Express Pharma (Vol.11, No.15) June 1-15, 2016 by Indian Express

VOL. 11 NO. 15 PAGES 66

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Market ‘There will be a shakeout in the CDMO industry’

Research ‘We have pioneered a fast RNA conjugation process which works in water within minutes’ 1-15 JUNE 2016,` 40

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

National Design Editor

DIA concludes two-day conference on pharmacovigilance in Mumbai Different aspects of pharmacovigilance discussed and debated at the conference by thoughtleaders and experts | P21

Bivash Barua Asst. Art Director Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Designer Rekha Bisht

■ INTERVIEWS

MARKETING Regional Heads Prabhas Jha - North Ravindra Pawar - South Harit Mohanty - West & East Marketing Team Rajesh Bhatkal Ambuj Kumar E Mujahid Arun J Debnarayan Dutta Ajanta Sengupta Nirav Mistry PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

KANDLA SEZ: A CAULDRON OF OPPORTUNITIES

REGULATED PRODUCT SUBMISSION: THE UPCOMING DATA EXCHANGE STANDARDS

RESEARCH

36 37

P12: ‘There will be a shakeout in the CDMO industry’

Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil

P15: ‘Our target is to ensure consistent growth in the next five years’

P33: ‘We have pioneered a fast RNA conjugation process which works in water within minutes’

SUBLINGUAL IMMUNOTHERAPY – AN UPCOMING OPTION FOR THE TREATMENT OF ALLERGY

PHARMA ALLY

P17: With our heat-stable rotavirus vaccine, we aim to support the govt’s efforts to reduce child mortality

WHAT’S IN A NAME?

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P LIFE

SALARY HIKES OF 13-19 PER CENT FOR SELECT TALENT IN PHARMA: KELLY SERVICES

P34: ‘We are creating national-level HIV cohorts’ P42: ‘We see India as a market with incredible growth potential for ATI’

Express Pharma® Regd. with RNI No. MAHENG/2005/21398,Postal Regd. No. MCS/164/2016 – 18. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2016. The Indian Express (P) Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

Moving up the green ladder

s the Modi Government launches its second anniversary celebration on May 26, the BJP will be organising 200 odd events over a fortnight, accompanied by a social media blitz. It will naturally be all about its achievements, making it clear that it has upcoming state polls and the 2019 elections in mind. But let us hope that party leaders also introspect, at least in private, on which initiatives have remained mere slogans, and how many have been converted into action. Success in even a few of the key initiatives can win them a second term, without all this fanfare, provided the results are clear to the voting population. A natural corollary of Prime Minister Modi's flagship scheme Make in India, is 'zero defect, zero effect' (on the environment), dubbed ZED. Against the backdrop of the drought in various parts of India, his weekend 'Mann Ki Baat' radio broadcast of May 22 too called for protection of the environment, highlighting that conservation of water and forests was people's responsibility. Both his Independence Day speeches too mentioned environmental pollution. Recognising that manufacturers in the MSME segment would be the category which needed awareness and handholding the most, the government decided to use the time tested carrot and stick approach. It has created a process to incentivise companies to move towards greener processes, using a rating system. Going ahead, ZED accreditation, created and executed by the Quality Council of India (QCI) will help MSMEs pitch the rating to global clients who now require their vendors to follow the same sustainability practices. FDI investors too would find this a handy indicator. ZED ratings are also likely to be a benchmark for suppliers to PSU and defence establishments . The ZED Pilot Report was released at the mega Make In India Week in February and 11 companies have already signed up to create ZED cells. The ZED rating, starting from Bronze, Silver, Gold, Diamond and finally Platinum, across 50 parameters, each with five levels, is valid for four years and can be displayed on e-commerce sites. This will be a huge benefit for export-oriented companies as well. The initiative is being driven by the Department of Industrial Policy and Promotion (DIPP) and with the likes of Tata Chemicals already signing up, it is only a matter of time that pharma companies too join the group. The focus states that will drive ZED initially are Maharashtra, Uttar Pradesh, Tamil Nadu, Gujarat and Karnataka, which have been shortlisted to be the first four states to drive the process. These four states reportedly have 57 per cent of total MSME

10 EXPRESS PHARMA June 1-15, 2016

We hope to see many MSME players use the ZED initiative to move up the green ladder. This would prove whether they are truly living the 'keen to be green' slogan or merely keen to be seen to be green

employment with 59 per cent of the sector's exports. A change in mindset in just a few companies in these states could influence peers in the same state to follow suit. Officials are no doubt betting that some of these 11 early birds will see the benefits and savings of going green and then spread the word. Most subsidiaries of global pharma companies would already have sustainability measures in place but there is growing awareness among the MSME sector as well. The cover story in this year's World Environment Day issue covers both perspectives (See story: Going Green, pages 24-28). Representatives from both ends of the spectrum call for greater support from the government in terms of putting up common effluent treatment plants in SEZs as well as encouraging investments in alternative cleaner energy sources, like wind and solar energy. We hope to see many MSME players use the ZED initiative to move up the green ladder. This would prove whether they are truly living the ‘keen to be green’ slogan or merely keen to be seen to be green. In last year’s June 1-15 issue, I had made a wish list for PM Modi’s second year in office. (http://www.financialexpress.com/article/pharma/edito rs-note/wish-list-for-pm-modis-second-year/76681/) The Cabinet approved the National Intellectual Property Rights Policy on May 13, with a new slogan: Creative India; Innovative India. This is one major item off the list, though IP experts like Prof Shamnad Basheer have found little to praise in the policy. (http://spicyip.com/2016/05/the-new-ipr-policya-pitiful-paradox.html) The Opposition has vowed to block another major item on the wish list, the GST Bill, stalling it in the Rajya Sabha though it was passed by the Lok Sabha. But the BJP’s recent victory in Assam seems to have re-energised the party, with the government reportedly aiming to introduce it on the first day of the monsoon session and hoping to pass it this year itself. Specific to the pharma sector, the API and bulk drug segments were promised policy initiatives, but now there is a consensus that promoting APIs, as per the China model, will be counterproductive. While policymakers will encourage API manufacturing, they are firm that it will not be at the cost of the environment. They would rather incentivise companies to move up the ladder, to value added formulation research and pure R&D. Let’s hope that we have learnt from China’s experience.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

‘There will be a shakeout in the CDMO industry’ Swedish Recipharm has been on an acquisition spree, buying out Italian CDMO, Mitim Srl in February, and completing acquisition of India-based Nitin Life Sciences and announcing another deal with Kemwell in April. Viveka Roychowdhury quizzes Mark Quick, Executive Vice President, Recipharm and Dr Chetan Sobti, CEO, Nitin Life Sciences on the consolidation in the CDMO market and whether quality concerns will drive a shift towards insourcing

Going by the recent acquisition of Nitin Lifesciences and now Kemwell’s CDMO businesses, Recipharm seems to be targeting emerging markets and more specifically, India. Post these deals going through, what will be the share of Recipharm in emerging markets, in terms of global CDMO business? Mark Quick (MC): Recipharm sees emerging markets as an important source of growth for two main reasons. Firstly, with the increasing spend in healthcare in these markets it is growing at a far quicker rate than the traditional developed markets albeit from a low level. In order to

grow and become a leading CDMO we felt it was important to have exposure in these markets. Secondly, our customers are all looking to work in emerging markets, for very much the same reasons. We are therefore able to provide access to these markets and particularly India through our investments there. It is actually very difficult to provide hard numbers on Recipharm’s market share of emerging market sales. What is Recipharm’s market share of the global CDMO business? MC: Again this depends how you define the global CDMO business. There are various studies around but in terms

of position in global CDMO’s we are certainly within the top 10. How much of Recipharm’s business currently comes from emerging markets? Which is the fastest growing among these countries? (Kindly mention which countries are covered as emerging markets for the company.) MC: Post transactions (Nitin and Kemwell) approximately one third most of which will come from India. Is Recipharm looking for more such deals? What kind of companies would fit the bill, in terms of filling the gaps of the existing portfolio of products,

We are always looking at opportunities to expand through acquisition and would not rule out further transactions in emerging markets MARK QUICK, Executive Vice President, Recipharm

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MARKET

services, dosage forms, etc? MC: We are always looking at opportunities to expand through acquisition and would not rule out further transactions in emerging markets. We are looking to fill some gaps in technologies too including pre-filled syringes and cytotxic production. In terms of markets, we are looking at the US and potentially other markets in emerging Europe, Latin America and Russia How will the deal with Recipharm change the outlook and operations for Nitin Lifesciences? Dr Chetan Sobti (CB): We are very pleased to be partnering with Recipharm and see a number of advantages. Firstly Recipharm will bring a larger customer network to Nitin just as we will bring new customers to Recipharm. In addition, Recipharm will be able to add strength and support to Nitin particularly with the MNC’s who will get a great deal of confidence from the Recipharm brand. We have an excellent position already but this transaction will reinforce things. Your company is essentially debt free and has been doing reasonably well, with a CAGR of over 20 per cent since 2012FY. What made you sell 74 per cent stakes to Recipharm? CB: We recognised that to take the company to the next level and develop it, we needed to partner with a company who could bring a

more international and global perspective. We were very pleased to meet with Recipharm and over the time have built up a strong trust and relationship. The deal will allow us access to Recipharm’s wider expertise and customer network which will in turn help Nitin to develop. Do you envisage further consolidation in the CDMO space in India? Are deals like yours, and the more recent one with Kemwell, a sign of this trend? CB: This is probably going to be the case. In any fragmented market, there will over time be consolidation. I think there will be a shakeout in the industry with some of the weaker CDMO’s falling by the way side and the stronger ones developing. India is certainly an attractive market. Pharma manufacturers across the globe have to face increasing scrutiny on GMPs. Between 2008 and 2014, the number of product recalls and warning letters received by pharma companies globally tripled. At least one pharma facility worldwide has entered into a consent decree every year since 2008 globally. Some pharma MNCs are reverting to insourcing, reversing the outsourcing trend, citing better tracking of quality. Your comments. MC: There will no doubt be movement between outsourcing and insourcing particularly where an issue

has occurred. However, the clear trend is for more outsourcing. Pharma companies are becoming more aware of costs and having underutilised facilities is not only costly but also carries risk in itself. I do not see any reverse in the outsourcing trend. What I do see is that customers will be far more discerning when they place a contract with a provider. There will be much more indepth due diligence to ensure that the partner has the capabilities and longevity to deliver the product at a satisfactory quality. The last thing a company wants to do is have to take back in house or transfer a product once it has been outsourced. CB: I agree that there has been some insourcing, but this is certainly not a reversal of the trend. We have seen a number of MNC approaches specifically to address concerns about quality with other suppliers. Pharma manufacturers in India have been particularly hit by 483s and warning letters. Would this be one reason to anticipate more such takeovers of CDMOs in India, as pharma MNCs would prefer a global name on their supplier list as a risk mitigation strategy? MC: We thought about this issue very much before our investments in India and visited lots of facilities. It is clear that there are some facilities which are not up to the standards that they

The deal will allow us access to Recipharm’s wider expertise and customer network which will in turn help Nitin to develop DR CHETAN SOBTI, CEO, Nitin Life Sciences

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should be at. However, in Nitin and Kemwell we certainly saw a very good picture. I would agree that a MNC placing an order would ideally like to see a global CDMO as a supplier and this indeed could lead to more takeovers of local companies by organisations similar to ourselves. So far though, we have not seen this. CB: I think that there will be a natural move to

consolidation as the market matures. In addition, companies and in particular MNC’s tend to want to deal with fewer suppliers. However, I am not certain the 483 issue will actually drive the consolidation. The Nitin name has always stood for high quality and this is what Recipharm saw when they conducted their evaluation. viveka.r@expressindia.com

MARKET I N T E R V I E W

‘Our target is to ensure consistent growth in the next five years’ Ketan Zota, Director, Zota Healthcare, talks about his company's growth plans to Sachin Jagdale, besides giving details about its proposed IPO Give details regarding your proposed IPO offering. Zota Healthcare plans to offer the IPO during the second quarter of fiscal year 2016-17. As of now, the net tentative amount that we have planned to raise has been agreed upon which is approximately ` 60 crores. The IPO, once offered,

will be utilised to effectively set up manufacturing plant as well as expansion of existing business model. Apart from this, working capital will be given importance to grow and increase along with the company. The same funds will also be used to set up a comprehensive marketing

programme for Zota Healthcare’s upcoming products as well as existing/upcoming projects. Zota Healthcare has been in the market since the last two decades. How has your product portfolio changed/evolved during

this period? Zota Healthcare as a pharma company believes firmly in having various brainstorming sessions and periodic market surveys to ensure that our marketing and product development teams respectively are in sync with market expectations as well

as company objectives. Our portfolio is based upon market response, gap in existing medications offered and patients and therapy requirements. We strongly believe that we develop new products that are in line with customer needs and this has in turn helped us establish a

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MARKET ensure that targets are reached. Our target is to ensure consistent growth in the next five years in order to reach a turnover of approximately ` 500 crore.

Zota Healthcare as a pharma company believes firmly in having various brainstorming sessions and periodic market surveys to ensure that our marketing and product development teams respectively are in sync with market expectations as well as company objectives

strong presence in many untapped segments of the pharmaceutical market in India. Our company manufactures products inhouse. We do not tend to lend our ideas and objectives to a third party. We also market our line of products based on the requirements of the end consumer as well as the market conditions. Since we have a strong value system, we prefer to keep them in place by having our team drive everything from understanding what the

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consumer needs till the point of marketing them in a manner that makes a strong impression in the end user’s mind. We believe in marketing our own products as well and do not represent any other pharma company other than Zota Healthcare. Zota Healthcare deals with formulations, nutraceuticals and ayurvedic products. Which is the most profitable category for you? Our target audiences are different pertaining to

different product category. We believe that all segments mentioned by you are profitable to us. However, the company has more experience and expertise in the nutraceutical segment. Overall, it has also brought in more profits for Zota Healthcare. We are proud to have several patents under the category of nutraceutical as well. What was your turnover during the last financial year? What is the expected revenue rise over the next

five years? As of the last financial year, 2015-16, our company’s turnover is ` 64.50 crores. In lieu of last year's performance, profit targets are set for the performance of the next financial year as well as next five years. Zota Healthcare is expecting an increase in growth of around 11.4 per cent in the coming year of 2016-17. Marketing strategies are in place to ensure that profit margins set are met by the team. Implementation of marketing policies will be in full swing to

Are there any new product/s in the pipeline? As a company, we are in the practice of introducing new brands every month and take pride in expanding our line of business with upcoming brands in the segment of beauty products. Some of the products that Zota Healthcare will introduce to the pharma sector will include a new range of kits for acne, dark circle removal, hair, post pregnancy kits for mothers and muscular pain reliever kit. Other new launches entailing complete care for new born include Nutravedic ACNOBYE kit, Nutravedic Glowtouch DCR Kit, Nutravedic Hair Kit, Nutravedic Happimom Kits, Nutravedic Its Relax Kit and Nutravedic Baby Kit respectively. All products mentioned are going to be fully ‘ayurvedic’ and each kit is going to consist of three to four products that will serve a distinct purpose. Apart from this, we also have Zota Generics Products (Davaindia.com), Dip Sip Health Drink Powder and Ayurvedic tooth paste. What is going to be your growth model in future? Currently, Zota Healthcare is doing well and we only wish to capitalise on this momentum going forward. We expect tremendous growth in domestic as well as in the international markets. We feel our vision is justified keeping in the mind that our ‘patent’ products are making profits in both markets – domestic and international. Our sustainable growth model majorly relies on our products – existing as well as upcoming. Some of them include the entire range of Nutravedic products that come as a kit, generic products that are part of Davaindia.com and all else mentioned above. sachin.jagdale@expressindia.com

MARKET I N T E R V I E W

With our heat-stable rotavirus vaccine, we aim to support the govt’s efforts to reduce child mortality Hilleman Laboratories has recently initiated phase I/ II clinical trials for both rotavirus and cholera vaccines in Bangladesh. Dr Davinder Gill, Chief Executive Officer, Hilleman Laboratories in an interaction with Usha Sharma, provides details on the progress of the trials and what it has in store for the Indian market Recently, Hilleman Laboratories formed a JV with MSD and Wellcome Trust to initiate two vaccines into the clinical trial stage. Tell us more about these leads and their relevance to the Indian market. Hilleman Laboratories is a global vaccine research and development organisation focused on making affordable vaccines using innovation to address gaps that exist in low resource settings. Hilleman Labs received approvals to conduct phase I/ II clinical trials for both rotavirus and cholera vaccines from all relevant approval authorities in Bangladesh. The trials were conducted in collaboration with Bangladesh-based International Centre for Diarrhoeal Diseases (ICDDR, B) and will establish the safety

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MARKET and immunogenicity of the vaccines in infants and adults to decrease the child mortality both in Indian and regional markets. For our cholera vaccine, we have partnered with Gotovax AB of Sweden and with Incepta Vaccines, Bangladesh. Our rotavirus vaccine is a collaboration with MSD.

hospitalisations and child deaths globally. Together, they account for approximately one in six deaths among children younger than five years. Of India’s more than 2.3 million annual deaths among children, about 334000 are attributable to diarrhoeal diseases. Rotavirus is the leading cause of severe diarrhoea in children in developed and developing countries. Introduction of these vaccines is expected to reduce child mortality by decreasing the incidence of severe diarrhoea and the frequency of death from diarrhoeal disease. The Indian Government’s efforts to reduce child mortality by including rotavirus vaccines under the UIP is highly appreciated. However, success of the vaccine is highly dependent on cold chain process and delivery system. With our heat-stable rotavirus vaccine, we aim to further support the government’s efforts of expanding coverage and reducing child mortality.

The company has already obtained regulatory clearances for the preclinical stage, what’s the progress on both the studies After conducting pre-clinical studies, we have now initiated clinical studies in Bangladesh. Both the studies will complete enrolment and follow-up of study participants by Q4 2016. Final study report will be submitted to regulators and ethical bodies by Q1 2017. How many healthy volunteers have you enrolled for individual studies and how soon do you intend to enter into phase II clinical trials? Since both the vaccine formulations of Hilleman laboratories are being tested for the first time in human subjects, the studies have staggered enrolment of adult participants, followed by adolescents and infants. Rotavirus study will enrol 100 healthy subjects whereas cholera vaccine will have 840 subjects. After successful completion of the above pilot studies, we will initiate phase IIb pivotal studies by Q2 2017,

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for both vaccines. Tell us about the objective behind conducting a clinical study on a rotavirus vaccine candidate in India? Our rotavirus vaccine is a heat stable vaccine. We are presently conducting our clinical trials in Bangladesh. If proven safe and immunogenic, the vaccine could be brought to India as early as 2020 to help

bridging the gap in vaccine delivery caused by high dependence on cold chain systems for preservation in India. This vaccine can withstand extreme climates. How will the new vaccine help the government reduce child mortality? Hilleman Labs is focussed on the diarrhoeal diseases which are major cause of

India lags in supply chain maintenance and vaccines need high end supply chain systems, how are you going to ensure it? Are you working with the government on this front? At Hilleman Labs, we have developed rotavirus vaccine heat / thermostable which can sustain higher temperature for longer duration of time. With this technology of heat stability, we can overcome the problem of cold chain. We will be delighted to work with and

support the efforts of the government. How much do you plan to invest in different phases of clinical trials? When do you plan to launch the vaccines in the Indian market? We have just entered into the clinical phase of trials and it’s too early to comment on the investment in different phases. Hilleman could seek licensure based on the non-inferiority date for its rotavirus vaccine within the four year timelines as it is a heat stable formulation of an exciting vaccine. While on one hand, our heat-stable technology will offer longer stability to the rotavirus vaccine in extreme climates, the next-generation oral cholera vaccine will be affordable and easy to administer. How do you plan to overcome regulatory hurdles in India? We are working along with the government and will be focussing on meeting all regulatory requirements in India. Which are your other research molecules, and in which stages of development? When are they likely to hit the market? We are presently working on Meningococcal and ETEC vaccine. We have initiated the processes and it’s too early to comment on its availability in the market. u.sharma@expressindia.com

MARKET GROWTH TRACKER

IPM clocks ` 8446 crores in April 2016 12 therapies have outgrown the IPM growth THE INDIAN Pharma Market (IPM) has clocked ` 8446 crores in April 2016 and has grown at 3.5 per cent. Amongst the top 10, Mankind grew at 12.3 per cent, Abbott at 9.9 per cent followed by Macleods at 5.8 per cent. 21 corporates have crossed the growth of IPM amongst top 50. Amongst the top 50 corporates, Bharat Serum has the highest growth of 25.2 per cent followed by Systopic at 18.3 per cent and Eris at 15.6 per cent. 10 corporates have shown growths of more than 10 per cent amongst the top 50. Amongst the 11-20 ranked corporates, Intas has the highest growth of 10.8 per cent followed by Micro at 8.6 per cent and USV at 5.1 per cent. Amongst the 21-30 ranked corporates, Eris has the highest growth at 15.6 per cent followed by Novartis at 12.1 per cent and Wockhardt at 4.8 per cent. Amongst the 31-40 ranked corporates, Bharat Serums grew at 25.2 per cent followed by Akumentis at 11.8 per cent and Wallace at 11 per cent. Amongst the 41-50 ranked corporates, Systopic has the highest growth at 18.3 per cent followed by Janssen at 15.3 per cent and WinMedicare at 12.3 per cent. Amongst the 51-60 ranked corporates, Boehringer grew at 58.7 per cent followed by Fresenius Kabi at 29.2 per cent and Corona at 19 per cent. Amongst the 6170 ranked corporates, Shreya grew at 37.8 per cent followed by RPG at 15.7 per cent and East India at 7.8 per cent. Amongst the 71-80 ranked corporates, Samarth grew at 38 per cent followed by Danone at 20.8 per cent and Lincoln at 11.2 per cent. Amongst the 81 -90 ranked corporates, Dabur grew at 61.7 per cent followed by Veritaz grew at 30.5 per cent followed by Galderma at 17.6 per cent. Amongst the 91- 100 ranked corporates, Ind-Swift grew at 67.2 per cent followed by Sanzyme at 30.8 per cent and Curatio at 27 per cent. The 100th biggest corporate is

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MARKET Curatio and 150th biggest corporate is UTH in the IPM. Abbott HC grew at 9.8 per cent whereas Abbott India grew at 10.8 per cent. Zuventus crossed ` 1000-crore on MAT Basis to be at ` 1006-crores as per April MAT 2016. Indian companies have grown at 3.6 per cent versus 3.4 per cent for MNCs in April 2016. Amongst the top 50 in MNCs, Janssen grew at 15.3 per cent followed by Novartis at 12.1per cent and Abbott at 9.9 per cent. Under the non-NLEM category, Indian companies grew at 4.6 per cent whereas MNCs grew at 3.3 per cent. The NLEM 2013 containing molecules market grew at -2.7 per cent whereas the non-DPCO market grew by 4.3 resulting in an overall growth of 3.5 per cent for April 2016. The NLEM and Non-NLEM category showed unit growth of -3.2 per cent and -6.5 per cent respectively. From therapy perspective, 12 therapies have outgrown the IPM growth. The respiratory market grew at -6 per cent, gastrointestinal market grew at 5 per cent, pain and analgesics market grew at 0.7 per cent whereas anti-infectives grew at -3.5 per cent. The anti-diabetic market grew at 12.1 per cent and cardiac at 7.4 per cent, neuro/ CNS at 9 per cent in chronic business. The anti-malarials grew at -14.7 per cent and the derma market grew by 7.1 per cent followed by the urology market at 10.4 per cent. From the regional perspective, 17 regions have outgrown the IPM growth. The Punjab market grew the highest at 12.9 per cent followed by Haryana market at 9.1 per cent and Saurashtra market at nine per cent. Eight regions had negative growth in April 2016. The Amoxycillin + Clavulanic acid market grew at -4.9 per cent and Glimepiride + Metformin market grew at 10.6 per cent. The markets of paracetamol grew at 12.1 per cent, Atorvastatin 0.7 per cent, Probiotic Microbes at 25.6 per cent, Cefixime at -8.1 per cent, Pantoprazole at 8.5 per cent, Montelukast + Levocetrizine at -1.7 per cent, Glimepiride + Metformin + Pioglitazone at -19.2 per cent, Vitamin-D at 15.2 per cent, Hydroquinone + Mometasone +

20 EXPRESS PHARMA June 1-15, 2016

Val in Crs CORPORATE IPM Sun + Ranbaxy Abbott + Abbott HC + Novo Cipla Zydus + Biochem Mankind Lupin Alkem + Cachet + Indchemie Glaxo Pfizer Macleods Intas Emcure + Zuventus Aristo Dr. Reddys Glenmark Sanofi India

With Bonus Units at Full Value Rank MATApr-16 MAT MTH Val (Cr) MS% GR% 98857 100.00 11.5 1 1 8668 8.77 13.2 2 2 6089 6.16 10.7 3 3 4909 4.97 11.3 4 4 4201 4.25 11.0 5 5 3723 3.77 18.1 6 6 3429 3.47 14.7 7 7 3377 3.42 8.3 8 9 3158 3.19 3.0 9 8 2887 2.92 8.5 10 11 2857 2.89 9.9 11 10 2826 2.86 21.9 12 12 2601 2.63 9.4 13 13 2427 2.45 11.4 14 17 2373 2.40 18.4 15 15 2373 2.40 20.7 16 14 2355 2.38 5.8

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

Tretinoin at -1.3 per cent, Voglibose + Metformin + Glimepiride at 32.6 per cent, Rosuvastatin at 12.2 per cent, protein supplements at 5.8 per cent, Azithromycin at -10.1 per cent, Calcium Carbonate + Vit D3 market at -5.8 per cent, Paracetamol + Phenylephrine + Chlorpheniramine at -16.7 per cent, Meropenem at 37.2 per cent, Montelukast + Fexofenadine at 5.6 per cent, Diclofenac at 13.3 per cent, Telmisartan at 3.3 per cent, Levetiracetam at 20.5 per cent. The 50th biggest market is Voglibose + Metformin + Glimepiride and the 100th biggest market is Levofloxacin for April

MATApr 16 VAL IN CRS 98857 14905 12371 11623 8685 8097 7652 6808 6158 6050 4973 1674 1649 1540 1445 1158 1148 1083 555 550 405 215 115

GR% 11.5 6.4 13.3 13.6 8.9 19.8 8.9 10.1 15.1 15.3 10.4 10.9 9.2 2.4 11.2 13.6 25.7 14.6 -2.8 11.9 6.7 -4.3 7.8

2016. Mixtard leads the pack with ` 36 crores followed by Glycomet GP at ` 31 crores, Corex at ` 28 crores and Augmentin at ` 23 crores for April 2016. Few brands which have gained ranks include Revital H (+2399), Meronem (+94), Rotarix (+73), Trajenta (+59), Januvia (+41), Rabipur (+36), Minipress XL (+34), Ultracet (+30), Udiliv, Novomix (+27), Unwanted Kit (+26), Galvus (+21), Rosuvas, Mikacin, Vertin, Aciloc RD (+20), Telma H (+19), Electral Powder (+18), Cardace (+16), Duphaston (+15), Galvus Met (+14), Istamet (+13), Atorva, Mucaine (+12), Pan D, Allegra (+11),

Val (Cr) 8446 749 543 439 357 325 284 282 250 251 240 240 220 204 184 194 201

Apr-16 MS% 100.00 8.87 6.43 5.20 4.23 3.85 3.36 3.34 2.96 2.97 2.84 2.85 2.60 2.42 2.18 2.30 2.38

GR% 3.5 5.2 9.9 2.1 1.0 12.3 -4.4 -0.9 -8.6 2.8 5.8 10.8 1.1 0.1 -1.5 4.5 -0.5

Month Apr-16 VAL IN CRS GR% 8446 3.5 1162 -3.5 1103 7.4 1045 5.0 772 5.4 727 12.1 576 -6.0 569 0.7 540 9.0 523 7.1 442 4.0 139 2.1 132 -2.3 122 -16.3 137 6.8 99 2.1 114 30.5 100 10.4 32 -14.7 49 8.4 36 6.6 20 0.7 7 -7.8

Levipil (+10), Synflorix, Jalra M (+9), Lantus, Volini (+8), Betadine, Pan, Gemer (+7), Voveran, Susten (+6), Corex, Rantac, Thyronorm, Pantop (+5), Clapol, Clexane (+4), Zoryl M (+3), Dolo (+2) amongst top 100 Brands over April 2015. Lonopin, Lobate GM, Razo D, Sporlac, Zerodol P, Candid, Mero, Acitrom, Metpure XL, Prega News, Telma AM, Cilacar, Enterogermina are few brands which have gained ranks in 101200 ranked brands. A few of the brands that have moved up ranks fastest into Top 300 brands for April 2016 are Revital H, Hucog HP,

Imicrit, Similac, Lonopin, Candiforce, Lobate GM, Orofer FCM, Razo D, Looz. The 300th biggest Brand is Pentaxim from Sanofi A total of 306 brands and 489 SKUs were launched in April 2016. The top new brands for April 2016 were Vivitra, Insta and Lomofen Plus. Three brands were launched each in Teneligliptin Plain and in Combination with Metformin. Sanofi launched Gemigliptin under the brand name Zemiglo. Within the VMS category, Jubinerv (Jubilant), PartySafe (Obsurge), Escor Z (Adroit) were launched followed by Glyciphage VG (Franco), Tiban M (Ajanta) & Teneliglip (Akumentis) in anti-diabetic, Itratuf (Alkem), Kromalite (FDC) & Kezolin (FDC) in derma, Ovalife Met (Macleods) and Mychiro (USV) in gynaec, Ostivestin, Candivestin (Zydus), Dologesic SP (Micro) in pain and analgesics category, Airlung FX (Zydus), Kofirax ( Hetero), Newcold ML (Abbott) in respiratory, Rozagold (Sun), Telmurix (Akesiss) & Roseday Gold (USV) in cardiac and Novogermina (Alkem), Acidart (Juggat), Fosaprepit ( Cipla) in gastro intestinal segment. The biggest new launch by a MNC is Zemiglo from Sanofi in April 2016.

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.aiocdawacs.com

MARKET POST EVENT

DIAconcludes two-day conference on pharmacovigilance in Mumbai Different aspects of pharmacovigilance discussed and debated at the conference by thoughtleaders and experts Usha Sharma Mumbai DIA INDIA recently organised a two-day conference on ‘Innovations in Pharmacovigilance – the era of e-PV’ in Mumbai. During the conference, speakers touched upon different aspects of pharmacovigilance, including the importance of European Union electronic application forms and procedures of submission. Stewart Geary, Chief Medical Officer, Vice President and General Manager, Eisai, delivered the keynote speech on the role of post-marketing safety studies in pharmacovigilace in the era of ePV. Other speakers at the event were Stewart Geary, Chief Medical Officer, Vice President and General Manager Eisai; Dr Seema Jaitly- Managing Director, Essjay Solutions; Sameer Thapar, Global PV Operations and Quality Assurance, Oracle, Jose Alberto Ayala Ortiz, Chief Executive Officer, Pharmacovigilance Consultant, Pvpharm; YK Gupta, Head Department of Pharmacology, AIIMS; Moin Don, CEO and President, PVCON; Suneela Thatte, Vice President Global Operations, Quintiles; Renuka Munshi, Associate Professor and Head Department of Pharmacology, TN Medical College and BYL Nair Hospital; Swapnil Raut, Director Compliance and Oversight, Pfizer; V Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India; Sibin Kurian, Head DS&E, Clinical Scientific Director, Novartis Pharmaceuti-

cals; Christine G Lim, Head Regional Medical Safety (APAC, EMEA and LATAM) Medical Devices and J&J; Milind Sardesai, GM, Medical Safety Services, Cognizant; Pooja Jadhav, Drug Safety Physician, Sun Pharma, Sanyogita Rane, Senior Lead Safety Physician, Sciformix; Gunjan Shah, Delivery Manager, Sciformix; David Balderson, Global Vice President Safety Operations, Sciformix; Rajesh Jain, Director Operations, Cognizant; Jayathirtha Gopalakrishna, Principal Sales Consultant, Oracle; Balaji Shantharam & Padmanabhan GM, Compliance Lead, ArisGlobal; Shravanti Bhowmik, Associate Vice President, Clinical Research, Sun Pharma; San-

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jay T Gandhi, Vice President Public Health, GSK; Sayed Ziaur Rahman, Associate Prof – Dept of Clinical Pharmacology, Aligarh Muslim University; Sachin Kuchya, Associate Professor in Pharmacology, NSCB Medical College; Dr Jamal Baig, Country Head, Pharmacovigilance, Merck Sharp and Dohme; Dr J Vijay Venkatraman, Managing Director and Chief Executive Officer, Oviya Medsafe; Shefali Gupta, Head of Strategic Initiatives, LS – BPS TCS; Sumanta Ghosh, VP Operations, PV Capability Lead, Accenture; Vineet Shastri, Sr Director and Head, Life Style Medical Services, Global Delivery Network, Quintiles; Manish Paralikar, Process Excellence Lead, Life Sciences

BPS, Cognizant and Sanjeev Miglani- Head PV US Operations, APCER Life Sciences. Jaitly spoke on EU’s electronic application forms. She also briefed how marketing authorisation holders should register all non-international PostAuthorisation Safety Studies (PASS). She also highlighted how the new EU legislation helps in maintaining consistency, reducing complexity, sharing of information and avoiding duplication. Thapar talked about the benefits of going the automation route in signalling while Ortiz talked on understanding Eudravigilance and XEVMPD. The first day saw a panel discussion which addressed the issues faced by the Indian clinical trials industry. The panelists, also highlighted the steps being implemented by the industry to regain the growth momentum. They also discussed the significant regulatory changes implemented in the Indian clinical trials industry in the last three years and their impact. Don was the moderator of the session. YK Gupta provided detailed information of the Indian clinical research industry and put forth his views on why India should conduct more clinical trials. He also spoke on the need and relevance of the compensation guidelines for clinical trials in India. Answering Don’s query on whether media has contributed to the negative image about the Indian clinicial trials industry, Raut opined that the media needs to be more balanced in its reporting. She also pointed out that not a single CRO in India

has received warning letters from US FDA. However, Gupta offered a counterview and said that the Indian clinical trials industry and institutional researchers should proactively engage with the media and talk about their efforts to ensure a balanced coverage of the issues by the media. Moin pointed out that in 2010, there were over 500 plus ongoing trials in the country but by 2013, there were only 100 plus trials being conducted. He asked Thatte about the steps needed to bring back clinical trials to India’s shores. She spoke on the reasons that caused the exodus of clinical trials from the country but also emphasised that there was a need to implement better regulations to ensure that patients do not suffer. She opined that the measures introduced in the last three years has helped in creating a more robust regulatory system for clinical trials. She gave examples of the rise in adverse drug reporting (ADR) and better compensation guidelines to prove her point. Munshi spoke on the clause which requires AV recording of patients’ consent before beginning the clinical trials and the challenges in doing so. Thus, the two-day conference brought together many thought leaders and stakeholders of the pharma industry to deliberate on current best practices, novel initiatives to augment handling of drug safety data and other pivotal areas in ensuring pharmacovigilance in India. u.sharma@expressindia.com

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June 1-15, 2016

EVENT BRIEF AUGUST - NOVEMBER 2016 5

PharmaLytica 2016

PHARMALYTICA 2016 Date: August 5-6, 2016 Venue: HITEX Exhibition Centre, Hyderabad Summary: The third edition of PharmaLytica 2016 will see the pharma community pick up on the latest industry trends, innovations and do business with analytical, bio tech, lab, pharma machinery and outsourcing services. PharmaLytica conference, co-located with the exhibition will bring an entire range of topics in analytical, outsourcing, laboratory, scientific and biotechnology sector. The event is likely to witness 150+ leading local, regional, and international exhibitors, with 4500 expected visitors. It will be an industry focused conference with latest pharma market insights, in-depth case studies, and exceptional networking opportunities. Both the events are supported by Ministry of Science & Technology, Govt of India Contact UBM India Times Square Unit No 1 and 2, B Wing, 5th Floor, Andheri Kurla Road,

PharmaTech Expo 2016

Marol, Andheri (East) Mumbai - 400 059 Tel: +91 22 61727272 Fax +91 22 61727273

PHARMATECH EXPO 2016 Date: August 21-23, 2016 VENUE: Ahmedabad Summary: The 4th Edition of 'PharmaTech Expo 2016, a PharmaTechnologyIndex.com venture will organise a pharma expo. The expo will be concurrently held with 'Pack & PrinTech Expo' and introduction of 'PIC India Expo.' It will focus on pharma ingredients and chemicals, giving a large scale exposure to pharma machinery, pharma ingredients and chemicals, packaging, printing, lab and analytical equipment etc. More than 150 exhibitors are likely to participate in the event. A special pavilion has been created for 'Track & Trace and Vision Inspection Equipment' to focus on the superior technologies available in India and the major industry players involved. Contact Aarjav Shah

2nd Edition of Asia Labex

PharmaTechnologyIndex.com (A Division of KNS Group) Tel: +91 – 79 – 27540493 / +91 – 79 – 40306340, 9879616665 E-mail: expo@pharmatechnologyinde x.com / events@knsmedia.com Website: www.PharmaTechExpo.com / www.PackPrinTechExpo.com / www.SwarnimVision.com

2ND EDITION OF ASIA LABEX Date: September 22-24, 2016 Venue: Gujarat University Convention & Exhibition Centre, Ahmedabad Summary: Asia Labex is a premiere exhibition and conference on laboratory, analytical, scientific, diagnostic, biotech, research and testing instruments and consumables. The exhibition will be organised by Fenza Exhibitons. Contact Fenza Exhibitions Plot No 1, 2nd Floor, GT Karnal Road, Opposite PNB Bank, New Delhi – 110033

ANALYTICA ANACON INDIA AND INDIALAB EXPO 2016 Date: October 20-22, 2016 Venue: HITEX Exhibition Centre, Hyderabad Summary: analytica Anacon India and India Lab Expo happens to be India's largest trade fair for the analysis, laboratory-technology and biotechnology sectors. As the industry's leading marketplace, it brings together scientists, entrepreneurs and users from around the subcontinent. At the analytica Anacon India and India Lab Expo Conference, scientists from around the world will present their innovative analysis solutions. Contact Email: info@analyticaindia.com

CPHI AND P-MEC INDIA Date: November 21 – 23, 2016 Venue: Bombay Exhibition Centre & MMRDA Grounds, BKC, Mumbai Summary: The event will be an ideal congregation for companies to pick up on the

analytica Anacon India and IndiaLabExpo 2016 latest trends and innovations the market has to offer. CPhI India is also co-located with P-MEC India, the pharma machinery show in Asia. This year, the expo has grown from a three day exhibition to a show spanning a week, Pharma Week, (November 17 to 23, 2016). The Pharma Week will hold more than 12 events that will take place across the city of Mumbai focusing on business, knowledge, leadership, innovation and recognition in the field of pharma. With two venues this year, Bombay Exhibition Centre and Bandra Kurla Complex in Mumbai, CPhI & P-MEC 2016 will include exhibitor showcase, innovation gallery, speed meetings, live entertainment and much more. Contact details UBM India TIMES SQUARE Unit No 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol, Andheri (East) Mumbai - 400 059 Tel.: +91 22 61727272 Fax. +91 22 61727273

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GOING

GREEN Though the government is encouraging pharma companies to explore less accessed zones across India, it also expects companies to adhere to stringent environmental guidelines.Are pharma companies ready to take up the challenge? BY USHA SHARMA

24 EXPRESS PHARMA June 1-15, 2016

(

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cover ) The pharmaceutical bulk drugs (APIs) have chemical waste, but since they are producing in kilograms, it is not comparable to cement plants, which produce in tonnes. Hence, effluents from the pharma industry is comparatively less than other sectors

We are not only compliant with current regulations, but have also taken adequate steps to run environmentalfriendly operations

The effluent treatment plants installed by many companies ensure that the waste water is treated before discharge

Aparna Thomas

DG Shah

Senior Director – Communications and CSR (India & South Asia), Sanofi

Secretary General, Indian Pharmaceutical Alliance (IPA)

SV Veerramani National President, IDMA

he Government of India is aggressively working towards creating a healthy business environment for attracting domestic as well as foreign investors to India. It is also closely working with state authorities to improve the quality of and access to medicines for its citizens. Pharmaceutical companies are being encouraged to increase their business reach to less accessed zones like the North Eastern region of the country and offer better healthcare services to the population. The government feels that there are several locations across India that can be leveraged and turned into pharma manufacturing hubs/clusters. To achieve this, plans are afoot to introduce new schemes/programmes whereby the pharma industry is being motivated to take part in such initiatives/programmes. Today, small and medium sized pharma companies face several challenges like logistics, financial burden etc due to strict environmental guidelines. To help them overcome these challenges, these

26 EXPRESS PHARMA June 1-15, 2016

companies should participate in various programmes/initiatives run by the government. These issues are not only restricted to SMEs. Big pharma companies also face similar challenges, particularly while setting

up facilities in remote locations. SV Veerramani, National President, IDMA, while informing about the regulatory requirements which pharma companies need to adhere to for environment safety measures before

setting up a manufacturing facility says, “Before setting up any manufacturing facility, pharma companies need to get clearance from the government for environmental issues and safety measures. Today, it has become

mandatory to get the clearance from the Ministry of Environment & Forests before setting up any pharma plant.” Aparna Thomas, Senior Director – Communications and CSR (India & South Asia), Sanofi says, “Safeguarding the environment has now become a greater responsibility for all companies. We are conscious of this and take a number of measures to ensure that we are not only compliant with current regulations, but have also taken adequate steps to run environmental-friendly operations.” While mentioning about the environment-friendly steps taken by Sanofi, Thomas says, “At Sanofi, we have adopted the concept of recycling, reprocessing and recovery. Our manufacturing facilities are eco-friendly and undertake the following action: waste water management, zero liquid discharge, recycling of treated waste water to conserve and reuse water, minimise air emissions, proper scrubbing, dust collector systems to protect the air from pollution, waste management (hazardous and non-hazardous) and disposal via incineration with heat recovery

(

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programme (eg. power generation, water heating, etc.). In addition, we have rigorous inspection and maintenance procedures in place.” Despite Indian pharma companies adhering to several guidelines in order to conserve the environment, still its image has been blurred in the global pharma arena on the quality front. In terms of sustainability, India has not fared well. And when the government is encouraging the industry to develop pharma zones/park, it is also important to know what industry expects in terms of support from the government. Thomas adds, “While the government is encouraging the industry to develop pharma zones, the industry would definitely welcome the following changes like common infrastructure for waste water treatment, water supply, power generation, more solar power plants and wind power generation, incineration facilities with heat recovery programme, ‘industrial banks’ for various types of waste, ie. one company’s waste may be utilised as raw material for some other company, tax benefits on waste water treatment expenditure and single window clearance for manufacturing facility, simplification in license issuance procedures.” Veerramani informs, “Whenever the government is helping to set up a Pharma Park, we request a common effluent treatment plant, which can be used by all the units in the park. With this, the individual investments and expenses from various units can be avoided. At the same time, a common effluent treatment plant can take up the responsibility for the effluent treatment of the entire park, effectively.” This can be a corrective measure, as pharma industry also produces a lot of chemical waste. Replying to a query on whether the industry produces maximum chemical waste, Veerramani elaborates, “Many times while providing environmental clearance, the department considers pharma sector at par with large chemical industry and

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cover ) cement industries. This is not true. The pharmaceutical bulk drugs (APIs) have chemical waste, but since they are producing in kilograms, it is not comparable to cement plants, which produce in tonnes. Hence, effluents from the pharma industry is comparatively less than other sectors. In case of pharma formulation sector, it is much less than the API sector.” Thomas agrees and says, “Every industry that deals with chemicals produces chemical waste. Thus, there is a limited scope for recycling and reusing chemical waste.” She suggests, “We can overcome this challenges primarily by conducting research and development for all processes and products, to optimise the manufacturing process to increase yield and reduce waste generation. In addition, by adopting the concept of 3Rs – Recycling, Reprocessing and Recovery, industries can overcome the challenge of dealing with chemical waste to a good extent.” The pharma industry generates waste water mainly through washing of equipment, or as part of the inherent ongoing processes. Even though waste water may be discharged in small volumes, it is highly polluted owing to its highly toxic organic content. It is, therefore, critical that industry ensures that this waste water is managed in a most eco-friendly way. Another challenge being faced by the pharma industry is waste water management. Thomas feels, “As a pharma company, we need to understand the composition of our waste water if we are to find ways to effectively treat it. Some waste products are not treatable by traditional methods and so the need to implement and install special treatments and techniques to treat such waste becomes imperative.” DG Shah, Secretary General, Indian Pharmaceutical Alliance (IPA) says, “The active pharmaceutical ingredient (API) is a polluting industry and subjected to stringent norms by the authorities. The waste water management is critical. The effluent

28 EXPRESS PHARMA June 1-15, 2016

At Sanofi’s Ankleshwar manufacturing site, the company has installed windmills to generate renewable power, for captive consumption.Its Goa manufacturing site utilises biomass from agro waste, to generate energy

treatment plants installed by many companies ensure that the waste water is treated before discharge.” Informing about Sanofi’s waste water management activities, Thomas says, “In addition to the processes, we use waste water management, such as the zero liquid discharge. We also use innovative technologies like membrane filtration and thermal evaporation/crystallisation to treat, recycle, and reuse waste water.” Many pharma companies do have pollution control systems in place. Veerramani informs, “Many of the API plants already have a green belt around the industry. Besides, by establishing a sound effluent treatment plants systems, the pharma sector can definitely be a clean industry without affecting the environment.” Sanofi has already commenced several activities on this front. Thomas shares, “There are several such measures that pharma companies are and should undertake towards a clean and green industry. At Sanofi, we have been successful in implementing initiatives at our production sites that have given us excellent result.” She continues, “We also strongly support the use of renewable energy to reduce carbon footprint. In fact, Sanofi is amongst the few healthcare companies that explores the use of renewable energy sources for our manufacturing operations. At Sanofi’s Ankleshwar manufacturing site, we have installed windmills to generate renewable power, for captive consumption. Our Goa manufacturing site utilises biomass from agro waste, to generate energy. The biomass project helped create employment for local villagers and reduce the site’s steam cost as well as its dependence on fossil fuel. Thus pharma companies in India do seem to be on the right path, but will need a helping hand from the government as well. u.sharma@expressindia.com

MANAGEMENT

Kandla SEZ: A cauldron of opportunities Kandla SEZ, with its world class facilities, strategic location and technically advanced as well as customer focused support services, offers myriad growth opportunities for pharma players and is attracting significant investments from the sector. Usha Sharma reports

andla, situated on the Gulf of Kutch on the west coast of Gujarat, holds the distinction of being home to Asia’s first Export Processing Zone (EPZ). Set up in 1965, it was inaugurated by Lal Bahadur Shastri, the then Prime Minister of India. It was established to attract foreign investments and offer multiple, hassle-free business services to domestic companies. After the government announced a SEZ policy in April 2000 and the SEZ Act was passed in 2005, Kandla emerged as a leading SEZ in the country. Today, the Kandla SEZ (KASEZ) is spread over 400 hectares of land and offeres ample facilities to businesses. Informing about the benefits and facilities offered at KASEZ, Upendra Vasishth, Zonal Development Commissioner – Gujarat (SEZs & EOUs) adds, “KASEZ provides world class, technically advanced, value added and customer focused support services to create an environment that allows units to grow and flourish in the global market.” Besides these, the KASEZ’s location provides significant logistic advantages and connectivity benefits which are unique. Vasishth elaborates, “It is a government-run SEZ, hence the rent and other user charges are less as compared to other private SEZs. At our SEZ, lands or sheds are provided without any encumbrance. KASEZ, with its strategic location, provides a competitive edge. It is also well connected to the Kandla port which is just nine kilometres away from KASEZ. The Mundra port with a modern interna-

tional container terminal is also only 60 km away. There are other few small ports too in the vicinity of the SEZ.” Vasishth further points out, “Investors have total freedom to establish their units at KASEZ and produce superior products and services from a strategic location enabling them enhanced marked access. KASEZ is connected to a well developed road and rail network. Also, Bhuj Airport is just a one-hour drive from the SEZ.” The SEZ has attracted a lot of investment from the pharma industry as it is a major exporter of generic medicines across the globe. KASEZ, with its myriad facilities and support from the government, serves as an ideal location for setting up units of pharma companies. Several well-known pharma firms like Galentic Pharma, Ipca Labs, Keval Export, Medicare Industries, Mission Pharma Logistics, Vifor Pharma and Rusan Pharma have already set up their

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June 1-15, 2016

MANAGEMENT

manufacturing facilities at KASEZ. He also reveals that many more pharma companies are likely to set up their units/facilities at KASEZ. Giving an example, he says, “We have received an application for one unit which has been already approved in principle. As per the project report, submitted by the unit, they are planning to invest ` 3677 lakhs over a period of five years.” Thus, KASEZ is drawing investment to the state and creating employment opportunities as well. The government is also providing all possible support. The Government of Gujarat has enacted Gujarat SEZ Act 2004, and Gujarat Special Economic Zone Rules, 2005. Under the Gujarat SEZ Act, the state government has given powers of labour commissioner, factory inspector etc. to the development commissioner (DC) to create a single window to ensure easier approvals. It is the DC, who meets the industries commissioner, Gujarat, periodically to sort out any issues of SEZs pending with the State Government. Moreover Gujarat has a SEZ committee chaired by Chief Secretary in which Zonal DC is also a member; this committee meets periodically to review various issues of SEZs. Vasishth informs, “SEZ policy announced by the Central Government aims at providing an internationally competitive and hassle free environment of exports. Many benefits are given to the companies who have setup their production unit/s in SEZ.” Kandla SEZ, since its inception, has contributed its share to the growth of Indian economy. Vasishth informs, “KASEZ has played a dynamic role in the successful saga of SEZs in our country which have contributed a lot in the economic growth in this country.” Vasishth shares the export figures of the top three major pharma exporters at KASEZ, “Top three pharma companies are Mission Pharma, Ipca Laboratories and Rusan Pharma with exports worth ` 24268.99 lakhs, ` 9203.35 lakhs and ` 3406.47 lakhs respectively.” Last year, KASEZ successfully completed 50 years of

30 EXPRESS PHARMA June 1-15, 2016

operations and today it has become the largest employer among all the SEZs in the country and a multi-product SEZ facility. Presently, the state has two more notified pharma SEZs including Pharmez SEZ promoted by Zydus. It has 11 units out of which seven are functional with export of ` 1508.11 crores during 2015-16. However, being a multiproduct SEZ, Kandla has a considerable pharma export business presence. KASEZ has received a recent investment of ` 100 crores by Rusan Pharma. It has launched a state-of-the-art R&D centre, Navin Saxena Research

& Technology (NSRT), Quest Care. It is a custom-built clinical research organisation (CRO) and a specialised manufacturing unit for transdermal patches. Reportedly, Rusan Pharma will manufacture nicotine transdermal patches in India. With a recent investment made by Rusan Pharma and Vasishth indicating that there will be many more pharma companies looking to set up their manufacturing facilities at Kandla SEZ, it is likely that in the near future, the SEZ will attract huge investment and create good employment opportunities. u.sharma@expressindia.com

PHARMA MANUFACTURING UNITS AT KANDLA Sl.no

Name of the unit

Date of commencement of production

Value of capital goods imported (In lakhs)

Total investment made (In lakhs) Building

P&M

Employment generated so far

Total exports

Galentic Pharma(I)

14/12/2011

41.36

1267.41

2052.01

Ipca Laboratories

07/01/87

11.56

609.21

2665.52

9203.35

Keval export

27/04/2012

168

73.72

Medicare Industries

02/01/08

4.89

2.55

31.68

448.6

Mission Pharma Logistics

28/11/2011

18.91

391.46

268.41

24268.99

Rusan Pharma

07/12/01

45.63

558.19

2777.95

123

3406.47

Vifor Pharma

10/08/92

174.31

128.77

1998.48

3198.08

EDGE OF DOING BUSINESS IN KASEZ UNITS IN ZYDUS PHARMEZ SPECIAL ECONOMIC ZONE Edge in doing business on site customs facilitation at Kandla Import Extra Customs services round the clock,without extra cost

1.Amneal Pharmaceuticals

All activities , unless otherwise specified are on a self certification basis

2. Famy Care Ltd.

No import license for imports into SEZ

3. Zydus Hospira Oncology

Proposals including 100% FDI cleared under the automatic approval route in matter of days

4.Jai Pharma

Entire export proceeds can be kept in EEFC proceeds

5. Intas Pharmaceuticals

Domestic sales on payment of duty No duties on imports from preferred sources, including procurement from domestic market No central Excise duties on goods procured from domestic market or on goods produced in the Zone No Central Sales Tax

6. Cadila Healthcare 7.Alidac Pharmaceuticals 8. Zydus Technologies

No Service Tax

9. Biomedical Life sciences

Single window clearance Mechanism

10. Fisher Bio Pharma Services

Income Tax benefits are also given to the units

11. Piramal Enterprises

MANAGEMENT

Regulated Product Submission: The upcoming data exchange standards Divya Jaiswal, Business Analyst, HIL Domain Consulting Group, Infosys, Chandigarh, elaborates on how by implementing RPS, FDA will be able to implement a standards-based end-to-end fully electronic receipt, review, distribution and archival environment of its data JUST AS electronic common technical document (eCTD) is moving towards v 4.0 in the journey of format for electronic regulatory submissions, the Food and Drug Administration (FDA) is thinking way ahead. The next standard is Regulated Product Submission (RPS), which FDA is planning to implement in order to replace eCTD. By introducing RPS, FDA is planning to work towards implementing a standards-based end-to-end fully electronic receipt, review, distribution and archival environment.

What is RPS? RPS is a standard proposed by Health Level 7 (HL7), an accredited standards organisation. Presently, the second release of RPS is in progress. This new standard has two distinct benefits above eCTD. First, RPS will launch two-way communication between the submitting organisation and all FDAregulated product centres within the agency, such as pharmaceuticals, medical devices, veterinary medicines, biologics, radiologics and foods. Second, RPS will allow cross-referencing of previously submitted information and hence will effectively manage the life cycle of submissions.

What changes will RPS bring? To pharma companies: Organisations will be able to send electronic applications with automated cross-links to earlier submitted data and information. It will save huge time as data has to be submitted only once. To FDA reviewers: FDA reviewers will get efficient tools to search and analyse data to support their review. It will enable them to retrieve all significant submissions and associated data electronically from their work station.

To FDA: RPS will make FDA capable to handle two-way regulatory correspondence with industry, which will fast track movement towards all-electronic submission and review environment, and will reduce paper submission management systems. From 2002 eCTD 3.2.x is in place. Although much has been done for its development and implementation, still many restraints are not addressed and will take long procedure to solve these. Few of the issues with current eCTD are: ◗ It cannot support to other submission structure apart from CTD (e.g. CTAs, paediatric investigational plans, etc.) ◗ Difficulties to change any existing part (a new DTD version has been required when e.g. a new section is required, an agency changes its name, or new country joins the EU, etc.) ◗ Lack of ability to spot-on metadata if we get it wrong ◗ Limited ability to reuse of content across submissions ◗ Limitations on performance of vali-

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June 1-15, 2016

Experts in Pharmaceuticals, Cosmetics and Nutraceuticals Products

MANAGEMENT

dation ◗ RPS will launch two-way communication between the submitting organisation and all FDA-regulated product centres within the agency Two-way communication: Current structure of eCTD allows submitter to send response to the healthcare authorities but doesn’t allow authorities to send correspondence to submitter. With the help of RPS structure, it will be possible for FDA and other regulatory authorities to send correspondence to submitting organisation/ sponsors. RPS may be capable to resolve these, but it will involve efforts, time and money. It won’t be so simple to read and understand the XML file, or to review the submission via the folder structure or stylesheet. The eCTD builders will need to be enhanced, and (re)view-

ing tools used. It is something that won’t be implemented immediately, particularly in Europe, since a lot will need to be done to support its implementation. For example, there will need to be ICH and regional guidance developed and published. In the US, the FDA is keen to use RPS in other areas where it is responsible for regulation (such as Medical Device submissions), so it could move relatively quickly. However, in Europe, RPS is likely to remain focused on use for human pharmaceuticals, at least in the medium-term. Moreover, before the standard can be used in the EU and Japan, it will be essential to move the HL7 standard onward to be an international standard via ISO. Though there is much collaborative work on-going between Stan-

dards Development Organizations to develop joint standards (eg. ICSR, IDMP), it has become clear that there are strains because of differences in the funding models between organisations. The implementation also needs to be tied in with the European e-submission roadmap which is going through approval by the European regulators at present. According to the roadmap, a single format for e-submissions at European level (Central/MRP/DCP) is to be implemented from Q1 2018 but this may be extended to National procedures in future. The roadmap also notes that RPS could be used to support veterinary submissions.

RPS Vs eCTD ■ Similarity In many ways RPS is

similar to the eCTD. Contentedly, the FDA wants to implement RPS as the next recapitulation of eCTD. RPS and ICH’s eCTD has same concept —the use of a consistent format for regulatory submissions, which includes PDF documents and SAS datasets.

for HL7 standard to be implemented first at the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) were decided till late 2011, FDA is yet to determine the final date of adaptation of RPS but most probably it will be by 2018. Whenever RPS will be implemented, FDA will offer a training programme for reviewers, including hands-on training classes.

■ Dissimilarity: While document contents are same for eCTD and RPS, the internal (extensible markup language (XML) structures differs from each other.

Reference

■ Milestones and future planning for RPS At present, the second release of RPS is under development. ICH is planning to direct the third release. The objective behind release three is to have more international requirements. The timelines

1. http://www.bioitworld.com/news/2009/06/23 /RPS-trumps-ectd.html 2. https://en.wikipedia.org/ wiki/Regulated_Product_Submissions 3. http://www.fda.gov/ ForIndustry/DataStandards/RegulatedProduct Submission/default.htm

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RESEARCH I N T E R V I E W

‘We have pioneered a fast RNA conjugation process which works in water within minutes’ Dr Ishwar Singh, Senior Lecturer, School of Pharmacy, University of Lincoln, UK discusses about his areas of research, their objectives and the evolving sphere of pharma research, with Lakshmipriya Nair Give us an overview about your research on fast ribonucleic acid (RNA) conjugations. How far has it progressed and what does it seek to achieve? The research on fast RNA conjugations seeks to achieve two objectives. One is to label the RNA with different labels for different diagnostic applications and second is to conjugate the RNA to different delivery vehicles for its therapeutic applications. RNA is a sensitive (easily degradable), water soluble molecule, however, most of the conjugation done in the laboratory uses organic solvents. We have pioneered a fast RNA conjugation process which works in water within minutes. The results from this project are very exciting we have been able to label RNA with diverse molecules. This conjugation also worked very well on deoxyribonucleic acid (DNA). You are part of a project which aims to develop a nanodevice to improve treatment options for cancer patients. Can you elaborate on in it? Will it be a cost-effective option as well? The nanodecoder (nanodevice) has different components such as a scaffold and would offer nanometer precision with different functions to detect multiple markers in one test rather than doing multiple tests from skin cancer samples. It is a platform technology and later on we would like to develop it for other cancers also. It will be a costeffective option because it will have the capability to do multiple marker tests in one run.

What is your team’s contribution to the project? Who are the others involved? When is the project likely to be concluded? The diagnostic nanodecoder project is a very interesting project. It brings together experts from different countries (UK, Italy, the US and Argentina) with diverse expertise. For instance; the scaffold of the nanodecoder is designed by one group, we are installing the functions to detect multiple markers in one test rather than doing multiple tests, it will be tested by two different groups on samples of skin cancer. The current project will be concluded in 2019. What are your other areas of research? What are their objectives?

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Continued on Page 35

EXPRESS PHARMA

June 1-15, 2016

RESEARCH I N T E R V I E W

‘We are creating national-level HIV cohorts’ Dr Rajat Goyal, Country Director – India, International AIDS Vaccine Initiative (IAVI), in an exclusive interaction with Sachin Jagdale, gives details regarding recent developments in AIDS vaccine research in India

How will you describe the progress of AIDS vaccine research in India over the last three decades? While scientists first began to turn their attention to an AIDS vaccine about three decades ago, in 1994, the Rockefeller Foundation convened a meeting of 24 authorities on the disease. Two major themes emerged in their discussions. First, that the institutions most capable of developing such vaccines, particularly pharmaceutical companies, lacked the financial incentive to invest sufficient resources in the task. Second, although HIV was already taking a disproportionate toll on developing countries (like India), none of the handful of vaccine candidates then under development was devised to address the epidemics and particular needs of such nations. So, in 1996, IAVI was launched to address these problems and in 2002, IAVI began conducting vaccine and research preparedness activities in India. Since then, the focus has been on translating research activities towards the design of a safe and effective vaccine. This has covered the entire value chain from next-generation approaches in our HIV Vaccine Translational Research Laboratory (in partnership with the Translational Health Science and Technology Institute), through global linkages with other organisations and labs working on AIDS vaccine design, and through bilateral collaborations with Africa where we are working on the specific strain of the virus pertinent to India and Africa so that we can design a more region specific vaccine.

34 EXPRESS PHARMA June 1-15, 2016

These activities are intertwined with various partners such as the National AIDS Research Institute, YRGCARE, and regional scientific hubs in India to name a few. Is India keeping pace with global AIDS vaccine research efforts? If yes, explain how. If not, where are we lagging behind? Yes, India is playing an important role and contributing to global efforts in accelerating the discovery of an AIDS vaccine. One of the most promising breakthroughs in this regard is the identification of people who have demonstrated natural immunity to the virus in varying levels. These include people who are able to show low viral loads for an extended period of time after exposure to the virus, and people who have been exposed to the virus but not contracted an infection. Efforts are underway in India and various parts of the globe to study the unique immune responses of such individuals and isolate the broadly neutralising antibodies (bNAbs) that help them control the disease. Scientists are working to reverse engineer immunogens that will elicit similar immune responses in other people to protect them from HIV. This is something that has not been attempted in vaccine science before, and once successful, will inform vaccine discovery efforts for multiple other diseases in the future. In addition to bNAbs, India is working to further the understanding of the HIV-1 clade-C strain which predominantly circulates in India and Africa, and comprises more than three-

quarters of the global HIV burden. We are creating national-level HIV cohorts and a national bio-repository to store blood and tissue samples covering varying stages of the infection. Towards this end, we will begin collaborating with researchers in the Netherlands to share expertise and ensure adherence to global standards in research. Additionally, the HVTR lab along with various collaborations that have been set up nationally, bilaterally and globally are producing cutting–edge scientific outputs that are catalysing efforts for a global effective vaccine. What are specific challenges faced by Low and Middle Income Countries (LMICs) as far as AIDS vaccine research is concerned? The biggest challenges faced by (LMICs) in innovative clinical and immunobiological research are lack of trained human resources and poor access to latest technologies and infrastructure. This slows down the pace of research and development. India is in the unique position of being a developing country, and yet

having steadily and gradually developed significant capabilities in health and biotechnological research. We are harnessing these capabilities not just to fuel our own thriving and innovative biotechnological ecosystem, but are also working with various African nations to enhance their capabilities in disease research and prevention through various collaborative research projects, training and capacity building programmes, etc. At last years’ India Africa Forum Summit (IAFS – III), India committed significant resources towards development and health funds for Africa. The resulting SouthSouth collaborations will have a significant impact on scaling research capabilities in LMICs. Explain the limitations of drugs available in the market that AIDS vaccine will manage to get rid of? There are a variety of prevention, treatment and care tools, including medications, currently available and all of them are part of a comprehensive response to the epidemic. In India, these tools include condoms, antiretroviral therapy (ART), public health education and behaviour change campaigns. Male and female condoms, when used consistently and correctly, are highly effective in preventing the sexual transmission of HIV though there is still a risk of failure and women may face resistance in negotiating condom use with some men. In fact, even with female condoms, cost and access, consistency of use or incorrect use, amongst others, remain important challenges. Access to available prevention and treatment is

also a barrier to specific populations and regions in India and elsewhere. Similarly, enrolment and adherence targets for current treatment and prevention approaches have been difficult to meet in many cases. With respect to ARTs, key challenges include the burden of expenses (including the cost of transport to often distant treatment centres, lost wages, registration fees and user fees), side-effects, waiting times at the treatment centres, inconvenient dosing frequency, dietary restrictions and fear of stigma and discrimination. As well, the emergence of drugresistant HIV variants remains a key risk. Finally, public health education and behaviour change campaigns face challenges in terms of cost, reaching the intended audiences, overcoming social pressures or norms, and so on. What could be the limitations of AIDS vaccine? As part of a comprehensive response, an effective vaccine could prevent millions of HIV infections, averting deaths, suffering and long-term treatment costs. A vaccine has many advantages including that it can be delivered before exposure to the virus, provide long-lasting protection, be distributed widely and confidentially within broader public health programmes, enhance control of vulnerable people and populations over their health and rights, and overcome challenges of behaviour change and adherence. The limitations of any vaccine discovery project are mostly related to the uncertain time for development,

RESEARCH prolonged lab-to-market time due to multiple phases of trials to ensure safety, and depending on the final product – efficacy and number of doses needed to yield optimal results. But given that vaccines are the most effective and cost-effective disease prevention tools known to man, they are worth the wait. The reason we have vaccines for dozens of diseases is because they all received the sustained support and investments through various phases of discovery and clinical trials that they required. What is your take on the Indian Government’s efforts to keep check on HIV infections? Which are the improvement areas for the government? India’s response to the HIV epidemic has been globally recognised as having been particularly effective in reducing rates of infection in the country. That said, we believe that prevention tools will continue to play an important role in reducing new infection and IAVI remains firmly focused on accelerating vaccine R&D. How can AIDS vaccine become a tool for women empowerment? Women are more vulnerable to HIV than men and AIDS is the number one cause of mortality among women of reproductive age. Gender inequity or violence, poverty and limited education can restrict a women’s ability to learn about HIV prevention or to negotiate safe sex. These same factors can force women into the sex trade, increasing the risk of infection and the stigma that can inhibit access to HIV prevention testing and treatment. However, an AIDS vaccine, which can be distributed as part of broader public health programmes and remains invisible to others (unlike, for example, condoms), could help women to independently protect themselves and their children from HIV infection and strengthen their power over their lives. sachin.jagdale@expressindia.com

EXPRESS PHARMA

June 1-15, 2016

‘We have pioneered a fast RNA... Continued from Page 33 Our other areas of research comprise broad spectrum antibiotics, novel antimicrobials based on a rational design against clinically important resistant bacteria, biologics delivery, peptides, sequence selective

DNA cross linking, nanoparticles modifications for drug delivery and diagnostic applications. Our objectives are developing effective antibiotics against resistant bacteria, non-toxic biologics delivery, and sequence selective detection of dsDNA.

What are the major challenges in the arena of pharma research globally? What are the steps needed to mitigate them? Limited collaborative research. More interactions and collaborative projects among industries as well as universities are the need of the hour.

How has R&D segment in pharma evolved? R&D is pharma is evolving quite fast however we need more collaborative projects between different stakeholders to address complex challenges such as antimicrobial resistance and cancer. lakshmipriya.nair@expressindia.com

RESEARCH

What’s in a name?

Though naming bacteria is a relatively simple process, in some cases it may become a subject of an argument too, especially when harmful bacteria are named after a particular place By Sachin Jagdale NAMING BACTERIA after geographical locations is a standard practise. Though there have been instances where bacteria have been named after valleys, rivers, islands, volcanoes, trees etc as well. Hans G Truper, Institute for Microbiology and Biotechnology, University of Bonn, Germany, describes this phenomenon of naming bacteria after a particular locality as ‘localimania’. Truper explains his point of view, “I have witnessed that naming prokaryotes after localities has become quite a fashion, especially – but far from only – after localities in Eastern Asian countries. A rough calculation from the Validation Lists and Notification Lists published in International Journal of Systematic and Evolutionary Microbiology (IJSEM) in 1998, 2000, 2002 and 2004 shows that 11, 13, 15 and 26 per cent, respectively, of all new specific epithets were formed from local names by adding -ensis (-ense). This does not include other (classical) epithets formed after localities, such as hispanicus, indicus and antarcticus. It becomes clear that the slow increase in the percentage of epithets formed from a locality since 1998 has suddenly shown a boost in 2004. That this is not just an intermediate peak is shown by looking through the original papers in the May 2005 issue of IJSEM, where slightly more than 24 per cent of all new specific epithets are formed by adding -ensis (-ense).”

Bringing a bad name However, the discussion continues over whether associating a microbial bug with a particular place brings a bad name to it. India has been a crucial stake holder in this debate. Bacteria named after the Indian capital, New Delhi Metallo-beta-lacta-

36 EXPRESS PHARMA June 1-15, 2016

be the biggest loser in this scenario.”

Rules are ‘ruled out’?

mase-1 (NDM-1) had generated strong protest from the Indian Government few years back. NDM-1 is an enzyme that makes bacteria resistant to a broad range of beta-lactam antibiotics. However, there are examples of such nomenclature like SPM-1 for Sao Paulo metallo-b-lactamase, VIM for Veronna imipenemase in Italy, GIM for Germany imipenemase and DIM for Dutch imipenemase etc. Dr Yogesh Shouche, Scientist 'G' Microbial Culture Collection (MCC), National Center for Cell Science (NCCS), NCCS Complex, Pune University Campus, says, “Naming bacteria after cities is done in many ways. Sometimes a genus or species is named after city (Clostridium punense) or sometimes a strain is named after city for eg: NDM-1. Yes, if the organism is harmful it does bring a bad name to city as was the case in NDM-1.”

According to Dr Girish Mahajan, Vice President, Microbiology Divison, HiMedia Laboratories, there is nothing like bad name or reputation to that city due to using its name for microbe. On the contrary, he points out that the city becomes important destination for researchers. “It becomes a land mark for identification for first discovery of that new microbe. Further, if the same so called 'bad' new microbe is isolated and identified with statistically significant frequency in that particular geographical region then that region becomes medically significant to take necessary remedial actions,” opines Mahajan. However, Dr Hemant J Purohit, Chief Scientist and Head, Environmental Genomics Division, National Environmental Engineering, Research Institute, NEERI, CSIR, Nagpur, agrees to the fact that

the city gets a bad reputation if it is named after a harmful bacteria. He says, “Yes, it can or sometimes it is seen that city has got the bad name.”

Economical impact It is always believed that besides affecting the social status, finding a bug in a particular region may affect its economics as well. For example, when NDM-1 was identified in New Delhi, it had considerably affected its medical tourism industry. Mahajan says, “If the ‘bad’ microbe which has been named after that geographical region is found in such a statistically significant amount that it has become main etiology of particular disease/spoilage causing in that area then its medical alert to take Save Or Suicide (SOS) remedial actions over it to prevent further spread or infections. It will surely have economical impact on the region. Tourism industry will perhaps

To avoid the controversies associated with naming bacteria after a place, should there be a particular rule for this? Dr Purohit has his own reservations in this regard. He says, “Why should the bacteria be named after a city? Since, a bacterium is host or ecosystem specific it has nothing to do with the city.” According to Shouche, it is very difficult to frame a rule in this regard as this requires a certain amount of data generated prior to naming and this does not happen. He informs, “Name is given first and then the data is collected.” Mahajan says, “As such there is no such rule over what the genus or species name is to be derived. There are proper ways of formatting those names as species or genus names. However, there are cases where the names are also derived from institutes or mythological names when it becomes difficult to apply similar rules for all such sources.” A few hundred years ago, Shakespeare had written immortal lines ‘What’s in a name?” and perhaps nobody had ever questioned it. However, as far as naming bacteria is concerned questions have been raised. But, there are examples of beneficial microbes as well that have been named after city like, antibiotic Hamycin which is produced by Streptomyces Pimprina. So, it is indeed difficult to decide on the rules to name microbes. In today’s scientific world a focus should be on what is scientifically proven instead of getting carried away by emotions. sachin.jagdale@expressindia.com

RESEARCH INSIGHT

Sublingual Immunotherapy – An upcoming option for the treatment of allergy

DR SUBROTO GHOSHAL, Manager – Human Resources, Mindteck (India)

Dr Subroto Ghoshal, Manager – Human Resources, Mindteck (India), talks about how sublingual immunotherapy can be a safe alternative to subcutaneous immunotherapy globally for treatment of allergy SUBLINGUAL Immunotherapy (SLIT) has become a topic of interest globally and is being debated by the allergists in recent years. Allergen immunotherapy has been focusing on subcutaneous immunotherapy (SCIT) for many years, but now the interest has been shifted towards sublingual immunotherapy (SLIT) globally to study the efficacy and safe alternative to subcutaneous immunotherapy (SCIT). Numerous studies have been carried out to establish the efficacy and superiority of sublingual immunotherapy over subcutaneous immunotherapy. Even though USFDA approval has been obtained only for SLIT in the form of tablets for ragweed and grass pollen, other doses forms are also under development like drops and stripes. SLIT is being used in Asia, Australia, Europe and the US for treatment of specific allergic diseases.

Immunotherapy and allergy Allergy is a very common disease condition which is caused by allergens where the immune system is over sensitive. An allergen is any substance that cause allergic reaction while antibody (IgE) is substance produced by body’s natural system to defend against infection and other disease. Immune system generally protects the body against allergies such as bacteria and virus. In persons whose immune system is over sensitive, it releases chemicals like histamines which trigger allergic reaction. Allergens produce reactive antibodies (IgE) and allergy symptoms in the body.

Allergies are managed by using drugs but it provides temporary relief and the chances of re-occurrence again arises once the usage of drug is discontinued. Allergen specific immunotherapy is one of the most accepted line of treatment for general allergic conditions. Subcutaneous immunotherapy (SCIT) is a very old therapy but still followed for treating allergic diseases particularly in the treatment of allergic rhinitis, rhinoconjunctivities and asthma, where its efficacy and safety has been established. For certain allergy patients, there are two types of immunotherapy treatment available; (1) Allergy shots and (2) Sublingual immunotherapy (SLIT). In the allergy shots treatment, injection of allergens are administered by gradual increase of the dose. It has been observed that allergy shots have been effective for people having allergy to pollen, pets, dust, asthma or stinging insects but not much with allergy to food, medicine or eczema. SLIT on the other hand is a line of treatment without injection. The treatment is administered by placing small doses of allergen under the tongue. This helps improve tolerance to the allergens. SLIT has been found effective and recommended for treatment of nasal allergies and asthma 1. The ideal mechanism to manage allergy is by developing tolerance in the body for allergens which cause allergy symptoms.

Present scenario on allergy According

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the

World

Allergen specific immunotherap y is one of the most accepted line of treatment for general allergic conditions Allergy Organisation (WAO), industrialisation and changing lifestyle are causing the rise of allergic diseases, especially among children in India. It estimates around 20 to 30 per cent of India’s population suffer from different kinds of allergic diseases 2. There are numerous factors which causes allergy like dust allergy, pollen allergy, contact allergy, food allergy etc. Food allergy alone is becoming a global scenario. In countries like Spain, Italy and Greece, melon, peach and apple allergy is common while in Switzerland celery and celeriac allergy is prevalent. UK and US hosts a lot of allergy related to peanut, nuts, sea food, egg and dairy. In India alone, food allergy causes around 30,000 emergency treatments per year3. Allergic rhinitis is a cause of concern for pediatric disorder. The International Study for Asthma and Allergies in Childhood (ISAAC) found that 14.6 per cent rhinoconjunctivities symptoms were seen in children in the age group of 13 to 14 years

and 8.5 per cent was seen in children in the age group six to seven years considering global average. In India, the ISAAC showed that children with nasal symptoms in the age group of six to seven years accounted for 12.5 per cent and in the age group of 13 to 14 years accounted for 18 per cent4. As per the report of Indian Journal of Medical Research 141, April 2014, it is estimated globally the prevalence of asthma is approximately 4.5 per cent. There are about 334 million asthma patients spread across all age group. In India, it is estimated that asthma patients are around 17.23 million 5. Allergic rhinitis in India has been underestimated in terms of severity in spite of the fact that 75 per cent of children and 80 per cent of asthmatic adults suffer from this disease 6.

SCIT SCIT is specific to allergy related diseases. This therapy provides symptomatic relief to the patients by targeting the immunological mechanism. It is given by subcutaneous route and known as allergy shots. The main focus of allergen specific immunotherapy is to decrease the symptom which gets aggravated by allergens and to restrict the disease to reoccur in the future. This therapy is known as SCIT which involves the administration of specific allergen dose by modifying the immunological mechanism7. Many studies have indicated that efficacy and safety of SCIT is dependent on the dose. SCIT has shown to be effective in reducing the clinical symptoms related to asthma, allergic rhinitis/ rhinoconjunctivitis and

venom hypersensitivity.

Limitations of SCIT A major drawback with SCIT is the use of subcutaneous injection. Studies carried out points that there is a potential risk of severe systemic reactions with SCIT, including anaphylaxis. Though the numbers have been very less, but there have been some cases of fatal reactions to subcutaneous immunotherapy reported in the study conducted by American Academy of Allergy, Asthma and Immunology (AAAAI) 8. The other concern is that it is non patient friendly due to regular injections, which are sometime painful locally, fear among children and few adults, increased indirect cost due to frequent visit to doctor’s office.

SLIT SLIT is the new interest of study to treat allergies without injection. Patient is given a small dose of allergen under the tongue to boost tolerance to the substance and reduce symptoms. In order to determine the allergens causing allergy symptoms, tests are carried out in the form of blood test or skin prick test (SPT). Once the allergens are tested and determined, they are introduced into the body through the sublingual (under the tongue) route. Currently FDA has approved SLIT only in the form of tablets for ragweed and grass pollen 9. Apart from tablets, drops and stripes are also being administered under the tongue generally on a daily basis.

Management of allergy with SLIT SLIT formulations are to be

EXPRESS PHARMA

June 1-15, 2016

RESEARCH placed under the tongue because it dissolves with saliva and is absorbed directly into blood circulation. By this method maximum allergens are absorbed by the body as against swallowing where it loses its potency in the stomach. Once the allergy is confirmed for the patient, customised tablet or drop is prepared for the patient. The dosage is administered by taking the drops or tablet under the tongue daily. During the initial period also known as the escalation period, the dosage of drops is increased gradually. In the case of tablets, maintenance dose is given for a four to five year period. The general prescribed period for the SLIT is a minimum of five years 10. The purpose behind the long treatment period is to ensure that the symptoms do not recur after withdrawal. If there is a premature withdrawal of usage of medication, although there are no side effects indicated but the chances of recurrence of the symptom gets high due to the incomplete enhancement of the immune system. There are different dosage form of SLIT available for SLIT drops, SLIT tablets and SLIT stripes.

Advantages of SLIT Reaction to SLIT is very rare. It has been found very safe for children and adults. Unlike going to the doctor’s chamber to take allergy shots, tablets or drops can be taken conveniently at home. ‘The World Health Organisation (WHO) has endorsed SLIT as a viable alternative to injection therapy’ 11. Even though SLIT is considered a very safe therapy, there are some known mild side effects like sneezing, itchy tongue, lips, mouth, skin rashes diarrhoea, headache etc. which last only for a few days. It is advised to take an antihistamine for immediate relief. SLIT does not induce any kind of toxicity on long term use and no anaphylactic reaction has been observed. SLIT can be used with all drugs except with oral steroids.

38 EXPRESS PHARMA June 1-15, 2016

Various studies show that SLIT is very safe when administered in children. It has been suggested that the efficacy of SLIT has been higher if it is started early. But the study does not establish the age of the children when the administration can be started 12. However in one of the studies on children, a few cases of oral itching, abdominal pain and gastrointestinal side effects were cited which was later brought under control by reducing the dose. Certain studies discourage the usage in children below five years of age while certain other study showed it is safe to use SLIT in preschool age children for treatment of allergy 13.

SLIT research and treatment in Bengaluru Bengaluru is witnessing the research and treatment in the field of SLIT segment. Bengaluru Allergy Centr was established in 1980. This allergy centre headed by Dr Nagendra Prasad K, founder director, expert in allergy disorder provides complete allergy treatment. Bengaluru Allergy Centr has introduced sSLIT and is carrying out research activities in this therapy segment. The research team is headed by their principal scientist Dr Paranjothy Kanni who introduced sublingual therapy formulations in Bangalore. This centre had carried out research in the management of allergic rhinitis with custom made SLIT tablets. Bengaluru Allergy Centr selected 390 subjects who were suffering from rhinitis sensitive to house dust mite (HDM). 173 subjects were male and 217 were female and age ranged from 2 to 74 years. Clinical confirmation of sensitivity was done by skin prick test (SPT). The SLIT tablets were dispensed for two months with one tablet once daily. The patients were instructed to keep the tablet under the tongue for five minutes before dinner. SLIT tablet disintegrated within 90 seconds. The patients were instructed to keep the saliva for three to five minutes below the tongue to generate maxi-

mum tolerance and minimum adverse effect. The SLIT tablets were initiated with maintenance dose from day one. The SLIT tablets were dispensed once in two months after every follow-up visit monitoring the symptoms. The personalised SLIT medication with sublingual tablets initiated for six months with observing the adverse effects, symptom score and medication score. It was observed that there were no adverse effect with these subjects and noticed good symptoms relief 14. The other research carried out was on formulation and evaluation of custom made sublingual films (stripe) of house dust mite extract. House dust mite (HDM) is one of the common cause of asthma and allergic symptoms. Bengaluru Allergy Centr’s objective is to formulate the sublingual films (Stripe) with purified extract of HDM for SLIT. The sublingual immunotherapy films (Stripe) have been evaluated. In-vitro dissolution test have been performed as per USP type II apparatus using distilled water as the medium at a speed of 50 rpm, maintaining a temperature of 37 oC. more than 80 per cent of biologically active content was released in five minutes 15. Dr Paranjothy Kanni, Principal Scientist of Bengaluru Allergy Centr states “SLIT stripes are emerging as an alternate to the traditional drops, spray and tablets. SLIT stripe containing HDM extracts are prepared using hydrophilic polymers that dissolve under the tongue, delivering the allergens into the systemic circulation via dissolution when in contact with saliva”. This centre is equipped with various instruments and software to diagnose, develop and deliver SLIT treatment to the patients using the process of allergen ultra-filtration and lyophilisation. Lyophilisation is a process where in the liquid allergen is converted to powder form at -50 0C under vaccum. Most of the diagnostic process is carried out by (enzyme-linked immunosorbent assay) ELISA method.

Kanni opines, “There is a need to have better diagnostic software which will give results faster and have more parameters applicable to the Indian patients with various types of allergy. Software available in the West, which are trying to enter the Indian market, have considered allergens from Europe and American origin but not with respect to allergens from India.” It is understood that Mindteck (India), a Bengaluru -based software development company, providing services in the niche domain of medical device segment with specialisation in medical imaging, remote diagnostics and patient monitoring system, is in talks with Bengaluru Allergy Centr to explore the opportunity to develop software which can cater to their needs. Mindteck specialises in offering software solutions related to compliance regulation, in the areas of laboratory informatics, data management. It has vast experience in laboratory data management and the quality management system which is governed by ISO 13485:2003, 21 CFR Part 11 and 21 CFR part 820 standards and confirm to FDA regulations16.

Conclusion and future of SLIT SLIT appears to be better tolerated than SCIT. The majority of the adverse reaction seen in SLIT were local reactions that were found to occur during the starting of the treatment and were brought under control by adjustment of doses and medication. But no case has been reported for fatalities. There are still certain issues which remains unresolved. “Some of the issues where we still need more data, is regarding the safety on SLIT in patients who have systemic reaction with SCIT and whether the gastrointestinal and oropharyngeal infections and lesions (e.g., apthous ulcer, gingivitis, eosinophilic esophagitis) risk factors for SLIT systemic reaction,” indicates Prasad. SLIT is a safe and effective in the treatment of allergic rhinitis and allergic rhinoconjunctivitis. Although US Food and Drug Administration (FDA) has approved three

SLIT tablets, there is still a long way to go as approval of other formulations is under review and still pending. Research is still being conducted on SLIT on allergic asthma, food allergies, atopic dermatitis and others 17. Extraction procedure and standardisation of the allergens to the purest level need further extensive research to provide a precise allergen in SLIT dosage forms.

References 1. Aafa.org/page/allergy-treatments.aspx 2. Medind.nic.in/iac 3. Foodsmatter.com /allergy_intolerance/miscellaneous/articles/food_allergy_india 4. Asia Pac Allergy. 2012 Apr;2(2):93-100. English. Published online http://dx.doi. org/ 10.5415/apallergy. 2012.2.2.93 5. Icmr.nic.in/ ijmr/2015/april/editorial2 6. Ncbi.nlm.nih.gov/ pubmed/19548632 7. Aris aacijournal.biomedcentral.com/articles/10.1186/17101492-7-S1-S5 8. Aacijournal.biomedcentral.com/ articles/10.11.86/1710-1492-10-22 9. Acaai.org/allergies/treatment/sublingual-immunotherapy-slit 10. Hopkinsmedicine.org/otolaryngology/specialty_areas/sinus_center/sublingual_immunotherapy.html 11. Hopkinsmedicine.org/otolaryngology/specialty_areas/sinus_center/sublingual_immunotherapy.html 12. Medscape.com/viewarticle/782318 13. Ncbi.nlm.nih.gov/ pubmed/15898975 14. Komarla Nagendra, paranjothy kanni, European academy of allergy & clinical immunology (EAACI) conference 2014, Copenhagen, abstract No 1116 15. Kanni paranjothy et al, isolation and characterization of house dust mite and formulation of its extract into sublingual tablets for sublingual immunotherapy, ISMA 2013 Abstract 2484129 16. Mindteck.com/industries/ health-care 17. Ncbi.nlm.nih.gov/ pubmed/26149585 (Views expressed by the author are personal)

RESEARCH RESEARCH UPDATES

German Merck,Pfizer immunotherapy shows promise in rare skin cancer The data will be presented at the American Society of Clinical Oncology meeting in Chicago next month, and could be used as a basis for seeking US approval MERCK HAS reported encouraging interim data against a rare and aggressive form of skin cancer from a mid-stage trial of its experimental drug that helps the immune system attack tumours. In the 61-patient study, about 30 per cent of those with Merkel skin cell carcinoma treated with Merck’s avelumab saw their tumours shrink or disappear. Avelumab, which German Merck is developing with Pfizer, belongs to a class of drugs called PD-L1 inhibitors that block a mechanism tumours use to hide from the immune system, allowing it to recognise and attack the cancer. They are closely related to the PD-1 drugs already on the market from Bristol-Myers Squibb (Opdivo) and Merck & Co (Keytruda) seen as major advances against melanoma, lung cancer and

other malignancies. Roche’s Tecentriq earlier became the first approved PDL1 drug, gaining US approval to treat advanced bladder cancer. Patients in the avelumab

skin cancer study had not been helped by prior treatment with standard chemotherapy, leaving them without further treatment options, known as second-line therapy.

"As there are no approved treatments for second-line metastatic Merkel cell carcinoma and the standard of care is participating in clinical trials, these data represent a potential breakthrough for these patients," said LucianoRossetti, Head of Research for Merck's biopharma business. The drug was not tested against another medicine or placebo. But researchers concluded from an interim analysis that avelumab demonstrated "a manageable safety profile with durable responses." Six patients, or about 10 per cent, experienced complete responses with no signs of cancer, while 12 others saw significant tumour shrinkage. The data will be presented at the American Society of Clinical Oncology meeting in Chicago

next month, and could be used as a basis for seeking US approval. The US Food and Drug Administration awarded avelumab its breakthrough designation, which is given to drugs seen as a potentially important advance for specific diseases and can speed up the approval process. For Merck, which also makes chemicals for display screens and lab supplies, avelumab could help to revive its fortunes in pharmaceuticals after a string of setbacks. For Pfizer, seen as lagging the leaders in the immuno-oncology field, avelumab could be its first significant entry. The drug is also being tested against lung, breast, gastric and ovarian cancers, and in combination with other medicines. Reuters

Pfizer’s Ibrance delays breast cancer progression: Study Patients who received the Ibrance combination on average went 24.8 months before the disease began to worsen PFIZER’S IBRANCE in combination with another commonly-used drug kept advanced breast cancer in check significantly longer than the standard treatment alone in a late stage study, according to data released. Ibrance received an accelerated US approval in February 2015 based on its ability to delay disease progression in an earlier, smaller Phase II clinical trial, with the condition that the results be replicated in a larger study in order to gain

full approval. The oral drug, which has a list price of about $10,300 a month, has quickly gained acceptance among oncologists as an improvement over prior treatments. Some 28,000 women in the US have received Ibrance therapy since the accelerated approval, Pfizer said. A confirmatory trial called Paloma-2 studied the treatment with letrozole, which reduces estrogen production, in 666 postmenopausal women.

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Patients who received the Ibrance combination on average went 24.8 months before the disease began to worsen. That compared with 14.5 months for women who received letrozole and a placebo, according to a brief summary of data that will be presented next month at the American Society of Clinical Oncology meeting in Chicago. The 10month difference, deemed by researchers to be highly statistically significant, likely paves

the way for full US Food and Drug Administration approval of Ibrance, also known as palbociclib. The data will also be used to apply for Ibrance approval in other major markets, Pfizer said. "It was a very reassuring study," said Mace Rothenberg, Chief Medical Officer for Pfizer Oncology. The clinical benefit rate for patients taking Ibrance, defined as the proportion of women whose tumours disappeared, shrank significantly or had no

evidence of growth for at least six months, was nearly 85 per cent versus 70 per cent for letrozole alone. The overall response rate, a measure of significant tumour shrinkage, was 42.1 per cent for Ibrance versus 34.7 per cent for the placebo group. The overall survival benefit could not yet be assessed as most of the women in the study were still alive. Reuters

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June 1-15, 2016

RESEARCH

Merck,Bristol drugs show longer US FDA approves Roche’s survival for deadly cancers They work by blocking a protein called PD-1 that tumours use to evade detection by the immune system TWO NEW drugs that help the immune system fight some of the deadliest cancers are helping patients live years longer than older treatments, according to clinical trial results that should further boost confidence in this approach to oncology. Merck & Co showed that its Keytruda drug helped many patients with advanced melanoma survive at least three years, while Bristol-Myers demonstrated that Opdivo can prolong life for a significant number of patients with advanced lung cancer by at least two years. The results were released ahead of the American Society of Clinical Oncology meeting in Chicago next month. Keytruda and Opdivo are among the first wave of successful immuno-oncology drugs with a list price of about $150,000 a year. They work by blocking a protein called PD-1 that tumours use to evade detection by the immune system. In one study, researchers following 655 patients with advanced melanoma reported 40 per cent of those who received Keytruda were still alive three years after beginning treatment. Prior to the appearance of these new drugs, this deadliest form of skin cancer had no effective treatments and most patients died less than a year after the disease spread to other parts of the body. In a separate study testing Keytruda against Yervoy in advanced melanoma, 55 per cent of those who received the Merck drug were alive after two years versus 43 per cent for Bristol’s Yervoy. “These are previously unattainable results, but could represent the new normal,” said Dr Roger Dansey, who oversees late-stage oncology

40 EXPRESS PHARMA June 1-15, 2016

immunotherapy for bladder cancer Tecentriq, known also as atezolizumab, is approved to treat patients with advanced or metastatic bladder cancer whose disease worsened within a year of receiving chemotherapy

drug development for Merck. Data was made available through abstracts, or brief descriptions, of the studies to be formally presented at the ASCO meeting. In a pair of lung cancer studies, Bristol’s Opdivo kept far more patients alive at least two years after beginning treatment compared with those who received chemotherapy. One Opdivo study involved 272 patients with the squamous form of non-small cell lung cancer (NSCLC) that had progressed after prior chemotherapy treatment. 23 per cent of those who received Opdivo were alive two years after beginning therapy versus eight per cent of those treated with the standard chemotherapy docetaxel. For those alive after two years, there was no evidence that the Opdivo benefit had begun to wane, Bristol-Myers said. “We’re really beginning to deliver now on the promise of immuno-oncology, which is to provide as many patients as possible with the potential for survival benefit,” said Nick Botwood, development chief for lung and head and neck cancers at Bristol-Myers. "There’s a very clear dif-

ference between Opdivo and the old standard of care, which is chemotherapy." In a separate study of 582 patients with advanced nonsquamous NSCLC, 29 per cent of those treated with Opdivo following chemotherapy were alive after two years versus 16 per cent for docetaxel. Both forms of NSCLC are associated with smoking and relatively short-term survival. NSCLC accounts for more than 80 per cent of lung cancers. The incidence of serious side effects in the two studies was much lower for Opdivo than chemotherapy, the company said. “With long-term follow-up, we’re not seeing any increase in Opdivo related side effects,” Botwood said. Opdivo and Keytruda, both injectable biotech drugs, are fast becoming the second-line standard of care for NSCLC after chemotherapy, as well as the treatment of choice for melanoma that has spread. They are also being tested against a wide variety of cancers, and in combinations with many drugs, including other immunotherapies and other types of cancer medicines. Reuters

ROCHE HOLDING won earlier-than-expected US approval for its bladder cancer drug Tecentriq, the company’s first entry in a new class of cancer drugs that work by harnessing the body’s own immune system. Tecentriq is the first new drug to treat patients with the most common form of bladder cancer approved by the US Food and Drug Administration in 30 years, and the first in a class known as PD-L1 inhibitors which help prevent cancer cells from evading the immune system. PD-L1 drugs and their close cousins, PD1inhibitors, are considered one of the most promising areas of cancer research. The FDA has already approved PD1-inhibitors made by Bristol-Myers Squibb Co's and Merck & Co in a variety of cancers. AstraZeneca is also developing a PD-L1 inhibitor for bladder cancer. Tecentriq, known also as atezolizumab, is approved to treat patients with advanced or metastatic bladder cancer whose disease worsened within a year of receiving chemotherapy. Roche is also studying it to treat other cancers. Analysts expect the drug could generate sales of $2.8 billion by 2020. Roche, the world's biggest maker of cancer drugs, is counting on Tecentriq to offset competition from cheaper ‘biosimilar’ versions of its older medicines.

Bladder cancer is the fifth most commonly diagnosed cancer in the US, according to the Bladder Cancer Advocacy Network. In a clinical trial of 310 patients, 14.8 per cent experienced at least a partial shrinkage of their tumours, an effect that lasted from more than two months to nearly 14 months, the FDA said in a statement. In patients whose cancer cells expressed the PDL1 protein, 26 per cent experienced a tumour response, compared with 9.5 per cent of patients who were classified as ‘negative’ for PD-L1 expression. “The greater effect in those who were classified as ‘positive’ for PD-L1 expression suggests that the level of PDL1 expression in tumour-infiltrating immune cells may help identify patients who are more likely to respond to treatment with Tecentriq,” the FDA said. The agency also approved a test, the Ventana PD-L1 assay, to detect PD-L1 protein expression levels to help doctors determine which patients might benefit the most from treatment. The test is made by Ventana Medical Systems. The FDA gave Tecentriq accelerated approval based on its ability to shrink tumours, a so-called ‘surrogate’ endpoint that can reasonably be predicted to result in a clinical benefit. The company will need to conduct studies to confirm that hypothesis. Reuters

RESEARCH

Oramed says oral insulin succeeds in midstage type II diabetes trial Oramed uses a protective coating and a high-enough dose of insulin so that most of it can be destroyed and still deliver a clinically beneficial amount of the hormone ISRAELI DRUGMAKER Oramed Pharmaceuticals said its experimental oral insulin succeeded in significantly reducing night-time blood glucose in patients with type II diabetes, according to initial data from a midstage trial. The result is likely to surprise many skeptics who did not believe insulin could be delivered orally because they doubted it could survive the onslaught of digestive juices so it could have the intended effect. Oramed uses a protective coating and a high-enough dose of insulin so that most of it can be destroyed and still deliver a clinically beneficial amount of the hormone. The positive results must be repli-

cated in a larger phase III trial before the drug, known as ORMD-0801, can be submitted for approval. But the data from the phase II, 180-patient trial represents a major milestone.

“It's been a long trip but it’s finally at the point that it’s beyond a doubt, the oral insulin works,” Nadav Kidron, Chief Executive, Officer, of Jerusalem-based Oramed,

said. The 28-day study involved patients whose type II diabetes was not adequately controlled by metformin. They were dosed before bed time and had their overnight glucose levels continuously monitored. Those who received the oral insulin had a mean night-time glucose reduction of nearly 6.5 per cent compared with a placebo. There were no reported serious adverse side effects and no issues with hypoglycemia, or dangerously low blood sugar, the company said. Oramed said it plans to publish more detailed data from the study once it has had time to analyse the full results. Reuters

Beyond immuno-oncology,AstraZeneca builds up ‘DNA damage’drugs Astrazeneca’s Lynparza fights tumours by disrupting cancer cells' natural ability to repair themselves as they replicate, causing them eventually to die DRUGS TARGETING DNA repair mechanisms inside cells are showing real promise for a range of tumours and AstraZeneca believes it is well ahead of rivals in the emerging cancer field. Pascal Soriot, Chief Executive Officer, Astrazeneca, said that while DNA damage response (DDR) was under-recognised by investors, oncologists were already ‘very excited’ by its potential. Work on how cells repair damaged DNA landed Swedish, US and Turkish scientists the Nobel Prize for Chemistry last year and AstraZeneca’s recently approved Lynparza is an

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early example of a drug that builds on this new understanding. Lynparza fights tumours by disrupting cancer cells' natural ability to repair themselves as they replicate, causing them eventually to die. The British drugmaker is now combining different DDR medicines and will present early results at the American Society of Clinical Oncology annual meeting next month, including data on using Lynparza with an experimental WEE1 inhibitor. Reuters

Icelandic gene study spots possible new wayto cut heart risks A RARE and previously unknown variation in some people's genes substantially reduces heart attack risk and cholesterol levels, potentially paving the way to new drugs, Icelandic researchers said. The missing 12 letters from a gene on chromosome 17 were spotted in a study of genomes and clinical data across the population of Iceland. It was confirmed in data from some 300,000 people in other countries. The findings by researchers at deCODE genetics, a subsidiary of Amgen, were published online by the New England Journal of Medicine (NEJM). Interestingly, the genetic variation offers more heart protection than can easily be accounted for by the reduction in cholesterol alone, implying that other processes, such as reduced inflammation, could well be involved. An editorial in the NEJM said the association “may suggest a new path to the development of future therapies for the prevention of coronary artery disease,” although it noted the mechanism of action remained unclear. The discovery has already prompted Amgen to start drug discovery work on ways to inhibit the ASGR1 protein connected with the gene. Although statins have done much to cut heart attack risks, cardiovascular disease is still a leading cause of death and drug companies have continued to hunt for new therapies. These include recently launched so-called PCSK9 drugs, such as Amgen’s Repatha and Sanofi’s Praluent, whose development was also spurred by analysis of genetic mutations. Reuters

EXPRESS PHARMA

June 1-15, 2016

PHARMA ALLY I N T E R V I E W

‘We see India as a market with incredible growth potential for ATI’ Recently, Jon Beville, Director Sales & Marketing of Air Techniques International, USA was in India. He speaks on the significant developments in his company, strategies for growth, the company's plans for the Indian market etc. with Express Pharma. Excerpts

A bit about the history of ATI? Air Techniques International is a division of Hamilton Associates, a privately-owned Baltimore, US-based manufacturing firm comprising several speciality businesses. Hamilton Associates was established in 1951 by two brothers and continues to be family owned and operated, exhibiting the same professional and timehonoured principles of its founders. Our history of innovation begins in 1962, with the introduction of the world’s first portable photometer for cleanroom certification. More recently: ✦ 1996 – the world’s first digital aerosol photometer ✦ 1999 – TDA-100P Penetrometer/Filter Tester, supplanting the MIL STD 282 test requirement with a neat, cold nebulized aerosol, which remains the industry standard ✦ 2005 – Joint Service Mask Leakage Tester (JSMLT) for integrity testing of US military protective masks ✦ 2012 – Model 2i the only photometer providing full functionality and operational control from the scanning probe ✦ 2016 – The launch of the Environmental Biosurveillance system. EBS is the state-of-the-art in realtime biological threat detection, and uses a patentpending polarisation-based optical technology to classify

42 EXPRESS PHARMA June 1-15, 2016

airborne biological threats. What are the products manufactured by ATI? Our range of equipment includes aerosol photometers and generators for HEPA Filter leak testing, respirator/mask testers, automatic filter testers, aerosol reagents, diluters, etc.

ATI’s focus is on building stateof-the-art instrumentation and monitoring systems for contamination control. Over the next six to 12 months, you will hear more from ATI as we expand and globalise the Academy for Cleanroom Testing

Tell us about your recent acquisition of a British company On March 9 this year, ATI announced its acquisition of DOP Solutions, UK and its sister company, the Academy for Cleanroom Testing. Through these acquisitions, ATI will expand the breadth of its cleanroom testing products and services. DOP Solutions manufactures aerosol photometers and generators, while the Academy for Cleanroom Testing (ACT) provides training and education services. We believe there is a strong cultural fit, and our combined capabilities will create significant value for our customers in India and world-wide. Since 1988, DOP Solutions has been a leader in clean air testing, offering aerosol detection and generation instruments and accessories including positive injection pumping systems, aerosol injection ports, sparge pipes, and smoke generators. The Academy for Cleanroom Testing grew from a heritage of

providing theory and practical training for cleanroom testing, based on proven techniques and industry standards such as ISO14644 and EN12469/NSF49. What are your plans for this year, especially India? Are you looking at any M&As in India? This is a very big time of change for ATI. In March, we announced the acquisition of DOP Solutions which is a very significant development in the photometer market globally. With respect to India, I think our goal with the acquisition is to raise and maintain the high level of service that ATI has focused on with our partner MeasureTest for many years. I don't think we are looking at any M&As in India but India is an important focus for the photometer market for ATI. 2016 is really an opportunity for ATI to listen, learn and gauge the market in a way that we haven't done in a long time. So, we have a unique position, especially with the acquisition of DOP Solutions as well as the incredibly long history and heritage that ATI has in the Indian market through our partnership with MeasureTest. So, we have a unique opportunity to listen to customers from both companies to understand their needs and expectations and then to plan for the future. How does ATI interact with

and train its customers in the cleanroom and filter testing industries? We have a knowledge centre on our website, where answers to FAQs are given including: ◗ PAO-4 particle size distribution on a thermal condensation generator ◗ Particle size distribution of Laskin Nozzle Generator using PAO-4 ◗ Compressed air volume required for a Type IIIA Laskin Nozzle Aerosol Generator ◗ Upstream challenge aerosol introduction point ◗ Required upstream aerosol concentration ◗ Loading effect of oil aerosol challenge during filter leak testing We also associate with various firms and organisations to impart training including Institute of

Environmental Sciences and Technology (IEST); International Air Filter Certifiers Association (IAFCA); National Sanitation Foundation (NSF); National Environmental Balancing Bureau (NEBB) Where can one physically see your products in India and world-wide? Some of the many industry events we will be participating and exhibiting our equipment this year: ◗ CBRNe Convergence Asia (Tokyo, Japan; June 1-3 2016) ◗ ABSA (Grapevine, TX; Oct 13 2016) ◗ CBRNe Convergence (San Diego, CA; October 31 – November 2 2016) ◗ Filtration 2016 (Philadelphia, PA; November 6-10 2016)

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In India, our distributor MeasureTest Corporation regularly participates in industry events such as the CCSI-ISHRAE-ASHRAE lecture and product presentation held in Mumbai recently. The theme was 'Latest Trends in HEPA filter Testing & New Developments in Contamination Control'. Earlier, they took part in the One Day Theory & Hands-on Training Workshop on 'Testing, Adjusting & Balancing (TAB) of HVAC Systems & Validation of Cleanrooms' where I understand over a hundred delegates participated. Sheesh Gulati, CEO, MeasureTest is also Chairman of Contamination Control Society of India (CCSI). I am informed that CCSI is a member of the International Confederation of

Contamination Control Societies based in the Netherlands, and conducts one, two and four day certificate courses with exams on Cleanroom Technology. What have been significant developments at ATI lately, globally and for India? From a global perspective, ATI is going through a period of profound change. In 2014, Ron Adkins joined ATI as the new president. Then on, we started to build our new leadership team and strategy for ATI. I think you would see more changes for ATI in 201617 globally, especially in product development and expansion in contamination control technologies. Over the next six to 12 months, you will hear more from ATI as we expand and globalise the

Academy for Cleanroom Testing. ATI's focus is on building state-of-the-art instrumentation and monitoring systems for contamination control. This is a very exciting time for ATI, both in terms of developments that are taking place among the company leadership as well as in terms of our outlook on the global market. We see India as a market with incredible growth potential for ATI and other companies in contamination control technologies. It is very exciting to work with our local partners and the customers as we realise that growth together. Our mission is to protect people, protect products and protect critical infrastructure. EP News Bureau-Mumbai

EXPRESS PHARMA

June 1-15, 2016

PHARMA ALLY VENDOR NEWS

TCI launches world-class cold chain warehouse in Gurgaon The warehouse will be managed by TCI Supply Chain Solutions, a division of TCI for multi user customer requirements TRANSPORT Corporation of India (TCI) inaugurated its first state-of-the-art cold chain Warehouse on Pataudi Road, Gurgaon in the NCR region. This is TCI’s first foray in temperature controlled warehouses as part of an overall strategy to build a cold chain network of warehouses and refrigerated trucks and partner with the high value added segments of Quick service restaurants (QSR), retail and life sciences. The warehouse will be managed by TCI Supply Chain Solutions, a division of TCI for multi-user customer requirements. Clients from these industries were present at the inauguration and were taken on a tour of the facility. Speaking on the occasion, Vineet Agarwal, Managing Director, TCI Group said, “TCI believes in creating state-of-the-art

infrastructure and this warehouse is one more step towards continuous commitment to our clients. Our plan is to build a nationwide cold chain logistics network comprising five large-scale cold storage facilities by 2020. These facilities will be supported by a comprehensive range of distribution and logistics services, providing our customers with efficient, cost-effective solutions, so that they can focus on enhancing their product and service quality.” Jasjit Sethi, CEO, TCI Supply Chain Solutions shared technical aspects of the warehouse and mentioned the availability of value added services for clients from industries. A company presentation highlighted that this cold storage would be ideal for vaccines and gelatin capsules and the high

level of construction and facilities would allow a client to apply for FDA/Drug license at this premise. In addition, TCI’s refrigerated (reefer) vehicle network provides end-to-end seamless SCM solutions to clients. The reefers have a payload capacity ranging from one tonne to 18 tonne (+25° C to –25° C Temp) and are fitted with advanced GPS tracking devices and digital data loggers, tracked by a central control room for time definite services. The new facility is one of the largest and most advanced of its kind. Located in heart of NCR, the cold storage is a part of a large 250,000 sq ft multi-user warehouse facility. The cold warehouse has 5,000 pallet positions, totalling 11,700 CMT of temperature-controlled space. The warehouse is divided into

seven zones, with full temperature control ranging from -30 to +25 degrees celsius. It can also maintain relative humidity levels upto 35 RH. The facility incorporates world-class warehouse design and technology, offering integrated cold chain services, and encompassing multi-temperature refrigerated storage, blast freezer, ante room, processing area, warehouse and inventory management services, and transport and distribution

solutions to meet customers’ varying requirements. The sophisticated warehouse management system includes RF barcode scanning technology that increases efficiency and accuracy and enables customers to access inventory data and track orders in real-time around the clock. The facility has features designed to lessen environmental impact that include solar panels, rain water harvesting and STP system. EP News Bureau-Mumbai

Aesica highlights modular solution for serialisation The platform can be used across multiple geographies AESICA Pharmaceuticals, a global pharmaceutical contract development and manufacturing organisation (CDMO), provides pharmaceutical customers with a highly flexible, efficient and reliable technological resource that enables full and fast compliance with all the varying serialisation regulations across the globe - including China and Korea. The modular technology and system has the distinct benefit of being the same for all

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countries, whilst enabling pharmaceutical customers to meet specific serialisation regulations that vary markedly across different nation states and regions. The highly flexible solution has the capability to maintain data in multiple formats bespoke to each country’s individual regulatory rules. Consequently, customers are provided with a resource that ensures all serialisation requirements can be managed locally.

Aesica is currently applying its novel solution to enable customers to meet the specific serialisation demands of China and South Korea. The implementation of serialisation services for the Chinese market, one of the world’s most complex for serialisation regulations, reportedly took under six months for Aesica to complete. The company’s serialisation module is also already on hand for customers that need to satisfy the demands of

Brazil, the especially complex serialisation regulations of Turkey and Argentina and those faced by EU countries. According to a press release, in the output phase, Aesica can create whatever files the customer requires including satisfying demand for a format that suits a specific country. Both the input and output of the data generated for serialisation and aggregation is completely customised. The module provides full

logistical flow and aggregation support – providing customers with the capability to seamlessly track and trace every single package of medication. The platform supports all levels of aggregation including units, shippers and pallets – with the capability to aggregate individual unit serial numbers as packages are bundled, boxed and placed on shipping pallets. EP News Bureau-Mumbai

PHARMA ALLY PRODUCTS

LAUDAPRO launches bath and circulation thermostats CORRECT TEMPERATURE control is a critical requirement for countless applications in research laboratories and industrial production. Progressive technical development is exponentially increasing the demands placed upon temperature control technology. Demand for universal devices is quickly giving way to the need for solutions to specific challenges. With the market introduction of the new product line of bath and circulation thermostats, LAUDA PRO, the worldwide leading manufacturer of constant temperature equipment and systems once again proves its ability to innovate while simultaneously meeting growing market demand for individual products and more variety. Powerful bath thermostats for precise internal temperature control from -100 to 250°C and efficient circulation thermostats for dynamic heating and cooling of external applications from -45 to 250°C underscore the orientation of the LAUDA PRO product line to a wide variety of applications. Three high-temperature and six low-temperature thermostats with different bath volumes of 10, 20 and 30 litres are available for internal temperature control. All devices guarantee the highest level of temperature stability and homogeneity. One heating circulation thermostat and two cooling circulation thermostats ensure 100 per cent efficiency in external applications. Extremely low filling volume combined with a powerful vario flex pump facilitate dynamic temperature control with

minimum energy consumption. The operating concept also allows for individuality in a big way. The user may select between two completely redesigned LAUDA PRO control units. The base model option provides the user with all of the important parameters on an ultra-bright and high contrast OLED display. Individual programme items are easy to control using soft keys and cursor. Five available languages (English, German, French, Spanish and Italian) and clear menu guidance enable the intuitive and confident operation of the base control unit. The functionality of a second model developed by LAUDA, the command

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touch operating unit, is even more user-friendly and comprehensive. The command touch model is equipped with a large and brilliant 5.7” multitouch screen and provides the option to individually organise the menu icons. This makes it possible for the user to structure the control menu according to individual and very specific requirements. Other benefits include a zoomable graphics display and eight languages in total (the Command Touch control unit additionally offers menu guidance in Chinese, Japanese and Russian). Setpoints and actual values of key parameters are clearly displayed on the screen. Swipe

and zoom features make the visualisation of temperature profiles and individual parameters easy. The popular smartphone ‘finger touch principle’ even works with lab-gloves, a special comfort appreciated by lab professionals. Whether the base or command touch model, both operating consoles are removable and provide users with flexibility in terms of device positioning and control. An optional cable length of up to 50 metres provides an extremely high degree of flexibility for the set-up of LAUDA PRO devices. Environmental awareness also played a role in the development of the new product line.

All cooling circulation thermostats purchased in the European Union and Switzerland are supplied with natural refrigerants. This makes the new LAUDA PRO bath and circulation thermostats the new standard for temperature control without compromise. Contact details LAUDA DR R WOBSER GMBH & CO. KG P.O. Box 12 51 97912 Lauda-Königshofen Pfarrstraße 41/43 97922 Lauda-Königshofen Germany Phone: +49 (0)9343 503-0 Fax: +49 (0)9343 503-222 E-mail: info@lauda.de

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PHARMA ALLY

Waters Corporation introduces Xevo TQ-XS WATERS CORPORATION has launched Xevo TQ-XS mass spectrometer. Enabled by the newly designed StepWave XS ion guide, this mass spectrometry system features a unique combination of ion optics, detection and ionisation technologies resulting in levels of sensitivity not previously seen. The Xevo TQ-XS is expected to be available for shipment in June 2016 and will be on public display for the first time at MSSJ in Osaka, Japan and at ASMS in San Antonio, TX, June 5 â&#x20AC;&#x201C; 9. The new StepWave XS ion guide removes neutral species and transmits ions in a more focused beam to the detector by incorporating segmented quadrupole transfer optics in the second stage. The result is a 2x to 10x increase in signal/noise over its StepWave predecessor, and it delivers excellent robustness over thousands of injections. The refined design allows the system to quantify challenging

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compounds at trace levels even if they are labile or show poor transmission efficiency. Customer experience has been improved through the introduction of the new tool-free

atmospheric pressure ionisation probes. These allow scientists to perform routine maintenance in less than two minutes meaning greater operator-to-operator repro-

ducibility and more time analysing samples. The Xevo TQ-XS also incorporates the XDR Detector. First introduced on the Xevo TQ-S micro, it is a photomultiplier detection system capable of quantifying sample compounds across a concentration range of six orders of magnitude. Scientists no longer need to dilute and re-inject samples in order to stay within the limited dynamic range of the instrument they have been using. UniSpray, a novel, proprietary ionisation source available on the Xevo TQ-XS, enables ionisation of a wider range of analytes in a single chromatographic run. The result is an increased response across a wide range of compound polarities for a broader range of compounds accompanied by a boost in signal/noise, making it possible to consolidate several analytical methods into one, or eliminate the need to change ionisation sources

between analyses, saving time and increasing laboratory efficiency. The Xevo TQ-XS system joins a portfolio of Xevo mass spectrometers including; the Xevo TQD, the Xevo TQ-S micro and the Xevo G2-XS QTof. Xevo mass spectrometers are characterised by their universal ion source architecture: interchangeable ion sources that can be fitted to, or removed from, the face of the mass spectrometer in minutes, without the need to vent the system. This has changed the way analytical chemists with little previous mass spectrometry experience working in highthroughput labs can use the instrumentation at maximum performance. Contact details Dayamani Santosh Sr Admin Officer Waters India 36A, II Phase Peenya Industrial Area Bangalore 560 058

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PHARMA LIFE NEWS

Salary hikes of 13-19 per cent for select talent in pharma: Kelly Services Hikes during job shifts could touch 30 per cent for certain skill sets

ccording to data from Kelly Services, certain skills sets within sectors will see attractive percentage hikes in this year’s appraisals. For instance, within the pharma and healthcare vertical, talent in demand would include professionals in early biology research and toxicology, analytical development scientists, biostatisticians and product development professionals. They can expect a hike of 13-19 per cent this appraisal cycle. For comparison, Kelly Services predicts that talent could see average appraisals of 18-20 per cent across e-commerce firms, both travel and non travel. Critical skills and good

Hyderabad tops the list, contributing as much as 30 per cent of the jobs in pharma, life sciences and medical devices and agro performers in product development, strategy, alliances and sales and marketing can also expect 20-25 per cent hikes Reviewing key workforce trends this year across sectors, Kamal Karanth, MD, Kelly Services & KellyOCG India, said companies would focus on flexibility and automation to ensure process efficiency, better turnaround time and to mitigate costs. There will be more em-

phasis on going digital, with companies increasingly hiring dedicated digital talent and developing their own digital strategies to keep up with fastchanging technologies and business needs. Within the pharma sector, besides the skill profiles mentioned above, Kelly Services sees candidates in the areas of Environment, Health & Safety (EHS) and Environment, Occu-

pational, Health and Safety (EOHS) to be in demand because of the niche skills they possess and general unavailability of good talent. Senior candidates in Supply Chain and R&D (New Product Development) also are in demand. These are skills that can fetch hikes of 3035 per cent while shifting jobs. As far as locations go, Hyderabad tops the list, contributing as much as 30 per cent of the

jobs in pharma, life sciences and medical devices and agro. Bangalore and Mumbai follow at 25 per cent, followed by Ahmedabad (10 per cent) and trailed by Pune (five per cent) besides other locations. Employees in pharma companies in the ` 5-10 lakhs bracket can expect salary hikes of is 11-16 per cent within the current organisation but this could jump to 30-35 per cent while shifting jobs. Similarly, 10 per cent is the average hike in the same organisation for employees in the ` 10-20 lakhs and above ` 20 lakhs brackets, where as they could expect a 25 per cent hike while shifting jobs. EP News Bureau-Mumbai

SPJIMR launches programme for NGOs working in cancer care The one-year 'Organisational Development Programme' is conceived, developed and delivered by SPJIMR’s Centre for Education in the Social Sector and is supported by Novartis India THE SP Jain Institute of Management and Research (SPJIMR), a leading school of management, has launched a capacity building programme for community caregivers and NGOs working to support cancer patients and their families. The one year ‘Organisational Development Programme’ is conceived, developed and delivered by SPJIMR’s Centre for Education

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in the Social Sector and is supported by Novartis India. The one-of-its-kind programme will cover four modules to be conducted over two days each in the month of August, November 2016 and January 2017. Javed Zia, Country President, Novartis group of companies, India, said, “By associating ourselves with this programme, we are doing our bit to educate the NGOs and caregivers so

that they can better relate to and empathise with cancer patients, taking care of them in a much better way and helping them fight the disease more effectively.” A total of 43 participants representing 20 NGOs from seven states working for causes related to cancer care are enrolled for the programme, which will cover subjects like strategy formulation, resource mobilisa-

tion, finance, governance, advocacy skills, basic counselling skills, among others. The programme will help participants create a shortterm and long-term roadmap, embrace best practices in cancer care and offer hand-holding and support in between modules. The modules will help strengthen organisational management, governance, leadership skills and advocacy.

Speaking on the occasion, SPJIMR Dean Dr Ranjan Banerjee said, “Through this programme, we will endeavour to build capacities of NGOs, support community workers, caregivers, patient groups and others working for the cause of cancer care and help cancer patients lead productive lives and continue to contribute to the society.” EP News Bureau-Mumbai

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