Express Pharma (Vol.12, No.3) December 1-15, 2016

VOL. 12 NO. 3 PAGES 48

www.expresspharmaonline.com

Market

Hyderabad to host 68th IPCE

Management

Encouraging IPR: Pivotal to quality healthcare

1-15 DECEMBER 2016,` 40

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CONTENTS MARKET French Republic confers Dr Shailesh 8 Ayyangar with 10 the Officier de l’Ordre national du Merite

Vol.12 No.3 DECEMBER 1-15, 2016 Chairman of the Board Viveck Goenka

HYDERABAD TO HOST 68TH IPCE

Sr Vice President-BPD Neil Viegas

INDIA PHARMA WEEK 2016 DEBUTS AT CPHI & P-MEC INDIA WITH PRE-CONNECT CONGRESS

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

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DESIGN

Pg

National Design Editor Bivash Barua 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

P8: PRE EVENT

CubeX to host conference on consumer healthcare in Mumbai

RESEARCH

MANAGEMENT

P14: POST EVENT

Mauritian PM inaugurates AYUR herbarium in Goa

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SOME RESPIRATORY INFECTIONS MAY NOT NEED ANTIBIOTICS

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HEREDITY ISN'T ALWAYS DESTINY WHEN IT COMES TO HEART ATTACKS: STUDY

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NEW DRUG CAPSULE DELIVERS MEDICINE FOR WEEKS AFTER SWALLOWING

P25: UPDATES

No early win for Sanofi, Regeneron cholesterol drug in study

P29: VEND0R NEWS

Mettler Toledo opens Dubai free zone competence centre

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ENCOURAGING IPR: PIVOTAL TO QUALITY HEALTHCARE

P43: CAMPUS BEAT

STEERLife and Manipal University to set up Centre of Excellence for life sciences industry

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

More power to GST

T

he ongoing winter session of Parliament is crucial as there are many big ticket bills awaiting a nod.

The most crucial ones are the draft laws related to the Goods and Services Tax (GST) – Model GST, Integrated (IGST) and GST (Compensation to the States for loss of Revenue) . The GST Council, headed by Finance Minister Arun Jaitley, has been trying to achieve a consensus between the states and centre on various contentious issues. The Council hopes to iron out all the creases so that these draft laws can be introduced in Parliament and passed in this session. Though significant ground has been covered, it hasn't been a smooth road. For instance, the latest meeting of the GST Council scheduled for November 25 has been postponed to December, as the states asked for more time to revert with suggestions on the changes in the model GST law and compensation formula. Both these are politically sensitive issues so the rescheduling is understandable but with the winter session due to close on December 16, the timeline looks challenging.

The passage of these GST related laws in the winter session is crucial also because the Modi government has decided to prepone the Union Budget by a month to February 1. This is to ensure that it can be passed by end March, in time for the new financial year. Thus, it is no wonder that the government has propose to introduce all three GST-related Bills as money bills which need to be voted on only in the Lok Sabha. If this happens, the government is reasonably assured of a safe passage, as it has a clear majority. In fact, Parliament started a week earlier to ensure enough time to discuss GST but so far, protests from opposition parties to the demonetisation issue have hogged the limelight.

As our cover story in the Express Pharma December 1-15, 2016 issue points out, pharmaceutical companies, as their peers in other sectors, see GST as a simpler tax regime. No doubt the devil lies in the details, but by and large, there is hope that these will be sorted out later as the implementation rolls out. GST is one policy which could potentially unite SMEs as well as larger players as almost all sections see benefits.

Hopefully the benefits of a more rational tax regime will percolate down to the consumers and

Mega policy changes like GST are required because the pharma sector, as others, need to squeeze out efficiency wherever they can

patients will gradually see reduced medical costs.

Mega policy changes like GST are required because the pharma sector, as others, need to squeeze out efficiency where ever they can as global markets are set to become even more competitive. According to Mergermarket's sector trend report for Q1-Q3 2016, the Pharma, Medical & Biotech (PMB) sector took another dive in Q3 2016, to end at $ 56.9 billion, over 316 deals. This represented a loss of 31.4 per cent of its deal value and 12.2 per cent of its deal count compared to Q2 2016 ($ 82.9 billion, 360 deals). Though this was the second consecutive decrease in value since Q4 2015, the report stresses that despite the quarteron-quarter downward trend, year-to-date activity in the PMB sector remained relatively robust and amounted to 1,033 deals worth $ 228.7 billion in Q1-Q3 2016. Deal activity was the third-highest by both deal value and deal count in Mergermarket history (to 2001), with only the previous two years topping these results. M&A in the sector might thus take a slightly different shape in the future, with companies opting for fewer mega-deals in favour of ‘smaller’ transactions, says the report.

Another report, this time from GBI Research, titled Strategic Trends in Private Equity and Venture Capital Funding for Healthcare, points out that the healthcare sector has seen a decline in venture investments, particularly for early-stage investments, as pricing pressures, stringent regulations, rising development costs, reimbursement issues, and declining R&D productivity have proved significant barriers.

Again, this could be a temporary blip, as the number of new molecular entities launched globally in 2014 reached a 17-year high of 46.

GBI Research report ends on a note of hope, highlighting how some nimble players, like healthcare startups, particularly those in the biotech segment, are tapping angel investors, typically individual high-net-worth investors that provide financing through loans or equity investments.

Can the government take on the role of an angel investor in the pharma and healthcare sector? Policies like GST would make India a better investment destination but tax exemptions on life saving medicines and medical devices, for instance, would directly benefit the consumer. Is the Prime Minister listening?

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET PRE EVENT

Hyderabad to host 68th IPCE Delegates from across the world will congregate in Visakhapatnam from December 16 to 18, 2016

T

he 68th successive edition of Indian Pharmaceutical Congress and Exhibition (IPCE) organised jointly by the Indian Pharmaceutical Association (IPA) and Orbit Exhibitions is all set to host a large volume of business delegates from all parts of the world from December 16 to 18, 2016 in Visakhapatnam, under the patronage of Chandrababu Naidu, Chief Minister, Andhra Pradesh.

The first ever summit for the pharma industry in India

IPCE will see active support from Central and state government and non-government bodies such as IDMA, Pharmexil, etc was the inaugural edition of IPCE in 1948 at Kolkata. Over the years, this industry spe-

cific exhibition has played a vital role in showcasing the complete spectrum of the

pharma industry and IPCE has always been the growth engine for the Indian pharma industry. The show has been a perfect platform for Indian pharma industry to showcase their advancement in technology and product profile in front of a large audience of national and international delegates.

With India's new initiative of 'Make in India' campaign, the show will witness a huge boost with national and international participation.

IPCE will see active support from central and state government and non-government bodies such as IDMA, Pharmexil, etc.

The five federating associations of IPCA are IPA, Indian Hospital Pharmacists' Association (IHPA), Association of Pharmaceutical Teachers of India (APTI), Indian Pharmacy Graduates' Association (IPGA) and All India Drugs Control Officers' Confederation (AIDCOC).

EP News Bureau

CubeX to host conference on Manufacturing Pharma consumer healthcare in Mumbai to be held in Nigeria It will be held on December 9, 2016 in Mumbai 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-

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

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

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consumers 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 Pharma 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

The exhibition will attract more than 100 international and regional companies MANUFACTURING Pharma, the new platform for Nigeria’s industrial pharmaceutical sector, will be held at Landmark Centre, Lagos, Nigeria from April 25 – 27, 2017.

The exhibition will attract more than 100 international and regional companies showcasing their drug excipients, machineries, packaging materials and drug manufacturing services to Nigeria’s leading pharma companies, government representatives and drug manufacturing professionals.

The Manufacturing Pharma conference programme will attract key decision makers in Nigeria’s pharma manufacturing sec-

tor. Two action-packed days will highlight presentations and high-level debates and discussions for pharma manufacturing professionals who are interested in developing their business in line with Nigeria growth path for the pharma industry. Attendees will have an opportunity to discuss the latest manufacturing trends, discover transformative technologies and enhance their best practices in pharma processing. Key leaders will also share insights on how to become global players in the pharma industry.

Express Pharma is the media partner for the event.

EP News Bureau

MARKET POST EVENT

India Pharma Week 2016 debuts at CPhI & P-MEC India with Pre-Connect Congress Leaders from the Indian pharma industry came together to discuss and debate on pertinent issues faced by the sector at the event Lakshmipriya Nair Mumbai THE INDIA Pharma Week 2016, organised as part of CPhI and P-MEC India 2016, kickstarted with the 2nd PreConnect Congress held at Hotel Westin, Mumbai on November 17-18, 2016. Leaders from the Indian pharma industry came together to discuss and debate on pertinent issues faced by the sector on the first day of the Pre-Connect Congress.

Welcoming the delegates, Yogesh Mudras, MD, UBM India, the organiser of the show, spoke on how CPhI and P-MEC have evolved over the years from a three-day exhibition to a marquee show spanning a week. He also spoke on the various activities planned for the delegates across Mumbai as part of the India Pharma Week, to mark the 10th anniversary of CPhI and P-MEC India 2016. He said, "The India Pharma Week is a melting pot of ideas and a wholesome knowledge sharing avenue through which our flagship pharma event, the CPhI & P-MEC goes beyond the realm of a wall-bound show to one with considerable intellectual value addition. It provides key stakeholders a chance to interact, align, partner, learn, share as well as identify key opportunities unfolding in the developed as well as emerging markets. With a focus on the pillars of business, knowledge, leadership, innovation, recognition and networking, we at UBM India are honoured to be the catalysts of change in the pharma industry – equally supported by the doyens and innovators from the sector.”

Rutger Oudejans, Brand Director – Pharma Portfolio,

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Rahul Deshpande, Group Director, UBM India, SM Mudda, Director , Global Strategy (Technical), Micro Labs, Sandeep Sood, MD, Fette Compacting, Sanjit Singh Lamba, MD, Eisai Pharmaceuticals, Yogesh Mudras, MD, UBM India, Rutger Oudejans, Brand Director – UBM EMEA, at the inauguration of CPhI & P-MEC India’s ‘INDIA PHARMA WEEK 2016’

CPhI and P-MEC India 2016 provided a chance to interact, align, partner, learn, share as well as identify key opportunities unfolding in the developed as well as emerging markets EMEA gave the keynote address and spoke on the objectives of the event. He spoke on the growth of the Indian pharma industry and highlighted its potential to take a leadership position in the global

arena. He also gave a preview of the topics which would be addressed during the day.

The first panel discussion for the day was on an interesting topic, 'Exploring conventional and unconventional av-

enues to enhance pharma export potential for India'. Moderated by D Roy, Former Deputy Drugs Controller (India), CDSCO, MoH&FW, Govt of India, the session's panelists comprised Milind Joshi, President,

Global Regulatory Management, JB Chemicals; Satya Karm Punia, Founder and MD, Camus Pharma; V Prasada Raju, Chief Scientific and Strategy Officer, Granules India and Rakesh Mehta, Sr VP & HeadGlobal Sales & Marketing – API, Sun Pharmaceuticals.

Adherence to superlative quality standards, extensive IT adoption, leveraging the potential in herbal and cosmoceutical sectors, reducing India's dependence on APIs, international collaborations to export technical know-how, promoting

MARKET indigenous manufacturers, urging cohesiveness between industry and government were some of the measures recommended by the panelists to enhance exports in India's pharma sector.

'Mergers & Acquisitions – Driving force for Indian Pharma Sector', was the next topic of discussion. The panelists for this session were Ranjan Chakravarti, Former Head Global Pharma Business, Ranbaxy Laboratories; Jatin Lal, Head Mergers & Acquisitions, Piramal Enterprises; Sanjay Singh, Partner, Deal Advisory M&A, KPMG India; and Bhupender Saggu, Pharma Specialist, Thomson Reuters. The session was moderated by Ranga Iyer, Former MD, Wyeth India.

The discussion revolved around the slack in M&As in the Indian pharma sector.

The panelists deliberated on various reasons which have hampered M&As in the industry with cases in point. The global sentiment for Indian pharma compnaies, role of regulatory amendments in hindering M&A activity, challenges in integration post M&As etc. were taken up during the discussion.

The third panel discussion was on 'Biosimilars – The next big thing?'. The panelists for this session — Kanchana TK, Director General, OPPI; Sharad Tyagi, MD, Boehringer Ingelheim; and Dhileep Krishnamurthy, Chief Scientific Officer, Zhejiang NHU Company gave an overview on the current scenario in this arena as far as India is concerned. They also shared their insights on the various measures needed to leverage the potential in this sector. Recommendations included revamping current guidelines to improve patient safety and drug efficacy, encouraging innovation in biosimilars, cultivating a culture of innovation and making the country's IP more secure. The experts opined that these measures need to be implemented on priority to encourage growth in biosimilars.

Quality Compliance – A cultural pre-requisite or external obligation, another pivotal topic was addressed by the

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L-R: D Roy, Former Deputy Drugs Controller (India), CDSCO, MoH&FW, GoI; Milind Joshi, President, Global Regulatory Management, JB Chemicals; Satya Karm Punia, Founder and MD, Camus Pharma; V Prasada Raju, Chief Scientific and Strategy Officer, Granules India and Rakesh Mehta, Sr VP & Head-Global Sales & Marketing – API, Sun Pharma

L-R: Ranga Iyer, Former MD, Wyeth India; Ranjan Chakravarti, Former Head Global Pharma Business, Ranbaxy Labs; Jatin Lal, Head M&As, Piramal Enterprises; Sanjay Singh, Partner, Deal Advisory M&A, KPMG India; and Bhupender Saggu, Pharma Specialist, Thomson Reuters

panelists in the next session.

CT Renganathan, MD, RPG Lifesciences; DG Shah, Secretary General, IPA; Ashok Bhattacharya, MD, Takeda Pharmaceuticals; Sanjit Singh Lamba, MD, Eisai Pharmaceu-

ticals and Sireesha Yadlapalli, Senior Director -Strategic Marketing & External Affairs, USP were the panelists for this discussion.

The discussion revolved around cost of compliance vs

cost of non-compliance, the need to become more quality conscious and the measures to ensure adherence to quality.

Hiring and training the right talent, investing in technology, creating leaders who walk the

talk were the recommendations offered by the panelists.

‘Make in India’ – A Pharma Perspective was the final panel discussion for the day. Moderated by Parizad Elchidana, Independent Director &

MARKET Former MD, Apotex Pharma; the sessions panelists were Srini Srinivasan, Managing Director, Hospira Healthcare, Amit Sanghivi, MD, Shaily Engineering Plastics, Sudhir Nambiar, President Research & Technology, and G Munjal, MD and CEO, Ind-Swift.

Corporate presentations from West Pharma, Finar and UL India were also part of the first day's agenda. The first day of the Pre-Connect Congress ended with closing remarks from Rahul Deshpande, Group Director, UBM India.

The second day of the Pre Connect Congress also had a line-up of interesting events such as ‘The Women in Pharma-Power Breakfast’ session to address the fact that despite advancements, women still comprise only 15 per cent of the total workforce in the Indian pharma industry. Women

Quality, compliance, enhancing exports, M&As in the pharma sector etc. were some of the topics discussed at the Pre Connect Congress

who have broken the glass ceiling in the pharma sector such as Samina Vaziralli, Executive Vice-Chairman, Cipla; Dr Anurita Majumdar, Sr Medical Director & Global Established

Pharma Medical Lead, Pfizer; and Dr Rashmi Hegde, Director – Medical, Abbott, were part of the power breakfast.

The India Pharma Awards, an endeavour to recognise

pharma industry stalwarts, were also held on the second day.

Thus, the India Pharma Week, got off to a great start. A CEO Round Table, Pharma

Leaders’ Golf etc were some of the other interesting activities lined up for participants at the CpHI & P-MEC India. lakshmipriya.nair@expressindia.com

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MARKET

Mauritian PM inaugurates AYUR herbarium in Goa AYUR herbarium is an initiative by Sandu Pharmaceuticals in association with Union Ministry of Ayush and Directorate of Health Services, Government of Goa Sachin Jagdale Goa PRIME MINISTER of The Republic of Mauritius, Sir Anerood Jugnauth, recently inaugurated AYUR herbarium at Bardez, Goa. AYUR Herbarium is an initiative by Sandu Pharmaceuticals in association with Union Ministry of Ayush and Directorate of Health Services, Govt. of Goa. Present on the occasion was Union AYUSH Minister, Shripad Naik. The directors of Sandu Pharma, Shashank Sandu and Umesh Sandu hosted the event. The medicinal herbarium is located within the premises of Sandu Pharma, which has a collection of various ayurvedic medicinal plants exhibited with informative details of medicinal properties and uses of each herb.

Sir Jugnauth along with his delegation was on a tour of In-

dia to reciprocate the cordial invitation of delegates of Goa government, who visited the island country in the recent past, a government spokesperson said.

Government of Goa and Government of Mauritius are actively collaborating on various

projects related to healthcare, ayurveda, medical tourism and tourism. Both Mauritius and India have similitude in the wealth of medicinal flora and fauna. The inauguration of AYUR herbarium at the hands Sir Jugnauth was part of this

bonding.

Shashank Sandu, Director, Sandu Pharma, said, “More than 50 plant species have been included in the herbarium.

These are unique species and are not easily available. We want to propagate these species.

Western Ghats and Central India are major sources of these plants.”

He added, “More than 60 per cent of the medicinal plants required to manufacture ayurvedic medicines are available in Mauritius. We are willing to establish our base in Mauritius. We are also interested in setting up an ayurvedic therapy centre in the country.”

“Inauguration of herbarium was something innovative, which I was asked to do,” said Sir Jugnauth. He added, “Medical services and medical care is free in Mauritius. I am also trying to set up an ayurvedic hospital in Mauritius soon. Though we do not offer any special benefits to companies, we are an investor-friendly nation and we welcome investors from all over the world.” sachin.jagdale@expressindia.com

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EVENT BRIEF DECEMBER-2016 TO FEBRUARY-2017 IPC EXPO 2016 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 with national and international participation.

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

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 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 pharma industry starting

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from finished formulations, APIs, bio-pharmaceuticals, fine chemicals and intermediates, natural extracts, excipients and many more.

Latest pharma machinery, plants, laboratory equipment, analytical instrument and cleanroom equipment will also 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

MARKET GROWTH TRACKER

IPM clocks ` 9744 crs in Oct 2016 Dermatology was the fastest growing therapy area registering a growth of 16 per cent THE INDIAN Pharmaceutical Market (IPM) was valued at ` 9,744 crores in the month of October 2016 falling below the ` 10,000-crore mark for the first time in last four months. Festivities and closure of trade channel due to festivities had an impact on sell out of drugs resulting in a steep dip of growth for the month to six per cent. On a MAT October basis, the industry was valued at ` 111,576 crores and reflected a 12 per cent growth with volumes contributing around 34 per cent of this growth and new introductions playing an important role with around 41 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 12 per cent growth on MAT Basis. The hospital and doctor channel contributed to 10 per cent and 6 per cent of the overall sales and reflected a 15 per cent and 13 per cent growth respectively. It is expected that the hospital channel will continue to report robust growth rates due to rapid capacity expansion in this space. As per QuintilesIMS data which captures sales from trade stockists more than 10 therapy areas in the IPM have already crossed a sale of ` 500 crores in the hospital segment, namely, anti infectives, cardiac, gastrointestinals, pain, neuro, VMN, gynae, antidiabetics, vaccines and respiratory. IPM continued to remain fragmented with top 10 companies occupying 43 per cent share. Top 30 companies reflected subdued single digit growth for the month. Lupin (15 per cent), Macleods (11 per cent), Alkem (10 per cent), Aristo (11 per cent), Glenmark (12 per cent) and MSD (24 per cent) were the only companies among top 30 to reflect a double digit growth for the month.

Among top 25 companies, Sun Pharma has maintained its top position in the IPM with a market share of 7.95 per cent,

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SUBGROUP D07D8 OTH.CLOBETHERAPYAREASOL+A.FUN+A.IN A10C3 INTER.-ACTING+FASTACTING D01C3 ITRACONAZOLE J05BB CARICA PAPAYA A10BC SGLT2 INHIBITOR A10BC SGLT2 INHIBITOR R05B1 COUGH PREP. ETHICALS R03EL SALBUTAMOL COMB. T02X1 OTHER DIAGNOSTIC AGENTS A10BY DPP4 INHIBITOR AND COMB. R05A1 COLD PREP. SOLIDS R05A2 COLD PREP. LIQUIDS G03K2 MIFEPRISTONE+MISOPROSTOL J07C1 VARICELLA (CHICKEN POX) A10BC SGLT2 INHIBITOR A10BC SGLT2 INHIBITOR B01AS TICAGRELOR A10BY DPP4 INHIBITOR AND COMB. T02X1 OTHER DIAGNOSTIC AGENTS G03GA FOLLITROPIN A/B RECOMB. A10BY DPP4 INHIBITOR AND COMB. D07D8 OTH.CLOBETHERAPYAREASOL+A.FUN+A.IN D10AV OTHER ANTIACNE PREP. R05C1 OTH.COUGH and COLD PREP. V03A1 ALL OTH.THERAPEUTIC PREP. A10BY DPP4 INHIBITOR AND COMB. J07C4 TYPHOID

PRODUCT LAUNCH 201605 201412 201510 201507 201505 201510 201503 201608 201501 201509 201607 201607 201604 201503 201503 201510 201510 201512 201501 201509 201506 201607 201506 201506 201506 201509 201507

COMPANY MACLEODS PHARMA ABBOTT MACLEODS PHARMA MICRO LABS ASTRAZENECA BOEHRINGER INGELH GLENMARK PHARMA ARISTO PHARMA JOHNSON and JOHNSON GLENMARK PHARMA IPCA LABS IPCA LABS MACLEODS PHARMA MSD PHARMACEUTICA JANSSEN USV SUN LUPIN LIMITED JOHNSON and JOHNSON MERCK LIMITED GLENMARK PHARMA MANKIND HAMDARD HAMDARD HAMDARD GLENMARK PHARMA ABBOTT

Source: QuintilesIMS TSA & SSA, Oct 2016 Glenmark and Torrent have gained two ranks each and occupied 13th and 14th position respectively. Lupin, GSK, Pfizer, Sanofi, Alembic and Novartis have

gained a rank each and moved to 6th, 8th, 11th, 16th, 20th and 24th respectively.

Domestic companies continued to dominate the market with

a 79 per cent share in October 2016 with a growth of 13 per cent. MNCs on the other hand reflected a growth of 9 per cent for the month, after reaching a

Total 7.8 6.8 5.1 5.1 5 5 4.3 4 3.9 3.9 1.3 2.3 3.4 3.3 3.2 3 2.8 2.7 2.7 2.7 2.7 2.6 2.4 0 2.4 2.3 2

six month high growth of 12.5 per cent in August. Large MNCs like Abbott, GSK and Pfizer which contributed around 57 per cent of the total MNC share in the month reflected growths of 9 per cent, -1.7 per cent and zero per cent respectively.

Acute therapies remained the strongest pillar of IPM with a 67 per cent contribution to the total market. After reaching a 12 month high of 20 per cent growth in August 2016, acute therapy areas reflected a slowdown with a 4.4 per cent growth for the month of October 2016.

Chronic therapy area on the other hand outpaced acute therapy area reflecting a growth of 9 per cent.

Anti-infectives was by far the largest therapy area for the month with a revenue of ` 1377 crores reflecting stagnancy on account of festivities across the country. Four out of the top 10 molecules reflected de-growth

MARKET with Ceftriaxone injectables reflecting stagnancy. Meropenem and Amoxyclav liquids were the only molecules reflecting robust growth of 23 per cent and 16 per cent respectively among the top 10 molecules. On a MAT basis, volumes have driven about 60 per cent of the overall growth of the therapy area.

Cardiac therapy area maintained it’s number two position in IPM with a value of ` 1096 crores for the month of October 2016 growing at 5 per cent. The therapy area continued to be driven by Rosuvastatin (12 per cent growth), Amlodipine + Telmisartan (15 per cent growth) and Olmesartan (11 per cent growth). Telmisartan which recently came under price control reflected a -6 per cent growth for the month.

Gastrointestinals continued to be the third largest therapy area for the month garnering a revenue of `988 crores with a growth of 5 per cent. Proton Pump Inhibitors (PPIs) and their combination with Domperidone contributed about 20 per cent of the overall therapy area value, growth however was subdued for most molecule classes. Digestive enzymes, Pantoprazole and Lactulose were the only molecules among the top 10 which reflected a double digit growth of 10 per cent, 11 per cent and 22 per cent respectively. Gastrointestinals as a therapy area has leveraged all three levers of growth with volumes, new introductions and price contributing to about 30 per cent of growth for the therapy area.

Anti-diabetics replaced respiratory to be the fourth largest therapy area in IPM for the month of October 2016 clocking a growth of 15 per cent for the month. Dipeptidyl peptidase-4 (DPP4) inhibitors was the largest molecule category and registered a growth of 26 per cent driven by Januvia, Janumet, Istamet and a plethora of brands in the Teneligliptin space. Top five molecules which contribute 70 per cent of the total therapy area reflected an average growth upward of 23 per cent. On a MAT basis, 54 per cent of growth in the anti-diabetics space was contributed by new introductions primarily in Teneligliptin.

Source: QuintilesIMS TSA & SSA, Oct 2016 TABLE 1: PHARMA MARKET SIZE IN MILLION $ USD BY COUNTRY All values in Million USD

Sep Month

Month Growth %

MAT Sep

MAT growth %

Global Pharma Mkt

84821

-8.1

1040230

3.1

USA

44042

4.1

445592

7.1

JAPAN

6789

12.4

79927

10.3

GERMANY

3516

6.1

40496

0.9

VENEZUELA

1967

83.3

17331

48.1

UK

1957

-13.1

25050

-0.9

BRAZIL

1916

34.7

19652

-6.1

FRANCE

1810

-33.9

31944

-4.3

CANADA

1597

0

19149

-3.3

INDIA

15187

7.3

Dermatology was the fastest growing therapy area registering a growth of 16 per cent Same Period Last Year (SPLY) with a value of Rs 699 crores. With resistance emerging as a major concern, anti-fungals continued to reflect a good pick up driven by top molecules like Itraconazole, Terbinafine and Clortimazole growing at 132 per cent, 32 per cent and 14 per cent respectively. Emollients continued to be the largest category within dermatology reflecting a 21 per cent growth for the month.

Neurology reflected a slowdown for the month with a 7 per cent growth. Levetiracetam continued to be the largest molecule in the space clocking a value of ` 41 crores with a 10 per cent growth for the month vis-Ă -vis 20 per cent in the previous month.

Escitalopram which reflected consistent growth through the year reflected de-growth to the tune of -0.7 per cent. Escitalopram combination with Clonazepam, however, continued to reflect high growth of 11 per cent consistent with the trend throughout the year.

In terms of New Introductions, Glenmark had the highest number of new introductions with four new introductions, among the top 25 new introductions in the industry, followed by Macleods and Handard with three each, Abbott, JandJ and IPCA with two new introductions.

1406

9.2

ITALY

1132

-53.9

27273

1.8

AUSTRALIA

1130

26.8

12428

11.1

RUSSIA

1050

8.9

11655

-12

Global (September 2016)

SPAIN

922

-47.4

20234

0.6

The global pharma market is valued at $ 1040 billion growing at 3.1 per cent. The US continues to dominate the market with 42 per cent market share with growth of 7.1 per cent.

Amongst the top market, India is ranked 9th in the month of September 2016 and growing at 9.2 per cent. Indian companies hold 3.9 per cent share in the global market and growing faster than the global market.

Amongst the top five Indian companies, Lupin and Cipla are in double digit growth rate while Sun Pharma is growing in single digit; DRL and Zydus with negative growth rate.

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

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

Sept Month

Month Growth %

MAT Sept

Indian Pharma Market Globally

3317

5.1

36968

MAT growth % 7.4

SUN PHARMA

464

8.3

5311

7.2 24.4

LUPIN LABS

383

33.6

3975

DR REDDYS LAB

274

-3.7

3064

-3.2

CIPLA

185

19.1

1845

10.2

ZYDUS CADILA

183

-5.6

2044

-3.4

AUROBINDO

173

-11.5

2261

3.4

TORRENT

173

3.5

1948

7.7

GLENMARK PHARM

161

1.8

1765

5.4

INTAS

128

-13.6

1763

13.4

ALKEM

113

14.5

1117

11.7

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EXPRESS PHARMA

17

December 1-15, 2016

cover )

18

EXPRESS PHARMA

December 1-15, 2016

(

THE MAIN FOCUS

GST will take our economy a notch up as two per cent GDP growth will be seen through it. We also believe that the new tax form will attract a lot of foreign investments KT Rama Rao Minister for Industries and IT Minister, Telangana

A

BY PRATHIBA RAJU

s the sector grapples multiple taxation issues at the central, state and municipal levels, the pharma industry is gung ho about Goods and Services Tax (GST) as the country's biggest tax reform promises significant benefits.

The roll out of GST is expected to bring in several changes in the way pharma business functions. It will have an impact on varied aspects of the business processes like product pricing, supply chain management, IT, finance and accounting, legal and compliance etc. According to industry experts, GST is likely to bring in more operational efficiencies as well as reduction in manufacturing cost.

A gateway of opportunity The recently passed GST has opened a new gateway of opportunities for the pharma industry, as it would rid the sector of problems caused by the multiplicity of taxes. Under the current indirect tax regime, the pharma sector is burdened with numerous taxes, which are levied at various stages such as central levy (central excise duty, service tax and customs duty), state levy (sales tax, value added tax (VAT), entry tax etc.) and other municipal taxes (octroi duty, local body tax (LBT).

All these taxes will be subsumed into a single tax called the Goods and Service Tax (GST), which will reduce multiple compliance and cost of goods.

Also, one can expect free flow of credit under the new GST regime. “GST is not just a tax change but a business change. Hence, it will change the way pharma business functions and business decisions will be made on the basis of pure economic factors without taking into consideration the taxation point of view. It will help mitigate the cascading or double taxation effect on transactions. Under the current indirect tax regime, there are several transactions that fall within the ambit of two or more levies, which is finally borne by end consumers. GST will create a completely tax-neutral

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cover )

Single tax rate across all goods and services will result in redistribution of taxes across all categories. This will lead to a reduction in taxes on manufactured goods and thereby impact the pricing of the final product Amit Varma Managing Partner, Quadria Capital

GST is not just a tax change but a business change.

It will change the way pharma business functions. Business decision will be made on the basis of pure economic factors without taking into consideration the taxation point of view Santosh Dalvi Partner, KPMG

20 EXPRESS PHARMA December 1-15, 2016

environment for business.

The compliance-related services such as registration, returns, payment of tax, etc. will be available to the tax payer online under one single portal, thereby reducing the compliance cost. The same will eventually increase the competitiveness of Indian goods and services in the international market,” shares Santosh Dalvi, Partner, KPMG. Elaborating on the provisions of GST, KV Subramaniam, President, Reliance Life Sciences said, “As with most other sectors, GST is expected to be beneficial for the Indian pharma industry. In the medium-to-long run, it aims to simplify the tax structure and bring about commercial efficiency. The pharma sector is currently faced with issues of multiple taxes at central, state and municipal levels. GST promises to simplify and streamline the indirect tax structure and will mitigate the cascading effect of the taxes. It also proposes seamless credit across all value additions. All these should lead to an improvement in supply chain efficiency and reduction in manufacturing costs.”

Displaying the same optimism, Dr Amit Varma, Managing Partner, Quadria Capital, explains, “Single tax rate across all goods and services will result in redistribution of taxes across all categories.

This will lead to a reduction in taxes on manufactured goods and thereby impact the pricing of the final product.

The integration of tax on goods and services through GST will provide the additional benefit of credit for service tax paid by manufacturers. Both CENVAT and VAT, which are being levied at present, give tax credit to the manufacturers for the tax paid on raw materials. There are various services, including logistics, involved in getting the input material to its final customers. Service tax is paid on the cost of such

TAX

GST: POSITIVES AND NEGATIVES

Positives ◗ ◗ ◗

Taxation will have positive impact in the medium to long term.

Traditional cost and distribution model will get replaced by supply chain efficiencies and therefore reduce cost GST will also have positive effect on warehousing strategy

Negatives ◗ ◗

Tax bracket is expected to increase and will have short term negative impacts Free samples given as physician's samples for promotion could attract GST. These would impact the bottom line of the pharma industries marginally in a short term but expected to be set-off for better operational efficiency in the long term

services as well. With implementation of GST, the cost of services, including logistics, will be considered as value add, and the manufacturer will get tax credit for the service tax paid.”

Informing that GST is a step towards ‘One country, one tax,’ KT Rama Rao, Minister for Industries and IT Minister, Telangana said, “We have supported GST in the Parliament and have also ratified GST amendment in the state legislature. From an industry perspective, it will have a positive outcome as it rationalises lots of taxes and uncomplicates them. Now, how will this work out for manufacturing state to consuming state is what we need to wait and see because the Government of India has promised to support whatever deficit might come for about the next five years. I believe that GST should ensure that the same level of support is maintained irrespective of what form or shape it will be. I do hope that GST will take our economy a notch up because a two per cent GDP growth can be expected through GST. We also believe that the new tax form will uncomplicate things and attract lot of foreign investments.”

Thus, the sector hopes that GST would increase compliance, remove complexities, ensure hassle-free functioning and pave way for more opportunities.

Role of IT Although GST will reduce multiplicity of taxes, taxpayers need to reprogramme their entire Information Technology (IT) system by creating new codes (eg.

CGST, SGST and IGST) in place of existing tax codes – Excise, VAT, CST and others.

The Enterprise Resources Planning (ERP) system needs to be aligned with GST requirements and it will have an impact on various business processes like tax configuration, computation, invoicing requirements, reporting requirements, master data amendments and documentation requirements.

In a highly-regulated sector like pharma, upgradation of new IT systems could take anywhere between 12 to 15 months, informs Verma.

Detailing about the issues in enhancing the ERP system, he said, “With the implementation of GST, they will have to move from their current system, where every transaction is recorded separately, to an upgraded system where there is a correlation between every entry. Under the current system, every state is treated differently. The solution won’t be a one-size fit approach. All modules and business processes should be mapped as per company needs, taking in account sector-specific requirements.

Implementing the new IT system could take a few months.

GST will mainly impact master data management, tax computation and business process localisation.”

Mentioning that GST implication for ERP is multifold, Subramaniam opined that it is necessary to have a robust ERP system to ensure seamless business operations, compliance, tax administration and a detailed impact analysis.

“Pharma companies need to take a close review on all inward and outward processes, like stock transfers, loan-licensing etc. Subcontracting transactions must be closely evaluated as such transactions will fall under the ambit of GST. Further, credit available to the taxpayer will depend on proper filing of sales and purchase register. Invoices also need to be amended as per the GST rules and regulations. Hence, changes need to be made accordingly. A thorough review of the ERP is needed in terms of adaptability with GST,” Dalvi added.

In a way, the new tax reform will streamline the Indian pharma business. It will help to consolidate the warehouse segment and rationalise supply chain networks as well as take advantage of economies of scale.

Foreseeing huge benefits GST is set to transform the way goods are transported within the country. The pharma industry is set to enjoy the benefits of the logistics sector and bring in a more streamlined flow of goods. It will facilitate interstate flow of goods and will help in meeting the demands of healthcare delivery systems. Obstacles in the form of check posts, way bill requirements, octroi, entry tax, cess and central sales tax during transactions within the state and interstate will be subsumed. It will be cost effective and have operational advantages.

“Most pharma manufacturers maintain warehouses

( in different states so as to save on Central Sales Tax (CST). Some manufacturers also went to the extent of setting up warehouses at locations like Puducherry or Daman as CST rates in those locations were previously lower than the rates prevalent in other states. Therefore, with the implementation of GST, pharma manufacturers can set up warehouses for distribution at select strategic locations resulting in reduction of cost of operations. This will enable companies to consolidate warehouses, rationalise supply chain networks and take advantage of economies of scale,” states Varma.

Opining that optimal usage of warehouses will reduce in-

GST will have an overall impact on the supply chain management of the pharma vertical ventory costs, Phanish Chandra, CEO, Docplexus, says, “With the new tax regime, a better optimised hub and spoke model in warehousing is expected. There will be a boost in demand for refrigerated, temperature-controlled warehouses and transportation solutions as the overall costs of logistics is said to be reduced.”

According to KPMG, under GST, warehousing decisions shall be based on strategic locations rather than tax requirement. GST will have an overall impact on the supply chain management of the pharma vertical. The traditional clearing and forwarding or consignment sales agency distribution model may have

EXPRESS PHARMA

21

December 1-15, 2016

to be re-aligned by distribution models, which will be effective under the GST regime.

“Currently, most of the pharma companies maintain their warehouses/C&F loca-

tions in different states primarily to cater to the demands at remote locations and also to do away with additional CST impact. GST is going to be imposed on stock transfer be-

THE MAIN FOCUS

tween manufacturing locations to C&F locations (which is not the case as of now). This may pose an issue of additional working capital blockage,” viewed Subramaniam.

Ramesh Agarwal, Chairman, Agarwal Packers and Movers Ltd (APML), speaking about GST, during the foundation day of APML, informs that with a uniform tax

cover )

GST is expected to be beneficial for Indian pharma industry. In the medium-to-long run, it aims to simplify tax structure and bring about commercial efficiency KV Subramaniam President, Reliance Life Sciences

regime they could offer Virtual Warehousing Solution (VWS) to big companies. He says, "Consumers will be surprised to know that the logistics cost for our customers will actually come down by eight per cent even as they are catered to a superior and more efficient service.”

Hence, pharma companies are trying to upgrade their ERP systems and enhance warehousing capabilities to equip themselves to comply with the upcoming GST guidelines in the shortest possible time. Thus, a lot of advantages will come the way of pharma players after the GST roll-out. Yet, another one of them is that it may correct the inverted tax structure which has plagued the sector for a long time.

Reversing inverted tax structure

In addition to taxation, GST also brings the opportunity to look at various business processes with a much holistic approach. Pharma companies will embrace this change and growth expectations will be achieved Phanish Chandra CEO, Docplexus

22 EXPRESS PHARMA December 1-15, 2016

Inverted duty structure in excise taxes, i.e., higher rate of taxes (12.5 per cent) on inputs vis-à-vis lower rate of six per cent on formulations has negatively impacted the sector. The GST law provides for a refund of accumulated credit due to an inverted tax structure. This is a welcome step for the pharma sector. However, it will be better to wait and watch, inform experts.

“The pharma sector has always been affected by an inverted tax structure. In this scenario, the tax cost of inputs is higher than the tax cost of outputs. This has affected domestic manufacturers as the inverted tax structure has resulted in blockage of accumulated input credit.

Currently, the credit is merely on paper since there is no refund available for such credits. The GST will be a boon for such manufacturers as it may completely abolish the inverted tax structure or will release the blockage of credit accumulated in the form of refund as stated in the model GST law,” Dalvi informs.

Explaining how the inverted tax structure discour-

ages domestic value addition and promotes imports, Subramaniam says, “At present, APIs attract an excise duty of 12.5 per cent, while formulations are subjected to an excise duty of six per cent. This often leads to accumulation of credit which ultimately becomes cost to the manufacturer. In this context, the model GST law provides for a refund of accumulated credit on account of an inverted tax structure. However, it would be better if, in the first instance itself, the GST regime does not provide for an inverted tax structure.”

Pricing concerns Though the pharma sector finds the new tax reform a good step forward, veterans also recommend certain suggestions to plug certain gaps in the law.

The pharma sector unanimously voice their concern that if the rates exceed 12 per cent, price of various drugs may rise in the short-tomedium term. They suggest that the rates should remain at 12 per cent to keep the impact on pharma pricing neutral. They also believe that if appropriate exemptions are made by the GST council then the prices of drugs may remain stable for a long term.

Experts express concerns on the price of life-saving drugs which currently enjoystax exemption. They hope that they continue to enjoy the benefits as this will ensure that the impact of the new tax regime on the cost of healthcare to the patients remains positive. However, if medicines are subject to a higher GST rate, regulatory restrictions in India with respect to increasing the MRP for notified drugs, may pose a challenge to the industry.

“Presently, unless exempted, pharma products attract an excise duty of six per cent computed on MRP as reduced by 35 per cent. It further attracts VAT of five to six per cent depending upon the state on the selling price,

including excise duty. Moreover, for interstate transactions, two per cent CST is applicable. Going forward, GST (both Centre and State) will be applicable on transaction price with seamless credit available throughout the value chain. The cascading effect present under current tax regime is expected to get addressed under GST. Thus, a rate of up to 12 per cent is expected to keep price of drugs neutral, beyond that it may have inflationary effect,” explains Subramanian.

Apart from prices, the pharma sector also insists that in public interest, all anti-cancer drugs, products made from human blood plasma, drugs covered under Drug Price Control Order (DPCO) or under Essential Commodities Act, be kept free from tax. Instead of giving exemption, these drugs should attract zero rate of tax under GST. This will enable manufacturers to take credits of inputs and input services used for manufacturing these medicines and in the true sense, make life-saving drugs available to patients at affordable prices.

Insisting that the National List of Essential Medications (NLEM) must be exempted from the GST regime, Chandra says, “The drugs used to treat epidemics such as dengue, malaria, chikungunya, diphtheria, etc. must be kept out of the GST regime. India also has a huge burden of disorders like diabetes and cardiovascular diseases (CVDs). It will be a welcome step if the common drugs used to treat these are kept out of the GST regime for a long term.”

Citing that there is a proposal to keep life-saving drugs and the physician's sample out of the purview of GST, Varma says, “We have to find out what the exact rate is and what comes under exemption finally.

Any form of direct or indirect GST on free supplies could have a significant impact on the sales and promotional

spend of pharma companies, specifically those introducing new drugs. Medical professionals use these free samples to distribute and gain first-hand experience on the performance of the drugs. Model GST law provisions for free supply of drugs should be taxable.

Hence, free samples given as physician's samples for promotion could attract GST.”

A growth engine As a whole, GST will open a vista of opportunities for the pharma sector by harnessing them to digital prowess, a positive trigger which needs to be duly supported with clear government policies, initiatives and approval mechanisms to promote pharma sector in India and achieve the target, inform experts.

According to KPMG, the Indian pharma market is expected to grow over 15 per cent per annum by 2020, which in value terms will make it a $55 billion industry.

With new GST in the pipeline, the pharma sector is expected to foster exponentially as it will lead to ease of doing business. GST will ensure to bring out tax savings in multiple levels of the supply chain.

“Many pharma companies have been working in internal silos. GST will push them to undertake steps to streamline their operations. In addition to taxation, GST also brings the opportunity to look at various business processes with a much holistic approach. Pharma companies will embrace this change and growth expectations will be achieved,” says Chandra.

Subramanian sums up, “We have to wait and watch on the decisions taken by the GST Council on the few critical issues such as rate of tax and exemption, list to understand the full impact etc.

With simplified tax structure, one country one tax rate and automated compliances, GST has given a hope that it will have an advantage over current regime.” prathiba.raju@expressindia.com

MANAGEMENT INSIGHT

Encouraging IPR: Pivotal to quality healthcare Dr Amir Ullah Khan, Visiting Professor, ISB and Director, Research, Aequitas Health Consulting cautions that access to quality healthcare won’t be achieved by discouraging patents and recommends letting the private sector play a stronger role in provision of drugs and vaccines

GIVEN THE current climate, the new government is talking about increasing involvement of the private sector and on the other side there is harsh price cutting.

So the government needs to be clear in terms of its stance. There is a direct correlation between IPR and access to healthcare. It has been observed that countries with strong access to medicines have a strong IP regime and vice versa.

Intellectual Property Rights are granted to protect and incentivise innovation. In sectors such as healthcare,

innovation is key for reduction of drug prices. New compositions, molecules and formulations are by and large more effective and less expensive and therefore are tools used to universalise healthcare.

For the poor, drug prices constitute a share of medical out of pocket expenses that are often seriously debilitating. As the demand for healthcare increases, the pressure on Universal Healthcare provision requires affordable and far more easily available drugs. Towards this end, each country ought to be working towards providing the best incentive to pharma research by way of encouraging higher outlays in research and development, particularly for neglected diseases.

Medicines, their molecules and formulations are patented by drug companies that invest large sums of money in research and development. These investments often exceed one billion dollars.

Therefore, drug manufacturers claim patents, disallowing others from making the same drug. The patent law gives inventors twenty years of absolute ownership after which any other manufacturer can produce and sell the same drug.

This is what the intellectual property regime provides as incentive to innovators for sharing their inventions, their algorithms and their templates. Once the patent period is exhausted then the right to manufacture goes to every capable manufacturer and this is how human knowledge gets expanded with more people incentivised to share their secrets and

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EXPRESS PHARMA

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December 1-15, 2016

MANAGEMENT contribute to public knowledge.

The most efficient market incentive for investors and innovators has been the granting of patent rights through the patent mechanism. Inventors are encouraged to invest in research and development of new therapeutic and diagnostic methods.

Research is then shared and published in the public domain on the guarantee that it would not be copied and abused.

Patenting has resulted in millions of dollars’ worth of investment in upstream activity by drug firms working on the frontiers of diagnostics and therapy.

It is therefore immediately obvious that any limitation or cessation of property rights would further hurt the investment climate in countries that resort to quick fixes.

FDI flows definitely get impacted by any measure that gets technology owners worried, with instances such as compulsory licences. The note of caution that needs to be highlighted when studying health outcome is that the poor or the emerging economies spend very little on health, especially in terms of public expenditure. However, the out-of-pocket expenses are

Intellectual Property Rights are granted to protect and incentivise innovation. In sectors such as healthcare, innovation is key for reduction of drug prices. New compositions, molecules and formulations are by and large more effective and less expensive and therefore are tools used to universalise healthcare usually very high. While out of pocket expenses are high, they are not high because drug prices are high. The reason behind this is inability to pay. It is not about prices, it is about increasing healthcare coverage and allowing uniform access to all and it seems convenient to attribute every problem to patenting issues. It is indeed important for any study that looks at health outcomes to also look at how overall expenditure on health care increases in any country. Investment in healthcare, increase in public expenditure on healthcare, and on public health has a significant impact on the improvement of health outcomes.

What is interesting is that

with the exception of North America, the countries which rely on compulsory licenses are all those that have very low budgets for health.

They are also countries that suffer from large fiscal deficits and which is why their usual inclination is to pressurise drug firms into either reducing drug prices, or by intimidating them through the use of compulsory licenses. Most of these countries also use severe drug price controls to curb prices. The pharma sector is almost always particularly vulnerable. Drug prices are so easy to clamp down upon given the emotion and ideological basis that abounds.

The hidden costs of drug

discovery never get accounted or noticed, but are a critical component in the discovery of new therapeutic methods and more affordable treatment. By discouraging a technological climate in the country, the usage of draconian measures like compulsory licensing goes towards curbing innovation, lowering the number of patent filings, disturbing the investment climate and in driving away firms looking for new opportunities.

Patenting and protection of intellectual property has a direct impact on growth. Patents have a close correlation with per capita income as well as innovation. If we do not have an innovation climate, then new solutions cannot

emerge. In the healthcare system in India where lots of people die due to neglected diseases on one hand and non-communicable diseases on the other, a large proportion of the problem will always persist.

There is nothing that stops the state from bringing drugs under bulk procurement. This is how costs can be cut and one can meet large requirements as well as address private sector sustainability issues. Tamil Nadu’s success with procurement and inventory management is indeed a great example. If one arbitrarily cuts costs and issues compulsory licenses then one is actually striking at the root of innovation.

When it comes to provision of medicines and medical devices, private sector's role is irrefutable. There are many other ways in which the cost of medicines and equipment can come down. The bottom line is that you cannot proceed in providing universal healthcare without providing good healthcare infrastructure, larger public investments in health, or without letting the private sector play a stronger role in provision of drugs and vaccines.

REPORT

Myelofibrosis market will exceed $1 billion by 2025 According to GlobalData, the growth will be driven by factors include an increase in the incidence of myelofibrosis, and a rise in the use of drugs for the treatment of splenomegaly and constitutional symptoms THE MYELOFIBROSIS market is expected to almost double in value from $545.2 million in 2015 to $1.02 billion by 2025, representing a compound annual growth rate of 6.4 per cent, according to research and consulting firm GlobalData.

The company’s latest report states that the strength of this growth, which covers the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan, will primarily be driven by the launch of pipeline agents,

24 EXPRESS PHARMA December 1-15, 2016

including Gilead’s momelotinib, Promedior’s PRM-151, and Johnson & Johnson/Geron’s imetelstat. Other factors include an increase in the incidence of myelofibrosis, and a rise in the use of drugs for the treatment of splenomegaly and constitutional symptoms.

James Beggs, Analyst, GlobalData covering Oncology and Hematology, explains: “Incyte/Novartis’ Jakafi is currently the only drug approved for the treatment of myelofibrosis-associated splenomegaly and constitutional symptoms

in the 7MM. Currently, there are no drugs approved for patients who are refractory or become unresponsive to Jakafi treatment, and momelotinib and imetelstat are expected to contribute towards addressing this issue with launches in the second-line setting in 2017 and 2021, respectively.”

Despite this rising competition from pipeline agents, Jakafi is expected to retain its leading spot in the market, with just over 50 per cent of the market share in 2025.

Global Data expects that mo-

melotinib can ultimately only capture about 25 per cent of Jakafi’s patient share in the first-line setting, as Jakafi has the first-to-market advantage, and long-term efficacy and safety data are available.

Beggs continues, “Imetelstat, a first-in-class telomerase inhibitor, is expected to struggle for market penetration due to late market entry and the high level of toxicity shown in previous clinical trials. GlobalData estimates sales of the drug in 2025 to be only $21.2 million, representing just 2 per

cent of the myelofibrosis market in the 7MM. PRM-151, however, looks more promising in terms of expected sales. If the drug manages to demonstrate anti-fibrotic effects in myelofibrosis patients in a pivotal trial, it may reduce patients’ dependency on treatments for anaemia, splenomegaly, and constitutional symptoms, thereby fulfilling unmet needs.

In effect, it will potentially limit the growth of other drug classes in the myelofibrosis landscape.”

EP News Bureau

RESEARCH UPDATES

No early win for Sanofi,Regeneron cholesterol drug in study The trail has been designed to demonstrate that the cholesterol drug reduces the risk of serious cardiovascular events, like heart attacks and strokes

S

anofi and Regeneron Pharmaceuticals said that they would continue a large clinical outcomes study with their injectable cholesterollowering drug Praluent, confounding hopes of some investors for an early win. There had been an option for the trial to be stopped early if it showed overwhelming efficacy at the interim stage but an independent data monitoring committee recommended it should continue.

The trial involves more than 18,000 patients from 57 countries and is designed to demonstrate that Praluent reduces the risk of serious cardiovascular events, like heart attacks and strokes. Some investors had thought the drug might be so effective that the trial, called Odyssey Outcomes, would be halted at the interim point, although many analysts had viewed this as an outside chance.

Praluent could still prove itself at the final stage, when more data will have been amassed.

The treatment belongs to a new class of medicines targeting the PCSK9 protein that maintains LDL cholesterol in the bloodstream. They work differently from statins, which block the liver's production of LDL cholesterol in the first place.

Amgen sells a rival product called Repatha. Both Praluent and Repatha have been approved for sale based on earlier trials showing they lower LDL in patients whose cholesterol is not controlled by other drugs, those who cannot tolerate other drugs and people genetically predisposed to high cholesterol. Although the new drugs can slash LDL cholesterol almost 60 percent, the key to long-term demand is proof that this translates into fewer heart attacks and other cardiovascular problems in patients.

Reuters

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RESEARCH

Some respiratory infections may not need antibiotics Patients with bacterial infections were more likely to be smokers and to have lived with the cough a little longer before seeing a doctor, compared to people with viral infections ACCORDING TO a recent study, some patients with bacterial respiratory infections may be able to skip antibiotics, a recent study suggests. That's because most lower respiratory infections caused by bacteria are not much more severe than infections with other causes, researchers say.

“Physicians fear missing lower respiratory tract infection with a bacterial cause, because they generally assume that disease course is more severe and prolonged in these patients and prescribe antibiotics as a defensive strategy,” lead study author Dr Jolien Teepe of University Medical Center Utrecht in The Netherlands.

“Our results show that the illness course of bacterial lower respiratory tract infection is generally mild, uncomplicated, and similar to that of non-bacterial lower respiratory tract infection and does not warrant the immediate prescribing of antibiotics,”

Teepe added.

Antibiotics only fight bacterial infections, not viruses like colds, flu and most sore throats.

For the current study, researchers examined data on 834 adults who visited primary care providers with an acute cough and were diagnosed with lower respiratory tract infections.

Most of the participants had viral infections that wouldn’t respond to antibiotics, while 162 had bacterial infections.

Patients with bacterial infections were more likely to be smokers and to have lived with the cough a little longer before seeing a doctor, compared to people with viral infections.

Doctors generally assessed symptoms as a bit more severe in patients with bacterial infections.

None of them – even patients with bacterial infections – received antibiotics.

All of them kept symptom diaries for four weeks.

In the first two to four days after the initial check-up for the cough, patients with bacterial infections reported worse symptoms than people with viral infections, researchers report in the Annals of Family Medicine.

With bacterial infections, 27

per cent of patients felt bad enough to return to the doctor at least once during the study, compared to 17 per cent with viral infections.

But by the end of four weeks, patients with different types of infections didn’t report clinically meaningful differences in how much their worst symptoms had

improved.

One limitation of the study is that more severely ill patients were referred to a hospital and excluded from the analysis, leaving only people with milder symptoms, the authors note.

Researchers also were not able to follow the full course of the illness for 7 per cent of patients who still reported moderately bad or severe symptoms at the end of the four-week study.

Even so, the findings add to a growing body of evidence suggesting that antibiotics may not benefit people with respiratory infections, particularly when pneumonia isn’t suspected, said Dr Louise Vaz, an infectious disease researcher at Oregon Health and Science University’s Doernbecher Children’s Hospital in Portland.

“Antibiotics will be needed if there is concern for pneumonia,” said Vaz, who wasn’t involved in the study. “However, for the majority of patients presenting to

their doctor for cough, antibiotics may not be needed.”

Each time patients take antibiotics they don’t need, they also contribute to the development of superbugs that are resistant to treatment with these medicines, noted Dr Sharon Meropol, a researcher at Case Western Reserve University School of Medicine in Cleveland, Ohio.

“The bigger picture is that the more antibiotics we use for society as a whole, the faster antibiotic resistance will develop, and future bacterial infections for all of our patients will become increasingly difficult to treat,” Meropol said.

“That’s why judicious antibiotic use, using them only when they are likely to be of benefit, will preserve antibiotics’ usefulness as long as possible for each of us individually, as well as for society as a whole,” Meropol added.

Reuters

Amgen cholesterol drug reduces artery-clogging plaque:Study Patients in the study had symptomatic heart disease and blockages of 20 per cent to 50 per cent in the tested artery AMGEN'S POTENT new drug Repatha, when added to statin therapy, not only took 'bad' LDL cholesterol down to extremely low levels but caused declines in artery-clogging plaque in a majority of high-risk heart patients after 18 months of treatment, according to data from a clinical trial.

Amgen had previously announced the study was a success. But the percentage of patients who experienced a decrease of the substance that is the underlying cause of heart disease and magnitude of plaque regression was revealed at the American Heart Association scientific meeting in New Orleans recently.

The 968-patient trial compared the effect of monthly injec-

26 EXPRESS PHARMA December 1-15, 2016

tions with Repatha plus a cholesterol-lowering statin with statins alone on the plaques that can break off and cause heart attacks. The plaque measurements were collected with an ultrasound probe placed inside the diseased artery.

Patients in the study had symptomatic heart disease and blockages of 20 per cent to 50 per cent in the tested artery.

"We saw profound regression," said Dr Steven Nissen, head of cardiology at Cleveland Clinic who presented the data.

The combination therapy led to a further 60 per cent reduction in LDL levels beyond statins alone to an average LDL of a mere 36.6. That translated into a decrease in percent of blockage volume of about 1 per cent com-

pared with no change for statins alone.

In all, 64.3 per cent on the combination therapy experienced plaque regression compared with 52.7 per cent with statin monotherapy.

For those who began the trial with LDL below 70, the lowest target guideline for high risk patients, 81 per cent experienced coronary plaque regression with the addition of Repatha compared with 48 per cent for statins alone. Those Repatha patients on average saw LDL levels drop to 24 with a low of about 15.

"That's unbelievable. So when you get down to 24 you've got a really high chance of your plaques melting away," Nissen said.

Repatha and Praluent from

Regeneron Pharmaceuticals and Sanofi belong to an expensive new class of drugs known as PCSK9 inhibitors. They carry a list price of more than $14,000 a year before discounts and rebates.

Many heart doctors have been upset by barriers to access to these drugs they encounter from health insurers and pharmacy benefit managers, even for their sickest patients who meet all the criteria mandated by the US Food and Drug Administration. More than 100,000 prescriptions have been written for Repatha in the US since its approval, but two-thirds of patients are ultimately denied, Amgen said.

"It's crazy what's going on.

They've basically destroyed our

capacity to treat our patients with the drugs that we need to treat them with," said Dr Seth Baum, President of the American Society for Preventive Cardiology.

In the third quarter, Repatha had anaemic sales of just $40 million, while Praluent took in $38 million for drugs forecast to be multibillion-dollar products.

It is widely believed that payers will not lift reimbursement restrictions until they see results from huge studies designed to show that the new medicines cut the risk of heart attacks and death in addition to their ability to slash LDL levels. The Repatha outcomes data is expected in early 2017.

Reuters

RESEARCH

Heredity isn’t always destiny when it comes to heart attacks: Study But the study also confirms that genes play a key role in the risk of heart attack, regardless of lifestyle IF HEREDITY puts you at higher risk for a heart attack, maintaining a healthy lifestyle can bring that risk down dramatically, below the risk faced by some people whose genes would normally protect them from heart disease, according to a new analysis of more than 55,000 people. “We were a little surprised by how much you could offset your inherited risk by adhering to a healthy lifestyle,� said Dr Sekar Kathiresan, Chief Author of the new study, presented at an American Heart Association meeting and published online simultaneously by the New England Journal of Medicine.

The 20 per cent of the population with the highest genetic risk had a 5.1 per cent chance of having a heart attack over 10 years if they practiced a healthy lifestyle.

That was lower than the 5.8 per cent likelihood among people with the lowest genetic risk but who had an unfavourable lifestyle.

But the study also confirms that genes play a key role in the risk of heart attack, regardless of lifestyle.

Among people who practiced hearthealthy habits, the odds of a heart attack among people with a low genetic risk was 3.1 per cent over 10 years compared with 5.1 per cent when their genetic risk was high.

Among people who were obese, didn't exercise, smoked, and didn't eat a healthy diet, the heart attack rate when the genetic risk was low was almost double (5.8 per cent per decade) the baseline risk of 3.1 per cent. It jumped to 10.7 per cent when their genetic risk was high.

Because people can't alter their genetic profile and their only option is to change their lifestyle, the good news from the study is that making those lifestyle changes can have a real impact, said Kathiresan, Director at the Center for Human Genetic Research at Massachusetts General Hospital in Boston.

"Many physicians and patients assume if you have a strong inherited risk, you're destined to have a heart attack; you can't change the hand that's dealt to you in terms of genetics," he said. "But if you adhere to a healthy lifestyle, you can reduce your risk by maybe 50 per cent."

More than 55,000 people from four large databases were included in the study. To rank their inherited risk of a heart attack, the researchers tested them

for 50 genetic variants linked to a higher risk of cardiovascular disease.

People who met three or four of the healthy criteria were classified as living a favourable lifestyle. Those who met one or none were classified as having an unfavourable lifestyle.

"This is the first study to look at the interplay of both genetics and lifestyle, and how much you could offset your genetic risk with an optimal lifestyle," said Kathiresan.

Doctors have known since the late 1930s that the risk of heart disease is partly inherited. In recent years, genetic studies have refined the risks. The degree to which lifestyle changes, including quitting smoking, can reduce that risk has remained uncertain.

Among risk factors that people could alter, the researchers found that not smoking cut the overall heart attack risk by 44 per cent, not being obese reduced it by 33 per cent, getting regular physical activity dropped it by 16 per cent and maintaining a healthy diet made a heart attack 9 per cent less likely.

"People react to genetics in one of two ways," said Dr Kathiresan. "They react with fatalism, saying, 'I don't have any control. Why not go out living high?' The other way is, "I get religion and make a big set of changes.' For the first approach, that's not needed. DNA is not destiny. You still have some control. You can cut that inherited risk by more than half."

To subscribe: bpd.subscription@expressindia.com

Reuters

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December 1-15, 2016

RESEARCH

New drug capsule delivers medicine Long-lasting cholesterol lowering seen with for weeks after swallowing

Medicines Co drug: Study

The capsule, developed by researchers in the US, could be The study tested several strengths a powerful weapon in fighting malaria, HIV and other of inclisiran against a placebo in diseases about 500 patients, many of whom SCIENTISTS HAVE developed the study. This really opens the digestive tract, but too small to had had a prior heart attack or a new drug capsule that stays in door to ultra-long-lasting oral cause a blockage. the stomach for up to two weeks systems. There are a lot of excit"When the star opens up instroke after being swallowed, gradually releasing its payload.

The capsule, developed by researchers in the US, could be a powerful weapon in fighting malaria, HIV and other diseases where successful treatment

depends on repeated doses of medicine.

In a study published in the Science Translational Medicine journal recently, the researchers used the new capsule to deliver an anti-parasitic drug called ivermectin, which they believe could help fight malaria.

The long-acting pill technology could also have a range of other applications, the scientists said — from use in treating Alzheimer's disease and mental illnesses to HIV and tuberculosis.Although long-acting drug delivery systems already exist, they are either injectable or implantable, or involve an invasive procedure and are not suitable for many situations.

"Until now, oral drugs would almost never last for more than a day," said Robert Langer, a professor at MIT who worked on

28 EXPRESS PHARMA December 1-15, 2016

ing things this could someday enable.

Drugs taken orally tend to work for a limited time because they pass quickly through the body and are exposed to harsh environments in the stomach

and intestines.

Langer said he and his team have been working for several years to overcome this problem, initially focusing on malaria and ivermectin, which kills any mosquito that bites someone who is taking the drug.

The new long-acting pill has a star-shaped structure with six arms that can be folded inwards and are encased in a smooth capsule. Drug doses are loaded into the arms, and each arm is attached to a core by a linker that is designed eventually to break down.

After the capsule is swallowed, acid in the stomach dissolves the outer capsule layer, allowing the arms to unfold. Once the star expands it stays in the stomach. It is big enough to resist the forces that would normally push something down the

side the stomach, it stays inside the stomach for the duration that you need," said Tyler Grant, another researcher on the project.

In tests in pigs, the researchers found that drug

doses were gradually released over two weeks, and the linkers that join the arms to the core then dissolved, allowing the arms to break off and pass through the digestive system.

The researchers ran mathematical models to analyse the potential impact of the long-acting capsule with ivermectin.

Models suggest that if the capsules were used to deliver ivermectin along with antimalaria treatments to 70 percent of a population, malaria transmission could be cut by as much as it would have been if 90 percent had been treated with antimalaria treatments alone.

The team is working on developing similar capsules to deliver drugs against other tropical diseases, as well as HIV and tuberculosis.

Reuters

A NEW type of heart drug developed by Medicines Co significantly lowered ‘bad’ LDL cholesterol in high-risk patients with no major safety issues, according to data from a mid-stage trial that helped the company identify the dose it will move into advanced testing.

The drug, now called inclisiran, belongs to a new class of drugs that inhibit a protein known as PCSK9, which prevents the removal of LDL from the blood. But the Medicines Co drug works in a different way than the two already on the market and is given far less frequently, an important potential commercial difference if it eventually wins approval.

The study tested several strengths of inclisiran against a placebo in about 500 patients, many of whom had had a prior heart attack or stroke.

All had high LDL levels despite most being on high doses of cholesterol-lowering statins.

The study found 300 milligrams to be the minimum dose to achieve maximum efficacy, having shown itself to lower LDL about as much as the 500 mg strength. That is the dose that will be used in larger Phase III trials aimed at winning regulatory approval, the company said.

One 300 mg dose of inclisiran led to an average lowering of LDL by 51 per cent at Day 60, which was maintained over three months. Two 300 mg injections given on Day 1 and Day 90 on average took LDL down by 57 per cent at Day 120, and maintained its effectiveness over six months.

The data indicates the

drug "is likely to ensure significant and durable reductions in LDL cholesterol and could potentially impact cardiovascular outcomes," said Dr Kausik Ray, who presented the data at the American Heart Association scientific meeting in New Orleans.

Dr Borge Nordestgaard, who was not involved in the study, called the data 'really, really encouraging.'

Only 189 patients were available for evaluation at 180 days. Six-month data for all

The drug, now called inclisiran, belongs to a new class of drugs that inhibit a protein known as PCSK9 patients is expected by year-end.

Inclisiran is designed to be taken just twice or three times a year. Amgen's Repatha and Praluent from Regeneron Pharmaceuticals and Sanofi are injected either every two or four weeks.

Those drugs are antibodies that block PCSK9 from doing its job in the blood. Inclisiran utilises a technology known as RNA interference, or RNAi, that blocks PCSK9 production at its source in the liver.

Reuters

PHARMA ALLY VENDOR NEWS

Mettler Toledo opens Dubai free zone competence centre The centre will help Middle-East labs and manufacturers enhance their processes and profitability

M

ettler Toledo has recently launched its new Dubai free zone competence centre. The new facility will offer advanced analytical support for all industries operating in the Middle East and North Africa. It will also provide hands-on equipment training for Mettler Toledo’s range of products, which are designed to provide unparalleled accuracy while also saving time in busy labs and production environments.

The advanced support facility will result in process improvements that can enhance throughput and protect profits, said Jean-Claude Alder, GM, Mettler Toledo Sales International. “For example, by

improving analytical method parameters or advising clients to adjust their procedure, we can help ensure they’re meeting productivity, quality and regulatory goals in the most

cost-effective way,” he advised.

Centre experts will cover all Mettler Toledo lab products - from its precision balances to its titrators and meters. Products specifically

designed for samples characterisation, such as Mettler Toledo’s moisture analysers, UV/VIS Spectrophotometer and thermal analyser, will also be available for demonstration and use.

“Analytical products such as these find application across many industries, including petrochemicals,” Alder noted. “Additionally, certain Mettler Toledo technologies may be of particular importance to food and pharmaceutical producers at this time, as both industries are facing increasingly stringent regulatory climates,” he added.

Across all industries, centre experts will help deter-

mine if equipment being considered is right for a lab’s intended purpose. This handson environment will also help train operators so they can get started with newly-purchased equipment right away as an alternative to company-based site training.

In addition to direct technical assistance, the centre will also make it easier for Mettler Toledo to support the region’s developing industries through trade show participation. “We expect to make significant contributions to the petrochemical, food and pharma industries from this regional anchor point,” Alder said.

EP News Bureau

Avery Dennison showcases labelling products at Labelexpo India 2016 The four-day expo saw representatives from the labelling and package printing industry CALIFORNIA-BASED packaging and labelling company, Avery Dennison, showcased its new products, including a new photo-reactive adhesive technology and clear-on-clear pressure sensitive label materials, at the recently held Labelexpo India 2016 in Greater Noida.

Pankaj Bhardwaj, Commercial Director, Labels and Packaging Materials, South Asia, Avery Dennison, told Express Pharma, “We have a comprehensive range of products for the pharma sector. However,

we are displaying only the innovative products. We are displaying the TT sensor plus, a product which helps to ensure the quality of temperature-sensitive products like pharmaceuticals. A time/temperature indicator, which has a NFC chip powered by an on-board battery, allows to monitor perishable goods through the supply chain. The technology incorporates sensor functionality and temperature data logging capabilities in a cost-effective, disposable label solution. The la-

To subscribe: bpd.subscription@expressindia.com

bel’s temperature data can be uploaded to a smartphone, reviewed and sent from an Android smartphone or tablet with the easy to-use TT sensor plus mobile app.”

Elaborating on other pharma products, Bhardwaj informed that niche varieties like moist surface label products, luminescent label, low surface energy label and labels for primary and secondary blood bags are also being displayed.

EP News Bureau

EXPRESS PHARMA

29

December 1-15, 2016

PHARMA ALLY PRODUCTS

Gandhi Automations’cleanroom high speed doors for controlled environment DOES YOUR business plan include the development of an area in your plant for clean manufacturing?

Better quality or better yield is the primary reason for investing in a cleanroom space.

Numerous manufacturing facilities now require a controlled environment in which the amount of dust and dirt is limited in the area of the manufacturing. Medical instrument manufacturing and packaging, electronics and computer manufacturing, food preparation and some military applications are but a few of the instances that have strict requirements for maintaining a clean environment. Clean rooms have become integral part of pharma manufacturing facilities.

One of the most important

aspects of cleanrooms is the doors which are chosen for cleanroom facility. Time for which door is open will play a

critical factor in avoiding dust, outside temperature, humidity etc. Opening and closure of door has to be quick enough to

isolate the outside environment and internal facility.

At Gandhi Automations, cleanroom high speed doors are specifically designed for the above purpose. The cleanroom high speed doors are best suited for facilities where need controlled environment.

The opening and closing of door is quick enough to separate outside environment and internal facility.

High Speed Clean Room Doors designed by Gandhi automation are engineered carefully with feature below:◗ Concept of low air permeability in pressurised rooms with positive and negative air pressure ◗ Designed to fit inside the columns ◗ Self-supporting construction

◗ Minimises air leakage ◗ Can be equipped with transparent PVC horizontal sections or vision windows ◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h Δ 50 PA. ◗ Control device enclosure in Stainless Steel SS 316

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Contact details Corporate Office Gandhi Automations Chawda Commercial Centre, Link Road, Malad (West), Mumbai - 400064 Tel: +91-22-66720200 / 66720300 (200 lines) Email: sales@geapl.co.in

REMI launches walk-in stability chambers THE REMI walk-in stability chambers are designed for precise simulating, monitoring and control of temperature and humidity conditions required for long term, intermediate and accelerated stability studies at pharmaceutical, chemical, agrochemical manufacturing facilities. These chambers are manufactured as per GMP norms.

They are available in standard or can be tailor made to suit specific requirements. From maintaining of set parameters to documentation, these chambers meet all critical requirements.

Advantages

◗ Maintains precise long-term conditions

30 EXPRESS PHARMA December 1-15, 2016

◗ Complete solution for simulation of desired temperature and humidity in the chamber

Performance characteristics

◗ Tailor made sizes as per available space ◗ Microprocessor controlled refrigeration system and heaters provide temperature accuracy and reproducible results ◗ Temperature range 20 °C to 60 °C, Accuracy ± 1°C ◗ Humidity range 40 per cent to 95 % RH,Accuracy ± 2 per cent RH ◗ User friendly LCD screen ◗ Easy-to-read large display ◗ Integrated data logger for large data storage

◗ Variety of options for the graphic display of process parameters and utilities ◗ Real time clock for proper data management. ◗ Electronically controlled humidification system with capacitance type humidity sensors. ◗ Suitable for stability studies according to ICH guidelines ◗ Sealed toughened glass view window on door felicitates sample viewing ◗ Temperature, humidity and utility failures visual and audible alarms ◗ Remi ‘DATASOFT’ data monitoring software as per FDA guideline of 21 CFR Part 11 ◗ Stainless steel racks and trays

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Delhi: Ambuj Kumar 09999070900

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Chennai ■ Bangalore: Mathen Mathew 09840826366

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Hyderabad: Mujahid 09849039936 ■

Kolkata: Ajanta 09831182580

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December 1-15, 2016

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December 1-15, 2016

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PHARMA LIFE RECOGNITION

French Republic confers Dr Shailesh Ayyangar with the Officier de l’Ordre national du Merite Dr Ayyangar has received the merit for his outstanding achievements in business, and commitment to Indo-French relations

O

n behalf of the President of the French Republic, Alexandre Ziegler, Ambassador of France to India conferred the prestigious officier de l’Ordre national du Merite (Officer in the National Order of Merit) upon Dr Shailesh Ayyangar, MD – India and VP – South Asia, Sanofi.

Dr Ayyangar received this recognition for his ‘distinguished merit’ and outstanding achievements in the field

of business and commitment to FrenchIndian relations.

Ziegler said, “It is an honour to confer the Ordre national du Mérite on Dr Shailesh Ayyangar, a dedicated and successful corporate leader who placed Sanofi in a solid position in India, turning it into a remarkable example of Make in India, and initiated numerous projects to promote public health, particularly for children and people

(L-R) Dr Shailesh Ayyangar, MD - India and VP - South Asia, Sanofi and Alexandre Ziegler, Ambassador of France to India

suffering from diabetes.”

On receiving the award, Dr Ayyangar said, “I am privileged and honoured to be conferred with the French Government’s recognition of the officier de l’Ordre national du Merite. I owe this recognition to my entire team at Sanofi India and the trust and confidence I have been privileged to enjoy with my parent company in France. This IndoFrench collaboration in the field of medicine has helped transform scientific innovations into therapeutic solutions that empower people to enjoy a healthier life, every day.”

EP News Bureau

CAMPUS BEAT

STEERLife and Manipal University to set up Centre of Excellence for life sciences industry The Centre of Excellence will expose students and researchers to cutting edge technology capable of processing materials of the future without the limitations present in today’s solutions STEERLIFE, creator of proprietary continuous processing technology and Manipal University have announced a partnership to establish a Centre of Excellence dedicated to helping the pharma and life sciences industry transition from conventional batch processing to continuous processing thereby providing time and cost efficiencies, reducing wastage and delivering greener process.

The Centre, located at the Manipal College of Pharmaceutical Sciences (MCOPS) campus, will develop solutions in highly diversified areas of life sciences that can effectively help the industry battle problems related to regulatory burden, reject

rates, time and cost inefficiencies as well as limitations of working with sensitive and valuable materials.

“Under the terms of the partnership STEERLife will provide proprietary co-rotating twin screw technology platform and equipment, sponsor a doctoral research program and impart the requisite training.

The Centre will also engage students pursuing their Masters, Doctoral and Postdoctoral studies on research based projects and mentor them in specific areas. As part of this engagement, the identified students will spend time at STEERLife’s Pharmaceutical Development Center in Ben-

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galuru for hands-on industrial experience,” said Indu Bhushan, CTO, STEERLife.

Speaking of the partnership, Dr Babu Padmanabhan, MD and Chief Knowledge Officer, STEERLife and Founder & Promoter, STEER Group, said, “The Centre of Excellence provides a platform for the industry and academia to work together on developing innovative solutions that could transform millions of lives. Our proprietary continuous processing technology helps control shear, remove stagnation and effectively transform characteristics of bio-based and synthesised materials making pharma products, food, and

nutritional products safer and more effective. The technology when coupled with some of the most intelligent minds from Manipal University, can truly help India deliver solutions that are world class and life changing”.

The Centre of Excellence will expose students and researchers to cutting edge technology capable of processing materials of the future without the limitations present in today’s solutions.

Dr H Vinod Bhat, Vice Chancellor, Manipal University, said, “Manipal Institutions have long been distinguished for excellence in education. We strive to provide our students

with world-class facilities and real-time experiences that can help develop them into global leaders. The Centre of Excellence is one such initiative — where for the first time engineering and pharma sciences are coming together to give our students access to cuttingedge technology and expertise that has the potential to revolutionise life sciences. We are delighted to partner with STEERLife in making this a reality.”

The STEERLife Manipal Centre of Excellence is likely to commence operations on January 1, 2017.

EP News Bureau

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