Express Pharma (Vol.12, No.1) November 1-15, 2016

VOL. 12 NO. 1 PAGES 54

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Market

CPhI & P-MEC India to be held along with India Pharma Week

Research

Tesaro’s ovarian cancer drug benefits all patients in study 1-15 NOVEMBER 2016,` 40

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CONTENTS Vol.12 No.1 NOVEMBER 1-15, 2016 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury*

ACG ORGANISES SEMINAR ON INDIA’S READINESS FOR GLOBALTRACKAND TRACE

MARKET

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EXPRESS PHARMA AND SCHNEIDER ELECTRIC CO-HOST SEMINAR ON FUTURE READY PHARMA PLANTS

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CPHI & P-MEC INDIA TO BE HELD ALONG WITH INDIA PHARMA WEEK

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UNIQUITY INDIA FOCUSES ON BRIDGING THE GAPS IN GLOBAL SERIALISATION MANDATES

Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua

MANAGEMENT

Asst. Art Director Pravin Temble Senior Designer Rekha Bisht Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Ajanta Sengupta Ambuj Kumar E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

Senior officials from the pharma packaging industry took part in the seminar | 14 P31: UPDATES Tesaro’s ovarian cancer drug benefits all patients in study

PHARMA ALLY

34

ORPHAN DRUGS HAVE A LIMITED MARKET SHARE, BUT HAVE HIGH VALUE AND MARGIN

35

JUBILANT BIOSYS INSTALLS AGILENT'S RAPIDFIRE/MS SCREENING PLATFORM

P35: VENDOR NEWS Schreiner Group starts celebrating anniversary year

P48: INTERVIEW 'More than 50 per cent of bio-pharma companies have vacancies in key roles'

29

PARADIGM SHIFT IN CONSUMER HEALTHCARE PRACTICES IN INDIA

RESEARCH

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HORMONAL CONTRACEPTION TIED TO INCREASED DEPRESSION RISK

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

In search of sustainable growth

W

hen Ministers speak like CEOs, industry sits up and listens. The relatively newly minted state of Telangana is racing to catch up to its peers and hence it is only natural that aggression is the name of its game.

In the November 1-15 2016 issue of Express Pharma, KT Rama Rao, popularly known as KTR, Minister of Industries and Commerce, Information Technology, Urban Development and other important profiles in Government of Telangana has spelt out his vision for building the proposed Pharma City into not just a national but global hub for the pharmaceutical sector. Of course, the state already had the building blocks for such a set up, with the likes of Dr Reddy's Laboratories, Aurobindo Pharma etc. emerging from this state. Our cover story delves deeper into the plans for the Pharma City (See story: A Milestone in the Making, pages 22-26).

The state scores on the other pillars that make up this ecosystem like academic institutes etc but one area which could be a sore point could be concerns about the impact on the environment. Pharma manufacturing is one of the most polluting activities and successive governments in various states have struggled to address this issue.

Last November, the Central Pollution Control Board (CPCB) revealed the list of companies which had not responded to its directions regarding installation of continuous online pollution monitoring devices. Telangana came second on the list of defaulters/non-responders with 117 companies. Of the 143 pharma companies in the list, the highest, 59, were from

10 EXPRESS PHARMA November 1-15, 2016

The Telangana government seems to be cracking down and forcing erring pharma companies to clean up their act

Telangana. What is worse, is that 45 of these are located around Hyderabad in Medak district, mostly in Patancheru and Jinnaram mandals, according to the CPCB list. The CPCB followed by sending closure notices to 26 pharma companies in Telangana in May this year. Again, the state was second only to Maharashtra, which topped the list with 28 pharma companies.

While these numbers are damning, the Telangana government does seem to be cracking down and forcing erring companies to clean up their act. And this is where the Pharma City comes in. In July, KTR met members of the Bulk Drug Manufacturers Association, to assure them that the Pharma City would meet all their requirements, like the provision of common effluent treatment plants and other incentives. The grouse of most pharma companies is that such facilities are not viable investments for individual companies but when provided by the government, this concern is addressed.

This seems like a very pragmatic carrot-andstick approach. Not only will the polluting manufacturing activities be shifted out of high density residential localities like Hyderabad, the state government also gets them in one location, which will make it easier to monitor their activities. This way, the state retains a key revenue generating industry, while hopefully addressing the pollution problem as well. Let's hope this tactic plays out as per the blueprint.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET POST EVENT

Express Pharma and Schneider Electric co-host seminar on future ready pharma plants Held in Vadodara, Gujarat, industry stakeholders discuss the role of technology to keep processes and infrastructure at peak performance in pharma facilities Lakshmipriya Nair Vadodara PRODUCTION INNOVATIONS are influencing every company in pharma, be it giant multinationals or third-party manufacturers. This scenario has made embracing change through technology vital to maintaining and creating a competitive edge. Therefore, Express Pharma, a leading publication from The Indian Express Group and Schneider Electric recently co-hosted a seminar on ‘Future Ready Pharma Plants’ in Vadodara, Gujarat.

The unique, knowledge-sharing event saw a congregation of industry experts, thought leaders and peers as they jointly discussed just what it takes to leverage technology to keep processes and infrastructure at peak performance in pharma facilities.

The event began with live demonstration of Schneider Electric’s practical and actionable solutions for the edification of representatives from leading pharma companies. It was followed with a presentation by Rakesh Mukhija, Director, Life Sciences Solutions, Schneider Electric, who spoke on the role of technology in improving financial performance and the need to create a technology blueprint to build world class pharma facilities.

A panel discussion which brought together different stakeholders of the pharma industry, including the regulators, was the highlight of the event. Dr CD Shelat, Assistant Commissioner, FDCA, Surat; Bharat Desai, Managing Director, Bharat Parenterals and Immediate Past Chairman, IDMA – GSB; Rajubhai R Shah,

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November 1-15, 2016

Eminent panelists comprising Appasaheb S Kabadagi, Associate VP Head – Central Project Cell, Alembic Pharma; Bharat Desai, MD, Bharat Parenterals; Dr CD Shelat, Asst Commissioner, FDCA, Surat; Rajubhai R Shah, MD, Mercury Labs; and Shrinivas Chebbi, VP, Partner Projects and Eco Buildings, Schneider Electric, discuss and debate on the need for a technology blueprint to create future ready pharma plants

Managing Director, Mercury Laboratories; Appasaheb S Kabadagi, Associate Vice President Head – Central Project Cell, Alembic Pharmaceuticals; and Shrinivas Chebbi, Vice President, Partner Projects and Eco Buildings, Schneider Electric were the eminent panelists. Moderated by Viveka Roycowdhury, Editor, Express Pharma, the session addressed the need to reduce energy costs and improve processes, reinforce plant security to protect staff, equipment and reput ation and take a modular approach to build a world-class pharma plant. It also highlighted the various challenges hampering the growth of the industry and the measures which can help tackle them effectively.

Roychowdhury began the session by drawing attention to the pain points in the industry such as product recalls, warning letters from international regulators, and loss of credibility for Indian Pharma Inc and asked Dr Shelat to share his views on these issues.

Dr Shelat stated that lack of awareness, improper processes are the leading causes which have led to these challenges.

A live demonstration of Schneider Electric’s solutions for the pharma sector

He urged the industry to upgrade themselves regularly and implement better good manufacturing processes (GMPs) and standard operating procedures (SOPs) to reduce and prevent issues with quality. He also emphasised on the need to move with the times and embrace technology to improve efficiency and efficacy in the pharma industry. He also opined that continuous training for not only the industry but also the regulators can have tremendous positive impact

and mitigate the current challenges significantly.

Next, Roychowdhury asked Desai to share his perspective as an industry veteran on the measures needed to build future ready pharma plants.

Desai emphasised that energy conservation is an important aspect when it comes to creating world-class pharma facilities. He pointed out it is an energy-intensive industry and strategic measures such as opting as renewable energy sources, technological in-

terventions to prevent loss of energy etc. can go a long way in making a pharma plant future ready. He underlined that technology is a major facilitator of efficiency and urged the audience to adopt high-tech solutions to enhance the relevance of their business in the current scenario. Desai also explained the role of industry bodies like IDMA in encouraging pharma companies to be more techevolved and utilise the potential of technology to gain rich dividends.

MARKET The moderator then asked Kabadagi to speak on the experiences of Alembic Pharma as a early adopter of technology to drive their growth. She also asked him to explain how his organisation can be a role model for other pharma companies to emulate while transitioning as high-tech entities.

Kabadagi spoke on Alembic Pharma’s growth as a leading pharma player in the country and the role of technology in its progress. He explained the concept of future ready pharma plants in detail and shared valuable insights on the parameters which need to be considered while choosing technology solutions for pharma plants. As a customer of Schneider Electric, he also recommended the company as a great partner which can hand hold pharma companies as they embrace technology in different aspects of their operations to evolve as better entities offering enhanced value to their customers. He emphasised that the journey towards being future ready begins today.

The next panelist, Shah addressed an allegation often levelled at the pharma sector of being a technology laggard.

He refuted the allegations and traced the tremendous progress made by the industry since Independence. He pointed out that the industry has evolved and transformed from being a major importer in the 1950s to a leading exporter of pharma products in the current times. But, he also admitted that at times pharma companies refrain from adopting technology as they are unsure of the dividends and believe that it would eat into their profit margins. He advised the pharma sector to be more open to change and implement measures which give them long-term benefits instead of looking at short-term gains.

Roychowdhury then asked Chebbi to give his views on this pivotal issue and explain how Schneider Electric can play a role in transforming the life sciences industry through technology solutions.

Chebbi pointed out that India is taking great strides and the pharma sector has

EXPRESS PHARMA

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November 1-15, 2016

Rakesh Mukhija, Director, Life Sciences Solutions, Schneider Electric

A Revanand, Regional Sales Director, Proximity, Schneider Electric

huge potential to accelerate the country’s progress march.

He also states that the lifesciences could be the segment which can bring in very rich dividends, similar to the IT boom which highlighted India as an emerging leader in the global arena. He, however, opined that the potential needs

to be leveraged in the right way at the right time and pointed out the role of technology in doing so. He expressed concerns that unless strategic measures were taken by the industry, it is possible that we might miss the bus and not be able to optimise the opportunities opening up for growth in

MARKET the life sciences sector. He also said that his company is interested in building sustainable collaborations with the life sciences industry and would like to extend a hand to any pharma company who wishes to improve there future readiness. He also highlighted the various solutions offered by Schneider Electric for the life sciences sector.

The audience also posed several questions to the panelists. Various interesting suggestions and recommendations emerged during the interactive Q&A session. One of them was that Schneider Electric should adopt a pharma company and by example demonstrate the benefits of going high-tech.

Roychowdhury summed up

(L-R) A Revanand, Dr CD Shelat, Bharat Desai, Rajubhai R Shah, Appasaheb S Kabadagi, Shrinivas Chebbi and Rakesh Mukhija

the session with a message that being future ready involves a cost but it is much

lesser than the cost of not doing so. The seminar concluded with a vote of thanks by

A Revanand, Regional Sales Director, Proximity, Schneider Electric. He thanked all the

participants for making the event a great success. lakshmipriya.nair@expressindia.com

ACG organises seminar on India’s readiness for global track and trace Senior officials from the pharma packaging industry took part in the seminar ACG INSPECTION, part of ACG Worldwide Group, and provider of high-tech camera systems, recently organised a technical seminar called ‘Índia’s Readiness for Global Track & Trace.’ Senior officials from the pharma packaging industry took part in the seminar to explore the latest developments in the field of serialisation. Express Pharma was the exclusive media partner for the event.

ACG Inspection fills the gap between effective online checks and product quality.

As an advanced inspection company, it provides its expertise in both manufacturing and packaging. With the Indian pharma companies making efforts to adapt global standards in serialisation, the seminar gave them crucial inputs on how to manage this transformation with greatest degree of success while also minimising business disruption.

14

EXPRESS PHARMA

November 1-15, 2016

Ettore Cucchetti, CEO, ACG Inspection Systems gave the welcome address.

The chief guest for the event, Rahul S Shakhapure, Assistant Drug Controller (India), (Air Port), Central Drug Standard Control Organisation (Mumbai), said, “Many deliberations have taken place at various forums on serialisation. There are few regulations in countries like China, Brazil etc. European Union and India too have issued their guidelines and circulars in this regard in a phased manner. The US has passed the resolution in 2013 on serialisation and track and trace system. The Government of India (GoI) is of the view that we can have barcode systems of international standards.

These barcodes will be 14 digits barcodes which will have GTI number, batch number, expiry date and unique identification number. The information in the 14 digit barcode will

(L) Harpal Singh, Director, ACG Inspection Systems felicitates (R) Rahul S Shakhapure, Assistant Drug Controller (India), (Air Port), Central Drug Standard Control Organisation (Mumbai)

Bill Fletcher, Managing Partner, Pharma Logic Solutions (Left), US, with Ettore Cucchetti, CEO, ACG Inspection Systems (Centre)

MARKET A very stormy debate on GS1 standards was the highlight of the seminar where almost every attendees tried to clear their doubt by asking different queries to the speaker be uploaded on the national server given by the GoI. There can be advantages and disadvantages of the entire process.

It can make it easier to trace the product but implementation of serialisation can al so add to the cost. Harmonisation depending on different regulations will also be a challenge.”

Bill Fletcher, Managing Partner, Pharma Logic Solutions, US, spoke on the topic, 'understanding Drug Supply Chain Security Act (DSCSA) and sharing its implementation experience across 33 companies. Fletcher said, “Indian companies are facing problems while exporting because different countries have different regulatory requirements. Many times, genuine companies suffer because counterfeiters counterfeit their drugs and final consumer and also the doctor think twice before prescribing that particular brand. Global trade will drive counterfeiting to areas of the world lacking adequate traceability regulations. Variations in product identification and requirements for uniqueness necessitates data system agility.”

According to Abhijit Puradkar, Implementation Officer, GS1 India, who was also

EXPRESS PHARMA

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November 1-15, 2016

one of the speakers at the event, such events help pharma companies to get knowledge about the regulatory requirements in several countries. They also get a chance to clarify their doubts regarding the regulatory requirements by the expert panelists. These events also help

to spread awareness about Indian regulatory requirements on pharma exports.

“Implementing track and trace systems leads to secure healthcare supply chain and also help in tackling the healthcare industry challenges like counterfeits , authentication, traceability and

recall. Due to this reason, many countries are enforcing regulatory laws and hence it’s important for Indian companies to make themselves aware of such requirements,” said Puradkar.

A very stormy debate on GS1 standards was the highlight of the seminar where al-

most every attendee tried to clear their doubt by asking different queries to the speaker. Professionals present for the seminar expressed their desire to attend more such seminars in future as well. sachin.jagdale@expressindia.com

MARKET PRE EVENTS

CPhI & P-MEC India to be held along with India Pharma Week UBM India set to celebrate 10 years of success with one week of glory

T

he Indian pharmaceutical industry is all set to experience South Asia’s largest pharma event, CPhI & PMEC India in an unprecedented manner by commemorating its 10th successful year in India with India Pharma Week (November 17 to 23, 2016), a week-long celebration packed with avant-garde events prior to the expo. Traditionally a three-day exhibition at the Bombay Exhibition Centre (BEC), this year for the first time, CPhI & P-MEC India (Novmber 21 to 23, 2016) will be held concurrently at two venues- BEC and the MMRDA Grounds, Bandra Kurla Complex (BKC). While celebrating a decade of CPhI India, the India Pharma Week will hold more than 10 events and activities taking place across the city of Mumbai focusing on busi-

ness, knowledge, leadership, innovation, recognition and networking in the field of Pharma.

The week will include a PreConnect Congress; Women in Pharma – Power Breakfast; the India Pharma Awards; Networking Evening; Plant Visits, Pharma Leaders’ Golf; the CPhI & P-MEC India Exhibition, a closed door CEO Roundtable and many more activities.

This year's event will see more than 1,300 exhibitors, a 100-plus countries’ participation and close to 40,000 attendees spread across the two locations in Mumbai. While BEC will have traditional participants for CPhI and P-MEC, the concurrent venue – BKC will also include participants for ICSE and BioPh. Speaking on the occasion, Yogesh Mudras, MD, UBM India said, "CPhI & P-MEC 2016

This year for the first time, CPhI & P-MEC India (Novmber 21 to 23, 2016) will be held concurrently at two venues BEC and the MMRDA Grounds, Bandra Kurla Complex (BKC)

is perfectly placed to provide a most comprehensive industry platform for every company that deals with pharmaceuticals in India. We have consistently received an overwhelming response from the participants. This year, we are excited about the innovations we are bringing to the expo, which will simultaneously be held at the BEC, as well as the MMRDA grounds, BKC. In addition to the Pre- Connect Congress and CEO Roundtable the introduction of ‘India Pharma Exporters - Collector's Edition’ & ‘The World of P-MEC - Collector's Edition’ will bring in more insightful exchanges amongst the industry veterans and stalwarts."

“CPhI is UBM's flagship engagement platform and the world's leading pharma networking event. If pharma key

players have to congregate to connect, share and ideate then CPhI is the single largest global platform for them to do so,” he further added.

CPhI India is an industry platform for CROs, CMOs and manufacturers of API, generics, excipients and drug formulation, fine chemicals, biosimilars, finished formulations, lab chemicals and biotechnology.

Whereas, P-MEC includes manufacturers of pharma machinery and equipment, analytical equipment, automation and robotics, packaging equipment and supplies, plant/facility equipment, automation & controls, processing equipment, tableting / capsule fillers, clean room equipment, filling equipment and laboratory products.

EP News Bureau

CubeX to host conference on consumer healthcare in Mumbai It would cover diverse topics such as building mega brands to penetrating unchartered territories, creating multiple touch points for consumers and devising collaborative strategies through multiple stakeholders CUBEX, A division of Sorento, in association with Nicholas Hall & Company, will organise a conference titled, ‘Achieving Scale in Consumer Healthcare’. It will be held on December 9, 2016 at Sofitel, Mumbai.

Along with global OTC expert Nicholas Hall, prominent in-

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November 1-15, 2016

dustry experts who have led the path for their companies, will share their success stories on this single platform. They will throw light on various facets ranging from building mega brands to penetrating unchartered territories, creating multiple touch points for con-

sumers and devising collaborative strategies through multiple stakeholders.

Reportedly, some of the speakers at the conference will be Susan Josi, Managing Partner, Sorento Healthcare Communications; Kedar Rajadnye, COO, Piramal Enterprises;

Prof.Piyush Kumar Sinha, IIMA; Swapneel Naidu, VP, Glenmark Pharmaceuticals; Subodh Marwah, Head, Consumer Healthcare, Sun Pharmaceutical Industries T; Gangadhar, MD, MEC-South Asia; Dalveer Singh, CEO, GroupM Dialogue Factory; Dinar Mhatre, Head

Integration, Johnson and Johnson Consumer; N Rajaram, Country Head & GM – Pharmaceutical Operations, Sanofi India and K Ganapathy Subramaniam, Head – OTC category, Dabur India.

EP News Bureau

MARKET POST EVENT

Robert DeJean, CEO, Systech International gives the welcome address

Uniquity India focuses on bridging the gaps in global serialisation mandates With the DSCSA and other serialisation deadlines looming ahead, Uniquity India 2016 served as a timely status check Viveka Roychowdhury “YOU HAVE 500 days to meet the November 27, 2017 deadline,� said Arjun Guha Thakurta, Director Operations, Life Science Consulting, a Conval Group Company. He was speaking at Uniquity India 2016, a recently held one-day meet organised by Systech International in Mumbai.

His statement caught the attention of all attendees as he was alluding to the next milestone of the Drug Supply Chain Security Act (DSCSA), which requires pharmaceutical manufacturers distributing and selling in the US, to print a unique product identification code on all sale units and homogeneous cases of prescription medicines.

Attendees included over a hundred industry specialists, from companies like

Johnson & Johnson, Teva, GlaxoSmithKline, PharmaSecure, Merck, Abbott, Biocon, Dr Reddy's Laboratories, industry leaders, as well as equipment manufacturers like IMA-PG India.

Setting the tone for the day, Robert 'Bob' DeJean, CEO, Systech urged the attendees to use Uniquity India 2016 as a forum to share experiences and best practices which will make all of us stronger together.

The Indian regulatory side was represented by Anice Joseph Chandra, Director, Ministry of Commerce & Industry, Government of India, who directs the track and trace programme, implemented by the Department of Commerce, for the promotion of Brand India, ensuring that spurious health products

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

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November 1-15, 2016

MARKET are not exported under a ‘Made in India’ label. In her special address, she shared details and upcoming changes to India's track and trace initiative, the Drugs Authentication and Verification Application (DAVA).

Giving real life examples, Dr Hemant Koshia, Commissioner, Food & Drugs Control Administration, Government of Gujarat, gave his perspectives and insights as a regulator. Drawing an analogy between the gotra system of keeping track of families through generations and the present day need to track and trace medicines through the supply chain, he showed photographs of raids on sites of spurious medicine manufacturing sites conducted in his state, to illustrate the success of the anti-counterfeiting initiative in Gujarat.

The industry's implementation challenges were highlighted by Arun Gupta, Strategic Advisor, Systech and ex global CIO, Cipla, when he commented, “Serialisation is not an IT but a business problem but IT (department) is expected to play a leadership role in this initiative.”

While Gupta spoke about his experiences in the pharmaceutical sector and gave hints of the many legacy challenges faced by pharma companies in India as they gear up to meet global serialisation mandates, other

Dirk Rodgers – Global Regulatory Strategist, Systech International, moderates the panel discussion with panelists (from left to right) Arjun Guha Thakurta, Director Operations, Life Science Consulting, a Conval Group Company; Dr Hemant Koshia, Commissioner, Food & Drugs Control Administration, Government of Gujarat; Arun Gupta, Strategic Advisor, Systech International, and Ex Global CIO, Cipla and Dr Avi Chaudhuri, Senior Global Partner, Systech International

speakers gave details of the regulations that are rolling out across the globe.

Guha Thakurta, whose company advises pharma manufacturers on their serialisation strategies, spoke on ways to bridge the gaps between the DGFT/DAVA mandate and global serialisation regulations.

He further outlined the crucial

nature of the challenge when he said that 84 per cent of world GDP is covered by track and trace regulations and described many ‘implementation black holes.’

Dirk Rodgers, Regulatory Strategist, Systech International conducted workshops, detailing aspects of the US DSCSA law, highlighting the

hidden complexities that Indian exporters need to know, and what they should do to be complaint with multiple country-specific global regulations.

Dr Avi Chaudhuri, Senior Global Partner, Systech International, who first got involved with track and trace initiatives after falling a victim to counterfeit medication himself, gave an

overview of Systech's solutions and its unique benefits to the Indian pharma industry.

The highlight of Uniquity India 2016 was a very interactive panel discussion, moderated by Rodgers with Guha Thakurta, Koshia, Gupta and Chaudhuri fielding queries from the audience. viveka.r@expressindia.com

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

❒ We welcome information on new products and

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

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

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

18

EXPRESS PHARMA

November 1-15, 2016

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

The Indian Express (P) Ltd, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021.

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

MARKET GROWTH TRACKER

IPM clocks ` 10,278 cr in Sept 2016 Domestic companies continued to dominate the market with a 79 per cent share THE INDIAN Pharmaceutical Market (IPM) was valued at `10,278 crores in the month of September 2016 clocking a strong 10 per cent growth over the same period last year (SPLY). On a MAT September basis, the industry was valued at ` 111,022 crores and reflected a 13 per cent growth with volumes contributing around 40 per cent of this growth and new introductions playing an important role with around 38 per cent contribution to the overall growth.

The retail channel remained the largest channel in IPM contributing 84 per cent of the overall sales and reflected a 13 per cent growth. The hospital and doctor channel contributed to 10 per cent and six per cent of the overall sales and reflected a 17 per cent and 15 per cent growth respectively on a MAT September basis. It is expected that the hospital channel will continue to report robust growth rates due to rapid capacity expansion in this space.

As per IMS data, which captures sales from trade stockists, more than 10 therapy areas (TAs) in the IPM have already crossed a sale of `500 crores in the hospital segment viz. anti infectives, cardiac, gastrointestinals, pain, neuro, VMN, gynae, anti-diabetics, vaccines and respiratory.

IPM continued to remain fragmented with top 10 companies occupying 43 per cent of the share and top 20 companies reflecting strong double digit growth for the month. Companies 31-40 collectively reflected a single digit growth on account of Himalaya (nine per cent), Unique Pharma (nine per cent) and Astra Zeneca (three per cent) which reflected a low growth.

Seven out of the top 10 companies reflected a double digit growth with Sun Pharma (11 per cent), Cipla (11 per cent), Alkem (16 per cent), Macleods

Sr. No

BRANDS

PROD_LNCH

COMPANY

Sep 2016 Val (Rs. Crs)

1

PANDERM NM

201605

MACLEODS PHARMA

6.2

2

RYZODEG FLEXTOUCH

201412

ABBOTT

6.2

3

CARIPILL

201507

MICRO LABS

5.1

4

FORXIGA

201505

ASTRAZENECA

5

5

IT-MAC

201510

MACLEODS PHARMA

4.9

6

JARDIANCE

201510

BOEHRINGER INGELH.

4.7

7

ASCORIL-D

201503

GLENMARK PHARMA

4.5

8

ONE TOUCH SELECT

201501

JOHNSON & JOHNSON

4.4

9

VARIPED

201503

MSD PHARMACEUTICA

4.1

10

ZITA-MET PLUS

201509

GLENMARK PHARMA

4

11

INSTAKIT

201604

MACLEODS PHARMA

3.8

12

GONAL-F

201509

MERCK LIMITED

3.4

13

INVOKANA

201503

JANSSEN

3.1

14

SAFI

201506

HAMDARD

3.1

15

ONE TOUCH ULTRA

201501

JOHNSON & JOHNSON

3

16

SULISENT

201510

USV

2.9

17

TERBINAFORCE-LITE

201607

MANKIND

2.9

18

ZITA PLUS

201506

GLENMARK PHARMA

2.7

19

AXCER

201510

SUN

2.7

20

AMBRODIL-S PLUS

201608

ARISTO PHARMA

2.6

21

ONDERO

201512

LUPIN LIMITED

2.5

22

ZITEN-M

201509

GLENMARK PHARMA

2.2

23

JANUMETXR

201410

MSD PHARMACEUTICA

2.2

24

BGR-34

201510

AIMIL

2.2

25

SUALIN

201506

HAMDARD

2.1

TABLE 1: PHARMA MARKET SIZE IN MILLION $ USD BY COUNTRY All values in million USD

Aug month

Month growth per cent

Aug MAT

MAT growth per cent

Global Pharma Mkt USA

73043

1.2

957084

3.5

34726

5.2

443724

7.8

JAPAN

6900

22.5

79180

8.6

CHINA

6315

7.3

73986

0.4

GERMANY

3424

13.9

40295

-0.4

BRAZIL

1995

26.6

19158

-11.6

UK

1949

-5

25330

0.6

CANADA

1696

11

19143

-4.5

FRANCE

1663

-29.2

31928

-5.2

VENEZUELA

1653

57.9

15293

33.1

INDIA

1424

15.1

15064

7

AUSTRALIA

1244

38.6

12182

7.2

ITALY

821

-56.2

27340

1.9

SPAIN

820

-45

20286

1

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(18 per cent), Lupin (15 per cent) outpacing the market for the month while among the 1120 companies, Aristo (17 per cent), Glenmark (16 per cent), USV (11 per cent), Micro (15 per cent) and IPCA (13 per cent) grew faster than the market.

Among top 25 companies, Sun Pharma maintained its top position in the IPM with a market share of 7.84 per cent and 11.4 per cent growth, Intas gained two ranks and moved to 10th rank for the month while, Zydus and Novartis gained one rank each and moved to eighth and 15th rank respectively vis-Ã -vis August 2016.

Domestic companies continued to dominate the market with a 79 per cent share in September 2016 with a growth of 11 per cent. MNCs on the other hand reflected a growth of 6.5 per cent for the month, after reaching a six month high growth of 12.5 per cent in August. Large MNCs like Abbott, GSK and Pfizer which contributed almost 57 per cent of the total MNC share in the month reflected growths of 10 per cent, three per cent and one per cent respectively.

Acute therapies remained the strongest pillar of IPM with a 66 per cent contribution to the total market. After reaching a 12 month high of 20 per cent growth in August 2016, acute TAs reflected a slowdown with a 9.5 per cent growth for the month of September 2016.

Chronic TAs on the other hand outpaced acute TAs reflecting a growth of 11 per cent for the month.

Anti-infectives (AI) was by far the largest TA for the month with a revenue of `1542 crores reflecting a 10 per cent growth on the back of a good monsoon witnessed across the country.

This was an impressive performance considering 14 per cent of the portfolio impacted by the FDC ban consisted of anti infectives while it was also one

EXPRESS PHARMA

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November 1-15, 2016

MARKET

20 EXPRESS PHARMA November 1-15, 2016

TABLE 2: INDIAN COMPANIES MARKET SIZE IN THE GLOBAL MARKET All values in Million USD

Aug Month

Month Growth per cent

Aug MAT

MAT growth per cent

Indian companies market size

3160

11.2

36712

7.1

SUN PHARMA

448

15

5264

5.2

LUPIN

335

37

3874

20.8

DR REDDYS LAB

239

-4.1

3073

-3

CIPLA

177

22.7

1815

8.9

ZYDUS CADILA

176

3.7

2052

-2.3

TORRENT

174

11.1

1939

8

AUROBINDO

156

0.9

2269

3.9

GLENMARK PHARM

152

11

1760

5.9

INTAS

122

-8

1745

13.7

ALKEM

110

23.5

1103

11.8

MANKIND PHARMA

107

17.4

1115

13.9

MACLEODS PHARMA

97

27.2

999

10.7

Acute and Chronic Therapy Trends Growth (%)

25

IPM

Top 5 TC 4s

Acute

Chronic

20 15 10 5 Oct’15

Nov’15

Dec’16

Growth (%)

Jan’16

26

Feb’16

March’16

16

184

Value (Rs Crs)

DPP4 INHIBITOR AND COMB.

April’16

May’16

Jun’16

19

July’16

Aug’16

12

Sept’16

16

181

158

150

COUGH PREP. ETHICALS

GLIMEPIRIDE+METFORM.

FOOD SUPPLEMENTS

121

cent growth for the month.

Among chronic TAs, anti-diabetic, urology and neurology were among the fast growing TAs, growing at 17, 11 and 10 per cent for the month respectively.

DPP4 inhibitors driven by teneligliptin and the unprecedented number of players it has got into the market and glim+ met formulations spearheaded growth for the AD market. In the neurology space, Levetiracetam continued to be the fastest growing molecule in neuro psychiatry for the month clocking a value of `43 crores with a growth of 20 per cent in September 2016. Betahistine & Escitalopram + Clonazepam found place among the fastest growing CNS molecules for the month with a growth of 14 per cent and 13 per cent respectively.

In terms of new introductions (NI 24 months) which played a crucial role in growth of the IPM, Glenmark had the highest number of NIs (four) among the top 25 NIs in the industry, followed by Macleods (three), J&J, MSD & Hamdard with two NIs each featuring among the top 25.

INTER.-ACTING+FAST ACTING

Global (August 2016) Value (Rs. Crs)

Top 3 Cos. in TC4

of the largest TAs to be affected by the NLEM notification. Top 10 anti-infective molecules reflected an average growth of 16 per cent for the month with Amoxyclav liquids, Cefpodoxime, Meropenem & Cefixime + Oflox combination reflecting superlative growth of 25 per cent, 20 per cent, 19 per cent and 17 per cent respectively.

Cardiac TA maintained its number two position in IPM by a whisker beating GI with a value of `1103 crores for the month of September 16 growing at six per cent. The TA was driven by Rosuvastatin (11 per cent growth), Amlodipine+ Telmisartan (13 per cent gwth) and olmesartan (10 per cent gwth). Telmisartan which recently came under price control reflected a -2 per cent growth for the month.

Gastrointestinals continued to be the third largest TA for the month garnering a revenue of `1064 crores with a growth of eight per cent. PPIs and their combination with Domperidone reflected strong double digit growth. Rabeprazole + Domperidone, Pantoprazole + Domperidone and ranitidine were among the fastest growing molecules with a growth of 11 per cent, 10 per cent and 17 per cent respectively. Lactulose reflected a healthy 31 per cent growth for the month clocking a value of `29 crores.

Respiratory was the fourth largest TA for the month maintaining its rank gain and clocked an 18 per cent growth over SPLY. Cough preparations, Levosalbutamol combinations, Budesonide and Levocetirizine were among the fastest growing categories in the respiratory space reflecting growth of 16 per cent, 95 per cent, 26 per cent and 23 per cent respectively.

Dermatology was one of the fastest growing TAs for the month registering a growth of 15 per cent SPLY with a value of `691 crores. Anti- fungals reflected a good pick up during the monsoon season with top molecules like Itraconazole, Terbinafine & Clortimazole growing at 126 per cent, 26 per cent and 17 per cent respectively. Emollients continued to be the largest category within dermatology reflecting a 14 per

45

MSD*

NOVARTIS*

USV

Value (Rs. Crs)

33

23

GLENMARK

18

WOCKHARDT *

22

Value (Rs. Crs)

APEX

21

ABBOTT*

ELI LILLY

LUPIN LIMITED

17

ABBOTT*

20

SUN*

15

SUN*

18

11

ABBOTT*

34

USV

Value (Rs. Crs)

Value (Rs. Crs)

84

21

BIOCON 6

Acute therapies continue to dominate the market constituting 66% of the IPM The top TC4 in the IPM is DPP4 Inhibitor & Comb with the a value growth of 26%

Therapy Trends Value (Rs Crs)

CARDIAC

1,103

11

1,064

10

Respiratory

852

8

Pain / Analgesics

843

8

Anti Diabetic

832

8

Neuro / CNS Gynaec.

-2 8

-4 18

190

2

Hormones

168

2

Urology

167

2

VACCINES

156

2

-1

9

0 15

0

10

0

4

5

485

Ophthal / Otologicals

-1 17

6

590

-1

10

7

691

-4

6

8

803

Derma

-2

10

15

Gastro Intestinal

Vitamins / Minerals / Nutrients

10

100

1,542

Anti-infectives

Gwth% (Prev. Month)

Gwth % (SPLY)

MS % 10,278

IPM

-1 10

1

8

0 11

-2

The global pharma market is valued at $957 billion growing at one per cent, the US being the market leader with 47 per cent share and growth of five per cent.

Amongst the top 15 market, India is ranked 10th and growing at 15 per cent for the month of August and seven per cent in the MAT year ending August 2016.

Indian companies holds 4.3 per cent share in the global market and growing faster than the global market. The share of Indian companies has grown due to higher demand generation in India on account of rainy season. Amongst the top five Indian companies, Lupin is growing at 37 per cent while Cipla at 23 per cent and Sun Pharma at 15 per cent respectively in the month of August.

-2

-9

• Anti-infectives and Cardiac therapy continue to constitute the largest market share in IPM occupying 15% & 11% resp.

• Respiratory & Anti Diabetics registered growth of around 18% and 17% respectively for the same period last year

(IMS Health is a leading global information and technology services company providing endto-end solutions to the life sciences and healthcare industry)

EVENT BRIEF NOVEMBER-2016 TO FEBRUARY-2017 17

CPhI Preconnect- Day Zero

21

CPhI and P-MEC India

16

IPC Expo 2016

CPHI PRECONNECT- DAY ZERO Date: November 17, 2016 Venue: Mumbai Description: CPhI’s Pre Connect Congress will bring together thought leaders under one roof to discuss on the latest trends and advancements in the Indian pharma industry.

Discussions will be held on key topics such as M&A, regulatory challenges, drug discovery and other critical topics which are a burning issue in the pharma industry.

Contact: E: sean.palanna@ubm.com T: 91-22-61727072

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 latest trends and innovations the market has to offer. CPhI India is also co-located with PMEC 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

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Fax: +91 22 61727273

with national and international participation.

IPC EXPO 2016

Contact details University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh-530003 Ph: 0891 2526143 Mob: 7036164555 Email: loc@68ipc.com Website: www.68ipc.com

Date: December 16-18, 2016 Venue: Visakhapatnam The 68th Indian Pharmaceutical Congress (IPC) will host IPC Expo 2016, which will be jointly organised by the Indian Pharmaceutical Association (IPA) and Orbit Exhibitions.

The expo will see a congregation of business delegates from all parts of the world. Visakhapatnam, the upcoming pharma hub will host the fair under the patronage of N Chandrababu Naidu, Chief Minister, Andhra Pradesh.

With India’s new initiative of ‘Make in India’ campaign, the show will witness a huge boost

INDIA PHARMA 2017 Date: February 9-11, 2017 Venue: Bangalore International Exhibition Centre, Bengaluru Summary: India Pharma 2017, an international exhibition and conference on pharmaceutical

9

India Pharma 2017

industry is a joint initiative of Department of Pharmaceuticals, Government of India and Federation of Indian Chambers of Commerce & Industry (FICCI). It will provide a common platform where all the participants will get an opportunity to enhance their brand value by displaying their product and the capabilities among the conference delegates and business visitors provided by the event.

India Pharma 2017 will cover all the sectors of the pharmaceutical industry starting from finished formulations, APIs, biopharmaveuticals, fine chemicals and intermediates, natural extracts, excipients and many more.

Latest pharmaceutical machinery, plants, laboratory equipment, analytical instrument and cleanroom equipment will be showcased.

Contact details Kamal Bhardwaj Deputy Director Mob: 9899392930 Email: kamal.bhardwaj@ ficci.com Federation of Indian Chambers of Commerce & Industry (FICCI) Federation House, Tansen Marg, New Delhi 110001

EXPRESS PHARMA

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November 1-15, 2016

cover )

22 EXPRESS PHARMA November 1-15, 2016

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T

A MILESTONE IN THE MAKING Telangana’s proposed Pharma City will take the country’s pharma industry to the next level

BY PRATHIBA RAJU

he 29th state of India, Telangana, formed in the year 2014, is striving hard to make its mark globally by developing a world class Pharma City, located 70 kms from the city of Hyderabad. Spread across a sprawling 12,000 acres of land, the proposed ‘Pharma City’ is gradually taking its shape in Rangareddy and Mahbubnagar districts. Industry experts believe that the largest integrated industrial ‘Pharma City’ is going to be a milestone in the Indian pharmaceutical industry.

Department of Industrial Policy and Promotion (DIPP), Union Ministry of Commerce and Industry, has also accorded in-principle approval for setting up of National Investment Manufacturing Zone (NIMZ) for the proposed Pharma City. The government aims to build a sustainable ecosystem where pharma players across the value chain — intermediates/bulk drug manufacturers to pharma formulations players, biotechnology players to R&D labs and education institutes — are likely to co-exist, enabling faster collaboration and evolution of the industry as a whole.

Pharma calling Hyderabad is well known as the bulk drugs capital of India, which accounts for almost 20 per cent of pharma exports from the country and is now providing an impetus to the pharma industry by its proposed Pharma City project.

The industry-friendly hub is likely to attract new investments in manufacturing and allied segments of the pharma industry.

“Hyderabad has been the bulk drugs capital of the country accommodating over 400 pharma companies and 173 bulk drug units spread all over the state. We would like to further enhance the pharma sector by setting up the mega ‘Pharma Çity,’ which can translate research capabilities into

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commercially viable products and contribute to the global pharma industry. The region has been blessed with diverse resources waiting to be tapped and we are making it possible,” said KT Rama Rao, Industries and IT Minister, Telangana.

(Read exclusive interview ‘Telangana Pharma City: An investors’ paradise’ on pages 27-28) The proposed Pharma City will have components and other related activities with regards to antibiotics, fermentation products, synthetic drugs, large volume chemical synthesis, intermediaries, vitamins, vaccines, drug formulations, nutraceuticals, herbal medicinal products, speciality chemicals. Also, it will have a R&D incubation centre, central testing facilities facilitating clinical trials, testing and certification, contract research and custom synthesis.

“Developing the largest integrated industrial city, keeping a focus exclusively on pharma and biotechnology products, is an exciting task,” Rao informed.

Rao further said, “The ‘Pharma City’ will have worldclass facilities with state-ofthe-art infrastructure. Discharged polluted water will be brought to zero discharge level from common effluent treatment plants, which will be set up in the proposed ‘Pharma City.’ It will be built according to international standards.”

According to KPMG report, in recent times, India is facing stiff competition from countries like China, especially in intermediates and API business. For India, to maintain its dominant position in the global generics market, there is a need for continuous investment to scale up manufacturing capabilities. The proposed Pharma City will help India to become more cost competitive in the international market.

“The proposed Pharma City would help to adopt new technologies along with worldclass infrastructure. It would focus on R&D, which can help

EXPRESS PHARMA

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November 1-15, 2016

cover ) India move up the value chain to manufacture complex products. Products worth $129 billion will lose their patents during 2016–20 with most of them belonging to therapeutic areas that require complex manufacturing processes, such as oncology (27 per cent), immunology (20 per cent) and cardiovascular (19 per cent). In this aspect, various provisions under the proposed Pharma City is likely to provide an environment where R&D and process innovation may support manufacturing of these complex products in India. It will help India gain a share in the complex formulations market as well,” said Utkarsh Palnitkar, Head – Lifesciences, KPMG India.

India, being the largest supplier of cost-effective generic medicines to the developed world, is on its path of becoming a leader in pharma exports.

With a widest range of benefits, be in terms of labour cost, R&D cost or scientific manpower, India offers myriad opportunities for growth. Hubs like Pharma City are always welcome and will be an added benefit to the industry. The integrated approach where industry, R&D centres, academia and startups could work together, the proposed Pharma City project is expected to help India become capable in manufacturing complex products, allowing growth in exports. It will also fulfill domestic demands.

Informing about the upcoming Pharma City as a major attraction, Jaiprakash S Vastrad, Sr General Manager – Pharmacy, Sagar Hospitals said, “Any state that supports the pharma sector will witness a decent growth in its economy.

At a time, when most of the investments are directed towards the IT sector, Telangana, by developing the Pharma City has put things on the right track to attract more investments in the sector. Definitely, it has a huge growth potential and hence will contribute to the healthy economy of the state.

He further said, “Telangana has already carved a niche for itself by being one of the lead-

24 EXPRESS PHARMA November 1-15, 2016

Pharma city will be a world class facility with state-of-the-art infrastructure. It will be built on par with international standards.

This will be a new benchmark made by the state in the pharma industry KT Rama Rao Telangana Industries and IT Minister

The proposed project is expected to provide shared infrastructure and utilities to SMEs and this would help them reduce their overhead costs and become cost competitive in near future, while providing access to world class infrastructure

Telangana, by developing the pharma city, has put its right foot forward to attract investments in the sector which has a definite growth potential and hence it would contribute to the healthy economy of the state

Utkarsh Palnitkar

Jaiprakash S Vastrad

Head – Lifesciences, KPMG India

Sr General Manager – Pharmacy, Sagar Hospitals

IMPORTANT FEATURES OFA PHARMA CITY PHYSICAL INFRASTRUCTURE: For the smooth functioning of Pharma City, one needs to ensure adequate all-weather road network, captive power plant, power distribution network, electrical sub-stations and power feeders, effluent conveyance system, water overhead tanks, water reservoir and tanks, fresh and recycled water pipelines, steam pipelines, common solvent recovery plant, etc.

ENVIRONMENTAL INFRASTRUCTURE: Pharma City should be eco-friendly, one must include facilities like water treatment plant, common effluent treatment plant with three-stage treatment, solid waste management, including a hazardous waste management centre, incinerator and a central environment management centre.

CIVIL INFRASTRUCTURE: The pharma hub should require a common

R&D facility, quality certification lab, material testing lab, administrative block, office space, fire control station, banks and ATMs, telephone and broadband connectivity centres, a guest house, etc.

ACADEMIA INFRASTRUCTURE: A steady flow of relevantly trained skilled manpower would require schools, universities, community housing, a hospital, shopping centres and training centres.

LOGISTICS INFRASTRUCTURE: Common logistics centre with container terminal need to be appropriately planned to ensure that pharma products reach domestic buyers and export points, such as ports and airports. Airport and railway connectivity is of paramount importance for the success of a pharma city.

Source : KPMG

ing suppliers of bulk drugs of highest quality. At a time when Government of India's new policies are attracting a lot of MNCs to set up their manufacturing facilities in India, Telangana's proposed Pharma City, which promises good infrastructure, has been able to attract several MNCs, who have expressed their interest in setting up their manufacturing facilities over here. Quality infrastructure, friendly government policies and proximity to major bulk drug suppliers will definitely attract investors in the pharma sector.”

Operating in a conducive ecosystem like that of a 'Pharma City' will be beneficial for large and small scale manufacturers, both in terms of scale and efficiency, opined manufacturers.

Ground for growth According to Palnitkar, small and medium pharma companies are major players in the Indian pharma industry, which contribute approximately 48 per cent of the country’s pharma exports. He further mentioned that the Indian pharma industry is fragmented. Strict regulations, financial crisis, high competition from existing and other lowcost nations make it extremely difficult for SME players to scale up.

“This project is expected to provide shared infrastructure and utilities to SMEs and this would help them reduce their overhead costs and become cost competitive in the near future, while providing access to world class infrastructure. It is also expected to support big pharma companies to establish large manufacturing base, to compete against dominant players from countries like China, and help them achieve economies of scale to become cost competitive in the export market,” he added.

According to experts, the proposed Pharma City should also focus to develop an SME centre, which will help small and medium-sized pharma companies with infrastructural

( support. Common infrastructural facilities will help SMEs share the cost and remain costcompetitive in the market. Further, to encourage innovation in the industry, it could develop adequate incubation support centres for start ups.

Alluring investors As per an official in Telangana State Industrial Infrastructure Corporation (TSIIC), many big pharma companies, both national and international, who have their headquarters in different parts of the country, are showing interest in opening their units in the upcoming Pharma City, even though it is yet to start operations.

“Several companies from the US, Canada, France and Germany, besides some Indian companies, have submitted applications seeking land allotment in the proposed Pharma City, amounting to 8000 acres.

With an increasing demand, we are on a full swing to expedite the land acquisition process, so that the project can be developed at the earliest,” a senior official from TSIIC, on condition of anonymity told Express Pharma.

A recent study by The Associated Chambers of Commerce and Industry of India (ASSOCHAM) and global professional services organisation EY, said that the production cost of pharma products in India is around 30 per cent cheaper than that in the US, while the cost of developing a generic drug is about 50 per cent cheaper. Hence, MNCs are making a beeline for Indian companies in order to gain access to generic drugs being developed by the latter for the US market.

The officials also noted that they were optimistic about top pharma companies setting up shop in the proposed Pharma City, but never expected the demand to be so high at an early stage.

“We have issued tenders to prepare a master plan for the development of the Pharma City. Though several top-notch international and national

THE MAIN FOCUS

DIFFERENT PARAMETERS OF PHARMA HUBS Parameters

Proposed Telangana Pharma City

Baddi Industrial Area

Jawaharlal Nehru Pharma City

Area (in acres)

12500

395

2399

Vicinity to nearest sea port

500km (establishment of dry port ?multi modal logistic park at Jadcherla in future)

1,200km

20km

Nearest airport

35km (Hyderabad)

45km (Chandigarh)

20km (Visakhapatnam)

Presence of drug regulatory body centre

Yes

No

No

Presence of common infrastructural facilities

Yes

No

Yes (CETP, Hazardous waste management plant)

Power distribution centres

Yes

Yes

Yes

Presence of relevant educational institutes

Yes

No

No

Exclusive pharma focus

Yes

No

Yes

Social infrastructure

Yes

Yes

Yes

Customs, excise and income tax incentives

Yes

Yes (expiring in 2020)

Yes

NIMZ status

Yes

No

No

Encouragement for innovation

Yes

No

No

Source : KPMG

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THE PROPOSED PHARMA CITY INTEGRATED PHYSICAL AND SOCIAL INFRASTRUCTURE ◗ External road, rail, water, power linkages . ◗ Well developed plots with all utility linkages - steam, fresh water, recycled water, wastewater conveyance, power etc ◗ Integrated Environment Management Infrastructure: CETP, STP, solid waste management facility including hazardous waste management, green belts for odour management and pollution control ◗ Technical infrastructure: Environmental management cell, quality certification lab, material testing lab ◗ Pharma university ◗ Integrated township with housing and allied social infrastructure

Source : TSIIC

EXPRESS PHARMA

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November 1-15, 2016

cover ) firms have submitted bids to develop the hub, Singaporebased Surbana Jurong, was shortlisted,” Rao added.

Officials said that while a few companies from the US

have submitted applications to purchase land in the proposed Pharma City, nearly a dozen firms from Germany, France, Switzerland, Canada etc., besides some Indian firms, have

already sought land.

In an official statement, multinational pharma company Jlabs has informed that they are exploring the possibility to set up a unit in Hyderabad.

Merck has also expressed its interest to set up a vaccine centre of excellence in Hyderabad, which will impart skill training based on specific requirements by the companies.

● Employment potential : ● Investment potential: ● Export potential:

● Hyderabad Pharma NIMZ proposed over 13,030 acres (52.73 sq.km) of land within the 18,411 acres (74.51 sq.km) of contiguous land proposed Hyderabad Pharma City project. ● To become ‘Asia’s Biggest Project”

26 EXPRESS PHARMA November 1-15, 2016

being cost competitive. At this juncture, both the aspects are critical for the Indian pharma industry. India can potentially use its cost-competitive manufacturing capability and de-

3.25 lakhs (1.3 lakhs direct employment) ` 64,000 cr ` 58,000 cr

The Telangana government has asked the Industries Department to be in constant touch with these companies and forward their proposals.

The department has been asked to expedite the creation of infrastructural facilities in the Pharma City like water, power, internal roads etc.

“With the completion of the proposed Pharma City, Hyderabad will become an important centre for contract manufacturing of pharma products.

Pharma marketing companies, which procure their products by third party manufacturing agreements, are now largely dependent on manufacturing facilities in Himachal Pradesh and other northern states of India. The Telengana Pharma City is the first-of-its-kind in South India. Once fully operational, it would reduce this dependency,” Vastrad informed.

Experts cite that big-scale pharma hubs, like Pharma City, are likely to help manufacturers become innovative while

velop a strong R&D ecosystem using such pharma hubs to stay competitive in the mid to long term.

The US FDA in a written communication recently stated that the proposed Pharma Çity near Hyderabad can be the first of the international clusters it seeks to link scientific and medical advances from across the globe for better healthcare.

Telangana aims to help pharma companies become more cost-competitive against global players, while bolstering manufacturing activities in the sector. This approach offers an effective and sustainable strategy for enabling quality and productivity at a single set-up, which is need of the hour. With a perfect blend of policy, latest facilities, eco friendly and pollution-free clime, the pharma city is on the threshold of becoming a pharma hub not just of the country , but of the world. prathiba.raju@expressindia.com

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E X C L U S I V E

TELANGANA PHARMA CITY

An investors’ paradise Kalvakuntla Taraka Rama Rao (KTR), Minister of Industries and Commerce, IT and Urban Development, Government of Telangana, in an interaction with Prathiba Raju, elucidates on how Telangana’s upcoming Pharma City will be a major boost for the Indian pharma industry

The Telangana government has listed pharmaceuticals as the top two priority sectors in its recently announced industrial policy. What are the reasons behind this?

Telangana has 14 industrial thrust areas. For the city of Hyderabad, we have three important industries, number one being the pharma, second comes the Information Technology (IT) and third is the aerospace division. The reason why I put pharma in number one position is because, in this sector, Hyderabad is the capital of the entire life sciences industry — be it bulk drugs, chemicals or vaccines. The entire gamut of pharma is present in Hyderabad, for example more than one fifth of global vaccines are manufactured here and when it comes to pharmaceuticals, this city is where the core action is taking place. Today, a large number of pharma companies in the country, Dr Reddy's Laboratories, Aurobindo Pharma, Mylan and Hy-Gro

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Chemicals Pharmtek, are based out of Hyderabad. We are proud of what the pharma industry has contributed to the city. That is the main reason why the government wants to make sure that we build a world class Pharma City in Telangana.

What is the current status of Telangana Pharma City?

We have already started the land acquisition process.

Acquiring land after Land Acquisition Act 2013 has definitely been a difficult task, but fortunately we have completed acquiring 6000 acres and we are in the process of acquiring about 7000 to 8000 acres more. We are confident enough that it will happen on time. Pharma City will be a complete state-of-theart world class facility. Master planning for this has been done by a Singapore-based company, Surbana Jurong. It is an infrastructure company, which takes up housing programmes in Singapore and provides

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cover ) infrastructure and public services. They have also developed many pharma parks across the world.

What are the unique features of this pharma city and how does it differ from many other existing pharma hubs ?

The government is focused to build a Pharma City, which will have zero liquid discharge and state-of-the-art solid waste discharge. So, developing such a huge expanse of a full-fledged Pharma City is an exciting opportunity for us. We are looking forward to it with a great deal of optimism. Our government believes that it will take the Indian pharma industry to the next level. Apart from it, we are also into setting up a medical devices park and two electronic manufacturing clusters (EMC). Our government is focusing upon the medical devices park, electronic clusters and Pharma City, adding to it the Genome Valley. Hence, the whole combination and intersection of pharma, technology and lifesciences is prodigious. Soon, Hyderabad will be the digital healthcare capital of the country.

Your government has been taking unique initiatives to attract investors for the pharma city like road shows in the US. How do you work on this?

Being a new state, we are very upbeat and agile. We call ourselves the start-up state of India, think and act like a startup. When it comes to promotion of our state, be it pharma or other sectors, we take innovative steps and reach out in a different way towards the bigwigs of the industry. As part of our promotion, our core areas where we are seeking investments would be pharma, healthcare, IT, aerospace and defence. Our strategy is to set up agencies in various parts of the world like two in North America, one each in the Middle East and Europe, the Far East and also possibly in Japan and Korea. The idea of setting up such a country desk

28 EXPRESS PHARMA November 1-15, 2016

In 2018, the first phase will be coming alive and the second phase will be completed by 2020. With its full capacity, Pharma City will be employing 1.5 million people directly and indirectly is to promote and seek investment. For example, if I need investment in pharma, then my destination would be Europe, Singapore. Studies can be undertaken about the common effluent treatment plants and also seek large scale expertise and get investment opportunities from those countries. Thus, each of our country desk will be given a focus area and a task. This is how it is designed and strategised. We are also looking to tie up with different consultants for the same in North America, it could be McKinsey or EY. This will ensure that Telangana's presence is felt across the world.

You have been asking for ` 1500 crore from the central government for the Pharma City. What is the centre's response on the same?

We sought the help of the Union Government to set up common effluent treatment plants. The government has come forward to help us and offer some support. However, we are not entirely dependent on the central government 's help. Our government is exploring options and looking out for Public Private Partnerships (PPP). In fact, we are talking to several large scale agencies which are engaged in such activities and many of them are interested. Our first round of discussions is already complete, so it will be a state and private sector partnership

Our government believes that it will take the Indian pharma industry to the next level

which will enable us in this task.

How much will be invested into the common effluent treatment plants, the main component of the pharma city?

Hyderabad pharma city has a total discharge capacity of 250 MLD. So, our effluent treatment plants should cater to it. However, it will be built in phases and not in one go. These will be built in three or four phases, each MLD will cost about `10-15 crores.

Why are investors attracted towards Telangana?

The very first thing is the vision of our Chief Minister, KC Chandrasekar Rao, who asks us not only to focus on a specific sector, but also its various sub sectors. Carrying forward his vision, Telangana is the first state in the country which has

come out with ten sub sectoral policies viz innovation, rural technology policies. These policies give lucid details on what to do, how to approach. In India, unless government backs it up with policies and legislation, things will not move.

Therefore, our government is in the forefront of making progressive policies. Secondly, when it comes to ease, scale and quality of doing business, definitely Telangana is creating a new benchmark. Thirdly, Hyderabad is a cosmopolitan city with a large pool of human resources, good weather condition, availability of land, water and power, which naturally makes it an attractive composition. Adding to it, good governance and progressive policies make Hyderabad a perfect combination for investors.

Your comments on the 'Make in India' initiative?

As of now', we import 17 per cent of our requirement, which needs to change. We should not Make in India for India but make it for other countries. The country should transform into an export hub because China is getting more and more expensive especially in labour costs. India is sitting on the cusp of á big opportunity as the workforce in India which is 64 per cent will keep growing and it will be the biggest in the world by 2020. The country can achieve excellence in manufacturing. ‘Make in India’ is a fantastic initiative. But the

central government has to take more efforts and pull in different states, which are progressive into this process, or else things cannot deliver as quickly as expected.

When will the ‘Pharma City’ be functional? In next five years, how will it reshape the pharma industry in the country?

In 2018, the first phase will come up and the second phase should be completed by 2020.

With its full capacity, it will be employing 1.5 million people directly and indirectly. This world-class facility will be a new benchmark in the country and will ease the process of setting up a pharma unit. Usually, there are challenges like environment clearances, public hearing and hurdles with US FDA clearances. Hence, if someone is looking to set up an enterprise in the pharma city, they shouldn't need to get an environment clearance, as we have that for the whole facility and no need for a public hearing because the whole pharma city would be owned and run by the state itself. The US FDA will have a office inside the pharma city for easy access.

Apart from it there will be a pharma university inside the facility. With human resources, exports, environment clearance and effluent treatments taken care of, the pharma city will be an investors' paradise. prathiba.raju@expressindia.com

MANAGEMENT

Paradigm shift in consumer healthcare practices in India As consumers are becoming more imperative, effective brand strategies to work alongside traditional pharma marketing tools that are more centred on doctors are devised. An insight by Sreedevi Yallamrazu, Business Manager, CubeX

W

ith a rapidly evolving self-medication landscape in India, CubeX – a division of Sorento Healthcare Communications, Nicholas Hall’s Network Partner in India – has revisited its highly popular Mirror OTC Report 2006, with the latest allencompassing version tracking the changing trends over the last 10 years. Through 920 faceto-face interviews, the 2016 edi-

tion has deciphered the beliefs and practices of consumers, doctors and chemists in order to provide a fresh outlook and attainable strategies for pharma marketers in India.

The team at CubeX outline the key findings in this article.

Consumers: Evolving trends in health behaviour “May you cure sometimes, treat often, comfort always” is a piece of advice Hippocrates shared for healthcare professionals in the 4th century BC and it still holds relevance in the information age. The digital revolution

has led to the emergence of Dr Google as a key healthcare influencer and the “zero moment of truth” – a term coined by Google where a consumer becomes aware of a brand through online communication.

Over time consumers’ circle of influence has expanded beyond the traditional point of care, the family physician, to include multiple touch points for varying needs ranging from infor-

mation to healthcare solutions and even compliance enhancing tools such as smartphone apps.

This has empowered ‘patients’ with sufficient knowledge to self-medicate to assume the role of “active consumers,” especially for common ailments where they can bank on the trust and endorsement of brands by healthcare professionals. In this context, knowing the consumer is becoming imperative in devising effective brand strategies to work alongside traditional pharma marketing tools that are more centred on doctors.

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common ailments, believing that buying medicines OTC helps to save time and money.

This indicates immense potential to drive consumption of deemed OTC brands not included in Schedule H and X that can be advertised to consumers. The role of digital – and the rise of smartphones – is evident in this shift. Consumers are seeking answers to their health problems with

Self-medication doubles Self-medication rates have almost doubled in the last ten years – 23 per cent of interviewed consumers reported that they self-medicate in 2006 vs 41 per cent in 2016 – and is likely to continue increasing at a rapid pace. For common illnesses such as pain, cough and cold and indigestion, self-medication is the primary treatment approach and consumers tend to recycle older prescriptions or recall a previously prescribed brand.

Where possible, they also try to avoid doctor visits for

minimal intervention from healthcare professionals.

Health-related websites, many of which are written in consumers’ language, help to impart confidence in understanding their health better and at leisure, which is not always possible with physicians.

Chemists used for validation In the process of going digital, the role of chemists – a major touch point for consumers ten years ago – is being challenged.

Chemists are no longer seen as an advocate empowered with

brand information to engage with consumers. Rather than seeking a brand recommendation from chemists, consumers now turn to them to validate the brand choices they have already made.

However, chemists are also expected to provide general advice about a medicine, such as contraindications and possible side-effects.

Natural ingredients preferred More than 50 per cent of consumers report to opt for natural ingredients, which are perceived to be safer than allopathic rivals. As a result, brands such as Eno (GSK), Kayam Churna (Sheth Brothers) and Dabur Chyawanprash (Dabur), which contain natural ingredients in convenient formats, continue to be popular with consumers.

Additionally, for some ailments – such as insomnia and anxiety – consumers are unaware of how to seek appropriate solutions owing to many concerns. A lack of awareness of a condition might mean a sufferer dismisses symptoms as general stress, or there may be a social stigma associated with visiting a therapist. Often in these instances, natural solutions are preferred to lower the risk of dependence. As the awareness of the importance of good health increases, consumers are shifting their priorities from treating illness to maintaining wellness, for which sustainable natural solutions are sought.

HCPs still important for child illnesses Parents exhibit different be-

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MANAGEMENT haviour when their child is ill, with the key objective to get the right diagnosis and treatment so that the child can return to normalcy as quickly as possible. Doctors are the most influential healthcare advisors in this case with the majority of mothers responding that they prefer taking a doctor’s advice.

However, in terms of children’s wellness needs, friends, family and the media are major influences.

Marketers: Identify winning strategies Almost 60 per cent of India’s $2.6 billion OTC market consists of deemed OTCs according to Nicholas Hall’s DB6 Global OTC Database. Yet pharma companies are still skeptical of promotional switches despite possessing many heritage brands and the need for such products as selfmedication continues to take precedence. The key is to identify opportunities to strategically engage with stakeholders.

Promotional switches enjoy strong equity HCPs are more supportive of OTCs when they are still pro-

moted to them or, even better, they are given the choice of a superior brand to prescribe.

This can be seen in the case of Novartis’ Otrivin nasal decongestant (now a GSK brand), where Otrivin is promoted to consumers and sister product Otrinoz was launched to be promoted to doctors only. In these examples there may not necessarily be any difference in efficacy – although Otrinoz has the additional ingredient sorbitol that lines the mucous membrane to avoid irritation – but the strategy helps to appease doctors and consumers alike. Indeed, over 40 per cent of doctors agree to continue prescribing a brand if it is also promoted to them or an alternative product is offered.

It is no accident that brands which continue to be promoted to doctors, such as Volini (Sun Pharma), Digene (Abbott) and Ostocalcium (GSK), feature among the products with the highest top-of-mind recall. However, doctors believe that marketers should also provide complete information in A+P to promote the brands responsibly.

Responsible education and engagement Consumer education through digital education is crucial as healthcare brands need to have more than just a social media presence. A brand that can help consumers to make healthcare choices – either self-medication or to seek professional help at the right time – will stand to enjoy long-term success in an intensely competitive environment. This will also promote responsible self medication, a key concern of HCPs and regulators.

Additionally, while TV continues to be the lead awareness medium, consumers are actively seeking more information through packaging and digital media, meaning marketers may need to rethink conventional resource allocations.

Leverage HCPs’ equity to build trust A key deciding factor for consumers choosing a brand while self-medicating can be a doctor’s influence owing to wariness of side-effects of allopathic medicines. Building on a brand’s doctor equity to pro-

vide professional advocacy and communicate the safety profile of OTCs will further reinforce consumers’ belief in the benefits of these products. It will also be important to identify innovative line extensions of the brand exclusively for HCPs.

Re-strategise chemist engagement methods Marketers need to re-strategise their chemist engagement strategies in light of consumers’ increasing confidence to self-medicate. Chemists tend to use other patients’ experiences to convince potential new consumers about a product. It may therefore be beneficial to share brands’ success stories with chemists to enable them to assure new users. It would also be favourable to empower chemists with brand / therapy information that would be relevant in the context of different consumer profiles that they encounter to engage more effectively.

Explore virgin opportunities Marketers can also leverage the growing self-medication

trend in emerging categories, such as sleeps aids and eye care. Consumers are not as aware of how to treat these conditions or are seeking natural alternatives to allopathic medicines, which represent virgin opportunities for marketers. Within existing categories, increasing usage occasions and purchase touch points are also becoming critical to stand out from rivals and expand the consumer base further.

Prospects It is time for marketers to embrace change and pave the way for Rx brands in the OTC space. Some of the recent promotional switches such as VWash (Glenmark), Benadryl (J&J), Dulcoflex (Boehringer Ingelheim) and Nicotex (Cipla) have overcome various barriers and are reaping success with renewed vigour in the Indian OTC market.

(CubeX is the Strategic Consulting and Business Intelligence division of Sorento Healthcare Communications)

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RESEARCH UPDATES

Tesaro’s ovarian cancer drug benefits all patients in study Tesaro hopes to show its drug can work across the entire population of women needing maintenance therapy for ovarian cancer after being given platinum-based chemotherapy esaros experimental drug niraparib improved outcomes for all women with recurrent ovarian cancer in a clinical study, boosting prospects for the product, part of a

T

by the drug because of their genetic profile saw a benefit of 3.1 months, researchers told the meeting. Niraparib and other PARP inhibitors block enzymes involved in repairing damaged

closely watched class of new medicines called PARP inhibitors. The finding suggests that a Myriad Genetics companion diagnostic test, designed to select suitable patients, may not be necessary. US biotech company Tesaro already cheered investors in June by saying that the study had met the main goal of prolonging survival without disease worsening, but full results were only reported at the annual European Society for Medical Oncology congress in Copenhagen.

The treatment helped patients live longer without their disease progressing. Even those least likely to be helped

DNA, thereby helping to kill cancer cells. AstraZeneca’’s Lynparza became first of the new class of drug to reach the market when it won US approval at the end of 2014, but it was only cleared for patients whose cancer tested positive for defective BRCA genes. Tesaro hopes to show its drug can work across the entire population of women needing maintenance therapy for ovarian cancer after being given platinum-based chemotherapy.

Study leader Mansoor Raza Mirza of Copenhagen University believes that case has now been made. “Our conclusion is that all patients have a

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benefit and all patients must be treated,” he told reporters at the meeting. “This is a breakthrough for patients with ovarian cancer. We have never seen such large benefits in progression-free survival (PFS) in recurrent ovarian cancer.” The latest findings showed that various patient populations all responded, with the biggest median PFS of 15.5 months seen in the BRCA mutation group.

However, even those with no BRCA mutation and who tested negative to another test called HRD, made by Myriad, still saw a benefit of 3.1 months.

There is now likely to be debate among doctors and investors as to whether this is enough for Tesaro to win very broad approval for its drug or whether it should be reserved for a narrower group of patients based on genetic testing. Mirza is convinced it should be used widely and dismissed the need for the HRD test. “You don’t need it because all patients benefit,” he said.

He estimates niraparib could benefit 70 per cent of all ovarian cancer patients, against 15 to 20 per cent who are currently deemed suited for AstraZeneca's Lynparza. Myriad’s CMO, Johnathan Lancaster, contested Mirza’s view, arguing that a treatment benefit of just over three months was modest and patient selection still made sense. Results of the study were also published online in the New England Journal of Medicine. Interest in PARP inhibitors has grown apace over the last year as drug developers try to target DNA repair mechanisms inside cells as a way to fight cancer.

Reuters

FDApanel backs Allergan’s drug for frequent nightly urination THE BENEFITS associated with Allergan experimental drug to treat frequent nightly urination outweigh the risks for certain patients, an advisory panel to the US Food and Drug Administration concluded. The panel voted 14-4 to recommend that the drug, SER120, be approved for certain patients with nocturia, defined as waking to urinate two or more times a night. The FDA is not obliged to follow its advisory panel’s recommendations, but typically does so. SER120 is a low-dose nasal version of desmopressin, a drug used to treat a variety of conditions, including diabetes insipidus, a rare disorder that causes an imbalance of water in the body.

Allergan is seeking approval to market the drug for frequent nightly urination in general. The panel recommended the FDA approve it for a narrower population of patients whose nocturia is specifically caused by an increase in total urine volume, a condition known as nocturnal polyuria. The panel made its recommendation based on a subset of patients in the clinical trial who seemed to fit the narrower criteria though the company's clinical trial was not specifically designed to test that population.

Some panelists described the drug's efficacy as modest, and only at the higher dose studied, 1.5 micrograms. They also expressed concern physicians may prescribe it indiscriminately, increasing the risk of side effects, especially in the elderly.

Desmopressin carries the risk of hyponatremia, or abnormally low sodium levels in the blood. Allergan acquired exclusive rights to develop and sell the drug in 2010 from privately held Serenity Pharmaceuticals.

Reuters

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RESEARCH

Hormonal contraception tied to increased depression risk The risk was about 120 per cent higher among those using progestin-only birth control pills HORMONAL contraception, including birth control pills or implants, may increase a woman’s odds of depression and antidepressant medication use, according to a large study of Danish women. Based on data about prescription drug use for more than one million women, researchers found that those who started using hormonal contraception were significantly more likely to subsequently get a first-time prescription for antidepressant medication, compared to women not on hormonal contraception.

For adolescent girls, starting on hormonal contraception was tied to an even greater increased risk of antidepressant use. Depending on the type of hormonal contraception, there may have also been a link to risk of being diagnosed with depression. “Such a comprehensive study on this issue hasn’t been made before,” said senior author Dr Ojvind Lidegaard, of the University of Copenhagen.

Previous studies have tried to clarify connections between contraceptive hormones and depression, Lidegaard and his colleagues write in JAMA Psychiatry, but these produced mixed results. The authors point out that the lifetime prevalence of depression is about double among women compared to men. That difference doesn’t emerge until after

puberty, though. Two female sex hormones - estrogen and progesterone - are thought to be factors in that increased risk once the reproductive years begin.

Lidegaard and his colleagues used data from the ongoing Danish Sex Hormone Register Study, which includes all women living in Denmark.

The new piece of research includes women who were ages 15 to 34 years from 2000 through 2013. Any women with a diagnosis of depression that occurred prior to 2000 were excluded from the analysis, as were women with any other major psychiatric diagnosis.

The included women were followed for around seven years each. About 55 per cent used hormonal contraception during the study period. During that time, 133,178 women were first prescribed antidepressant medications and 23,077 were first diagnosed with depression. Compared to women who didn't use hormonal contraception, those who used birth control pills were 23 per cent more likely to be prescribed an antidepressant medication for the first time during the study period.

Those using birth control pills that only contained the hormone progestin were 34 per

cent more likely to be prescribed antidepressant medications. For women using a birth control ring, the increased risk was 60 per cent and it was doubled among those using a birth control patch. These risks were also slightly higher among adolescents, the researchers found.

Compared to girls 15 to 19 years not using hormonal contraception, the researchers found an 80 per cent increased risk of being prescribed antidepressant medication for the first time among girls using birth control pills. The risk was about 120 per cent higher among those using progestin-

only birth control pills. While the overall risk of being diagnosed with depression was generally the same or lower regardless of the type of birth control women used, the researchers did find some increases in the first diagnosis of depression for women using specific types of hormonal contraception.

Lidegaard said past studies of women on hormonal contraception may not have found differences in depression treatment or diagnosis because women who experience mood changes after starting hormonal contraception often stop taking the pills and become non-users again.

The researchers caution that their findings are limited by several factors, though. For example, the fact that antidepressant medications are sometimes prescribed for reasons other than depression.

Also, depression is listed as a potential side effect of hormonal contraception, they write, so these drugs and devices might not be prescribed as often to women already at risk, which would mean the real depression risk is higher than indicated by these results.

“All women, doctors and contraception advisers should realise we have this potential side effect in the use of hormonal contraceptives,” Lidegaard said.

Reuters

Rigel’s bleeding disorder drug fails late-stage study The drug, fostamatinib, was successful in an earlier study, achieving a stable platelet response RIGEL Pharmaceuticals said its lead drug to treat a bleeding disorder failed in a second late-stage trial. Data showed that one patient receiving a placebo achieved a stable platelet response, the main

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goal of the study, indicating there was no statistical significance, the company said. The drug, fostamatinib, was successful in an earlier late-stage study, achieving a stable platelet response compared

with no response in those on placebo. Rigel is developing the drug to treat chronic immune thrombocytopenia (ITP) in which the immune system attacks and destroys the body’s own blood platelets,

resulting in bleeding. ITP patients can suffer extreme bruising, bleeding and fatigue due to low platelet count. The company, however, said on when data from both latestage studies were combined,

the patients showed a significant increase in their platelet counts within weeks of initial treatment, highlighting the potential benefit.

Reuters

RESEARCH

Anti-inflammatory pills tied to heart failure risk Not all NSAIDs carry the same risk, however WIDELY USED non-steroidal anti-inflammatory drugs (NSAIDs) are associated with an increased risk of heart failure - even in people without a history of cardiac issues, a recent study suggests. Overall, the odds of a hospital admission for heart failure was 19 percent higher for people who used NSAIDs in the previous two weeks than for individuals who didn’t take these drugs, the study found.

Not all NSAIDs carry the same risk, however. The increased odds of a heart failure hospitalisation were, for example, just 16 per cent for naproxen but 83 per cent for ketorolac. Many NSAIDs, including celecoxib (Celebrex), were tied to little or no in-

creased risk. “There is difference between the NSAIDs in risk of heart failure and higher dosages are associated with increased risk,” said Dr Gunnar H Gislason, CSO, Danish Heart Foundation and author of an editorial accompanying the study.

“NSAIDs increase risk of heart failure independent of sex or previous heart failure status,” Gislason added. “How-

ever, if you have established heart disease, heart failure or carry many cardiovascular risk factors, your risk associated with NSAID use is more pronounced – thus especially the elderly and patients with any heart condition should avoid NSAIDs,” Gislason said. While plenty of previous research has linked NSAIDs to an increased risk of heart failure, the current study sheds new light on the risk of individual drugs in this family of medicines, researchers note in The BMJ. To assess the cardiovascular safety of these medicines, researchers analysed data on 27 different NSAIDs taken by adults in the Netherlands, Italy, Germany and the UK between 1999 and 2010. The analysis in-

cluded more than 92,000 people admitted to the hospital for heart failure and a control group of more than 8.2 million similar individuals without a record of hospitalisation for this condition. A total of 16,081 people, or 17.4 per cent, with a heart failure hospitalisation were current users of NSAIDs, as were 14.4 per cent of the individuals without a this history, the study found. Nine NSAIDs

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had a significantly higher risk of heart failure for current users: ketorolac, etoricoxib, indomethacin, rofecoxib, piroxicam, diclofenac, ibuprofen, nimesulide and naproxen.

These nine drugs were associated with an increased risk of heart failure in both men and women and regardless of whether or not there was a previous heart failure diagnosis.

Current users of very high doses of diclofenac, etoricoxib, indomethacin, piroxicam and rofecoxib had more than twice the risk of heart failure than past users, the study also found. One limitation of the study is that researchers lacked data on over-thecounter NSAID users, which means some patients classified as non-users in the analysis might actually take nonprescription versions of the drugs, particularly ibuprofen, the authors note. This might understate the impact of NSAIDs on heart failure risk.

Another drawback is the potential for some heart failure admissions to be linked to other cardiovascular problems, with hospital discharge records noting a different reason for the admission, the researchers point out. Even so, the findings add to a growing body of evidence pointing to the risk of heart failure associated with NSAIDS, the authors conclude.

Patients in pain also have other options - such as acetaminophen, known as paracetamol outside the US, or a weak opiate - that don’t carry the same risk of cardiovascular disease as NSAIDs, Gislason said.

Physical therapy, exercise, or weight loss can also help with some situations, he said. “If you need NSAIDs for pain or arthritis, you should consult your physician who could advise about alternative pain management,” Gislason added.

Reuters

Roche’s lung cancer drug wins US approval Patients getting Tecentriq lived on average 4.2 months longer than those taking chemotherapy SWISS DRUGMAKER Roche Holding’s new immunotherapy, Tecentriq, won approval from US health regulators as a second-line lung cancer treatment, a decision seen likely to erode Bristol-Myers Squibb’s position in this hotly contested market. The US Food and Drug Administration approved Tecentriq to be used in non-small cell lung cancer patients previously treated with chemotherapy, regardless of whether their tumours express a protein called PD-L1.

People with high PD-L1 levels are generally more receptive to immunotherapy.

In study results released this month, patients getting Tecentriq lived on average 4.2 months longer than those taking chemotherapy.

Tecentriq is aiming for a share of the treatment market now dominated by Bristol’s Opdivo, a drug which doctors can also prescribe for patients regardless of their levels of immune-sys-

tem suppressing PD-L1 expression. In the first half, Opdivo sales hit $1.58 billion, about three times that of Merck & Co’s drug, Keytruda, that is prescribed only for people who express a certain level of PD-L1. Analysts estimate Tecentriq's annual sales across all cancers - it is already approved for bladder cancer and will seek approval for more indications - will reach $4 billion in 2021, according to consensus figures compiled by Thomson Reuters.

Tecentriq, Opdivo and Keytruda are the initial entrants in a highly promising class of immunotherapy drugs now transforming cancer treatment and are jockeying for pole position, either for use alone or in combination with other drugs. Lung cancer, responsible for 20 per cent of the annual 8 million annual cancer deaths worldwide, is the top commercial opportunity.

Reuters

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PHARMA ALLY I N T E R V I E W

Orphan drugs have limited market share, but high value and margin Dr Piyush Gupta, Associate Director, GNH India- a renowned global pharma distributor, talks about the challenges in pharma exports, in discussion with Sachin Jagdale

How has the Indian pharma export industry evolved over the years?

What kind of symbiotic relationship should be maintained between drug manufacturers and drug exporters?

Indian industry was born out of the need to fulfil domestic requirements. To give you a background, until the 90s, exports was non-existent.

However, it gradually started expanding in the overseas markets. By the year 2000, the industry evolved and received success to such an extent that over 50 per cent revenue was generated outside of India.

And today, highest numbers of US FDA approved facilities are located in India.

Talking about symbiotic relations, they are still in the developing phase where manufacturers are focusing on manufacturing and exporters on international sales. In India, a majority of exporters of finished formulations are manufactures themselves, there are very few exporters (merchant exporters) without a manufacturing base, and most of them fall under the ‘unorganised’ category.

We should take a leaf from the rich legacy of ayurveda and find solutions to modern issues in our past

R&D has never been the strength of the Indian pharma industry. Do you really think that it is possible for the Indian pharma operators to manufacture drugs which are unique in nature? These drugs will again have unique logistics requirements during the export process…

I agree that R&D has not been

our strength, as the industry was born to ‘fill the gap’, but with different innovations, at present we are trying to catch up on the R&D segment, as well.

In my opinion, rather than focussing on R&D for synthetic drugs, we should take a leaf from the rich legacy of ayurveda and find solutions to modern issues in our past.

34 EXPRESS PHARMA November 1-15, 2016

In the last few years, many reputed Indian pharma companies have been pulled up by overseas regulatory authorities over quality related issues. As an Indian pharma exporter how does such events affect your business?

Today, the largest numbers of US FDA approved facilities outside of US are in India.

Hence, it is obvious that we are going to be crosshair forregulators due to the sheer volume of our engagement with them. This should be taken in a positive spirit as it’s part of natural progression.

Every country or industry goes through issues and currently it’s pharma from India. Such regulatory issues make things difficult for everyone, including exporters.

The right way to address the issue is to take it on the chin accept the mistake and take corrective action.

Unique logistic requirements are mainly for biologic drugs where we need to transport ‘proteins’, ‘cells’ etc… also called ‘live’ content.

If R&D is done from India by Indians for Indian issues, the unique logistic requirements can be mitigated altogether as the drug/product can be adapted to Indian temperature conditions at R&D level.

How is pharma manufacturing in India and pharma export policies interdependent? What kind of export policy changes/ modifications would you like to recommend?

Pharma manufacturing and exports does get affected by domestic policy because of the direct link. The present government is doing a good job and at this point no specific lacuna is coming to mind in terms of policies or notifications. But yes, I think, customs process can be made a lot simpler and these are more at the field level than the policy level.

Orphan drug segment has very limited market share.

How does this category fit into your business model?

Orphan drugs have a limited market share, but high value and margin. In order to be called a ‘full line wholesaler’ orphans have to be a part of our portfolio. Orphan drugs is more of a service to the society than a money making business. If everyone ignores orphan drugs - where will the patients go?

What kind of opportunities and the challenges would you predict for the Indian pharma exporters in future?

As far as challenges are considered, I would like to highlight that the single most important challenge is the ‘image’ of Indian products, which still suffers considerably. The first question people ask us, even after 13 years in the business is "hope that the drugs are not counterfeit?"

There is an unequal distribution of medicines like every other commodity all over the globe. Some countries have all medicines while others lack even basics. The opportunity for us here lies in fulfilling these unmet needs across the globe. The total pharma market is estimated to around $340 billion of which close to $80 billion is wholesale trade - this is the domain we operate in and hope to become the champions from India in the future. sachin.jagdale@expressindia.com

VENDOR NEWS

Schreiner Group starts celebrating anniversary year The anniversary year will see the launch of a new communication format called 'lunch roulette' SCHREINER GROUP is celebrating its 65th anniversary with a variety of internal and external activities. Established on October 1, 1951, the former specialised printing shop has since evolved into an international high-tech company for innovative functional labels.

On the occasion, President and CEO Roland Schreiner thanked all employees for their contribution to the company’s successful development. On February 17 and 18, 2017, Schreiner Group will host an 'Open House,' opening its doors to customers, employees and their families, media and anyone interested in getting to know the company.

At the internal event that kicked off the company’s an-

niversary year in Oberschleissheim, Roland Schreiner, the third-generation managing shareholder cut a cake that was shared with every employee on site. Expressing his appreci-

ation for the outstanding work of the company’s nearly 1,100 people, Schreiner said, “Every one of you, with your commitment, your ideas and your work day in day out, con-

Jubilant Biosys installs Agilent's RapidFire/MS screening platform The company's Bengaluru facility will be the first in India to be equipped with Agilent's state-of-the-art RapidFire JUBILANT BIOSYS announced the addition of Agilent Technologies' RapidFire/MS screening technology to its integrated drug discovery platform.

RapidFire is a robust solid phase extraction technology that enables fast label-free detection of native compounds by mass spectrometry in a wide range of in vitro assays, DMPK/ADME studies, hit/lead applications for drug discovery across a broad spectrum of therapeutic areas and also for screening difficult targets that are not amenable to labelled

assays. Jubilant Biosys's Bengaluru facility will be the first in India to be equipped with Agilent's state-of-the-art RapidFire.

"The installation of the Agilent RapidFire platform shows Jubilant's continued commitment to make the necessary investments with an objective to remain on the cutting edge of drug discovery.

This platform will enable us to increase our productivity and to enhance our capabilities to successfully meet the needs of our clients," said Steven Hutchins, President, Jubilant

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Biosys (Drug Discovery Solutions).

"Agilent RapidFire solution enables our clients with increased accuracy, provides faster results, better economic value, enhanced analysis capabilities, improved efficiency while maintaining robustness and we are pleased to see Jubilant Biosys being the first organisation in India to take advantage of this cutting-edge technology," said Bharat Bhardwaj, Country Manager, Agilent Technologies.

EP News Bureau

tributes to advancing the company bit by bit. Together, we have already achieved a lot and are looking forward to the future with confidence and a zest for action. Thank you to each and every one of you!”

Schreiner Group offers a wide range of training and advanced educational opportunities. The anniversary year will see the launch of a new communication format called 'lunch roulette' aimed at promoting cross-functional exchange of experience. For this purpose, table-mates will be mixed at random for lunch at the cafeteria, so that employees whose paths tend to rarely cross on the job can engage in exchanges in a relaxed atmosphere. Getting to know

each other and networking is intended to strengthen cohesion and stimulate creativity, as in addition to the corporate values of quality, performance and enthusiasm, innovation is the one that, above all, makes up the DNA of Schreiner Group.

Schreiner Group–Past and Present: An in-house anniversary exhibition was recently opened. which shows milestones from the company’s 65-year history, featuring the seal stamps with which everything began, as well as functional labels and selected product highlights from its three business units. The exhibition is part of a show room to be opened at the 'Open House' on February 17 and 18.

EP News Bureau

ACG Inspection launches Convel Srl’s liquid inspection machines in SAARC region The machines are well suited for medium and large scale production capacities ACG INSPECTION, a member of ACG Worldwide, has entered into an agreement with Convel, Italy to sell its liquid inspection systems in the SAARC countries.

The vision inspection machines, viz. C2 and C2D, are 21 CFR Part 11 compliant and enable reliable and efficient inspection of foreign matter and cosmetic defects in ampoules, vials and carpoules.

These machines are well suited for medium and large scale production capacities. With the

addition of these machines to its diverse portfolio of inspection systems, ACG Inspection now offers a complete range of inspection solutions for solid and liquid dosage forms.

Ettore Cucchetti, CEO, ACG Inspection said, “ACG Inspection has been a pioneer in providing regulatory compliant solid dosage inspection systems. With these advanced liquid inspection machines, we have amplified our inspection competencies.”

EP News Bureau

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November 1-15, 2016

PHARMA ALLY PRODUCTS

Dock levellers by Gandhi Automations GANDHI AUTOMATIONS, an entrance automation and loading bay equipment company, is an ISO 9001 : 2008 company. Since its inception in 1996, the company has manufacted, imported, distributed and installed products that are problem free and easy to operate.

The company offers complete logistics solutions by providing dock levellers, dock shelters, sectional overhead doors and dock houses.

Electro-hydraulic, mechanical and air-powered dock levellers offered by Gandhi Automations are not only a bridge for connecting a vehicle, but also facilitate fast, smooth and safe transition by compensating the difference in heights between the loading bay and the vehicle. This contributes to minimising energy used and savings on heating and chilling costs resulting in maintaining the quality of the transported goods. Dock levellers offered by Gandhi Automations are designed as per EN 1398 standard for the most demanding loading and unloading operations.

Efficient loading and unloading of goods The importance of efficient loading the goods has always been evident, and it has increased over the years, essentially for two reasons: the lesser availability and the higher cost of manpower. Consequently lesser qualified manpower is being utilised which leads to damage in the goods.

The cost of loading and unloading the goods can be calculated precisely and is exactly definable, which allows for a scientific approach to find out the investment that goes into the process. Gandhi Automations has always designed solutions based on such scientific approach and

36 EXPRESS PHARMA November 1-15, 2016

feedback from clients. The dock levellers offered by the company ensure loading and unloading with lesser effort and minimal cost.

It is possible to load and unload your products in a safe way and in the process obtain remarkable energy savings.

The loading bay remains with the dock leveller in rest position and the sectional overhead door closed, until the vehicle is positioned. The driver drives back centring to the dock shelter and stops the vehicle the moment it gets in contact with the bumpers.

The sectional overhead door is then opened only when

the vehicle is positioned, brakes applied and engines shut off .This eliminates the exit of hot air, intake of cold air (or the opposite in hot and inside conditioned places) and intake of exhausting gases in the warehouse. After the sectional overhead door opens, the lip of the dock leveller connects to the truck bed for loading / unloading to take place.

At the end of the loading/unloading, the dock leveller is put in rest position and the sectional overhead door is closed, without moving the vehicle. The vehicle then departs at the end of the process.

Following are the two types of dock levelers a) Radius lip dock levellers Radius lip dock levellers allow the dock to connect with the truck bed, thus making it possible to drive directly on and off with forklift trucks etc.

The self-cleaning lip hinging system does not retain rubbish with automatic end-ofrun, so as to keep the 25 mm security distance between the folded lip and structure as per EN 1398 and EN 349. b) Telescopic lip dock levellers Telescopic lip dock levellers are ideal for connecting vehicles unable to drive near

dock i.e. sea containers, side loading railway wagons etc.

These types can be supplied with a lip extending up to 1 m.

Gandhi Automation’s dock levellers are equipped with the most secure safety devices and accessories.

Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064 Off: +91 22 66720200 / 66720300 Fax: +91 22 66720201 Email : sales@geapl.co.in www.geapl.co.in/dock-levelers.html

PHARMA ALLY PRODUCTS

Thermo Scientific Heratherm refrigerated incubators offer accurate temperature environment NEW REFRIGERATED incubators with thermoelectric Peltier technology are designed to provide stable temperatures for the secure incubation of bacteria, yeast, cell cultures, storage of vaccines and more, without the hazardous refrigerants or large energy consumption that are common with traditional units.

The new Thermo Scientific Heratherm refrigerated incubators provide a consistent temperature environment for incubation applications from 5 to 700 centigrade, with enhanced accuracy in the range of 15 to 25 degrees. The instrument’s easy-to-use interface can store up to 10 temperature protocols set by the user, with up to 10 steps in each, and in-

cludes an advanced timer function, an automatic temperature alarm and adjustable over-temperature protection.

The Heratherm refrigerated incubators employ Peltier technology, which circumvents the need for a refrigerant by using a thermoelectric element to cool or heat in one module, as needed. This element leverages the Peltier effect, where an electric voltage is converted into heat difference.

In addition to using insulation that is free of chlorofluorocarbons (CFCs) and hydrofluorocarbons (HFCs) — chemicals that are either phased out or are being phased out by the EPA to reduce the overall risk to human health and the environment —

Heratherm refrigerated incubators consume very little energy. In fact, tests against predecessor compressorcooled models show up to 84 per cent energy savings, making this system an ideal solution for many labs.

The highly accurate Heratherm incubator comes in two sizes: a 178-litre benchtop model and a 381-litre floor model for use in a variety of applications, including microbiology/fungi/yeast studies, reagent and antibody storage, and shelf life testing.

Contact details Lisa Robillard Thermo Fisher Scientific +1 781-790-7324 lisa.robillard@thermofisher.com

Agilent introduces new range of gas chromatographs CALIFORNIA-BASED LIFE sciences firm Agilent technologies has introduced a new addition to its gas chromatographs.

Agilent Intuvo 9000 GC helps laboratories to meet operational, scientific and financial goals.

The Intuvo 9000 GC with Intuvo Flow Technology chips and smart ID keys makes complex technology easy to use. It also has click-and-run connections eliminate ferrules, guard-chip technology which extends column life, and the trim-free column eliminates retention time shifts due to column trimming maintenance.

The new technology self-identifies installed components and self-configures methods. The touchscreen user interface provides quick access to system status and real-time data, and it guides the user through routine maintenance operations.

38 EXPRESS PHARMA November 1-15, 2016

Connection via smartphone or tablet notifies laboratory managers remotely of system status.

In addition, the new updated system, especially when coupled with mass spectrometry, is ideal for high-throughput contract laboratories and for labs dealing with challenging sample matrices in fields such as food, environmental, chemical, pharma and forensics testing.

Contact details Anwesha Brahma Blue Pigeon Image Management K 26, First Left Floor, Green Park Extension New Delhi - 110016 Phone: 011 410 36 234 M: +91-9650528722

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PHARMA LIFE I N T E R V I E W

â&#x20AC;&#x2DC;More than 50 per cent of bio-pharma companies have vacancies in key rolesâ&#x20AC;&#x2122; Kelly Scientific Resources has released data which highlights a severe talent crunch in the biopharma sector. Thammaiah BN, Chief General Manager, Kelly Services India shares more details of the study, the socio-economic of the talent crunch on the industry, measures to build competency and capacity in the sector and more, in an interaction with Lakshmipriya Nair

Can you give us an overview about the extent of talent scarcity in biopharma? A comprehensive idea about the demand and supply gap.

Bio-pharmaceuticals account for the largest share of the biotech industry revenues.

This segment is currently driven by biosimilar potential in India and companies are investing significantly in new product development.

However, Kelly Scientific India internal research data shows that the talent crunch is limiting the scaling up plans of bio-pharma companies.

The demand is up by 35 to 40 per cent in pertinent job profiles owing to stringent US FDA audit norms. There has been a 50 per cent increase in demand for job roles related to bio-similars as most pharma companies are getting into biosimilars while the existing players are ramping up their teams. More than 50 per cent of bio-pharma companies have vacancies in key roles. These are skills that can fetch hikes of average 30-35 per cent while shifting jobs.

What would be the socioeconomic implications of this scenario?

A talent crunch in this sector can derail the efforts of Indian pharma and biotech companies on the path of innovation and new drug discovery. The efforts to make drugs more affordable will also face challenges in the long

term with compulsory licensing snowballing into a major problem. The only longterm solution is to bolster domestic R&D capability. In the short term, loss of revenues in exports for the drug companies and foreign exchange for the Government of India are other implications.

initiatives. In the short term, corporates and industry bodies should collaborate with academia and research institutes to develop training to re-skill pharma and life sciences professionals.

What are the major reasons contributing to this talent crunch?

The biopharma industry currently is driven by biosimilar potential in India and globally. With several biologics drugs coming off patent, India stands on the shores of immense opportunity to become a world leading centre for bio-similars manufacturing, fuelled both by domestic as well as global demand. As such, most pharma companies are getting into bio-similars while the existing players are ramping up their teams. Indian companies are not just competing with international companies globally but also in India as these MNCs also are keen on doing cutting edge science out of India. All of this is leading to shortfall of talent.

formulations (5 to 12 yearsâ&#x20AC;&#x2122; experience range). The maximum demand from biopharma companies is for clone development, cell line development (CHO Cells), MSTAT, technology transfer skills, analytical development, Clinical Data and Medical Affairs (CDMA), upstream and down-stream professionals and senior quality professionals (USFDA exposure), those with manufacturing experience and biostatisticians. The lowest demand is for process chemistry and molecular biologists.

Which are the areas (positions, levels) that face serious inadequacy of manpower?

The areas that are witnessing high demand in pharma are Quality (USFDA), analytical process engineering,

What are the short-term and long term steps needed to tackle this issue?

In the long term, there needs to be an overhaul of pertinent education streams besides public-private partnership in large scale capacity building

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What is the industry doing to build capacity and competency in terms of human resources to serve the biopharma sector?

The lack of talent in areas like analytics, quality, manufacturing, clone development is making Indian pharma and bio-pharma companies look at global and Persons of Indian Origin (PIO) talent. Niche expatriates (lead to VP levels) are also on lookout for opportunities in India. Expats also come in when there are tie-ups for technology transfers, manufacturing, quality (US FDA).

Some companies club potential candidate meetings at a time when their business heads or top scientists travel for global meetings or conferences. HR consulting firms like Kelly proactively work with clients to build such a pipeline of potential candidates on foreign shores.

Expat and PIO talent with experience range of five to 20 years are being mainly sourced from the US, Europe and Singapore markets for positions across mid-level to VP roles. Pharma companies are also resorting to

international transfers wherein they depute employees from their US operations to India. Few of them have also established academies to train freshers and re-skill mid-level scientists. Some bio-pharma companies are also ready to offer premium salaries to fill key positions.

Can you elaborate on the advantages for people seeking a career in the biopharma sector?

The pharma industry, by and large is recession proof and has been growing at a steady rate in India. This industry offers stable job opportunities. As the industry takes strides towards innovation and new drug development from being a bulk drug and generics oriented market, the career opportunity is immense. This is more evident in the biopharma segment as most of the biopharma companies are planning capital investment in new product development in the coming years. India is also emerging as the most important growth markets in biopharma/biomanufacturing after China and North America. So, candidates joining this segment will have tremendous career opportunities in the years to come. lakshmipriya.nair@expressindia.com

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