VOL .9 NO.9 PAGES 68
www.expresspharmaonline.com
Cover Story: Women’s Day Special
Management Bringing in the moolah Research ‘Biologic molecules are complex’ 1-15 MARCH 2014,` 40
CONTENTS MARKET Vol 9 No.9 MARCH 1-15, 2014
Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* 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
8
BRINGING IN THE MOOLAH Regulatory concerns and adverse market conditions notwithstanding, the pharmaceutical industry in India continues to attract retail, as well as institutional investors and looks poised for growth in the coming years
10
INTERIM BUDGET DISAPPOINTS PHARMA ... YET AGAIN
12
MSD AND CIPLA ANNOUNCE INDIASPECIFIC STRATEGIC PARTNERSHIP
13
JUBILANT BIOSYS EXPANDS DRUG DISCOVERY ALLIANCE WITH JANSSEN PHARMACEUTICA
14
IPM CLOCKS `6227 CRORES IN JAN 2014
15
FICCI WITH DOP TO HOST THE INDIA PHARMA SUMMIT 2013-14
Senior Graphic Designer Rushikesh Konka Layout Rakesh Sharma Photo Editor Sandeep Patil MARKETING Deputy General Manager Harit Mohanty
P35: RESEARCH UPDATE ‘Biologic molecules are complex’
P40: VALUE ADD Cleanroom gloves or medical gloves?
Senior Manager Rajesh Bhatkal PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar
P64: APPOINTMENT Lupin appoints Dr Maurice Chagnaud as President-Europe & Head of Inhalation Strategy
MANAGEMENT
33
‘RATING MODELS ARE GOOD INDICATORS OF CORPORATE GOVERNANCE, NOT A SOLUTION’
‘INDIAN PHARMA CAN USE IRELAND AS A GATEWAY TO THE GLOBAL LIFE SCIENCES INDUSTRY’
P64: CAMPUS BEAT Sinhgad College of Pharmacy organises Bravura 14
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
Raising the bar
A
fter visiting the Taj Mahal
industry meet organised by the Indian Drug
on her recent visit to India,
Manufacturers’ Association (IDMA), senior
FDA Commissioner Margaret
management from some of these companies point
A Hamburg blogged, “those
out that India has been exporting to the US and
responsible for building the
other countries for over 25 years. Warning letters
Taj and those that are preserving the centuries
and 483s are part of GMP inspections and were
old structure are committed to extraordinary
dealt with as per procedure. It is only in the
quality”. Throughout her visit, she stressed on
last year that investors have become aware of
the importance of quality, linking it to product
the risk of these issues. One managing director
safety and the possibility of patient harm if quality is neglected. She left with a promise to increase staff strength in India, so pharmaceutical manufacturing plants in the country can expect an uptick in surprise inspections. Ranbaxy, Wockhardt and other companies from India received about half of the warning letters issued by the US regulator last year. The steep increase in such missives from previous years can be explained by the fact that the US regulator now has a physical presence here. There is also the theory that this backlash is all about pharma companies in the US protecting their turf, using both GMP and IP to cut to size the ambitions of Indian companies. Secondly, while the US FDA is coming down hard on India,
related how they were forced to organise a conference call with investors and pressed to explain that the latest 483 was not cause for panic and had been addressed to the satisfaction of the US FDA inspectors. Post Hamburg’s visit, companies who have so far eluded the regulator’s lens will no doubt have to engage in introspection. Sustainable compliance will be the buzzword this year and echoing these concerns, Express Pharma's next issue will focus on some aspects of how this can be achieved. And in this issue, to mark International Women’s Day, we put the spotlight on a few more women leaders to find out about their journey and suggestions. Hamburg too held a special closeddoor meeting with some of the leading ladies in
citing it as the second largest supplier of over-the-
the pharma sector and participants expressed the
counter and prescription drugs to the US, it
need to make the industry attractive for women
can hardly use the same stick with China, its
as well as encouraging women entrepreneurs.
largest supplier, thanks to the firm stance of the
Here’s hoping that women, who today constitute
Chinese authorities.
only 8-15 per cent of the workforce employed in
Conspiracy theories aside, Hamburg has it right when she said, “if you want our market, play by our rules.” Most pharma companies have already been toeing the US FDA’s line. At an
6
Post Hamburg’s visit,companies who have so far eluded the regulator’s lens will no doubt have to engage in introspection. Sustainable compliance will be the buzzword this year
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March 1-15, 2014
the Indian pharma industry, will swell the ranks in the next few years. VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com
MARKET I N T E R V I E W
‘Indian pharma can use Ireland as a gateway to the global life sciences industry’ Brian Conroy, Director, Asia-Pacific, IDA Ireland reflects on the outcomes of the last delegation to India and outlines how Indian companies could plan and strategise their regulatory strategies for entering various European countries from Ireland. Excerpts from an interview with Viveka Roychowdhury
What were the objectives of your visit last November and what was the outcome of this trip? India is a key market in IDA Ireland’s growth strategy. IDA Ireland opened an office in Mumbai in 2008 and now has five people working in Mumbai and Bangalore. From Q1 2014 IDA will post an Irish member of staff to head up the India team based in Mumbai. IDA seeks to win quality investments from globalising Indian companies looking to access the European market. IDA concentrates on sectors with the highest potential for delivery and fit with Ireland’s value proposition. IDA has built relationships with the top players in the key sectors of technology, life sciences, financial services and engineering. The Minister held one-onone meetings with CEOs and senior executives from 12 major Indian companies including a financial services company, a conglomerate, two life sciences companies (pharmaceutical and medical device companies) and eight technology/Internet companies.
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Some of India’s largest and best known companies have operations in Ireland such as HCL, Wipro, Wockhardt, Reliance, Ranbaxy, Crompton Greaves, Tata Consultancy Services and Firstsource. Total employment in Indian-owned companies operating in Ireland is just under 3000 people. During the mission three Irish companies announced contracts and business growth worth over €15 million and two Indian companies announced plans to set up operations in Ireland and create 75 new jobs. Among the announcements made during the trade mission were that Synowledge, an Indian company specialising in the provision of drug safety and regulatory affairs services for the pharma, biotech and medical device sectors, is to establish an international headquarters in Dublin with the creation of 35 new high quality jobs. How does Ireland’s economy, in terms of GDP compared to the rest of Europe? What is the contribution of the pharma segment to the
Irish economy vis a vis other sectors? Irish GDP in 2013 grew at a faster rate than the EU and the same is expected in 2014. As per Eurostat, while Ireland’s GDP for 2013 was +0.3 per cent, the EU was zero and in 2014, Ireland’s was 1.7 per cent while the EU’s stood at 1.4 per cent. The pharma sector accounts for over one fourth of Irish exports.
Ireland’s pharma exports are the seventh largest in the world and is the largest net exporter of pharmaceuticals in the world
What makes Ireland an attractive business destination for India Inc? EU market for pharmaceuticals is going through an inflection point. Traditionally an innovator drug market, it is trying to transition into a generics market to bring down healthcare costs owing to recessionary pressures. An Indian company looking at marketing its branded generic drugs directly to its consumers in the EU region could take typically 12-14 weeks for the go-to-market strategy. This is because it involves the process of the drug leaving its manufacturing facility in India, shopping, getting the QA-QP approvals etc and then reaching the consumer marketplace.
Furthermore, complexities in demand forecasting, managing inventory to fulfill the demand in the EU region are deepening further. Unlike the US market, the EU market is heterogeneous – it is made up of 27 different pricing and regulatory structures. If one does not have a US FDA approval, getting an approval in each of the EU countries is a cumbersome procedure. Each country in the EU region has typical characteristics of operating the pharma industry. For e.g. Germany is a tender driven market whereas France and UK are innovator markets. With such a background, it becomes absolutely essential for Indian pharma companies to have an on-ground EU presence in order to expand into the territory. With an on ground presence either in terms of sales and marketing or a small manufacturing base, one can achieve radical benefits in terms of expediting go-to-market strategy by 40 per cent, reducing costs of inventory stuck in pipeline etc. Ireland has a long track record of being a pharma manufacturing hub. Nine of
What are the challenges faced by Indian companies who want to enter the EU region? A new directive released by the EU on June 8, would have an impact on manufacturing, packaging and regulatory approvals for drugs/pharma product coming out of India. According to the directive, only authorised individuals or companies must be involved in the packaging of medicinal products. All authorised individuals or companies will have to comply with ‘good manufacturing and distribution practices’ and perform inspections at their manufacturing and distribution units. The directive also highlights the need to introduce an anti-tampering device so as to authenticate whether the outer packaging of the medication has been messed around with or not. All this would take a while to conduct a detailed analysis of the drug export to Europe. However, Indian companies can combat all this by establishing a base in Ireland to access Europe for product sales, supply chain and logistics, IP management, financial HQ and revenue optimisation because of the efficient low corporation tax regime present in Ireland. Indian companies could plan and strategise their regulatory strategies for entering
EXPRESS PHARMA
9
March 1-15, 2014
various European countries from Ireland. Ireland could be a base for small to medium plants of Indian companies that could carry out final formulation and finishing with custom packaging for Eu-
rope. The Irish manufacturing site could compliment other manufacturing sites in India and would also act as a de-risking strategy in terms of production capacities and supply, easing regulatory
challenges and hurdles and cushion against any new EU policy and compliance measures that could come up in the future. The EU pharmaceuticals market is worth $48 billion,
$16 billion is generics. This presents huge opportunities for Indian players to use Ireland as a gateway to the global life sciences industry. Continued on Page 11
Your journey begins with an
© 2014 PAREXEL International Corp. All rights reserved.
the top ten global and 25 of the top 50 global pharma companies have operations in Ireland - predominantly involved in development and manufacturing (D+M) including Pfizer, Merck, Lilly, Gilead, Novartis, Shire Allergan and Indian companies Reliance, Ranbaxy and Wockhardt. Ireland’s pharma exports are the seventh largest in the world and is the largest net exporter of pharmaceuticals in the world. 25,300 people are employed in the Irish pharma and chemical sector, 46 per cent of which are third-level graduates and 25 per cent of all PhD researchers in Irish industry are employed in the sector.
array of beautifully complex molecules, which, when bonded together in just the right way, have a chance of curing a disease, treating a condition and perhaps changing the world. But the journey to market can be a very difficult one — full of roadblocks, hurdles and obstacles at every turn. It is an arduous process. It shouldn’t be that way. What if you had a partner who could walk beside you through every step until you safely arrived at your destination? What if we could help make the journey just a bit simpler? At PAREXEL, this is what we do.
YOUR JOURNEY
OUR MISSION
Our mission is to discover, create and build the shortest path to market possible for the new ™
treatments, drugs and molecules that will make for a healthier tomorrow. We bring together the best minds, processes and technology to see our clients through. Ultimately, we are a company focused on one goal: getting new treatments into the hands of those who need them most. And we won’t stop until our mission is complete. To learn more about how we can help your journey, visit PAREXEL.com/Journey
MARKET BUDGET REACTIONS
Interim budget disappoints pharma ...yet again Express Pharma presents industry reactions on the Interim Budget 2014
DR AJIT DANGI,
RENU RAZDAN,
SHAMSHER GORAWARA,
RANJIT SHAHANI,
President and Chief Executive Officer, Danssen Consulting
Vice Chairman, ACRO India
Spokesperson, Lupin
Vice Chairman and Managing Director, Novartis India
“T
he Budget is marginally positive for some sectors such as automobile and capital goods. Excise duty cuts for some sectors are welcome as it will reduce cost of major capital intensive projects such as power and transmission. Continuation of 10 per cent surcharge on those with taxable income in excess of ` one crore is a disappointment for many pharma CEOs. One rank one pension for armed forces, albeit late, is a positive step. Containing the fiscal deficit to 4.6 per cent of the GDP can be achieved only by financial jugglery. The finance minister has certainly kept international rating agencies away from downgrading Indian economy for some time. Our own Dalal street, however, is not impressed.”
TAPAN J RAY, Independent Pharmaceutical Industry Analyst and Consultant
“T
his is just a 'Vote on Accounts' for the interim period till a new Government takes over. For pharma, just like many other industries, there is nothing in it, except a R&D fund, which is good for the domestic players.”
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March 1-15, 2014
“T
he Union Budget does not offer anything significant to the pharmaceutical and drug development industry. The need of the industry to provide incentives for innovation in pharma and drug development industry has also not been addressed. The long standing demand of the industry for creation of bio-clusters for pharma industry and API manufacturing finds no mention in the Union Budget.”
PAWAN CHAUDHARY, Chairman and Managing Director, Venus Remedies
“W
e are happy with the growth-oriented approach adopted by the Finance Minister by reducing excise duty rates. It may help in giving a boost to demand. Reduced government borrowings in 2014-15 will also bring fiscal discipline and put less pressure on domestic liquidity and rupee. The FM has put ample stress on the manufacturing sector and FDI, which will be beneficial for the pharma industry. The pharma sector will eagerly await the research funding body proposed by the FM to promote scientific research.”
“T
he Interim Budget 2014 seems like a positive and welcome development. The manufacturing sector, in particular has benefitted, especially given the slump that the sector has been witnessing over the last several quarters. With duty cuts on auto and capital goods, and a general move to curb expenditure, there will be some relief for the middle class. With regards to the pharma and healthcare sector, spends have been kept at a constant, with a marginal change from last year. We welcome the liberalisation of FDI, which will inevitably allow for larger investments to pour in. Despite volatility in global markets and slowdown in economic growth, pharma as a sector has continued to clock in double digit growth in terms of earnings and India has emerged as the 3 rd largest drug manufacturer globally. We do think that there is a need for the government to build an ecosystem that encourages innovation and R&D; we haven’t heard from the government on increase in weighted reduction or incentives for research and development or for that steps that would promote local manufacturing and exports from the Indian pharma industry.”
“T
he healthcare challenges for the country are large and successive budgets have had a high degree of tokenism with the latest one being no different. It does not add up to much given the fact that two thirds of the population i.e. 750 million people have no access to healthcare.
Highlights of the health budget Health and Family Welfare 10 years ago, the Central Government spent ` 7,248 crore on health; this year, it will spend ` 36,322 crore Ministry of Health and Family Welfare has delivered new technologies to the people: the JE vaccine, a diagnostic test for thalassaemia, and a magnivisualiser for detection of cervical cancer. Skill development must rank alongside secondary education, university education, total sanitation and universal health care in the priorities of the government. Ministry of Health and Family Welfare has requested that services provided by cord blood banks are also healthcare services and should be exempted from service tax. Propose to accept the request. The fi-
nance minister announced that all the ministries/departments that run key flagship programmes of the UPA Government have been provided adequate funds. These include ministries namely, Minority Affairs, Tribal Affairs, Housing and Poverty Alleviation, Social Justice and Empowerment, Panchayat Raj, Drinking Water and Sanitation, Women and Child Development, Health and Family Welfare, Human Resource Development and Rural Development. Amongst these is also the Ministry of Drinking Water and Sanitation that has been allocated ` 15,260 crore for FY 2014-15.
Funding scientific research The income-tax Act allows deductions for expenditure on scientific research, but it is limited to direct funding. There is a proposal to set up a Research Funding Organisation that will fund research projects selected through a competitive process. Contributions to that organisation will be eligible for tax benefits. This will require legislative changes which can be introduced at the time of the regular budget.”
MARKET Continued from Page 9
‘Indian pharma can use Ireland... What are the specific benefits offered to Indian pharma companies by the Irish government/ agencies? The main advantage available to life sciences companies is Ireland’s young, skilled, and educated workforce. Ireland has one of the youngest populations in Europe, with 36 per cent of the population under 25 years of age. Ireland’s unique population and age structure will continue for the next 15 years with a key focus on education and research. Ireland has an exemplary
record with the regulatory agencies. There are 33 FDA approved pharma/biopharma plants located in Ireland. Regulatory agencies work closely with companies to achieve trouble-free start-ups. Certification agencies in Ireland operate in accordance with the European and global standard procedures and no warning letters have been issued by the FDA to Irish plants. Investing within Ireland benefits life science companies because investors get to partner with Ireland’s key re-
search institutes, with $10.5 billion of research funding provided by the Irish Government. The key priority areas are therapeutics, manufacturing and process development. Ireland has set up its own R&D institute for bioprocessing. The location of investment in Ireland gives a whole set of benefits to companies locating there – the talent, the tax, the regulatory environment and the track record is there for attracting key players. In addition IDA Ireland can offer a range of incentives including employment grants, R&D
grants, training grants and capital grants. What are the advantages for Ireland if a country like India makes such investments? The Irish Government aims to continually build on the pharma cluster which has grown in Ireland and extend it’s footprint in markets like India, Brazil, China etc. The industry in Ireland also seeks to learn from Indian pharma manufacturing companies who are world leaders in generic drugs manufacture. A synergy of knowledge
will help strengthen the Irish pharma industry over time. The government task it’s FDI attraction agency, IDA Ireland with attracting more than 130 new investments, secure €500 million worth of R&D investment and help create 13,000 new jobs each year. Indian companies setting up operations in Ireland to services the European market help the Irish government achieve it’s FDI targets and create jobs in the Irish economy which helps drive growth. viveka.r@expressindia.com
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March 1-15, 2014
MARKET COMPANY WATCH
MSD and Cipla announce India-specific strategic partnership To co-market MSD’s raltegravir 400 mg tablet, for Indian market MSD AND pharmaceutical major Cipla announced the formation of an India-specific strategic partnership. Within the scope of the partnership, Cipla will have a non-exclusive license to market, promote and distribute MSD’s raltegravir 400 mg tablet, under a different brand name in India. Access to treatment and patient-centric
approach are the cornerstones to this partnership. With this model both companies expect to broaden reach of raltegravir in private and public markets of India. Access to raltegravir is important for patients who require it as part of third line salvage regimen when there are few options left. Announcing the partnership,
KG Ananthakrishnan, Managing Director, MSD in India said, “MSD is committed to developing innovative therapies that offer advances in the treatment of infectious diseases – including HIV. MSD's efforts to develop treatments for HIV/AIDS have been under way for more than 20 years and continue today. We are proud to have entered into a
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: Express Towers, 2nd Floor Nariman Point,Mumbai-400 021 : FORTNIGHTLY : MS. VAIDEHI THAKAR : Yes : Express Towers, 2nd Floor Nariman Point,Mumbai-400 021 : MS. VAIDEHI THAKAR : Yes : Express Towers, 2nd Floor Nariman Point,Mumbai-400 021 : Ms.Viveka Roychowdhury : Yes : Express Towers, 1st Floor Nariman Point,Mumbai-400 021 : The Indian Express Limited Express Towers, Nariman Point, Mumbai 400021 : Indian Express Holdings & Entp Limited Express Towers, Nariman Point, Mumbai 400021 : Mr. Viveck Goenka & Mr. Anant Goenka Express Towers, Nariman Point Mumbai 400021 : Mr. Shekhar Gupta & Mrs. Neelam Jolly C-6/53, Safdarjung Development Area New Delhi 110 016
I, VAIDEHI THAKAR., hereby declare that the particulars given above are true and to the best of my knowledge and belief.
Date : 1/3/2014
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sd/VAIDEHI THAKAR Publisher
strategic, India-specific partnership with Cipla. This partnership is aligned with our commitment towards patients in India and also addressing treatment challenges for high risk patients by providing broader access to our innovative medicines and vaccines. It is a complementary partnership as MSD brings the research and scientific excellence for raltegravir, and Cipla brings their marketing excellence, significant reach among key clinician categories to drive product access. MSD and Cipla both share the same commitment of providing broader access to HIV treatment.” Announcing the partnership, Dr Jaideep Gogtay, Chief Medical Officer, Cipla said, “This partnership reinforces Cipla’s ongoing commitment to HIV/ AIDS treatment making life-saving drugs accessible. Raltegravir, a third line therapy treatment will be a value addition to Cipla’s portfolio of HIV/AIDS treatment, especially for those patients who are resistant to the first and second line therapy treatment. Cipla’s HIV/AIDS medications, including the innovative triple cocktail drug has been available for patients for over a decade now. Cipla has been instrumental in physician and patient education and also instrumental in changing the perception of people about HIV being a fatal disease to a chronic infection. Since Cipla has such an extensive marketing and sales operation in India, the company will ensure that this vital treatment reaches those patients who are in need. In this way, Cipla will fulfil its promise of access in terms of geographical areas. We anticipate this drug being available to patients from
middle of this year.” Subhanu Saxena, Managing Director and Global Chief Executive Officer, Cipla said, “With Cipla’s strength in India, South Africa and other emerging markets, we have long been the pharma company serving patients who most need access to affordable medicines. By entering into this marketing partnership with MSD, Cipla is demonstrating its commitment to working with partners
Both companies expect to broaden reach of raltegravir in private and public markets of India globally who share the same pro access philosophy of Cipla. We want to ensure that all patients, particularly in developing countries, get access to the most innovative, breakthrough medicines available. We look forward to more such collaborations ensuring lifesaving drugs like raltegravir reach the patients in need.” Identifying this significant disease burden challenge and the need for newer innovative therapies, this partnership is built on a patient-centric model, which will help all eligible needy patients’ access raltegravir molecule for the benefit of their ongoing treatment regimen. EP News Bureau – Mumbai
MARKET
Jubilant Biosys expands drug discovery alliance with Janssen Expansion will focus on discovering NCEs in multiple disease areas JUBILANT BIOSYS, a Bengalurubased subsidiary of Jubilant Life Sciences, has expanded its drug discovery alliance with Janssen Pharmaceutica, Beerse, Belgium. The alliance was forged initially in the year 2011 and aims to deliver preclinical candidates to Janssen. The new agreement into multiple therapeutic areas has been expanded owing to Jubilant’s diversified skill sets in various therapeutic areas. Most of the research will be undertaken at Jubilant Biosys, India and some parts at Jubilant Discovery Centre, US. Janssen Pharmaceutica, Belgium is part of the ‘Janssen Pharmaceutical Companies of Johnson & Johnson’. The collaboration between the two organisations has been expanded to leverage Jubilant’s drug discovery capabilities on selected drug discovery targets to advance programmes in multiple disease areas. Jubilant will carry out research services and
will deliver preclinical candidates to Janssen for potential development and commercialisation. In addition to research funding, Jubilant will also receive milestones and royalties should Janssen successfully progress the assets into clinical development and commercialisation. “We are pleased to announce the expansion of the Janssen- Jubilant collaboration and look forward to discovering Novel Chemical Entities (NCE’s) that address the unmet medical needs in these important disease areas," said Dr Subir K Basak, President, Jubilant Biosys (Global Drug Discovery Services). Over the past several years, we have been strengthening our disease franchises from a scientific perspective, and this collaboration serves as a validation of those efforts. We look forward to a long, and mutually beneficial partnership.” EP News Bureau – Mumbai
Sun Pharma gets US FDA approval for generic Temodar Temozolomide capsules SUN PHARMACEUTICAL Industries announced that the US FDA has granted its subsidiary final approval for its abbreviated new drug application (ANDA) to market a generic version of Temodar, Temozolomide capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg. Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg are therapeutic equivalents of Merck Sharp and Dohme Corporation’s Temodar capsules. These capsules have annual sales of ap-
proximately $400 million in the US. Temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment and for adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. EP News Bureau – Mumbai
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March 1-15, 2014
MARKET GROWTH TRACKER
IPM clocks `6227 crores in Jan 2014 32 corporates have crossed the growth of IPM for January 2014 amongst top 50 With Bonus Units at Full Value
THE INDIAN Pharma Market (IPM) clocked ` 6227 crores in January 2014 and has grown at 8.5 per cent. January 2013 growth driver split shows positive on the parameter of volume and new introductions leading to overall positive growths. For January 2014, amongst the top 10 corporates, Emcure has seen a growth of 20.9 per cent followed by Sun Pharma at 20.1 per cent and Lupin at 15.4 per cent. 32 corporates have crossed the growth of IPM in January 2014 amongst top 50 corporates. Biocon has the highest growth of 41.2 per cent followed by Ajanta at 36.1 per cent and Allergan at 35.7 per cent. Amongst the 11-20 ranked companies, Aristo has shown a high growth at 21.8 per cent followed by Macleods at 20.9 per cent and Torrent at 15.8 per cent. Serum Institute has entered the ` 100-crore club and Glenmark into the ` 1600-crore club. Ajanta Pharma has moved into the top 50. Indian companies have grown at 11.4 per cent versus one per cent for MNCs in January 2014. Amongst the top 50 in MNCs, Allergan grew the highest at 35.7 per cent, followed by MSD at 17per cent and Merck at 15 per cent. The DPCO 2013 containing molecules market was at –10.5 per cent whereas the nonDPCO market grew by 11.7 per cent resulting in an overall growth of 8.5 per cent. The DPCO 2013 portfolio for GSK de-grew at 28.4 per cent and Ranbaxy de-grew by 24.7 per cent, whereas Sun Pharma had the least impact with its DPCO 2013 portfolio de-growing at 4.2 per cent. From therapy perspective, 13 therapies have outgrown the IPM growth and nine therapies have double digit growths. The respiratory market grew at 9.8 per cent, gastrointestinal market grew at 10 per cent whereas anti-infectives grew at 0.6 per
14
EXPRESS PHARMA
March 1-15, 2014
Val in Crs COMPANY
Rank
MAT Jan -14
MAT
MTH
1
1
Jan-14
Val (Cr)
MS%
74490
100.00
5.9
6227
100.00
8.5
3985
5.35
17.2
377
6.06
20.1
IPM Sun Pharma
(Val in Crs)
GR% Val (Cr)
MS%
GR%
Cipla
2
2
3725
5.00
5.8
329
5.28
3.8
Zydus Cadila
3
3
2968
3.98
9.6
256
4.11
13.3
Ranbaxy
4
5
2886
3.87
-0.2
223
3.58
-3.6
Glaxo
5
7
2829
3.80
-12.9
215
3.45
-12.7
Abbott HC
6
6
2721
3.65
2.3
217
3.48
0.9
Mankind
7
8
2677
3.59
6.5
214
3.44
9.3
Lupin
8
4
2495
3.35
12.0
225
3.61
15.4
Alkem
9
9
2328
3.13
9.9
185
2.98
11.4
Sanofi-Aventis
10
11
1930
2.59
3.8
161
2.58
5.6
Macleods
11
10
1930
2.59
7.9
171
2.75
20.9
Intas
12
12
1889
2.54
11.5
161
2.58
5.1
Aristo
13
13
1787
2.40
10.5
145
2.33
21.8
Pfizer
14
16
1618
2.17
-3.5
131
2.10
-3.2
Glenmark
15
14
1607
2.16
16.9
143
2.29
15.6
Dr. Reddys
16
15
1601
2.15
5.7
133
2.13
5.4
Micro Lab
17
18
1510
2.03
8.6
122
1.96
14.9
SUPERGROUP
MAT VAL IN CRS MAT VAL GR JAN -14 MONTH JAN-14 MONTH GR
cent. The anti-diabetic market grew at 17.5 per cent and cardiac at nine per cent in chronic business. Opthal/Otologicals market grew by 18 per cent, whereas the derma market was at 16 per cent. From regional perspective, 12 regions have outgrown the IPM growth. Vidarbha market grew the highest at 18.1 per cent. No region had negative growths in January 2014 after three months. The biggest molecule Amoxycillin + Clavulanic de-grew by 0.3 per cent, whereas Cefixime de-grew at 2.6 per cent. Paracetamol grew at 10.5 per cent and Azithromycin de-grew by -1.4 per cent. The markets of Vitamin- D grew by 42.1 per cent, Glimepiride + Metformin grew at 35.2 per cent, Telmisartan by 22.4 per cent, Levocetirizine + Montelukast by 20.5 per cent and Rosuvastain by 20 per cent. A total of 83 brands were launched in January 2014. Gerbisa and Hyocimax are the top NIs for the month from Zydus.
IPM
74452.2
5.8
6232.6
8.6
ANTI-INFECTIVES
12559.5
0.6
964.9
1.3
CARDIAC
9240.4
8.6
823.2
8.8
About PharmaTrac
GASTRO INTESTINAL
8406.9
5.4
674.3
9.9
VITAMINS / MINERALS / NUTRIENTS
6592.8
4.8
531.2
10.9
RESPIRATORY
5848.1
9.1
543.7
9.8
PAIN / ANALGESICS
5363.6
3.7
428.7
5.8
ANTI DIABETIC
5209.1
14.8
481.5
19.1
NEURO / CNS
4674.1
8.1
410.4
8.5
GYNAECOLOGICAL
4653.3
2.2
383.9
1.8
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.
DERMA
4068.8
10.4
350.3
16.0
OPHTHAL / OTOLOGICALS
1352.0
9.0
110.8
12.4
HORMONES
1257.4
5.4
106.2
7.5
VACCINES
1087.3
-4.3
85.7
-3.3
ANTI-NEOPLASTICS
977.5
21.1
85.2
37.0
Terminologies used
OTHERS
912.6
1.9
82.2
18.3
BLOOD RELATED
882.5
2.1
72.1
9.2
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
ANTI MALARIALS
611.8
0.9
31.2
10.0
SEX STIMULANTS / REJUVENATORS
420.2
5.1
39.0
8.6
STOMATOLOGICALS
334.1
7.5
28.0
9.7
MARKET PRE EVENTS
FICCI with DoP to host The India Pharma Summit 2013-14 FEDERATION OF Indian Chambers of Commerce and Industry (FICCI) in partnership with Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India is organising its 5th edition of The India Pharma Summit 2013-14 on March 20, 2014 at Ramada Powai Hotel and Convention Centre, Mumbai. The vision of this conference is to set the motion for transforming India into a global hub for pharmaceuticals. The summit will connect the Indian life sciences sector stakeholders for facilitation of visionary policies in the areas of pharmaceuticals, biotechnology and clinical research. The Indian pharmaceutical industry which forms an important part of
the life sciences sector is expected to touch $35.9 billion by 2016. Over the years, the sector has attracted a huge outsourced research activity from global companies and FDI worth $11,958 million during April 2000 to September 2013. The sector which offers tremendous opportunities to the life sciences industry is an important mandate for The Department of Pharmaceuticals, Government of India and has been comprehensively providing requisite support by way of world class infrastructure, internationally competitive manpower for R&D and venture fund for research in the public and private domain. EP News Bureau – Mumbai
Mumbai to host 2nd Edition of Healthcare & Pharma Expansion Summit THE 2ND Edition of Healthcare & Pharma Expansion Summit 2014 will be held in Mumbai on March 7, 2014. The summit will explore the key aspects, issues related to healthcare as well pharma sector, their best practices and their applications as business drivers for innovation and growth. The platform will see around 200 leaders and decision makers. Speakers who will attend the summit are Dr Girdhar Gyani, Director General, Association of Healthcare Providers (India); Anupam Verma, President, Wockhardt Hospitals; Dr Preetha Reddy, Managing Director,
Apollo Hospitals; T S Jaishankar, Managing Director, Quest Life sciences; Dr Ravindra V Karanjekar, Chief Executive Officer and Executive Director, Global Hospitals Group; Arun Gupta, CIO, Cipla; Dr Uma Nambiar, Special Advisor, Minister of Health Djibouti, Africa; Dr Vishal Beri, Chief Executive Officer, Hinduja Healthcare Surgical; Jamila Joseph, Vice President, Reliance Life Sciences; Dr Tarang Gianchandani, Chief Executive Officer, Jaslok Hospital & Research Centre. EP News Bureau – Mumbai
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MARKET POST EVENT
CII hosts round table with US FDACommissioner It was on 'Role, Opportunities and Challenges of Women in Indian Pharmaceutical and Food Industries’
A SPECIAL round table session ‘Role, Opportunities and Challenges of Women in Indian Pharmaceutical and Food Industries’ was recently organised in Mumbai by the Confederation of Indian Industry (CII) in association with the US Food and Drug Administration (US FDA). Visiting US Food and Drug Administration Commissioner Margaret A Hamburg, participated in the event. During the discussion, participants expressed the need to make the Indian pharmaceutical industry attractive for women. They also noted that
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encouraging women entrepreneurs was very necessary to increase the participation of women in the sector. As of now, women constitute only 8-15 per cent of the workforce employed in the Indian pharma industry. The forum called for enhanced co-operation in areas of regulatory capacity building, training and education, guidance on meaningful collaboration among regulatory organisations and similarly among academic institutions. EP News Bureau – Mumbai
EVENT BRIEF MARCH 2014 4
4th Annual Vaccine World Summit India 2014
TH
4 ANNUAL VACCINE WORLD SUMMIT INDIA 2014 Date: March 4– 6, 2014 Venue: Hyderabad International Convention Centre, Hyderabad Summary: The fourth Annual Vaccine World Summit India 2014 is the longest running vaccine conference in India which provides an excellent platform for attendees to learn and network with industry front runners. This year, more than 30 industry experts will share their experiences and technical knowledge in this two days conference. On the first day of the conference there will be in-depth discussions on the most pertinent issues in the vaccine market by industry experts while the second day of the conference will feature two streams of topics - ‘Vaccine Manufacturing, Technology and Partnerships’ and ‘Vaccine Clinical Trials’. Contact details Jen Cheng Number:+65 6493 1871 Fax Number:+65 6722 0649 Website:http://www.imapac.co m/index.php?page=VaccineWorldSummitIndia2014 Email: jen.cheng@imapac.com
SMART PHARMA MANUFACTURING INDIA 2014 Date: March 4– 6, 2014 Venue: Hyderabad International Convention Centre, Hyderabad Summary: The Smart Pharma Manufacturing India 2014 is specially tailored for technical directors, heads of operational excellence, plant
4
Smart Pharma Manufacturing India 2014
heads and quality heads looking to transform and optimise its current manufacturing processes to maintain cost advantages and achieve quality assurance at the same time. This conference serves as a platform for industry stakeholders to meet and discuss the challenges of today and tomorrow. Key topics that will be discussed include: ● Manufacturing leadership and strategy ● Operational excellence and automation ● Handling GMP and regulatory compliance ● Achieving QBD via PAT ● Cold chain management and distribution for bioPharmaceuticals ●Future manufacturing Contact details Jen Cheng Number:+65 6493 1871 Fax Number:+65 6722 0649 Website:http://www.imapac.co m/index.php?page=VaccineWorldSummitIndia2014 Email:jen.cheng@imapac.com
2ND EDITION HEALTHCARE AND PHARMA EXPANSION SUMMIT Date: March 7, 2014 Venue: Mumbai Summary: The Indian healthcare industry, which comprises hospitals, medical infrastructure, medical devices, clinical trials, outsourcing, telemedicine, health insurance and medical equipment, is expected to reach US $160 billion by 2017. India is now among the top five pharma emerging markets globally and is a front runner in a wide range of specialties involving complex drugs’ manufacture, develop-
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2nd Edition Healthcare and Pharma Expansion Summit
ment, and technology. However the pharmaceutical industry has been buffeted by several issues recently, which has not only affected the very nature of the industry but has also adversely impacted its players. After consolidation in the last few years, the pharma industry continues to see a lot of changes. What are the challenges faced by these sectors today? The demand for Healthcare services in India is poised to grow exponentially to cater to a growing old age population, with rising incidence of lifestyles diseases, rising incomes and affordability, and increased penetration of health insurance. Another key segment of the Healthcare Industry is the Pharmaceutical Industry that contributes a significant portion of the overall revenues in the Indian Healthcare Industry. The 2nd Edition Healthcare and Pharma Expansion Summit 2014, Mumbai sources and presents leading global case studies from top healthcare and pharma Sector and Service providers across India. The summit is packed full of issues and challenges faced as well the opportunities that lies within for the year 2014. Contact details: Ashfan Karkal Exito Media Concepts Pvt. Ltd. #677, 2nd Floor, 13th Cross, 27th Main Sector - I, HSR Layout Bangalore - 560102 (India) Tel: (080) 42015540 / 6570 5295 Fax: (080) 42012720 Email: enquiry@exito-e.com / ashfan@exito-e.com Website: http://hpesummit.com/
20
5TH EDITION OF THE INDIA PHARMA SUMMIT 201314 Date: March 20, 2014 Venue: Ramada Powai Hotel and Convention Centre, Mumbai Summa ry: Federation of Indian Chambers of Commerce and Industry (FICCI) in partnership with Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers, Government of India and World Health Organization (WHO) is organising its 5th edition of The India Pharma Summit 2013-14. The vision of this conference will be to set the motion for transforming India into a global hub for pharmaceuticals. The summit will connect the Indian life sciences sector stakeholders for facilitation of visionary policies in the areas of pharmaceuticals, biotechnology and clinical research. Contact Details: Federation of Indian Chambers of Commerce and Industry Federation House Tansen Marg New Delhi - 110001 Tel: (011) 23487264 Email: Pharma@ficci.com Website: www.ficci.com / www.indiapharmasummit.in
EMERGING TRENDS IN DRUG DISCOVERY: AICADD – 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 organised aims to make a "industry-scientists-
5th Edition of The India Pharma Summit 2013-14
academics" 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, will be participating in the conference. 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. Contact details Dr PK Krishnan Namboori Associate Professor, (Executive Coordinator) AMRITA Insight into Computer Aided Drug DiscoveryAICADD-2014, Computational Chemistry Group (CCG), Computational Engineering and Networking, AMRITA Vishwa Vidyapeetham-Amrita University, Amritanagar, Coimbatore-641 112 Phone: +91 422 2685000 Extn: 5592 Email: aicadd_2014@cb.amrita.edu aicadd2014@gmail.com URL: http://www.amritaccg.in/ Conference URL: http://www.amritaccg.in/ aicadd2014
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cover ) Pg 23: INTERVIEW KUMAR HINDUJA
Pg 20: INTERVIEW DR RENU SWARUP
Pg 22: INTERVIEW DR SAFIA RIZVI
Pg 25: INTERVIEW DR DEEPA DESAI
Pg 28: INDUSTRY VOICE
Pg 26: INTERVIEW DR MANU CHAUDHARY
Pg 21: INTERVIEW RANJANA SMETACEK
WOMEN’S DAY SPECIAL What's on the mind of today's women? Find out from the leading ladies of Indian pharma in this special issue
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cover ) I N T E R V I E W
'I would love to see more women entrepreneurs' Dr Renu Swarup, Advisor, Department of Biotechnology, Ministry of Science & Technology Government of India and Managing Director, Biotechnology Industry Research Assistance Council (BIRAC) has been closely involved in programmes and activities related to women and science. She was responsible for implementing the DBT Scheme on Biotechnology Career Advancement for Women Scientists – BioCARe
Dr Swarup, you joined as a Science Manager in the Department of Biotechnology, Ministry of Science and Technology, Government of India, in 1989. In the nearly 25 years that you have been in the Ministry, you have risen steadily through the ranks. Who have been your sources of inspiration, your role models? I think it is all about growing up with a strong value system and imbibing those values. And for that I have to thank my parents. It is to them that I owe my value system of integrity, the attitude that 'work is worship'. These helped me to be where I am today. In my career and profession, I have been very lucky that all my seniors have been very supportive and I have been able to imbibe the best qualities from all of them. Science is a male dominated field and even more so at the regulator level. Can you share some success mantras? What really pays is hard work, sincerity, integrity and commitment. My father used to say that 'work is worship'. And I believe that you will not get respect if you use special considerations.
20 EXPRESS PHARMA March 1-15, 2014
In my career and profession, I have been very lucky that all my seniors have been very supportive and I have been able to imbibe the best qualities from all of them
You were also a member of the Task Force on Women in Science constituted by the Scientific Advisory Committee to the Prime Minister. What were your recommendations? What are the outcomes of this Committee? Broadly speaking, we made specific recommendations to empower and track the career paths of women scientists by enabling career advancement and re-entry through measures like refresher training and mentorship programmes. We are asking for special considerations due to the socio-economic conditions which impact their careers and cause a break in their career. We also made recommendations to better the working conditions, as well as create better mobility options. Further, we recommended measures to attract girls into science careers through education reform and holding camps and role model programmes. We have already activated schemes. For instance, the Department of Biotechnology, Government of India initiated the Bio-CARe scheme in 2010 to build capacities for women scientists employed fulltime in univer-
STRAIGHT FROM THE HEART
M
y first wish is that women get due recognition for the work they have done. We need to look at what can be done to see more women at higher levels. We need to analyse the reasons why they drop out, and identify gaps that can be fixed. I would love to see more women entrepreneurs. We are not giving them the confidence to start their own company. We have excellent role models like Kiran Mazumdar Shaw. We need incubators, accelerators to become more proactive towards women entrepreneurs. We need to create more networking platforms and initiatives like the first biotechnology park for women, The Golden Jubilee Biotech Park for Women Society, situated inside the SIPCOT IT Park in Tamil Nadu which provides opportunities in the field of biotech to prospective women entrepreneurs. There are excellent examples of women entrepreneurs here.
sities and small research laboratories or unemployed women scientist after a career break so as to help them undertake independent R&D
projects. So far 63 women scientists have been supported viveka.r@expressindia.com
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‘I think we have to first empower ourselves’ As the first woman to become the Director General of the Organisation of Pharmaceutical Producers of India, Ranjana Smetacek, believes that women bring a different and enriching viewpoint to the table and this perspective makes for more robust decisions and leads to better results What attracted you to the assignment of Director General of OPPI? As a communicator, I have the deep belief that there is nothing that can’t be resolved or at least made better with thoughtful dialogue. I started my career with a hotel and moved to a PR agency, before joining a pharmaceutical major. My decade at Monsanto saw me dealing with serious issues relating to hunger and food security and then, with Fortis, I migrated to healthcare. So it has been a steady progression towards sectors relating to essential human needs, where there is an opportunity to touch lives in meaningful ways. Healthcare is a hugely important sector and the pharma industry plays a critical role. I believe OPPI and its member companies can make a real difference in improving access to healthcare in India. Given your experience across diverse sectors, what is your perception of the pharma industry? If, as an outsider on the inside, you are able to step back and see the big picture, what would you change about the industry? My experience across diverse sectors, and in diverse geographies, has taught me that when it comes to essential needs, people the world over really have the same questions, the same concerns and the same hopes. In any industry, an
STRAIGHT FROM THE HEART
I
I believe OPPI and its member companies can make a real difference in improving access to healthcare in India outsider will introduce a fresh perspective, as distinct from someone deeply immersed in the daily business. In our industry, I consider it important to never lose sight of why we exist – to serve the patient who benefits from our medicines. I would also suggest that we might lis-
think that at the top of my wish list would be representation. I would like to see leaders make a genuine effort toward inclusion and gender balance at the important forums and platforms within their organisations. Women bring a different and enriching viewpoint to the table and it is widely acknowledged that the inclusion of this perspective makes for more robust decisions and leads to better results. Also, as a woman in healthcare, I would want more attention paid to women’s needs in healthcare. Women are caregivers - to siblings, to families, to society - but their healthcare needs are frequently neglected. When it comes to gender diversity being good for business, I would say this relates to both men and women. The world of Communications and Public Relations, which I have always inhabited, is predominantly peopled by women. I think the entry of more men in these fields is a good thing as well!
ten more to our consumers and to other stakeholders. How do you hope to achieve these objectives as DG, OPPI? We have thought long and hard about what we want to achieve, both in the year ahead and in the longer term. We are
committed to making a real difference in the nation’s healthcare and, with this in mind, have narrowed in on three areas of focus: intellectual property protection, access to healthcare, ethics and compliance. We will try to make progress in all these areas with outreach and dia-
logue and collaboration. I see it as my role to optimise OPPI’s functionality across three levels: within our small secretariat, in the interaction with our diverse member companies and of course in our communication with the external world. As a woman professional who has served on every continent, what do you feel are the best ways to encourage/enable/empower women professionals/ entrepreneurs in the life sciences sector? Is OPPI involved in any initiatives? Speaking for myself, I once attended the St Louis Business Journal's Annual Women's Conference, with more than 1,100 business professionals, and it was the most empowering experience! We entirely took over the gigantic downtown venue (including the men’s restrooms!) and the speakers included luminaries like Kathleen Kennedy Townsend, Suzy Welch, Priscilla Hill-Ardoin and Jean Chatzky. I think we have to first empower ourselves and it certainly helps to speak to one another! It is very encouraging that organisations have started thinking, talking and acting on gender diversity and this ‘movement’ is gaining momentum. As for OPPI, well, for the first time since we were established in 1965, there is a woman Director General at the helm. So, I would say that is a good initiative! viveka.r@expressindia.com
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cover ) I N T E R V I E W
‘There is no substitute to good old-fashioned hard work’ Dr Safia Rizvi, Managing Director, UCB India has worked in the US, Europe and India. Her experience spans academia, scientific research linking genomic sequences with drug discovery, B-school as well as industry roles. The founder of eLIT, an initiative for the empowerment of economically challenged women, she has won awards like ‘National Working Mother of the Year’ in 2011 and the ‘Women of Distinction Award 2005’ Dr Safia, your experience spans academia, scientific research linking genomic sequences with drug discovery, B-school as well as industry roles at GSK, MedImmune and now UCB India. At a professional level, how did you strategically prepare yourself for the shift from academia/science to the management/business side of the industry? Any mantras/tips for success? Switching from science to business was greatly facilitated by the MBA programme at Wharton. My friends, classmates and mentors were very helpful in making this transition. It also helped that I am a very resilient and determined sort of person. Sheer grit has always been my weapon of choice and at times, that was also the only one accessible. My mantra has always been that there is no substitute to good old-fashioned hard work. You have received many awards, the latest being the ‘National Working Mother of the Year’ in 2011 and the ‘Women of Distinction Award 2005’. At a personal level, how do you maintain a work-life balance? I am not sure if I am a great example of good work life balance now. However, earlier when my daughter was young, her presence provided great deal of structure and balance to my day and my life. I always
22 EXPRESS PHARMA March 1-15, 2014
While the US and Europe offer personal privacy and anonymity and thus a sense of freedom, India offers a very good support system to manage home and other aspects
made fresh home cooked dinner, worked with her on her projects, home work etc. It was not so much by design as it was by sense of responsibility and necessity. Now that she has grown, I tend to lose that balance and at times it becomes all work, no life. I like my work so it does not seem like work. But generally speaking, it is an ongoing struggle for all women so one of the things that I have stopped worrying is ‘small things,’ I do not spend time and energy focusing on matching of sofa covers and curtains or other things like that. Having lived and worked in the US, Europe and India, how was your experience as a working woman across these continents? There are pros and cons of every situation. While the US and Europe offer personal privacy and anonymity and thus a sense of freedom, India offers a very good support system to manage home and other aspects. One of the key difference I noticed when I came here was lack of women at senior positions in pharma industry. It led to several funny situations. Most of my team had never had a female manager before. That said, every one accepted my leadership and for the most part I do not even remember that I am a woman. Over all, I have had a great experience here in India.
STRAIGHT FROM THE HEART
W
hat I want is a world where women can make informed choices, about their life, body and health, family’s health, career, etc. A world that has equality of human kind. A world where women do not have to apologise for their luck in gender lottery.
You have been involved in empowerment of economically challenged women through access to education and are the founder of an initiative, eLIT. Can you tell us what inspired you to start this? And give us a gist of its objectives, scope, impact? eLIT or rather developing a pragmatic and practical method to empower women was inspired by a specific incident. I attended a talk by Asma Jahangir at Asia Society in New York. She described the details of a legal case where a 13-yearold blind girl was abused by her employer and then sent to jail for the act that was forced on her. It hit me like a ton of bricks and I came to realise how fortunate I am and how privileged
my life is. I have the power of making choices. Choices that are not accessible to many millions of women. I wanted to somehow help create empowerment for women to enable them to make informed choices for life, career, health etc. My path crossed with like-minded people and we started eLIT, a 501 C3 non profit organisation committed to providing empowerment to women and children from socially and economically challenged background. We started with electronic literacy as key tool and we have expanded to scholarships and other forms of educational support for women and children. viveka.r@expressindia.com
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Haematinics continues to dominate Women’s health has for long been centered around contraceptives. Kumar Hinduja Senior Director, Strategy Planning, Business Development, Pharma & Payer Solutions, IMS Health offers an insight into how pharma companies are catering to this market
How big is the women's healthcare market in India? By how much is it growing? The women’s healthcare market stands at `4336 crores growing at 7.5 per cent value growth, while volume growth stands at -2.1 per cent, price led growth at 4.1 per cent and new introductions have been growing at 5.5 per cent. Which therapy areas dominate the market? Why? Who are the major players? Haematinics continues to dominate with a value of `1500 crores and is growing at nine per cent value growth, progestrogens and combinations seen more progressive at 15 per cent value growth. Due to lack of innovation the market remained largely dependent on haematinics and hormones which together constitute about 80 per cent of women’s healthcare market. Typically how much of a company's portfolio is attributed to women’s health? Has the market moved beyond contraception? Has the market matured? On an average 11 per cent portfolio amongst the top 10 players is attributed to women’s healthcare, still there is high dependency on contraception seen in at least four of the top 10 players. The market is evolving slowly and not much is happening towards innovation. Are companies looking at newer products and
MAJOR PLAYERS
Haematinics continues to dominate with a value of `1500 crores and is growing at nine per cent value growth, progestrogens and combinations seen more progressive at 15 per cent value growth
Company
FY 2013
VAL Growth FY 2013(%)
Zydus Cadila
338
7
Emcure
314
10
Sun
268
28
Franco Indian
216
25
Mankind
197
-3
Pfizer
180
0
Cipla
155
-44
Abbott
153
9
Novartis Intl
123
-10
Alkem
102
20
WOMEN’S HEALTHCARE PORTFOLIO OF MAJOR PLAYERS Company
Total sales (in crores)
WHC sales (in crores)
Contraception sales (in crores)
Value of WHC portfolio (%)
Value of contraception portfolio (%)
Zydus Cadila
3055
338
194
11
57
Emcure
1819
314
0
17
0
Sun
3638
268
71
7
27
Franco Indian
623
216
0
35
0
Mankind
2584
197
150
8
76
Pfizer
2478
180
94
7
52
Cipla
3814
155
85
4
55
Abbott
5245
153
0
3
0
Novartis Intl
1295
123
39
9
32
Alkem
2716
102
0
4
0
DATA for FY 2013
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cover ) therapies? Are they actively investing in R&D? Which companies stand out uniquely on these two parameters? MNC’s typically are known to bring innovation, however, India companies continue to see me-too offerings. MNC’s are more careful now to bring their innovation in India looking into the patent and policy related issues. What are the challenges of operating in the segment for companies? Is it a revenue generating stream for companies and do you see more companies entering into the segment? We see this segment largely crowded. There exists a constant movement of new entrants as well as players exiting segment ,thus the overall attractiveness remains less due to lack of innovation, high cost associated with sales force and manufacturing. Who is the typical target audience here- urban or rural women? Statistics on
NEW PRODUCTS
MNC’s typically are known to bring innovation, however, Indian companies continue | to see me-too offerings. MNC’s are more careful now to bring their innovation in India
this. Has the ratio changed over the years? How? The market remains largely urban driven, the rural growth slowed down in 2013 significantly compared to previous years. What does the future of the segment look like? In the future we see ● New Introductions & Innovation drying up. ● Chronic therapies generating better growth & more players shifting focus to the chronic side. ● MNC’s will be more careful
to bring innovative products in India post Glivec (Novartis) episode ● MNC’s increasingly not willing to spend on R & D in India. ● Contraceptive pills stagnate while consumption of non-contraceptive modes to grow ● Stringent MTP act & applications leading to reduced usage of MTP pills. MTP Kits have also moved towards doctor dispensing route from retail/trade channel.
Company
Total sales of NIs (in crores)
Sun
26
Emcure
21
Bafna Pharma
20
Cadila Pharma
17
Alkem
15
Mankind
10
Sanzyme Ltd
10
Akumentis Health
10
Bharat Serum
9
Alembic
5
Zydus Cadila
5
Merck Limited
7
NI=New Introductions Data for FY 2013 NI value benchmark> 5crs
shalini.g@expressindia.com
WOMEN’S HEALTHCARE PRODUCTS SALES IN URBAN AND RURAL AREAS
FY 2010
FY 2011/12
FY2012/12
FY2013/12
Urban/Extra urban
Town class
Value (crores)
Value growth (%)
Value (crores)
Value growth (%)
Value (crores)
Value growth (%)
Value (crores)
Value growth (%)
Urban
CLASS I
1079
19
1239
15
1348
9
1481
10
Urban
Metro
921
22
1078
17
1147
6
1207
5
Extra Urban
CLASS II to IV
683
22
768
12
822
7
879
7
Extra Urban
Rural
429
14
626
27
717
14
769
7
All India
All India townclass
3175
20
3712
17
4034
9
4336
7
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‘I believe that everyone lives by the choices they make’ Healthy work culture in an organisation is an output of employee-friendly policies and regulations. Today, 56 per cent of the work force at Qunitiles India’s Cardiac Safety Services business division are women, evidence of their women-friendly environment. The company’s policies are formed to help the people working in the organisation to achieve a work-life balance. It also offers flexibility in working hours. Dr Deepa Desai, Executive Director, Cardiac Safety Services, Quintiles India talks about the company's work culture, her personal successes and more
You joined Quintiles in 2002 as Operations Manager and have climbed the ladder to become the Executive Director & Global Head. Tell us about this journey and experience? The journey so far has been exciting and a wonderful learning experience. As with any business, we have gone through our ups and downs but I have enjoyed every minute of it. Launching the Cardiac Safety Services business in India was a small, but confident step towards a larger vision of demonstrating to the world that we had the competence and could deliver international standards of safety and quality from India. We were amongst the first biopharma companies to offer corporate jobs to medical professionals and had the additional challenges so that they could be successfully integrated into the corporate culture. These challenges taught me a lot. I am extremely proud of the great work we have done and a wonderful team that we have built over the years. At a personal level, the experience of growing a business has broadened my horizons and made me look at patients from a wider lens
than just a homeopathic one (I am a qualified homeopath). Today, I am also a much better human being because of the experiences I have been through. Have you ever found yourself in a position where conflicts with co-workers has affected your performance? How have you managed to handle such situations? I believe conflicts are vital to the health of a business and have always embraced situations of conflict with an open mind. Conflicts result from a difference of opinion someone may have based on his or her previous experience and we should not discount the experience or point of view. It is important, within the dynamics of an organisation, to create an environment where colleagues have the freedom to express an opinion even if it is at dissonance with everyone else. As long as the interests of the team, organisation and customer are kept central in the resolution of a conflict, I believe conflicts contribute to learning and are easy to manage. Have you had a hand in formulating women-friendly
STRAIGHT FROM THE HEART
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want to be a successful and respected leader and a better and happier human being. To be loved and respected, recognised and given equal opportunities to succeed. I am what I am today because my family gave me all of these and this is what I would like every woman to enjoy.
We offer our women to work in shifts, flexihours and work from home options so that they can suit their convenience
policies within your organisation? If yes, please elucidate. Yes, Quintiles is an organisation that is recognised and acknowledged as providing an enabling work environment for women employees and I am equally passionate about fostering a conducive work environment for our women. Over 56 per cent of our Cardiac Safety Services workforce in India is women. We have created an environment
where women feel safe and are able to progress their careers even as they balance the demands of personal and professional life. We offer our women to work in shifts, flexi-hours and work from home options so that they can suit their convenience and manage their work-life balance more effectively. We also ensure that newly wed and expecting or young mothers do not work Continued on Page 27
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‘I don’t see any fierceness in the competition’ With over two decades’ experience in the organisation, Dr Manu Chaudhary, Joint Managing Director, Venus Remedies & Director-Research, Venus Medicine Research Centre has several achievements to her credit. Her contribution to pharma research has been instrumental in enhancing Venus Remedies’ capabilities in the field. She speaks about her accomplishments, vision for the company, women-friendly policies at Venus and more
You have been associated with Venus for the last 22 years and you have spearheaded the company to achieve many milestones. Tell us about your learning experiences and how did you overcome the challenges that came up before you in the course of your career? It was indeed a great learning experience. I could witness the pharmaceutical industry passing through radical changes with respect to understanding of quality norms as per international standards, the shift from process to product patent and ultimately evolution of India as a solution provider in medicine research. Not even a single milestone can be achieved without focus, passion, hard word and team work. For instance, we received GLP (Good Laboratory Practices) accreditation after stringent audits which lasted up to three years because we were determined to be pioneers in research. We keep on raising our bar of excellence and make it a point to constantly improve. You have devoted more than 10 years to drug development and research in the area of antimicrobial resistance (AMR), how challenging or rewarding
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was it for you? I could foresee the need for AMR solutions and fortunate enough to get an opportunity to work on these solutions passionately. We were committed to finding fairly quick solutions to drug-resistant bacteria and a timely launch of these research projects gave us an edge over others. Today, AMR has become a global concern, which claims thousands of lives annually. We have hit the right chord at the right time. In Venus, our vision is to constantly develop perpetual innovations. Working on AMR is part of this vision. We have taken it forward by turning it into a mission to eradicate AMR. It has been a bumpy ride but nothing is more satisfying than saving precious lives through the novel antibiotic adjuvant entities developed by us when all other medicines fail to respond in ICU. Focused research can make a difference to the lives of millions of people. Infections caused by resistant micro-organisms often fail to respond to the standard treatment, resulting in prolonged illness and greater risk of death. Today, we are at least in a position to provide solutions to major superbugs like MRSA and NDM-1. Venus has become a pioneer in the field of AMR and
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he top priority in my wish list is to take Indian innovations globally and bring back the culture of innovation in India. I also want everybody to have access to good-quality education based on sound moral values so that we can build a healthy society free from all pressures.
If a woman is competent and determined, nothing can come in her way. I would like the leadership space to be gender-free
has surpassed its bigger competitors in developing novel antibiotic adjuvant entities to counter the growing threat of antimicrobial resistance. We have filed more than 340 patents in 60 countries, of which we have received 102. Our success speaks of itself. We have been conferred many awards, including a gold medal for Elores under the DST-Lockheed Martin India Innovation Growth Programme. Your impressive contributions in the field of operations have helped the com-
pany to implement cost-effective and efficient manufacturing processes, your expertise has guided the company to meet GMP and International Conference on Harmonisation (ICH) guidelines. Moving forward what new strategies do you plan to implement? Constant upgradation of intellectual property and infrastructure is the need of the hour. We are driven by the mission of turning ‘Made in Venus’ into a benchmark of quality in the pharma indusContinued on Page 27
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‘I don’t see any...
‘I believe that...
try, I feel training, system development and implementation and regular audits, followed by risk management, are required to be on the top. We have developed a basket of 75 superspeciality products, which are at par with international standards. This includes our 15 innovative products. We have secured 22 GMP accreditations from across the world for our manufacturing facilities with perseverance and dedication. The entire Venus team is doing everything it can to maintain the company’s edge and launch our research products all over the globe. We are determined to provide consistent and uniform quality in all markets irrespective of the paying capacity of those markets. We are just a 23year-old company, but we are present in 60 countries. With the passage of time, we will have a presence in more and more countries. There are very few women who are at your level in this industry? How fierce
is the competition for a woman in this sphere? What is your message to fellow women professionals? The number of women holding senior positions is going up, but not at a very encouraging pace. However, I don't see any fierceness in the competition. If a woman is competent and determined, nothing can come in her way. I would like the leadership space to be gender-free. Let merit have a say. Message to fellow women professionals: Believe in yourself and your capabilities. If you do that, nothing is impossible. Each one of us has her own strengths. We should discover them and expand our horizons. Accept challenges with passion and the doors of success will open automatically. What policy reforms/amendments have you created in your organisation to inculcate a women friendly culture ? Venus Remedies is the
only company from the North India to have made it to the list of Top 100 in the 'India's Best Companies to Work for' study conducted by the Great Place to Work Institute, India. It was placed at the nd 72 position. We have inculcated a healthy work culture and provide a learning atmosphere to every employee, where they can enjoy their work and perform without any stress. Our women employees enjoy equal opportunities when it comes to increments or promotions. Ensuring the welfare of our employees is of utmost concern to us. There is no gender bias at Venus Remedies. We work as a team where the best employees have every opportunity to grow and move ahead of others. Venus has formulated various women-friendly policies. The company provides monetary benefits to women employees on various occasions. u.sharma@expressindia.com
late hours. While I have been actively involved in taking decisions to create a nurturing work environment for women, I would like to add that growth opportunities for both men and women employees are equal in our organisation. Your current leadership position reflects your industry knowledge, as well as work experience. What are your recommendations for women intending to carve a career for themselves in the pharma industry? I don’t believe that women need to necessarily have a different approach than men to succeed in the biopharma industry. The ingredients for success are the same – passion, commitment, hard work, flexibility and willingness to embrace change. In the biopharma industry, a life sciences background is an advantage as inbuilt in that experience and exposure is patient-centricity, which is so core to the work that we do. You have also been a lecturer. Tell us about your teaching experience?
Teaching, for me, is a form of learning. Learning that takes place at two levels – in preparing for a class and in interacting with the students when teaching. I have had no formal training in management or leadership skills – all that I have learnt has come through my teaching and interactions with colleagues. How have you managed to handle both professional as well as personal commitments? Have you ever had to compromise on one to fulfil the other? It’s all about making choices. I have a diverse set of interests that includes music (I enjoy listening to music and learn a percussion instrument, the tabla), watching movies and going on long drives. I believe that everyone lives by the choices they make and therefore the question of having to compromise should not arise if you have made the choice. When you make a choice, you will find the time to pursue them whether they are in the personal or professional realm. u.sharma@expressindia.com
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cover ) STRENGTHENING THE SISTERHOOD Kiran Mazumdar-Saw Chairman and Managing Director, Biocon
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he life sciences sector offers a wide ranging career and entrepreneurial opportunities to women scientists, engineers and business graduates. India has an important role to play in drug research, bio-pharma manufacturing and marketing. I would urge women to pursue these opportunities with zestful interest.
With International Women’s Day around the corner, Express Pharma gets stalwart women from the Indian pharma industry to share their thoughts and recommendations for other women in the sphere
Chitra Lele Chief Scientific Officer, Sciformix
T Archana Dubey Mitra Vice President-International Marketing, Bal Pharma
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he Indian pharma industry offers tremendous opportunity to empower females. Being an intellectual industry it has scope for us to contribute and grow along with the industry. Unlike finance, banking, IT and FMCG, pharma is yet to see many women reaching great heights. I feel our leading lady Kiran Mazumdar Shaw is an example for every woman to come forward and explore their talent.
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he biopharmaceutical industry landscape is the most dynamic due to mounting business pressures and the increasingly stringent regulatory environment. Of relevance to those of us in India is the increased focus on emerging markets.All of these changes present a lot of challenges, but come with opportunities as well. From the perspective of the CRO industry, while the traditional clinical trial business has seen a sharp decline, other opportunities on the services side are presenting themselves.The mantra is to recognise the trend and quickly adapt the business to take advantage of it.All companies that are part of the biopharma industry have to be extremely nimble like never before and adapt quickly to seize the new opportunities. My message to all fellow women colleagues is to keep up with the changing environment and the emerging trends as well as be more flexible about balancing personal and organisational priorities.
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HR initiatives at Indian pharma/CROs
Dr Manu Chaudhary Joint Managing Director, Venus Remedies, Director, Research, Venus Medicine Research Centre
he changing dynamics of the business environment has provided ample opportunities to women to make a mark for themselves in their respective careers. This has, in turn, helped in bridging the gender divide to a large extent, but we still have a long way to go. There are lots of avenues for women in the pharma, biotech and CRO industries, especially in the areas of research, academics and quality control. My message to fellow women engaged in these fields is to think beyond the obvious and challenge their limits by making it a point to not confine themselves to the boundaries of science. India still does not have many women in senior leadership positions or boardrooms. I feel women need to be mentally and emotionally stronger to break the male bastion and fit into roles which were hitherto considered male-specific. If they take this up as a challenge and channelise their energies in this direction, there will be no stopping them. By improving their presence in senior leadership positions, they can set a benchmark for the next generation of women managers. The mindset of the society has undergone a sea change as far as working women are concerned. This should give all the more reason to them for competing with their male counterparts and prove that they
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are second to none. It is the duty of every corporate to provide a safe workplace and a conducive working environment to women through policies that encourage their greater participation. Our women-friendly policies are aimed at bringing out the best in them. The logo of our company, “Enjoy innovation”, gels with the ethos of the company to create an atmosphere where all employees, women included, enjoy their work in a stress-free environment. We provide monetary benefit to women employees in the form of ‘shagun’ at the time of their marriage. We have also extended the ‘shagun’ scheme to the daughters and sisters of our employees. Besides, we provide financial assistance in the form of ‘kanyadaan’ for the marriage of our workers’ daughters. Women workers and wives of male workers who have upto two children are provided financial aid for their delivery. We also provide money to workers who have daughters studying in class 1 to 8 for the purchase of school uniforms, textbooks and notebooks. No incident of sexual harassment has happened in the company since its inception. We offer time relaxation and flexible working hours to women employees who join work after maternity leave to enable them to take good care of their children.
where women not just feel safe and secure, but one that also enables them to progress in their careers as they balance the demands of personal and professional life. In addition to the many initiatives that build employee engagement, there are Trupti Talati several programmes that Senior Director, Global Human Quintiles India offers to make Resources, Quintiles India a conducive environment for women. These include: uintiles is globally Flexi work: Quintiles recognised as one of the offers a variety of flexible World’s Best Multinaworking options. Employees tional Workplaces by the can work from home and are Great Place to Work Institute equipped with laptops and and is also known for fosterconnectivity devices to help ing a women-friendly work them operate with ease. They environment. Globally, Quinhave the option to work in tiles runs a Women Inspired shifts and flexi hours. Part Network (WIN), a forum time employment options are whose mission is to inspire also available. women to take advantage of Home-based employleadership opportunities at ment: There are employees Quintiles and within the who are home-based. This is industry. Through various particularly beneficial for initiatives like leadership women who relocate to places coaching programmes, inforwhere Quintiles India has no mal conversations, book reoffice or women who need to views and discussions and work from home due to newsletters, women have an extraneous circumstances. opportunity to network with We offer extended paid maother women, be inspired and ternity leave of one month in learn from them. Networking addition to the statutory is facilitated through a WIN three months. community on our awardLogistic support: Our winning Intranet, video contransport system to shift staff ferencing, face to face meet(both male and female) is ings and several other state-of-the-art and has the channels of communication. safety and security of women There is a higher ratio of employees at its core. There female to male employees are special cars assigned for across Quintiles India which pregnant women. does not change significantly There are other profrom business unit to busigrammes for general staff ness unit whether it is one that are particularly helpful that predominantly hires for women employees given medical and scientific talent the challenges that women or technology or general have in balancing the management talent. Quintiles demands of family and profesis an equal opportunities emsional life. These include: ployer and offers equal career Healthy U Healthy Q, an opportunities and growth for internal employee wellness both men and women employ- programme has four compoees. We are aware of the need nents comprising a physical to provide an environment activity reimbursement
Q
programme, an online health and well-being assessment, a dedicated wellness website HealthyUHealthyQ.com and a tobacco free workplace. Under the physical activity reimbursement programme, eligible employees can be reimbursed upto a fixed annual amount for gym memberships, personal training, fitness classes, massage, race registrations and durable home exercise equipment and outdoor bikes. Quintiles also offers Employee Assistance Programme (EAP), counselling and advisory service that is available at no cost to employees and members of their immediate family (spouse/partner, children and dependent parents). The service is provided through PPC Worldwide, a leader in the global EAP arena, for physical well being. Besides the regular reward and recognition programmes, Quintiles India also provides unique opportunities for employees to fulfil their non-work related aspirations and goals within their work environment. Events like Employee Appreciation Day (EAD) recognise and showcase the varied extracurricular talent of employees; Q Day provides time off for employees to participate in a social cause of their choice; Open Day offers employees an opportunity to bring their family to work. Several such initiatives go a long way in creating a conducive work environment for our employees. Above all of these, there is intrinsic joy and satisfaction that employees have in knowing that the work they do contribute to better healthcare for millions of people the world over. (Compiled by Usha Sharma)
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BRINGING IN THE MOOLAH Regulatory concerns and adverse market conditions notwithstanding, the pharmaceutical industry in India continues to attract retail, as well as institutional investors and looks poised for growth in the coming years BY USHA SHARMA
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n today's competitive market, investors have a slew of choices to infuse their money apart from public and private institutions. In a fastmoving, technology-driven society, investors have ample resources to ensure transparency in their dealings by obtaining information on various sectors. In the case of retail investors, they can invest in private and public institutions for short term or long term
without venturing into any kind of trading. Whereas, the capital market, comprising the stock market and bond market, offers a single platform to investors to do their trading and get live updates of the Sensex index to understand the market sentiments. The Indian capital market is divided into the Bombay Stock Exchange (BSE) and the National Stock Exchange of India (NSE). At present, the BSE has 82 industries listed with manifold companies. All these companies have individual scrips which differentiates them from others. 225 pharma companies are registered under the BSE listing of which the current status of 75 listed pharma companies show 'suspended for undisclosed reasons'. Indian pharma sector is very fragmented yet it has the maximum US FDA approved manufacturing facilities outside the US and leads the race in
generic manufacturing. India exports medicines to about 210 countries and vaccines to about 150 countries in the world. These medicines while being affordable are as effective as branded drugs manufactured in the developing countries. US is the topmost destination for exports as far as Indian pharma companies are concerned, followed by Russia, Germany, Austria, LATAM and Japan. Dheeraj Aggarwal, Chief Financial Officer, Venus Remedies mentions, “Private equity (PE) investors have been keen on investing in the pharma sector because of its traditionally defensive approach, but the industry is now fast shedding its defensive approach and becoming growth-oriented.” Commenting on the Indian pharma companies’ performance, Dheeraj Aggarwal says, “The Indian pharma industry is one of the fastest growing industry worldwide. It is expected to grow at a compound annual growth rate (CAGR) of 17.8 per cent during 2008–16 and reach $36 billion (as per an August 2013 Indian Brand Equity Foundation (IBEF) report). The industry has witnessed a threefold increase in PE investments since 2005.” This prediction proved to be accurate till 2013. However, during 2013, Indian pharma companies saw many regulatory reforms and faced various challenges on both the fronts, domestic as well as internation. Companies like Wockhardt, Strides Acrolab came under the US FDA scanner, again raising questions about the manufacturing standards of Indian pharma players. This is not the first time that US FDA has raised an issue with regards to the manufacturing practices of
Indian pharma companies. Earlier too, companies like Ranbaxy Laboratories which is now Ranbaxy-Daiichi, Lupin, Sun Pharma and Cadila Healthcare, Aurobindo Pharma have received warnings from the US FDA. Some of them like Lupin, Aurobindo Pharma and Cadila Healthcare have been quick to resolve the issues. Ranbaxy-Daiichi have witnessed a long battle with the US FDA, it started in 2009 and is still on. The company had already signed a decree with the US FDA in 2013 which also includes its largest facility at Mohali. Commenting on the Indian pharma companies' battles with US FDA, Sarabjit Kour Nangra, Vice President, Research-Pharma, Angel Broking says, “The battle with the US FDA is an overdrawn one and not new to the industry. The companies that have rectified the issues on time have reduced the serve impact of the same on their operations, while companies like Ranbaxy have taken a lot of time resolving their issues and hence have seen their profitability get diversely impacted, in recent times more so, due to lack of any Para-IV opportunities.” Sreenivasa Prasanna, Senior Director - Corporates, India Ratings and Research, gives an insight on the imbalanced regulatory scenario of India and how detrimental it is to the growth of Indian pharma companies, “Many Indian manufacturers have been subject to adverse regulatory action by the US FDA, with 10 ‘warning letters’ issued to Indian companies during 2013 alone. While such regulatory action leads to disruption of manufacturing and loss of revenues for the affected
Private equity (PE) investors have been keen on investing in pharma sector because of its traditionally defensive approach, but the industry is now fast shedding its defensive approach and becoming growthoriented Dheeraj Aggarwal Chief Financial Officer, Venus Remedies
The Indian pharma industry has been logging a robust 20 per cent growth in the US markets despite regulatory hiccups and given the cost benefit of the Indian manufacturing Sarabjit Kour Nangra Vice President, Research-Pharma, Angel Broking
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MANAGEMENT company, these incidences have been few, considering that there are over 500 US FDA facilities in India and are unlikely to affect the sector as a whole.” Analysing the profitability impact on Ranbaxy's financial performance after falling under US FDA scanner, DK Aggarwal, Chairman and Managing Director, SMC Investments and Advisors says, “Companies like Ranbaxy Laboratories has been under pressure as it has been dragged up frequently by the US drug regulator. The US FDA has banned its manufacturing plants in India from exporting to the US. Hence its profitable share has been badly hit as the US alone contributed more than one-third of Ranbaxy’s revenue. Now the company has decided to focus on the domestic markets. No doubt the Indian market will also prove to be challenging as competitive intensities are very high here.”
ment and devices. But there is huge expectation and dependence of the public on the regulator to ensure the quality of what people consume through drugs and food, and also whether there are barriers being created to new opportunities.” Hamburg also stated that quality regulation can go a long way in strengthening the robustness of the clinical industries and noted that India has made a very serious commitment to strengthen regulatory framework to enhance transparency. India and the US need to be effective partners and work on transparency as there are common goals and aspirations and both are world leaders in the field of medicines. There should be common set of standards so that people have quality, safe and efficacious drugs, she noted. She said that the 'Statement of Intent' will enhance transparency in the field of medicine.
Will it be a ‘U’ turn?
Scrips performance
After the US FDA banned drugs manufactured by Ranbaxy-Daiichi's Punjab-based Toansa Active Pharmaceutical Ingredients (API) plant there were a lot of apprehension in the Indian pharma industry. However, US FDA Commissioner, Margaret Hamburg recently visited India and met with Ghulam Nabi Azad, Union Health Minister, India, to sign the 'Statement of Intent' for cooperation in the field of medical products. This move has alleviated the industry's fears to a certain extent. Post this move, the Indian Health Minister stated that being affordable should not mean that they are cheap and spurious. Efficacy of the Indian drugs should not be judged on the basis of their cost as the input cost in India is much less than that in the developing countries due to less expensive human resources. He further opined that developing countries such as India with a budding pharma industry should be allowed to grow. According to the official press release issued by the Government of India, Ministry of Health and Family Welfare, Hamburg said, “India is the second largest exporter of drugs to the US, and has a significant contribution in medical equip-
US FDA commissioner's recent visit to India indicates their eagerness to resolve the issues with Indian pharma companies and Indian regulators at the earliest. In the past 10 years, India has emerged as the largest global supplier of generic medicines and bulk drugs. Strong product R&D has helped Indian pharma companies to lead the pack of foreign suppliers of generic drugs to the US. Prasanna comments, “Coming as it does when Obamacare policies have given a fillip to generic drug use in the US, continued R&D effort will help Indian pharma companies consolidate their lead in the US generic market.” The dominance of Indian pharma companies in getting US FDA (ANDA) approvals increased during 2013, with close to 45 per cent of all product (ANDA) approvals given to Indian pharma companies. Dheeraj Aggarwal says, “The sliding rupee has given more edge to all export-oriented industrial units in India, especially the pharma sector which, along with the IT sector, has benefited the most from the depreciation in rupee. The Indian healthcare sector, including the pharma industry, enjoys a tax-friendly
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Continued R&D effort will help Indian companies consolidate their lead in the US generic market Sreenivasa Prasanna Senior Director Corporates, India Ratings and Research
The sector is expected to continue to benefit from a weak rupee. The Indian pharma players still have the robust pipeline of ANDAs with the US FDA and most of these could be complex and niche generics launches despite the end of the patent cliff DK Aggarwal Chairman and Managing Director, SMC Investments and Advisors
regime, which gives further impetus to investments in this sector. Since India still spends meagrely on healthcare as compared to other countries, there is a huge scope for growth in this sector, which will translate into bigger opportunities for investors.” DK Aggarwal presents his analysis, “During the year 2013, the Indian pharma stocks such as Ranbaxy Laboratories, Wockhardt, Strides Arcolab and Jubilant Life Sciences remained in limelight despite quality problems, FOREX losses, interest burden and Drug Price Controlled Order (DPCO); the Indian pharma has witnessed 2013 as a year of both achievements and setbacks. He further elaborates, “Due to price control requirement which has been introduced by the Union Government, in May 2013, pharma companies should look to redesign the product portfolio and also need to renew focus on quality manufacturing norms. Also, there is an urgency to modify innovation and R&D efforts in India to move on from the generics model as it is considered unsustainable.” However, despite several pitfalls, the Indian pharma industry is expected to see strong growth in CY2014 driven by a 20 per cent plus growth in exports. R&D driven products, ANDA approvals in the US are likely to help the Indian pharma exporters to maintain the growth. Capacity utilisation will improve as more and more capacity is used up to manufacture the increasing number of products. Prasanna comments, “Capacities created during the recent past will start contributing to the output, operational leverage would drive up EBIDTA margins, increasing profitability. Exporters with low debt levels or those with only domestic debt will also gain from the depreciation in the rupee against the US dollar. Overall financial risk can also come down if higher cash flows are used to reduce debt intensity.”
Moving forward Nangra informs, the Indian pharma industry has been logging a robust 20 per cent growth in the US markets despite such
regulatory hiccups and given the cost benefit of the Indian manufacturing, the Indian companies can grow robustly in these markets. And a look at the ANDA filings pending with the US FDA, Sun Pharma, Lupin, Dr Reddys Labs and Ranbaxy Labs, appear amongst the top 10 US FDA filers. Predicting the Indian pharma industry's future and assuring the retail investors, DK Aggarwal says, “The pharma sector is expected to continue to benefit from a weak rupee. The Indian pharma players still have the robust pipeline of ANDAs with the US FDA and most of these could be complex and niche generics launches despite the end of the patent cliff. Further, cost cutting measures in US under healthcare reforms and austerity measures in Europe will boost demand for Indian cost effective products. The multinational companies have already begun with their strategies to join hands with the Indian pharma companies. In the long term, this kind of partnership will enable to inflow the foreign cash in India and will encourage the retail investors sentiment to opt pharma scrips as a safest destination.” Agreeing with his colleagues, Dheeraj Aggarwal also forecasts, “The Indian pharma industry has already cleared the litmus tests on quality and pricing. This growth story would remain intact in coming years, especially with a slew of patent expiries of top selling brands in the US and European Union from 2011-2015. With the easing of mergers and acquisitions (M&A) regulations and FDI norms, large MNCs are looking towards Indian companies for acquisition or joint ventures, as shown by the recent deals struck by Mylan, GSK and Hospira.
Conclusion The pharma sector in 2013 has seen a healthy export growth with better top lines due to new product launches, higher investments in R&D etc. but it has been a bumpy ride. Yet, the rough patches have not deterred the investors and India continues to a be a preferred destination for short-term investments. u.sharma@expressindia.com
MANAGEMENT I N T E R V I E W
‘Rating models are good indicators of corporate governance, not a solution’ Corporate governance has been the need of the hour for the pharmaceutical industry which has been plagued by a string of frauds. Thomson Reuters alongwith the Indian Institute of Corporate Affairs (IICA) is working to raise awareness on corporate regulation among Indian firms. Swarup Choudhury, Managing Director, Thomson Reuters India, shares more in an interaction with Shalini Gupta
What changes in the Indian Company Law recently enforce a greater need for corporate governance? The Companies Act 2013 is a landmark legislation in the Indian Corporate Governance journey. The new set of rules and regulations have set a framework to create strong and effective measures which include: 1. Disclosure and transparency – Preparation of consolidated financial statements made mandatory for all companies with a subsidiary/JV/Associates; internal control reporting and internal audit made mandatory for specified class of companies including listed companies with board’s assurance required on internal control reporting. 2. Auditing – Mandatory auditor rotation for listed and other prescribed companies every five years depending on whether the auditor is an individual or a firm including approval of auditors by the shareholders at every annual general meeting of the company. 3. Board Structure and Responsibilities – Mandatory director appointments such as at least one India resident director for all companies to create accountability; at least one
woman director for specified class of companies to bring in diversity of views; one-third of the board to be comprised of independent directors for specified class of companies and clear definition of role and responsibilities of independent director. With the roles of MD and Chairman diffused in some companies, it was observed that these should be split in order to tide over governance issues. 4. Corporate Social Responsibility – Mandatory for specified class of companies to make CSR contributions towards specified causes amounting to two per cent of the average net profit before tax for the last three financial years. It is mandatory for these companies to create a CSR committee with three or more directors with at least one independent director. What is the current status of corporate governance in the pharma industry? Pharma industry is very global in nature and essentially draws a lot of attention in the local and international markets that the companies have operations in. Add to that increasing US FDA control, patent issues, regulatory concerns and government pressures, companies
are working at ironing out risk control with an increased awareness of the regulatory expectations and a focus on establishing sound corporate governance systems.
Pharma industry is very global in nature and essentially draws a lot of attention in the local and international markets that the companies have operations in
Does a rating system of corporate governance help as in US and Europe (AGR ratings)? Are companies in India rated too? Is such a process being initiated? Rating systems on corporate governance serve as a quick reference point to get an objective and quantitative view of key accounting and corporate governance aspects. Quantitative ratings on corporate governance can help stakeholders in screening, compliance and risk monitoring in the companies of interest. For example, Thomson Reuters provides indepth, objective and comparable ESG (Environmental, Social and Governance) data covering environmental, social, and corporate governance aspects for 4300+ companies globally including S&P 500, FTSE 250, the MSCI World Index, the 250 MSCI emerging markets companies etc. However, it should be kept in mind that qualitative factors such as quality of interactions at board meetings, active role played by independent
directors play an equally important role. Some of the global rating data providers are already offering corporate governance ratings for key Indian companies and such ratings are also being offered by local rating agencies such as CRISIL, ICRA etc. Pfizer is rated F with an AGR score of 1, whereas GSK is rated 52 but both had to pay $2.3 million and $three million respectively for allegations of fraud. How do rating models help then? Without commenting on specific players or specific rating models, I believe rating models on corporate governance are good indicators to get a measurable sense of corporate governance initiatives, they are not a solution to governance woes though. It is equally important to focus on a variety of other factors like quality of interactions at board meetings, tough and probing questions by directors on critical issues, active role of independent directors including separate meetings on key issues, thorough review of board pre-read materials etc. Therefore, in addition to such external monitoring measures, companies should
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MANAGEMENT also focus on reviewing internal frameworks for risk control and monitoring mechanisms. How aware and proactive are board members in India when it comes to corporate governance? What risk management systems are in place? With the enhanced regulatory scrutiny, guidelines and general awareness on corporate governance, boards are increasingly becoming aware of their critical role and responsibilities in tackling issues around corporate governance. For example, the section 134 of the Companies Act mandates a Board of Director’s Report covering key elements like risk management policy, internal financial controls, board performance evaluation etc. This ensures that the board of directors adhere to key elements. How do you hope to make board members more aware of corporate governance and the role they need to play?
Thomson Reuters is committed to create greater awareness of and establishing standards in corporate governance, board collaboration and transparency in India. We intend to achieve this through: 1. Thought leadership events ● In collaboration with IICA,
we recently conducted a round table discussion on “Corporate Governance Standards in India – Gaps and Global Practices” hosted on the distinguished visit of The Lord Mayor of London, Alderman Fiona Woolf CBE. The round table brought diverse perspec-
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tives from the corporate sector, consulting, academia, legal and government professionals and delved deep on elevating corporate governance standards in India. ● We plan to follow this with a white paper on corporate governance covering the four
broad themes discussed at the round table - board composition, global governance requirements, anti- corruption and fraud risk mitigation and corporate social responsibility. 2. Orientation programmes - Each orientation programme conducted by us for the board of directors comprehensively covers the roles and responsibilities of the directors as well as the Indian and global best practices. We have already conducted such programmes for public sector boards in India. We are now looking at expanding to other sectors in collaboration with the IICA. Thomson Reuters Governance, Risk and Compliance (GRC) solutions are designed to empower audit, risk and compliance professionals, business leaders, and the boards they serve to reliably achieve business objectives, address uncertainty, and act with integrity. shalini.g@expressindia.com
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RESEARCH I N T E R V I E W
‘Biologic molecules are complex’ Ashleigh Wake, the Biotechnology Programme Manager, Intertek Pharmaceutical Services Manchester, talks about different aspects related to characterisation of biopharmaceuticals, in discussion with Sachin Jagdale
What are the essential steps you would have to take to comprehensively characterise a protein therapeutic? The analytics chosen should be capable of fully elucidating the physiochemical, structural and biological features of the molecule, as well as quantifying purity and levels of impurities. More so, the testing should have a strategic approach – meaning that it should include consideration of features which are of greatest potential relevance to efficacy or safety of this specific molecule. For example, prior to finalising a testing programme designed to assess purity/impurities it should be fully understood what the potential impurities are and thus confirm that the methods applied are fully capable of identifying, and if appropriate, quantifying these species. This particular aspect should be achieved through the application of forced degradation studies using extreme environmental factors to aid in the prediction of likely, or possible, degradation pathways. Which regulatory guidelines are pertinent to this area? Regulatory agencies throughout the world have issued documents detailing the general expectations for characterisation of biopharmaceuticals such as the EMEA Biolog-
The testing should have a strategic approach – meaning that it should include consideration of features EXPRESS PHARMA
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RESEARCH ical Medicinal Products, last updated May 22, 2015. In terms of the considerations during characterisation the guidance in 'ICH Q6B; Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products,� adopted May 2001, gives perhaps one of the most detailed descriptions of what should be included or considered during characterisation. Explain the concept behind the 'orthogonal technique' approach? Given the complexity of the biologic molecules under evaluation, the application of 'orthogonal' or alternative techniques are often required in order to provide confidence in results but also to provide analytical packages to support product development from R&D through to manufacture. For example, considering an evaluation as simple as intact molecular weight, mass spectrometry provides perhaps the most accurate measure of molecular weight and this approach is ideal when considering analysis of a lyophilised material typical of an early phase product. Once the material is formulated as in the final product the excipients may be incompatible with a mass spectrometry endpoint and thus have to be removed prior to analysis. This introduces the risk of affecting the structure or properties of the
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active biologic in some way. Using an alternative technique such as SEC-MALLS or SDS-PAGE could be used in preference. What are some of the hot topics concerning characterisation currently? There are multiple areas which could be considered as hot topics at the moment, such as assessment of aggregation, post translational modifications and protein interactions. However, given the huge advances in analytical capability and information obtainable all topics can be considered as 'hot' as molecules can in general be characterised to a greater extent than previously possible. Protein aggregation remains to be a hot topic in the industry. How would you conduct an aggregation study? There are multiple methods applicable to the assessment of aggregation; this is one area in which orthogonal testing is a must to ensure the validity of the result. Typically one stationary and one dynamic approach is applied such as Analytical Ultracentrifuge (AUC) or Size Exclusion Chromatography (SEC) and Dynamic Light Scattering (DLS) or SDS/NATIVE PAGE/western blot. In the course of a protein therapeutic stability study what would be the key at-
Once the material is formulated as in the final product the excipients may be incompatible with a mass spectrometry endpoint and thus have to be removed prior to analysis tributes that you would monitor as stability indicating? Testing needs to be performed to assess the levels of purity and impurities using methods that have been shown to be stability indicating in a way similar to what would be expected for small molecules. This includes the assessment of fragments and aggregates etc. In addition the biological potency of the molecule throughout the storage needs to be established along with standards test such as pH, appearance sterility, bioburden and endotoxin etc. Specialised testing looking at certain pertinent structural features, such as secondary or other higher order structural features may also be required. Where these extended analytics are applied testing is usually performed at selected time points only. According to regulatory guidelines for biosimilars extensive comparability testing will be required to
demonstrate that a biosimilar has a comparable profile in terms of their quality, safety and efficacy as the reference product. What are the aims of these studies? To establish that the physiochemical, structural and biological aspects of the biosimilar are comparable to the innovator materials. This is absolute importance to establish that the biosimilar is infact a biosimilar and not a new biological entity (NBE). There is unavoidable heterogeneity observed between different batches of innovator materials themselves therefore when comparing a biosimilar to an innovator, multiple batches of each are required such that comparability can be based on determination if the variability of features within the biosimilar falls within the variability of the same aspect in the innovator. How would you perform them? Which analytical techniques would you use?
A full suite of analytics as used in characterisation are required, including assessment of physiochemical features (such as mass, size, purity/impurities, isoform distribution, concentration), structural features (such as amino acid distribution and sequence, terminal sequence confirmation, disulphide bridge assessment, spectroscopy studies) as well as assessment and comparison of biological potency. What is the importance of carrying out cell-based potency assays as part of a comparability study? Bioassays are used to assess the potency of the molecule. This is a fundamental feature for establishing comparability as it is not enough for the chemistry of the molecules to be comparable but the species such also be shown to have the potential to produce the same response Monoclonal Antibody therapeutics (mAbs) and Antibody drug conjugates (ADCs) appear to be very promising for the future. What are the specific complexities of a characterisation a mAb? Generally all issues to do with mAbs are related to their size which is around the 150KDa region. This makes all analytics more complex. sachin.jagdale@expressindia.com
RESEARCH INSIGHT
Genetically engineered livestock new technologies,new opportunities Prof Bruce Whitelaw, Genus Chair of Animal Biotechnology, The Roslin Institute, University of Edinburgh, Visiting Fellow, DBT National Institute of Animal Biotechnology, Hyderabad, gives an outlook about the requirement of genetic engineering
NEW GENETIC engineering (GE) tools are exciting both the international animal breeding and biotech commercial sectors. Given the opportunities to enhance Indian agriculture and the pressing need this large country has for food security, it is very timely for both the Indian academic and commercial entrepreneurial communities to embrace this motivating prospect. GE is a biotechnology tool involving manipulation of the genome of an organism. First applied in bacteria, GE mice followed quickly with initial success reported in 1974, followed by a rapid and huge uptake by the academic research community since. A decade later, the first GM livestock were produced in the US in 1985. Since then the gradual progress has deterred the wide scale application of the technology. Recent advances now change this entire sector. The genetic engineer, of which I am one, can alter the genome of animals in a precise manner; subtle genetic changes can be engineered which enhance the function of an animal. Working in this field for nearly 30 years I have seen it first emerge then stutter its way forward. Initially, simply being able to add a gene (termed a transgene) to the genome was deemed a success. However, the tools available were crude. A transgene could be added but it would be integrated randomly within the genome. The result was an ani-
PROF BRUCE WHITELAW, Genus Chair of Animal Biotechnology, The Roslin Institute, University of Edinburgh, Visiting Fellow, DBT National Institute of Animal Biotechnology, Hyderabad
mal which may or may not show beneficial transgene activity. We could not control the outcome – we lacked precision. This is no longer the case. The genome of an animal consists of about three billion bases (the bases are A, C, G, T). In this long ‘genomic text’ there are around about 20,000 genes. Genes encode proteins which make up the basis of animal life. We can now engineer in a predetermined manner exactly one base (the target site) in a specific gene – we can hit the ‘needle in the haystack’. To engineer the animal genome we now use genome editing tools. These tools appear to offer the ideal technology for producing GE livestock; one that is both efficient and precise. They function as 'molecular scissors' cutting double stranded DNA precisely at a
single, predetermined location in a genome. Thus specific allelic variation can be engineered, in essence capturing or copy what nature accomplishes through evolution – but on a much, much quicker timescale. Genome editor technology, beyond the desired allelic conversion event, leaves no ‘transgenic’ mark in the genome, and thus differs from the older technology. The impact this will have on regulatory processes and public opinion remains to be shown but has certainly enthuse the academic and interested the commercial sectors of our society. This emerging technology has the potential to be transformative in its impact if applied in the agricultural and biotechnology sectors. During my current visit to India I will be presenting these scientific developments and the opportunities that spring from this new technical position at the International Animal Health and Welfare Conference in Bangalore and the 17th ADNAT Conference in Thiruvananthapuram. The former is organised by the Commonwealth Veterinary Association and provides a key event for promoting and supporting excellence in veterinary education at an international level. At this event I will expound how this technology can be appropriately and successfully applied to agriculture, highlighting opportunities to increase animal welfare. At the latter Conference on Genomics in
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RESEARCH Personalised Medicine and Public Health, I will focus on biomedical applications. I also have the opportunity to address a wider audience at my public lecture hosted by the Karnataka Veterinary Council in association with the Royal (Dick) School of Veterinary Studies of the University of Edinburgh. I am very much looking forward to present the exciting prospect of using these new genetic tools to enhance India agriculture and provide commercial opportunities to the growing Indian bioscience community. In this regard, the progressing thinking by the Department of Biotechnology to establish a National Institute of Animal Biotechnology in Hyderabad provides a strong platform for the fusion of academic and commercial interests in this field. To demonstrate the power of this new technology we have embarked on key projects at The Roslin Institute of the University of Edinburgh, many of which could be easily and quickly developed further in India. Our initial projects aim to enhance the resilience of animals to infectious disease with the dual benefit of positively impacting on both productivity and animal welfare in agriculture. Important target diseases include those most severely affecting animal production, for example Foot and Mouth Disease (FMD), and zoonotic threats such as influenza. Infectious disease is the biggest threat to food security in the 21st century. As livestock production intensifies the industry becomes more vulnerable to devastating disease outbreaks potentially affecting millions of animals (recent examples in the UK being Classical Swine Fever, and Foot and Mouth Disease). In addition to significant primary production losses to individual farmers and disruption of supply chains, it can also result in collateral national losses due to export restrictions. Veterinary measures such as vaccines or traditional genetic selection are unlikely to provide complete protection from the threat of epidemic disease, whereas more radical solu-
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FMD is an OIE-listed disease. It is highly contagious and is perhaps the most feared disease amongst farmers of cloven-footed animals. In South Asia FMD is a priority disease tions do have such potential. The recent breakthroughs in genome engineering technology offer the possibility of developing animals with complete resistance to specific disease pathogens by simultaneously interfering with the biology of the disease agent at multiple points, reducing the possibility that the pathogens can mutate to become infectious to the resistant animals. In addition to enhanced productivity there will be obvious animal welfare benefits of this approach. FMD is an OIE-listed disease. It is highly contagious and is perhaps the most feared disease amongst farmers of cloven-footed animals. In South Asia FMD is a priority disease, with an estimated 600 million susceptible farm animals. In Indian livestock, particularly cattle, buffaloes and small ruminants have a great importance to food security, nutrition and livelihoods, the annual loss due to FMD has been estimated at $800 million. The devastation that this disease can impact on small rural farming communities goes well beyond monetary concerns. Even in countries designated free of FMD, outbreaks can have significant economic damage and social disruption as seen recently in
the UK. The main approach to combating viral infection is through the use of vaccines and although vaccination strategies can have a significant impact on the prevalence of FMDV, they are limited in that there is no cross-protection between the seven serotypes that exist worldwide. Moreover, since FMDV exists in wild-animal reservoirs around the globe, re-introduction of the disease into domesticated livestock poses an on-going problem. Therefore alternative approaches to combat FMDV should be evaluated to complement on-going strategies to combat this disease – and we are proposing
that GE technology could have a significant role in producing animals that are better able to combat this dreadful disease. We are also evaluating genetic engineering solutions to combat influenza in agricultural animals. Influenza also on OIE-listed disease, spreads around the world in seasonal outbreaks causing up to half a million human deaths per year. Although birds are the main animal reservoir from which arguably all new strains have their inception, influenza virus infects many animal species and transfer of viral strains between species occurs. This includes humans and thus this is a zoonotoic disease. Vaccines are available but differ in effect
between virus strains. A genetic approach would offer a long-term solution to controlling this disease. The recent development of genome editor technology has reawakened commercial interest in the use of GE livestock in animal breeding for agriculture and has the potential to re-shape the debate in this area. Genome editor technology, beyond the desired allelic conversion event, leaves no ‘transgenic’ mark in the genome. Opportunities for both the academic and commercial communities abound. I look forward to exploring the development of this biotechnology in India through colleagues and friends.
RESEARCH RESEARCH UPDATES
Sunshine Biopharma begins construction of mouse xenograft models for pancreatic cancer To advance Adva-27a as a treatment for this deadly form of cancer
SUNSHINE BIOPHARMA, a pharmaceutical company focused on the research, development and commercialisation of drugs for the treatment of various forms of cancer, has initiated the construction of mouse xenograft models for pancreatic cancer as part of the plans of positioning Adva27a for clinical development for pancreatic cancer in parallel with multi-drug resistant breast cancer. The work is being conducted in collaboration with Sunshine Biopharma’s parent company, Advanomics Corporation, the co-recipient of $1.45 million in research grants in Canada. As previously announced, Adva-27a, a Topoisomerase II inhibitor, was found
to be effective at destroying cells of the very aggressive pancreatic cancer cell line, Panc-1. "Conducting tests in pancreatic cancer xenograft models is the next step in our preparations for doing parallel breast cancer and pancreatic cancer clinical trials of Adva-27a," said Dr Steve N Slilaty, Chief Executive Officer, Sunshine Biopharma. "Pancreatic cancer is an extremely aggressive form of cancer with essentially no effective treatment options available today. We are heartened by the prospects that Adva-27a could become an effective therapy for patients suffering this deadly form of cancer.” EP News Bureau - Mumbai
Raptor says Huntington’s disease drug slows loss of muscle control RAPTOR PHARMACEUTICAL Corp said its experimental brain disorder drug slowed the loss of muscle control in patients with Huntington's disease after 18 months of treatment. The drug, codenamed RP103, slowed the progression of muscle spasms, eye and hand movements and loss of balance compared to a placebo, Raptor said. The news comes two days after Australia-based Prana Biotech-
nology said its experimental drug improved cognitive function in patients with Huntington's disease. Raptor's trial enrolled 96 patients with Huntington's disease, a genetic disorder caused by the degeneration of nerve cells in parts of the brain, resulting in the loss of executive function and uncontrollable movements. Patients enrolled in the threeyear study were allowed to take
other medications for Huntington's diseases, including tetrabenazine, a drug to treat involuntary muscle movements. Raptor said that of the 66 patients who had not been taking tetrabenazine, those receiving the company's drug showed a statistically significant 58 per cent slower progression in loss of muscle control, compared with the placebo. Including patients taking tetrabenazine and the
Raptor drug, the treatment group showed a 32 per cent slowdown in loss of control, compared with the placebo. Tetrabenazine is sold by Lundbeck under the brand name Xenazine, the only approved treatment for involuntary movements caused by Huntington's disease. The company also said seven patients discontinued treatment during the study. Six of them were
treated with the Raptor drug. Raptor said adverse events were similar in patients treated with the drug and the placebo. The company's drug is designed to increase the levels of a protein that supports the survival of cells in the brain. Raptor is also testing the drug in a midstage study for non-alcoholic fatty liver disease in children. Reuters
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PHARMA ALLY VALUE ADD
Cleanroom gloves or medical gloves? Suppliers of specialist gloves are often asked to supply medical gloves for use in cleanroom applications. On the face of it, this doesn’t seem unreasonable, however, the introduction of medical gloves into a cleanroom could have serious repercussions. A quick conversation is usually enough to help the customer to specify an appropriate product, but why does the misunderstanding arise in the first place? The following article by Derek Watts, Managing Director, Nitritex sets out to explain why the two applications are often incompatible
PERCEIVED WISDOM is that gloves used in medical environments are sterile, as the purpose of medical gloves is to prevent cross-infection from the clinician or surgeon to the patient. Surely, therefore, medical gloves must be very clean. This is a misconception and only partly true. The ultimate purpose of sterilising surgical gloves to be used in operating theatres is to prevent infection from bacteria which would otherwise be present on the gloves. Contrary to the belief of many, the standard dispenser boxed examination gloves used in medical and dental environments are not sterile, and all they can do is prevent cross infection spreading from the wearer of the gloves to the patient. The patient is not protected from the multiple bacteria that are already present on the gloves. Dentists are still allowed to use powdered gloves but all medical gloves used in hospitals in the UK have to be powder free. The traditional way to make a glove powder free was for it to be put through a process of chlorination after it had been removed from the production line. The process of chlorination not only removed all the powder but it also killed the bacteria on the glove. As such, provided the packers of the exam gloves wore clean gloves, one could be reasonably assured that the examination gloves would have a very low bacteria count.
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Nowadays, however, powder free medical gloves are rarely made through a process of chlorination (inside and out), as in the interests of economy, other manufacturing methods for these gloves have been developed and established. Most powder free medical examination gloves are now either produced on-line by dipping them into a polymer coating or by chlorinating them on-line prior to stripping them off the glove formers. Because gloves are moulded inside out, chlorination takes place only on what is ultimately the inside of the glove. The outside does not come into contact with the chlorine and therefore the gloves will be prone to having a lot more bacteria as compared with off-line chlorinated gloves. Pharmaceutical manufacturers will normally require
sterile gloves, but in addition to the sterility, they also require the gloves to be low in particulates, especially if they are making injectables. There are many ways that particles get on the gloves. The main origin of the particles is human cells, followed by tiny fibres from clothing. There is little emphasis
Figure 1: Surgical glove packaging showing peel pouch and paper wallet
during the production and packing of surgical gloves on the minimisation of either of these, and as a result sterile surgical gloves frequently have high particle counts, albeit of sterile particles. As a further indication of the lack of concern for particles in medical environments, you just have to look at the packaging of standard surgical gloves (see Figure 1). They are packed in paper inner wallets which are then, traditionally, sealed into paper pouches that have a tendency to shed particles when peeled open. The sealed pouches are then further packed into cardboard boxes. Paper is a no-no in all non-medical cleanroom environments, so all of this packaging is unacceptable. In contrast to the paper packing of surgical gloves, sterile cleanroom gloves are
packed using non-particulating materials such as polyethylene inner wrappers and easy-tear pouches (see Figure 2). All this packaging is itself manufactured in a cleanroom to ensure its cleanliness, and comes technically specified. In some cases, it will not be necessary for pharma manufacturers to use sterile gloves, for instance if making tablets. However, it is still important that the particulates on the gloves are low. Not only do the particulates need to be low, but the bacteria count on the nonsterile gloves will also need to be very low. This is why it is important that cleanroom gloves are used for this application. All good cleanroom gloves are chlorinated off-line, meaning that both the inside and the outside of the gloves are thoroughly dosed in chlorine. They
Figure 2: Cleanroom glove packaging showing easy tear pouch and PE wallet
TABLE 1. RELATIVE PERFORMANCE OF THE FOUR MAIN GLOVE MATERIALS Comfort
Elasticity
Strength
Durability
ESD performance
Latex
Excellent
Excellent
Excellent
Good, but punctures can be hard to spot
Very poor. Latex is an excellent insulator
Polychloroprene
Good; very close to Latex
Good
Good
Good
Poor – Good Insulator
Nitrile
Good; comfort improves with wearing
Medium
Medium
Good
Good. Static dissipative and improves with wearing
Vinyl
Fair; relatively stiff
Low
Low
Medium
Good. Static dissipative and improves with wearing
are then washed in highly filtered water to remove the residual chlorine and other particles. Whilst the removal of particles is important for gloves used in the manufacturer of pharma products, removal of ionic contamination is not of importance. However, for the micro-electronics industry, whilst a low particle count is extremely important, in addition to this, many manufacturers also consider low ion counts to be a critical requirement. Ionic contamination can greatly reduce the yields in the manufacture of electronic products such as hard disk drives, printed circuit boards and silicon wafers. Ions such as chlorides, nitrates, sulphides, sodium, potassium, etc are byproducts of the chemicals used in the manufacturing process. All of these particles rest on the surface of the glove and require mechanical removal. This is achieved by washing the gloves in ultra-pure, de-ionised water, and then drying just before packing. Having demonstrated that medical gloves are not suitable for cleanroom use, we have to ask “What actually are the important characteristics of cleanroom gloves.” The number one characteristic, which has already been established, is the cleanliness of both the glove and its packaging. However, beyond that, users have a wide selection of gloves to choose from to match their application. It is probably true to say that for every cleanroom application there will be a number of options available to the
purchaser, and that final selection frequently comes down to the preference for one glove over another based on purely subjective criteria such as fit and feel, level of grip etc. One thing that the user should be able to take for granted, is that the physical properties of the gloves should reach minimum standards. However, the cleanroom glove community has evolved without defining exactly what the minimum standards should be. This void has been partially filled by glove manufacturers using the existing medical glove EN 455 standards1-3, to define dimensions, strength and limits on the numbers of pinholes as a basis for quality assurance and quality control in their factories. What is equally important is that glove manufacturers specify the cleanliness class for which the glove is suitable, as defined in EN ISO 14644-14, e.g. ISO Class 4 or ISO Class 5. It should be noted that some cleanroom gloves are also specifically chosen because they protect the wearer from harm from chemicals. These gloves are classed as Personal Protective Equipment (PPE) and are regulated under the European PPE Directive5 and its associated standards6. Obviously such gloves must at the same time comply with cleanroom requirements. The other issues that the specifier needs to consider are the shape of the gloves and the type of rubber used for their manufacture. Lower cost bulk packed non-sterile gloves are normally flat form, ambidextrous, with the thumb emerg-
One thing that the user should be able to take for granted, is that the physical properties of the gloves should reach minimum standards ing at the side, allowing the glove to be donned on either hand. These gloves are excellent for general purpose use in the cleanroom, but every movement of the fingers and thumbs has to overcome the resistance of the glove material, which has a natural tendency to maintain its original shape. In most applications, this will not present a problem, however, if the wearer is constantly engaged in very fine work, requiring precise movements, then the resistance of the glove can cause fatigue in the hand and, in particular, the finger muscles. For precision work, hand specific gloves are a much better option. Hand specific gloves are moulded with a slight curve to the fingers, and with the thumb offset to the front in a much more natural position than am-
bidextrous gloves. These design features mean that the wearer is not fighting against the natural behaviour of the rubber and instead the rubber is assisting the wearer where fine control is required. If operators are involved in very fine work, the thickness of the glove becomes important, as does the level of grip and the texture of the fingertips and palm. In terms of wearer comfort, natural rubber latex (NRL) is probably the best option because of its elasticity and strength. However, there are concerns surrounding latex allergies which can affect the wearer and also make the gloves unacceptable in some pharma manufacturing applications where possible contamination with NRL proteins would render the processed drugs unusable. The alternative synthetic rubber materials are polychloroprene, nitrile and vinyl. Amongst the synthetic rubbers, polychloroprene has the characteristics closest to NRL and provides a very good alternative. Nitrile and Vinyl are stiffer materials with vinyl being the least elastic; however both nitrile and vinyl have good electrical conductivity properties making them ideal for use in electronics manufacturing or other static-sensitive environments such as explosive or combustible atmospheres. In conclusion, it is simple to state that medical gloves should not be used in a cleanroom environment. Medical gloves may appear to be clean (and might even have been sterilised), but in cleanroom
terms they can be very dirty. Cleanroom gloves are available in different materials, different shapes, different lengths, different thicknesses and different textures and levels of grip. It is, therefore, important that the person specifying the gloves knows a) what level of performance is required to match their process, and b) what the requirements of the wearers are. For some applications, the selection of the correct glove will be straightforward, but for others a bit more work may be required. Any good manufacturer of cleanroom gloves will be able to provide written specifications, advice and samples to aid the decision making process.
References 1. EN 455-1: 2000, Medical Gloves for single use – Part 1: requirements and testing for freedom from holes. 2. EN 455-2: 2009, Medical Gloves for single use – Part 2: requirements and testing for physical properties 3. EN 455-3: 2006, Medical Gloves for single use – Part 3: requirements and testing for biological evaluation. 4. EN ISO 14644-1:1999, Cleanrooms and associated controlled environments, Classification of air cleanliness 5. 89/686/EEC, Council Directive on the approximation of the laws of the Member States relating to personal protective equipment 6. Gloves as PPE: Standards for permeation and penetration, Derek Watts, Clean Air and Containment Review, Issue 2, April 2010
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PHARMA ALLY VENDOR NEWS
Agilent Technologies introduces ICP-MS and MP-AES platforms New systems provide unprecedented performance and value
AGILENT TECHNOLOGIES has introduced the 7900 Inductively Coupled Plasma - Mass Spectrometer (ICP-MS) and the 4200 Microwave Plasma Atomic Emission Spectrometer (MP-AES), the latest in a series of groundbreaking technologies featured in Agilent’s portfolio of spectroscopy solutions. The 7900 ICP-MS and 4200 MP-AES are the most sophisticated, userfriendly elemental analysis technologies available today. Newly streamlined operational features also make them ideal for a wider range of challenging applications and more accessible to a broader spectrum of laboratory personnel. “At Agilent we continue to introduce ‘new to market’ technologies across our platforms, enabling our many customers to expand their labs’ capabilities and simplify their workflows," said Philip Binns, Agilent, Vice President of spectroscopy products, Agilent Technologies. 7900 ICP-MS: A new standard in quadrupole ICP-MS Performance The 7900 ICP-MS is a complete redesign, sharing only a few key components from the world's bestselling 7700 series.
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The 7900 has been engineered and optimised to provide elemental laboratories with the industry's most powerful and easyto-use quadrupole ICP-MS solution.
and majors in the same run. An industry-first capability, this eliminates analyte-specific tuning and simplifies method development, virtually eliminating over-range results.
The features include:
Redesigned MassHunter software features a simpler, more intuitive user interface along with powerful method automation capabilities. Another industry first, the new method set-up wizard makes method development easier than ever, automatically building methods based on answers to a simple user questionnaire.
Unprecedented matrix tolerance - Ultra-high-matrix introduction technology enables laboratories to measure samples containing up to 25 per cent total dissolved solids, 10 times higher than the current benchmark held by the 7700 ICP-MS limit. This enables direct measurement of sample types previously inaccessible by ICP-MS. Enhanced trace-level detection - A novel interface design, optimised expansion-stage vacuum system and new orthogonal detector system (ODS) reduce background and improve sensitivity, dramatically improving signal to noise for 10-fold lower detection limits than any quadrupole ICP-MS system available today. Widest dynamic range of any quadrupole ICP-MS - patented ODS technology delivers up to 11 orders of magnitude dynamic range, from sub-ppt to per cent-level concentrations, which enables users to measure trace elements
4200 MP-AES Series: A novel breakthrough in entry-level elemental spectroscopy technology. The 4200 MP-AES features a variety of unique capabilities: Safe and economical - Because flammable and oxidising gas sources are not required for use, the system can be left unattended while performing overnight multi-element analysis, which dramatically increases laboratory safety and flexibility and reduces operating costs compared to flame AA. Robustness and reliability - Optimised high-performance waveguide and new torch design pro-
Stemade Biotech launches flexible payment option pricing plan Endeavour is to make the painless dental stem cell preservation an affordable one
duces a robust nitrogen plasma, which enables greater tolerance to complex matrix samples such as those used in mining, food and agriculture, chemicals, petrochemicals and manufacturing. Mass flow control of the nebuliser gas enhances accuracy and longterm stability in complex samples. Ease of use - Applicationspecific software applets plus plug-and-play hardware ensures that with just minimal training, any user can quickly and easily conduct analyses without the need for method development or alignment. Advanced software platform - Newly released MP Expert software features advanced tools such as "FLIC" and IECs for assisting in eliminating spectral interferences. Mobile and remote capabilities - With no external cylinder connections and no need for ongoing gas supplies, the MP-AES is ideal for any elemental analysis laboratory-especially remote sites and mobile laboratories. This eliminates the need to plumb multiple gasses into the laboratory or manually transport and handle hazardous gas cylinders.
STEMADE BIOTECH, which is into dental stem cells preservation in India, has launched a flexible payment option pricing plan that begins at just ` 33,000 for the first year. Speaking on the launch of these new pricing plans, Shailesh Gadre, Managing Director, Stemade said, “Our endeavour is make this painless process of stem cell preservation affordable and to reach out as many households in India as possible. Dental stem cell preservation is the perfect way for investing in future and securing the health of our loved ones. Stem cells are the future for therapeutic and regenerative medicine.” Dental stem cells preservation involves collection of stem cells from the dental pulp, which is the soft living tissue inside a tooth. These stem cells are found in both, baby teeth (milk teeth of children in the age group of five to 12 years) and permanent teeth of young adults ideally below 30 years of age. The cells can also be found in premolars of teenagers wearing braces. The quantity and quality of dental stem cells decrease with age and therefore, the younger the age of the person- the better the stem cells. The collected stem cells can be used repair and cure 'tissue and organ related diseases' such as bone, cartilage, liver, diabetes, arthritis and many more. These stem cells are preserved in cryogenic tanks at a temperature below minus 150 degrees. These dental stem cells have the potential to be used for treating many diseases. This eliminates the need to find a suitable donor and associated complications. Dental pulp stem cells are plentiful and easy to collect. Unlike other modes of getting stem cells, these stem cells are easy to collect as children lose their milk teeth as a part of growing up. These children can give one of their 'about to fall' milk teeth for securing their future. This is a painless process and takes less than 10 minutes to complete the tooth collection. Adults can also benefit if they are getting their premolar or wisdom tooth removed.
EP News Bureau-Mumbai
EP News Bureau-Mumbai
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We care for your family . . .
Anti-Inflammatory Enzymes Serratiopeptidase Peptizyme (enteric coated serratiopeptidase granules) Trypsin Chymotrypsin mix ( 6:1)
Probiotics Saccharomyces boulardii Lactic acid basillus sporogenous
Circulatory Health Nattokinase
Bio Catalysts Immobilized Cal B
Digestive Aids Alpha amylase / fungal diastase / fungal amylase Alpha galactosidase Bacterial alpha amylase Bromelain Hemicellulase Lactase Lipase Ox bile
Papain Pepsin Pancreatin Protease ( acid / alkali)
Advanced Enzyme Technologies Limited Sun Magnetica, 'A' wing, 5th Floor, Accolade Galaxy, LIC Service Road, Louiswadi, Thane(W) - 400604, India Tel: +91 22 41703200, Fax: +91 22 25835159 • E-mail : info@enzymeindia.com • Website: www.enzymeindia.com
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Gulf Analytical Supplies FZE M/s. Gulf Analytical Supplies FZE have an established presence of nearly a decade In the Middle East market and have a dominant presence in the field of separation science comprising mainly of chromatography with more than thousand columns supplied in the Middle East. M/s. Gulf Analytical Supplies FZE with the help of application support and technical support from our principals, are the pioneers in the field of column chromatography. M/s. Gulf Analytical Supplies FZE form a one stop shop for all chromatography related products including Columns, Guard columns, Ferrules, Septa, Focus liners, Unions, Injectors and the complete range of Analytical/ Auto sampler syringes beside HPLC syringes. Accessories include valves, jumbo syringes and Flow meters for LC columns. M/s. Gulf Analytical Supplies offer a range of GC based petroleum Analyzers from M/s. Great Scientific . M/s. Gulf Analytical Supplies offers a range of LABSERV micro pipettes from M/s. Fisher Scientific , part of Thermo Fisher. M/s. Gulf Analytical Supplies offers a range of LC columns from M/s. Knauer - Germany .
Product List Micro Syringes e Vol- World's First Digitally Controlled Analytical Syringe Capillary columns HPLC columns-UPLC, Analytical, Semi Prep, Prep, Chiral Septa, Liners, Ferrules, Traps, Tubing, Unions ETP - Electron Multiplier Micro Pipettes
Refinery Gas Analyser (RGA) Fast Refinery Gas Analyser (Fast RGA) Natural Gas Analyser (NGA) Fast Natural Gas Analyser (Fast NGA) PIONA /PONA/PNA, DHA Analyser Simulated Distillation Analyser (SimDis) Benzene Toluene Analyser (BTA) BTEX Analyser MTBE Analyser LPG Analyser Dissolved Gas Analyser (DGA) TOGA
Contact Us : Gulf Analytical Supplies FZE SAIF Plus R6 -47/B, P.O.Box: 7995, SAIF Zone, Sharjah, U.A.E. Tel. : +971 6 557 3341 | Fax : +971 6 557 3541 | Mob. No : +971 50 3011073 Email : support@gulfanalyticalsupplies.com | Website : www.gulfanalyticalsupplies.com
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14 Station Offline Dissolution System
5 Parameter Tablet Tester
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Quality Through Experience By Erweka India
GmbH Germany
TBH 125 TD
TBH 425 WTD
TBH 525 WTD
Dissolution Tester Tester Type Type USP 3 - 7
Dissolution Tester Tester
New Bathless Disintegration Tester Tester
Multicheck 5.1
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Leak Test Test Apparatus
Local Contact Erweka India Pvt Ltd. Plot No. 29, Survey No. 415, N. H. No. 8A, Sarkhej-Bavla Road Village-Moraiya, Tal. Sanand, Dist. Ahmedabad-382213 Tele: +91-9228022065 Email : sales@erwekaindia.com www.erwekaindia.com
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PHARMA LIFE APPOINTMENT
Lupin appoints Dr Maurice Chagnaud as President-Europe & Head of Inhalation Strategy Will assume full responsibility for the company’s European business including the company strategy for generics LUPIN HAS appointed Dr Maurice Chagnaud as its President, Europe and Head of Inhalation Strategy. He will be based at Schaffhausen, Switzerland. Chagnaud has over 20 years of experience in pharmaceutical business in Europe having worked with Teva and Merck Generics. He joins Lupin from Israeli drug
major, Teva, where he was the Senior Vice President, Central & Eastern Europe, responsible for revenues in excess of over euro one billion. In his new role at Lupin, Chagnaud will assume full responsibility for the company’s European business including the company strategy for generics and speciality busi-
ness in Western and CEE region including Russia and CIS countries. He will also be responsible for developing Lupin’s core strategy for inhalation in the developed markets. Vinita Gupta, Chief Executive Officer, Lupin said, “Over the years, Lupin has recorded consistent growth across ad-
vanced markets like the the US and Japan. With Maurice’s rich experience we look forward to building our business in Europe, in particular around complex generics and speciality. We are delighted to welcome him into the Lupin family.” EP News Bureau - Mumbai
CAMPUS BEAT
Sinhgad College of Pharmacy organises Bravura 14 Around 200 students from different pharmacy institutes participated
SINHGAD COLLEGE of Pharmacy recently organised Bravura 14 Pharma tech event. All pharmacy colleges of Sinhgad Technical Education Society (STES) took part in the event at Vadgaon campus. Around 200 students from different pharmacy institutes participated in it. Various competitions were held during Bravura 14 to exhibit out of box- innovative advertisement competition, logic to magic- industrial trouble shooting competition, eureka- research project competition and simulation- 3 D model making
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competition. Winners of the competition received cash prize of ` 5000 and runner up of the competitions received cash prize of ` 3000. Rachana Navle, Vice President Administration STES took the initiative and Dr KN Gujar, Principal, Sinhgad College of Pharmacy along with Dr SD Sawan, Principal, SKN College of Pharmacy, Dr SB Bhise, Principal Sinhgad Institute of Pharmaceutical Sciences and Dr CR Kokre, Principle, Sinhgad institute of Pharmacy executed the innovative idea. EP News Bureau - Mumbai
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.