2014 Waters Corporation. Waters is a registered trademarks of Waters Corporation.

Reliant is a trademark of Waters Corporation.

MARKET

THE BLOCKBUSTER GOES BUST? The blockbuster model has so far been the success formula of pharma companies, however, if statistics are to be believed, a churn is underway, the times may be changing

BY SHALINI GUPTA

I

n its heydays, Lipitor could perhaps be crowned the king of blockbusters, given that the drug was worth nearly $13 billion annually worldwide then. This, when, by its definition, a blockbuster drug is one which garners annual revenues of one billion dollar or more for a pharmaceutical company.

These drugs have long accounted for more than half of the revenue of major pharma companies and above one-third of the total pharma revenues.

For long the blockbuster model was a hit with pharma companies, but an increased focus on reducing healthcare costs, focus on utilisation of generics, patent expirations and other dynamic changes within the industry have led to a looming question mark on its feasibility.

Its time to wake up and smell the coffee.

Narrowing it down Analysts are of the opinion that the blockbuster era was characterised by pharma companies picking the ‘low hanging fruit’compounds that were easiest to

discover and turn into drugs and addressed large patient populations. Most of these were hugely oversold to consumers and over prescribed by their doctors thus racking up massive revenues in sales. Lipitor, for instance was originally developed

To subscribe: bpd.subscription@expressindia.com

for patients with heart disease, specifically, people who had already had a heart attack or stroke and were at high risk of another. For this patient group, reducing cholesterol with a statin cut their chances (by a little) of suffering a second heart

attack, stroke and death. However, this group wasn’t huge, rather the drug was marketed in a way that persuaded doctors and the public that anybody with a beating heart and even mildly elevated cholesterol needed to be on a statin.

Chips in Lisa Urquhart, Editor, EPVantage, “We are unlikely to see blockbusters like Lipitor, which has sold more than $60 billion over its lifetime, because drugs like statins and hypertension treatments addressed very large patient populations suffering from long-term chronic conditions, allowing them to rack up massive sales.” The verdict is clearly in favour of niche drugs.

“Drug developers are now addressing much harder targets like cancer, where treatment is becoming more and more personalised. This is leading to smaller patient populations and therefore lower revenues for companies over the lifetime of a drug, even if it does eventually reach blockbuster status. The regulatory and reimbursement spaces are also getting tougher,” she adds.

Oncology blockbusters clearly seem to be on manufacturers’ radar if we go by numbers, says Graeme Green, Principle Analyst, Pharmaview, Decision Resources Group.

From a count of 20 in 2009, they are projected to rise to 28 by

EXPRESS PHARMA

13

July 1-15, 2014

MARKET 2020. Drugs for cardiovascular(CV) and Central Nervous System (CNS) therapy areas will see a strong fall (from 18 to 12) while drugs on metabolism and musculoskeletal pain would gallop ahead showing a growth of 50 per cent since 2009. “The blockbuster count for CV and CNS falls strongly taking their rank from joint second to sixth and fifth respectively. Meanwhile, the oncology blockbuster count is expected to continue climbing, as too are the blockbuster counts for metabolism and musculoskeletal pain,” he analyses.

The world’s aging population is also a trigger behind the spurt in oncology drugs. In the US alone, the number of cancer cases is expected to grow to 22.2 million in 2030, from 12.8 million in 2008, Bloomberg reports. So, while cancer death rates have been declining over the past two decades and the number of cancer survivors growing, those gains could be undermined, according to the American Association of Cancer Research (AACR). “Given the aging population, the therapy areas that will dominate will be oncology and treatments for dementia, including Alzheimers. However, we have seen little progress with finding disease modifying treatments for both dementia and alzheimers. There have been some promising break throughs in cancer, including, some of the newer treatments for prostate cancer such as Zytiga and Xtandi. While Roche continues to make good progress in breast cancer with Perjeta,” Urquhart notes.

Orphan drugs When the Orphan Drug Act (ODA) was signed by President Reagan in 1983 there was only one orphan drug approval.

Since then, the number of market-approved orphan drugs has increased to about 400, while the number of approved non-orphan drugs has peaked. The compound annual growth rate of the rare orphan drug market stood at 5.7 per cent, a market estimated to be close to $100 billion with 43 brand name drugs having global annual sales of greater than $1 billion (for example Gleevec, Epogen, Herceptin, Neupogen and

14

EXPRESS PHARMA

July 1-15, 2014

Cerezyme) as of 2012. Of these blockbusters, 18 were approved solely as orphan drugs in the US of which 11 reached the blockbuster status within the seven year orphan drug market exclusivity period. Orphan drugs, then seem to be strong contenders for blockbusters.

John Cole, Director of Solutions and Business Practice, Thomson Reuters, enumerates succinctly the reasons for the statistics above. “We are seeing a shift towards niche and orphan diseases – the ‘nichebuster’.

This is driven by a number of factors, including unmet need in these segments, favourable regulatory regimes, reduced R&D costs and the potential of premium pricing,” he says.

Analysing the drug approvals over the past few years, Gideon Heap, Senior Analyst, Pharmaview, Decision Resources Group, points out, “2012 and 2013 saw a high number of new approvals in both the US and in Europe. This number was was partly driven by a wave of rare disease therapies that were approved. This has been supported by the introduction of market incentives established to encourage their development over the past few years such as, fast track designation, breakthrough therapy designation etc and not to mention the stiff competition in more mature disease markets, which has encouraged developers to look at more underserved indications.”

A recent Thomson Reuters study indicated that the economics of orphan drugs were favourable to those of non-orphan conditions. However, Heap is quick to add that it is unclear as to how long these favourable conditions will prevail, given that payers and governments increasingly focus on the cost of these drugs.

“In many cases pharmaceutical companies do not anticipate that these rare disease therapies will become blockbusters. The shorter regulatory approval times associated with rare

“Drug developers are now addressing much harder targets like cancer, where treatment is becoming more and more personalised.

This is leading to smaller patient populations and therefore lower revenues for companies over the lifetime of a drug, even if it does eventually reach blockbuster status” Lisa Urquhart, Editor, EP Vantage

“The shorter regulatory approval times associated with rare disease drugs serve to control development costs, and elongated market exclusivity makes a brand with a more modest annual turnover more financially viable” Gideon Heap, Senior Analyst, Pharmaview, Decision Resources Group

disease drugs serve to control development costs, and elongated market exclusivity makes a brand with a more modest annual turnover more financially viable. In fact, several smaller brands generating more sustainable revenues from niche markets may be more favourable than one traditional blockbuster,” he concludes.

So while the number of orphan drug designations by the FDA has increased , the number of approvals remain small in comparison. However, once approved and marketed, profits can be made and and patients be served despite smaller patient populations. Gross profit margins of upto 80 per cent are reported in the rare diseases industry vis-a-vis 16 per cent in the pharma industry. Profit further increases as the market widens and although some of these drugs might not be used for a record number of other indications, they have found a second or even additional market.

For instance Gleevec, which initially targeted 9,000 patients annually in the US diagnosed with chronic myelogenous leukemia in 2001 has not only been saving their lives but has garnered profits with a proportional increase in the population of these patients.

It was later found to be equally efficacious as a therapy for gastrointestinal stromal tumours, expanding the total patient population number using the drug to 120,000. In the 12 years since it was introduced, Gleevec has become a block-buster orphan drug.

Who will cross the finish line?

Gaining blockbuster status is easier said than done.

Thomson Reuters released its annual forecast of the leading drugs to watch in 2014, including three potential blockbuster treatments anticipated to attain more than $1 billion in sales through 2019, after entering the marketplace this year.

The consensus sales fore-

casts for the drugs expected to enter the market in 2014 tend to suggest that the blockbuster model is on its way out, with the vast majority of these drugs predicted to make sales of less than $1 billion by 2019.

Only three drugs are bucking the blockbuster trend so far as per the report. Gilead sciences’ Sovaldi (sofosbuvir), GSK/Theravance’s Anoro Ellipta (umeclidinium plus vilanterol) and Gilead’s Idelalisib are projected to have 2019 consensus sales forecasts of $7.518 billion, $3.081 billion and $1.100 billion, respectively. Other drugs to watch out include Eli Lilly’s long acting GLP-1 analog dulaglutide for diabetes and its anti-VERFRG2 Mab Cryramza(ramucirumab) for gastric cancer. The drugs have 2019 sales forecasts of $974.2 million and $904.4 million respectively and had both been filed for the US and European approval last year in October.

It observes that as developing a blockbuster becomes more difficult, the pharma industry must seek to find replacements for these revenue streams, for example by turning to more personalised therapies. the continued decline in the number of blockbusters, combined with patent expiry for several existing blockbuster agents this year, should make 2014 particularly challenging for the industry.

Heap offers a perspective, “Globally, payer systems are acting to maximise value from healthcare expenditure. UK’s NICE and Germany’s IQWiG have gained prominence over the last few years in their role for demanding pharma manufactures demonstrate benefit in comparison to existing therapies. Similarly, US insurers and pharmacy benefit managers are becoming tougher on drugs that do not demonstrate benefit.

These pressures are certainly increasing the risks for the developers achieving their desired return on investments.”

It appears that many of the challenges companies face are similar to 10 years ago. However, the requirement to deliver safe and efficacious drugs to patients has not changed. The economic challenges though have only become tougher with greater pressure on

MARKET

It is worth noting that the level of trust pharma companies have historically enjoyed is on the wane due to a number of recent well publicised scandals.

Companies have good amount of work to do to regain the patient’s trust.

Nevertheless, novel and interesting agents that are able to demonstrate true value to patients are still likely to achieve blockbuster status JOHN COLE, Director of Solutions and Business Practice, Thomson Reuters

NO OF DRUGS UNDER DIFFERENT THERAPY AREAS Selected Therapy Area

2009

2013

2020

Cardiovasculars (CV)

18

17

11

Central Nervous System (CNS)

18

18

12

Metabolism

9

13

20

Musculoskeletal-Pain

8

13

17

Oncology

20

21

28

Source: Decision Resources Group

demonstrating the value and cost effectiveness of a product. The explosion of data is a significant challenge in this space. The amount of genetic data is increasing and the volumes of information relating to the underlying pathophysiology of disease will continue to grow. Making sense of this big data and delivering true insight will be a major challenge to companies.

“The regulatory landscape also remains challenging and it will be interesting to see how the increase in stringent market access in the major

markets will impact the evolution of the emerging markets. It is worth noting that the level of trust pharma companies have historically enjoyed is on the wane due to a number of recent well publicised scandals. Companies have good amount of work to do to regain the patient’s trust. Nevertheless, novel and interesting agents that are able to demonstrate true value to patients are still likely to achieve blockbuster status,” Cole offers the final word.

To subscribe: bpd.subscription@expressindia.com

shalini.g@expressindia.com

EXPRESS PHARMA

15

July 1-15, 2014

MARKET I N T E R V I E W

‘Regulatory plays a major role in shaping up the market for infectious disease diagnostics in developing world’ Infectious diseases continue to account for majority of the disease burden in developing countries even as they grapple with an increasing share of non communicable diseases.

Jayant Singh, Associate Director, Healthcare Practice, Frost & Sullivan, shares his perspective in an interview with Shalini Gupta Which countries are the biggest markets for infectious diseases in a descending order: developing versus developed? Which diseases worldwide have a huge market? Why? Where does India figure here?

India and China are the biggest markets for infectious disease diagnostics from a volume perspective. However, from a value perspective the US and Europe lead the pack. This is primarily on account of the difference in technologies used, the primary technology used in India and China are the first generation ELISA (enzyme-linked immunosorbent assay) and rapid card tests which are low-priced, whereas the developed world has migrated to the latest advancement in ELISA and nucleic acid testing, that is gradually becoming a norm rather than a reference test.

Big markets exist for infectious diseases diagnosis in the western world for diseases like HIV, Hepatitis B and C and hospital acquired infection (HAIs). However, the testing is primarily done on very high end platforms like NAT and Chemiluminescence. In addition to the diseases mentioned above there is the additional burden of diseases like cholera, TB, pneumonia,

16

EXPRESS PHARMA

July 1-15, 2014

Kala Azar, malaria, dengue, swineflu, bird flu, trypanosomiasis, etc. in the developing world. India has a similar disease profile as that of the developing countries from an infectious disease diagnosis perspective.

How are governments in developing economies of Asia, Africa and Latin America tackling and further driving demand through the measures being taken. Explain.

Similar to the cases in India, other geographic regions like, Africa and Latin America are all resource scarce countries facing similar challenges of huge disease burden. With the lack of affordability coupled with difficulty of accessing the latest technology either due to cost or complexity for operating the technology, these countries are also characterised by being majority out of pocket markets from a payment perspective. This limits the scope of a government driven demand for these tests, however regulatory measures like the banning of serology tests for TB by Government of India is playing a major role in shaping up the market for various technologies for infectious diseases testing.

Having said that the government interventions

India and China are the biggest markets for infectious disease diagnostics from a volume perspective

driving the growth of this market (be it Asia or Africa) have been mainly felt in two disease areas namely, TB and HIV. The spending from donor agencies coupled with government funding for these two diseases has been a primary growth driver for testing e.g. Culture and NAT based tests for TB and NAT based testing for HIV and CD4 counting for disease monitoring have been the primary beneficiary of this phenomenon.

A similar phenomenon has been observed in certain blood banks, where respective state governments through a decree have made it mandatory for blood banks to use NAT technology for testing. To conclude, it can be said that the regulatory plays a major role in shaping up the market for infectious disease diagnostics in the developing world.

TB is a case where new molecular technologies (new estimates by WHO) for the screening of drugresistant TB are replacing culture-based tests. Which other infectious diseases have seen the introduction of improved devices and technologies?

This phenomenon has been observed in multiple areas and there is nothing new about the same, testing

for extra pulmonary TB through NAT has been there for quite some time in the market. A similar phenomenon has been observed in areas of HIV, Hepatitis B & C testing where, we have seen the markets moving from a rapid card test to a NAT based platform for organism identification and treatment monitoring.

NCD's (cancer, diabetes, heart diseases) have taken precedence over infectious diseases when it comes to policy, health initiatives, and even pharma R&D. Do you then think that infectious diseases and their diagnostics have taken a backseat?

From a policy perspective, the government’s focus area is still on infectious diseases, however, off-late the government have also started focusing on the NCDs which makes it seem that the government focus has shifted to NCDs. The impact of communicable diseases in form of death, disability, morbidity is much early visible than NCDs (polio and leprosy being a case in point), it has only been due to the government effort coupled with efforts from NGOs and society that we have been able to eliminate diseases like polio and leprosy. However having said that the government of

MARKET the day has taken a long way in terms of infectious diseases like TB, swine flu, cholera, malaria etc.

Pharma companies will be purely guided by commercial interests. Investing in a molecule for a disease of third world countries is considered a not so attractive proposition both from an investment as well as the price point of view.

However, the same can’t be said for diagnostics, where we are seeing R&D efforts in making more sensitive and accurate tests for diseases like TB, HIV, Toxoplasma etc.

This difference in behaviour can be primarily attributed to the low investments, higher success ratio, and lesser complexity in the areas of diagnostics compared to

Pharma companies will be purely guided by commercial interests. Investing in a molecule for a disease of third world countries is considered a not so attractive proposition both from an investment as well as the price point of view pharmaceuticals.

Malaria is one infectious disease which has remained where it was if one takes a look at the Lancet study. What diagnostic tests if any could help improve the situation?

Similarly for Hepatitis C? It can be as trying to kill a mosquito by a sword, effective tests like HRP, which are very

To subscribe: bpd.subscription@expressindia.com

specific to malaria tests like, PF & PV combined which can diagnose both strains of malaria are already available in the market at quite affordable prices. The failure is of the delivery mechanism to ensure that these tests reach the needy people, so the investment is required in strengthening the delivery system than investing in discovery of a new and more

sensitive and accurate test for malaria or Hepatitis C. Point of care tests could be the ultimate game changer when it comes to infectious disease diagnostics. How many infectious diseases have simple, cost effective point of care tests? How does the future look like?

Almost all the tests are available as point of care

tests, however, they suffer from a common problem of false positives and negatives, unless this aspect of the technology is worked upon, these tests will be used as, ‘something is better than nothing’ option and doctors will have a lack of confidence on the results delivered by these tests.

However companies like Alere have done good work in making CD4 tests as point of care without a loss of sensitivity and accuracy, if companies are able to do so in all other disease areas then the future of POC testing will be very bright, else it will be primarily used in resource scarce countries where something is better than nothing. shalini.g@expressindia.com

EXPRESS PHARMA

17

July 1-15, 2014

MARKET COMPANY WATCH

Cipla collaborates with Hetero to launch its second biosimilar drug Darbepoetin alfa Is indicated for the treatment of anaemia caused due to chronic kidney disease CIPLA HAS collaborated with Hetero to launch a biosimilar of the drug Darbepoetin alfa under the brand name ‘Actorise’. The collaboration stands as a multi-partner co-marketing deal which offers Cipla a license to make the drug accessible to a wide number of patients in India.

Actorise (Darbepoetin alfa) is available with stockists across the country in two SKUs, 25 mcg and 40 mcg.

The product is indicated for the treatment of anaemia caused due to chronic kidney disease and is available in prefilled syringes (PFS) – 25 mcg and 40 mcg.

“Following the launch of our first biosimilar product ‘Etacept’ (Etanercept) in collaboration with our partner from China last year, we will now introduce Actorise (Darbepoetin alfa) as the second product in partnership with Hetero in our biosimilar portfolio,” said Dr Jaideep Gogtay, Chief Medical Officer, Cipla.

Gogtay added, “More than 100,000 patients each year need renal replacement therapy i.e. dialysis and renal transplant. Most of these patients develop anaemia and will need drugs such as Darbepoetin alfa to maintain their haemoglobin and reduce the need for blood transfusions.

At Cipla, we believe that pa-

18

EXPRESS PHARMA

July 1-15, 2014

Recombinant human erythropoietin (epoetin) given by subcutaneous injection was first developed as a treatment for anaemia associated with chronic kidney disease. It has been highly effective in stimulating erythropoiesis and increasing the levels of haemoglobin tients should get the best medicines from the latest technology. The launch of Darbepoetin alfa reinforces our strong commitment to expand the product pipeline in biosimilars and to increase product access in various therapeutic areas. While Cipla incubates its own pipeline, we also look forward to partner with companies in India and around the world to bring wider access of biosimilar products to patients in need.

We have been recognised as the partner of choice because of our expertise in specialist therapies and efficient supply and distribution. Therefore, we anticipate more number of deals across therapy areas in

near future.”

Recombinant human erythropoietin (epoetin) given by subcutaneous injection was first developed as a treatment for anaemia associated with chronic kidney disease. It has been highly effective in stimulating erythropoiesis and increasing the levels of haemoglobin. However, since this is administered one to three times a week, it compromised patient compliance. Darbepoetin alfa which is a second generation erythropoietin maintains the haemoglobin levels for a longer period of time, and so the dose is only once a week.

EP News Bureau – Mumbai

Abbott to acquire Latin American CFR Pharmaceuticals Abbott will acquire the holding company that indirectly owns approximately 73 per cent of CFR Pharmaceuticals ABBOTT ANNOUNCED a definitive agreement to acquire Latin American pharmaceutical company CFR Pharmaceuticals, more than doubling its Latin American branded generics pharma presence and further expanding Abbott’s presence in fast-growing markets.

Under the terms of the agreement, Abbott will acquire the holding company that indirectly owns approximately 73 per cent of CFR Pharmaceuticals and will conduct a public cash tender offer for all of the outstanding shares of CFR. Assuming all publicly-held shares are tendered, the total purchase price would be approximately $2.9 billion, plus the assumption of net debt of approximately $430 million.

This acquisition immediately establishes Abbott among the top 10 pharma companies in Latin America, further broadening Abbott’s geographic presence across the region.

“With its scale and leadership positions in the region, strong commercial and development organisations, well-respected leadership team and a trusted portfolio of recognised brands, CFR is one of the leading branded generic companies in Latin America,” said Miles D White, Chairman and Chief Executive Officer, Abbott.

“This acquisition will significantly enhance and

broaden Abbott’s Latin American footprint, and is well aligned with our long-term strategy and commitment to fast-growing markets.”

Abbott expects the acquisition to add approximately $900 million to its sales in the first full year (2015), with expected double-digit sales growth over

This acquisition establishes Abbott among the top 10 pharma companies in Latin America, further broadening its geographic presence across the region the next several years.”

“We are pleased to join with Abbott to enhance CFR's leadership across Latin America,” said Alejandro Weinstein, Chief Executive Officer, CFR Pharmaceuticals.

EP News Bureau – Mumbai

MARKET

Merck Serono and Mersana to develop antibody-drug conjugates Mersana and Merck Serono will leverage Mersana’s Fleximer technology to generate ADCs for multiple undisclosed targets MERCK SERONO, the biopharmaceutical division of Merck and Mersana Therapeutics have signed an agreement to collaboratively develop next-generation antibody-drug conjugates (ADCs). ADCs are composed of an antibody linked to cytotoxic drugs, whereby the antibody part specifically targets and delivers the cytotoxic drug to cancer cells which could lead to higher drug levels at the tumour site. Mersana and Merck Serono will leverage Mersana’s Fleximer technology to generate ADCs for multiple undisclosed targets.

Both parties have agreed to test a

Merck Serono will provide monoclonal antibodies to Mersana, which will generate the Fleximer-ADCs and conduct drug discovery and preclinical development activities variety of ADCs by utilising Mersana’s platform technologies and several cytotoxic agents as conjugates. This agreement further underlines Merck Serono’s approach to employ a collaborative

research and development model, creating strategic partnerships to drive innovation, being consciously agnostic of the source of potential novel assets, and technologies.

“This new collaboration provides an exciting opportunity to expand our oncology drug discovery and development portfolio into the evolving ADC space,” said Dr Andree Blaukat, head of the Translational Innovation Platform Oncology at Merck Serono.

“We look forward to working with Merck Serono to apply our proprietary platform technologies to rapidly develop and demonstrate preclinical proofof-concept of several customised, novel Fleximer-ADC candidates,” said Timothy B Lowinger, Chief Scientific Offi-

cer, Mersana.

Under the agreement, Merck Serono will provide monoclonal antibodies to Mersana, which will generate the Fleximer-ADCs and conduct drug discovery and preclinical development activities. Merck Serono will be responsible for clinical development and commercialization of any products under an exclusive license from Mersana. In addition to an upfront payment, Mersana is eligible to receive milestones plus royalties on worldwide net sales of products.

EP News Bureau – Mumbai

MARKET

Arvind Remedies and Adesh University sign MOU To launch new drugs for treating Type-II diabetes, depression and coronary heart diseases ARVIND REMEDIES has entered into a Memorandum of Understanding (MoU) with Adesh University, Bhatinda, Punjab to transfer the patent right to undertake exclusive manufacturing, marketing and commercialisation of drugs for Type-II diabetes, depression, irritable bowel syndrome (IBS) and coronary heart disease.

These drugs will be manufactured in the form of tablets and will be launched in the end of 2017, first in the domestic market which will be followed by the global market.

PRODUCT PIPELINE 1.Diabetes Type II (association between neopterin concentration and neurovascular changes) –Ayurvedic formulation mainly containing Berberis aristata 2.Depression - A plant based formulation which will help in management of mild to moderate depression.

3.Irritable Bowel Syndrome (IBS) - A plant based formulation for the management of IBS 4.Coronary Heart Disease (CHD) - Role of Lupeol in the management of CHD

Dr B Arvind Shah, Managing Director and Chief Executive Officer, Arvind Remedies, said, “According to the International Diabetes Federation, 382 million people across world have diabetes, which is expected to rise to 592 million by 2035. The

number of people with Type-II diabetes is increasing in every country. In order to curb this disease, we have come up with new drug that is from the botanical source which ensures zero side effects on the health of the patient. We are expecting this

new drug to be available in the markets by mid 2015.”

He further added, “Coronary heart disease is also the most common type of heart disease and is killing more than 385,000 people annually. We are happy to share that, we have been suc-

cessful in developing a new drug, which will help in treatment of coronary heart disease.”

The MoU was signed in the presence of Prof (Dr) G P Dubey, emeritus professor, inventor of these new drugs. The Vice Chancellor of Adesh University, Col Dr G PI Singh signed the MoU on behalf of Adesh University, while Dr B Arvind Shah, Managing Director and Chief Executive Officer signed the MoU on behalf of Arvind Remedies, Chennai.

EP News Bureau – Mumbai

TO ADVERTISE IN EXPRESS PHARMA, CONTACT: 2nd Floor, Whites Road, Royapettah, Chennai- 600 014 Board Line: 044- 28543031/2/3 044- 42285522 Mobile: +91 9710022999 Fax: 044- 28543035 Email id: yuvaraj.murali@expressindia.com HEAD OFFICE MUMBAI Rajesh Bhatkal The Indian Express Ltd Business Publication Division 2nd Floor, Express Tower, Nariman Point, Mumbai- 400 021 Board line: 022- 67440000 Ext. 527 Mobile: +91 9821313017 Email Id: rajesh.bhatkal@expressindia.com

BANGALORE G.M. Khaja Ali The Indian Express Ltd Business Publication Division 502, 5th Floor, Devatha Plaza, Residency road, Bangalore- 560025 Board line: 080- 49681100 Ext. 108 Mobile: +91 9741100008 Fax: 080- 22231925 Email id: khaja.ali@expressindia.com

BRANCH OFFICES NEW DELHI Ambuj Kumar The Indian Express Ltd Business Publication Division Express Building, 9&10, Bahadur Shah Zafar Marg, New Delhi- 110 002 Board line: 011-23702100 Ext. 668 Mobile: +91 9999070900 Fax: 011-23702141 Email id: ambuj.kumar@expressindia.com

HYDERABAD E.Mujahid The Indian Express Ltd Business Publication Division 6-3-885/7/B, Ground Floor, VV Mansion, Somaji Guda, Hyderabad – 500 082 Board line- 040- 66631457/ 23418673 Mobile: +91 9849039936 Fax: 040 23418675 Email Id: e.mujahid@expressindia.com

CHENNAI Yuvaraj Murali The Indian Express Ltd Business Publication Division New No. 37/C (Old No. 16/C)

KOLKATTA Ajanta Sengupta The Indian Express Ltd Business Publication Division JL No. 29&30, NH-6, Mouza- Prasastha & Ankurhati,

20 EXPRESS PHARMA July 1-15, 2014

Vill & PO- Ankurhati P.S.- Domjur (Nr. Ankurhati Check Bus Stop) Dist. Howrah- 711 409 Mobile: +91 9831182580 Email id: ajanta.sengupta@expressindia.com KOCHI Yuvaraj Murali The Indian Express Ltd Ground Floor, Sankoorikal Building, Kaloor – Kadavanthra Road Kaloor, Kochi – 682 017 Mobile: +91 9710022999 Email id: yuvaraj.murali@expressindia.com COIMBATORE G.M. Khaja Ali The Indian Express Ltd No. 205-B, 2nd Floor, Vivekanand Road, Opp. Rajarathinam Hospital Ram Nagar Coimbatore- 641 009 Mobile: +91 9741100008 Email id: khaja.ali@expressindia.com

AHMEDABAD Rajesh Bhatkal The Indian Express Ltd 3rd Floor, Sambhav House, Near Judges Bunglows, Bodakdev, Ahmedabad - 380 015 Mobile: +91 9821313017 Email Id: rajesh.bhatkal@expressindia.com BHOPAL Ambuj Kumar The Indian Express Ltd F-102, Inner Court Apartment, 1st Floor, GTB Complex, Behind 45 Bungalows, Bhopal - 462 003 Mobile: +91 9999070900 Email id: ambuj.kumar@expressindia.com JAIPUR Ambuj Kumar The Indian Express Ltd S2, J-40, Shyam GHP Enclave, Krishna Marg, C-Scheme, Jaipur - 302 001 Mobile: +91 9999070900 Email id: ambuj.kumar@expressindia.com

IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express Limited. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications. We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

MARKET GROWTH TRACKER

IPM registers `6636 crores in May 2014 11 therapies have outgrown the IPM growth and five therapies have double digit growths THE INDIAN Pharmaceutical Market (IPM) clocked `6636 crores in May 2014 and the market has seen a growth of 8.1 per cent in the same month. Hegde & Hegde has become the 50 th biggest corporate in the IPM. Amongst the top 10, Sun Pharma grew at 15.2 per cent followed by Mankind at 13.3 per cent and Lupin at 11.7 per cent. 29 corporates have crossed the growth of IPM amongst top 50. Amongst the top 50 corporates, Akumentis has the highest growth of 54.1 per cent followed by Ajanta at 45 per cent and Biocon at 44.8 per cent.

Amongst the 11-20 ranked companies, Macleods has shown high growth at 26.7 per cent followed by Biocon at 44.8 per cent and Apex at 39.6 per cent. Amongst the 50-60 ranked corporates, Apex grows at 39.6 per cent followed by Troikaa at 30 per cent and Panacea at 25.2 per cent. Amongst the 61-75 ranked corporates, Corona grows at 41.1 per cent followed by Pharmed at 28.8 per cent and Serdia at 21.2 per cent.

Indian companies have grown at 10.5 per cent versus 1.8 per cent for MNCs in May 2014. Amongst the top 50 in MNCs MSD grew the highest at 20.9 per cent, followed by Merck at 13.9 per cent and Janssen at 8.1 per cent. Under the non-NLEM category Indian companies are growing at 10.4 per cent whereas MNCs are growing at 1.6 per cent.

The DPCO 2013 containing molecules market was at –11.5 per cent whereas the non-DPCO market grew by eight per cent resulting in an overall growth of 5.2 per cent for May 2014. The DPCO 2013 portfolio

From the regional perspective 13 regions have outgrown the IPM growth. Madhya Pradesh market grew the highest at 17.8 per cent followed by Vidarbha market at 15.3 per cent for Pfizer degrew at 26.9 per cent, GSK degrew at 19.5 per cent and Ranbaxy degrew by 25 per cent.

From the therapy perspective, 11 therapies have outgrown the IPM growth and five therapies have double digit growths. The respiratory market grew at 11.8 per cent, gastrointestinal market grew at 7.2 per cent whereas the anti-infectives grew at 2.5 per cent. The anti-diabetic market grows at 17.2 per cent and cardiac at 7.8 per cent in chronic business. The derma market grew by 12.9 per cent.

From the regional perspective 13 regions have outgrown the IPM growth. Madhya Pradesh market grew the highest at 17.8 per cent followed by Vidarbha market at 15.3 per cent. No regions had negative growths in May 2014.

Glimepiride + Metformin becomes the number one market growing at

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

21

July 1-15, 2014

MARKET 34.4 per cent, whereas Amoxycillin + Clavulanic Acid Market grows at 3.9 per cent. The markets of Vitamin-D grew by 34.7 per cent, Probiotic Microbes grew at 25.2 per cent, Levocetirizine + Montelukast by 24.4 per cent, Rosuvastain by 23 per cent, Levetiracetam by 22 per cent and Telmisartan by 19.4 per cent.

Lantus grows at 26.1 per cent amongst the top 10 brands and adds up nine ranks to be the seventh biggest brand in the IPM for the month of May 2014.

Amongst the brands who have gained ranks include Glycomet-GP (+7), Liv-52 (+7), Skinlite (+10), Zincovit, Galvus Met (+21), Gluconorm-G (+39), Jalra-M (+51), Telma (+16), Orofer – XT (+13), Susten (+32), Pan-D (+10), Dolo (+44), Zerodol-P (+66), Dynapar AQ (+90) amongst top 100 Brands.

Amongst the top brands in the IPM, Glycomet GP (23.7 per cent), Lantus (26.1 per cent), Galvus Met (45.1 per cent), Skinlite (24.1 per cent), Telma (22.4 per cent), Zincovit (32 per cent) Liv-52 (17 per cent) grew fastest amongst top 25 Brands over May-13.

A total of 160 brands were launched in May 2014. MY HMG, HYLASTO ONE, LUMIA were the top NIs.

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

Terminologies used MAT – Moving Annual TotalMTH – MonthVal (Cr) – Value in CroresMS per cent – Market Share in PercentageGR per cent – Growth in percentage.

For more information, visit http://www.aiocd.net

22 EXPRESS PHARMA July 1-15, 2014

With Bonus Units at Full Value Val in Crs CORPORATE

Rank

(Val in Crs)

MAT May-14

MAT

MTH

Abbott + Abbott HC + Novo

1

1

Sun Pharma

2

May-14

Val (Cr)

MS%

GR%

Val (Cr)

MS%

76567

100.00

5.9

6636

100.00

8.1

4893

6.39

3.8

414

6.44

4.8

2

4168

5.44

15.4

377

5.34

15.2

IPM

GR%

Cipla

3

3

3809

4.97

6.2

326

4.97

6.8

Zydus + Biochem

4

4

3363

4.39

6.3

281

4.39

4.3

Ranbaxy

5

6

2836

3.70

-3.6

233

3.98

-4.7

Mankind

6

5

2727

3.56

5.4

243

3.50

13.3

Glaxo

7

8

2710

3.54

-15.6

227

4.02

-7.8

Alkem + Cachet + Indchemie

8

9

2673

3.49

9.9

226

3.39

8.3

Lupin

9

7

2581

3.37

11.7

230

3.36

11.7

Pfizer

10

11

2226

2.91

3.0

189

2.95

4.0

Emcure + Zuventus

11

12

2162

2.82

15.0

183

2.65

12.9

Macleods

12

10

2056

2.69

11.5

198

2.55

26.7

Sanofi

13

13

1926

2.52

0.3

175

2.65

7.7

Intas

14

14

1909

2.49

7.0

168

2.55

7.4

Aristo

15

15

1877

2.45

14.7

164

2.17

23.1

Glenmark

16

18

1667

2.18

15.7

131

1.89

13.6

Dr. Reddys

17

16

1635

2.14

5.7

144

2.16

8.9

Micro + Bal

18

17

1572

2.05

9.3

139

2.15

5.7

USV

19

21

1407

1.84

9.1

118

1.87

3.1

Torrent

20

19

1394

1.82

14.0

127

1.79

15.1

IPCA

21

20

1372

1.79

20.4

124

1.59

27.8

Wockhardt

22

22

1222

1.60

3.0

102

1.53

8.6

Val in Crs

MAT May 14

MNTH MAY 14

Super Group

VAL IN CRS

GR%

VAL IN CRS

GR%

IPM

76567

5.9

6636

8.1

ANTI-INFECTIVES

12593

0.0

1009

2.5

CARDIAC

9519

7.6

848

7.8

GASTRO INTESTINAL

8591

5.4

809

7.2

VITAMINS / MINERALS / NUTRIENTS

6846

5.3

615

9.0

RESPIRATORY

6043

10.3

437

11.8

PAIN / ANALGESICS

5501

3.9

481

8.5

ANTI DIABETIC

5499

15.2

514

17.2

NEURO / CNS

4772

5.8

417

5.7

GYNAECOLOGICAL

4745

1.6

424

5.5

DERMA

4377

11.7

375

12.9

OPHTHAL / OTOLOGICALS

1387

9.1

129

11.8

HORMONES

1296

3.7

112

9.2

VACCINES

1094

-3.6

88

-9.3

ANTI-NEOPLASTICS

1079

28.6

102

26.2

BLOOD RELATED

925

4.1

78

2.3

OTHERS

896

4.4

87

22.5

ANTI MALARIALS

628

2.7

43

14.8

SEX STIMULANTS / REJUVENATORS

429

3.3

36

-2.7

STOMATOLOGICALS

346

9.1

32

15.5

EVENT BRIEF JULY 2014 11

Contract Manufacturing 2014

CONTRACT MANUFACTURING 2014 Date: July 11, 2014 Venue: Hotel Hilton, Sahar, Mumbai Summary: Indian Drug Manufacturers’ Association (IDMA) and IDMA Contract Manufacturing Subcommittee will organise the first conference on Contract Manufacturing 2014. The main theme of this conference is ‘360 degrees of Contract Manufacturing.’ Eminent experts in contract manufacturing, research, and regulatory spheres from the Indian pharmaceutical industry will converge and interact on various recent developments.

18

Pharmac South 2014

Contact details Varsha Surve – 09322037955 E-mail: info@pharmacindia.com

EMERGING TRENDS IN DRUG DISCOVERY: AICADD – 2014

PHARMAC SOUTH 2014

Date: July 23-28, 2014 Venue: Amrita Vishwa Vidyapeetham - Amrita University, Coimbatore Summary: Emerging Trends in Drug Discovery: AICADD – 2014 is an international conference which aims to make a ‘industry-scientistsacademics’ collaboration to meet the major challenges of drug discovery.

The emphasis of the conference will be on topics related to the Computer Aided Drug Discovery (CADD). The organisers are expecting more than 500 delegates including nobel laureates/ scientists/ researchers/ students and professionals from academia and industries from all over the country and abroad. A few identified thrust areas are: clinical pharmacy and pharmacy practice, natural products chemistry, medicinal chemistry, pharmaceutical technology, CADD, pharmacogenomics, pharmacoinformatics, SAR studies and machine learning, drug delivery system, nanomedicine, personalied drug design, bioinformatics and biomedical engineering.

Date July 18 -19 2014 Venue: Chennai Trade Center, Chennai, India Summary: Indian Drug Manufacturers Association (IDMA-TNPSB) and Orbit Exhibitions organising Pharmac South 2014 on July 18 -19 2014 at Chennai Trade Center, Chennai, India. The event will provide new opportunities for contract manufacturers of allopathy, ayurvedic, siddha, unani, nutraceutical and dietary supplements, outsourcing and export managers, brand managers along with with sections of the pharma industry.

With a special emphasis on contract manufacturing the event is poised to attract pharmaceuticals, nutraceuticals, herbal, veterinary formulations and experts from the medical and pharmaceutical sectors.

Contact details Dr PK Krishnan Namboori Asso. Professor, (Executive Coordinator) AMRITA Insight into Computer Aided Drug Discovery- AICADD-2014 Computational Chemistry Group (CCG) Computational Engineering and Networking AMRITA Vishwa VidyapeethamAmrita University Amritanagar, Coimbatore - 641 112 Tel: (0422) 2685000 (Extn: 5592) Email: aicadd_2014@cb.amrita.edu / aicadd2014@gmail.com Website: http://www.amritaccg.inConference URL: http://www.amritaccg.in /aicadd2014

Contact details T R Gopalakrishnan Deputy Secretary-General Indian Drug Manufacturers’ Association 102, ‘A’ Wing, Poonam Chambers Dr Annie Besant Road, Worli, Mumbai – 400018 Tel: +91-22-24944624/24974308 Mobile No. 9819035076 Fax: +91-22-24950723 Email: admin@idmaindia.com Website: www.idma-assn.org

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

23

July 1-15, 2014

cover )

RESTRUCTURING

A series of warning letters and import alerts seem to have convinced pharmaceutical companies to plug the loopholes in plant infrastructure. Are they on the right track?

BY SACHIN JAGDALE

R

eceiving Good Manufacturing Practice (GMP) certification and adhering to global regulatory norms would remain a distant dream if a company’s infrastructure is not up to the mark.

Infrastructural up-gradation, as directed by these norms, is not a cake walk and many aspects need to be considered before making any structural changes in a manufacturing plant or lab facility.

Old is gold?

Global regulatory norms and GMP requirements are increas-

24 EXPRESS PHARMA July 1-15, 2014

ingly getting more stringent and so do the modifications required in the manufacturing plants.

Pharma manufacturers have two options while complying to these norms, either modify the existing plant or set up an altogether new facility. In either of the cases, a considerable investment is involved. Setting up a new plant would escalate the cost but will also allow the manufacturer to introduce latest technological advances in the manufacturing plant.

“Constructing a new plant is a better option in order to have latest design, structural benefits

and energy conservation possibilities,” opines Sanjay Singh, SVP Operations, Aurobindo Pharma.

There are many domestic and multinational pharma manufacturing plants operational in India for decades. Domestic companies willing to tap the world market tried to upgrade themselves as and when demanded by global regulatory bodies. As per industry experts, the main focus of overseas regulators is on hygienic conditions at the plant.

However, the plant’s overall structure is also important because it houses all the sensitive

(

operations undertaken by manufacturers. Whether to upgrade the existing facility or to construct a new plant is solely decided by the company management but, it is usually believed that setting up a plant would be a more feasible option.

Kapil Bhargava, Former Dy Drugs Controller (I) CDSCO and advisor to pharma companies in India, says, “The biggest hurdle in modifying existing plants is to stop/ suspend production for six to 12 weeks. In case a fast moving product is made in such plants, the company will not take the risk of suspending production.

Suppose a plant is 25-year-old, it must have undergone several modifications already. Further modification is rather difficult. In my opinion, a better and safer option would be to make a new plant that can sustain GMPs for 15 years or so. This may cost 3040 per cent extra and I feel this would be worth spending.”

“Both options are feasible,” says Rajashri Ojha, Founder and Director, Raaj Global Pharma RA Consultants. Ojha is a regulatory Affairs (RA) and GMP expert and conducts audits, compliance workshops and trainings for pharma companies and CROs.

To subscribe: bpd.subscription@expressindia.com

She adds, “It purely depends on what kind of products are being planned. Capacity will also be an issue. Targeted markets like the US, Europe, the UK, Canada or ROW would also impact this decision. If the existing plant meets all the above requirements except the manufacturing capacity then you may expand the existing facility or you may think about constructing a new plant.”

Role of consultants and architects Expansion or construction of a new plant involves many technical aspects. Architects, project

THE MAIN FOCUS

It would be difficult to come out with a scheme for subsidy on facilities PK Kulkarni, Director, Oncology and Biotech facilitites, Technolutions Projects

EXPRESS PHARMA

25

July 1-15, 2014

cover )

The biggest hurdle in modifying existing plants is to stop/ suspend production for six to 12 weeks Kapil Bhargava, Former Dy Drugs Controller (I) CDSCO and advisor to pharma companies in India

We have to change the mentality right from the top management and train each working professional on different aspects of cGMP, GLP, regulatory, data integrity etc Rajashri Ojha, Founder and Director, Raaj Global Pharma RA Consultants

26 EXPRESS PHARMA July 1-15, 2014

managers etc need to be roped in to design and execute the construction of the plant. Consultants also play a crucial role in deciding the further course of action.

Singh says, “Many Indian and international consultants have expertise in the specific field of formulation or API manufacturing. Architects play a crucial role in designing the facility to have better man, material and scrap flows. Project managers keep track of review of the project at a defined frequency to identify any bottle necks / roadblocks and the ways to resolve them.”

Most company managements and boards of directors depend on their own production and engineering personnel to head such projects. Companies do engage consultants mainly for conceptual designs / drawings for all aspects depending on a company’s strengths and management approach.

Bhargava explains, “At times there is a possibility where the new head of the company is purely from a finance or marketing field. In that case the management would like to appoint technical consultants mostly on a turnkey basis. Architects are generally not employed by companies and are hired from outside.

They generally toe the line of management and do not offer what is concrete and correct.

Project managers are basically executors and are also involved in machine selection and further stages of project execution e.g. completing their part of validations etc.”

“This is a bit of an issue. A pharma facility is much more than just an RCC structure,” opines PK Kulkarni, Director, Oncology and Biotech facilitites, Technolutions Projects.

Kulkarni has designed many US FDA approved plants.

According to Kulkarni, many companies in the past first constructed the buildings based on a rough sketch

or estimate by senior experienced managers and installed the operational hardware later on. Consequently, companies fist approached architects. Kulkarni informs, “However, with more emphasis on Quality by Design (QbD) and a much higher insistence of Quality Assurance (QA) by all regulators, the trend is now to design custom built flexible plants and laboratories. The manufacturing and research professionals, QA/RA experts and pharma engineers are playing a much bigger role than architects.”

Infrastructural shortcomings or defects have always given sufficient fodder to regulatory authorities to keep pharma companies companies on their toes, more so when such issues lead to contamination or quality compromise in manufacturing plants.

“Infrastructural shortcomings in buildings and premises are commented

upon adversely only when these are not capable of avoiding contamination, cross-contamination and mix-up. Indian regulatory bodies take this more seriously as lay-out is to be further approved by them. They treat infrastructural defects as violation of condition of license, which may warrant penal action. According to me good neat and clean, well maintained and adequate size premises and support system will meet any GMP regulation. Operations are to be made safe for product as well as for patient. Such defects are not tolerated by any agency if critical products such as injections and other biological / critical care products are produced,” says Bhargava.

Is government funding an option?

The Indian government has high expectations from the pharma industry. Supply of cheap medicines is one such

demand and there is no doubt that its help in reducing operational cost would definitely help in lowering drug prices. Should the Indian government (centre and state) arrange for subsidy/incentive schemes for pharma companies to set up their plants or is it already in place?

“There are no such incentives. It would be difficult to come out with a scheme for subsidy on facilities. It may be possible on products since a plant can produce many products,” says Kulkarni.

Ojha says, “Currently I am not sure whether we have government incentives or subsidy schemes for setting up of plants in India. However, it would be a good idea if such schemes will be made available in future. In India we have enough talent and many pharmacists who are jobless can start their own small scale manufacturing units. A holistic approach should be considered while building a plant. Sufficient market survey and regulatory intelligence should be gathered and people should be trained to take up the challenge and risk in life.”

In comparison with their global peers, Indian manufacturers have generally opted for less complex moelcules . This is mainly because an increase in complexity leads to an increase in the investment. However, there is one view that since Indian players mostly focus on the the generics side of the business, the cost is contained to a greater extent. Thus Indian pharma companies would seem to be capable of self-financing their capex requirements and government incentives may not be required.

“I think Indian companies do not need subsidies,” opines Bhargava.

He explains, “I feel our current pharma industry is capable of generating their own resources for upgrading /

( re-modelling their infrastructure, if there is strong will and the commitment from management. The companies must have commitment to make good and safe products and demonstrate such an attitude.”

Bhargava adds, “We produce mostly generic formulations, our operations are rather simple and it is not as complex to design manufacturing plants. Whereas in Europe and other developed countries, the formulations are specialised and plants are made to suit such operations. Automation is also designed in that manner.

The machines and other support systems are computer controlled or atleast computer assisted. They are geared more towards good automated manufacturing practices (GAMP).

We make more versatile plants so that the number of simple or even complex products can be produced there. Our Small Scale Industries (SSI) or such companies have not even today understood the importance of contamination and cross-contamination and have not paid much attention to workers' comfort and safety, whereas this is an important aspect in western countries. Automation and computer assistance in manufacturing is slowly creeping in and may take 10-12 years.”

Uncalled for warnings India has the highest number of US FDA approved plants outside the US. But of late, India’s share of inspection observations (483s) and import alerts is larger than other countries. Is it because the infrastructure is outdated and becomes obsolete very fast? Are pharma managements unable to/cannot keep up with the change in technology?

“There is an increasing concern about the large number of observations and warning letters issued by the US FDA to Indian pharma manufacturers.

A closer look at these observations shows that most Indian pharma manufacturers are

THE MAIN FOCUS

system should be in place along with a risk, mitigation plan.

The training should be continuous as technology is evolving and many rules and regulations change frequently. People should be trained on countryspecific cGMP and regulatory requirements.”

Not just about infrastructure

India is among the leading countries to receive more inspection observations (483s) and import alerts these days. Is it because the infrastructure is outdated and gets obsolete very fast?

struggling with maintaining data integrity and updated records. The US FDA does not discourage the largest producer of generic pharma products. At the same time, they wish to have quality products and will enforce their quality standards,” says Singh.

Bhargava says, “India having the largest number of US FDA approved plants is mostly due to the fact that we supply APIs to several countries. I feel formulation plants will constitute 25-30 per cent of total number. 483s issued to our sites are not due to suboptimal infrastructure; they are more on aspects that we do not follow like good practices. We take things for granted, our data is not considered reliable and we are not able to demonstrate

To subscribe: bpd.subscription@expressindia.com

that we are honest in our operations and activities.”

Bhargava adds, “We try to be in readiness more for inspections and not at all times.

If you go to the warning letter site of the US FDA you will hardly find comments on infrastructure. The US FDA therefore expects more of automation so that mistakes can be traced back. Our managements probably are not confident of implementing a zero defect approach and not too willing to install for computer controlled systems. They are more comfortable with high speed, less automation and minimal computer assistance.”

Kulkarni echoes Bhargava’s views, opining that the insistence on data integrity is actually a shame for India. He says,

“There is no problem at these plants as far as hardware is concerned. It is the problem of software, mainly attitude, aptitude and transparency in everything we do.”

Ojha further analyses the reason behind warning letters.

She says, “The reason being that lack of knowledge, improper on-job training, noncompliance and attitude and behavioral problems. We have to change the mentality right from the top management and train each working professional on different aspects of cGMP, GLP, regulatory, data integrity, electronic data/records handling and maintenance system as per 21CFR part 11. Also, we need to train them on soft skills, people management, motivational skills etc. The quality

Infrastructure would hold little value if skilled manpower is not there to operate it. India has many pharma educational institutes, however, finding the right talent, at the right place, at the right time is still a challenge for recruiters. The industry's needs and courses offered at the institutes hardly keep any pace with each other.

Singh feels that the Indian pharma industry is gearing up on this aspect and many training programmes and workshops are being conducted to make the pharma fraternity aware of the latest trends in the field of pharmaceutical sciences.

According to Kulkarni, Indian companies have not yet placed the same premium on training as on production equipment as far as funds are concerned.

Conclusion There are many industrial zones and Special Economic Zones (SEZs) in the country.

Though recent warning letters to Indian pharma companies are mainly due to quality related issues, manufacturing facilities and its premises that provide space for various operations should also be properly taken care of. As discussed, experts from different fields are involved in making plants functional. It should be the prerogative of these experts to develop the infrastructure for the Indian pharma companies that will stand upto the expectations of not just Indian but also global regulators. sachin.jagdale@expressindia.com

EXPRESS PHARMA

27

July 1-15, 2014

cover )

CLUSTERING FOR COMFORT The proposed Cluster Development Programme for the Pharma Sector (CDP-PS), a part of the 12th Five Year Plan, has received a sanction of `125 crores from the Government. However, industry representatives protest that the allotted sum is too small to make any noteworthy impact

BY USHA SHARMA

T

he Special Economic Zones (SEZ) Act, introduced in 2005, had envisioned the creation of better infrastructure in the country which would generate employ-

28 EXPRESS PHARMA July 1-15, 2014

ment across sectors. This Act predictably saw a boom in the setting up of SEZs. For the corporate sector, it seemed like a win-win proposal as they hoped the subsidies received under the scheme would help exceed existing profit margins. Joining the race, many leading pharmaceutical firms set up pharma SEZs or commissioned manufacturing facilities in SEZs

across India. Unfortunately, the SEZ concept did not live up to expectations.

There are hardly any success stories of pharma SEZs. To overcome this and begin anew, the Department of Pharmaceuticals (DoP) released a concept note on a new programme, called the Cluster Development Programme for Pharma Sector (CDP-PS) on

May 25, 2010. With a special emphasis on enabling SME pharma units, the CDP-PS aims to encourage quality, productivity and innovation in the pharma industry by leveraging the geographical proximity of enterprises on the ‘collaborating while competing’ principle, to make the scheme more participatory and cost effective.

The scheme provides critical

mass for customisation of interventions, like standard testing facilities. Thus it will allow SME pharma players access to technology and facilities at a fraction of the cost.

A few pharma clusters already exist in India like Baddi (Himachal Pradesh), Haridwar (Uttarakhand) and Gurgaon (Haryana) in the north; Pattancheru Pashmalyram and

( Khazipalli (in Andhra Pradesh), Alandur and Ambattur (both in Tamil Nadu) in the South; Thane, Nashik, Aurangabad (Maharashtra), Vadodara and Ahmedabad (Gujarat) in the West region and Goa/Sikkim.

Giving more examples, BR Sikri, Vice President, Bulk Drugs Manufacturers Association and Vice President, Indian Drugs Manufacturers Associations informs, “Visakhapatnam has a cluster of active pharmaceutical ingredients (API) industries. Similar to these, there is a bio technology park set up near Hyderabad. Himachal Pradesh and Uttarakhand have dedicated pharma cities but these cannot be defined as clusters.”

Learning from the SEZ model The announcement of SEZ Act was welcomed by the industry and the pharma sector was one amongst the few which expanded its horizons and set up various SEZs. Parsvnath, Inspira Infrastructure, JB SEZ (HBS - Pharma SEZ), Ramky Group- Pharma SEZ, APIIC, KIADB (Pharma), Serum Biopharma Park, Wockhardt Infrastructure Development etc.

At that point of the time private banking firms also supported the venture and invested sizable sums through the PE/VC model. Leading pharma and biotech companies, like Ranbaxy, Dr Reddy’s Laboratories, Zydus Cadila, Jubilant Life Sciences, Biocon, Divi’s Laboratories, Piramal Lifesciences, JB Chemicals and many more set up their manufacturing units in various of these SEZ facilities.

Today the tide has turned and many pharma companies have opted to either shut down or run their units in such SEZs with a skeletal staff. Yet others are surrendering the allotted plots to the SEZ developers.

Even a location like the Indore SEZ, in Madhya Pradesh seems to have fallen out of favour, though its central location translates into better logistical connectivity within and outside India. Surprisingly, pharma companies still in-

vested in the Indore SEZ are not 100 per cent sure of continuing operations.

Sikri explains the hitches of such projects and opines that basic requirements need to be well defined before venturing into the space. “The basic concept of an SEZ has to be understood. The schemes introduced should continue but unfortunately this is not the case. Duties are changed, levies are changed, tax structure is changed,” he points out.

While sharing the example of our neighbouring country, China, where SEZs are a success story, he says that that country’s government strictly adheres to the announcements made throughout the period scheme. “Colonies for workers are set up, a waste management system is introduced, infrastructure is fully developed, water supply and power stations are installed, power backup is introduced, and other basic amenities are provided , which becomes a permanent place for employees as they get all facilities under one roof. Within India, Visakhapatnam is a great success as facilities like common lab, common library, common effluent treatment plant (ETP), waste management system and even common R&D centre can be created,” points out Sikri.

But not everyone is convinced that this model will work in India. Commenting on the cluster based model, Dinesh Mody, Director JB Chemicals stresses, “Development and joint management of common facilities requires a lot of trust and cooperation among cluster participants. Companies often view others as competitors and do not want to participate in common activities. Hence, it may not be feasible to set up pharma specific clusters, but chemical industry clusters could be considered as it would cater to all pharma manufacturers, as issues related to bank subsidies, effluent treatments, power and water requirements etc. are similar.”

Fixing the loopholes According to the scheme docu-

To subscribe: bpd.subscription@expressindia.com

“ India has the talent pool. They lack on the financial front. If clusters are created along the lines of China, then many young entrepreneurs will rush to set up facilities for pharma units” BR Sikri, Vice President, Bulk Drugs Manufacturers Association and Vice President, Indian Drugs Manufacturers Associations

ment, the CDP-PS is proposed as a Central Sector Scheme for the remaining years of the 12th Five Year Plan and to continue in the next Five Year Plan. The total size of the scheme is proposed to be `125 crores and envisions common facilities for testing, training centre, R&D centres, effluent treatment plant, logistics centres etc. The grant in aid to be provided is only for the common facilities and not for production units.

Commenting on the same, Sikri says, “`125 crore is a meager amount. If India wants to compete with China, then the budget of such a scheme should be in thousand crores. India has the talent pool. They lack on the financial front. If clusters are created along the lines of China, then many young entrepreneurs will rush to set up facilities for pharma units.”

The success of any project depends on the methods of approach and its accessibility. If the Government does not want another programme failing, then what should be the steps taken at both ends? Sikri suggests, “If the MSME segment is encouraged to begin with, it will be good move on the part of

THE MAIN FOCUS

the Government otherwise smaller companies will not be able to access this scheme and big giants with their muscle and financial power will try to grab such an opportunity.”

Mody remarks, “CDP-PS may be accessible provided a number of units join hands to approach DoP. However, whether the funds allocated would be enough is another matter.”

Commenting on the implementation mechanism, Mody emphasises, “Affordable clusters will need to be created with infrastructure and logistics. It is also possible to consider already set up units in an area as a cluster and provide suitable support/facilities.”

Sikri opines, “Single window system has to be really introduced so that all formalities for licencing etc. are completed under one roof. Red tapism has to go with the changed scenario.”

A model to follow According to Mody, “Baddi is a good example of a successful cluster, as the Centre and state combined to provide suitable facilities, with the Centre giving tax free holidays and state providing all the infrastructure and support. This attracted first time manufacturers as well as seasoned companies setting up yet another manufacturing unit to avail of the benefits. Maharashtra has two to three naturally formed clusters, but the state government must gear up to introduce planned clusters. Similarly other states like Madhya Pradesh, Karnataka etc can also develop clusters with adequate planning.”

The newly formed states need to have such cluster schemes on a priority basis.

Sikri says, “Seemandhra and Telangana are the two states in which this scheme can be immediately implemented because this area is surrounded by natural resources. Secondly, these are newly created states and both the Centre and state governments have the intention to create employment opportunities. The pharma sector is well

established in the surrounding areas and it is already considered a hub of the industry. In the second phase, such incentive schemes should be introduced in states like Orissa, Bihar, parts of Uttar Pradesh, so that there is an uniform distribution of employment opportunities all over India. This will ensure that the youth of all states get an opportunity to set up their units as young entrepreneurs and other youth get equal opportunities for employment.”

Indian entrepreneurs are capable enough to accept any global challenge. The business model has to be cost effective.

At present India has a fragmented life sciences industry with intense competition on prices, stringent government price controls, and limited availability of infrastructure.

Nonetheless, MNCs are increasing their operations in India and creating opportunities to drive industry growth in the country. But government should encourage the local domestic industry to come forward.

“India is among the top five pharma emerging markets.

The double digit growth registered by India’s life sciences and healthcare industry can be attributed to several socio – economic factors and plenty of scope is there to further improve on the health of the pharma industry by introducing new SEZs, as well as the new cluster scheme so that we reduce dependability on China and become self sufficient,” feels Sikri.

As Greek philosopher, Heraclitus says, ‘change is the only constant in life.’ This quote is very applicable in the pharma industry. After the SEZ model failed in various parts of the country, the government is trying to initiate the cluster model, albeit with limited funds. Though Indian pharma companies are trying to get more funds from the government, if this model manages to nail it then the growth of the industry would move on to the fast track. u.sharma@expressindia.com

EXPRESS PHARMA

29

July 1-15, 2014

cover )

Lending a helping hand Most medium and small sized pharmaceutical companies in India would like to upgrade their facilities but face many hurdles. A quick glance at some suggestions from industry associations and MSME players reveals that the wish list for revival ranges from increased financial incentives to having a larger voice in policy framing initiatives

BY USHA SHARMA

30 EXPRESS PHARMA July 1-15, 2014

(

THE MAIN FOCUS

‘We would be able to playour role in helping India’s pharma exports’ P

harmexcil has come into effect in May 2004. Since then it has been liaising between industry and Government to help promote India’s pharmaceuticals exports.

Pharmexcil, in the course of promotion of exports in cooperation with Ministry of Commerce, has conducted several

business meets. Besides, in identified markets to catch specialised attention, to help small and medium enterprises it has led many delegations and also invited those market’s potential importers for the benefit of our exporters. Pharmexcil has also conducted several seminars regarding regulatory

procedures of our destination countries inviting those officials to help our exporters get more familiar with their procedures.

Pharmexcil was adequately supported by Department of Commerce in all the above efforts and during other times too when India’s exporters

faced consignment seizures in Europe, which has happened due to misinterpretation of patent laws. We are sure we would continue to get the same support in future also and we would be able to play our role in helping India’s pharma exports to reach next level perfectly.

Dr PV Appaji, Director General, Pharmexcil

‘One windowclearance should be made possible’ ▲ Firstly, there has to be a separate documented booklet on schemes announced by the Government till today, specially for the pharma sector alone, by the MSME ministry. An urgent fact finding meeting should be held by all stakeholder associations with the Central Government to evaluate the true financial requirements for upgrading this knowledgebased industry and accordingly move and quantify the financial requirements which is holistic, factual and useful to the industry to establish a progressive path. ▲ The information in the booklet should contain all the details but in a brief format so that they could be authentically circulated by associations like Indian Drug Manufacturers’ Association (IDMA), Federation of Pharmaceuticals Entrepreneurs (FOPE) and the regional smaller associations in the country. A soft copy of the same could be sent to all relevant associations for circulation to their respective members. The title of the text should be ‘MSME (Pharmaceuticals).’ ▲ A clear directive should be given to nodal bankers like Small Industries Development Bank of India (SIDBI) as well as other nationalised banks to

enable pharma manufacturers to be addressed differently in a focussed way to enable them to get necessary working capital loans and disbursement of subsidised loan announced by the Central Government, as well as state governments for up gradations. ▲ One window clearance should be made possible if the papers of a loan seeker are genuine. If possible reduce taxes in pharma products including custom and excise duties in order to make the products cheaper to the ultimate consumer, the patient. This is in line with the principle of Drug Price Control Order basically mooted for reducing the prices of medicines.

SR Vaidya, Chairman, MSME Sub Committee, IDMA

▲ Any new programmes or initiatives announced by the Government should be only done after consultation with stakeholder associations. For e.g. barcoding, pet bottles etc. They are perceived as being without satisfactory inputs from the industry. ▲ Any draft circulation notification issued to be circulated to stakeholder associations by the Central Government should be done on time, possibly on the same date when notified. This enables the association and its members to seriously take a call and make as well as seek amendments if necessary. ▲ Encourage MSME (Pharmaceutical) organisations to get R&D facilities accentuated by

An urgent fact finding meeting should be held by all stakeholder associations with the Central Government to evaluate the true financial requirements for upgrading this knowledge-based industry and accordingly move and quantify the financial requirements which is holistic, factual and useful to the industry

To subscribe: bpd.subscription@expressindia.com

providing the academia co-ordination like universities and major reputed academics institutions. Realising the fact that MSME manufacturers alone cannot pour in that sort of capital for R&D activity, the Government can come forward and encourage universities to help MSME through funds to conduct R&D activities on behalf of MSME entrepreneurs. ▲ Exhibition platforms should be provided to MSME pharma manufacturers in different locations of the country, where in all allied industries connected with manufacturing, regulatory-oriented machineries and other relevant ancillary industries are displayed and thus encourage B2B activities. This is justifiable because the pharma industry is a knowledge-based industry and ever evolving. ▲ A more focussed approach by the Health Ministry and Commerce Ministry could be achieved by taking cognizance of various inputs required for the progress of the Indian pharma industry. All the views should be addressed and cleared for the industry, so as to achieve self-sufficiency in healthcare for one and all as well as achieve a robust manufacturing atmosphere for medicines in the country.

EXPRESS PHARMA

31

July 1-15, 2014

cover ) ‘The funding amount provided should be reasonable to meet requirements’ T

he best scheme for Technology Upgradation Fund Scheme (TUFS) for SMEs should be the one that identifies their need and meets their requirements.

Today, pharma SMEs require funding for HVACs, water purification, HPLCs, effluent treatment plants, besides several other manufacturing and quality control equipment and area expansions. Soft loans may also be required for staffing and training.

The funding amount provided should be reasonable to meet the above requirements. Many a time,

SV Veerramani, President, Indian Drug Manufacturers Association (IDMA)

The investment limits for pharma SMEs also need to be increased to accommodate the expansions required to meet global needs.The best platform for SMEs can be in contact manufacturing and exports the funds provided are unrealistic and inadequate. Subsidies of 20 to 30 per cent and concessional rate of interest of five per cent need to be considered. As the equipment and machineries will be mortgaged to the bank against the loan no other collateral securities should be insisted. Although Small Industries Development Bank of India (SIDBI) may be the nodal bank, the loan need to be disbursed through nationalised banks

32 EXPRESS PHARMA July 1-15, 2014

through a simple procedure.

The investment limits for pharma SMEs also need to be increased to accommodate the expansions required to meet global needs.

The best platform for SMEs can be in contact manufacturing and exports. Tremendous opportunities are opening in exports and if pharma SMEs are encouraged through TUFS schemes, they can increase India's share in supply of pharma to the world.

‘Government mayconsider offering higher depreciation benefits’ P

harma export associations should act as a facilitator in setting up warehouses in Asian, Latin American and African countries by providing high subsidised rental fees via a scheme by partnering with the Government of India. This shall facilitate exports of goods without incurring high logistics costs. Presently, costs of logistics account for as high as 40 per cent of the total cost of producing any pharma product, say industry players. This will be great boost to SME pharma exports.

Opportunities to co-market and co-promote products for major pharma companies in India pursuant to the amendment in patents in India should be encouraged. Necessary cheap easier financial assistance for implementing the measures under the Schedule M to the Drugs and Cosmetics Rules, WHO-GMP and other international norms relating to good manufacturing practices should be provided.

Best initiative or scheme to encourage MSME ▲ Workshops should be con-

ducted by the Government to disseminate information on various dimensions related to new Schedule M requirements. ▲ Training should be ensured for small scale firms in auditing and monitoring of quality systems. ▲ Speedy clearance of soft loans and subsidies for technical up-gradation and elimination of related bureaucratic hurdles should be ensured. ▲ The establishment of formal linkages between these firms and pharma research and educational institutions for technical up-gradation and knowhow related to R&D and quality control. The Government has taken a step in this direction through the efforts of

BG Barve, Joint Managing Director, Blue Cross Laboratories

The Government with the help of various pharma associations/ bodies can conduct awareness camps for SMEs

National Institute of Pharmaceutical Education and Research (NIPER) through the building of a specimen Schedule M unit and utilising the efforts of the institute to act as an intermediary organisation in providing technical support to small firms under the new regulatory regime.

Suggested initiatives During implementation of Schedule M, certain parameters can be modified for SME

players. For instance, room sizes and stores segments can be made smaller.

The chemicals and pharma should not be treated alike when it comes to pollution control measures, and therefore, pharma should be moved out of the Orange to the Green category.

Class I and Class II tier cities could be developed as pharma clusters, for which there should be proper support by the government, by way of subsidies, tax cuts, etc. which will encourage more entrepreneurs to enter the pharma sector as SME players.

To encourage pharma units to invest in better technology and pollution equipment, the Government may consider offering higher depreciation benefits of say at 150 per cent. This will be an incentive where there is no outflow of money as in the case of capital subsidy scheme for the Government, but at the same time would encourage profit making units go for better technology and pollution control. This effectively uses the carrot instead of the stick method, where the Government offers incentives instead of punitive measures to upgrade.

Lack of awareness in the area of patenting of technology, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) is an issue with SMEs. The Government with the help of various pharma associations/bodies can conduct awareness camps for SMEs. SMEs should be well educated of the R&D that is conducted in the developed markets as there is adequate scope for contract research. Government support in this area will help pharma units to match the expectations of developed markets.

(

THE MAIN FOCUS

‘Urge GoI to take strong steps towards ensuring availability of skilled manpower,electricity,water,infrastructure’ SEZ's pain TIL Healthcare has set-up a state-of-the-art facility at an SEZ in 2010 with a focus on export. However, two years down the line (after completion of the project), the Government removed 100 per cent tax incentives on units set-up in an SEZ and introduced MAT on the same. This is despite the fact that the investment was a fresh investment and not a shift from one facility to another.

For an SME that has set up a high investment pharma plant in a SEZ scheme, having retrospective tax implications for investments hurts the most. One of the most important initiatives that TIL would expect is to reverse such retrospective tax implications, which ultimately discourages SME’s from larger investments.

With a strong manufacturing capability, companies are looking to diminish the perception that India makes 'cheap drugs'.

But this requires constant upgradation of the facilities / ca-

of any company. The platform for manufacturing in India is slowly losing it sheen and we would humbly urge the Government of India (GoI) to take strong steps towards ensuring availability of skilled manpower, electricity, water and infrastructure.

pabilities of the companies.

SME’s should be incentivised through fair financial support/incentives for upgradation of such facilities that are meant to meet global standards.

This will help mitigate these wrong perceptions given the current stringent regulatory standards expected in even the poorest of developing countries.

SMEs need attention

Faster platforms to grow Today, challenges of any industry are related to infrastructure of the country and the rising costs attached to the lack of such infrastructure. This is making companies cost-ineffective thereby making countries like Vietnam and others more cost effective. Along with this, the high costs attached to the difficult regulatory environment (both within and outside the country) is posing a challenge to SME’s.

Having said that, TIL’s initiatives have always been towards ensuring a strong manufacturing capability to ensure delivery

Kapil Jhaver, President and Managing Director, TIL Healthcare

of quality products and services through its facilities. It is almost impossible to get the right amount of skilled labour, electricity or its lack of continued availability is a major hindrance and the lack of port infrastructure towards fast / efficient turnarounds causes a significant strain in the functional working

Today over 80 per cent of TIL’s formulation sales is through its own brands marketed in various countries. TIL is involved in strong OTC marketing done through radio, television, print, billboards through its teams based in various countries. We believe that this enhances not only the image of TIL and its brands, but also the image of India as a hub for quality products.

Selling branded formulations requires a significant amount of marketing investment and initiative in global markets towards acceptance of Indian products and further, making them prominent through OTC marketing. As an SME, financial in-

centives from the Government of India towards such initiates would immensely benefit SME’s in further taking larger initiatives towards building the ‘India Story.’

The focus market scheme did encapsulate this, however, it was surprisingly not available to SEZs even though this scheme was meant to help companies increase exports. The focus market scheme should be extended to SEZ’s as well, specifically for companies that are involved in formulation sales, which is far more tougher/stringent (both to market and to meet regulatory compliances) as compared to bulk drugs. To further mitigate such perceptions, GoI should encourage the setting up of laboratories across the states towards ensuring that quality medicines are offered. This should be made mandatory for all such imports of bulk/finished products to ensure material used is of the best grade thereby ensuring a quality product. u.sharma@expressindia.com

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

❒ We welcome information on new products and

regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industryaccepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant.

services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph.

Preferably in colour, postcard size and with a good contrast.

To subscribe: bpd.subscription@expressindia.com

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

The Indian Express Limited, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021.

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

EXPRESS PHARMA

33

July 1-15, 2014

MANAGEMENT

HOPE AGAINST HOPE The Modi-led Government will present its first General Budget on July 10. Representatives of pharmaceutical companies and industry associations put forth their wishlists hoping that unlike the past few years, the new government will fulfill their demands. Express Pharma presents some of the top points

34 EXPRESS PHARMA July 1-15, 2014

‘There is a greater need to set-up healthcare facilities in the metros,Tier-I and Tier-II cities in India’

I

n its pre-budget memorandum, the Organisation of Pharmaceutical Producers of India (OPPI) proposed budgetary measures in key areas such as building healthcare infrastructure, improving access to medicines, reducing transaction costs, incentivising R&D and reducing tax burden among others.

OPPI’s recommendations are as follows: Weighted Tax Deduction Section 35(2AB) of the Income Tax Act, 1961 makes provisions for weighted tax deduction in expenditure incurred on scientific research. The current provisions for deduction u/s 35(2AB) are restrictive in nature and cover expenditure incidental to research carried out at an in-house approved R&D facility.

Some of the activities though directly related to R&D are not eligible for weighted tax deduction such as clinical trials carried out in hospitals and institutions outside the approved R&D unit.

R&D is a segment which can become a key enabler of growth, for the Indian pharmaceutical sector. To encourage investments in R&D, any expenditure related to research carried out in the in-house facility i.e. clinical trials, bioequivalence studies, regulatory and patent approvals should be eligible for weighted tax deduction, even if these activities are conducted outside the approved R&D facility including overseas expenditure. There are no specific tax benefits available to units engaged in contract R&D or undertaking R&D for group companies. Benefits should be provided for units engaged in the business of R&D and contract R&D by way of deduction from profits linked to investments.

CBDT Circular no. 5/2012 on taxing freebies to doctors Through the circular no. 5/2012

of the Central Board of Direct Taxes (CBDT), the Union Finance Ministry brings under the purview of income tax any expenditure incurred by way of provision of freebies to doctors.

There is already a mechanism in Section 37(1) of the Act that disallows expenses which are personal or illegal in nature.

Any expenditure incurred by way of provision of freebies to doctors is inadmissible under Section 37(1) of the Income-tax Act, 1961 (‘the Act’) being an expenditure prohibited by law as per MCI Regulations. The circular, in its current form, is unclear on the scope of expense applicability and manner of administration. There is widespread ambiguity in the pharmaceutical industry and laying out such generic guidance would add to the confusion and lead to significant hardship to the taxpayers as it shall provide discretionary powers to the Assessing Officer (AO) thereby opening floodgates of unnecessary and unwarranted litigation.

The Circular should be linked to violations of Uniform Code of Pharmaceutical Marketing Practices for Indian Pharmaceutical Industry (UCPMP) as and when it becomes mandatory. Till such time, the circular should be kept in abeyance. As an another interim measure, the CBDT may consider constituting a panel with adequate representation from the Revenue, Department of Pharmaceuticals and Trade to define which expenses would be considered as ‘ethical’ or ‘unethical’ (e.g. samples, conferences, etc.) and lay down guidelines for implementation.

Tax holiday India's healthcare infrastructure is lagging behind when compared with other developing countries. There exists a huge gap between demand and supply of healthcare infrastructure facilities available in the country.

To subscribe: bpd.subscription@expressindia.com

hospitals set up in such urban areas to enable companies to commit substantial investments required in the healthcare sector.

OPPI recommends that Budget 2014 extend to certain urban areas, the 100 per cent deduction, currently granted to an undertaking deriving profits from business of operating and maintaining a hospital located anywhere in India. The above deduction which is available to hospitals under Section No. / Ranjana Smetacek, Director Rule No.: 80-IB (11C) for five conGeneral, Organisation of Pharmaceutical Producers of secutive years from the previous year in which hospital starts India (OPPI) functioning should be increased to 10 years. Another measure that can be adopted is to grant an option to the hospitals to select five consecutive years from initial 10 years of commencement.

Additionally, the current tax holiday is available only to hospitals which had started functioning before March 31, 2013 (except in urban areas). In order to incentivise the companies to continue setting up and operating hospitals, it is imperative for the tax holiday to be extended to hospitals that started functionTo achieve a desired bed density ing after March 31, 2013. of two per 1000 population by 2025, investment to the tune of FDI –Ambiguity on cover$86 billion would be required, a age (e.g. whether allied bulk of which is likely to come activities such as R&D, from the private sector or clinical trials are covered).

Currently, there are no speFDI going by the current figure of 74 per cent contribution com- cific guidelines laid down on ing from the non-government whether the FDI provisions are applicable to pharma companies sector.

Further, for India to emerge undertaking allied activities eg. as a low cost healthcare tourist R&D, clinical trials etc.

It is imperative to create an destination, there is a greater need to set-up state-of-the-art environment conducive for facilhealth care facilities in the met- itating investments into the secros, Tier-I and Tier-II cities in In- tor, by providing clarity on the dia. In view of huge capital out- FDI permitted in different areas lay for set-up, hospitals may take in the pharma sector and exfour to five years to breakeven tending the provisions to all aland hence not be able to obtain lied activities. the benefit of tax holiday.

Therefore, it is necessary to Excise Duty on APIs extend the tax holiday benefit to The Union Finance Ministry

R&D is a segment which can become a key enabler of growth, for the Indian pharma sector

levies 12 per cent central excise duty (plus three per cent cess) on active pharma ingredients (APIs), whereas the formulations is subject to central excise duty of six per cent (plus three per cent cess). This inverted duty rate structure has resulted in huge accumulation of Cenvat Credit for manufacturers especially those who are not engaged in exports or have minimal exports and cater only to the domestic market.

The higher rate of central excise duty on inputs namely API as compared to the duty on finished goods manufactured thereof (i.e. formulations) has led to accumulation of Cenvat Credit for the Indian pharma formulation manufacturers as the duty paid on inputs cannot be set off against the output central excise duty liability in spite of value addition on finished goods. Further, there is no provision for refund of the accumulated Cenvat Credit, which eventually appears as an added cost to the manufacturer.

OPPI recommends that the excise duty rate of API be rationalised and brought to par with pharma goods i.e. excise duty on the inputs (API) should be reduced from 12 per cent to six per cent. Alternatively, the Government may introduce a refund mechanism to enable pharma manufacturers to avail refund of excess Cenvat Credit especially in case of such an inverted duty structure.

Other expectations ■ Adoption and implementation of uniform marketing guidelines (eg UCPMP) ■ Rationalisation of clinical trial guidelines ■ Updation of governing laws such as Drugs & Cosmetic Act to reflect the current industry scenario ■ Stakeholder consultation while introducing and implementing drug pricing guideline.

EXPRESS PHARMA

35

July 1-15, 2014

MANAGEMENT

‘GOI can consider providing customs duty exemptions to all life saving drugs’

B

ourgeoning population, growing incidence of chronic and lifestyle diseases and increasing healthcare costs are calling for increased need for the Indian Government to focus on the healthcare. While Government of India (GOI) has been announcing several policy measures and programmes to support healthcare, support and participation from private players including pharmaceutical industry would be a key factor.

With budget around the corner, pharma industry once again expects that its unmet demands would be heard by the new Government. Here, we focus on the expectations from the forthcoming budget from a tax perspective, which can be put into three broad buckets – corporate tax, transfer pricing and indirect tax.

Corporate tax related expectations Expenditure on R&D activities With the talent pool and knowledge base, Indian industry has a potential to participate and contribute in global innovation.

There are several things the GOI can do to give a fillip to the R&D space: ❒ While India is perceived as an attractive destination to outsource R&D activities in view of availability of highly skilled personnel, to put India in a leading position, there is a need to provide impetus to such activities in the form of tax and fiscal benefits in addition to policy initiatives. The GOI can play its role by providing tax benefits such as export linked incentives to units engaged in the business of R&D, contract R&D and clinical research organisations. Further, benefits in the form of research tax credits which can be used to offset future tax liability, similar to those given in developed economies, can also be considered. ❒ The scope of 200 per cent weighted deduction allowed for in-house R&D facility approved

36 EXPRESS PHARMA July 1-15, 2014

by Department of Scientific and Industrial Research (DSIR) should be extended to cover significant expenditure incurred on consulting / legal fees for filings in USA for NCE (new chemicals entities) and ANDA (abbreviated new drug applications, preparations of dossiers, etc. for defending patent rights. Also, while approving the expenditure, the DSIR has been taking a narrow view that only expenditure incurred on activities undertaken within the premises of the R&D facility are eligible for weighted deduction. Thus, expenditure incurred on clinical trials and bioequivalence studies which by their very nature are conducted outside the laboratory are denied weighted deduction. Necessary instruction/ clarification should be provided

by GOI considering various practical difficulties faced by the companies in claiming the intended benefit.

Taxation of royalty receipts Budget 2013 increased the tax rate applicable to royalty earned by foreign companies from 10 per cent to significantly higher rate of 25 per cent even if the agreements were signed prior to the amendment. This has adversely impacted many companies which had entered into agreements factoring the 10 per cent rate. The industry wishes that the revised rate should be made applicable only to those agreements entered post March 31, 2013. Alternatively, the government may consider restricting the higher rate applicability only to notified jurisdictional areas.

Expenditure on freebies to doctors As a tool for educating, creating awareness of new medicines/ technologies among the doctors, pharma companies reach out to doctors by providing sponsorships, grants, etc.

Medical Council of India had prescribed regulations for cer-

Hitesh Sharma, Partner & National Leader, Life Sciences Practice, Ernst & Young

before March 2013. Setting up cost of a hospital involves huge capital and takes almost four to five years to reach breakeven. Hence, it is an industry demand to extend tax holiday benefit for 10 years instead of existing five years to enable companies to claim the benefit. It should also be extended to hospitals set up after March 31, 2013. Currently, hospitals set up in metro areas are specifically excluded from claiming tax holiday. Providing the benefit of tax deductions to hospital set up in metros could play a crucial role in promoting medical tourism in India.

pharmaceuticals ingredients (APIs)/ finished drug formulations (FDFs) imported from related parties are expected to maintain higher margins/ lower import prices, whereas Customs demands higher import prices.

GOI should provide necessary clarifications to harmonise these regulations.

Transfer pricing adjustments The pharma industry undertakes huge investments for infrastructure required for setting up a new unit and creating awareness about products. Further, it also experiences very stringent regulations for validation while launching a product/ module.

GOI can play its role by providing tax benefits such as export linked incentives to units engaged in the business of R&D, contract R&D and clinical research organisations tain activities which are not permissible to be undertaken by healthcare practitioners. In view of the circular issued by the Central Board of Direct Taxes considering expenditure incurred on such non-permissible activities to be in violation of law, tax officers deny deduction on adhoc basis. The circular is vague on the scope of expenses and manner of administration which leaves the tax officers to sit in judgement on matters to which their expertise does not extend, then leading to unnecessary litigation. In this regard, GOI can rationalise the provisions by providing for claim of expenditure on a self-certification basis or on the basis of specified documents such as CA certificate in hassle free manner.

Tax holiday for hospitals Tax holiday benefit has been the great source of support for setting up hospital in India which were functional

Depreciation Current 15 per cent depreciation rate applicable to medical/ surgical/ pathological equipment (other than life saving equipment eligible for depreciation at 40 per cent) assumes a life of 15-20 years which is highly unrealistic. The depreciation rate should be increased to 60 per cent to incentivise hospitals to upgrade their healthcare infrastructure consistently and provide patients with the latest technology.

Transfer pricing related expectations: Margins Transfer pricing is another area needing special attention for pharma industry. Pharma companies are witnessing difficulties in complying with conflicting regulations of Transfer Pricing and Customs (Special Valuation Branch). From a transfer pricing perspective, companies dealing in active

Accordingly, such companies incur losses during the initial years of set up. However, revenue authorities disregard the start-up phase of companies and nature of expenditure and disallow the expenses incurred in the initial year. The industry expects due consideration to the companies for expenses incurred in year of launch and specific guidelines to be prescribed to account for the cyclic nature of expenditure.

Safe Harbour Rules (SHR) The Central Board of Direct Taxes has issued draft SHR which provides for classes of transactions or certain margins or threshold limit which shall be accepted by revenue authorities for transfer pricing provisions.

The rules provide safe harbour for contract R&D with insignificant risk for development of generic pharma product as cost plus 29 per cent.

While it is accepted that safe harbour generally propounds a

MANAGEMENT

‘All excisable goods used for R&D purposes should be exempted from Central Excise Duty’

I

t is high time that the Government takes a serious note of the issues and concerns of the Indian pharmaceutical industry. The pharma industry has been providing efficacious, affordable and quality medicines. It has been growing despite dismal Government support as well as international pressures. A more industryfriendly approach would enthuse the pharma industry to provide almost all our people with access to good quality and affordable medicines at a faster pace.

There has been a fundamental shift in the business model of Indian pharma companies from business-driven research to research-driven business. Considering the long-term benefits of R&D to the economy at large, all excisable goods used for R&D purposes should be exempted from Central Excise Duty as import of all capital goods, raw materials, consumables and reference standards for R&D purposes must be fully exempted from customs duty and other related duties.

The third proviso to section 10B(1) restricts the deduction under this section upto assessment year 2012-13. By denying the deduction from the assess-

ment year 2013-14, companies who have invested substantial amounts in EOUs with the belief that deductions will be available for 10 consecutive years will be adversely hit. The Government can provide relief to EOUs, which they legitimately deserve, by deleting the said proviso. Therefore, it is suggested that the provisions of section 10B should be continued without any time limit. We request and expect that the weighted deduction of 200 per cent of R&D expenses in an inhouse facility will be extended for a further period of five years.

Also, a weighted deduction of twice the expenditure on scientific research incurred by a company is allowed. With increasing volume of exports all over the world, the companies need to invest substantial amounts in registration of products overseas. Hence, expenditure eligible for weighted deduction should also include expenditure on product registration in foreign countries and consultants’ fees for patent /product registration overseas.

At present, weighted deduction is not available for land and building. However, for carrying out modern day research,

Daara B Patel, Secretary-General, Indian Drug Manufacturers' Association (IDMA)

funds on purchase of land and for construction of buildings specially designed for research.

Therefore, it is imperative that such companies are also granted weighted deduction on the expenditure incurred on land and building since such expenditure constitutes a significant amount of the total amount spent on R&D. Also, pharma companies with their own approved R&D facilities have to get a bio-equivalence study done through outside agencies before they launch their products in the market. Since these expenses

are an integral part of the R&D activity, they should also be made eligible for the weighted deduction even though these costs are incurred outside the R&D facilities. Similarly import

of reference standards should be totally exempted from customs duty, CVD etc.

Pharma manufacturers are required to keep aside a few boxes of each batch of medicine manufactured till its expiry as ‘control samples’ as per the provisions of the Drug & Cosmetic Act & Rules. These cannot be sold and as such should be fully exempted from Central Excise Duty.

Similarly, some samples of their medicines are provided to the medical doctors as ‘physician’s samples’ to gauge their efficacy. These must be kept out of purview of all duties and taxes.

The last few budget presentations have overlooked the pharma industry whose capability in providing affordable quality medicines is recognised globally. This year we expect the dynamic and forward thinking new government to create a transparent atmosphere of confidence and trust by providing suitable incentives and concessions to keep our growth momentum going. We are confident that the principle of “less government and more governance” given by our Prime Minister, Narendra Modi will do the magic.

which becomes a cost to the manufacturers. The Government could consider rationalising the duty structure by reducing excise duty on inputs from 12 per cent to six per cent. Alternatively, GOI should also provide for refund mechanism to enable pharma companies to claim excess credit.

To summarise, there is immense potential for the Indian pharma industry to contribute in sustainable growth of the country. It is already reeling under challenges of regulatory and

price control issues and government’s active support to overcome these challenges and make further contribution. This government had made right noises during election campaign and the first few days of its reign and has encouraged business fraternity to express their demands and concerns. The forthcoming budget will tell how much of the wish list will materialise.

(Isha Shah, senior tax professional, EY contributed to the article) (Views expressed are personal)

We expect the government to create a transparent atmosphere of confidence and trust by providing suitable incentives and concessions to keep our growth intact pharma companies need stateof-the art facilities. Several leading companies carry out research at locations exclusively designated for the purpose.

This requires infusion of huge

‘GOI can consider providing customs duty ... higher than arm’s length margin as a cost to taxpayers for the reduced compliance burden and certainty of tax outflows, the quantum of the premium as per the SHR appears to be high from a taxpayers perspective and ought to be reduced to a smaller number.

Indirect tax related expectations In 2008, abatement rate of 35 per cent was introduced on medicaments while calculating the assessable value for excise

duty. However, pharma companies expect to receive 40-50 per cent of abatement in order to recover its costs like other industries.

Considering the need to make available life-saving drugs to the patients at reduced prices and bring down the cost of treatment for these ailments, GOI can consider providing customs duty exemptions to all life saving drugs and reducing the duty on medical devices. Also, diagnosis being an important aspect in detecting, preventing and curing

To subscribe: bpd.subscription@expressindia.com

diseases, industry expects to receive custom or excise duty exemption on the diagnostic equipment and consumables.

Further, the levy of excise duty on API @ 12 per cent (plus three per cent cess) and on output of six per cent (plus three per cent cess) has led to accumulation of Cenvat credit in the books of manufacturers especially those who are not engaged in exports and cater only to the domestic market. Further, there are no provisions to recover the accumulated Cenvat credit,

EXPRESS PHARMA

37

July 1-15, 2014

MANAGEMENT

‘Invest $4-5 bn each year in the next five years to grow the biotech industry to $100 bn by 2025’

M

ake bio-manufacturing the next big opportunity after generics for India. Invest $4-5 billion each year (`24,000 to 30,000 crores) in the next five years to grow the biotech industry to $100 billion by 2025 with a 25 per cent return on investment and set a growth rate of 30 per cent year-on-year.

Allocate `500 crores each year from the R&D cess accessible by the Technology Development Board to stimulate the biotech sector across the range: from human resource development, high-end institutional development in biotech, stimulating incubators, ignition grants, start-ups and small businesses, and collaborative efforts in cutting-edge technologies with business of all sizes on one hand and national and international academia on the other.

Corporate Social Responsibility (CSR) funds may be used for stimulating public-good and socially-relevant research in collaboration through partnership with the biotech industry Research Assistance Council (BIRAC) of the Department of Biotechnology (DBT). All such contributions to BIRAC should be fully-tax exempt. As of now only incubators in academic institutions are eligible for availing

CSR funds for promoting innovation. This was passed as a GO last year. This should be extended to all incubators and science/ biotech/ knowledge parks, whether they are part of academic institutions or not.

The Department of Biotechnology be allotted an additional `50 crores a year to further stimulate and develop the International Centre for Genetic Engineering and Biotechnology (ICGEB) into an India-led hub for high-end application oriented research in the life sciences and biotech in international partnership stretching from Africa and West Asia to Japan and the Pacific.

Service tax for the CRO industry is putting Indian companies at a significant disadvantage over some of our neighbours and competitors. We request elimination or substantial reduction in the service tax, especially for overseas clients paying in foreign currency.

Weighted tax deductions should be applicable to outsourced clinical trials and R&D, preparations of dossiers, foreign consulting/ legal fees for New Chemicals Entities (NCE) and Abbreviated New Drug Applications (ANDA) filings with the US FDA and Patent

Dr PM Murali, President, Association of Biotechnology Led Enterprises (ABLE)

defending charges.

Encourage setting up of venture capital funds focused on investments in biotechnology. All contributions by Indian corporate, including pharma companies, to SEBI registered biotechnology funds should be eligible for the weighted average tax deduction under Section 35 (2AB). ❒ Incentivise investment bankers to list biotech companies on SME exchanges ❒ Allow a tax holiday of 10 years for indigenously developed biopharma drugs ❒ Mandate that only India manufactured drug products would be

eligible for weighted premium and tenders. ❒ Extend 100 per cent tax free status for biotechnology special economic zones (SEZs). ❒ Current tax incentives of 200 per cent weighted deduction should be increased to 300 per cent with a validity of 10 years. ❒ Create technology parks similar to IT/ITES parks, with tax and duty benefits to support industry efforts in attaining selfreliance in this critical component of our scientific and economic growth. ❒ Education systems must be developed to support the requirements of the industry for research and development. ❒ Companies must be encouraged to start their manufacturing operations in India. However, the current duty and tax structure acts as a deterrent for local manufacturing as Customs Duty on complete system is lower than the components for manufacturing and in addition the buyers have to spend additional Central Excise Duty and sales tax on locally manufactured goods making it prohibitively expensive compared to imports ❒ When computing the MAT, weight deduction should be al-

lowed under Sec-35 (2AB). ❒ Tax rebates to encourage green manufacturing services ❒ Provide grants for hiring trainees in skill development programmes and also 50 per cent matching grant for overseas training. ❒ 100 per cent Exemption of Excise/Customs Duty on: 1. All lifesaving medicinesanti-cancer, anti-AIDS etc.

2. Contract research organisations (CRO) involved in genomic services.

3. Consumables and capital goods of biotechnology industry.

4. Import duty for industrial biotechnology sector.

5. Raw materials used for manufacturing lifesaving drugs.

6. Diagnostic kits for infectious diseases 7. Molecular diagnostics for critical infections ❒ Exemption of all taxes (VAT, CST) on paediatric vaccines. ❒ Biotechnology companies should be treated as industrial, not as commercial consumers. ❒ Not for profit, section 25 incubators and biotech/knowledge /science parks be provided tax exemption. ❒ Price fixing for ethanol and incentives for biofuel industry. ❒ Setting up a Biotech Exports Promotional Council

‘Anew National Health Policy needs to be rolled out ’

A

high level FICCI delegation led by Sidharth Birla, President, FICCI met the Union Health and Family Welfare Minister Dr Harsh Vardhan recently. FICCI recommended a blended approach towards universal health coverage (UHC), one that strength-

38 EXPRESS PHARMA July 1-15, 2014

ens the links of social health insurance to healthcare providers (both public and private) but ties funding to performance.

“A new National Health Policy needs to be rolled out to support implementation of universal health coverage (UHC) over the next decade. To contain ris-

ing cost of healthcare, we also need to provide facilitating regulatory environment to promote innovative products and practices to make India a hub for medical technology,” said Birla.

“For reducing the disease burden, the Government should

focus on investments in preventive and promotive health in light of the rapid demographic and epidemiological transition in the country; significant incentives need to be extended to the health insurance and healthcare industry to introduce products and

Sidharth Birla, President, Federation of Indian Chambers of Commerce and Industry

MANAGEMENT services focused on prevention,” Birla further stated.

Birla also shared FICCI's wish list for the new Government with Dr Harsh Vardhan.

Dr A Didar Singh, Secretary General, FICCI, Dr Narottam Puri, Chairman, NABH and Advisor to FICCI Healthcare Services and Rakesh Sharma, CoChair, FICCI Forum on Medical Devices and Head, Regulatory Affairs, BD India accompanied Birla to call on the Minister.

Create an ecosystem for spurring R&D and innovation The global industry is highly research intensive and spend around 15 per cent turnover in R&D, however, in India it’s still low with less than two per cent spending. Although the Indian private players have increased investments in R&D, the focus is on the thriving generics business instead of new drug discovery. As a global player we need to remove this weakness in the system by: ❒ Setting up a ‘National R&D Observatory’ in India, which will provide technical support to establish a system to monitor R&D investments and pipelines and recognising the considerable gaps that exist ❒ Ensuring flow of funds by raising the weighted tax deduction from 200 -250 per cent and extending it to clinical trials as well extending exemption from excise/custom duties on raw materials, capital goods and diagnostic kits. ❒ Building synergy with industry and major government institutions and universities for technology transfer and intellectual property right for research and innovation ❒ Encouraging innovation on continuous basis in order to create a favourable environment for incubation of new and unique recombinant biologics that will address the three issues of affordability, availability and quality in overall healthcare scenario.

Create a common understanding of clinical trials (CTs) landscape in India From 2010 onwards India has witnessed heightened activism and media sensationalism targeting clinical research

There is a need to reconsider the notification issued by NPPA and issue guidelines to calculate and notify separate ceiling prices for different packs in case of injections, liquids and ointments resulting in a slew of new regulations. While these regulations have been well-intentioned, they have proved to be disastrous for clinical research in the country and the long-term future of pharmaceutical innovation in India. There is an urgent need to revive the sector to address the burden of existing and new diseases. This would include recasting of adverse regulations introduced in 2013-14.

FICCI proposes ❒ A framework of internal operating procedures should be put in place for the efficient functioning of the regulatory authority in order to maintain a high level of documentation, probity, and transparency. The functioning of the regulatory authority should be subject to regular audits. Summary audit data in appropriate format should also be available in the public domain. ❒ The regulatory authority should function at a high measurable standard of customer service with regards to research applicants. This should include time-bound review and disposal of applications. Customer service metrics should be available in the public domain in a timely manner. ❒ The CDSCO should be strengthened through a comprehensive programme of upgradation of qualifications, skills and experience of personnel dealing with the review of research applications within the regulatory authority. ❒ Several issues pertaining to BA-BE studies, compensation packages, long processing time due for approvals etc. needs to be streamlined for reviving clinical trials in the country. ❒ Create awareness amongst judiciary, media and civil societies in order to enable them to take informed decisions.

To subscribe: bpd.subscription@expressindia.com

Foster the quality agenda for API manufacturing Some of the recent events have brought forth the need for incentivising and promoting quality practices in the API manufacturing in India.

FICCI proposes ❒ Encourage development of innovative API technologies and promote indigenous manufacturing of APIs ❒ The existing Indian GMP (schedule M + guidelines) should meet the international standards ❒ The existing clusters in the sector need to have common facilities for testing etc. ❒ Expedite the setting up of mega parks and new clusters in the API segment with common facilities ❒ Focus capacity building endeavours for both regulators and manufacturers in India.

Issues related to Drug Price Control Order 2013 There are lot of issues in implementation of DPCO 2013 and there is no clarity on inclusion of different dosage and different delivery system in the NLEM list. Slow process of price approval of new drugs and retail and wholesale margins to trade etc. is also an issue. NLEM list is expected to be further expanded which will create conflicting situations for drug manufacturers, importers, marketers and retailers and potentially lead to lack of access of medicines to the community at large.

FICCI proposes ❒ Device different guidelines for biopharmaceuticals that involve formulations based on biological products from chemical drugs ❒ Exclude brands with less

than one per cent market share from ceiling price calculation ❒ Apply price fixation formula only to products, dosages and strengths specified in Scheduled I o DPCO, 2013 ❒ Revise trade margin for retailers to compensate loss under DPCO 2013 ❒ Price implementation in 45 days of notification/order from prospective batches.

NPPA’s order no. S.O. 1157 (E) regarding fixing of ceiling prices for 12 formulations Dexamethasone and Gentamicin injections are being marketed in 2 ml (single dose vial) and bigger vials of (multi dose) 10ml, 20ml and 30ml packs.

The ceiling prices of these formulations have been worked out by averaging the prices of different packs to retailer (PTR) as per MAT value as on September 30, 2013. Averaging prices of different packs to arrive at ceiling price for all packs would not be in the interest of the manufacturer as it will not only impact the reduction in the ceiling prices but will also cause loss to the industry and impact the availability of these formulations in the market as the manufacturer will be forced to discontinue these products due to negative/low margin.

There is a need to reconsider the notification issued by NPPA and issue guidelines to calculate and notify separate ceiling prices for different packs in case of injections, liquids and ointments. This will also be in line with notification on fixation of prices on pro-rata basis as per DPCO, 1995 which was applicable to only tablets and capsules

Foreign Direct Investments (FDI) Currently, India permits 100

per cent FDI in the pharma sector through automatic approval route in greenfield projects and on a case to case basis for brownfield projects. The DIPP had sought reduction of FDI limit for brownfield pharma projects from 100 per cent to 49 per cent in 'critical' areas as it feared that acquisition of Indian companies could vitally affect availability and affordability of generic (off-patent) medicines.

We recommend that the Government should continue with the present policy on FDI in pharma (uncapped). The free market should be allowed to prevail.

Ecosystem for biotechnology Since biopharma sector is one of the largest components of the Indian biotech industry and the most promising, India needs to maximise its presence in this space. This sector invests substantially in innovative product development and clearly a lot of companies see more value in ramping up their service offerings even as they try to overcome the technological, financial and regulatory challenges.

To help streamline the issues, we propose the following: ❒ Promote biopharmaceutical clusters for comprehensive indigenous manufacturing of similar biologics and vaccines ❒ Revive export incentives / BTP Schemes for this sector to realise its full potential.

Since, R&D in biotech, especially the biopharma sector is highly capital intensive, export tax benefits are required to de-risk and fund original research. The increased number of BTP schemes would also ensure provision of financial and logistical support for establishment of biotechnology parks and pilot projects in various states

Over the counter drugs (OTC) There is a need to have separate regulation for OTC sector as there is no legal recognition in Drugs and Cosmetic Act, definition of OTC drugs and positive list of OTC medicines.

(FICCI had submitted a Concept note on Over the Counter Drugs to the Drug Controller General of India as enclosed).

EXPRESS PHARMA

39

July 1-15, 2014

RESEARCH CLINICAL UPDATE

Piramal’s NCE research shares preclinical efficacy data for two promising molecules PIRAMAL LIFE Sciences NCE Research, a division of Piramal Enterprises Ltd (PEL), made poster presentations for drugs in early clinical development for metabolic disorders in two different sessions of the 74th Scientific Session of the American Diabetes Association (ADA) in San Francisco, California, USA. The presentations covered Piramal’s clinical stage GRP40 agonist, P11187 and Piramal’s clinical stage DGAT1 inhibitor P7435.

The P11187 presentation covered the preclinical pharmacological data in support of efficacy for a novel synthetic oral GPR40 partial agonist, P11187, which stimulates glucose-dependent insulin secretion.

The primary objective of the study was to evaluate the efficacy of P11187 to potentiate glucose-dependent insulin secretion. P11187 orally administered to both normal and diabetic mice and rats showed significant reduction in blood glucose

levels. P11187 treatment in normal rats in the hyperglycemic clamp model results in considerable increase in glucose infusion rate and glucose-stimulated insulin secretion.

P11187 has been found to be a highly selective and potent partial agonist for these GPR40 receptors in humans, mice and rats. It is being developed for the management of Type II diabetes. Overall, P11187 has

demonstrated glucose-stimulated insulin secretion and antihyperglycemic potential in rodent models of Type II diabetes with excellent safety profile. The drug is currently being tested in Phase I trial in the USA. The P7435 presentation covered the preclinical data in support of efficacy for P7435, a novel, potent and selective, small molecule DGAT1 inhibitor in rodent models of hyperlipi-

demia and obesity. It also discussed the clinical results from a Phase I, randomised, doubleblind, placebo-controlled study of single ascending doses (SAD) of P7435 in healthy male volunteers conducted in India.

The Phase I trial showed that P7435 was safe and well-tolerated when given in single doses from 10mg to 300mg to healthy male volunteers. The only adverse effect of the treat-

ment seen was vomiting. The PK profile revealed that the increase in exposure from 10mg to 300mg of P7435 was dose-linear although less than dose-proportional.

In vivo data suggested that acute treatment with P7435 resulted in significant reduction in plasma triglyceride levels, and an increase in GLP-1 levels in the plasma along with sitagliptin.

An overall reduction was observed in the body weight, food intake, cholesterol, epididymal fat pad weight, plasma glucose, plasma triglyceride, insulin, Steatorrhea and liver triglycerides of High Fat Diet (HFD) fed hamsters, ob/ob mice and SD rats when given a chronic treatment with P7435. On the whole, P7435 showed significant efficacy in rodent models of hyperlipidemia. The investigational drug is currently moving quickly through a Phase I trial in the US. EP News Bureau-Mumbai

RESEARCH UPDATES

Bristol to test drugs with Gilead’s Sovaldi New York IN THE race to find a faster cure for hepatitis C, Bristol-Myers Squibb Co said it will test its experimental antiviral drug combination with Gilead Sciences’ blockbuster drug Sovaldi, hoping to cut treatment time to four weeks. Bristol-Myers disclosed plans for the exploratory 30-patient trial testing its three-drug combination with

40 EXPRESS PHARMA July 1-15, 2014

Sovaldi. Eric Hughes, the leader of Bristol's global hepatitis programme, said the details were due to be posted on the clinicaltrials.gov website soon.

Sovaldi's $84,000 price tag for a 12-week treatment has spurred outrage among insurers, state health officials and lawmakers who fear the cost of treating millions of Americans with the progressive liver disease will top $250 billion. Insur-

ers are pushing Gilead’s rivals to offer lower prices when their hepatitis C medicines reach the market. Using the drug for a shorter course of treatment could, in theory, lower the cost, even when combined with Bristol's therapies. Rivals Merck & Co and AbbVie are also racing to develop next-generation hepatitis C treatments that cure most people of the virus in a shorter time frame. But drug

pricing experts expect Gilead and its rivals may still argue that the quicker cure represents a value to patients, buffering any steep price reductions.

The new generation of oral drugs being developed by several companies has raised hepatitis C cure rates to well above 90 per cent from about 75 per cent without the need for interferon or ribavirin, which caused miserable side effects that led

many patients to delay or drop treatment. The drugs in clinical trials have already cut treatment time to 12 weeks from 24 to 48 weeks. Bristol’s plan essentially revives an effort to test its drugs in combination with Sovaldi. It previously tested a single compound with Sovaldi, achieving cure rates close to 100 per cent in 12 weeks.

Reuters

FDAapproves Lymphoseek To help determine the extent of head and neck cancer in the body THE US Food and Drug Administration approved a new use for Lymphoseek (technetium 99m tilmanocept) injection, a radioactive diagnostic imaging agent used to help doctors determine the extent a type of cancer called squamous cell carcinoma has spread in the body’s head and neck region.

In 2013, Lymphoseek was approved to help identify lymph nodes closest to a primary tumour in patients with breast cancer or melanoma. Lymph nodes filter lymphatic fluid that flows from the body’s tissues.

This fluid may contain cancer cells, especially if the fluid drains a part of the body containing a tumour. By surgically removing and examining the lymph nodes that drain a tumour, a procedure called a biopsy, doctors can sometimes

With this approval, Lymphoseek can now be used to guide testing of lymph nodes closest to a primary tumour for cancer determine if a cancer has spread.

With this approval, Lymphoseek can now be used to guide testing of lymph nodes closest to a primary tumour for cancer, called a ‘sentinel’ lymph node biopsy, in patients with cancer of the head and neck.

This new indication will allow for the option of more limited lymph node surgery in patients with sentinel nodes negative for cancer.

“For some patients with

head and neck cancer, removal and pathological examination of lymph nodes draining a primary tumour is an important diagnostic evaluation,” said Director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research. “To use Lymphoseek, doctors inject the drug into the tumour area and later, using a hand held radiation detector, find the sentinel lymph nodes that have taken up Lymphoseek’s radioactivity.” For this

new indication, Lymphoseek’s safety and effectiveness were established in a clinical trial of 85 patients with squamous cell carcinoma of the lip, oral cavity, and skin. All patients were injected with Lymphoseek. Surgeons subsequently removed suspected lymph nodes—those identified by Lymphoseek and those based upon tumour location and surgical practice—for pathologic examination. Results showed that Lymphoseek– guided sentinel lymph node biopsy accurately determined if the cancer had spread through the lymphatic system.The FDA, an agency within the , protects the public health by assuring the safety, effectiveness, and , vaccines and other biological products for human use, and medical devices.

EP News Bureau-Mumbai

Antidepressants in pregnancy pose little heart riskfor foetus: Study New York RECORDS FROM nearly a million women and their newborn children offer new evidence that common antidepressants taken during pregnancy do not increase the risk of having a baby with a heart defect.

The findings may help resolve the longstanding question of whether drugs like paroxetine, sold under brand names such as Paxil, and sertraline (Zoloft) carry serious risks for the fetus. “I don’t know if it will completely settle the debate over antidepressants during pregnancy, but I’m pleased to hear more support for the safety of these medicines in pregnancy,” said Dr Rebecca Starck.

The director of regional obstetrics and gynaecology at the

Cleveland Clinic in Ohio, Starck was not connected with the new research. “I think many practitioners and obstetricians will be happy to see this study come out,” she told. “We did not find any association for any of the antidepressant categories or the individual drugs we studied,” lead author Dr Krista Huybrechts of Brigham and Women’s Hospital in Boston said. “It will be up to individual physicians and women to determine how much it will sway their opinion one way or the other.”

About 10 to 15 per cent of pregnant women are diagnosed with depression. In 2005, the US Food and Drug Administration issued an alert about paroxetine based on two studies, warning that it might pose a risk of congenital heart de-

To subscribe: bpd.subscription@expressindia.com

fects, but noting that the benefits might outweigh the risk.

Huybrechts and her colleagues looked at the records of 949,504 pregnant women enrolled in Medicaid, the government-run health insurance for the poor.

Over 64,000 of the women, or almost seven per cent, had taken antidepressants during the first three months of pregnancy. The researchers also checked records for evidence of infant heart problems that appeared up to 90 days after birth.

They found that 72 out of every 10,000 babies not exposed to the drugs were born with a heart defect, compared to 90 out of every 10,000 babies whose mothers had taken antidepressants. That works out to a 25 per cent increased risk.

However, that finding didn’t take into account that

“women with depression often have behaviors that tend to increase their risk” of giving birth to a child with a heart defect, separate from their use of antidepressants, Dr Huybrechts said.

When the researchers looked only at the 217,342 women with depression, they found the increased risk linked to antidepressants dropped to 12 per cent. And when they further analysed the data to take into account other risk factors such as diabetes, high blood pressure and indirect measures of depression severity, the extra risk dropped even further, to six per cent. That effect was small enough that it could have been due to chance, according to findings published in the New England Journal of Medicine.

Reuters Health

Tau Imaging Agents to Advance Treatment of Alzheimer TAU IMAGING agents could offer the next frontier in neuroimaging for diseases such as Alzheimer’s disease (AD) and other forms of dementia, says an analyst with research and consulting firm GlobalData.

Niharika Midha, GlobalData’s Analyst covering Diagnostic Imaging, says that further positive clinical trial results will lead to tau protein-based therapies being developed to treat AD, as these imaging agents aid drug discovery.

Midha continues, “While the AD pathophysiology is still not entirely known, some experts believe that tau proteins are the main biomarkers that drive the loss of brain tissue, translating into loss of memory, rather than the Aß plaques, which are considered an early indicator of AD. “For example, a recent study showed that there was no change in the visualisation of Aß plaques as AD progressed, while tau proteins continued to increase and spread to different parts of the brain concomitant with disease progression. This clearly indicates the importance of tau proteins as a missing link in the pursuit of a more complete understanding of AD.” GlobalData epidemiologists estimate that there will be 4.3 million prevalent cases of AD by 2022 in the US alone. The analyst believes that as the prevalence of AD and other forms of dementia is expected to increase worldwide, the demand for imaging will increase proportionately, as it offers the possibility of accurate visualisation and quantification of the current condition of patients with these diseases.

EP News Bureau-Mumbai

EXPRESS PHARMA

41

July 1-15, 2014

PHARMA ALLY I N T E R V I E W

‘Ashland already has more than $1 billion sales coming from the Asia Pac region’ Luis Fernandez-Moreno, Senior Vice President, Ashland speaks to Viveka Roychowdhury on the company's investment in the Asia Pac business and the company's vision as Ashland approaches its centenary year Ashland has been in India since 1980. Where does the Pharmaceutical Centre of Excellence in Hyderabad fit into Ashland’s strategy for the India market?

We see India clearly as one of the growing economies of the world both in terms of manufacturing for local as well as for export markets. There's a variety of chemistries and technologies in our portfolio of products that would be a very good fit for India. Pharma is one of the portfolios, it is a key market for us. And with India becoming the capital of the pharma industry, as least as far as generics are concerned, it is obviously an area where we want to invest. We have a very strong position in the personal care market with ingredients for personal care. And in this case we believe that India, more for internal consumption, will continue to grow as the number of consumers will increase as the middle class continues to grow in India. We have products that 'go into coatings and construction and again we see opportunities for us to grow and get in products and technologies to get better products.

When it comes to the Pharmaceutical Centre of Excellence in Hyderabad, we see it as a very important piece of our strategy. This would be our second Centre of Excellence in India (we also have a Centre of Excellence for personal care in Mumbai, where we also have a coatings and constructions laboratory).

We call them Centres of Excellence because that's where we have scientists

42 EXPRESS PHARMA July 1-15, 2014

dedicated to an industry but they are a global resource. So even though the focus of research may be local, we see this as a global Centre of Excellence. We have nine of them across the globe, only three of them for the pharma industry (in Bridgewater, New Jersey, US, in Shanghai and now in Hyderabad, India). So this is definitely a milestone for us. We now have a world class, state-of-the-art laboratory with 20 top line scientists working out of Hyderabad. There's an opportunity for it to expand even further in the current footprint.

Ashland has transformed from an oil refinery in eastern Kentucky, US, in 1924, to emerging nine decades later as one of the world's leading speciality chemical companies. An important step was the acquisition of International Speciality Products Inc. (ISP) which has a wide portfolio of chemistries: from anti-aging ingredients for skin-care products, advanced styling and fixative polymers for hair-care products as well as active pharmaceutical ingredients with one of the broadest lines of excipients available. What were the global revenues in the last financial year and what is the share of the pharma business in this mix?

Ashland Speciality Ingredients (ASI )is $2.6 billion of the $8 billion company.

Within this, we have the consumer specialities business which is a $1.1 billion business in global sales. Pharma together

which improve the properties of their products like paints, or their blister pack, etc. as well as in many other speciality areas like graphic cards, etc. The core of this business is products for segments like coatings, followed by construction, adhesives and energy.

We call them Centres of Excellence because that's where we have scientists dedicated to an industry but they are a global resource with personal care are the two core areas of this business. We also have the nutrition, agriculture, beverage businesses etc. as part of this business but pharma and personal care, in terms of size, make up the two core parts of this business.

The industrial specialities business represents $1.4 billion in sales with very significant products where we provide additives to our customers

What is the geographical region wise breakup of revenues, which are the regions growing fastest?

We do not break up revenues by country but by region. Ashland already has more than $1 billion sales coming from the Asia Pacific (Asia Pac) region. So considering that an $8 billion company like ours has more than $1 billion coming from the Asia Pacific region, means that this region is quite significant for us. Europe and North America are similar in size and a smaller proportion comes from the Latin America market.

The Asia Pac strategy started around 30-40 years ago, with a presence in India as well as other South East Asian markets. It has evolved into a very strategic part of our business, where again we believe that the growth, predicted by most economists, together with the capabilities that this part of the world has, will continue to grow moving forward. So it is an exciting place to be.

On the regulation front, regulators are becoming more stringent on quality; not just of the finished product but also of excipients and APIs. How much does that

add to the cost of manufacturing and how are companies like Ashland preparing customers to deal with these changes?

There is no question that as regulations continue to evolve, two things happen. It does add to the cost to doing business in this space and in that regard we are always conscious and working with the authorities to make sure that those regulations make sense and are not an over burden without achieving a benefit for the consumer.

The one thing that those regulations do is that they provide assurance to the consumer that the goods that they are buying, which are eventually going to be in or on their bodies, are safe for themselves, as well as for the environment. But there's no question that they add certain costs to the business.

When it comes to Ashland, one of the things that we pride ourselves on and that we believe is important for us, is our expertise in understanding those regulations. In the end it is not only understanding those regulations but working with the authorities so the regulations are based on science, on really getting the benefit to the consumer, not just adding costs.

So as we see that evolving, we believe that Ashland is very well prepared and set to work with our customers to make sure that we all meet with regulations. We will continue to work with authorities anywhere in the world to provide science that is important for regulations to be

not a burden but something that is in the interest of the consumer.

We see this a source of competitive advantage in whatever geographies we are present. We are very good at this and that is one of the areas where we strive to be better than the competitors. When you look at the importance of the consumer and pharma industries to Ashland, this is absolutely an area where we have to be better than the competitor and we take it very seriously. For many of our competitors, it may be a smaller part of their entire business and they may not take it seriously but regardless of local or global (competitors), our focus is very much on this industry.

What is the next transformative step and the vision for the company for the next decade, as Ashland approaches its centenary year?

We will strive to be the best speciality chemicals company in the world. I think we are well on the way to achieving this (goal). We are definitely today one of the best speciality chemicals companies and a recognised leader in certain areas. We expect to continue to grow in that space and evolve until we achieve that vision.

Obviously I cannot reveal the specific steps that we are taking to achieve this goal but I

will mention a couple of tenets of the company.

Our motto is that with good chemistry, great things happen.

By good chemistry, we do not mean just knowing chemistry but also chemistry that is good for humanity.

Our sustainability programmes are very important, both in terms of the way we make our products as well as the products we make for the end user. If you see our portfolio of products, a good portion of them are based on natural raw materials. For instance, take our cellulosic excipients where we are the leader. We have the broadest product line and the raw material is either cotton or cellulose that comes from trees.

And all of our wood is from renewable resources. So a significant proportion of our products is based on renewable resources. Another significant portion of our product portfolio does use energy but this energy, as we continue to evolve into renewable energy, will be a renewable resource.

When it comes to operations, reducing our footprint, either carbon or environment footprint, has been a continuous priority and we continue to work on that.

Very close together with our green philosophy comes the element of innovation. If you are going to be a speciality chemicals company, you need to continue to invest in new

To subscribe: bpd.subscription@expressindia.com

Good companies that would give Ashland wider access to technology or markets, that enable better capability to service our customers would excite Ashland

dissolve, or not easy to have bioavailability in the human body. So what do our excipents do? They work in a way that either improves the solubility or bioavailability. So we are enabling the health of the world by making these active ingredients more effective when it comes to their usage in the human body. So it is a constant effort not only to be greener but to be better when it comes to society. And that is why we spend our money on R&D. Obviously with that comes not only organic growth but possibilities for M&As, investment in manufacturing and so forth. Those are parts of the vision. That is what will make us the best speciality chemicals company in the world.

products,ever evolving products that are more efficient, that are better for the consumer and our customers.

So we have continued to and will continue to invest in R&D. The perfect example of this is the opening of the new Centre of Excellence in Hyderabad to make sure we continue to develop the products required for the future.

When you talk about sustainability, many of the new drugs that are coming to market and that are being developed by large pharma companies are drugs that are difficult to process. For example they are not easy to

A major milestone in Ashland's pharma business is due to the acquisition of International Speciality Products Inc. (ISP) in March 2011, So what kind of a company would excite Ashland as an M&A opportunity at this point of time, in terms of complementary capabilities, etc.?

Good companies that would give Ashland wider access to technology or markets, that enable better capability to service our customers would excite Ashland. As you look at this vision, you can see the markets that we are playing in.

Any time we see a company with complementary technology, or the capability to provide access to a market that we may not currently have access to, which will enable access to innovation faster, in the specialities space would interest us.What is your revenue target for the current financial year?There will be a dip from $8 billion to $6 billion as we've sold the water technologies business in February this year. But we firmly believe that though the company will be smaller, it will be a better fit into the specialities business. For the water business, it will be a good opportunity to be run by a private equity firm (Clayton, Dubilier & Rice) that will be able to grow it. And this will enable us to focus our resources more into the speciality chemicals business.

So though in the short term we will obviously see is a reduction in the size of the company,.in the medium term we expect to see continued growth organically which will allow us to look in a more focused fashion at M&A activity in the future. We have invested over $250 million over the past seven years in the Asia Pacific region which gives an indication of the importance of the region to the company and the fact that it pays the necessary attention to this growth geography. viveka.r@expressindia.com

EXPRESS PHARMA

43

July 1-15, 2014

PHARMA ALLY VENDOR NEWS

Clariant inaugurates new India headquarters at Navi Mumbai The new facility will house around 400 employees across the various service functions CLARIANT CHEMICALS (India) has opened its new state-ofthe-art headquarters at Reliable Tech Park in Airoli, Navi Mumbai. The inauguration of this facility is in line with the company’s plan for increased growth

through greater focus on innovation and profitable growth. The new facility covers a total area of 140,000 sq feet and will eventually house around 400 employees across the various service functions and the businesses of pigments, additives, industrial and consumer specialities, masterbatches, and also their technical service teams.

Dr Hariolf Kottmann, Chief Executive Officer, Clariant International said, “The future of Clariant is in Asia and India is a key market for Clariant globally.

I am excited to open a new chapter for Clariant in the country with the new headquarter in

Navi Mumbai. The new office will afford us the opportunity to broaden our customer base, deliver innovative solutions and create value that will benefit all our stakeholders. We intend to improve our market presence and generate additional growth through a sustained thrust on innovation.”

“2014 is a year of transformation for Clariant in India. As we continue to grow, it is important that our facilities reflect and act as enablers for our commitment to innovation and fleet-footed customer services. It will be our endeavour to utilise this facility to its full potential and drive

Clariant into a new era of prosperity and success,” said Dr Deepak Parikh, Vice Chairman and Managing Director, Clariant Chemicals (India).

The new office reinforces Clariant’s commitment to growth through focus on technology and greater efficiency. It will allow the company to expand its capacity, generate value and greater service satisfaction to its customers. The new headquarters have been designed to act as a catalyst for the envisioned growth of the company’s operations in India.

EP News Bureau - Mumbai

(L-R) Dr Deepak Parikh, Vice Chariman and Managing Director Clariant Chemicals (India) and Dr Hariolf Kottmann, Chief Executive Officer, Clariant International inaugurates the new facility in Navi Mumbai

Lonza invests in single-use technology and facility upgrades for clinical ADC manufacturing The addition of single-use manufacturing systems will reduce potential product contamination risks and allow for increased manufacturing capacity of existing and novel ADC platforms LONZA ANNOUNCED its investment plans for technology and facility improvements to its Antibody Drug Conjugate (ADC) clinical manufacturing facility in Visp, Switzerland.

The planned upgrades include the introduction of single-use technology for flexible ADC manufacturing, along with a recently optimised plant layout and revamping of the Heating, Ventilation, Air Conditioning (HVAC) systems, which has resulted in a larger ADC production area.

The addition of single-use manufacturing systems will reduce potential product con-

44 EXPRESS PHARMA July 1-15, 2014

tamination risks and allow for increased manufacturing capacity of existing and novel ADC platforms. Currently, Lonza’s clinical ADC plant in Visp produces toxicology lots, early-phase GMP lots and GMP re-supply lots to support ongoing clinical trials for several different product candidates.

Oncology therapeutics represents one of the fastestgrowing segments of the pharmaceutical and biotech industry, and the deployment of ADC targeted therapies has intensified in recent years.

This growth has led to an in-

creased clinical pipeline, which necessitated the expansion of manufacturing capacity and the utilisation of new single-use technologies.

ADC cGMP manufacturing facilities must be designed to handle both biological species and highly potent cytotoxic small organic molecule drugs.

Since 2010, Lonza has validated large-scale commercial manufacturing of platform ADC technologies primarily utilised by ADC drug developers in conjunction with novel linker/payload platforms. The ADC facilities underwent a successful FDA Pre-Approval

Inspection (PAI) in October 2012.

“We have witnessed significant growth in the earlyphase ADC market in the last two years,” said Stefan Stoffel, Senior Vice President of Operations for Lonza’s Pharma&Biotech segment.

“This new investment is necessary to continue to support the growing pipeline of novel ADC platforms from our customers by offering them new manufacturing technology with increased throughput.”

The facility re-design will allow for greater flexibility in new clinical ADC product in-

troduction. The second wave of single-use technology adoption and qualification is underway and will ultimately reduce cleaning and changeover times between manufacturing campaigns.

The Visp site will continue to offer integrated end-to-end development and manufacturing of ADCs, including the cytotoxic small organic molecules used in these products and all associated analytics.

All current operations will continue without interruption.

EP News Bureau – Mumbai

PHARMA ALLY

NuLEAP and Venostic in agreement To offer computer systems validation and IT compliance services in India NULEAP TECHNOLOGIES and Venostic Solutions announced a new strategic partnership to support Indian pharmaceutical companies’ needs for computer systems validation and IT compliance as per international global requirements.

Under the terms of the collaboration, NuLEAP and Venostic will provide a comprehensive set of services that will enable Indian pharma companies to develop regulatory processes for their computer systems validation and IT policies to ensure data integrity as per international norms. Several regulatory actions in recent months are driving the requirement for an in-depth review and solutions to meet international standards for data integrity and IT policies. NuLEAP’s lo-

cal presence combined with Venostic’s international team will provide Indian organisations with the tools and services to effectively streamline their infrastructure, work practices and validation policies to meet international IT regulatory requirements that have been the subject of much attention in recent times.

For over 20 years David Stokes and his team members at Venostic have contributed to the development of US FDA, EU and PIC/S guidance and to the development of the GAMP guide and associated ISPE / GAMP Good Practice Guides, including: ❒ GAMP 5: A risk-based approach to compliant GxP computerised systems ❒ A risk-based approach to electronic records and signatures

ond edition)

NuLEAP and Venostic will provide services that will enable Indian pharma companies to develop regulatory processes for their computer systems validation ❒ A risk-based approach to

testing of GxP Systems (sec-

❒ Electronic Data Archiving ❒ Global Information Systems

Control and Compliance ❒ IT Infrastructure Control

and Compliance ❒ Manufacturing Execution

Systems – A Strategic and Program Management Approach ❒ Biopharmaceutical Manufacturing Facilities (Second Edition) With more than 30 years consulting experience, Venostic’s consultants have supported clients in North, Latin and South America, Europe and the Middle East, Asia and Africa to achieve and maintain a state of IT regulatory compliance. NuLEAP and Venostic will jointly support the new solution in the field.

Venostic will bring its international credibility and expert-

ise to the partnership and NuLEAP, based in Mumbai, India, will deliver the end-toend technological focus combined with on-the-ground market knowledge. This solution will offer professional advice as well as on-site support for development and training required for international levels of compliance, standardisation of computer systems validation and data management processes.

Louis Coutinho, Chief Executive Officer, NuLEAP Technologies stated, "There is an established customer base of pharma companies in India, who have an aggressive presence in the international market. Compliant enterprise electronic solutions are key to enable them to gain and sustain FDA approval.”

EP News Bureau - Mumbai

DKSH buys Zeus Química With the acquisition of Zeus Química, DKSH business unit performance materials is continuing its targeted strategic expansion DKSH ANNOUNCED the acquisition of Zeus Química, a top-ranking specialty chemicals distributor in Spain and Portugal. DKSH business unit performance materials considerably strengthens its market position in Europe, thereby complementing its market leadership in Asia.

With the acquisition of Zeus Química, DKSH business unit performance materials, the only chemicals distributor with blanket coverage in Asia and Western Europe, is continuing its targeted strategic expansion. It hereby enhances the position as a pan-European market expansion services provider.

In performance materials, DKSH provides distribution services for its clients and sup-

pliers to the chemical, personal care, pharmaceutical and food industry. In addition, DKSH offers sourcing services for specialty products in 17 markets across Asia, Europe and the Americas. DKSH optimises supply chains for specialty chemicals and food ingredients on a global scale. Founded in 1980 and with combined net sales of more than CHF 50 million, Zeus Química is one of the leading specialty chemicals distribution companies in Spain and Portugal. The company offers a full range of specialty products for the polymers, paints and coatings, personal care, nutrition and pharma sectors and has been able to increase net sales and profitability even during years of financial crisis on the Iberian

To subscribe: bpd.subscription@expressindia.com

Peninsula.

Ramón Viñas, General Manager, Zeus Química commented, “For us, the partnership with DKSH is an ideal succession solution. With this transaction, we are creating a solid foundation for the forward development of our 34year-old company. DKSH’s renowned reputation and global platform makes the company an ideal new owner. Beyond ensuring the successful continuation of our business, DKSH will provide our clients and customers access to wider opportunities and to an increased product portfolio. In addition, the integration of Zeus Química into DKSH opens up a new world of development opportunities for our company. Our specialists are

looking forward to becoming part of DKSH.” Zeus Química’s well-regarded management team stays with DKSH, continues to lead the Spain and Portugal operations and strengthens the Business Unit organisation further.

Thomas Sul, Co-Head Business Unit Performance Materials, DKSH says, "The acquisition of Zeus Química is an exciting and important step in strengthening our position as a leading performance materials market expansion services provider in Europe. Through the incorporation of Zeus Química into our DKSH platform, our existing partners and clients can now also utilise our service portfolio on the Iberian Peninsula, one of the main chemical and ingredients mar-

kets in Europe.

“Those business segments acquired from Zeus Química will be integrated into our significantly larger platform and successively expanded. We are well positioned to exploit our market leadership as the industry consolidator in our still highly fragmented industry. Both in Europe and Asia, there are promising opportunities to strategically complement our strong organic growth through bolt-on acquisitions,” adds Dr Joerg Wolle, President and Chief Executive Officer, DKSH Holding.

Both parties have agreed not to disclose further financial details of the transaction.

EP News Bureau – Mumbai

EXPRESS PHARMA

45

July 1-15, 2014

PHARMA ALLY PRODUCTS

Cognex DataMan 8050 Series launched WITHIN THE pharmaceutical industry, stringent legislation exists to combat counterfeit goods by ensuring that each product can be traced throughout the supply chain. In order to achieve the required levels of traceability, manufacturers are increasingly relying on printed 2-D codes combined with advanced code reading technology.

Regulations require unique identifiers to control

traceability and to combat counterfeiting from the single unit, to the package, to the carton, shipping boxes and pallets.

Cognex DataMan 8050 Series handheld barcode readers, which are designed specifically for the pharma industry, with a rugged polycarbonate housing to handle harsh factory floor conditions and feature Cognex 1DMax+ with Hotbars barcode

reading algorithms. The 210 mm x 115 mm x 85 mm readers feature a 752 x 480 global shutter sensor, integrated LEDs with near/far optics, and DataMan Setup Tool software, which enables imaging viewing, Java scripting and data formatting options.

Applications of DataMan 8050 in the pharma industry ❒ Reads all type of codes – 1D,

2D and Pharma Code ❒ Helps in reading codes on the

shipping cartons. ❒ Reads code on labels, packets, boxes and shipping cartons. ❒ The DataMan 8050 barcode readers read codes quickly and easily. ❒ The DataMan 8050 barcode readers are optimised for reading 1-D and 2-D label-based barcodes with the fastest performance

Waters introduces Xevo G2-XS QTof and Xevo TQ-S micro mass spectrometers WATERS CORPORATION has launched two new Xevo mass spectrometers and expanded the ionKey/MS System at the 62nd conference of the American Society of Mas Spectrometry (ASMS). The Waters Xevo G2-XS mass spectrometer, a new high performance benchtop quadrupole time-of-flight (QTofTM) mass spectrometer, and the Xevo TQ-S micro, a new and compact benchtop tandem quadrupole mass spectrometer, take benchtop quantitative and qualitative applications to new levelsWaters also announced

46 EXPRESS PHARMA July 1-15, 2014

the expansion of the ionKey/MS System to the SYNAPT G2-S, SYNAPT G2Si, Xevo G2-S QTof and the newly-introduced Xevo G2-XS QTof micro mass spectrometer with new UPLC grade iKeyTM chemistries.

Additionally, Waters unveiled Progenesis QI for proteomics Version 2.0, the latest advance in proteomics data analysis software, availability of Omics LLC’s PetroOrg Petroleomics Software on the SYNAPT G2Si for chemical composition characterization of petroleum and the exclusive rights to Prosolia's DESI (Desorption

Electrospray Ionization) technology for clinical research applications for use with Waters’ time-of-flight mass spectrometers.

Contact details Dayamani Santosh Administrative Officer Waters India 36A, II Phase Peenya Industrial Area Bangalore 560 058 [T] 080-49292200-03 [F] 080-49292204 [M] 9632786899 [W] www.waters.com [E] dayamani_santosh@ waters.com

Contact details Sunil Vaggu Cognex Corporation mob: +91 98814 66003

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

July 1-15, 2014 47

BUSINESS AVENUES

EXPRESS PHARMA

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

48

July 1-15, 2014

Non-GMO ISO CERTIFICATION

GOTS CERTIFICATION

Products

WHO cGMP

FDA

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

July 1-15, 2014 49

BUSINESS AVENUES

EXPRESS PHARMA

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

50

July 1-15, 2014

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

Top Tank / Reactor Sampler

Flush Bottom valve

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

July 1-15, 2014 51

BUSINESS AVENUES

52

July 1-15, 2014

EXPRESS PHARMA

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

July 1-15, 2014 53

BUSINESS AVENUES

54

July 1-15, 2014

EXPRESS PHARMA

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

Plastic Containers (HDPE, LDPE) Rubber Closures, Glass Containers Medical Articles & Packaging Materials Testing as per USP, EP&JP Biological

Chemical • • • • •

• •

Identification tests by MIR, DSC. Container permeation studies.

Extractables and Leachables.

Migration studies.

Physico chemical testing.

Environment Stress Crack Resistance Heavy metals, extractable elements, etc

SERVICES

• • • • • • •

Cytotoxicity; ISO 10993-5, USP <87> Systemic Toxicity; ISO 10993-11, USP <88> Implantation; ISO 10993-6, USP <88> Irritation / Intracutaneous Reactivity.

Hemocompatibility; ISO 10993-4 Sensitization; ISO 10993-10, USP <1184> Genotoxicity: ISO 10993-3

ACCREDITATIONS

Formulation Development.

Microbiological Studies.

Biological Studies.

Pre Clinical Studies.

Analytical Research.

Bio-equivalence Studies.

Clinical Trials.

Dossier Preparation.

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).

!"! $!%!&'('%" )*!+",+'- ,% ./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.

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

EXPRESS PHARMA

July 1-15, 2014 55

BUSINESS AVENUES

56

July 1-15, 2014

EXPRESS PHARMA

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

July 1-15, 2014 57

BUSINESS AVENUES

EXPRESS PHARMA

m-VROC is the leading small sample viscometer in biopharmaceutical applications used routinely by the leading biopharmaceutical companies at multiple locations globally. m-VROC is the ultimate viscometer for small sample protein therapeutics as little as 20 microliter and high shear rate viscosity measurement up to 1,400,000 s -1.

m-VROC Overview : Accuracy: 2% of readings Repeatability: 0.5% of the range Viscosity range: 0.2 ~ 100,000 m-Pas Shear rate range: 0.5 ~ 1,400,000 s -1 Sample volume: 20 microliter +

SpeciďŹ cation : : Accurate, Precise and top-of-the-line viscometer for R&D application : : 20 Îźl Repeatability Min sample volume : : Maximum shear rate, s-1 0.5 ~ 1,400,000 1 Temperature sensor : : 2 Viscosity range, mPa-s (cP) 0.2 ~ 100,000 Software : : Temperature range* 4~70 oC Non-Newtonians ? : Portable No Temperature sweep : : : Accuracy 2% of Reading Shear rate sweep Description

0.5% of full scale Built-in Included Yes Yes Yes

ROSALINA 127, Bussa Udyog Bhavan, Tokershi Jivraj Road, Sewri Mumbai - 400 015. INDIA

Advanced Radiotherapy Tel: 91 22 24166630 / 24173493 Fax: 91 22 66627766 E-mail support@rosalina.in www.rosalina.in

58

July 1-15, 2014

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

July 1-15, 2014 59

BUSINESS AVENUES

60

July 1-15, 2014

EXPRESS PHARMA

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

July 1-15, 2014 61

BUSINESS AVENUES

EXPRESS PHARMA

For Vacuum/ Pressure Transfer of Powder/ Granul es/ Tabl ets Crystal l ize M aterial in Pharma, Bul k Drug, Food, Chemical , Pl astic & Paint I nds.

Advertise in

Business Avenues Please Contact: Dilute Phase Material Conveyor Capacity: 50Kgs.-5000Kgs/Hr.

Dense Phase Type 50Kgs.-5000Kgs/Hr

In-line Rotary Sifter Vibro Sifter also avail.

Screw Conveyor 50Kgs.-5000Kgs/Hr.

■ Mumbai, Ahmedabad: Rajesh Bhatkal 09821313017 ■ Delhi: Ambuj Kumar 09999070900

Granulator-Shredder Capacity: 800Kgs./Hr

Ribbon Blender 50Kgs.-5000Kgs./Hr.

Octagonal Blender 50Kgs.-5000Kgs./Hr Conical /V-type also avail.

Batch Weighing System Bag/Drum Fill-up

Other Products: Bag Dumping Station # Jumbo Bag/ Big Bag Loading-Unloading System # Bin Activators & Discharger # Flexible Screw Conveyor # Capsule Loading/ Tablet Press Loading/ Blender Loading System # Bunker with Loading/ Reactor Loading system # Lumps Breaker # SS/ MS Storage Silo/ Bunker # Rotary Valve # Powder Conveying System Mobile type…………

For more details, please contact to:

A L ! X automation syst em TM

B/17, Adke Compound, Suryanagar, Vikhroli-W, Mumbai-400083. INDIA

Tel/Fax: +91-22-25776356 / +91-22-25796851.

Mobile: +91-9833297671 / +91-9819030056 e-Mail: info@powder-transfer.com / powdertransfer@gmail.com

www.powder-transfer.com

62

July 1-15, 2014

■ Chennai: Yuvaraj Murali 09710022999 ■ Bangalore: Khaja Ali 09741100008 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

UBM India the organizer of CPhI & PMEC - South Asia's biggest and most comprehensive Pharma event

proudly

announces

the

launch

of

PharmaLytica. PharmaLytica integrates UBM's expertise and understanding of Pharmaceuticals, BioServices, Analytical & Lab Services with the limitless possibilities on the Pharma Industries and presents it as one solid B2B package.

Thatâ&#x20AC;&#x2122;s what we call - Evolution Accelerated

25 - 27 September 2014

Bangalore International Exhibition Centre, Bengaluru, India

EXPRESS PHARMA

July 1-15, 2014 63

BUSINESS AVENUES

64

July 1-15, 2014

EXPRESS PHARMA

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

July 1-15, 2014 65

BUSINESS AVENUES

66

July 1-15, 2014

EXPRESS PHARMA

EXPRESS PHARMA

PHARMA LIFE AWARDS

BMS’s ‘The Pink Drive’campaign bags bronze at Abby awards 2014 Public Relations Abby category, a new category of awards introduced this year IN RECOGNITION of the work done in the field of breast cancer awareness Bristol-Myers Squibb (BMS) won the bronze at the Goafest’s Abby awards 2014. BMS bagged the award under the Public Relations Abby category, a new category of awards introduced this year. There was no gold in the category this year. The team includes Justin D’sa, Corporate Affairs and Vinod EV, Om Thakur from Marketing.

The ‘Pink Drive’ was a disease awareness initiative by BMS in collaboration with Priyadarshini Taxi service, a taxi service in Mumbai owned and driven by women. The aim of this initiative was to create awareness among women about breast cancer and edu-

The ‘Pink Drive’ was a disease awareness initiative by BMS in collaboration with Priyadarshini Taxi service, a taxi service in Mumbai owned and driven by women cate them on the importance of screening and diagnosis for early detection.

The taxis travelled throughout Mumbai with the message of breast cancer awareness.

Approximately 10,000 self breast examination pamphlets were given to all women commuters during Breast Cancer awareness month- October 2013. A leading female oncolo-

gist from Tata memorial Hospital, Mumbai inaugurated the Pink Drive. The highlight of the inauguration was the formation of ‘Pink Ribbon’ by the Priyadarshini fleet.

The taxis served as mobile billboards that carried the message of breast cancer awareness to women across Mumbai. Additionally press coverage of the event, acted as

a significantly larger medium to convey the disease awareness message.

Direct engagement with approximately 10,000 women who utilised the taxi service.

The entire fleet of Priyadarshini taxis acted as mobile billboards displaying the message of breast Cancer awareness to women across Mumbai. Print and television

coverage of the event with the oncologist from Tata Memorial Hospital conveyed key messages to millions of women across Maharashtra State and India.

Over 50 per cent breast cancer patients in India are diagnosed in stage three and four. Early detection of the disease remains the cornerstone of breast cancer control. When breast cancer is diagnosed and treated early, the chances of cure and survival rates improve significantly. If detected late, however, curative treatment is often no longer an option. In such cases, palliative care to relieve the suffering of patients and their families is the only option.

EP News Bureau-Mumbai

Jubilant Life Sciences,Johnson & Johnson bag FICCI awards 3rd FICCI Quality Systems Excellence Awards for manufacturing assess quality systems JUBILANT LIFE Sciences Gajraula, Uttar Pradesh won the platinum (first) prize in large size category while Johnson & Johnson, Baddi, Dist.

Solan, Himachal Pradesh won gold (second) prize in the same category at the 3rd FICCI Quality Systems Excellence Awards for Manufacturing.

The awards were presented by Sidharth Birla, President, FICCI. Also present on the occasion were MM Singh, Chair-

66 EXPRESS PHARMA July 1-15, 2014

man, FICCI Manufacturing Committee and Chief Mentor, Maruti Suzuki India; Rohit Relan Co-Chair, FICCI Manufacturing Committee and Managing Director, Relan Group of Industries and Dr A Didar Singh, Secretary General, FICCI. FICCI quality system awards are completing their third year of journey. The award institutionalised for excellence in quality systems in manufacturing, assesses the

‘Quality Systems’ in organisations unlike most other awards which focus on product quality.

The award is an initiative of FICCI Manufacturing Committee which works with an agenda of improving manufacturing competitiveness that would enable our economy to achieve increased contribution of manufacturing in our GDP. The current share of 16 per cent of manufacturing in India’s GDP has been stagnant for the last two decades and is

nowhere near its potential.

Achieving this target requires enabling policy environment and also the need to follow global best practices in the processes at firm level.

Firms and companies that display high performance quality system leading to systematic improvement in organisation performance are felicitated with these awards.

The awards provide a benchmark for the manufacturers as the best practices of awardees

are shared with other applicants and also with industry at large. These awards are expected to motivate and act as a catalyst to encourage Indian manufacturers to adopt robust quality systems and thereby successfully face competition in the global market. Since its inception, Quality Council of India (QCI) has been the Knowledge Partner for the Awards.

EP News Bureau-Mumbai

PHARMA LIFE FORUM

Kelly Services India organises its first Life Science Xchange 2014 Summit in Mumbai Previously the event has been organised in London and Paris KELLY SERVICES recently organised the first ever Life Science Xchange 2014 Thought Leadership Summit in Mumbai.

The event was partnered in association with KellyOCG (Outsourcing and Consulting Group) and Association of Biotechnology Led Enterprises (ABLE). It saw participation from leading industry heads and scientific scholars as part of the panel discussions.

This is the first time Kelly Services India has organised its proprietary event in India, previously the event has been organised in London and Paris.

The objective was to provide an open platform for business leaders and academia to discuss advancement of life sciences in India along with future trends and

best practices in the sector.

Kelly Services has a dedicated KSR (Kelly Scientific Resources) team which works towards providing workforce solutions across verticals such as pharma, medical devices, speciality chemicals/chemicals, agro and seeds and life sciences segment.

“This forum is a valuable op-

portunity for industry leaders to have an open dialogue on various new trends that are shaping up in the pharma and life sciences space. This event is an appropriate platform to offer our clients and future investors understand the growth opportunity India has in terms of the life sciences space which will further fuel the staffing industry in

Injeti Srinivas appoints as NPPA Chairman

APPOINTMENTS

IDAIreland announces appointment of CEO Will be appointing Martin Shanahan to the role of Chief Executive Officer IN ORDER to consolidate past success and build for the future, the Board of IDA Ireland, the foreign investment agency of the Irish Government, will be appointing Martin Shanahan to the role of Chief Executive Officer designate of IDA Ireland. Martin is currently the Chief Executive Officer of Forfas, the advisory board for enterprise, trade, science, technology and innovation.

Martin will take up the role in August and lead the development of a new strategy for IDA, along with client companies, the department of jobs, enterprise and innovation, other government departments and sister agencies.

Frank Ryan, Chairman, IDA said, “Martin Shanahan is an energetic senior executive, with extensive experience in both pub-

To subscribe: bpd.subscription@expressindia.com

the country in a big way”, said Christopher P Jock, Vice President and Practice Leader, Kelly OCG – STEM Group Head.

Highlights of the event included speaker sessions on topics like: ■ ‘Innovation: Interplay of science and technology in drug discovery and development’ ■ ‘Search for new antibiotics:

journey continues’ ■ ‘Bio-entrepreneurship: The new model for Biotech startups’• ‘Mapping the talent genome’ The event ended with a panel discussion that touched upon the challenges around acquiring good science talent in India, entrepreneurship and the need to create an ecosystem that supports research and innovation.

The essence of the event was also to provide a networking platform for leading Industry leaders to gather and share their business expertise on topics from minimising drug discovery risks to innovation to bridging the gap between progress in the scientific space and talent available in India.

EP News Bureau-Mumbai

lic and private sectors. He will bring a wealth of knowledge of economic development from his previous role as Chief Executive Office of Forfás. Working with the current dynamic IDA team, he will build on the successes of recent years and take the organisation into a new phase of its development.”

EP News Bureau-Mumbai

Srinivas is an economics graduate and also holds an MBA degree INJETI SRINIVAS has been appointed as the Chairman of the National Pharmaceuticals Pricing Authority (NPPA).

An IAS officer from the 1983 Odisha cadre, Srinivas replaces CP Singh from the Tamil Nadu cadre whose tenure was extended for 10 days due to the formation of the new government at the centre.

Srinivas is an economics graduate and also holds an MBA degree. He was born on May 26, 1960 and started serving from 1983. During the Commonwealth Games he was Joint Secretary, Ministry of Sports and was responsible for issues related to accreditation.

EP News Bureau-Mumbai

EXPRESS PHARMA

67

July 1-15, 2014

Mix with the world of pharma, products, people & solutions

2-4 December 2014

Bombay Convention & Exhibition Centre Mumbai, India

Network and do business

with 32,000 pharma professionals from all over the world @ CPhI & P-MEC India 2014!

CPhI India has always met our expectations. The quality of the visitor is very high and majority of the potential customers we have met will lead to additional business for us which has made our participation very worthwhile

Heldin, UK Trade & Investment

CPhI & P-MEC India is the single biggest event in India and anybody who is associated with Pharma should participate.

The quality of the visitor is pretty good and all the decision makers have been here. This time we had good walk-in along with good quality

Laxmikant, Mutisorb Technologies

CONTACT: Email: kumudini.bodha@ubm.com Call: +91 (22) 6172 7163 Email: rahul.deshpande@ubm.com Call: +91 (22) 6172 7165

www.cphi.com/india

Co-located with:

In partnership with:

Supported by:

SELECT YOUR SEPARATION PERFORMANCE 1D-LC

2D-LC

The Agilent 1290 Infinity 2D-LC solution gives you the separation performance you need, in a single system. Switch easily between one-dimensional UHPLC and the ultimate chromatographic power of heart-cutting, multiple heart-cutting and comprehensive 2D-LC. Boost Performance Achieve ultrahigh peak capacity with a single 2D-LC analysis Save Time

Get up-and-running fast with the quick-start kit, and setup new methods within seconds

Reduce Costs

Benefit from the first complete single-vendor solution, and upgrade seamlessly from your current Agilent instrument

INFINITELY BETTER TECHNOLOGIES

The Agilent 1290 Infinity 2D-LC solution is one of a wave of innovative Agilent technologies for ensuring your Agilent 1200 Infinity Series LC stays at the forefront of separation potential.

Download literature and order free primer at: www.agilent.com/chem/infinity-2D-LC

Š Agilent Technologies, Inc. 2014

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.