VOL. 10 NO. 5 PAGES 64
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Market ‘Regulation is an integral part of our business’ Management Towards holistic healing
1-15 JANUARY 2015,` 40
CONTENTS MARKET Vol.10 No.5 JANUARY 1-15, 2015 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap
Towards holistic healing
9 10
Delhi Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Yuvaraj Murali Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar
Express Pharma goes beyond allopathyin this special section, which looks at howage old remedies like ayurveda are being rediscovered as possible solutions to lifestyle diseases while stem cells,the product of newage medical science,offers tantalising possibilities | P28 P16: POST EVENT Indo-Israel Innovation colloquium discusses strategic business opportunities
P40: RESEARCH UPDATE People with blood groups A, B and AB at higher risk of type II diabetes than group O
MANAGEMENT
30
POTENTIAL OF REGENERATIVE MEDICINE
32
AYURVEDA – A POTENTIAL GLOBAL MEDICAL SYSTEM
35
INTEGRATIVE MEDICINE: AN IDEA WHOSE TIME HAS COME
P41: VALUE ADD Particle sizing — Exploring the rigour and requirements of analytical QbD
P45: VENDOR NEWS
‘REGULATION IS AN INTEGRAL PART OF OUR BUSINESS’ INDIA OFF USTR’S OCR HOOK … FOR NOW
RESEARCH
36
OUR FOCUS IS ON IDENTIFYING OTHER GENES THAT CONTRIBUTE TO HEREDITARY CANCERS
Express Pharma wishes all its readers a
HAPPY NEW YEAR
Kezzler partners with Belgium-based UCB for Indian market
P58: AWARD Biocon, Sun Pharma awarded for innovation
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
Forecast 2015: Hope springs eternal
A
s the adage goes, look before you leap. We’d like Express Pharma’s first issue of 2015 to be a primer for the year ahead and thus asked a cross section of industry thought leaders to crystal gaze into the future. The forecast for 2015 seems to be mostly ‘gloom and doom’, peppered with the hope that the worst is behind us. Culling the most recurrent predictions featured in our cover story (Jan 1-15 2015, pages 18-26), it’s clear that regulations and by extension, regulators, will set the pace of growth (or degrowth) in 2015 as well. Industry association chiefs like OPPI’s Ranjana Smetacek, IDMA’s SV Veeramani and ABLE’s Dr PM Murali remain cautiously bullish on the sector, provided progress is made on their laundry list of suggestions to the government, which are sure feature in their budget wish list. The government has shown it is willing to listen to industry demands; the latest example being the medical devices sector. On Christmas Eve, the medical devices segment was carved out into a separate sub category, with amended FDI rules that allowed 100 per cent FDI. 2015 could see a spurt in investments in local med device manufacturing and hopefully lower prices of medical devices like heart stents as well as diagnostic kits, most of which are imported today. Will 2015 will be a better year to conduct clinical research in India? Industry sources point out that in the two years since the Swasthya Adhikar Manch’s PIL, they have not had a chance to plead their case. They are hoping that since the next Supreme Court hearing on January 13 is on a non-miscellaneous day, they will finally have an opportunity to have their say. Dr Viraj Suvarna of Boehringer Ingelheim hopes that the Solicitor General of India will give a fitting riposte to the petitioners and the Chief Justice will be satisfied. His hope that the stranglehold on clinical trials will be lifted is echoed by LexCounsel, the legal firm representing the Indian Society for Clinical Research (ISCR) in the case, who reason that once the PIL is resolved, there will be some stability in the clinical research scenario in the country which will in turn allow regulators to address other areas of oversight in the modified regulations. Christmas Eve had another ‘gift’ for the pharma sector: the Department of Industrial Policy and Promotion (DIPP) released the first draft of the National IPR Policy. It will no doubt be analysed and compared to IPR policy recommendations submitted to the DIPP on October 21 by a three-
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It seems our analysts expect adversity to ignite survival instincts.Agile pharma players have revamped their strategy tool kit for 2015
member IPR think tank selected by the DIPP. The DIPP seemingly bypassed these recommendations, putting together a second IPR think tank. While the first think tank comprised three academicians, questions have been raised about the conflict of interest some members of the second think tank have, as they represent pharma companies on IPR matters. Legal eagle Dr Gopakumar Nair feels that the Indian pharma industry has been under a siege on various fronts in 2014 and with more changes on the anvil, like the proposal to bring all pharma related regulatory and administrative activities under one roof, there is no doubt that the churn will continue into 2015. To end on a more optimistic note, hope still springs eternal. It seems our analysts expect adversity to ignite survival instincts. Agile pharma players have revamped their strategy tool kit for 2015. For example, Glenmark’s Glenn Saldanha predicts that companies with a differentiated product portfolio and strong emphasis on brand building will outperform industry growth rates. In terms of which markets will be future growth drivers, he flags off LatAm and certain emerging markets in Asia and Africa. Both Saldanha and Venus Remedies’ Dr Manu Chaudhary are gung ho about the opportunities but underline the role of the government to create a supportive infrastructure, encourage R&D and fast track clinical trial and marketing approvals. Chaudhary also underlines the need for clarity on regulations related to herbal medicines. If 2014 was about surviving, 2015 will be about thriving. Tai Pi Advisors’ Anil Khanna predicts that as price controls put pressure on profits, companies will explore new distribution and marketing models, with some companies even supplying direct to patients. Such models are already underway globally (AstraZeneca’s Arimidex Direct and Pfizer's Lipitor for You programmes); it remains to be seen if these will fall foul of the pharma marketing practices code which as per government decree, will kick into effect from January 1. Stock analysts like Sarabjit Kour Nangra of Angel Broking predict that most pharma stocks will out perform the Sensex and as markets like Russia become unstable, developed markets will stabilise and strengthen. May the year 2015 bring collaboration rather than confrontation; stability, not strife. VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com
MARKET I N T E R V I E W
‘Regulation is an integral part of our business’ The rapid development and growth of the healthcare market in India requires a lot of innovation and therefore the match between Israeli and Indian companies is synergistic. Israel Makov, Chairman, Sun Pharmaceutical Industries while speaking with Usha Sharma emphasies on the need of innovation in India and shares an example of Taro’s acquisition by Sun Pharma, which had an impressive impact on both the companies
At the Indo-Israel economic forum organised by CII, you made a point that innovation was crucial to the pharma sector and Indian companies should look to Israel as a market as well as source of innovations. Can you elaborate giving us specific examples on the same? Innovation is a key success factor for companies in the pharma and medical device field. The output and productivity of innovation in Israel is one of the highest in the world. The rapid development and growth of the healthcare market in India requires a lot of innovation and therefore the match between Israeli and Indian companies is synergetic and has a potential to create huge value. Israel is a small market for Indian companies but they can make attractive investments there. A good example is the acquisition of Taro by Sun Pharma, which created enormous value for both companies. The rapid development and growth of the healthcare market in India requires a lot of innovation and therefore the match between Israeli and Indian companies is synergetic and has a potential to create huge value.
While Israel is a small market for Indian companies it offers attractive investments opportunities. A good example is the acquisition of Taro by Sun Pharma, which created enormous value for both organisations. You had also mentioned that Israel is a global pharma market and a lot of innovative drug research is in the process. If this is the scenario then why there are limited number of pharma companies in Israel? Israel is not a global pharma market but an important resource to the global healthcare industry, and thus we have very few global pharma companies but we have many start-up companies that are focusing on innovation. Why do you think it would be difficult for Israel-based pharma companies to venture on their own in India? Considering the scale and complex nature of India's pharma market, it makes significant business sense for Israeli companies to tap the Indian market through local collaborations.
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Regulator expectations are continually evolving across the globe, how will this challenging and crucial element impact pharma companies? And what are your suggestions to cope with this change? Regulation is an integral part of our business. As a responsible member of the pharma industry, it is important that we adapt ourselves to new regulator expectations.
Both governments should initiate, encourage and support events that will serve as a meeting place for both industries, such as conferences and trade fairs
You have said that Indian pharma companies need to have a broader mindset. What do you mean by this? There are over 3000 pharma companies operating in India, but a very small percentage has successfully gone global. Indian pharma companies need to be successful in scaling up businesses globally. To bring transparency and a better system in place what do both the governments need to do? Both governments should initiate, encourage and support events that will serve as a meeting place for both industries, such as conferences and trade fairs. You had mentioned that in Israel there are improved treatment procedures,
management systems. A huge centre of excellence too is coming up. Kindly elaborate. Israel is exploring cooperation in number of areas with Government of Gujarat, including agriculture, industrial research and development, solar and thermal power, pharmaceuticals, water recycling and water desalination plants. Besides India, which other countries are trying to tap the market and why? Why do you feel it is imperative for India to have a strategic partnership with Israeli pharma companies? Globally, Israel is on the R&D radar of most countries. Israel ranked third in the ‘Innovation’ category in the last Global Competitiveness Ranking published by the World Economic Forum. Globally, the country ranks fourth in scientific activity. Six Israelis have won the Nobel Prize in Chemistry in the past decade. Its spending on research and development as a percentage of GDP is consistently and substantially higher than that of such advanced research nations as Japan, the US and the UK. u.sharma@expressindia.com
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January 1-15, 2015
MARKET COMPANY WATCH
India off USTR’s OCR hook …for now 2015 Special 301 Review to be next test of India’s IP laws In a statement issued recently, the Office of the US Trade Representative (US TR) closed the Out-ofCycle Review (OCR) of India indicating that it had noted the steps taken by India on the IP front. But the US TR kept up the pressure, with the statement mentioning that a thorough review of India’s environment for IP protection and enforcement, including progress made on recent IP-related commitments and on engagement through the agreed work plan, would be reviewed as part of the 2015 Special 301 Review. After the 2014 Special 301 Report was published in April 2014, the USTR decided to adopt a ‘wait and watch’ pol-
USTR conceded that India has made useful commitments in recent months to institutionalise high-level engagement on IP issues, pursue a specific work programme and deepen cooperation and information exchange with the US on IP-related issues icy, to observe and engage with the new government taking charge. Against this backdrop, the US TR decided to initiated an OCR of India in the fall of 2014 ‘to evaluate
progress toward achieving meaningful, sustained and effective engagement on IP issues with India’. USTR’s December 12 statement referred to the
‘multiple engagements with Government of India officials at the staff and senior levels on the broad range of issues of concern to the US and to US stakeholders’. It also conceded that India has made useful commitments in recent months including steps to institutionalise high-level engagement on IP issues, pursue a specific work programme and deepen cooperation and information exchange with the US on IP-related issues under the US-India Trade Policy Forum. While it noted these steps, it urged India to further strengthen and deepen bilateral engagement on IP issues in the coming months and beyond. EP News Bureau-Mumbai
DRLcloses acquisition of Habitrol brand from Novartis DR REDDY’S Laboratories (DRL) has closed the acquisition of Habitrol brand (an over-the-counter nicotine replacement therapy transdermal patch) from Novartis Consumer Health following issuance of the proposed consent order from the US Federal Trade Commission (FTC) recently. The company had earlier entered into an asset purchase agreement with Novartis Consumer Health to acquire the title and rights of Habitrol brand and to market the product in the US market. With this closure, the company has assumed responsibility for the product and will commence shipments of the product in the market shortly. EP News Bureau-Mumbai
IITM Incubation cell launches bioincubator for biotech start-ups Endeavours to create a nurturing environment for innovation and encourage commercialisation of promising discoveries THE INCUBATION cell of IIT Madras added a biotech incubator for biotech start-ups to its gamut of incubators. With the support of Biotechnology Industry Research Assistance Council (BIRAC), Govt of India), the IITM bioincubator aims to help start-ups and SMEs develop globally competitive products and launch them into the market successfully. The inauguration of the facility at IITM’s Research Park was done by Professor Bhaskar Ramamurthi, Director, IIT Madras. Speakers who attended the function included, Dr Guhan
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January 1-15, 2015
Jayaraman, Coordinator, IITM Bioincubator, Dr Satya Dash, Manager, BIRAC, Prof Ashok Jhunjhunwala, Faculty-inCharge, IITM Research Park & Co-Chairman, IITM Incubation Cell, Srikumar Suryanarayanan, Chief Executive Officer, Sea6 Energy and Prof D Karunagaran, Head, Dept. of Biotechnology, IIT Madras. The bioincubator endeavours to create a nurturing environment for innovation, and encourage commercialisation of promising discoveries. It offers lab and office space, with the latest, most sophisticated equipment, and centralised
Four companies have been identified as the incubatees for the first phase
utilities for process and product development, to help technologies mature and attain commercialisation. Entrepreneurs can use this as a platform to gain technical advice from the expertise of IIT Madras faculty and researchers to realise business opportunities. Other support services like accounts and tax, company secretary-ship, legal, HR, audit, IP, access to funds, investors, mentors, advisers and consultants, training programmes, and networking events are also made available In collaboration with the IIT Madras Incubation Cell. The bioincubator will
also provide training through workshops to develop skills. Four companies have been identified as the incubatees for the first phase. They are Purius Nanosystems, FIB-SOL Life Technologies, Vital Bioscientific Solutions and Yaathum Biotech. Three of the companies have been started by doctoral students from the IIT Madras Biotechnology Department. This is a positive trend and provides a promising career avenue for those who want to combine research and entrepreneurship in biotech. EP News Bureau-Mumbai
MARKET
Panacea Biotec in collaboration with Rising Pharmaceuticals Under the terms of the agreement, Panacea Biotec shall receive an upfront research fee on signing as well as a milestone payment on approval of the product by FDA PANACEA BIOTEC has entered into collaboration with Rising Pharmaceuticals, involved in marketing and distribution of innovative branded and multisource prescription and overthe-counter pharma products in the US. The collaboration was recently established for an oral controlled release product utilis-
Consistent investments has ensured that our products are recognized worldwide for their quality and efficiency.
Both companies shall share the profits at a pre-agreed ratio
QUALITY EXCIPIENTS FOR THE
PHARMACEUTICAL INDUSTRY
ing Panacea Biotec’s platform oral drug delivery technology. The dossier for the product is currently under review by FDA. Under the terms of the agreement, Panacea Biotec shall receive an upfront research fee on signing as well as a milestone payment on approval of the product by FDA. Upon commercialisation of the product; both companies shall share the profits at a pre-agreed ratio. The product under the collaboration currently has a market size of more than $300 million in the US. Panacea Biotec shall undertake product development and shall manufacture and supply the products; while Rising Pharmaceuticals shall be responsible for sales and distribution of the products in the US. Both companies intend to expand the scope of the alliance by adding new drug delivery based complex generic products to the collaboration. EP News Bureau-Mumbai
EXPRESS PHARMA
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January 1-15, 2015
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MARKET GROWTH TRACKER
IPM grows 10.9 per cent, clocks ` 7243 crores in November 2014 11 therapies have outgrown the IPM growth and have double digit growths THE INDIAN Pharma Market (IPM) clocked ` 7243 crores in November 2014 and has grown at 10.9 per cent. Amongst the top 10, Pfizer grew by 34.1 per cent followed by Ranbaxy at 23.1 per cent and Sun Pharma at 14.9 per cent. 21 corporates have crossed the growth of IPM amongst top 50. Amongst the top 50 corporate, Akumentis has the highest growth of 68 per cent followed by Pfizer at 34.1 per cent and Ajanta at 33.1 per cent. 24 corporates have shown growths more than 10 per cent amongst the top 50. Amongst the 11-20 ranked corporates, Macleods has the highest growth of 24.6 per cent followed by Torrent at 23.3 per cent and Glenmark at 20.3 per cent. Amongst the 51-60 ranked corporates, Panacea grows at 31.3 per cent followed by Pharmed at 25.6 per cent and Corona at 21.9 per cent. Amongst the 61-75 ranked Corporate, Boehringer grew by 83.5 per cent followed by TTK at 18 per cent and RPG at 16.3 per cent. Merck entered the ` 500-crore club and Albert David in the ` 300-crore Club as on MAT November 2014. Indian companies have grown at 9.5 per cent versus 14.9 per cent for MNCs in November 2014. Amongst the top 50 in MNCs, Pfizer grew by 34.1 per cent followed by Merck at 24.5 per cent and Ranbaxy at 23.1 per cent. Under the non-NLEM category, Indian companies grew at 0.4 per cent whereas MNCs grew at 11.1 per cent. The DPCO containing molecules market grew at 3.1 per cent whereas the non DPCO market grew by 12.6 per cent resulting in an overall growth
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WITH BONUS UNITS AT FULL VALUE Val in Crs CORPORATE
Rank MAT
MAT Nov -14 MTH
IPM
Nov-14
Val (Cr)
MS%
GR%
Val (Cr)
MS%
GR%
82095
100.00
9.9
7243
100.00
10.9
Abbott + Abbott HC + Novo
1
1
5067
6.17
6.2
449
6.20
10.2
Sun Pharma
2
2
4449
5.42
14.8
411
5.67
14.9
Cipla
3
3
4099
4.99
11.0
355
4.90
8.3
Zydus + Biochem
4
4
3565
4.34
7.9
317
4.38
7.4
Ranbaxy
5
5
2993
3.65
8.7
297
4.10
23.1
Mankind
6
6
2949
3.59
11.7
259
3.58
11.6
Alkem + Cachet + Indchemie
7
7
2903
3.54
12.5
255
3.52
5.6
GSK
8
9
2777
3.38
-5.2
235
3.24
5.7
Lupin
9
8
2740
3.34
12.2
238
3.29
8.2
Pfizer
10
10
2426
2.95
11.6
223
3.08
34.1
Macleods
11
11
2356
2.87
24.9
209
2.88
24.6
Emcure + Zuventus
12
13
2215
2.70
9.1
191
2.63
7.3
Intas
13
12
2147
2.61
15.5
192
2.66
16.2
Aristo
14
15
2052
2.50
19.3
178
2.46
7.6
Sanofi India
15
14
2030
2.47
3.8
188
2.60
18.2
Torrent
16
17
1820
2.22
7.9
168
2.32
23.3
Glenmark
17
16
1788
2.18
15.0
177
2.45
20.3
Dr Reddys
18
18
1748
2.13
9.2
152
2.10
9.4
Micro + Bal
19
20
1602
1.95
8.3
136
1.88
3.2
USV
20
19
1580
1.92
15.7
142
1.95
15.0
Ipca
21
21
1474
1.80
20.7
124
1.71
4.2
Novartis
22
23
1154
1.41
1.0
97
1.33
5.2
of 10.9 per cent for November 2014. NLEM and non-NLEM category showed unit growth at -3.4 per cent and 0.3 per cent respectively. The DPCO 2013 portfolio for Pfizer grew at 20.9 per cent, GSK -1.5 per cent, Ranbaxy 34.3 per cent. From therapy perspective, 11 therapies have outgrown the IPM growth and have double digit growths. The respiratory market grew at 4.1 per cent,
gastrointestinal market grew at 12.8 per cent, pain and analgesics market grew at 8.1 per cent whereas the anti-infectives grew at four per cent. The anti-diabetic market grows at 23.8 per cent and cardiac at 12.8 per cent in chronic business. The derma market grew by 19.3 per cent and the urology market at 28.3 per cent. From regional perspective, 14 regions have outgrown the
IPM growth. The Gujarat market grew the highest at 22.4 per cent followed by Chattisgarh market at 19.6 per cent and Madhya Pradesh market at 19.3 per cent. No regions had negative growth in November 2014. Amoxycillin + Clavulanic acid market degrows at -1.4 per cent whereas Glimepiride + Metformin grows at 12.1 per cent at number two. The markets of paracetamol grew at
two per cent, atorvastatin 18.2 per cent, probiotic microbes at 30.6 per cent, cefixime -2.2 per cent, pantoprazole 15 per cent, montelukast + levocetrizine at 13 per cent, glimepiride + metformin + pioglitazone at 25.2 per cent, vitamin-D at 35.7 per cent, hydroquinone + mometasone + tretinoin at 32 per cent, voglibose + metformin + glimepiride at 53.8 per cent,
MARKET Val in Crs
MAT Nov 14
Super Group
VAL IN CRS
VAL GR%
VAL IN CRS
VAL GR%
IPM
82095
9.9
7243
10.9
ANTI-INFECTIVES
13198
5.7
1151
4.0
CARDIAC
10162
9.8
894
12.8
GASTRO INTESTINAL
9438
11.3
794
12.8
VITAMINS / MINERALS / NUTRIENTS
7425
10.9
640
13.9
RESPIRATORY
6337
11.1
616
4.1
ANTI DIABETIC
6124
20.0
559
23.8
PAIN / ANALGESICS
5893
9.0
511
8.1
NEURO / CNS
5103
7.8
450
11.2
DERMA
4701
16.0
445
19.3
GYNAECOLOGICAL
4176
4.5
348
7.9
OPHTHAL / OTOLOGICALS
1522
13.4
136
19.7
ANTI-NEOPLASTICS
1346
26.8
110
15.1
HORMONES
1344
4.8
118
8.7
VACCINES
1173
-7.3
96
-0.1
BLOOD RELATED
979
2.1
79
4.6
OTHERS
900
9.8
87
25.2
UROLOGY
858
20.2
78
28.3
ANTI MALARIALS
598
5.8
57
-7.5
SEX STIMULANTS / REJUVENATORS
458
3.4
42
8.7
STOMATOLOGICALS
358
11.8
31
13.7
leveteracetam at 26.4 per cent, protein supplements at 22.7 per cent. Mixtard continues to lead the pack with ` 31.1 crores for the month of November14 with a growth of 16.7 per cent. Lantus grew at 41.2 per cent, glycomet- GP grows at 21.9 per cent, monocef grows at 10.2 per cent, augmentin grows at 3.2 per cent, amongst the top 10 brands. Amongst the brands who have gained ranks include Glycomet-GP (+6), Lantus (+13), Dexorange (+3), Liv-52 (+7), Galvus Met (+12), Skinlite (+14), Pan (+19), Zincovit (+6), Thyronorm (+30), Pan D (+13), Shelcal (+78), Janumet (+84), Panderm Plus (+64), Levipil (+20) amongst top 100 brands over November 13 A total of 379 SKUs and 239 brands were launched in November 2014. Top new brands for November are Janumet XR CP, Bio Exidil & Celekast.
Month Nov-14
About PharmaTrac PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech. AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind AIOCD AWACS’ research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.
Terminologies used MAT – Moving Annual Total MTH – Month Val (Cr) – Value in Crores MS per cent – Market Share in Percentage GR per cent – Growth in percentage. For more information, visit http://www.aiocd.net
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January 1-15, 2015
MARKET PRE EVENT
Hyderabad to host 66 Indian Pharmaceutical Congress th
The event, held from January 23-25, 2015, will be organised by Indian Pharmaceutical Congress Association and hosted by All India Drugs Control Officers’ Confederation 66TH INDIAN Pharmaceutical Congress (IPC) will be held at Hitex, Hyderabad from January 23-25, 2015. The event will be organised by Indian Pharmaceutical Congress Association and hosted by All India Drugs Control Officers’ Confederation. The theme of the Congress is ‘India-Pharmacy of the WorldRole of Indian Regulators and Pharma Industry’. It will cover various issues related to the industry, academia and community pharmacy by technical and professional intellectuals from the relevant branches of pharmacy from all over the globe.
More than 10,000 national and international delegates are expected to attend the event which will provide a common platform to all the stakeholders to facilitate interaction among peers More than 10,000 national and international delegates are expected to attend the event which will provide a common platform to all the
stakeholders to facilitate interaction among peers and to update their knowledge to serve better in their field. On this opportune occasion, a
Pharmexcil to organise international pharma business meet during Vibrant Gujarat 2015
documentary record of collection of scientific, professional and marketing literature in the form of a Souvenir-66 IPC will be released and presented to each one of the delegate/ participant. Concurrently with the Congress, a Pharmaceutical Expo – 2015 Exhibition by FICCI will be held. It would project latest technological developments, upgradation and adaptation in pharma industry with a display of equipment, instruments and utilities.
PHARMEXCIL will participate for the third consecutive year at Vibrant Gujarat 2015 in Ahmedabad and organise the International Pharma Business Meet & Expo in Gujarat. The third edition of International Pharma Business Meet and Expo will have international delegates from all the major regions of pharma trading LAC, CIS, ASEAN, AFRICA and general areas. Around 70 international delegates from 20 to 25 countries and 200 Indian pharma companies are expected to participate in this event.
EP News Bureau – Mumbai
EP News Bureau – Mumbai
Bangalore INDIA BIO 2015 to be held from February 9-11, 2015 Theme for this year’s event is ‘Crystalizing India's Biotech Future’ THE CRYSTAL edition of Bangalore INDIA BIO will be held in Bangalore from February 9-11, 2015. The event will look into the rapidly evolving and changing future of Biotech and its impact in India. The theme for this year’s event is ‘Crystalizing India’s Biotech Future.’ The event will identify challenges and opportunities from funding into basic research to regulatory and policy action and
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EXPRESS PHARMA
January 1-15, 2015
draft a roadmap for the sector’s growth. The focal theme of Bangalore INDIA BIO 2015 is ‘Biotech for a better tomorrow.’ The trade show will serve as a market place for biotech companies and industry service providers to do business and close deals. Prescheduled partnering meetings will enable to assess and connect with potential partners. The conference will ad-
The trade show will serve as a market place for biotech companies and industry service providers to do business and close deals
and licensing and regulatory issues. A CEO Conclave will take place, which will see leaders from Biotech community (CEO' s, R&D Heads, VCs, Financial Institution Heads and policy makers) take part followed by a panel discussion. Express Pharma is the media partner for the event.
dress latest researches, business models and strategies,
alliances and partnering trends, product innovation
EP News Bureau – Mumbai
MARKET
BioAsia 2015 to herald ‘Opportunities in the Transition’for life sciences and healthcare industry 12th edition of the conference in Hyderabad will have seven focus areas THE 12TH edition of the annual international lifesciences conference, BioAsia 2015 will unveil the ‘New Opportunities in the Transition’ in the field of life sciences and healthcare industry. BioAsia 2015 will be held in Hyderabad from February 2 to 4, 2015. BioAsia 2015 is organised by the Federation of Asian Biotech Association (FABA) and the Pharmaceutical Export Promotion Council (Pharmexcil) with the support of State Government and the Government of India. Public Health Foundation of India (PHFI), PricewaterhouseCoopers (PwC), Biotech Industry Research Assistance Council (BIRAC)-GoI, TiE-Hyder-
in partnership to organise this event on a grand scale. BioAsia 2015 will include conferences and expert sessions, CEO conclave and workshops on following topics - ‘Drug Discovery and India’s Innovation Pipeline’, ‘Digital Health and Healthcare IT’, ‘Clinical Research’, ‘Supply Chain and Logistics’, ‘Rapid Diagnostics’ ‘Medical Electronics and Devices’, and ‘Public Health & Access’ along with international tradeshow, networking receptions, BioAsia connect and BioPark visits. Shakthi Nagappan, Chief Executive Officer, BioAsia said, “BioAsia 2015 will be organised with the theme of new era of life sciences to
BioAsia 2015 is organised by FABA, Pharmexcil, PHFI, PwC, BIRAC, TiEHyderabad, OPPI, NIMS, IMA, FICCI – Food 360, ACRO, Aurigene Discovert, Invest India, India Brand Equity Foundation among other organisations will be working in partnership abad, Organization of Pharmaceutical Producers of India (OPPI), Nizams Institute of Medical Sciences (NIMS), Indian Medical Association (IMA), FICCI – Food 360, Association of Contract Research Organizaions (ACRO), Aurigene Discovert, Invest India and India Brand Equity Foundation among other organisations will be working
symbolise the transitioning phase of opportunities in India and also contribute to the country’s economic revival agenda. The event is designed to offer the right opportunities to catch the right notes and develop strategies to succeed in emerging markets like India.” EP News Bureau-Mumbai
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MARKET POST EVENTS
Indo-Israel Innovation colloquium discusses strategic business opportunities Technology and innovation synergies have become key focus areas as avenues of collaboration and partnership in academia, IT, telecom, healthcare and other areas Usha Sharma Mumbai INDIA AND Israel are known names in the global generic pharmaceutical business but the ample opportunities to collaborate have not been fully explored. The Confederation of Indian Industry (CII), Ananta Centre (formerly Aspen India) and Tel Aviv University (TAU) recently organised the seventh India Israel Forum – the Indo-Israel Innovation Colloquium in Mumbai to address this gap. The meet was chaired by Israel Makov, Chairman, Sun Pharma and S Ramadorai, Vice Chairman, Tata, Consultancy Services in Mumbai. Over the decade, CII, Ananta and TAU have focused on broadening the India-Israel relationship.
Israel Makov, Chairman, Sun Pharmaceutical Industries commented that while both India and Israel are strong in generic pharma, the latter has shown more innovation in the pharma sector. While stressing the need for advanced technologies and medicines, Makov urged industry stakeholders to invest in Israel and vice versa. Dr Adheet Gogate, Senior Director and India Head, Philips
Healthcare Transformation Services explained the necessity of three pillars for improving the healthcare system in India. Firstly, India needs to become wealthy enough and also needs to get the economy growing faster. Secondly, the country needs to look at adopting new paradigms in healthcare delivery; for instance, where the poor pay lesser from their pockets and get better reach to healthcare. As the third pillar, he men-
tioned that there has to be a lot more coordination between different sectors. He signed off commenting that in the last 20 years we have not seen a single drug to treat drug-resistant infections which are crucial and we have to figure out how to make it profitable. Dr Hadar Ron, Managing Partner, Israel Health Care Ventures spoke about the opportunities existing in the Israel pharma market where Teva is the largest pharma company. She shared that many start-up companies involved in pharma research get good support from the Israeli Government and therefore urged Indian companies to invest in Israel. She also mentioned that while Indian pharma companies have the capabilities, they need better en-
gagement with Israel, citing the way their counterparts from the US, China and Singapore consider Israel as a strategic investment partner. She urged Indian pharma companies to follow suit. Technology and innovation synergies between India and Israel are immense and have become key focus areas as avenues of collaboration and partnership in academia, information technology, telecom, healthcare and other areas. The day long colloquium witnessed panel discussions, presentations as well as focused sessions on innovation, information technology, healthcare, water technology, renewable energy, wellness, engineering, etc. u.sharma@expressindia.com
National conference on ‘Drug Discovery and Drug Targeting in Metabolic Diseases’concludes in Mumbai Over 120 participants took part in the event Usha Sharma Mumbai WITH AN aim to provide better understanding about the pharmaceutical industry’s fundamental procedures and updates to academia about the current changes, Dr Bhanuben Nanavati College of Pharmacy recently organised a two-day national conference on ‘Drug Discovery and Drug Targeting in Metabolic Diseases’ in Mumbai. The chief guest for the event was Dr Nilima Kshrisagar, Dean ESI PGIMSR MGM Hospital
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and Dr Ritabelle Fernandes, Assistant Professor, Department of Geriatric Medicine, University of Hawaii was the guest of honour. There were more than 120 registered participants for the event. Besides, there were 16 oral presentations and 99 poster presentation. Dr Parthasarthi Gurumurthey, Dean, Faculty of Pharmacy, JSS, University, Mysore, Dr PV Bharatam, Professor, Med Chem Division, NIPER, Mohali, Dr M S Nagarsenkar, Professor, Bombay College of Pharmacy, Dr Mariam Degani, Professor, ICT,
Mumbai, Dr Krishan Kalliappan, Professor, IIT, Mumbai were the speakers. The symposium started with a speech by Yergeri. Kshirsagar spoke about the challenges faced by the industry. She also shared various incidences and case studies on different molecules and mentioned how her institute become a recognised institute and the steps they undertook to get a clearance from the local municipal corporation. Kshirsagar explained the difference between ‘similar’ and ‘same’ and its relevance in the
drug delivery process. “There is a big gap between what is available and what is need. For eg Under the National Rural Health Management (NHRM) scheme we have huge medicines stock for malaria and many more diseases but unfortunately there are limited drugs for the treat-
ment of hypertension and diabetes,” informed Kshirsagar. Fernandes shared her project’s works for the geriatric group. Parthasarthi, gave an overview of the clinical trial industry. u.sharma@expressindia.com
EVENT BRIEF JANUARY 2015 — MAY 2015 9
International Pharma Business Meet and Exhibition
INTERNATIONAL PHARMA BUSINESS MEETAND EXHIBITION Date: January 9-11, 2015 Venue: Vibrant Gujarat Summit 2015 Summary: Pharmexcil will participate for the third consecutive year at Vibrant Gujarat and will organise the 'International Pharma Business Meet & Expo' in Gujarat. The third edition of International Pharma Business Meet and Expo will have international delegates from all the major regions of pharma trading LAC, CIS, ASEAN, AFRICA & general areas. Around 70 international
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66th Indian Pharmaceutical Congress
delegates from 20 to 25 countries and 200 Indian pharma companies are expected to participate in this event. Contact details: Raghuveer Kini Executive Director ed@pharmexcil.com
66TH INDIAN PHARMACEUTICAL CONGRESS Date: January 23-25, 2015 Venue: Venue Hitex Exhibition Centre, Hyderabad Summary: Indian Pharmaceutical Congress Association will organise the 66th Indian Pharmaceutical Congress. It will be hosted by All India Drugs Control
Officers' Confederation (AIDCOC). The event will be hosted by All India Drugs Control Officers’ Confederation (AIDCOC). Theme for this year’s congress is India-Pharmacy of the world: Role of Indian regulators and pharma industry. Contact details: 66th IPC Secretariat 7-2-1813/5/A, Sipra Labs, Adj. to Post Office, Industrial Estate, Sanath nagar, Hyderabad – 500018
PHARMA PRO & PACK EXPO 2015 Date: May 13-15, 2015 Venue: Mumbai Exhibition
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PHARMA Pro & Pack Expo 2015
Centre, Mumbai Summary: PHARMA Pro & Pack Expo 2015 will be organised by IPMMA. 20,000 pharma trade professional/ decision makers and 250 industry majors will exhibit their technologies/ services. Visitors’ profile include biotechnology specialists, plant management, CEOs, engineers, technocrats and scientists, policy makers, diplomats and foreign commercial corp, compliance, process engineering, corporate management, procurement department, custom manufacturing/ marketing services, purchase officers,
equipment suppliers and distributors, quality assurance/ quality control, maintenance engineering, R&D professionals, manufacturing/ production engineering, regulatory officers, operations management, validation, packaging engineering, vendor development, pharmacists. Contact details: Indian Pharma Machinery Manufacturers’ Association 52, 1st floor, Suyog Industrial Estate LBS Marg, Vikhroli (West) Mumbai – 400 083 Tel: +91 22 6561 9272/ 2578 6007/ 2685 5108
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cover )
As 2014 draws to a close, Express Pharma presents some hopes and predictions from thought leaders as they gaze into their crystal balls
INSIDE 18
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NEED TRANSPARENCY, EFFICIENT IMPLEMENTATION' | PG 20
WE CAN GO BACK TO DOUBLE DIGIT GROWTH IN 2015 | PG 20
INDIAN PHARMA WILL CHANGE, HOPEFULLY FOR THE BETTER | PG 21
IS INDIAN PHARMA UNDER SEIGE? | PG 22
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We want to believe that the govt will fulfill its promise Ranjana Smetacek
T
he past year has been a year of change and it brought the Indian pharmaceutical industry more than its fair share of challenges. Still, the New Year offers a renewed sense of hope. The new government is beginning to make its presence felt, with creative initiatives like 'Make in India' and 'Swachch Bharat Abhiyan'. Investors, businesses, and the common man – we each want to believe that government will fulfill its promise of good governance, transparent policymaking and corruption-free growth. A recent pharma conclave in Delhi saw the coming together of the government, regulators, industry leaders and healthcare professionals from across the country. Discussion revolved around the ‘Make, Develop and Innovate in India’ theme and speakers debated India’s role as ‘Pharmacy to the World’. All stakeholders agreed on the need for a collaborative approach to support the nation’s healthcare objectives, they declared unanimously that the time is now. In 2015, the Organisation of Pharmaceutical Producers of India (OPPI) will continue to focus on some key priorities. Improved access to quality healthcare: Pro-innovation policies can go hand-inhand with access to
THE YEAR 2015 WILL BE NO DIFFERENT | PG 23
THE SECTOR WILL SIGNIFICANTLY OUTPERFORM THE SENSEX | PG 23
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DIRECTOR GENERAL, ORGANISATION OF PHARMACEUTICAL PRODUCERS OF INDIA
healthcare, for the benefit of our patients. Access to healthcare extends beyond the cost of medicine, to the proximity, quality and functionality of the infrastructure that supports that access. More than affordability, the barrier to access is the inability to pay out-of-pocket and the lack of insurance cover. The promised Universal Health Assurance programme will help benefit patients and increase access. In a recent assessment of the Indian economy, the Organization for Economic Cooperation and Development (OECD) identified India’s poor health outcomes as one of our major developmental challenges. Today, India has one of the highest disease burdens in the world. We ask the government to prioritise healthcare, strengthen infrastructure and focus on skill
GOVT SHOULD CREATE AN ECOSYSTEM THAT ENCOURAGES R&D | PG 24
development. We seek increased healthcare budgets, from the current one per cent to at least 2.5 per cent over the next two years. Stronger IP rights: A January 2014 study, by economists Robert Shapiro and Aparna Mathur, predicted that ‘India could well become a global centre for innovative drug development and production, increase the life expectancy of its people, expand output and employment, and achieve considerable cost savings in medical care and government subsidies’ by increasing its IP protection. A stronger IP environment will certainly have a positive impact on the Indian economy and encourage Foreign Direct Investment. In pharma, we need a holistic approach that balances the need for innovation with the necessity for more accessible medicines, within a robust IP environment. We must incentivise innovation for new solutions to treat critical and rare diseases and new medicines to save and improve lives. There are still huge unmet medical needs in cancer, diabetes and mental illness (Parkinson's and Alzheimer’s remain unconquered) and dengue remains a threat to 40 per cent of the world’s population. Ethics and the Uniform Code of Pharmaceutical Marketing Practices
HOPE THAT THE NEW YEAR WILL BRING GOOD OPPORTUNITIES | PG 24
(UCPMP): Responsible healthcare has to become a norm in India and patients guaranteed safe and quality healthcare. The entire healthcare ecosystem must comply with the highest ethical standards in manufacturing, marketing and prescribing. The formalisation of the UCPMP as a voluntary code, effective January 1, 2015, augurs well indeed. This longawaited and meaningful step from government will help shape a more ethical healthcare industry. Clinical trials: As the Indian economy grows, more people will have access to modern medicine. It is in India’s interest to encourage clinical trials, with adequate safeguards. This forms part of the research in the development of new medicines and is a part of the intellectual property. We need policies and regulations that will build confidence among innovators in India. We need a robust and transparent process to conduct clinical trials and obtain regulatory approvals for new drugs, while supporting government’s compensation framework. Today, India is a brand in pharma. We, the industry, are willing to shoulder our share of responsibility in improving the health of our nation. The stars are aligned and we must seize the day the time is now!
CLINICAL RESEARCH IN 2015: THE GHOST OF CHRISTMAS PAST, PRESENT AND YET TO COME | PG 25 EXPRESS PHARMA
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cover ) Need transparency,efficient implementation Dr PM Murali
T
ime flies, as people say. It is now nearly more than a decade that India has been stuttering for want of robust transparent policies for the pharma biotechnology and agri biotechnology sectors. Systematically our policies have driven away robust investment and a researchdriven innovation ecosystem to emerge out of India. In the pharma sector clinical trials, custom chemistry, R&D collaborations, multinationals shifting research to India have all suffered seriously due to knee jerk policies of successive governments. The biotech industry has highlighted that this is a $100 bil-
lion potential. It is just that nobody seems to be taking note that growing this sector is beneficial for Indians on self-reliance and also paving way for future drugs to emerge from here. Instead of the government bending backwards to roll a red carpet to this industry which is going to cater to the health and well being of the people of this country, we have gone on and on with investor unfriendly policies and announcements. While all our neighbouring countries are offering all sorts of incentives to the industry, we have made it very difficult for new ones to come in and do business. Countries are assessed for
PRESIDENT,ABLE
advancement based on the amount of innovation that happens and also how much growth that has been witnessed with respect to the healthcare segment. Drugs
and vaccines are essential components of the healthcare and developing them needs 10-15 years of research backed with a $1-2 billion investment. Everytime there is a set back to the ecosystem, the time and costs over run. How will companies bring affordable drugs? While the popular belief is companies try to make money exploiting poor patients, there is no accountability on what faulty policies can do to affordability. But as always a new government brings in lots of hope to the despaired and dispirited. “Make in India� is the right message to the world and already the Prime
Minister has taken the first correct steps in bringing in an urgency into the system. We feel there has to be an even greater urgency in bringing about transparency and efficient implementation to quickly regain lost grounds. The healthcare industry offers tremendous potential to mitigating unemployment by offering jobs all along the value chain. The industry is extremely positive that if the core issues that retards growth of this sector are identified (which the industry has done) and removed (role of the government), then we are likely to see a revolution in affordable healthcare in India.
We can go backto double digit growth in 2015 S V Veeramani
W
ith a favourable government atmosphere, we feel that we are in for better times for the Indian pharmaceutical industry. A new team has been formed in the Department of Pharmaceuticals. There is greater understanding on the various challenges facing the Indian pharma industry and the stimulus required for its development. We have started receiving communications from Department of Pharmaceuticals for meetings on various matters related to growth and development of pharma industry. There have been invitations to discuss about APIs, to promote growth of private pharma industry, Task force with other departments, plans to revive public sector under-
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PRESIDENT,IDMA
Our apprehensions are on the pricing front. We hope that price control and regulations will not disturb the sustainability of the industry to supply medicines to the public without any shortage
takings, venture capital fund for financing R&D, industry academy interaction, Jan Aushadhi Yojana, etc. We understand that the government is likely to come up with a good stimulus package for the API industry. They are also considering funding for the upgradation of SMEs. If these packages come into
operation, it can well pave the growth of the pharma industry in India. On the part of Department of Health and DCG (I), there are moves to simplify the forms and procedures. We understand that the approval formalities for clinical trials will be smoothened up. We are also happy that there will be a
considerate view for approval of FDCs which have been used for several years with good benefits to the Indian public. Hope the Department of Health will also consider the industry’s request for continuance of PET bottles. With respect to regulations, many Indian pharma companies are in the process
of training their technical personnel on quality culture and good compliance. We are sure, that they will meet the expectations of US FDA and other regulatory authorities in the World. With all this, we are very confident of a bright future for Indian pharma industry in 2015. Our apprehensions are on the pricing front. We hope that the number of NLEM drugs are not increased substantially to affect the viability of the industry. We also hope that price control and regulations will not disturb the sustainability of the industry to supply medicines to the public without any shortage. If everything goes well, we feel that we can go back to double digit growth in the Indian pharma industry in 2015.
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Indian pharma will change,hopefullyfor the better Anil Khanna sumers. It’s a nascent trend internationally, but being experimented. AstraZeneca started
with Arimidex Direct in 2012 to provide its off-patent breast cancer therapy via Express
PARTNER,TAI PI ADVISORS
Y
ears back, Isaac Asimov said, “Life is pleasant. Death is peaceful. It's the transition that's troublesome.” While it may not be a matter of life and death for the Indian pharma industry, it certainly is the transition time and like any transition, it has its pain, as well as gain. Indian pharma has enjoyed a decadal growth rate of ˜13 per cent, except in 2013, when due to large number of formulations coming under price control, growth rate plummeted by more than half to little over six per cent. For sure, during 2014, companies have been busy regaining their composure and the lost sales, but parallely, they have been trying to answer the vital question – what’s next? For starters, industry will learn to live with more price control at regular intervals. Same happened in 2014, and will continue in 2015 and beyond. There is absolutely no ambiguity in government thinking on this issue. Even now, only around 15 per cent of the domestic market is under price control, and hence government feels there is scope to ‘do more’ on the issue of price control, which will put further pressure on profitability. This would possibly lead to change in distribution and marketing model, with medicines for at least chronic medicines being supplied directly to con-
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www.merckmillipore.com/knowledgeinstitute
Scripts directly to consumer. Earlier Pfizer had taken this approach for Lipitor (with
‘Lipitor for You’ programme) and Viagra. Continued on Page 26
cover ) Is Indian pharma under seige? Dr Gopakumar Nair
I
s Indian pharmaceutical industry under siege? By whom? USTR & Big Pharma? US FDA? NPPA? CDSCO? Other regulatory agencies? NGOs? Indian pharma is facing more challenges than opportunities at current times. As the year 2014 is exiting and a New Year is dawning, the Indian generic pharma industry needs to lay down strategies for the future. On the international front, the first time in many years, quality related issues dominated over intellectual property disputes, even though there appeared to some relation between the two at the core. The offensive came from both the USTR and Big Pharma on TRIPs compliance issues. The US FDA inspections and warnings to Indian manufacturing sites of leading generic pharma companies were at too frequent intervals during the current year. On the domestic front, the pharma industry was hard-hit by a plethora of issues. Clinical trials and consequent drug approval processes were severely affected by delays and hold-ups. The fixed dose combination (FDC) approvals and re-approvals including issues related to irrational (?) combinations persisted. Most disconcerting and disturbing negative moves came from National Pharmaceutical
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Pricing Authority (NPPA) orders for extending the range of price controls beyond the ambit of the Drugs Price Control Order (DPCO). Government, more specifically the NPPA, appears to be not realising that the affordability is secondary to availability. The severe cuts and spreading of the net of controls, led to leading brands with high quality and reliability being replaced by newly introduced brands of companies who could afford to continue to market under low overheads. To add fuel to the fire of stress, IP related litigations were on the increase during the year, making deep dents in the budget of Indian companies.
Pharma under one roof? Pharma, biotech, herbal, neutraceutical, vaccines themselves make a wide range. By another classification, Active Pharmaceutical Ingredients (APIs), formulation dosage forms including parenterals, New Drug Delivery Systems (NDDS), Ayush (Ayurveda etc.), medical devices (implants and equipment), packing materials (capsules, glass, pet etc.) need a variety of expertise to oversee which is clearly lacking in single ministry. The pharma industry has to currently deal with a large number of ministries such as 1) Pharmaceutical Dept. of Chemicals Ministry – APIs,
CEO,GOPAKUMAR NAIR ASSOCIATES
pricing, infrastructure 2) Ministry of Health – CDSCO, DGHS, ICMR, Ethics Committee, DCG(I) 3) State FDAs – Manufacturing and product licences, sales and marketing 4) Ministry of Commerce – Pharmexcil (international trade) 5) Ministry of Environment – Bio Diversity Act, Pollution Control, Waste Management & disposal 6) Dept. of Industrial Policy & Promotion (DIPP) – Patents TMs, Designs, Bilateral Trade Negotiations 7) Ministry of HRD – Pharma Education, Copyrights 8) Ministry of Science & Technology – R&D approvals, research project related funding 9) Dept of Ayush – Ayurveda, herbal, neutraceuticals 10) Ministry of Industry – MSME, location approvals 11) Ministry of Finance/Rev-
enue – Customs, Excise (central and state excise), Service Tax 12) Narcotics Control Dept./NDPS (Dangerous Drugs Department) 13) Ministry of Labour – Perennial and ongoing dispute with Medical Representatives (FMRI) 14) Ministry of Transport, Aviation & Shipping 15) Ethical (?) marketing issues – MCI/IMA – Industry Codes The list is endless, many more. While all of this cannot be brought under one umbrella, the best possible is to combine health, pharma department and pharma trade both domestic and international, including pharma and health education under one ministry. This can only be done at the Centre, not at the State level, as the (Indian) Drugs and Cosmetics Act is a concurrent Act. Significant amendments will be required to Drugs & Cosmetics Act, 1940. It is admitted that such an amendment is long overdue. Lately, the government has come up with strict action against unethical practices in industry-medical profession relationships. It will be interesting to wait and see how and through which agency the government proposes to implement the statutory code and punitive measures, if any for violation thereof.
In conclusion, the entire exercise of bringing all pharma related regulatory and administrative activities under one roof can only succeed, if such a mammoth organisation is headed by a competent authority and is well structured and empowered with human resources, logistics and infrastructure. Very often the solution causes more problems. The phase which Indian pharma industry is currently undergoing is very critical. Quality issues including Good Manufacturing Practice (GMP) need to be utmost priority. Negotiations of Substandard /Spurious /Falsely-labelled/Falsified/Counterfeit FDC (SSFFC) and counterfeit at various global levels including with US and EU need to be handled in the best interest of India. International Conference of Harmonization (ICH) need to be addressed. On the biotech front, biosimilars need urgent expedited attention. Scaling up fermentation, serums and vaccines, both at research and production levels need urgent attention. Most deliberations lead to one report or another which collects dust in the shelves, thereafter, such a Mashelkar Committee Report and Satwant Reddy Committee Report. Hope the present move will also not land up in the dustbin.
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The year 2015 will be no different Dr Viraj Suvarna
T
he future isn’t what it used to be (Yogi Berra) More things change, more they remain the same. The year 2015 will be no different. On January 13, the next hearing of the infamous PIL will happen on a non-miscellaneous day in the Supreme Court. Hopefully the Solicitor General of India will give a fitting riposte to the petitioners, the Chief Justice will be satisfied, and will finally allow the impleaders to speak. The stranglehold on clinical trials will be lifted. Clinical research sites and ethics committees will need to
be accredited by the Quality Council of India through the National Accreditation Board for Hospitals & Healthcare (NABH). The Common Drug Authority (CDA) Bill will be passed but with it, will come penal provisions for those who abrogate the laws governing the conduct of CTs in India. The amendment to the gazette notification on compensation will be notified. Companies that decided to stop doing clinical trials in India, because of the ambiguity and unethicality of financial inducement that the compensation norms could lead to, will
MEDICAL DIRECTOR, BOEHRINGER INGELHEIM
start doing CTs again. Patents will continue to be challenged and the patent holders will take the infringers to court. Compulsory licensing may be promulgated where indicated. Price controls through the expanded national list of essential medicines will continue to plague the industry and a via media has to happen where both parties have to meet mid-way. Innovators will need to ensure maximum access so that patients can experience the value of the innovation through innovative pricing, access and assistance mechanisms.
Boehringer Ingelheim (BI) will need to position itself as BI India, poised to help the government shoulder the quadruple burden of stroke, diabetes, cancer and heart disease. In India, For India, and then the World or Reverse innovation. In the spirit of competitive collaboration, we can 'transcelerate' the number of appropriate patients who should be on the right products, in an ethical, quality conscious and compliant way. What we do for a living makes life worth living. Health will become a status symbol.
The sector will significantlyoutperform the Sensex Sarabjit K Nangra
D
uring 2014, the major trends that were visible in Indian pharmaceutical industry has been M&A activities, NPPA 2014 and continued USFDA import alerts. Amongst all these challenges, the sector continued to perform well on the bourses, on back of the robust earnings growth momentum during the period. Amongst the key developments the Sun–Ranbaxy Labs merger, was a significant M&A activity in India after Piramal Healthcare formulation business take over by Abbott labs (in terms of the overall consolidation of the Indian formulation industry). After this merger, Sun Pharmaceuticals has consolidated its position in the US generic markets also and strengthen its position in the ROW markets, where its presence has lower compared to its peers. Thus after the merger, the combined entity would be more diversified with US, ROW and India contributing 47 per cent, 31 per cent and 22 per cent of sales (FY2014) respectively.
In terms of market share, the combination of Sun Pharma and Ranbaxy creates the fifthlargest specialty generics company in the world (just behind Teva, Sandoz, Activas and Mylan), the largest pharma company in India with a market share of 9.2 per cent with a sales of $1.1 billion, and ahead of Abbott which has a market share of 6.5 per cent (which is a huge gap in the highly fragmented Indian market). In terms of asset base, the combined entity will have operations in 65 countries, 47 manufacturing facilities across five continents, and a significant platform of specialty and generic products marketed globally, including ~700 ANDAs. On the drug regulatory front, the NPPA 2014, made its pricing policy transparent by inking its pricing formula, though in nearterm some hiccups were noticed, which the government rectified by revoking the provision which allowed NPPA to put drugs under the pricing control even if there is an inter brand price differentials. On the, US front, the US FDA continued to
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have a strong vigil on the Indian companies good manufacturing practices. Amongst the noticeable ones units of Sun Pharma, which got an import alert and 483 respectively along with IPCA Labs, which also got the 483, while some of the units like that of Indoco Remedies, was able to come out of the US FDA import ban. Going into FY2015, we expect the companies to post robust growth during the period. On the earnings front, for the current quarter, the companies are expected to post a top line growth of 15-20 per cent, with both domestic and exports posting robust growth during the period. Most of the companies in our coverage have started posting robust growth in the domestic markets during the last quarter, which was earlier reeling under the adverse impact of the new NPPA 2014 order. On the net profit front, barring few companies, the sector is likely to post a 15-20 per cent net profit growth during the period. One near-term concern
VP RESEARCH - PHARMA ANGEL BROKING
looming on the sector is the current volatility in the currency market, on back of weakness especially in the emerging markets. However, in our view the same in unlikely to have that great impact on the earnings of the companies or impact, could be more company specific. The reason behind the same is the the developed markets like the US and Europe, are showing economic strength and hence will remain in the position of
strength in the near term, thus will compensate for the weakness in the Emerging Market (EM) currency weakness. Thus, with ~70 per cent of exports to the US and Europe, and around ~10 per cent to the EM we don’t expect any major impact on the earnings of the company. Over a longer period of time, i.e, over the next two years, significant number of drugs are going off patent, along with higher share of generic drugs will aid the export-oriented companies should do very well. Even on the domestic front, they will continue to keep a strong pace by growing at close 15 per cent, thus firing from all engines. On the back of this, the sector will significantly outperform Sensex over long run. Our top picks in the sector currently are Dr Reddys Laboratories, IPCA labs and Dishman Pharma. Apart from these stocks, the companies, where investors can create wealth if invested from long-term perspective of two to three years are Lupin, Cadila, Cipla, Wockhardt and Glaxo Pharmaceuticals.
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cover ) Govt should create Hope that the NewYear will an ecosystem that bring good opportunities encourages R&D Dr Manu Chaudhary
Glenn Saldanha
2
014 has been a challenging and eventful year for the global pharma industry; marked by acquisitions, increased government intervention on the sector, slowdown in product approvals across markets and more complex regulatory requirements. US, the world's largest market for pharmaceuticals is witnessing a slowdown in product approvals and channel consolidation which is impacting overall sales for the industry. We however, feel that the pace of approvals should hasten in the coming months of the New Year, thereby helping companies record improved growth rates. In the last couple of years, the Indian pharma industry has also seen a deceleration in growth rates (from healthy double digits a few years back to single digits today) due to factors like increasing competition and regulatory headwinds. But I feel companies with a differentiated product portfolio and strong emphasis on brand building will continue to do well in the coming year and outperform the industry growth rates. On the other hand, the resurgence of LatAm markets like Mexico and Venezuela in 2014 has come as a big boost for companies like Glenmark, which has a strong presence in the region. The growth in these countries has been driven by new product approvals and some severe shortages in these markets. Although challenges still persist in Brazil, the largest market in the region, I believe LatAm will be a key growth driver for pharma companies
24 EXPRESS PHARMA January 1-15, 2015
CHAIRMAN AND MANAGING DIRECTOR, GLENMARK PHARMA
in the coming years. Besides, certain emerging markets in Asia and Africa are also expected to do well in the future. As regards, the focus areas for companies in 2015 and beyond, the foremost emphasis should be on continually building R&D capabilities needed to drive innovation. This is particularly required for countries like India, which unfortunately leads the world in terms of share of disease burden. Hence, innovation leading to new drugs is critical if we are to address the unmet medical need in the country. The government should also create an ecosystem that encourages innovative R&D in the pharma space in the form of tax incentives, regulations and grants for various research projects in the sector. The events of the last couple of years have underlined the importance of quality and compliance in the pharma industry. Therefore it goes without saying that organisations need to continually take steps to ensure compliance at all times.
W
ith the New Year approaching, the milieu is filled with new hopes, excitement, new promises, better prospects and opportunities for a progressive future. It is the best time of the year to reflect and evaluate the past and work towards a better and streamlined future. The recent past was a mixed bag for the pharma industry as a whole wherein the industry saw many ups and downs, be it in terms of renowned mergers, global awareness on antimicrobial resistance, new recommendations for NLEM2011 policy or stringent laws on clinical trials, introduction of audio-visual consents of patients for clinical trials and so on. The Indian pharma industry operates in a very competitive environment and the road to success is full of hurdles in terms of the regulatory and pricing issues, stringent laws on research and development, clinical trials, poor funding on R&D in pharma and so on. Given the initiatives promised and taken by the new Indian Government and concerned pharma authorities, we expect certain changes for the betterment of this industry. We are hopeful that the New Year would bring good opportunities and healthy environment to this industry to add on to its growth pace. We expect the government to diligently consider the list of drugs of NLEM 2011 and fix the ceiling prices of the products not just for the benefit of general public but also for ensuring good quality standard products because quality has a price and must be paid by consumer. The same also applies to all government tenders where prices go down on an Y-O-Y basis irrespective of minimum price or-
JOINT MANAGING DIRECTOR AND DIRECTOR,RESEARCH , VENUS MEDICINE RESEARCH CENTRE
der. There must be a lower sealing cap on the tender amount to maintain the quality of drugs in government supplies. Apart from this, as a part of this industry and as a researchdriven company, we expect our government to consider the importance and requirement of research in pharma and take initiative to support the companies for bringing out revolutionary products for the critical medical problems in the existing times. R&D is a key area that can help stand apart in this highly fragmented industry and bring accolades from across the globe. In this dynamic pharma industry, growth and success comes through a perfect multipronged strategic and systematic blend of R&D coupled with right mix of marketing techniques and talent pool. It is the only and best foot forward to establish yourself in this industry and offer innovative solutions to the mankind which are within the reach of a common man. So this year, we would expect the Indian Government and the concerned authorities to focus on building and boost-
ing systems to promote Indian research products usage in government hospitals and tenders to boost in-house R&D companies. This will boost Indian lowcost innovative solutions in form of new drugs meant for fighting the deadly menace of antimicrobial resistance and oncology and help them come up as a better and affordable alternative to high cost imported medicines. Further, the government must devise systems to fast track regulatory approvals for clinical trials and marketing. A delay in dealing with regulatory approvals not only is a loss of market but sometimes a good drug is not accessible to public in times of emergency needs like Ebola/ bird flu/ antimicrobial resistance/ stress etc. The government must make GMP compulsory for herbal manufacturers and give more clarity on certain regulations related to herbal drugs. This will not only boost Indian ayurvedic products acceptance in international market, but will help improve the quality of herbal medicine at par with international standards. Every year, thousands of students pass out with M.Pharma /Ph.D/M.D degrees with some research projects, most of which do not reach the market ever. If the government makes at least 25 per cent of these research projects industry sponsored, this will not only lower the cost of R&D but the way to commercialisation of academic research will be increased significantly. We at Venus, on the other end would be welcoming New Year with new marketing projects for fulfilling our mission and vision to take our blockbuster products globally and cater to the needs of mankind.
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THE MAIN FOCUS
Clinical research in 2015: The ghost of Christmas past,present and yet to come
T
he past two years have been difficult for clinical research in India, akin to the grim dreams out of the pages of Dickens. With introduction of regulations with no parallels in the world, the stakeholders have been left baffled in their attempts to come to terms with this new regime. The genesis of the transformation can be traced to the sub judice (since early 2012) proceedings of ‘Swasthya Adhikar Manch, Indore & Anr. vs. Union of India & Ors.’ (Swasthya Adhikar Manch Case). In the aforementioned proceedings the petitioners (including Swasthya Adhikar Manch, Indore) have alleged glaring and shocking irregularities in the whole process and administration of clinical research in India. While going into the details of the petition would not be relevant to the present discussion, it would not be out of place to mention here that some of the inferences and arguments put forth therein represent a highly myopic assessment of the whole clinical research process in India. The ensuing judicial scrutiny has resulted in a backlash that the life sciences and healthcare sector have been reeling under since the early 2013. It is pertinent to mention here that, the industry is not an absolute victim, as it waited, watched and did nothing, till disaster actually struck. After drawing some criticism from the Apex Court along with adverse media coverage, the Government went into overdrive in January 2013, notifying amendments to the existing provisions in the Drugs and Cosmetics Rules, 1945 (Rules) in addition
to certain orders applicable to the clinical research stakeholders. Some of the key revisions/additions to the legal framework vis-à-vis clinical research, since then are: (i) In case of injury (or death, as the case may be) to the patients in a clinical research, the sponsor of the clinical research, i.e., the pharmaceutical company or the institution or the academician (who initiates the clinical research): (a) would be liable to bear the expenses for the medical management for the injury, for as long as required, irrespective of the cause thereof; and (b) would be is liable to pay financial compensation (over and above the expenses incurred for medical management) for an injury (or death, as the case may be) related to the clinical research (related injury/death). (ii) An injury or death of a patient is considered a related injury/death, if the same is resultant of: (a) adverse effect of the drug/devise under research; (b) violation of the approved protocol, scientific misconduct or negligence by the sponsor or his representative or the doctor (investigator); (c) failure of the drug/devise under research to have
Abhijeet Das
Alishan Naqvee
the intended therapeutic effect; (d) use of placebo in a placebo-controlled clinical research; (e) adverse effects due to concomitant medication excluding standard care, necessitated as part of approved protocol; (f) injury to a child in-utero because of participation of parent in clinical research; and (g) any procedures involved in the clinical research. (iii) The ‘provisionally final’ compensation formula was introduced providing for compensations for related injury/death, ranging from `4,00,000 (` four lakh only) to ` 73,60,000 (` seventy three lakh and sixty thousand only). Recently, on December 15, 2014, the CDSCO has notified the final compensation formula to determine the quan-
tum of compensation in the cases of related Injury (other than deaths). (iv) Mandatory registration along with provisions for suspension or cancellation, of the ethics committees which accord approvals to the clinical research along with the layout for its composition. (v) Mandatory audio-video recording of the informed consent process in clinical research. (vi) The number of clinical research that a doctor (as investigator) can participate in, is limited to three. The lacunae in some of these stipulations mandated under the new regime are apparent to everyone even remotely associated with clinical research in India. For instance, medical management for research patients is a noble idea, but the same
While the stakeholders were clearly hampered under the ambiguity and uncertainty of the new regulatory regime, the CDSCO was also quick to close its doors to the countless questions raised by the stakeholders
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may incentivise the patient to enrol in the study, thus making the enrolment unethical. Further, in spite of the fact that clinical research is undertaken to study the effectiveness of a particular drug, under the regulations if the same fails to have the desired effect, resulting in any injury/death to the patient; the sponsor would be liable to pay compensation. The aforesaid oversight by the regulators, were also compounded by the compensation formula, which has burdened the sponsor with liability in case of injury/death in the said circumstances, over and above medical management (which is irrespective of the injury being related or unrelated to the clinical research). The aforesaid revisions have left clinical researchers in a frenzy to adapt and translate the regulatory requirements into the day to day conduct of clinical research in India. While the stakeholders were clearly hampered under the ambiguity and uncertainty of the new regulatory regime, the Central Drugs Standard Control Organization (CDSCO) was also quick to close its doors to the countless questions raised by the stakeholders. In terms of an office order, the CDSCO has mandated all queries of the stakeholders to come through the state licensing authority and not directly. Separately, in August 2013, the Drugs and Cosmetics (Amendment) Bill, 2013 (Bill) was introduced in the Rajya Sabha, which envisaged an overhaul of the complete regulatory framework concerning clinical research. The Bill provided for the establishment of a Central Drugs Authority to replace the CDSCO, which
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cover ) would be in charge of registering all clinical research in India. Further, the Bill brought under its domain devices and cosmetics, which are to a large extent not included in the extant framework for clinical research, and amongst other things laid out the framework for the constitution and powers of ethics committees. One of the key features (and fear) of the Bill was the introduction of criminal/penal punishments (sometime going upto 10 years of imprisonment) along with minimum monetary penalties for most offences stipulated therein. It is pertinent to note that the Bill is presently ‘pending’ in the Rajya Sabha. In April 2014, the government notified the Drugs and Cosmetics (Third Amendment) Draft Rules, 2014 (Draft Rules), which had signs of offering a respite to this shackled sphere. Amongst other things the Draft Rules provided for: (i) Free medical management to be provided to the pa-
At the present time, we do not and cannot know what the year 2015 holds for clinical research in India. That being said, the ending of the proceedings in the Swasthya Adhikar Manch Case would most certainly be welcomed by the stakeholders tient for as long as required or till such time it is established that the injury is not related to the clinical research, whichever is earlier. (ii) In case of related injury/death arising out of, failure of the drug/device under research to have the intended therapeutic effect or, a placebo controlled trial; the obligation of the sponsor to compensate would be limited to cases where the standard care, though available, was not to be provided to the patient. (iii) The Draft Rules also
relaxed certain reporting time frames introduced under this new regime, which where proving difficult to comply with. Since April, the sector has been waiting with bated breath for the aforementioned revisions to take effect. However, the same has not been forthcoming. This would not have been an absolute solution, but certainly would have been a welcome relief from the continuous battering that clinical research participants in India have been under. In the last couple of years,
things have taken a turn for the worse vis-à-vis clinical research in India. The uncertainty surrounding the Swasthya Adhikar Manch Case and the subsequent scrutiny that the regulators have come under, has resulted in an onslaught of regulations being dealt on the life sciences and healthcare sector, specifically in the field of clinical research. While, regulation is always welcome and over regulation is acceptable (amid protest), the one thing that is a death trap to any sector, is uncertainty and ambiguity in
companies, which are doing cutting-edge biologics focused product development work for diseases like diabetes, arthritis etc. Large pharma companies would have no option but to do more work in this area but also develop the required skill set. Just for statistics, last year 40 per cent new drugs approved by US FDA were biologics. Regenerative medicines (based on stem cells) will pick-up momentum. Already there are companies working on treatment for diabetic ulcer, critical limb ischemia, burn cases etc. In drug exports, pharma companies would continue to face pressure, especially from US FDA. Let’s admit, this issue has been brewing up, and
now it is out in open in a big way. The result of this pressure would be that Indian pharma companies would in all likelihood will diversify in their exports market. Today around 37 per cent exports happen to US, with very little in other regions - < 5 per cent to Latin America, around five per cent to Russia. So there would be trend towards companies focusing more in these markets and in MENA region, to hedge any likely risks. With both healthcare services affordability and accessibility remaining a critical issue, there is likely to be an increased trend towards OTC medicines. Secondly, it has been seen globally, there is a direct co-relation between the
regulations. This is the case applicable to clinical research at the moment, and unless there’s some stability on this front, India would most certainly end up denying its citizens advanced healthcare, which it so obviously requires. At the present time, we do not and cannot know what the year 2015 holds for clinical research in India. That being said, the ending of the proceedings in the Swasthya Adhikar Manch Case would most certainly be welcomed by the stakeholders. This might allow the regulators to turn their attention on some of the aforementioned oversights in the extant regulations. If addressed adequately, the modified regulations would go a long way in getting clinical research in the country back on its feet. (Disclosure: Alishan Naqvee has represented ISCR in the Supreme Court in the Swasthya Adhikar Manch Case )
Continued from Page 21
Indian pharma will change... In the generics branded formulations market, going forward, companies will increasingly move up from ‘easy to copy-low value generics’ to ‘difficult to copy-high value generics’. Companies will focus on niche areas like oncology, hormones etc. There would also be increasing trend towards biosimilars. Herceptin biosimilar (CANMAb) by Biocon is one of recent example in this category. Another interesting trend that is being seen is the emergence of new pharma companies with differentiated product strategies. For instance, a very young company, not even two years old, launched its product range with clear focus on ‘first co-prescribed
26 EXPRESS PHARMA January 1-15, 2015
product’ for selected therapeutic areas. In its first year of operation, it has achieved good success in terms of revenue. Or there is another company, around four-year-old and with revenue of Rs 400 crore, focused significantly on women’s health segment. This company is already among the top 50, while it only operates in the 15 per cent of the overall market. Success of such companies may spawn the launch of more new companies, which will have focused and differentiated product strategies. On the discovery front, there is an emerging trend of pure-play discovery companies focusing on biologicals. There are young discovery
GDP growth and the OTC market growth. So with Indian GDP likely to be on an upward trajectory, OTC market should grow at a faster rate and may in fact double to more than $ 6 bn during next three to five years. Increased consumer awareness will also drive this market. It’s quite likely that other important trends during next year and beyond could be increasing collaboration between MNC & Indian pharma companies, increasing focus on IPR issues and more conflicts on account of this, more FDI in pharma. But one thing is sure that the shape of the Indian pharma industry will change. Hope is that change is for the better.
MANAGEMENT
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TOWARDS
Holistic HEALING
Express Pharma goes beyond allopathy in this special section, which looks at how age old remedies like ayurveda are being rediscovered as possible solutions to lifestyle diseases while stem cells, the product of new age medical science, offers tantalising possibilities
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MANAGEMENT INSIGHT
Potential of regenerative medicine
DR CHANDRA VISWANATHAN, Head, Regenerative Medicine, Reliance Life Sciences
Application of stem cell-based therapies will be the turning point in the treatment of hitherto inadequately treated or incurable diseases of the 21st century. But we urgently need stem cell regulations as a deterrent to indiscriminate use of stem cell products. An insight by Dr Chandra Viswanathan, Head, Regenerative Medicine, Reliance Life Sciences
STEM CELLS are special cells which are able to differentiate into either fewer cell types, called the multipotent adult stem cells or most cell types called the pluripotent embryonic stem cells, while self-renewing extensively to generate more stem cells. Human Embryonic stem cells (hESCs) are examples of pluripotent cells and adult stem cells like the Mesenchymal stem cells (MSCs) are multi-potent in nature. Because of their potency of differentiation, stem cells are often foreseen as the hope of novel cell replacement based therapies to regenerate tissues/organs damaged by injury or disease. Transplantation of stem cells or their derivatives into respective tissues or organs, is considered as one of the most promising remedies for hitherto incurable diseases. After almost a decade of experimentation, it has now become increasingly clear that realisation of this intuitively logical concept is far more complex than originally envisaged. Thus, the scope of regenerative medicine extends much beyond the simple paradigm of providing new building blocks to a failing organ, to processes that dynamically alters the molecular landscape within the tissue via a number of paracrine factors and other multiple potential reparative processes. Even though the feasibility and safety of stem cell use has
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been reasonably established by several groups, the superior efficacy of stem cell therapy in clinical settings seems to be better only in certain clinical conditions so far. All current efforts are directed towards this. Due to ethical issues involved regarding harvest of hES, the propensity for uncontrolled growth in vivo and the likely rejection upon differentiation, clinical focus shifted to the adult-derived phenotypes. The advent of bioengineered pluripotent stem cells from adult somatic tissues called the Induced Pluripotent cells, [iPSCs] has revolutionised the potential availability and applicability of personalised stem cells. The bioengineered platform has the potential to bypass the ethical and allogeneic limitation of hES and allows patient derived tissue to be reprogrammed back to the embryonic phenotype and the
opportunity to utilise the ‘autologous’ approach. As newer sources of pluripotent cells provide the capacity to achieve specified tissue differentiation from all three germinal layers, newer enabling technologies will probably be a stepping stone to maximise repair potency and has now ignited renewed clinical interest. Genomic and proteomic evaluation of adult stem cells will throw more light on the small molecule development for the future, help in companion diagnostics, and make Theranostics very significant. Such approaches would move naïve 'first generation' stem cells from achieving a specific limited therapeutic objective to another level of understanding delivery, evaluation of the risks and benefits of repeat therapy and use of well characterised, lineage specified stem cells, transplanted either
alone or in combination, which will mark the beginning of ‘ second generation’ stem cell medicine. So far, only haematopoietic stem cells based medical treatment is approved in the management of several acquired and congenital haematological disorders. As an extension to this, cord blood derived haematopoietic stem cells got recognised for its unique abilities. Several thousand cord blood transplants have been so far been conducted, and is now serving as an alternative to bone marrow transplants. Reliance Life Sciences established the first public cord blood repository in this part of the world, and is licensed by the Drug Controller General of India (DCG (I)), India. In the last few years, we have supplied cord blood grafts to at least 75 patients, admitted to various institutes of the
country. The other interesting stem cell type are the MSCs, initially isolated derived from the bone marrow, but now even from other sources like the umbilical cord tissue, umbilical cord blood, placental blood, adipose tissue, etc. MSCs are selfrenewing, multi-potential, easy to cultivate, and immune modulatory in nature and hence are under extensive research to evaluate its potential in treating several hitherto unmet medical needs. These can differentiate into cells of mesodermal, ectodermal and endodermal origin. This along with their property to secreting soluble factors help induce an immune modulatory environment- making them an attractive option for cell based therapies. Reliance Life Sciences is actively researching the applicability of these cells in diabetes, cirrhosis, wound healing, neurological disorders, closely adhering to the National stem cell guidelines released by the ICMR in 2013, and ably supported by the Institutional Stem Cell Ethics Committee. Reliance Life Sciences has been a pioneer in stem cell research with several ‘firsts’ to credit. It has a significant commitment to developing stem cell therapies, right from research, cell processing in cGMP facilities, clinical research and clinical practice. There is no other player in India comparable to Reliance Life
MANAGEMENT Sciences in the stem cell therapy domain.
Limitations Reliance Life Sciences has also completed clinical trials after regulatory approvals, using MSCs derived from the patient’s own bone marrow for myocardial infarction, Parkinson’s disease, spinal cord injury, application of stem cell-based therapies for stable vitiligo, non-healing diabetic ulcers, and autologous conjuctival and limbal stem cell graft. The strategy now is to see the effect of cell combinations at R&D and preclinical experiments. But novel and ‘not so routine’ approaches are less accepted by stem cell ethics committees and approving bodies. The other limitation for stem cell research in India is the lack of sufficient funds for conduct of large clinical trials and access to appropriate preclinical disease models. The funding agencies need to step up their support further, in this area. We believe and as can be seen from scores of publications from global researchers, through stem cells, the potential to treat a wide range of disease conditions (viz. spinal injury, muscular dystrophy, Parkinson’s disease, multiple sclerosis, diabetes, retinitis pigmentosa, ALS etc.) In India, there are multiple agencies which directly or indirectly govern stem cell research. i.e. Department of Biotechnology (DBT), Indian Council of Medical Research (ICMR) and the DCG (I). The revised comprehensive guidelines from the ICMR in India is aimed at guiding researchers and indirectly ensures ethical and responsible conduct of stem cell research. The efforts of the International Society for Stem Cell Research (ISSCR) stem cell standards committee in facilitating international guidelines and standards is a reflection of this global realisation. The main concern in India now, is the absence of stem cell regulations, without which the translation is taking too long despite stem cell committees’ support with review of applications from industry and academia. This must come into force very soon, as it can be a deterrent to the mushrooming of stem cell clinics and indiscriminate use of stem cell products.
The way ahead To keep the promise of cell-based therapies, we have miles and miles to tread. Although clinical trials of stem cell therapy have been criticised by a few as being premature, there is no substitute for the human model as stem cell therapies enter the era of
translation. The pace of medical and scientific advance is gaining significant momentum, and the travel from the bench to the bedside takes time and patience and close collaboration among multiple disciplines alone will define success. With more and more new molecules under development, the present challenges faced by this industry feels the need for organ specific toxicity studies, which could be redressed using hES and adult stem cell-based toxicity experiments. With the market size expected to touch the $200 million mark by the end of this decade, stem cell-based therapies will be a major component of the new era medicine. When results expected are significant, let us not dwell on the enormous cost implications. There are at least about 200 clinical trials in various stages registered in various websites, but results are yet to come! Regenerative medicine, comprising stem cell therapies and tissue engineered products, is still at a nascent stage in India. It is expected to be definitely useful for those suffering from diabetes, cardiovascular disorders, neurological disorders, burns and wounds, osteoarthritis, osteoporosis, bone, cartilage (joints and replacements), liver disorders, congenital abnormalities and neoplasms. Going by the results of the experiments from all corners of the globe, stem cell medicine and tissue engineered-based stem cell devices will find a major place in medical prescriptions in the next five to 10 years’ time frame. With a cohesive government initiative and appropriate funding, within the next 20 years, regenerative medicine will be the standard of care for replacing all tissue/organ systems in the body, in addition to its extensive industrial use for pharmaceutical testing. A conducive environment for international collaboration, industry academia relationships, safeguarding patents on process and products will instill the much needed confidence that researchers look forward to. In the coming months, we also hope to achieve major milestones starting with establishment of standards for the regulatory approvals and fast track review of applications within a defined time frame. Just as discovery and usage of penicillin was the inflection point in the fight against infectious diseases, application of stem cell based therapies will be the turning point in the treatment of hitherto inadequately treated or incurable diseases of the 21st century.
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MANAGEMENT
INSIGHT
Ayurveda – Apotential global medical system
SHASHANK SANDU, Executive Director, Sandu Brothers
The Government of India has recently drafted a national policy on traditional systems practiced in India. Shashank Sandu, Executive Director, Sandu Brothers, provides a few action points for the government to make ayurveda a global healthcare system GOOD HEALTH plays an important role in human development. Ayurveda emphasises on maintaining the equilibrium and happiness at spiritual, physical, mental and social status of an individual. This concept of health is in close proximity to the definition of good health mentioned by the World Health Organization (WHO). Unlike other medicinal systems, ayurveda advocates restoration of health and prevention of disease more than cure of disease. Ayurveda is a philosophy of life, which leads to long, happy, healthy and prosperous living. Contributions of Traditional Systems of Medicine (TSM) and their importance for the healthcare needs of the present and the future are well recognised worldwide. Ayurveda has the rich heritage of time-tested traditional medicines with consistent scientific and evolving approach. The comprehensive manner in which all matters related to health are addressed in ayurveda, it has the potential to become a global medical system.
National policy on Indian Systems of Medicines (ISM) in India Every country in the global fraternity aspires to meet the healthcare needs of its people through an appropriate and cost-effective approach. In India, the highest policymaking body regarding the matters concerned with health and family welfare is the Central Council
32 EXPRESS PHARMA January 1-15, 2015
for Health and Family Welfare. It strongly advocates systematic use of the Indian System of Medicine-ISM, consisting of Ayurveda-Yoga-Unani-SiddhaHomeopathy, and known as AYUSH, in the primary and secondary infrastructure. The Government of India has taken up the matter quite seriously and drafted a national policy on traditional systems practiced in India. Some highlights of the draft policy are as follows: ◗ It seeks to revamp the curriculum of the educational institutes
◗ It strongly advocates enforcement of good manufacturing practices (GMP) ◗ It encourages protection of the intellectual property rights (IPR) of the resources of this sector ◗ The policy encourages propagation of ayurveda and other ISM throughout the world, especially in areas where there is special interest in these systems, through Indian missions abroad. Promoting ISM as part of health tourism is being planned. Other approaches include international
collaboration and academic exchange between interested groups. ◗ It has been recommended to increase the share of ISM, in the national health budget. ◗ It recommends effecting policy changes to cover nutraceuticals and food supplements. ◗ There will be policy support and taxation incentives to promote high standards of manufacture. ◗ It seeks to support evidencebased research to determine the efficacy of ISM drugs and therapies
◗ There will be strong encouragement for undertaking research on basic principles of Ayurveda
Efforts at government level to promote ayurveda Ayurveda is quite popular, being practiced throughout the country including tribal and remote areas where other modes of therapies are not readily available. Though it does not have an elaborate organised structure, it plays a major role in meeting the healthcare needs of a large section of India.
MANAGEMENT
❑ Academics Post graduate education in ayurvedic medicines is available in over 30 research institutes and offers specialisation in 16 clinical and preclinical ayurvedic speciality areas. The Gujarat Ayurvedic University has signed a Memorandum of Understanding (MoU) with nine Ayurvedic institutions functioning in Japan, Australia, the Netherlands, Italy, Argentina, and Germany to coordinate and facilitate the globalisation of ayurveda through academic collaboration. Earlier, Medical (Ayu) Institute of Russia had signed an MoU with the Government of India, in which the Gujarat Ayurvedic University is also one of the implementing authorities. ❑ Medicinal plant resources The drugs used in the AYUSH, are mainly plant based, in addition to mineral and animal origin. The Government of India has set up a National Medicinal Plant Board (NMPB), which has been given the responsibility of coordinating all matters related to medicinal plants. The Planning Commission set up a task force, to inter alia provide policy directives on – 1.Conservation and sustainable use of medicinal plants 2.Growth of domestic and foreign trade 3.Development of an equitable market system 4.Regulation of this sector to maintain quality control 5.Protection of IPR of medicinal plants ❑ Trading of ayurvedic herbs and herbal compound formulations Ayurvedic medicines are marketed in various forms. They may be traded in simple form of cultivated and harvested plant parts, or may be in form of traditional dosage forms like juice (swaras), decoction (kwath), and naturally preserved thru fermentation, products (asava-arishta). In addition, many patent drugs are sold in modern drug dosage forms like syrups,
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Though tremendous progress has been made in the treatment of many dreaded diseases, remedies are yet to be found for treating diseases like tuberculosis, cancer, rheumatoid arthritis, hepatitis, AIDS, etc.
granules, creams, lotions, etc., which constitute around 65 per cent of the market share. There are more than 8500 manufacturers of ayurvedic drugs in the country. Manufacturing of ayurvedic medicines is governed by local FDA body through enforcement of the Drugs and Cosmetic Act (1940) and Rules (1945) of the country. Manufacturers must comply with the rules mentioned under this act. ❑ Research and development There are research councils and institutes functioning throughout the country on different aspects of ayurveda. The Central Council for Research in Ayurveda and Siddha (CCRAS) is an apex body for the formation, coordination, development, and promotion of research on scientific lines in ayurveda and the siddha system of medicine. The research activities in various fields can be broadly categorised as follows: ◗ Clinical research ◗ Drug research ◗ Literary research ◗ Family welfare research Existence of the ‘therapeutic gap’ in modern medicine is well known. Though tremendous progress has been made in the treatment of many dreaded diseases, remedies are yet to be found for treating diseases like tuberculosis, cancer, rheumatoid arthritis, hepatitis, AIDS, etc. In these areas ayurvedic drugs and procedures may have beneficial effects. Similarly, ayurvedic drugs are proving to be beneficial in the treatment of iatrogenic disorders like
Parkinsonism and to attenuate drug-induced toxicity when administered as adjuvant. Intensive research efforts are required to explore these possibilities.
care needs of their people after categorisation of the plants according to ayurvedic concepts.
Globalisation of ayurveda
The department of AYUSH Govt of India has signed an MOU with the University of Mississippi’s department of Pharmacognasy, and established the National Centre for Natural Products Research, where scientists are researching the efficacy of many Indian plants and herbs. A recent review points out that more than 13,000 plants have been investigated during past five years. A number of medicinal plants (like Curcuma longa, Boswellia serrata, Picrorhiza kurroa, Terminalia chebula, Emblica officinalis, Bacopa monnieri, Phyllanthus niruri, Ocimum sanctum, Gymnema sylvestre, Momordica charantia, Commiphora mukul, Tribulus terrestris, Withania somnifera, Tinospora cordifolia, and Terminalia arjuna) have been shown to possess important pharmacological activities in preclinical testing; however, the generated leads have not been adequately followed up with double-blind, placebocontrolled clinical trials. One of the main lacunae that becomes apparent for any reviewer of this sector is that most of the studies are undertaken on an individual pharmacologic-effect basis. These studies need to be organized and reviewed. Such a review of these studies is likely to provide scientific basis to the traditional usage of ayurvedic therapies. Furthermore, many more studies are required to be un-
Globalisation of ayurveda has gained momentum. Many active groups have been formed in many parts of the world, including developed countries, to spread the concept and practice of ayurveda. Following reasons make ayurveda a trustworthy medical system across the globe: 1. The holistic approach advocated by ayurveda in therapeutic practice 2. It has one of the most extensive and profound conceptual bases among the traditional system of medicines of the world, and 3. It has survived for more than 4000 years as a vibrant medical system.
Academic role of ayurveda in future healthcare Facilities have been established in many countries like the US, Australia, the UK, Brazil, New Zealand and Japan to impart training in Ayurveda. The concepts of proper lifestyles, dietary habits, and daily and seasonal routines followed in ayurveda can be adopted with suitable modification to different countries in different parts of the globe after giving due consideration to the cultural milieu existing in each country and also the constitutional profile of each population. Attempts are being made to utilise the medicinal plant resources of these countries for meeting the health-
Research at the international level
dertaken on compound (multicomponent) formulations and assessment of synergistic effects of the combination of herbs, possible drug interactions with concomitant use of modern drugs, etc. should carried out.
Action points for the government Ayurveda has an exceptional potential to become a global healthcare system, government policies should be focused on following action points to make the path of its globalisation hassle-free: ◗ The first requirement is to undertake globalisation of ayurvedic education to generate high-quality, competent manpower with the requisite communication skills to teach the principles and practice of the system. ◗ The second requirement is to globalise ayurvedic practice and marketing of ayurvedic drugs. There are many obstacles to achieve this. A twopronged strategy is required to overcome this problem. a) The first one is to undertake multicentric collaborative studies on internationally acceptable guidelines to prove therapeutic utility and safety of ayurvedic drugs and practices. b) The second one is to establish ayurvedic clinics and hospitals in countries where there is no such barrier. ◗ Standardisation of ayurvedic drugs and formulations should be given top priority — without this it would not be possible to promote the utilisation of Ayurvedic drugs at the global level. ◗ Another aspect that needs to be taken into consideration is the possibility of existence of constitutional differences (Prakruti) among different races and communities as per the concepts of Ayurveda, therefore an ayurvedic concept based epidemiology linkage is necessary. ◗ It is also necessary to explore the possibility of utilisation and integration of locally available flora into ayurvedic practice of the particular country or region.
MANAGEMENT
INSIGHT
Integrative medicine: An idea whose time has come
DR PRALHAD PATKI, Head - Medical Services & Clinical Trials, R&D, The Himalaya Drug Company
As the benefits of integrating ayurveda and allopathy, especially in the treatment of lifestyle diseases and post operative care receive more attention, Dr Pralhad Patki, Head - Medical Services & Clinical Trials, R&D, The Himalaya Drug Company urges advocates of ayurveda to de-mystify and contemporarise the 5,000-year-old science by pursuing hard scientific evidence to establish safety and efficacy of ayurvedic drugs A RECENT study from Germany suggests that a compound found in turmeric could promote growth of nerve cells.1 This could open the way for future drugs for strokes and Alzheimer’s, say scientists. The medicinal properties of turmeric have been well-documented in ancient ayurveda texts. For eons, turmeric has been the ‘go-to-herb’ for treating various ailments in Indian homes. However, today the interest in herbs like turmeric is not restricted to the four walls of a house. In recent times, the interest in Ayurveda has renewed. Scientists are researching and evaluating herbs. Doctors are integrating ayurveda and yoga into mainstream allopathic medicine, giving rise to ‘Integrative Medicine’, a new approach to medicine and healthcare that rests on building synergies between traditional and modern medicine. The Center for Integrative Medicine at the University of Arizona in the US defines it as, “…healing-oriented medicine that takes account of the whole person (body, mind, and spirit), including all aspects of lifestyle. It emphasizes the therapeutic relationship and makes use of all appropriate therapies, both conventional and alternative.” Integrative medicine recognises that both conventional and alternative therapies have an important role to play in healthcare and each has its own unique benefits. Dr Andrew Weil, a Harvard Medical School graduate and
world-renowned proponent of integrative medicine emphasises the need to use Complementary and Alternative Medicine or CAM, in conjunction with conventional medicine to give patients a healthcare model that treats both cause and symptoms. Closer home, Dr Naresh Trehan, renowned cardiac surgeon and Chairman & Managing Director of Medanta – The MediCity, established the Department of Integrative Medicine at his hospital in 2008 with the objective of incorporating traditional medicine and therapies in the treatment of certain specific diseases conditions to ensure better patient outcomes. This renewed interest in ayurveda is a testament to its benefits in healthcare. Holistic in nature, ayurveda focuses on preventative and curative healthcare. Leading policy makers, scientists and doctors are seeing the benefits of integrating ayurveda and allopathy, espe-
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cially in the treatment of lifestyle diseases and postoperative care. The objective is to draw from different systems of medicine to develop a healthcare model that has the ‘patient’ at its core. Ayurveda, however, has been riddled with inconsistencies and challenges. Allopathic medicine has advanced due to its emphasis on empirical evidence, whereas ayurveda has drawn its credibility from ancient texts. This leaves it open to interpretation or misinterpretation, leading to ambiguity, false claims and wrongful practices. An unclear regulatory environment has further hampered advancements in ayurveda. While ayurvedic medicines are available over the counter (OTC) and consumers can buy it freely, there is a debate over cross-pre-
scription, fuelled by a section who hasn’t understood that anybody can use ayurveda. Trehan in an interview to a leading publication clearly stated that, “… because ayurvedic medicines are OTC products and do not require any prescription at all.” While the majority of doctors echo his sentiment, a section is refraining from practicing or prescribing ayurveda due to this confusion. Advocates of ayurveda need to de-mystify and contemporarise the 5,000year-old science. Ancient texts need to be preserved and retold in a language understood by the public, which means pursuing hard scientific evidence to establish safety and efficacy of ayurvedic drugs. Often as a brand, we are asked if ayurveda can be contemporised. Interestingly, the answer lies in ayurveda itself. Charaka Samhita, the most ancient and revered ayurveda text, makes a progressive statement, which in essence means that one must be aware of the latest developments in science in order to
provide the best care to society. At Himalaya, we invest heavily in drug development protocols and firmly believe in empirical evidence. We have conducted clinical studies in institutions like AIIMS New Delhi, BHU Varanasi, KEM Mumbai, Nanavati Hospital Mumbai among others and published papers in leading medical and peer-reviewed journals. This has helped in convincing allopathic doctors of the benefits of herbal medicine in a scientific manner and ensuring that our drugs are of high quality, safe and effective. We are seeing the strength of herbal medicine play out in our cancer research. Himalaya is in the advanced stages of developing a herbal drug that immunologically tackles the side effects of oncotherapy by significantly boosting immunity and addressing anaemia, thereby decreasing the chances of infections. The drug aims to increase a patient’s immunity, which is heavily suppressed due to cancer or chemotherapeutic agents. If we succeed, it will be a breakthrough in herbal medicine. For a long time, Himalaya has been speaking about integrative medicine. Today, we are seeing doctors, healthcare professionals and even government bodies support the idea. To quote Victor Hugo, “There is nothing more powerful than an idea whose time has come!”
Reference 1. Stem Cell Research and Therapy Journal
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RESEARCH I N T E R V I E W
Our focus is on identifying other genes that contribute to hereditary cancers Dr T Rajkumar, Director and Scientific Director, Cancer Institute (WIA), Adyar elaborates about the ongoing research work at the institute as well as his perspective on what should be the priorities and economics of onco drug therapy, in an interaction with Usha Sharma The Cancer Institute (WIA), Adyar, Chennai was first mooted in 1954 by Dr Muthulakshmi Reddy, India’s first woman medical graduate and set up a year later under the auspices of Women’s India Association (WIA). This year, the institute completes its 60 years of service. What unique research projects have been taken up by the institute towards cancer diagnosis, care and prevention? The institute has four components: The hospital section which provides state-ofthe-art cancer care to all patients irrespective of their socio-economic status; the research section which includes the Department of Molecular Oncology, which works on cervical, breast, gastric, ovarian, bone and hereditary cancers; the college which offers DM, MCh, MD courses in medical oncology, surgical oncology and radiation oncology, respectively; PhD programmes in oncology, diploma courses for technicians, etc. and fourthly the preventive oncology and epidemiology section which carries out field studies and trials, runs the Madras Metropolitan Tumour Registry and the Dindigul District Tumour registry, maintains the hospital tumour registry etc. The institute was a pioneer in the multi-modal form of treatment way back in early 1960. This multi-modal approach uses initial radiation or chemo-radiotherapy to shrink locally advanced head, neck and breast cancers and
36 EXPRESS PHARMA January 1-15, 2015
then operate on them. This has contributed significantly to improve cure rates. The institute was also a pioneer in early detection by population-based screening in the 1960s and followed it up in the 80s by training the Tamil Nadu Government’s health workers in visual inspection after application of acetic acid and trained technologists for reading PAP smear. You received the Kobayashi Foundation Award for Cancer Research in recognition of your work which provides a new level of understanding on drug resistance in aggressive bone cancer among children and adolescents (osteosarcomas). What is the progress of your research in this front? We have been trying to identify novel molecules which help overcome drug resistance in osteosarcomas. Lichenbased extracts are being evaluated not only for anticancer activity but also for overcoming drug resistance. As the Professor and Head, Dept. of Molecular Oncology, Cancer Institute (WIA), you have established a population-based Hereditary Cancer Registry covering Madras Metropolitan Area, which was funded by WHO between January 2002 to December 2003,thereafter by Cancer Institute (WIA). Much of your research work involves looking for links between genes and incidences of cancer. What are the outcomes of these studies and
The hereditary cancer programme benefits the person already affected by cancer, since there are therapeutic decisions which could be influenced by the mutation what does this mean both for clinical oncologists like yourself as well as patients? About five to 10 per cent of the common cancers such as
breast cancer can be hereditary. Our hereditary cancer programme consists of the hereditary cancer clinic, laboratory for mutation detection and a populationbased hereditary cancer registry. Mutation analysis was done free of cost for all eligible patients and the genes tested included BRCA1 and BRCA2 [for hereditary breast and ovarian cancers], MSH2 and MLH1 [for hereditary nonpolyposis colo-rectal cancers]. Our analysis had revealed novel deleterious mutations in our patients, which contributes to around 25 per cent of all deleterious mutations. The most common deleterious mutation seen in our clinic is a deleterious mutation prevalent in Ashkenazi Jewish population. However, our patients are non-Jewish and in 30 per cent of the patients, there was no family history of any other member being affected with breast and or ovarian cancers. The affected patients are from different parts of South India and from different castes and religious backgrounds. Given the tendency for marriages within the caste, there is a possibility of this mutation being prevalent in these castes and this needs to be confirmed. The hereditary cancer programme benefits the person already affected by cancer, since there are therapeutic decisions which could be influenced by the mutation. As an example, breast conservation surgery in a lady carrying a deleterious mutation in BRCA1 or BRCA2, is fraught
with an increased risk for local recurrence, increased risk of developing opposite side breast cancer and offers the potential to use newer drugs such as PARP inhibitors. More importantly, it also helps other unaffected family members of the same family, if they are found to carry the same deleterious mutation. In these members, early detection, prophylactic surgeries, chemoprevention and life style modifications will help reduce the risk of developing cancer. Long-term follow-up of these carriers (of deleterious mutations) is needed. What percentage of the Indian population faces hereditary cancer problems? Tell us about the key areas which have the potentials for hereditary cancer and what kind of research work are you conducting? Our research is now focusing on identifying other genes which can contribute to the hereditary cancers. We are now using a panel of 56 genes in our next generation sequencing platform to address this. Additionally, up to a third of the mutations seen are classified as ‘mutations of unknown significance.’ We are trying to identify at least in some of these mutations if functional studies could be done to address the issue. The newly donated Ion Torrent PGM unit with a rapid turn-around time will help patients in having mutation detection done within a week to 10 days, so that decision of the best management options can be taken. This will benefit
patients suffering from breast, ovarian, lung, and colon cancer. As ever, the institute will support the poorer patients. You are involved in the evaluation of the Dendritic vaccine for the treatment of cervical cancer. What is the progress? We were the first in the country to develop Dendritic cell vaccine for the treatment of cervical cancer. Dendritic cell vaccine is a form of immunotherapy and has shown promise in several cancers. Our phase I study, funded by DBT, showed that this form of treatment is well tolerated. One of the patient who received Dendritic cells primed with her own tumour lysate proteins and subsequently had cisplatin chemo for a very large lung metastasis is free of disease for more than seven years. Based on our results, we have submitted the phase II trial in stage IIIB cervical cancer to DCG (I) and are awaiting for the clearance. How many biomarkers have you developed and which cancers are these linked to? You are involved in / leading gene expression studies in cervical, breast and gastric cancers. How far are we from having prognostic markers for these cancers? The Department of Molecular Oncology has been funded by DST, Government of India to help develop potential diagnostic biomarkers for cervical, gastric and breast cancers. In cervical cancer, PAP smear plays an important role in screening women for early detection in the pre-cancerous stage itself. While in the Western countries, this has been the main stay, in India it does not seem to be a feasible method due to the fact that it needs a qualified and trained pathologist/cyto-pathologist for interpreting the smear. We simply do not have the number of pathologists for a population-based study. Additionally, the interpretation can be subjective particularly in the borderline smears. To this end, we have developed a novel double antibody sandwich ELISA to detect p16, a protein which is expressed after the human papilloma virus infection becomes potentially deleterious [patent Application number 475/CHE/2014, filed on 03-02-2014]. Testing for HPV infection has its limitation since 95 per cent of women infected with HPV will clear the infection and hence will need re-
testing after a year. Over expression of p16 in contrast occurs only when the HPV infection affects the cell deleteriously. Hence, p16 protein over expression is a down-stream event and once detected will need to be acted upon. p16 over expression is seen in the pre-cancerous stages of the cervical cancer itself and hence can be used for population based screening. The other major advantage of this ELISA-based test is that it can be at the point of care such as primary health centres and does not require highly qualified staff. A technician familiar with the use of the ELISA plate reader should be able to provide the results from the smear lysates and in an objective manner. What has been your strategy for diagnosing early stage gastric cancer? Gastric cancer is a lethal disease in our country, especially in South India, since more than 90 per cent of cases are detected at an advanced stage. Population-based screening using endoscopy or barium meal will not be feasible in our country due to the sheer number of individuals required to be screened. A better alternative is to identify potential plasma- based biomarkers for early detection of gastric cancer. We have used micro array studies to identify differentially expressed genes in gastric cancer compared to normal stomach. We then validated this using quantitative RTPCR and the validated genes were then shortlisted based on whether they were secreted or potentially secreted. 15 proteins were then further validated in gastric tissues, cancers, paired normal and apparently normal gastric tissues. Once we validated the differential protein expression, we then looked for the levels of the protein in the plasma of healthy normal individuals whose OGDscopy (oesophago-gastro deuodenoscopy) was normal; in individuals with benign gastric conditions such as gastritis, ulcer etc. and in patients with gastric cancer. We found that 10 out of the 15 protein bio-markers could be used to differentiate plasma from cancer patients and plasma from healthy individuals or from patients with benign gastric pathologies. A large scale validation is under-way using 400 cancer patient samples and 800 control samples. A similar strategy was used in breast cancer to identify differentially expressed genes. We are now trying to validate the protein levels in tissues from breast cancer patients and
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RESEARCH tissues from patients with benign pathologies. These studies are being funded by the Indian government through DBT & DST but you have also worked on WHO projects. What has been your experience as far as ease of administration of funds, etc. is concerned. We have received most of our funding from DST and DBT. Our experience with these agencies has been good, although last year due to budgetary cuts, some of the projects had their funds released late. You had published a paper in The Indian Journal of Cancer Chemotherapy, (10: 73-82, 1988) titled 'Drug therapy in oncology - its priority and economics'. What are your views on Mumbai's Tata Memorial Hospital recommendation that prices of certain cancer drugs
38 EXPRESS PHARMA January 1-15, 2015
should be brought under price control? Your perspective on what should be the priorities and economics of drug therapy. The essence of the article referred to still stands good. Use of combined modality treatment in most cancers will achieve a better result. Hence, in the management of most cancers all the three primary therapeutic modalities should be employed. The pricing on anticancer drugs as well as on adjuvant drugs used during chemotherapy [anti-emetics, G-CSF, etc.] needs to be realistic in our environment. Most of the patients seen in our country are from the lower socio-economic strata and do not have insurance and hence are dependent on state-run institutions and not for profit institutions. Some of the targeted therapies, such as Herceptin used for HER2 positive breast cancer are very expensive, so much so that
The pricing on anticancer drugs as well as on adjuvant drugs used during chemotherapy [anti-emetics, G-CSF, etc.] needs to be realistic in our environment hardly one to five per cent of the patients in premium institutions such as Cancer Institute [WIA], Adyar or Tata Memorial Hospital can afford it. The arrival of bio-similars is eagerly awaited, which can help bring down the cost. The top
priority for any not-for-profit institution is to optimise its resource utilisation to allow more patients to be cured. When there are patients competing for the beds, prudence dictates that the bed be offered to one who has the potential to be cured. Every institution has its bed strength limited to a certain level wherein they can provide quality care to all it admits for treatment with an intent to cure. Over burdening of such institutions will be counterproductive, as the quality of care will come down. The answer to this is to have more centres which are either supported by the government or by not-for-profit institutions, to take care of the patients from the lower socio-economic strata. In this regard, the Tamil Nadu Governmentâ&#x20AC;&#x2122;s Chief Ministerâ&#x20AC;&#x2122;s Comprehensive Health Insurance Scheme helps the government hospitals and the not-for-profit
institutions in becoming selfsufficient Is there a way for the government's pricing authority, the NPPA, to balance profits permitted to drug manufacturers with access to oncology therapy? The Indian patent regime permits local manufacture of generic drugs for critical illnesses if the international pharma majors pricing is unrealistic for our country. However, there has been a negative trend with some of the newer targeted therapies. Some of these drugs cost a fortune and the increase in survival rate is from few days to few weeks. The oncologists also need to be careful when prescribing such expensive drugs which virtually can break a householdâ&#x20AC;&#x2122;s resource but provide virtually nothing to the family. u.sharma@expressindia.com
RESEARCH RESEARCH UPDATES
Psoriasis study demonstrates superiority of Novartis Cosentyx to Stelara in clearing skin CLEAR is the second head-to-head study for Cosentyx following the phase III Fixture study that showed Cosentyx was superior to Enbrel (etanercept) NOVARTIS ANNOUNCED that the phase IIIb CLEAR study for Cosentyx (secukinumab, formerly known as AIN457) demonstrated superiority to Stelara (ustekinumab) and met its primary endpoint of achieving PASI 90, which represents clear or almost clear skin at week 16 for psoriasis patients[1]. The study also met the secondary endpoint of achieving PASI 75 at Week 4[1]. Safety results were consistent with previously reported phase III clinical trials for Cosentyx. The CLEAR study is the second head-to-head study for Cosentyx versus established psoriasis biologic treatments. It follows on from the phase III FIXTURE study, which showed that Cosentyx was superior to Enbrel (etanercept), a current standard-of-care, in clearing psoriasis skin with a comparable safety profile[2]. Achieving clear skin is the ultimate aim of psoriasis treatment for patients. Data from the Cosentyx clinical trial programme has also shown a significant positive relationship between achieving clear to almost clear skin and psoriasis patients' health-related quality of life[3]. Additionally, 50 per cent of psoriasis patients are not content with current therapies, including biologic treatments[4]-[7]. “We are delighted that our IL-17A inhibitor Cosentyx showed superiority over Stelara, a widely-used biologic for moderate-to-severe psoriasis patients and a newer treatment alternative to TNF inhibitors,” said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. “Patients need more effective treatment options for psoriasis and these im-
pressive results add to the robust body of evidence that patients dramatically benefit and can achieve clear skin with Cosentyx.” The study involved 679 moderate-to-severe plaque psoriasis patients and will be submitted for presentation at an international medical congress in 2015. Topline results follow a positive CHMP opinion for Cosentyx as a first-line systemic treatment for patients with moderate-tosevere psoriasis. Currently, all biologic treatments for psoriasis, including anti-tumor necrosis factor therapies (anti-TNFs) and ustekinumab are recommended for second-line systemic therapy in Europe[8]-[10]. In addition, the FDA Advisory Committee voted unanimously for the approval of Cosentyx in the US. Cosentyx works by inhibiting the action of IL-17A, a protein that is found in high concentrations in skin affected by psoriasis[11]-[16]. Psoriasis is a chronic immune-mediated disease associated with significant impairment of physical and psychological quality of life[4],[17],[18]. Psoriasis affects up to three per cent of the
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world's population, or more than 125 million people[19].
References [1] Novartis, Data on file. [2] Langley RG, Elewski BE, Lebwohl M, et al. "Secukinumab in plaque psoriasis: results of two phase three trials." New Engl J Med. 2014. Jul 9;371(4):326-38. [3] McLeod LD, Mallya UG, Fox T, Strober BE. "Psoriasis Patients With PASI 90 Response Achieve Greater Health-Related Qualityof-Life Improvements Than Those With PASI 75 Response." European Association of Dermatology and Venereology Congress. Amsterdam, Netherlands. 10 October 2014. [4] Stern RS, Nijsten T, Feldman S, et al. "Psoriasis Is Common, Carries a Substantial Burden Even When Not Extensive, and Is Associated with Widespread Treatment Dissatisfaction." J Investig Dermatol Symp. 2004;9(2):136-9. [5] Christophers E, Griffiths CEM, Gaitanis G, et al. "The unmet treatment need for moderate to severe psoriasis: results of a survey and chart review" J Eur Acad Dermatol Venereol.
2006;20:921-925. [6] Krueger JG, Koo J, Lebwohl M, et al. "The impact of psoriasis on quality of life: Results for a 1998 National Psoriasis Foundation patient membership survey." Arch Derm. 2001;137:280-284. [7] Sterry W, Barker J, Boehncke WH, et al. "Biological therapies in the systemic management of psoriasis: International Consensus Conference." Br J Dermatol. 2004;151 Suppl 69:3-17. [8] European Medicines agency website, "Enbrel Summary of Product Characteristics" http://www.ema.europa.eu/docs/ en_GB/document_library/EPAR __Product_Information/human/000262/WC500027361.pdf. Accessed November 2014. [9] European Medicines agency website, "Humira Summary of Product Characteristics" http://www.ema.europa.eu/docs/ en_GB/document_library/EPAR __Product_Information/human/000481/WC500050870.pdf . Accessed November 2014. [10] European Medicines agency website, "Stelara Summary of Product Characteristics" http://www.ema.europa.eu/docs/ en_GB/document_library/EPAR
__Product_Information/human/000958/WC500058513.pdf. Accessed November 2014. [11] Gaffen SL. "Structure and signaling in the IL-17 receptor family." Nat Rev Immunol. 2009;9(8):556-67. [12] Ivanov S, Linden A. "Interleukin-17 as a drug target in human disease." Trends Pharmacol Sci. 2009;30(2):95-103 [13] Kopf M, Bachmann MF, Marsland BJ. "Averting inflammation by targeting the cytokine environment" Nat Rev Drug Discov. 2010; 9(9):703-18. [14] Onishi RM, Gaffen SL. "Interleukin-17 and its target genes: mechanisms of interleukin-17 function in disease." Immunology. 2010;129(3):311-21. [15] Krueger J, Fretzin S, SuárezFariñas M, et al. "IL-17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis." J Allergy Clin Immunol. 2012;130(1):145-154. [16] Johansen C, Usher PA, Kjellerup RB, et al. "Characterization of the interleukin-17 isoforms and receptors in lesional psoriatic skin." Brit J Dermatol. 2009;160(2):319-24. [17] Rapp SR, Feldman SR, Exum ML, Fleischer AB, Jr., Reboussin DM. "Psoriasis causes as much disability as other major medical diseases." J Am Acad Dermatol. 1999; 41(3 Pt 1):401-7. [18] Farley E et al. "Psoriasis: comorbidities and associations." G Ital Dermatol Venereol. 2011 Feb;146(1):9-15. [19] International Federation of Psoriasis Associations (IFPA) World Psoriasis Day website. "About Psoriasis." http://www.worldpsoriasisday.co m/web/page.aspx?refid=114. Accessed December 2014. EP News Bureau-Mumbai
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RESEARCH
People with blood groups A,B and AB at higher risk of type II diabetes than group O A 35 per cent increased risk of type II diabetes was found in those with group B A STUDY of more than 80,000 women has uncovered different risks of developing type II diabetes associated with different blood groups, with the biggest difference a 35 per cent increased risk of type II diabetes found in those with group B, Rhesus factor positive (R+) blood compared with the universal donor group O, Rhesus factor negative (R–). The study is published in Diabetologia (the journal of The European Association for the Study of Diabetes) and is by Dr Guy Fagherazzi, and Dr Francoise Clavel-Chapelon, Center for Research in Epidemiol-
ogy and Population Health, INSERM, Villejuif, France, and colleagues. While previous studies have investigated the links between blood group and stroke (finding an increased risk for group AB versus group O), those on blood groups and their link with diabetes have been small and thus underpowered and unable to provide definitive results. In this new research, Fagherazzi and colleagues took data from 82,104 women from the large prospective E3N cohort in France followed between 1990 and 2008. The objective of this study was
to evaluate the relationship of ABO blood type (A, B, AB and O), Rhesus factor (positive or negative) and a combination of the two (ABO×Rhesus) with type II diabetes (T2D). The results showed that,
compared with women with group O blood, women with group A were 10 per cent more likely to develop T2D, and those with group B 21 per cent more likely (both statistically significant). The AB group was 17 per cent more likely to develop T2D, but this result was not statistically significant. When looking solely at R+ versus R– women, neither group was at increased risk of developing T2D compared with the other. The authors then combined ABO group and Rhesus group and compared each possible combination with O negative
(O–), which is known as the universal donor group because since it contains none of the A. B, or Rhesus antigens, blood from people in this group can be successfully donated to any other group (without rejection). Compared with O– women, the highest increased risk of developing T2D was found in B+ (35 per cent increased risk), followed by AB+ (26 per cent), A– (22 per cent), A+ (17 per cent). The results for O–, B–, and AB– groups were not statistically significant. EP News Bureau-Mumbai
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PHARMA ALLY VALUE ADD
Particle sizing — Exploring the rigour and requirements of analytical QbD
STUART WAKEFIELD, Director, Malvern Aimil Instruments, India
Analytical QbD (AQbD) promises to extend the rigour and benefits of QbD into the area of analytical method development. Stuart Wakefield, Director, Malvern Aimil Instruments, India, provides an introduction to the methodology involved and takes as an example the application of AQbD to the development of a laser diffraction particle sizing method THE APPLICATION of Quality by Design (QbD) has become second nature to the pharmaceutical industry. The concept of scoping, understanding and controlling a pharma manufacturing process within the ‘design space’ is well-established. The FDA have encouraged the adoption of QbD by offering, in return, operational freedom within the design space. This enables a responsive approach to be understood but unavoidable variability and can substantially enhance manufacturing efficiency. Such gains prompt the question as to whether the principles enshrined in QbD are applicable to other processes, and analytical method development is now a focus. Just like conventional QbD, analytical QbD (AQbD) holds out the prize of flexibility, in contrast to the rigidity of Standard Operating Procedures (SOPs). The FDA has already released guidance outlining the potential benefits that this flexibility might bring. The view is that the adoption of AQbD will support the development of robust analytical methods which will more easily transfer with the product, through scale-up, from site to site and indeed from instrument to instrument. This represents a considerable incentive for an industry so
heavily reliant on rigorous analysis.
Introducing the concept of AQbD
Figure 1 Parallels the QbD and AQbD work flow
Figure 2: A typical analysis report from a laser diffraction system
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The generally accepted definition of QbD, as presented in International Conference of Harmonisation document Q8(R2) (ICHQ8), is: ‘A systematic approach to development that begins with predefined objectives and emphasises product and process understanding, based on sound science and quality risk management.’ This central idea of a structured and rigorous approach to the development of a process has resonance in the development of analytical methodologies. Conventional QbD begins with the identification of performance targets for the product, the Quality Target Product Profile (QTPP). This usually takes the form of a defined pharmacological or physical feature, such as the dissolution profile and disintegration time for an oral dosage form or bioequivalence to an innovator product. The next step is to identify the attributes and features which deliver the QTTP, the Critical Quality Attributes (CQAs). These are then controlled through knowledgeable manipulation of the Critical Process Parameters (CPPs), which define how the process is
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PHARMA ALLY
Figure 3: Relative potential error in particle sizing from 3 important sources
operated, and the Critical Material Attributes (CMAs), which are properties of the raw and intermediate ingredients. For AQbD the starting point is identification of an Analytical Target Profile (ATP). This is the definition of what the analytical method is required to do, which is usually to measure a property that directly affects product quality. For instance, rate of dissolution has a substantial impact on product performance so determining particle size might be necessary to control product quality. Detailed consideration of the ATP identifies the reproducibility and accuracy which must be delivered for the analysis to fulfil its purpose. The next step in AQbD is to determine an appropriate technique for analysis. Rarely is a measured parameter supplied exclusively by a single technique so the choices available must be considered carefully, with reference to the ATP. Once a technique has been selected, AQbD focusses on building a robust method by identifying critical method attributes and systematically assessing the risks and variability associated with the technique. This systematic study of risk factors may be supported by Design of Experiments (DOE) or Multi-Variate Analysis (MVA) tools and leads to scoping of the ‘design space’ for the analytical method, the Method Operable Design Region (MODR). Once an MODR is defined that produces results which
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consistently meet ATP goals, appropriate methods of control are put in place and method validation carried out following ICH Q2. As with QbD, the entire AQbD workflow is held within a system of ‘Life Cycle Management,’ which implies a process of continuous improvement. In going beyond simple SOP definitions to create an analytical design space, AQbD enables a responsive approach to the inherent variability encountered in day-to-day analysis, delivering robust methods for use throughout the pharma life cycle. It also has the potential to reduce the risks involved in analytical method transfer, where the root cause of failure usually stems from insufficient consideration of the operating environment and a failure to capture and transfer the information needed to deliver robust measurement.
AQbD in practice The easiest way to understand AQbD is by considering a practical example. A suitable illustration is the application of AQbD in the development of a particle sizing method. Particle size is routinely measured across the pharma industry and laser diffraction is very often the technique of choice.
Define goals — Setting the ATP '…particle size analysis is not an objective in itself but a means to an end…" H Heywood Proc, Ist Particle Size Annual conference Sep-
Figure 4: Fishbone Risk assesment for a wet method
tember 1966 In an industrial setting, particle size is measured because it correlates with properties of a finished product or has an impact on the manufacturing process. To identify an ATP for a particle sizing method it is therefore vital to ask: “why is particle size being measured?” To answer this question it is helpful to refer back to the QbD workflow. This enables an understanding of which CMA (solubility or content uniformity for example) or CPP (perhaps powder flowability) it is that particle size analysis is being used to control. This will establish whether or not particle size is a CQA for the product. ICHQ6A is very useful here since it supports a systematic assessment of whether or not a particle size specification is required [ICHQ6A]. In general particle size specification should be considered if a pharma product contains particles and if the size of those particles influences: ◗ Dissolution profile, solubility or bioavailability ◗ Processability ◗ Content uniformity ◗ Stability If a particle size specification is required then this is the basis for an ATP. However, an ATP should outline not only which variable must be measured, but also why, and which attributes of the measurement — reproducibility and accuracy, for example — will define success. Defining the ATP also requires a consideration of the analytical technique that will be
used and the specific metrics it will deliver. Laser diffraction is now the preferred choice for particle sizing in the micron range, in many instances, and is therefore the focus of this AQbD example.
Introducing laser diffraction In laser diffraction particle size analysis, the particles in a sample are illuminated by light from a collimated laser beam which is then scattered by the particles present over a range of angles. The angle of this scattered light is proportional to its size. Figure 2 shows a typical report from a laser diffraction analysis highlighting the metrics that the method supplies which can be used to set particle size distribution specifications. The most commonly used values are the percentiles Dv(10), Dv(50), and Dv(90), the size below which 10 per cent, 50 per cent and 90 per cent of the particle population falls respectively, on the basis of volume. Additionally, the mean particle diameters D[3,2] and D[4,3] which are based on surface area and volume respectively may also be used.
Develop the method determining the CQAs for the analytical procedure The ATP identifies what will be measured, for example, Dv(50) and Dv(90) to an accuracy of +/-3 per cent, to meet the stated purpose of the analysis. The next step is to look at what parameters must be controlled to meet this target per-
formance: the CQAs of the method. Figure 3 presents the relative potentials for error in particle sizing from three important sources: sampling; instrumentation; and dispersion. It is clear that errors resulting from dispersion and sampling are generally larger than the error associated with the instrument. Both sampling and dispersion are clearly highlighted as CQAs and must therefore be rigorously controlled. The control of sampling begins with extracting the sample from the bulk, but extends through the analytical method to measurement time, which reflects how much of a gathered sample is actually analysed. When it comes to dispersion it is vital to refer back to the ATP to identify the purpose of the measurement. For instance, if the goal is to understand powder flowability then measuring the sample in its agglomerated state may give more relevant information. On the other hand if the intent is to control clinical features, such as solubility or bioavailability, then dispersing the material to its primary size is more beneficial. In most cases primary particle size is the parameter of interest, and dispersion forms part of most laser diffraction analyses. Here there is a choice to be made between dry and liquid dispersion.
Assessing the options for sample dispersion Liquid
dispersion
uses
a
PHARMA ALLY wetting agent to reduce the forces of attraction between particles, and dispersion is induced by stirring and/or sonication. The use of a liquid dispersant makes this technique more complex and less environmentally favourable than dry measurement, especially for samples that are sensitive to water, the preferred dispersant. However, wet dispersion is both gentle and effective and therefore is well suited to fragile and friable samples that are prone to breakage/damage. It is also the dispersion method of choice when working with compounds where exposure needs to be tightly controlled. Dry dispersion, a more physically intense process, involves entraining samples within a high-velocity air stream. Dispersion results from collisions between particles and/or between particles and a surface and the shear stress induced by the rapid acceleration and deceleration of particles . The advantages of dry dispersion are simplicity, speed and low environmental impact. Ensuring complete dispersion, either wet or dry, is an essential element of laser diffraction analysis. This makes the parameters that control dispersion CPPs for the laser diffraction method - variables that directly impact data quality. The following example outlines how to scope the MODR for a wet dispersion but clearly the same process could be applied to a dry measurement. Clearly a wet or dry measurement will be followed in a typical AQbD project, rather than both.
Risk assessment: Scoping the MODR for liquid dispersion In summary the development of a wet dispersion method involves: ◗ Choosing an appropriate dispersant ◗ Determining the amount of energy required to ensure complete dispersion ◗ Verifying the state of the dispersion using a reference technique such as imaging Figure 4 shows a 'fishbone' risk assessment that summarises all the potential sources of variability that impact a wet method. Risk factors fall into
Figure 5: Effect of ultrasound on particle size
Figure 6: Impact of sample concentration on particle size in laser diffraction
three distinct groups: noise factors (green), control factors (orange) and experimental factors (red). It is the experimental factors that require systematic investigation to determine the MODR for the analytical method. The following experimental examples show how this can be achieved. Sonication power/time Figure 5 shows the results from an experiment to investigate the effect of sonication on sample dispersion. Particle size is clearly reduced by sonication but there is an appreciable time taken to reach stability, a phenomenon that must be reflected in the developed method. Sample quantity/laser obscuration Figure 6 shows data from experiments investigating the impact of laser obscuration, which is often taken as a measure of sample concentration. Laser diffraction systems do not directly report sample concentration. Instead users add sample to
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achieve a certain level of obscuration, which is the percentage of light intensity that is attenuated through absorption or multiple scattering by the particles, during measurement. However, obscuration depends not only on particle concentration, but also particle size. Achieving a specific obscuration with fine particles requires a much higher sample concentration than with larger particles because of the increase in scattering efficiency that occurs as particle size reduces. The results from this experiment reflect these effects. For the sample containing larger particles, the reported particle size is independent of sample concentration. However for fines, a reduction in the reported particle size is observed above four per cent obscuration. At this point the sample concentration is so high that multiple scattering has begun to occur. With these finer particles a relatively low obscuration is required to approach the robustness achieved with the coarser sample.
Stirrer speed Figure 7 shows the results of stirrer speed titration, an assessment of the impact of stirrer speed on measured particle size. Above 2500 rpm, particle size is stable indicating that the whole sample is in suspension. Below this speed, larger particles are settling and fine particles are being sampled disproportionately. Measurement time Figure 8 shows the results of an experiment to assess the impact of measurement time. If the duration of measurement is too short, then larger particles that are present in small numbers might be missed. For samples with broad distributions, measurement duration is especially important. These results show that measurement times in excess of 10 seconds provide consistent data in this case.
Control — method validation for particle size measurements The final step in the AQbD
process is to ensure that the necessary control is in place, that the method is validated. USP<1225> and the FDA’s latest Guidance for Industry for Analytical Procedures and Methods Validation both provide a list of analytical validation characteristics which should be considered when validating physical property methods. Stress is laid on a case-bycase assessment of the characteristics which should be considered, with the goal of determining that the procedure is suitable for use. USP<1225> goes on to specify a generic approach for selecting the appropriate characteristics based on the category in which the technique in question falls, with the main characteristic for particle size analysis being precision. However, the specific use of the method and the characteristics of the material being analysed should be taken in to consideration before defining the most appropriate characteristics. These reference back to the ATP. Both USP <429>, the USP general chapter relating to laser diffraction methods, and USP<1225> specify the importance of accuracy assessment to ensure optimum equipment performance prior to carrying out methods validation, and guidance is provided on how this should be achieved using standard reference materials. USP<429> also suggests that the sample concentration range should also be considered, so as to ensure that the measured particle size distribution is not affected by changes in concentration within the concentration range specified for the method. Concentration range definition should be assessed on a case by case basis and will be highly dependent on the nature of the sample and the type of method being validated. Considering the method validation process, the following should be considered in confirming that a particle sizing method is fit for purpose: ◗ A system calibration (accuracy assessment) should be performed according to the manufacturer’s and/or the laboratory’s specification using a certified reference material. ◗ The precision and intermediate
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PHARMA ALLY precision of the method should be assessed. ◗ The robustness of the method should be understood, with reference to the critical method attributes. ◗ Assurance should be provided that the data generated is reproducible and is effective in controlling the product’s quality. Assessing precision involves seven measurements of the same sample. It therefore tests the consistency of the sampling and dispersion process. Intermediate precision is then assessed by considering different operators. Reproducibility is a broader concept that also encompasses multiple analytical systems, possibly across multiple laboratories on different company sites. The method robustness is defined with reference to the risk assessment stage of the AQbD process. USP<429> and ISO13320: 2009 provide guidance as to the precision (repeatability) and reproducibility that particle sizing should deliver. However, the specifications are relatively broad and far closer tolerances may be set where necessary. At this point it is crucial to ensure that the precision and reproducibility match the requirements of the ATP rather than simply answer to regulatory guidance, since ultimately this will determine the success of the analytical technique across the lifetime of the product.
Precision Precision is assessed by running the developed method a number of times on the same sample. Table 1 shows the results from this type of experiment, with the analyses conducted by a single operator. In accordance with USP guidance more than six measurements are performed. The Coefficient of Variation (COV) is found to be within USP limits, with the slightly broader spread of results for the Dv10 and Dv90 bring attributed to dispersion and sampling respectively. Table 2 shows the results recorded when a different operator conducts the same series of analyses. COV is again within the limits set by USP guidance.
44 EXPRESS PHARMA January 1-15, 2015
Table 1
Figure 7: Effect of stir speed on particle size Table 2
Figure 8: Effect of measurement time on particle size
Performing the measurement a number of times with a range of different operators scopes the impact of operator variability and enables calculation of the intermediate precision, by pooling all of the results. Once precision has been validated to an acceptable level, attention can then turn to testing reproducibility, the precision of the method when used with fresh samples prepared by a different operator for example, or at different laboratories to complete the validation process.
Easing the analytical workload — tools that help with AQbD Recent advances in analytical instrumentation, and associated software, can make a big difference when it comes to the application of AQbD. For example, some laser diffraction systems (such as the Mastersizer 3000, Malvern Instruments) have SOP player functions, which allow method development or validation testing to be automated. Using this tool, users can build measurement sequences around existing SOPs to enable rapid experimentation. Malvern’s Data Quality tool
for the Mastersizer 3000, for example, enables operators to critically assess measurement data and results during an analysis. Figure 9 shows an example output from this software. Advice is given relating to the measurement process (e.g. instrument cleanliness and alignment) and also the analysis process. The net result is to deliver Malvern expertise directly at the point of analysis in a way that that makes it possible to detect measurements that may be out of specification, and also to obtain the advice needed to optimise SOPs. Laser diffraction is a wellestablished and highly automated technique. Arguably, tools that support the implementation of AQbD may be more advanced in this area than elsewhere. However, other instrumentation increasingly offers functionality that can be very helpful in AQbD. SOP-driven operation is now a standard feature in many of Malvern Instruments technologies such as Dynamic Light Scattering, Imaging and Rheological measurement systems and advancing SOPdriven operation, a valuable asset in AQbD related studies.
Figure 9: Malvern Mastersizer 3000 Quality Data Tool reporting
Looking ahead More than a decade ago Malvern Instruments broke new ground by delivering standard operating procedure-driven analysis in the Mastersizer 2000, helping to bring robust and reliable analysis to the pharma industry. Today, with the benefit of QbD experience, the strict ad-
herence to SOPs has rightly been identified as an overly rigid approach to analysis. The advent of AQbD brings the promise of flexibility and an associated easing of method transfer that will ensure analytical methods are efficient and robust, and useful throughout the lifetime of an analytical product.
PHARMA ALLY VENDOR NEWS
Kezzler partners with Belgium-based UCB for Indian market The new partnership will cover domestic products within the Indian market, with expected roll-out in Q1 of 2015 KEZZLER, A global leader in brand protection at the unit level, has been adopted by Belgian pharmaceuticals giant UCB for the Indian market. UCB have for several years applied Kezzler’s technology platform for protection of its exported products out of India. The new partnership expands that operation to cover domestic products within the Indian market, with expected rollout in Q1 of 2015. The company claims that Kezzler was the first company to introduce the concept of serialisation to India as a way to protect both consumers and brand owners against the menace of counterfeiting, duplication, product diversion, and other illegal activities. UCB was among the first companies to use the Kezzler technology, which allows con-
Kezzler was the first company to introduce the concept of serialisation to India as a way to protect both consumers and brand owners against the menace of counterfeiting, duplication, product diversion, and other illegal activities sumers to instantly verify after purchase whether the medicine is genuine, within the valid expiry period, and not subject to a recall notice. A simple SMS of a unique code on the package (or scanning of the barcode with a Smartphone) covers all of the
possible safety provisions. Kezzler’s approach to serialisation and track and trace starts with a Unique Identifier Code (UID) for secure generation and authentication/tracing of codes (encrypted digital identities) in a mass production environ-
Honeywell announces price increase for Aclar films
ment and at the unit level in multiple business sectors, including pharma, consumer goods, food and dairy to mention a few. “We believe our technology platform has been proven as a cost effective business solution in preventing counterfeit products with seven of the top 10 pharma companies in the world and is now being utilised with global consumer goods companies,” said Magnar Loken, Chief Executive Officer, Kezzler. “The scalability and power of our platform is something that has been proven in the brand protection space and now is gaining significant traction in supply chain management and consumer engagement via mobile and digital applications.”
HONEYWELL Healthcare and Packaging has increased the price for its Aclar films of 4.2 per cent on average, effective on all shipments on or after January 1, 2015. This increase covers Aclar films for healthcare and pharmaceutical blister packaging applications. The company cited increasing costs of raw material and other operating expenses as the reasons for this price increase. Aclar films are based on polychloro-tri-fluoro-ethylene (PCTFE) fluoropolymer technology and have excellent moisture barrier and chemical stability properties. Aclar thermoformable films are used in a broad range of markets including originator and generic pharmaceutical, over-the-counter (OTC) pharmaceutical and animal health packaging.
EP News Bureau-Mumbai
EP News Bureau-Mumbai
Schott Fiolax Scholarship Programme launched Six scholarships were awarded to students pursuing B Pharmacy and M Pharmacy degrees in Mumbai SCHOTT GLASS India has launched its first scholarship programme aimed to foster deserving students of pharmacy in India. In the first installment of the Schott Fiolax Scholarship Program, six scholarships have been awarded to meritorious students pursuing Bachelors (B. Pharmacy) and Masters (M. Pharmacy) Degrees in Pharmacy in Mumbai. The process of selecting candidates for Schott Fiolax Scholarship Programme was
completed in September 2014, with a final list of five meritorious B Pharmacy students: Pradnya Bapat, Pooja Hegde, Saili Narwankar, Ashwini Ashtekar and Varshida Kadam and M Pharmacy student, Saloni Jain. The initial programme, which had proposed scholarships worth ` 25,000 each for four candidates, was broadened to provide sponsorships to total six students. Encouraged by the great response of applicants, Schott
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will now extend the programme to top institutions of Vadodara in Gujarat from next year. The shortlisted six candidates were awarded gift cheques of ` 25000 each by Sundeep Prabhu, Vice President- Sales and Marketing, Schott Glass India, on December 2, 2014. The winners will also be given an exclusive tour of Schott Glass India’s tubing plant in Vadodara in January next year. The application process
took a total of six months to complete, with more than 100 applicants who were able to clear the challenging eligibility criteria of passing 2nd year with more than 70 per cent in case of B Pharmacy students and on the basis of outstanding research for M Pharmacy students. 15 students were shortlisted as applications were further weighed in a step by step process. After evaluation of their academic qualifications which had 70 per cent
weightage, students were asked to prepare a two page write up about a selected topic submitted to their principals for the next 20 per cent. The final 10 per cent evaluation was done based on a personal interview with SCHOTT’s elected threemember panel in which students were assessed on basis of their aspirations, academic understanding and industry knowledge. EP News Bureau-Mumbai
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PHARMA ALLY PRODUCT
Cognex Corporation revs up 2-D barcode reading COGNEX CORPORATION launched its PowerGrid technology, a texture-based location algorithm that takes a unique, inside-out approach to reading 2-D matrix and Direct Part Mark (DPM) codes. While conventional feature-based algorithms start by locating the finder pattern, Cognex’s PowerGrid technology looks for a pattern of alternating light and dark modules within the code. PowerGrid technology dramatically increases read rates in 2-D barcode-reading applications where a part’s geometry, poor lighting, occlusion, or print-registration errors make it difficult to capture an image of the entire code. Unlike previous solutions, PowerGrid technology can locate and read
codes even when they exhibit significant damage to or complete elimination of the finder pattern, clocking pattern, or quiet zone. Cognex’s PowerGrid technology is now available on the X models of the DataMan 300 series fixed-mount barcode readers.
Contact details Gayatri Belpathak Manager - Relationships Mind Matters Brand Communications Consulting M: +91 70587 53514 e-mail: mails@mindmatterscorp.com Website: www.mindmatterscorp.com
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PHARMA LIFE AWARD
Biocon,Sun Pharma awarded for innovation Study shows hi-tech engineering, pharma as front runners of innovation in India BIOCON AND Sun Pharma were honoured at Thomson Reuters’ India Innovation Awards 2014, announced at the recent launch of its 2014 State of Innovation India report. This is the second consecutive year of the study, which analyses innovation in 12 leading sectors based on patent activity for inventions originating from India, using the Derwent World Patents Index, Thomson Reuters’ proprietary patent database. Hi-tech engineering and pharma companies emerged as as front runners of innovation in India. The study showcases 12 leading sectors and analyses the innovation in each based on patent activity. Among the top 10 patent filers in India, eight of these are Indian organisations, Tata Consultancy, CSIR, Larsen & Toubro, Crompton Greaves, Infosys, Tata Motors, TVS Motor, Bharat Heavy Electricals. The two nonIndian top filers are Robert Bosch and Samsung India. Computing and Control led the innovation activity drawing level with the pharmaceutical sector for the first time, while new sectors like hi-tech and mechanical engineering displaced traditional chemical and agricultural industries. “India is an important global innovation hub, with both local and global organisations conducting critical R&D activities in India. Patenting activity is growing rapidly and this has a direct impact on the country’s economic growth,” said Pradeep Lankapalli, Managing Director, India and Head of Global Operation Centres, Thomson Reuters India. The India Innovation Awards are designed to recognise innovation and entrepreneurship in India, based on Indian patent publications. The awards honour the most innovative academic institutions and commer-
58 EXPRESS PHARMA January 1-15, 2015
The India Innovation Awards are designed to recognise innovation and entrepreneurs hip in India, based on Indian patent publications
(L-R) Arshad Jamil, Senior Director, Intellectual Property, Biocon, receives the Thomson Reuters India Innovation Award 2014, in the pharma category. Also seen in the picture are MS Unnikrishnan, Managing Director and Chief Executive Officer, Thermax and Pradeep Lankapalli, Managing Director, India and Head of Global Operation Centres, Thomson Reuters India
(L-R) Dr Rajamannar Thennati, Head R&D, Sunpharma, MS Unnikrishnan, Managing Director and Chief Executive Officer, Thermax and Pradeep Lankapalli, Managing Director, India and Head of Global Operation Centres, Thomson Reuters India
cial enterprises headquartered in India for their spirit of innovation in R&D Along with Biocon and Sun Pharma in the Corporate Pharma category, awards were presented to Infosys and Suxlon Energy representing the Corporate Hi-Tech sector, while IITBombay and Defence Research and Development Organisation (DRDO) bagged honours in the Academic and Government category. Kiran Mazumdar-Shaw, Chairman and Managing Director, Biocon informed, “Our focus on innovation has enabled Biocon to cross new milestones in the area of drug affordability through our range of biosimilars and biologics. Dr Rajamannar Thennati, Head – R&D, Sun Pharma said, “At Sun Pharma, innovation is the core of our organisation. In our business, innovation is directly linked to helping patients by providing medicines at affordable cost. We are focussed on finding solutions to complex scientific challenges, environmental safety and creating an intellectual asset for sustained growth.” 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.