Express Pharma November 1-15, 2014

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Cover Story ‘India can be an innovator as well as a leader in generics’ Market Health experts press for early introduction of injectable polio vaccine in India Management Zooming drug prices in US 1-15 NOVEMBER 2014,` 40

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CONTENTS MARKET Vol.10 No.1 NOVEMBER 1-15, 2014 Chairman of the Board Viveck Goenka

14

HEALTH EXPERTS PRESS FOR EARLY INTRODUCTION OF INJECTABLE POLIO VACCINE IN INDIA

15

ELDER PHARMA RELAUNCHES AMPM MOUTHWASH

16

BIOCON POSTS `773 CRORES REVENUE IN Q2 FY15

19

CPHI INDIA, P-MEC, ICSE AND BIOPH TO BE HELD IN MUMBAI

20

CSI WITH SIES INSTITUTE OF CHROMATOGRAPHY AND SPECTROSCOPY TO ORGANISE SYMPOSIUM

21

SOCIAL MEDIA WEEK FOCUSES ON ‘IMPACT OF SOCIAL MEDIA IN HEALTHCARE SECTOR’

22

SELECT BIOSCIENCES INDIA ORGANISES TRICONFERENCE IN MUMBAI

24

7TH ANNUAL IDMA – APA PHARMACEUTICAL ANALYSTS’ CONVENTION HELD

Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Delhi Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka

HILLEMAN LABORATORIES: AGAME CHANGER IN VACCINE TECHNOLOGY Research labs across the world are pouring moneyinto finding a viable vaccine for the Ebola virus.Asmall start up nestled in Delhi’s Jamia Hamdard Universityis also thinking big: adding value to existing vaccines bymaking them more effective for populations in developing countries | P28

Senior Artist Rakesh Sharma Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Yuvaraj Murali Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia

P17: GROWTH TRACKER IPM clocks ` 7738 crores in Sept 2014

P32: INSIGHT Zooming drug prices in US

PHARMA ALLY

38

BRIO PHARMA, IMA ORGANISE TECHNICAL SEMINAR ON ‘CAPSULE TECHNOLOGY’

38

QUINTILES WINS SOCIETY FOR CLINICAL RESEARCH SITES’ 2014 EAGLE AWARD

39

CORDEN PHARMA INKS PACT WITH SIGNET CHEMICAL CORPORATION

P34: CLINICAL UPDATES Shantha’s investigational rotavirus vaccine enters phase III clinical trials in India

P36: RESEARCH UPDATES US FDA approves first combination pill to treat hepatitis C

Scheduling & Coordination Rohan Thakkar

P66: PHARMA LIFE NEWS

CIRCULATION Circulation Team Mohan Varadkar

DRL donates ` 2 crores to Hudhud cyclone relief fund

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011. The Indian Express Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

On the ‘red list’ in Vietnam?

N

ews that regulators in Vietnam cancelled the business license of Intas Pharma in early September raises fresh doubts on the integrity of India's pharma products. A circular dated September 5, from the Drug Administration of Vietnam (DAV), a part of Vietnam’s Ministry of Health, accuses Intas of supplying low quality products manufactured at facilities which they apparently never registered with the Vietnamese authorities. Indications are that all product registrations of the company have been cancelled and a cash penalty has been imposed. This is not the first time that pharma companies from India have faced the ire of the Vietnamese health agency.

In April this year, Vietnamese authorities released a 'red list' of pharma companies whose products did not meet their standards. The list included companies from India, other Asian countries like Korea, Bangladesh, Philippines, Pakistan, and Indonesia as well as those from developed nations like US, France, Russia, Germany and Canada.

But while most countries had just a few companies on the red list, there were 45 Indian pharma companies, including industry biggies like Strides Arcolab. The sheer number of Indian pharma companies in comparison to their peers from other countries unfortunately fed into the perception that pharma companies in India will cut any and all corners possible in the quest to make a fast buck.

Officials from India's pharma export promotion council, Pharmexcil, insist that there is a simple explanation: Indian pharma companies outnumber exporters from other countries and have a larger presence in the Vietnamese market.

Export figures do indicate that Vietnam is a desirable export destination for India Pharma Inc. As per data from the Directorate General of Commercial Intelligence and Statistics (DGCIS), pharma exports to Vietnam increased from `709 crores in 2009-10 to `891 crores in 2011-12 after a dip to `691 crores in 2010-2011.

Pharmexcil officials hint that this is a larger conspiracy to discredit the quality of ‘Made in India’ pharma products but the September circular points to not just faulty manufacturing practices. Manufacturing products at facilities not registered with the Vietnam authorities goes beyond GMP violations and points to a willful noncompliance not by faceless staff manning manufacturing equipment but by management themselves. Vietnam is considered a low barrier country and India already faces tremendous competition in such markets, where the volumeplay eats into the profit margins. Unfortunately, the reputational loss from such regulatory raps impacts not just one company. Other Indian pharma companies doing business in Vietnam too will face increased scrutiny. Many distributors are

12

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November 1-15, 2014

It is abundantly clear that pharma companies in India are yet to learn from the misdeeds of their peers.Ranbaxy could lose six months of exclusive sales of generic Nexium, worth $170-$180 million,if the US FDA withholds approval of its manufacturing plants beyond end November.The writing is on the wall, but are the right people reading it?

left high and dry with huge inventory of companies on the red list and dread the backlash from consumers as well. Pharmexcil and Commerce Ministry officials have engaged with Vietnamese officials and expressed willingness to discuss the way forward. Is it a simple disconnect between two different regulatory systems and processes? Will familiarising Vietnamese drug regulators with CDSCO procedures chip away at the differences? Will visits to pharma manufacturing facilities in India erase some of their doubts?

On the political front, India and Vietnam are finding new ways to collaborate, to counter China's growing aggressiveness in the South China Sea. United against a common threat, the two countries have made considerable progress.

Consider that following the successful visit of External Affairs Minister Sushma Swaraj to Hanoi in August 2014, seven agreements were signed during the four-day state visit of President Pranab Mukherjee in mid-September. (Recall that the DAV circular was dated September 5: could this have been an attempt to queer the pitch before the Indian President’s visit?)

More recently, the Vietnamese Prime Minister’s visit to India from October 27-28 saw Prime Minister Modi reaffirm that the country was an important pillar of India’s ‘Look East Policy’. Pharma exporters will be pleased that pharmaceuticals is one of the sectors identified as a priority area for cooperation. Both premiers called for close cooperation via Regional Comprehensive Economic Partnership Agreements (RCEP) with the goal of enhancing trade targets to $15 billion by 2020.

PM Modi has specifically invited Vietnamese companies to join the accelerated economic growth programme ‘Make in India’ and reap the benefits of this new initiative. The statement agreed to utilise the Customs Cooperation Agreement, another sore point with pharma exporters who allege that customs clearance takes an inordinately long time, with some pharma products not stored appropriately. Only time will tell if and when this joint statement and the ‘warm, cordial and friendly’ interactions between the two heads of state will make any difference to the ground realities.

But it is abundantly clear that pharma companies in India are yet to learn from the misdeeds of their peers. Ranbaxy could lose six months of exclusive sales of generic Nexium, which could be worth $170-$180 million, if the US FDA withholds approval of its manufacturing plants beyond end November. The writing is on the wall, but are the right people reading it?

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET COMPANY WATCH

Health experts press for early introduction of injectable polio vaccine in India Top doctors and medical professors opine that injectable vaccine is much more effective than oral vaccine and eliminates the risk of vaccine-polio RANBAXY SCIENCE Foundation’s 32nd Round Table Conference on “Lessons from the Success of Polio Elimination” was recently held wherein top doctors and medical professors highlighted the importance of switching from the oral polio vaccine (OPV) to the injectable polio vaccine (IPV) in India beginning next year. They warned that any delay in introducing it can have detrimental effect on public health.

Dr T Jacob John, Chairman, Child Health Foundation, said, “Though we have successfully combated the menace of polio using oral vaccines containing live viruses, it has to be kept in mind that only the wild polio viruses have been eliminated from India, while the vaccinederived polio viruses still remain a threat. IPV, planned to be introduced in 2015, is inevitable if we have to prevent vaccine-derived cases of polio and achieve total eradication of the disease. Once IPV is launched to preempt circulating vaccine-derived polio virus, we can gradually discontinue OPV, starting with type 2 component.”

According to health experts, IPV, though more expensive, carries inactive forms of all three strains (Type 1, 2 and 3) of the polio virus, with no risk of virulence. In contrast, OPV carries live but weakened form of the virus which can give rise to occasional cases of polio, especially of the Type 2

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November 1-15, 2014

Health experts warned against the threat of the wild polio virus infiltrating into India from Pakistan and restarting the epidemic that was eliminated recently strain, the wild counterpart of which is now absent. Said Dr John, “IPV is much more effective than OPV in a country like India when introduced in the routine immunisation programme. Had we adopted IPV earlier, we could have banished polio years ago from our shores due to it having much higher efficacy than OPV. As India moves to IPV next year, it would be critical to achieve and retain high levels of routine immunisation in all states.”

Prof NK Ganguly, Former Director General, Indian Council of Medical Research, said, “For a successful rollout of IPV in the country, the government needs to build capacity and ensure sufficient stocks and logistics. The availability of the vaccine would be a critical factor. We also need to build advocacy among the people and have trained manpower ready from the primary immunisation field to administer the injections.”

Dr John added, “Policies on polio immunisation, polio

control and polio elimination ignored results from Indian research for too long and science continued to be neglected during programme design. The importance of science was only appreciated in 2005, followed by a flurry of science reviews and new research in tackling the problem. It was only after science offered solutions that polio could be successfully eliminated in the country. This offers important lessons for controlling other diseases like TB in India.”

According to experts, the polio programme was a success because it gave equal importance to three crucial areas of sociology, epidemiology and vaccinology. Many challenges still remain, however. India needs to sustain its wild polio-free status, prevent the importation of the virus, begin phase two (end game) of the war on polio, and withdraw Type 2 from the trivalent oral polio vaccine because it causes polio at an unacceptable frequency.

Health experts also warned against the threat of the wild polio virus infiltrating into India from Pakistan and restarting the epidemic that was eliminated recently. Prof Ganguly said, “The threat of virus importation from Pakistan is very real. Though it is now mandatory for everyone from the neighboring country to take an additional dose of polio vaccine before entering India, measures like this can only reduce the risk, not eliminate it.

The number of polio cases in Pakistan have already crossed 200 this year, the highest in more than a decade, setting alarm bells ringing. It is necessary for India to keep 100 per cent immunity status against polio until Pakistan gets poliofree. Till that happens, we have to act as if we continue to have polio in our country.”

The conference also discussed various aspects of India’s disease-control policy, data-driven strategies and interventions, polio laboratory network and economic benefits of polio elimination. Health experts such as Dr Sunil Bahl from WHO, Dr Jagadish Deshpande from Enterovirus Research Centre, Dr Arindam Nandi from Public Health Foundation of India, Dr Roma Soloman from the Core Group Polio Project, Dr Shobha Broor from AIIMS, Dr Anis Siddique from UNICEF, Deepak Kapur from Rotary International, attended the conference.

EP News Bureau-Mumbai

SignalChem Lifesciences opens facility in Bangalore RICHMOND-BASED life sciences company, SignalChem Lifesciences has opened a new research facility in Bangalore. The research facility will identify the cause of disease in each patient and determine a drug candidate that can potentially cure that disease. It will also increases the value of the company’s therapies and helps increase its intellectual property.

“SignalChem Lifesciences’ expansion into the Indian market is great news for both the company and those working in B.C.’s technology and life sciences sector,” said Premier Christy Clark. “Because of this research facility expansion, the company will need more employees at its facility in BC. This is a great example of how international economic opportunities are spurring job creation at home.”

“Our province’s biopharmaceutical sector is one of the fastestgrowing in Canada, and the opening of this new research facility demonstrates that,” said Advanced Education Minister Virk, who attended the facility’s opening ceremony as part of Premier Clark’s India Trade Mission. “I am proud to see B.C. companies like this one making a global impact by making the necessary connections to expand their businesses into new markets.”

“SignalChem has developed a technology platform to discover new drugs by exploiting protein kinases that are known to cause diseases such as cancer, inflammation or central nervous system disorders,” said Dr Akash Mathur, Chief Business Officer, SignalChem and Resident Director, SignalChem India. “These diseases impact populations world-wide and opening a research and development facility in India is a key part of our plan to address these diseases. Upon success, our plan will be a breakthrough contribution by a Canadian biotech company.”

EP News Bureau-Mumbai

Elder Pharma relaunches AMPM mouthwash Also introduces specific mouthwash for smokers/tobacco users ELDER PHARMA, in joint co-operation with practicing dentists and R&D scientists, has relaunched the new AMPM mouthwash with an addition of a range for smokers/tobacco users. It has the key ingredient ‘Triclosan’, an antibacterial and antifungal agent.

Alok Saxena, Managing Director, Elder Pharma said, “Among oral care products, the mouthwash category has seen high penetration levels with substantial market expansion even in rural and semi-urban areas.

There is a major change in the consumer tastes and prefer-

ences towards easy-to-use oral care products in the market.

Companies like Elder, focusing on advance solutions for oral health problems for the consumer, are receiving good response from the market.”

Triclosan has shown to be effective in reducing and controlling bacterial contamination and fighting germs. In addition to its anti plaque and anti cavity properties, AMPM has been designed to fight gum recession, dry mouth, tobacco odour, tartar build up and tooth staining from smoking, yellowing or browning of front teeth due to exhaling

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tobacco smoke.

AMPM is available in three variants AMPM PLUS, AMPM SPECIAL and the newly launched AMPM NICOFRESH which is specially formulated for smokers/tobacco users.

In addition to Triclosan, AMPM NICOFRESH contains sodium perborate which helps remove smoke and tobacco tar. The oxygenating effect of NICOFRESH hits one of the most stubborn sources of sulphur-producing bacteria and stops it at its source.

Elder also plans to launch mouthwashes based on natural

ingredients like aloe vera, green tea and probiotics under the AMPM range. The company hopes to garner a five to seven per cent share in the next few years.

Saxena said, “The industry has expanded with the introduction of innovative and conditionspecific products like mouthwashes for sensitive teeth, for gum care, for discolouration of teeth, for smokers etc. Increased competition from international players has also meant reaching out to the last mile population to promote products.”

EP News Bureau-Mumbai

EXPRESS PHARMA

15

November 1-15, 2014

MARKET

Biocon posts `773 crores revenue in Q2 FY15 Branded formulations records strong growth of 17 per cent BIOCON HAS recently posted the Q2 FY15 results. The biopharma segment recorded revenues of `442 crores in Q2FY15. The biopharma business continues to be impacted by various factors like geo-political challenges in terms of credit risk in the MENA region, reduced off-take of speciality API, and capacity constraints, affecting the growth of this business.

The outlook for the biopharma business remains challenging for the remaining part of this fiscal.

The branded formulations business recorded revenues of `116 crores in Q2 FY15. The vertical grew ahead of the industry reporting a robust growth of 17 per cent YoY. The growth this quarter was driven by oncotherapeutics, metabolics and nephrology divisions. The vertical continues with the strategy to drive synergies and profitable growth around key anchor brands and optimisation of product portfolios.

The research services segment recorded revenues of ` 192 crores.

Kiran Mazumdar-Shaw,

The growth this quarter was driven by oncotherapeutics, metabolics and nephrology divisions Chairman and Managing Director, stated, “The growth of our core biopharma business this quarter has been muted largely due to capacity constraints and geo-political challenges in the Middle East. However, clinical progress in our key global programs for generic Insulin Glargine and Trastuzumab is indicative of the value accretion that is realisable in the foreseeable future. The strategic investment by Silver Leaf Oak in Syngene validates the strength of our research services business and sets a good valuation bench-

mark. Whilst we continue to invest in R&D and capacity building for our insulins and antibodies portfolio, we expect branded formulations and research services businesses to drive growth in the interim.”

Peter Bains, Director Syngene International, said, “Research services delivered a sequential revenue growth of 11 per cent in Q2 FY15 reflecting steady business traction for our services. Our recent capacity additions have come online and we have a strong order book to support these in the near term. We continue to invest further across new and existing service platforms to sustain our growth curve and support the developing pipelines of our clients. A key highlight this quarter was the successful completion of a US FDA pre-approval inspection of one of our manufacturing facilities. We have, in the past 12 months, cleared two successive FDA audits with no 483s, underpinning the quality of our systems and processes” EP News Bureau-Mumbai

Indoco Remedies Q2 PAT grows by 40 per cent Domestic formulation business revenues grew by 14 per cent at `137.4 crores INDOCO REMEDIES has reported a 40 per cent growth in Profit After Tax (PAT) during second quarter of FY15 at `22.4 crores compared to `16 crores in the corresponding quarter last year. Net revenues during the quarter under review grew by 16.1 per cent to `226.4 crores as against `195 crores for the same period last year. Earnings before interest, taxes, depreciation, and amortization (EBIDTA) margins to net sales for the quarter improved to 21.5 per cent at `48.6 crores as against 16.9 per cent at `33 crores during the same quarter last year.

During Q2 September 2014, the domestic formulation business revenues grew by 14 per cent at `137.4 crores as against `120.6 crores for same quarter last year. The company’s domestic growth rate has exceeded the pharma industry growth rate of 12.3 per cent for the quarter. In this quarter, six new products were launched by the company in

the domestic market. International business revenues grew by 21.1 per cent at `81.7 crores as against `67.5 crores for same quarter last year. In the regulated markets, contribution of Europe was at 61.9 per cent, followed by the US at 21.9 per cent. Earnings per share in July’14 - Sept’14 rose to `2.43 from `1.74 in the same quarter last year.

Suresh G Kare, Chairman, Indoco Remedies said, “The company started the current financial year well and the second quarter has also delivered promising results. Apart from the boost in revenue growth, the net profit for the second quarter was also driven by improved operational efficiency which has enhanced the EBITDA margin to 21.5 per cent compared to 16.9 per cent for the corresponding quarter last year. Well laid down strategies on all business fronts have helped us in delivering good performance.”

EP News Bureau-Mumbai

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

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

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

16

EXPRESS PHARMA

November 1-15, 2014

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

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

MARKET GROWTH TRACKER

IPM clocks ` 7738 crores in Sept 2014 The Jharkhand market grew the highest at 36.4 per cent followed by Vidarbha at 32.5 per cent THE INDIAN Pharma Market (IPM) clocked ` 7738 crores in September 2014. It has seen a growth of 18.8 per cent in the same month. Amongst the top 10, Cipla grew by 38.4 per cent followed by Mankind at 30.9 per cent and Pfizer at 23.9 per cent. The company became the number one company in September.

23 corporates have crossed the growth of IPM in September amongst top 50. Amongst the top 50 corporates, Akumentis has the highest growth of 92.5 per cent followed by

Apex at 62.2 per cent and Bharat Serums at 49.9 per cent. 12 corporates showed growths more than 30 per cent amongst the top 50.

Amongst the 11-20 ranked corporates, Macleods has the highest growth of 44.2 per cent followed by Aristo at 39.7 per cent and Glenmark at 27 per cent. Amongst the 51-60 ranked corporates, Eli Lilly grows at 34.9 per cent followed

by Allergan at 31.3 per cent and Pharmed at 26 per cent.

Amongst the 61-75 ranked corporates, Boehringer grew

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by 88.8 per cent followed by Corona at 27.8 per cent and British Biological at 27.4 per cent.

Indian companies have grown at 19.8 per cent versus 16 per cent for MNCs in September 2014. Amongst the top 50 in MNCs, Pfizer grew by 23.9 per cent followed by Janssen at 18.8 per cent and Abbott at 16.7 per cent.

Under the non-NLEM category Indian companies grew at 21.7 per cent whereas MNCs grew at 17.8 per cent.

The DPCO 2013 containing

molecules market grew at 10.8 per cent whereas the nonDPCO market grew by 20.7 per cent resulting in an overall growth of 18.8 per cent for September 2014. NLEM and nonNLEM category showed positive unit growth at 6.6 per cent and 12.1 per cent respectively.

The DPCO 2013 portfolio for Pfizer grew at 6.2 per cent, GSK 12.9 per cent and Ranbaxy 19.7 per cent.

From the therapy perspective, nine therapies have outgrown the IPM growth and 18 therapies have double digit

growths. The respiratory market grew at 28.6 per cent, gastrointestinal market grew at 19.4 per cent, pain and analgesics market grew at 17.7 per cent whereas the anti-infectives grew at 23.3 per cent. The anti-diabetic market grows at 24.6 per cent and the cardiac at 13.1 per cent in chronic business. The derma market grew by 19.1 per cent and the urology market at 29.9 per cent.

From the regional perspective, 13 regions have outgrown the IPM growth. The Jharkhand market grew the highest

EXPRESS PHARMA

17

November 1-15, 2014

MARKET at 36.4 per cent followed by Vidarbha market at 32.5 per cent and Madhya Pradesh at 32.3 per cent. No region had negative growth in September 2014. Amoxycillin + Clavulanic acid market grows at 34 per cent whereas Glimepiride + Metformin grows at 13.3 per cent and is at number two.

The markets of Paracetamol grew at 28.1 per cent, Atorvastatin 14.7 per cent, Azithromycin at 39.7 per cent, Probiotic Microbes at 40.3 per cent, Cefixime 21 per cent, Pantoprazole 21 per cent, Montelukast + Levocetrizine at 36.6 per cent, Glimepiride + Metformin + Pioglitazone at 18.6 per cent, Vitamin-D at 39.6 per cent, Hydroquinone + Mometasone + Tretinoin at 13.3 per cent, Voglibose + Metformin + Glimepiride at 39.1 per cent, Telmisartan + Metoprolol at 41.3 per cent.

Mixtard continues to lead the pack with ` 35.2 crores in September with a growth of 38.8 per cent. Augmentin grows at 52.1 per cent, followed by Monocef at 45.7 per cent and Lantus at 42.2 per cent amongst the top 10 brands.

Amongst the brands who have gained ranks include Augmentin and Glycomet-GP (+1), Lantus (+9), Galvus Met (+6), TaximO (+4), Moxikind CV (+7), Spasmoproxyvon Plus (+37), Zincovit (+17), Thyronorm (+27), Novomix (+12),Panderm Plus (+77), Jalra M (+29), Sinarest (+5), Shelcal (+16) amongst Top 100 brands over September 13.

On MAT basis, Bifilac has entered into the Top 300 brands. Amongst the top brands in the IPM, Spasmoproxyvon Plus (67 per cent), Augmentin (52.1 per cent), Monocef (45.7 per cent), Taxim O (33 per cent), Aciloc (26.2 per cent),Dexorange (22.7 per cent), Liv-52(19.5 per cent), GlycometGP (14.9 per cent) grew fastest amongst the top 30 brands over September 2013 A total 283 brands were launched in September 2014. Felbinac is a new subgroup launched in the same month.

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech. AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind AIOCD AWACS’ research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

Terminologies used MAT – Moving Annual Total MTH – Month Val (Cr) – Value in Crores MS per cent – Market Share in Percentage GR per cent – Growth in percentage.

For more information, visit http://www.aiocd.net

18

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November 1-15, 2014

WITH BONUS UNITS AT FULL VALUE Val in Crs

Rank

CORPORATE

MAT Sep -14

MAT

MTH

Val (Cr)

MS%

1

1

80565 5030

Sun Pharma

2

Cipla

3

3

4343

5.39

2

4038

5.01

Zydus + Biochem Ranbaxy

4

4

3480

4.32

5

7

2908

3.61

Mankind

6

5

2899

3.60

Alkem + Cachet + Indchemie

7

6

2887

Glaxo

8

8

2729

IPM Abbott + Abbott HC + Novo

Sep-14 GR%

Val (Cr)

MS%

GR%

100.00

9.1

7738

100.00

18.8

6.24

5.8

467

6.03

16.7

15.0

378

4.89

8.9

10.3

427

5.51

38.4

8.0

312

4.03

12.0

4.9

273

3.53

15.8

10.2

305

3.95

30.9

3.58

13.8

290

3.75

19.1

3.39

-11.1

264

3.41

14.9

Lupin

9

9

2710

3.36

12.8

259

3.35

19.7

Pfizer

10

12

2348

2.91

6.3

229

2.96

23.9

Macleods

11

10

2279

2.83

21.4

244

3.15

44.2

Emcure + Zuventus

12

14

2193

2.72

11.1

191

2.47

4.9

Intas

13

13

2098

2.60

15.3

195

2.51

18.8

Aristo

14

11

2023

2.51

19.9

230

2.98

39.7

Sanofi India

15

16

1984

2.46

-0.5

180

2.32

13.2

Torrent

16

18

1779

2.21

5.4

167

2.15

18.4

Glenmark

17

15

1754

2.18

16.6

185

2.39

27.0

Dr. Reddys

18

17

1719

2.13

9.4

167

2.15

17.5

Micro + Bal

19

20

1616

2.01

12.0

143

1.85

4.6

Ipca

20

19

1470

1.82

24.7

152

1.96

22.1

USV

21

21

1466

1.82

10.0

128

1.66

7.6

Novartis

22

23

1145

1.42

-1.0

105

1.36

13.4

Alembic

23

22

1103

1.37

12.8

117

1.51

30.6

Wockhardt

24

25

993

1.23

6.1

84

1.09

7.6

Val in Crs

MAT Sep 14

Month Sep-14

Super Group

VAL IN CRS

GR%

VAL IN CRS

GR%

IPM

80565

9.1

7738

18.8

ANTI-INFECTIVES

13075

3.8

1390

23.3

CARDIAC

9961

9.3

891

13.1

GASTRO INTESTINAL

9252

10.7

874

19.4

VITAMINS / MINERALS / NUTRIENTS

7183

9.6

691

18.7

RESPIRATORY

6263

11.1

622

28.6

ANTI DIABETIC

5922

19.5

561

24.6

PAIN / ANALGESICS

5795

8.3

564

17.7 10.3

NEURO / CNS

5025

7.7

448

DERMA

4550

15.4

436

19.1

GYNAECOLOGICAL

4143

3.7

371

11.0

OPHTHAL / OTOLOGICALS

1459

11.3

141

22.2

HORMONES

1332

3.9

123

11.4

ANTI-NEOPLASTICS

1306

28.4

114

29.1

VACCINES

1149

-8.5

104

9.6

BLOOD RELATED

986

3.7

86

3.9

OTHERS

906

6.0

85

16.9

UROLOGY

819

17.3

83

29.9

ANTI MALARIALS

620

7.0

82

15.0

SEX STIMULANTS / REJUVENATORS

455

3.6

38

10.4

STOMATOLOGICALS

364

12.3

35

20.2

MARKET PRE EVENTS

CPhI India,P-MEC,iCSE and BioPh to be held in Mumbai The event from December 2 to 4, 2014 will see record participation CPHI INDIA, P-MEC, iCSE and BioPh will be held at Bombay Convention and Exhibition Centre, Mumbai, from December 2 to 4, 2014. CPhI will concentrate on pharmaceutical ingredients, P-MEC for pharmaceutical machinery, equipment and technology, iCSE for pharmaceutical contract services and outsourcing solutions and BioPh: for bio-solutions for pharma.

CPhI India will bring pharma professionals from all over the world to Mumbai

which will facilitate initiating and closing business deals.

CPhI & P-MEC India 2013 saw participation from 27,237 attendees from 94 countries across the globe. The event witnessed a record participation of 1045 exhibitors from 21 countries, spread over 55,000 sq mt in eight exhibition halls.

The exhibitor’s profile for the 2014 event include active pharmaceutical ingredients, alkaloids, amino acids, antibiotics, antibodies, antimicrobial preservatives, antioxidants, bio-

CPhI & P-MEC India 2013 saw participation from 27,237 attendees from 94 countries worldwide

catalysts, biotechnology, capsules/encapsulation, chemical synthesis/analysis, chira intermediates, coating agents, colour and dispersions, custom manufacturing, cytokines, emulsifying/solubilising agents, enzymes, excipients and drug formulation, fine chemicals, flavours and perfumes, glidants, herbal teas, hormones and synthetic substances, immunochemistry, intermediates, medicinal plants, microen capsulation, ointments bases, peptides, phospholipids,

plant/animal extracts, prostaglandins, publisher, purification and separation techniques, regulatory affairs, sera and vaccines, solvents, stiffening agents, stiffening bases, suppository bases, suspending/viscosity, increasing agents, sweetening agents, synthetic organic chemistry, tablet binders, tablet disintegrants, tablet fillerbinders, tablet lubricants, tissue culture medias, wetting/solubilising agents.

EP News Bureau-Mumbai

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November 1-15, 2014

MARKET

CSI with SIES Institute of Chromatography and Spectroscopy to organise symposium Symposium to be held in Navi Mumbai on December 18 and 19, 2014 CHROMATOGRAPHIC Society of India (CSI) has announced a two-day symposium on ‘The Application of Chromatography and Spectroscopy Techniques in Pharma and Food Analysis’ in Navi Mumbai on December 18-19, 2014 in collaboration with SIES Institute of Chromatography and Spectroscopy.

The idea of holding the two -day symposium was conceived by the CSI, mainly to bring out the significance of the various analytical techniques, that are used in the above two important indus-

tries, throughout the entire value chain of the products.

The symposium will cover the important instrumental methods of analysis in both the industries. Various contemporary subjects have been identified for this symposium and the expert speakers have been selected to cover these topics. Dr Pat Sandra, a scientist in analytical chemistry known worldwide, will deliver four major talks. Dr AV Rama Rao, a scientist turned industrialist, will be the keynote speaker at the symposium.

CSI has in the past recognised the significant contribu-

The idea of holding the symposium was to bring out the significance of the various analytical techniques, that are used in the pharma and food industries, throughout the entire value chain of the products tion of a few outstanding individuals in the area of chemistry education, research and

application of analytical instrumentation in their field of work and industrial develop-

ment. The stars of this ‘CSI Hall of Fame’ to receive the’Lifetime Contribution Award” are (Late) Dr SC Bhattacharyya, Dr Sukh Dev, Dr RT Sane, Dr RM Iyer and Dr SM Khopkar. Dr Pat J Sandra and Dr AV Rama Rao, will also be felicitated during the ensuing symposium.

On this occasion, CSI will bring out a technical souvenir publication. The authors of the chosen articles for printing will receive a certificate of appreciation and an honorarium from CSI. EP News Bureau-Mumbai

Asia Pharma Expo 2015 to be held in Bangladesh More than 470 exhibiting companies from 28 countries will participate ASIA PHARMA Expo 2015 (APE2015), the 7th international exhibition on complete pharma manufacturing technologies, is an acknowledged business platform for all companies currently having business ties with Bangladesh.

Asia Pharma Expo 2015 is scheduled to be held from January 8 to 10, 2015 at the Bangabandhu International Conference Centre in Dhaka, Bangladesh.

Asia Pharma Expo 2015 will be beneficial to all participants from local business associates to international machinery manufacturers and even API / bulk active manufacturers get benefits from participation in the exhibition.

The APE 2015 will have more than 470 exhibiting companies from 28 countries along with 8,500 square metres of floor space and 9,000 trade professionals are expected to visit

20 EXPRESS PHARMA November 1-15, 2014

Asia Pharma Expo 2015 will be beneficial to all participants from local business associates to international machinery manufacturers and even API / bulk active manufacturers get benefits from participation in the exhibition the show.

The exhibitor’s profile includes pharma processing and packaging machinery and materials, API, bulk drugs, additives, intermediates, analytical laboratory supplies (instruments, glassware, lab. reagents - chemicals), environment control equipment and services, utility, utility services and maintenance, R&D, Biotechnology, CROs, contractors – Turnkey, trade associations / trade publications, for-

mulations and contract manufacturing.

Bangladesh is one of the fastest growing economies of the world and pharmaceutical segment has always been top priority for the nation. There are more than 300 pharma multinational corporations operating in the country producing 97 per cent of the local demands for drugs. With an annual double digit growth rate, the pharma industry in Bangladesh is heading to-

wards complete self sufficiency in meeting local demand. There is a surety of steady growth in investments and sustained future development in the pharma industry in Bangladesh.

In Bangladesh, the pharma sector is one of the fastest growing sectors. In 2008 the total size of the pharma market in Bangladesh was estimated to be $700 million and is growing at a steady rate.

The pharma sector is the sec-

ond highest contributor to the national exchequer and the largest white collar labour intensive employment sector of the country. There are 245 registered pharma manufacturing companies in Bangladesh.

Today, the Bangladesh pharma industry successfully exports APIs and a wide range of products covering all major therapeutic classes and dosage forms to 71 countries.

Beside regular forms like tablets, capsules and syrups, Bangladesh is also exporting high-tech specialised products like HFA Inhalers, CFC Inhalers, Suppositories, Nasal Sprays, Injectables and IV Infusions. These products have been well accepted by medical practitioners, chemists, patients and regulatory bodies of all importing nations.

EP News Bureau-Mumbai

MARKET POST EVENTS

Social Media Week focuses on ‘Impact of Social Media in Healthcare Sector’ Patient engagement and community building are the unexplored mediums SOCIAL MEDIA Week (SMW), a worldwide event exploring the social, cultural and economic impact of social media, was recently held simultaneously in 12 cities including Berlin, Chicago, Johannesburg, London, Los Angeles, Miami, Rome, Rotterdam and Mumbai.

It focused on the impact of social media in the healthcare sector and a panel discussion on the topic was held on the third day of the Social Media Week. It revolved around the various challenges faced by healthcare and pharma sectors to reach out to their audiences through social media. The panel discussion also touched important aspects of ‘patient engagement’ and on how to make patient education more interesting.

Priti Mohile, Managing Director, MediaMedic Communications spoke about healthcare searches and conversations on social media. She mentioned that while people increasingly search for health related information, they hesitate to converse openly about their illness. Cultural and traditional aspects of our society play an important role in whatever is expressed on social platforms. Hence, interpretation of such data needs special expertise.

She also said, “There is now a shift observed when we track such conversations, the younger generation who is on social media tends to be more open. Moreover, entertaining, fun-filled stuff Continued on Page 23

EXPRESS PHARMA

21

November 1-15, 2014

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Select Biosciences India organises triconference in Mumbai Triconference witnesses 250 attendees from India and abroad DRUG DISCOVERY India 2014, Drug Metabolism & Discovery ADMET, Indian Lab Automation 2014 were recently organised by Select Biosciences India in Mumbai. The triconference had the themes Drug Discovery, Drug Metabolism and Discovery ADMET and Drug Discovery Laboratory Automation. Express Pharma was the media partner for the event.

The conference was inaugurated by Dr Rathnam Chuguturu, Founder and Chief Executive Officer, iDDPartners, Dr Harish Pant, Senior Investigator, National Institute of Health, USA, Asit Chakraborti, Professor and Head, National Institute of Pharmaceutical Education and Research and Dr Sanjay Bajaj, Managing Director, Select Biosciences India .

Over 250 attendees attended the conference from India and abroad. The attendees included drug discovery scientists both from academics and industry as well as pre-doctoral researchers. The conference saw participation from over 15 different countries and across 20 states in India. The conference witnessed over 50 talks, more than 35 poster presentations, a discussion on OSDD and a panel discussion on the topic ‘Drug Discovery Contract Research Landscape – India 2020.’

The DDI conference was divided in two tracks. Track 1 was entitled ‘Synthesis & Screening of Drugs and Phytochemicals’ and Track 2 ‘Chemical Biology Approaches to Drug Discovery’ running simultaneously in two separate halls. The Drug Metabolism and Discovery ADMET and Indian Laboratory Automation were conducted in the third hall simultaneously.

Bajaj welcomed the speakers and delegates and introduced the organisation and activities.

He informed the audience that Select Biosciences India is now doing over 100 events per year

22 EXPRESS PHARMA November 1-15, 2014

across the globe and over 15 events per year only in India. He also introduced their new events and the new activities like ‘Medha-Knowledge Contest’

which is open to all scientists.

Chaguturu said, “There is a need to expand the wealth of chemical diversity to strategically cover available chemical

space and include drug-like compounds with improved pharmacologic, pharmacodynamic and pharmacokinetic properties as compared to their

current nitrogen-rich counterparts.” This was followed by inauguration of the exhibition having participation by companies namely, Promega, Grace, Freeslate, ACD Labs, Agilent, Accelerys, Elsevier and BioScreen.

In his keynote address, Chakraborti said that his research is directed towards the implementation of green chemistry principles adopting aquatic organic reaction and nanocatalysis through the development of new concept on ensembling catalysis by binary metal nano cluster.

In another keynote address Dr Jyoti Chattopadhyaya, Professor, Uppsala University presented experimental evidence in support of the fact that water deprivation in the RNA duplexes retards its cleavage/degradation rate.

Amongst the other notable speakers were Dr Yacine Laabi - Senior Group Leader, i-STEM, France, Dr Anamik Shah, Professor/Principal Investigator, Saurashtra University, India, Dr GN Sastry, Scientist and Head, CSIR-Indian Institute of Chemical Technology, India, Dr Ashok Vaidya, Research Director, Kasturba Health Society, India, Dr Giancarlo Basile, Editor In Chief, CRDD, Italy, Dr Ian Gilbert, Professor, University of Dundee, UK, Dr Harish Pant, Senior Investigator, National Institute of Health, USA, Dr Umesh Desai, Professor, Virginia Commonwealth University, USA, Dr Maria Costi, Professor, University of Modena and Reggio Emilia, Italy.

After the first day of the conference an evening workshop entitled 'RNA Silencing for Drug Discovery-Challenges and Strategies' was conducted. Albert Li, President and Chief Executive Officer, In Vitro ADMET Laboratories while speaking on the session on Drug Metabolism and Discovery

MARKET ADMET, presented novel findings including the successful preparation of plateable cryopreserved human hepatocytes from multiple donors (pooled plateable human hepatocytes) and application of hepatocytes to evaluate hepatic metabolismdependent hepatotoxicity and non-hepatic toxicity.

On the second day, a session was held on laboratory automation in which discussions were held by application experts from companies like Agilent, ACD Labs and Freeslate.

The event also featured an open discussion on the “Collaborative and open Source drug discovery” which was initiated

by Dr Anshu Bhardwaj - Scientist, CSIR-Open Drug Discovery Unit, India followed by other experts including Shah, Dr Sanjay Batra - Principal Scientist, CSIR-CDRI, India and Dr G Narahari Sastry Scientist and Head, Indian Institute of Chemical Technology The open discussion was followed by a panel discussion on the 'Drug Discovery – Contract Research Landscape in India 2020.' Discussions were held on was the changing scenario of drug discovery in India which is moving from drug discovery towards drug development by CRO mainly for in-vitro assay development and screening and bioassays mainly for biosimilars and clinical trials. It was also discussed that there were issues related to regulatory approval for conducting clinical trials and the CROs do look forward to streamlining of the approval process in near future.

Posters presentation by Devyani Swami was adjudged the best by a panel of judges and was awarded 'Budding Drug Discovery Scientist Award 2014.' The award included a certificate, a plaque, cash prize and Free Registration for Drug Discovery India 2015, Hyderabad.

Bhasakr Balaji bagged the Best Poster Award for Drug Discovery India conference and Shalu Jhajra was the winner of The Best Poster Award for Drug Metabolism and Discovery ADMET Conference.

The event concluded with the closing remarks by Chaguturu while Bajaj presented the vote of thanks.

EP News Bureau-Mumbai

EXPRESS PHARMA

23

November 1-15, 2014

Continued from Page 21

Social Media Week focuses on ‘Impact... is more readily consumed on social media.” She also gave examples of some international case studies carried out by her company on Progeria.

Dr Aniruddha Malpani, Medical Director, HELP, spoke about the change that has taken place

in social media in India. He also emphasised that the doctor’s key focus should be patient education. Doctors should take the initiative to reach out to their patient and help them understand their health conditions. He also encouraged doctors to have their

own websites and interact with patients more. Dinesh Chindarkar, Co-Founder, MediaMedic Communications anchored the session. The Social Media Week in Mumbai helped pharma and healthcare professionals get insights on newer in-

novative ways to reach out to their target audience, build awareness in simple yet attractive format. The Indian Express and The Financial Express were the official media partners for Social Media Week 2014.

EP News Bureau-Mumbai

MARKET

17 Annual IDMA– APAPharmaceutical Analysts’Convention held th

The theme for this year’s convention was, 'Challenges in Global Quality Management' THE INDIAN Drug Manufacturers’ Association (IDMA) and the Association of Pharmaceutical Analysts’ recently organised the 17th Pharmaceutical Analysts’ Convention in Mumbai.

The theme for this year’s convention was, ‘Challenges in Global Quality Management.’

The PAC 2014 commenced with the lighting of the lamp by the dignitaries. The inaugural session was facilitated by Daara B Patel, Secretary General, IDMA. SV Veerramani, President, IDMA welcomed the delegates, guests, invitees and supporters.

The chief guest Dr Ronald T Piervincenzi, Chief Executive Officer, United States Pharmacopoeial Commission and the Guest of Honour, Dr K Bangarurajan, Deputy Drugs Controller,(I) CDSCO (West Zone) were formally introduced to the congregation by Patel.

Around 200 participants from various disciplines such as pharma analysis, quality control, quality assurance, regulatory, production, R&D, academia, marketing, media etc., including guests and invitees attended the convention. Past presidents and executive committee members of IDMA along with IPC Officials, CDSCO Officials and members of the USP also participated. The event was supported by over 15 companies including LGC Promochem, Vacs Technologies, Shasun Pharmaceuticals, Micro Labs, Fourrts (India) Laboratories, Mercury Laboratories, Alembic Pharmaceuticals, Schott Kaisha, Manish Analytical Labs, Crescent Scientific Instruments, Sotax India, Thermofisher, Pharmaffiliates, Oasis I-Tech, Conval Group & the United States Pharmacopoeial Commission.

The PAC 2014 commenced with the ceremonious lighting of the lamp by the dignitaries. The inaugural session was facilitated

24 EXPRESS PHARMA November 1-15, 2014

Around 200 participants from various disciplines such as pharma analysis, quality control, quality assurance, regulatory etc attended the convention Delegates at the event

by Patel. Patel said, “The Pharmaceutical Analysts’ Convention is a ‘movement’ conceived, organised and run by Pharmaceutical Analysts for Analysts with the active support of the IDMA Secretariat. PAC. It brings together personnel from all aspects of the industry on a common platform to discuss the achievements and future initiatives of the domestic and international pharma industry.”

Piervincenzi’s in his keynote address thanked India for providing the highest number of expert volunteers after the US which was appreciated by all the participants. Piervincenzi and other dignitaries released the 17th IDMA-APA-PAC 2014 Souvenir and the APA FORUM quarterly newsletter. The ‘Young Pharmaceutical Analyst Award 2014’ was awarded to Dr N Satheesh Kumar, NIPER. The ‘Outstanding Pharmaceutical Analyst Award 2014’ was presented to AG Raghu, Gland Chemicals. Awards were also given to JL Sipahimalani, and G Asrani, for their contribution towards IDMA’s training initiatives in technical and qual-

ity management.

The technical session was facilitated by Dr Milind Joshi, President, Global Regulatory Management, JB Chemicals & Pharmaceuticals.

Dr Nandkumar Chodankar, Chief Executive Officer and Promoter Director on Board, ASolution Pharmaceuticals delivered a presentation on, ‘Challenges in Global Quality Management – API.’ SM Mudda, Executive Director, Technical & Operations, Micro Labs spoke on, ‘Challenges in Global Quality Management – Formulations’, Rajiv Joshi, Partner, Fraud Investigation Dispute Services, Ernst & Young delivered a presentation on, ‘Eagle’s Eye on Quality Systems,’ Dr Raman Mohan Singh, Principal Scientific Officer, Indian Pharmacopoeial Commission, Ministry of Health & Family Welfare spoke on, ‘Frequently asked Queries Related to the Indian Pharmacopoeia.’ Dr KV Surendranath, Senior Vice-President, United States Pharmacopoeial Commission delivered a speech on, ‘USP Perspective on Elemental

Impurities based on general chapters (232) and (233).'

Milind Dhupkar, Business Consultant – IT, Analytics and SCM, VACS Technologies spoke on, ‘Technology for a Global Business.’ Sanjay Dasmohapatra, President – Technical and Operations, Medopharm delivered a presentation on, ‘Self Inspection and Quality Audit: An effective way to ensure compliance of practices with the laid down GMP standards.’

Dr Kavita Mehrotra, Global Head, Global Strategic Alliances, UL (Underwriters Lab EduNeering spoke on, ‘Before During and After a Regulatory Audit.’ AG Raghu, Technical Director, Gland Chemicals spoke on ‘Operational Excellence.’

R Raghunandanan, Pharmaceutical Consultant, Mumbai delivered a presentation on, ‘Criticality of Laboratory Documentation.’

Breakout sessions were held where delegates were divided into four groups, with a thought leader directing deliberations in each group. Each group elected a member to take down all the key points from the session and

create a presentation, which was then delivered by a representative delegate on behalf of the group. This session was facilitated by Kapil Bhargava, Consultant and Director, ISPE USA – India Affiliate.

Breakout session 1 was on ‘Quality Culture (Management/Involvement/Attitude),’ where the thought leader Gidy Asrani, Vice Chairman of IDMA Quality Management & Technical Sub-Committee and Founder President, Pharmacon. The breakout session 2 on was ‘Investigations and Effective CAPA Systems’ and the thought leader was Vijay Kshirsagar, Consultant, Board of Directors, ISPE. Breakout Session 3 on ‘Documentation and Records Management’ and the thought leader was Shailesh Nagarsenkar, Pharmaceutical Consultant. The breakout session 4 was on ‘Recent Challenges in Global Regulatory Management’ where Meena Shah, Senior Manager, Regulatory Affairs, JB Chemicals & Pharmaceuticals was the thought leader.

EP News Bureau-Mumbai

EVENT BRIEF NOVEMBER 2014 - MAY 2015 3

Multicentre International Data Integrity Workshop

MULTICENTRE INTERNATIONAL DATA INTEGRITYWORKSHOP Date: November 3-4, 2014 Venue: New Delhi Date: November 6-7, 2014 Venue: Mumbai Date: November 10-11, 2014 Venue: Hyderabad Date: November 13-14, 2014 Venue: Bangalore Summary: Members of the US Food and Drug Administration along with other international regulatory agencies such as the European Directorate for the Quality of Medicines & Healthcare (EDMQ) and others will be hosting a two-day workshop. It will provide an opportunity to build awareness for regulatory agencies and industry regard-

ing the importance of integrity in pharmaceutical science.

The workshop will include focused discussions related to trends concerning data integrity, and the exploration of potential solutions.

Contact details: Manoj Trivedi Sr Manager (Mktg & Program Development) DIA (India) Mob: +91 9819777493 Email: Manoj.Trivedi @diaindia.org

ASIA PHARMA EXPO-2015 Date: January 8-10, 2015 Venue: Bangabandhu International Conference Centre, Dhaka, Bangladesh

To subscribe: bpd.subscription@expressindia.com

8

Asia Pharma Expo-2015 Summary: Bangladesh Association of Pharmaceutical Industries will host international exhibition on South Asian Pharmaceutical industry, Asia Pharma Expo-2015.

The exhibiting companies from more than 26 countries across the world are expected to participate.

The expo will be accommodating 400 booths to the exhibitors. Major OEM suppliers from Asia, Europe and the US are likely to participate.

Contact details: Tel: +91 7940008233/ 53 Mob: +91 8000481114 Email: ceo@GPEexpo.com Website: www.asiapharma.org

13

PHARMA Pro & Pack Expo 2015

PHARMA PRO & PACK EXPO 2015 Date: May 13-15, 2015 Venue: Mumbai Exhibition Centre, Mumbai Summary: PHARMA Pro & Pack Expo 2015 will be organised by IPMMA. 20,000 pharma trade professional/ decision makers and 250 industry majors will exhibit their technologies/ services. Visitors' profile include biotechnology specialists, plant management, CEOs, engineers, technocrats and scientists, policy makers, diplomats and foreign commercial corp, compliance, process engineering, corporate management, procurement department, custom manufacturing/ marketing

services, purchase officers, equipment suppliers and distributors, quality assurance/ quality control, maintenance engineering, R&D professionals, manufacturing/ production engineering, regulatory officers, operations management, validation, packaging engineering, vendor development, pharmacists.

Contact details Indian Pharma Machinery Manufacturers’ Association (IPMMA) 52, 1st floor, Suyog Industrial EstateLBS Marg, Vikhroli (West) Mumbai - 400 083 Tel: +91 22 6561 9272/ 2578 6007/ 2685 5108

EXPRESS PHARMA

25

November 1-15, 2014

cover ) I N T E R V I E W

‘INDIA CAN BE AN INNOVATOR AS WELL AS A LEADER IN GENERICS’ Dr Swati Piramal, Vice Chairperson, Piramal Enterprises stresses on the need for new government policies in an interaction with Viveka Roychowdhury

Piramal Healthcare has announced that it is re-focussing on late-stage research rather than early-stage research. What is the future course for the pharma sector in India? Is it doomed to be an imitator rather than an innovator?

Piramal Enterprises will continue to focus on drug development. It is only downsizing drug discovery in Mumbai but will continue research and development in nine other facilities. These include Ahmedabad, Hyderabad, Chennai and Indore and five facilities in the US, the UK and Germany.

India can be an innovator as well as a leader in generics. However, to be an innovator all parts of the ecosystem including clinical trials, intellectual property, research tax credits etc must also be developed. These depend heavily on a forward looking government policy. It is clear that extensive price controls deter innovation.

You and many industry leaders have been critical of the indecision surrounding policy change, an attitude of not consulting the industry. What are your expectations from the NaMo government? Can he and his team reverse this trend?

Indeed, activists have not invested anything in making medicines.

Scientists spend most of their life studying only a part of a human cell, they fail 99 times out of 100 of

26 EXPRESS PHARMA November 1-15, 2014

discovering and successfully launching a drug, the process takes 12 years at least. People are not aware what it takes and the years of hard work that go into making a tiny pill that has the power to cure disease. We are hopeful that the NaMo government will be alerted by falling investment in new manufacturing, slow domestic sales. Again the new government must call a halt to increasing price control as that is short-sighted. Instead focus on better distribution and buying strategies by state governments.

What about the industry’s attitude to implementing GMP and GCP guidelines. Have unscrupulous players who took advantage of the regulators’ inability to implement and enforce these standards, come to define the industry’s standards?

Indeed, small operators and manufacturers have defied the norms set by the regulator particularly relating to GMP guidelines. Larger

companies who make the same standards of drugs whether the consumer is Indian or foreign are subjected to price controls where the price offered by these kind of poor quality operators is compared to the best quality ones. It is like comparing apples and oranges though the medicine has the same generic name.

Is this the reason for the ‘Look West’ policy of Indian pharma leaders in total reversal of the ‘Look East’ to India policy, which was touted just a couple of years ago?

The India Advantage - the promise is being lost and Indian companies are looking West as regulatory bottlenecks are stymying the promise of Look East.

India can make drugs for a tenth of the cost in the West for the six billion people in the world who cannot afford Western prices. Indian pharmaceuticals can reduce the burden of disease not just in India but globally. The biotechnology and life

We are hopeful that the NaMo government will be alerted by falling investment in new manufacturing, slow domestic sales

sciences sector can follow the IT sector and India can become the centre of innovation and be the drug maker for the whole world.

However, the mind-set of price control and low consumer prices continues and hampers the great potential of Indian technology to make enormous gains on public health. In five years if this industry is not liberalised and competition not allowed, most of the drugs will come from the West at even higher prices.

Tropical diseases will have no cures and the ordinary consumer shortchanged by a leadership that is shortsighted. Most of the scientific talent will not reach its full potential unless this sector is liberalised. Research needs investment and this is the time to make these investments or countries like China will win the race hands down. World class clinical trials need to be done in India to develop the ecosystem of innovation.

Any quick fix solutions? And longterm measures you would like to suggest?

A hard look needs to be taken by the government. With different ministries - health and pharmaceuticals, environment and commerce and law - all need to iron out the bottlenecks. The status quo cannot continue if we want to once again regain global leadership in the pharmaceutical sector.

(

THE MAIN FOCUS

Express Pharma completes 20 years this December. In these two decades, the pharma industry in India has survived the TRIPS threat, has thrived through the economic meltdown, and has tapped the potential of patent cliffs to emerge as a global generics powerhouse. What should be our next avatar? How do we future proof ourselves for the next threat, the next decade?

I dream of an India that can Make new drugs that heal Our citizens, cancer or diabetes Tuberculosis or malaria That in sickness and wellness Medicines will prevent and help Reduce the burden of disease.

We cannot afford to move like a snail The boat buffeted by the wind In all directions and no direction We need to steer a ship to a Glorious future, a great country Where India is the Medicine-maker for the world.

I congratulate Express Pharma for being a staunch supporter of progress in the pharma industry. viveka.r@expressindia.com

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cover )

Research labs across the world are pouring money into finding a viable vaccine for the Ebola virus. A small start up nestled in Delhi’s Jamia Hamdard University is also thinking big: adding value to existing vaccines by making them more effective for populations in developing countries

BY SHALINI GUPTA

T

he recent outbreak of Ebola virus disease (Ebola) has brought to the fore the importance of vaccines as a tool for public health as companies are gearing up to be the first in line. However, unlike drugs, developing a vaccine is not easy. While the search for vaccines begun with diseases such as smallpox, cholera, rabies, measles etc, today the unmet needs lies in having vaccines against malaria, herpes, flu and even for diabetes and cancer. Yet, despite the huge

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public health impact that they create, they present both a tremendous opportunity and a challenge. In an important development, Novartis recently sold off its vaccines division to GSK, with a long standing expertise in the area.

Collaboration is the word What is needed today is not only the development of novel vaccines, but optimising existing vaccines to better suit the needs of populations across the globe and this is where Delhi-based

Hilleman Labs comes across as an interesting example of venturing into formidable territory with a strategy few can match.

In 2006, two oral vaccines, Rotarix by GlaxoSmithKline and RotaTeq by Merck, both against Rotavirus infection A were shown to be safe and effective in children. They contained genetically engineered live attenuated human rotavirus strains or hybrid human-bovine re-assortment rotavirus strains. Three years later in 2009, WHO placed rotavirus on its list of critical

immunisations for all its national programmes.

Taking cognisance of these developments, the same year saw the inception of Hilleman Labs, an R&D joint venture set up by the Wellcome Trust and Merck with a not-for-profit mission to focus on developing affordable vaccines to prevent diseases that commonly affect low-income countries. Fast forward to 2014 and in July this year, Prime Minister Narendra Modi added four new vaccines to India’s Universal Immunisa-

tion Programme (UIP) including rotavirus (rubella, injectable polio and Japanese encephalitis) which further underscores the importance of the path Hilleman has committed itself to.

Today this small start up company with a staff of less than 50 people has a pipeline of two prominent vaccines, one for rotavirus and the other for cholera. Both the vaccines are in the pre-clinical stage, undergoing toxicology studies which will finish by the end of this year.

There is still a long way to go,

(

THE MAIN FOCUS

A researcher working hard on a thermostable rotavirus vaccine

and Hilleman Labs is not one to take short cuts. Traditional pharma models have a bench to bedside approach negating any outside influence, implying they shoulder all the risk of developing the product and taking it to market. However, Hilleman Lab’s approach is different.

“The pharma model says, we know what the problem is, we know how to solve it and we can fix it ourselves. There is this inherent notion that the entire spectrum of the solution resides within the organisation and hence by virtue of that the burden of risk is huge. We are promoting a collaborative model.

Even as we bring a unique perspective to the vaccine space, we realise that we don't have the expertise for the entire spectrum and so we need collaboration. Together we are more likely to solve the problem than by doing it ourselves and attract

funding and support. Secondly by doing this, we are reducing the risk since we have other partners who have the expertise,” elaborates Dr Davinder Gill, Chief Executive Officer, Hilleman Labs.

He took over in January 2012, when there was a shuffle in the management and helped formulate a roadmap and vision. With an experience of close to 15 years in the pharma industry ranging from start ups with as less as 15 people to multinational companies, he has seen the innovation, rigour and skill required for R&D and drug development from close quarters.

He was also involved in setting up R&D facilities for Hilleman Labs in Europe, namely Ireland and Scotland, working with the local

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“We are promoting a collaborative model. Even as we bring a unique perspective to the vaccine space, we realise that we don't have the expertise for the entire spectrum and so we need collaboration” Dr Davinder Gill, CEO, Hilleman Labs

government. However, a lot of foresight has gone into setting up the India operations and it wouldn’t be incorrect to say that it has rightly put its money where its mouth is. “Unlike Biotechs which don't hesitate to put their money behind a crazy idea, our concept was that we would not begin on a project unless we had a clear line of sight on its public health impact as well as utility to a larger population,” he chips in.

David Vs Goliath?

Unlike drugs where even small companies are manufacturing niche therapies, vaccine companies have traditionally been into the business and are huge.

GSK, Merck and Sanofi to name a few. So is Hilleman Labs trying to take on these

Goliaths? The answer is no. It is not trying to fulfill a significant unmet need, in say, malaria, HIV, tuberculosis, or dengue and try to come up with something novel, but rather optimising existing vaccines, rotavirus (for thermo-stability) and cholera (making it more affordable). It is about combining the manufacturing aspect with the thermostability aspect. It hopes to achieve a proof of concept in the next five years as the candidates enter the orbit of advanced clinical development soon.

Having chosen such a goal, getting there must be fraught with challenges especially in the Indian ecosystem with a resource crunch and inadequate infrastructure even as one has to carry out cutting edge R&D of global standards. This is where a focused approach and SWAT anaylsis comes in.

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cover ) A biotech company in India usually begins with an idea that originates at an academic lab somewhere and the company is put together. It was the other way round for Hilleman Labs, it was decided that it would focus exclusively on translational R&D in the vaccine space.

Rather than taking up complex diseases such as HIV, malaria, TB, where the likelihood of success over a period of say 10 years is small, it took over the mantle of putting a twist to existing vaccines.

“Working in a tiered approach, we broke down our future in five year cycles and decided that right at the outset, lets take those products that do exist, but they aren’t necessarily designed or optimised for the use of the developing world. By doing so, we’d have established ourselves by building capacity and capability. In the next fiveyear cycle, we could envision taking up new things, that don’t exist, that includes novel vaccines,” echoes Gill. Zeroing upon this approach took time, picking and choosing the right targets, but it is more practical and is being executed to a T right now.

“We looked at mortality data for infants less than one year of age for countries like India and found that they either have severe respiratory or gastrointestinal infections. Thats where we decided on enteric diarrhoeal disease as an area to focus on so that is where rotavirus, cholera and some of the other things fit in,” he adds.

The biggest risk in vaccine R&D is technical- will the innovative idea on paper ever become a product or not. With reference to thermostable vaccines, there were two schools of thought. One is that we need thermostable vaccines and other asks why? Partnership was crucial to scale up this innovative approach. Hilleman Labs understood early on that it doesn’t have all the pieces of the puzzle and its absolutely fine to be in that spot. It partnered with Gotovax AB, a biopharmaceutical company, spun off from the University of Gothenburg, early this year for its cholera vaccine.

The company today is an

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Scientists busy working at Hilleman Labs

With India topping the list of developing countries including Indonesia, Pakistan and Nigeria when it comes to rotavirus infections, the opportunity is huge. Sub-Saharan Africa, South-east Asia, Bangladesh and China are other promising markets amalgamation of these three strategies: a tiered approach, focus on enteric diarrhoeal diseases and the partnership model which not only helps it leverage its resources but also reduce risk. It has been able to crack that strategy and able to demonstrate technical excellence with both the programmes in pipeline. Partnership for manufacturing and commercialisation is crucial and it has already begun talks with manufacturers within and outside India to see these projects through to commercialisation through both national level and procurement agencies.

Miles to go before hitting the market 20 years back a set of guidelines from WHO were available to countries for expanded immunisation programmes. It was when agencies like The Global Alliance for Vaccines and Immunizations (GAVI) stepped in, that vaccination came top on most countries priority list

from a public health perspective. The challenges of today are in the implementation looking at the size, scale and heterogenity of the population as well as health, education, sanitation, infrastructure in countries etc. “A country like India is stepping into a Catch 22 situation. While at the national level the government is struggling to see that 95 per cent of the babies born annually get vaccinated, at the grassroot level, vast majority of mothers aren't aware of the benefit of vaccination,” envisions Gill. However, he is positive that 20 years from now, we shall see more awareness.

As companies come up with newer and innovative vaccines, two factors will be differentiator: affordability and efficacy.

“How can one come up with novel processes to make complex vaccines cheaply? Once this question has been addressed, there will be a strong demand for vaccines that are just as effective in low resource countries as they are in devel-

oped countries,” he feels. The company itself is looking at how oral vaccines can be combined and delivered, be it through innovative delivery systems or reducing dosing regimen, maximising the impact of multiple vaccines using the most efficient delivery mechanisms.

However, this might not always be possible, since not all pathogens affect us at the same time in our lives. For e.g. India has a lot of rabies vaccines, used sparingly due to an eight dose regimen which is difficult to adhere to. The holy grail is a one dose vaccine, however, considering how the immune system works, it remains to be seen how that can be a reality.

Cold chain storage and distribution presents another formidable challenge. It takes approximately a year for a product to reach a primary healthcare centre when it starts out from a government medical store. This creates a forever increasing burden, as the birth cohort increases and more vac-

cines are added to the system.

Having a thermostable vaccine which can survive at 45 degree celsius for a year and bypass the system, such as Hilleman Lab’s rotavirus vaccine could have a profound impact. As per projections by UNICEF, by 2016, 180 million doses of rotavirus vaccine will be required just for the GAVI public market.

Adding the GAVI private market and India to this would total 250-300 million doses per year. The company hopes to create a dramatic impact even if it is able to cater to one fifth of this market to begin with.

With India topping the list of developing countries including Indonesia, Pakistan and Nigeria when it comes to rotavirus infections, the opportunity is huge. Sub-Saharan Africa, South-east Asia, Bangladesh and China are other promising markets. With notable rotavirus vaccines already in the market, how important then is it to be first to market? Gill feels that unlike drugs, in the vaccine business, the first in class, is not necessarily the best in class.

“I'd strongly argue that for the developing world the product that is actually going to win in the end is the best in class. That means a product which is safe, affordable and ranks good in field adaptabilty,” he exhorts.

Hilleman Labs is surely a company to watch out for in the coming years. It has set up an ambitious target for itself and is galloping fast towards its goal.

However is in no hurry to reach there, lest there be any compromises. Gill is hopeful that the clinical trial scenario in India is on the brink of a change and this should bode well for the company whose products are soon to reach that stage. “In the next stage, we are looking at successful completion of our programmes as well as incorporating new ideas into our R&D portfolio. Through a combination of those, we aim to achieve our operating goals to make ourselves financially sustainable in the long run while staying a lean and agile biotech company,” he concludes. shalini.g@expressindia.com

MANAGEMENT INSIGHT

Zooming drug prices in US A molotov cocktail of higher demand and lowered supply is believed to have caused an explosion in generic drug prices in the US, making affordable healthcare yet more inaccessible, say Bhavik Narsana, Partner, and Arijeet Mukherjee, Associate, Khaitan & Co1

P

ricing of drugs has been one of the most talked about topics in the recent times in India, whether it is a company’s strategy on pricing or the regulator controlling the prices of drugs.

Unlike the Indian pharmaceuticals market, the American market does not have price control regulations i.e., it is a freely competitive market where prices of drugs are determined by market forces of supply and demand.

In the US, the price control of the drugs has been opposed mainly on the grounds that this would cut revenues and consequentially affect innovation.

There are advantages and disadvantages in regulating drug prices. Controlling prices would probably lower the prices, cutting pharmaceutical company’s revenues and with that it will also affect its ability to carry out research and development activities for new drugs. Therefore, it becomes a choice between lower drug prices versus jeopardising long-term innovation. Regulators face a challenge of striking the right balance between the two.

In the American scenario i.e., the unfettered free market scenario, various factors such as demand and supply of products, closing down of production plants, etc. (discussed later in this article) have had an effect on the price of generic drugs.

32 EXPRESS PHARMA November 1-15, 2014

US pharma market The American pharma market is the largest and most developed market in the world. For several years this market has been characteristic of cutting edge innovation, research and development. In 2013, it was estimated that certain American drug companies have spent around $51 billion in research and development.2 American corporations also happen to hold intellectual property rights on most new medicines.3 In 2012, the pharma market of North America was roughly worth $348 billion,4 making it

the largest pharma market worldwide. American pharma giants such a Pfizer, Abbott, Merck, Wyeth and Bristol-Myers Squibb have made their global presence felt and are considered amongst the largest healthcare companies worldwide.

Though the American pharma industry figures seem impressive, the availability of affordable healthcare in America has remained, for most, an unachieved American dream.

It is an open secret that despite having one of the largest pharma bases in the world, the healthcare costs in the US are

amongst the world’s highest.

In 2011 itself, the per capita healthcare expenditure of the US was above $8,500,5 much higher than any other industrialised country.

The primary reason for the burgeoning healthcare expenses are the costs of drugs in the US, stated to be one of the highest in the world.

Recently, the prices of generic drugs in the US have skyrocketed. This increase in prices in some cases is more than 800 per cent, a case in study is that of the drug ‘Xyrem’ manufactured by Jazz Pharmaceuticals and used for Narcolepsy symptoms. This drug has seen a price rise of 841 per cent from 2007 to 2014, which means that what used to cost about $2 in 2007 now costs over $19.6 This multifold increase in prices of drugs pushes affordable healthcare out of the reach of millions of Americans.

Recently, a Congressional investigation has been initiated into why the prices of these generic drugs are on the rise.

On the scanner of this investigation are three Indian manufacturers: Dr Reddy’s, Sun Pharma and Cadila Healthcare.

Supply and demand In a free market, price is a function of supply and de-

BHAVIK NARSANA, Partner, Khaitan & Co

ARIJEET MUKHERJEE, Associate, Khaitan & Co

mand. In the present situation in the US, the generic drug prices are spiraling out of control in America due to an upward push in demand and a downward push in supply.

The demand for generic drugs has gone up due to their price competitiveness. Generic drugs not only cost lower, but sometimes cost just a fraction of what their branded counterpart costs.

The introduction of Patient Protection and Affordable Care Act, 2010 also popularly known as ‘Obamacare’ would lead to greater emphasis on the prescription of generic drugs to reduce healthcare costs and increase access to healthcare. In 2013 nearly 86 per cent i.e. four out of five prescriptions in the US were for generic drugs.7 This coupled with an increased presence of generic alternatives to branded drugs in the market have put an enormous upward pressure on the demand curve.

To have price stabilisation, an increased demand of generic drugs must be met with an increased supply. However, the supply has not increased or remained the same, rather the supply has fallen.

Such fall of supply may be attributed to the recent increase by the US FDA of its investigation and enforcement activities in relation to generic manufacturers located outside the US. A case in example is Ranbaxy, which supplies generic drugs

to the US, has recently had four of its manufacturing plants banned by the US FDA.8 India may have the maximum number of US FDA approved plants outside the the US, but India is not the only country facing the ire of such US FDA inspections and enforcements. Manufacturing facilities in Australia, Canada, the UK, Brazil, China, Austria, Germany, Netherlands, Ireland, and Spain have also been hauled for non-compliances.9 The US imports around 40 per cent of the finished drugs and nearly 80 per cent of the active pharma ingredients it needs, with plants being banned and warning letters being issued, the supply has gone down.

This molotov cocktail of higher demand and lowered supply is believed to have caused the explosion in drug prices in the US, making affordable healthcare yet more inaccessible.

User fees for generics In 2012, the Generic Drug User Fee Amendment (GDUFA) was brought into the Food and Drug Administration Safety and Innovation Act. The GDUFA was designed to speed up access to safe and effective generic drugs to the public and reduce costs to industry. The law requires the generic drug industry to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. Additional resources will enable the agency to reduce a current backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.10 For the first time US FDA was to receive funding from the generic drug industry. It was estimated that this ‘user fee’ would generate about $299 million each year from 2013 to 2017, which would supplement the resources of the US FDA and help in assessment of the generic drugs. The implementation of this ‘user fee’ was supported on the ground that a well-resourced US FDA will be able to inspect and approve

generic drugs expeditiously.

Though the system of ‘user fee’ was applauded by many, it is widely believed that this may be a factor contributing to rising prices of generic drugs in the US. As generic firms pay higher user fees for getting an approval, in a free and uncontrolled market they pass this cost to the ultimate consumers, thereby increasing the prices of the generic drugs, which ironically is contrary to the main intent of levying user fees in first place.

Once all the provisions of Obamacare are brought into effect, it would drive a demand for generic drugs

Disproportionate rebates In America there is a system of rebates wherein insurance providers / pharmacy chains / government programmes such as Medicaid (for families and individuals with low income and resources) and Medicare (mainly for persons above 65 years) negotiate with pharma manufacturers and are given a rebate. In the past, this rebate has been a substantial chunk of the cost.11 However, it is believed now that rebates have not increased proportionately to the increase in prices of drugs, thereby not countering the effects of price increase.

Further, these rebates are only usually offered to the insurers and government programmes, and not to the individuals.

This rebate and price increase disparity is having a rippling effect and experts believe that this is further pushing up the cost of health insurance and co-payments in America.

Obamacare demand Generics have played an important financial role in the American pharma markets, as per the Generics Pharmaceutical Association situated in Washington, the use of generic prescription drugs instead of their branded counterparts have saved the US healthcare system around $931 billion from 2001 to 2010.12 There is an increasing reliance on generic drugs pushing up their demand, in 2013 alone nearly 86 per cent i.e. four out of five prescriptions in the US were for generic drugs.13 Once all the provisions of Obamacare are brought into ef-

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fect, it would drive a demand for generic drugs even further as generics would be more sought after due to their price advantage. In the absence of an increased supply to meet this demand, the prices for generics may spiral further; however, they will continue to remain lower than their branded counterparts.

cations on the Indian generic manufacturers as well and the large workforce it employs.

What’s next An interesting debate has opened up with the Congressional investigation into the generic drug price increase issue: would the investigation report recommend price control and would the US, the campaigner of free market philosophy, join the league of countries which regulate drug prices. In the past the pros and cons of price control in the American drug industry has been debated heavily and even studies carried out to see the effects of price regulation in OECD countries on the US.15 If the Congressional investigation finds a discrepancy in drug pricing, it would be interesting to see what would be the next step that would be taken and how the landscape of the world’s largest pharma market changes.

The India nexus This scenario of increase in drug prices in the US has a strong India connect.

Three of the companies under Congressional scanner are Indian generic pharmaceutical companies (Dr Reddy’s, Sun Pharma and Cadila Healthcare).

Around 40 per cent of the generic drugs in the US come from India and with Obamacare coming in this figure is set to rise further.14 India has the largest number of US FDA approved plants outside the US. US FDA inspection and actions have targeted many Indian production plants, affecting supply in the American market.

The levy of ‘user fee’ in the US is said to affect Indian generic companies as well.

Capitalising on the generics demand, many mid and small- level Indian pharma companies are entering the American market.

This Indian nexus with the drug price increase in America ensues that the steps the American government takes on this issue will have ramifi-

References 1. Bhavik Narsana is a partner and Arijeet Mukherjee is an Associate in in Khaitan & Co, Mumbai, they are members of Khaitan & Co’s pharmaceutical and life sciences specialty practice. They can be contacted at pharma@khaitanco.com.

2.“2014 Profile of Biopharmaceutical Research Industry” by Pharmaceutical Research and Manufacturers of America.

Please see (http://www.phrma.org/sites/default/files/pdf/2014_PhRMA_P ROFILE.pdf) 3.“The Pharmaceutical and Biotech Industries in United States”. Please see (http://selectusa.commerce.gov/industrysnapshots/pharmaceutical-andbiotech-industries-united-states) 4.As per IMS Health Market Prognosis, June 2013. Please see (http://www.imshealth.com/deployedfiles/imshealth/Global/C ontent/Corporate/Press%20Roo m/Total_World_Pharma_Market_Topline_metrics_201217_regions.pdf) 5. Centre for Disease Control and Prevention data. Please see (http://www.cdc.gov/nchs/fastats/health-expenditures.htm) 6Drug Prices Soar for Top

Selling Brands” by Bloomberg.

Please see (http://www.bloomberg.com/infographics/2014-05-01/drugprices-soar-for-top-sellingbrands.html#humulin-r-u-500) 7. “The Reality of Prescription Medicine Costs in Three Charts”

by Pharmaceutical Research and Manufacturers of America.

Please see (http://www.phrma.org/catalyst/the-reality-of-prescriptionmedicine-costs-in-three-charts.)

8.USFDA. Please see (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm382736.htm) 9.“US Regulatory Warnings on Drug Producers Extend Well Beyond India”. Please see (http://www.thepharmaletter.co m/article/us-regulatory-warnings-on-drug-producers-extendwell-beyond-India) 10.USFDA. Please see (http://www.fda.gov/ForIndustry/UserFees/GenericDrug UserFees/default.htm) 11.“Inside The Secret World of Drug Company Rebates”.

Please see (http://www.forbes.com /sites/matthewherper/2012/05/10/why-astrazeneca-gives-insurers-60-discounts-on-nexiums-list-price/) 12.“An Economic Analysis of Generic Drug Usage in the US”

by Generics Pharmaceutical Association. Please see (http://www.tevagenerics.com/a ssets/base/pdf/Savings,AnEconomicAnalysis.pdf) 13.“The Reality of Prescription Medicine Costs in Three Charts”

by Pharmaceutical Research and Manufacturers of America.

Please see (http://www.phrma.org/catalyst/the-reality-of-prescriptionmedicine-costs-in-three-charts) 14> “Obamacare Has Hidden Benefits - For India”. Please see (http://www.bbc.com/news/worl d-us-canada-24407452) 15. “Pharmaceutical Price Controls in OECD Countries Implications for U.S. Consumers, Pricing, Research and Development, and Innovation” by US Department of Commerce International Trade Administration.

Please see (http://www.ita.doc.gov /td/chemicals/drugpricingstudy.pdf)

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RESEARCH CLINICAL UPDATES

Shantha’s investigational rotavirus vaccine enters phase III clinical trials in India The live, oral, ready-to-use tetravalent rotavirus vaccine candidate is designed to protect young children from severe diarrhoea SANOFI PASTEUR, the vaccines division of Sanofi, announced the start of a phase III clinical trial in India for its investigational rotavirus vaccine, developed and manufactured by its affiliate Shantha Biotechnics in Hyderabad. The trial is designed to show non-inferiority against a currently licensed vaccine with the use of three, ready-to-use liquid doses administered orally, starting from six-to-eight weeks of age, with the subsequent doses administered at four weeks intervals.

Close to 1,200 volunteers are being sought at 12 clinical trial sites in India. Shantha’s investigational rotavirus vaccine includes antigens against serotypes G1, G2, G3 and G4.

A phase I/II study was carried out with the long-term aim to produce a locally licensed vaccine that is safe and able to protect children against rotavirus gastroenteritis. Overall, the results showed that all three doses of the vaccine evaluated in the study were safe, well tolerated and displayed good immunogenicity (dose–response) in healthy Indian infants.1 Olivier Charmeil, President and Chief Executive Officer, Sanofi Pasteur, said, “We aim to provide an affordable vaccine to meet the still significant medical need in emerging markets.”

The World Health Organization (WHO) recommends that vaccination with rotavirus vaccines should be included in all national immunisation programmes.2 Gavi, has established an accelerated vaccine introduction initiative with the objective of driving the sustainable introduction of rotavirus vaccine in 30 Gavi-eligible coun-

34 EXPRESS PHARMA November 1-15, 2014

tries by 2015.3 In addition, PATH, an international, nonprofit organisation to improve public health, is working to accelerate access to rotavirus vaccines and sustain their implementation and use in countries where children need them most urgently.4 Rotavirus infections, caused mostly by Group A viruses, are prevalent in human populations worldwide. Although the virus can and does infect older individuals, illness caused by rotavirus can be quite severe in infants and young children. In low income countries, the median age at the primary rotavirus infection ranges from six to nine months (80 per cent occur among infants less than one year old) whereas in high income countries the first episode may occasionally be delayed until the age of two to five years, though the majority still occur in infancy (65 per cent occur among infants less than 1 year old).1 The WHO estimates that in 2008 approximately 453,000 (420,000–494,000) rotavirus gastroenteritis (RVGE)-associated child deaths occurred worldwide. These fatalities accounted for about five per cent of all child deaths and a causespecific mortality rate of 86 deaths per 100,000 population aged less than five years. About 90 per cent of all rotavirus-associated fatalities occur in low income countries in Africa and Asia and are related to poor healthcare.

It is estimated that one of every 260 children born each year will die from diarrhoea caused by rotavirus infection by their fifth birthday.2 Recent

studies indicate that rotavirus causes approximately 40 per cent of childhood diarrhoeal hospitalisations worldwide,3 40.7 per cent in Sub Saharan African countries, 4 33 per cent in Nepal, 5 34 per cent in Pakistan6 ,40–50 per cent in Japan,7 and around 39 per cent in India in children less than five years of age.8 India, with more than one billion people, 11 per cent of whom are less than five years of age, has an especially large population at risk of clinically significant RVGE.9 There is no specific drug approved to cure or ameliorate rotavirus gastroenteritis. Since virtually all infants and young children will suffer at least one rotavirus infection and many will become infected two or more times, even in settings where good hygiene is practiced, universal immunisation of infants with a vaccine is clearly the way to reduce rotavirus related morbidity, mortality, and associated medical costs.1

References 1 M.S. Dhingra et al. Evaluation

of safety and immunogenicity of a live attenuated tetravalent (G1–G4) Bovine-Human Reassortant Rotavirus vaccine (BRV-TV) in healthy Indian adults and infants. Vaccine 32S (2014) A117–A123 2 http://www.who.int/immunization/topics/rotavirus/en/ Accessed 15 Sept 2014 3 http://www.gavi.org/support/nvs/ rotavirus/ Accessed 15 Sept 2014 4 http://sites.path.org/rotavirusvaccine/ Accessed 15 Sept 2014 5 WHO. Rotavirus vaccines.

WHO position paper - January 2013. Wkly Epidemiol Rec 2013; 88:49–64.

6 Tate JE, Burton AH, Pinto CB, Steele AD, Duque J, Parashar UD, et al. 2008 estimate of worldwide rotavirus-associated mortality in children younger than 5years before the introduction of universal rotavirus vaccination programmes: a systematic review and meta-analysis. Lancet Infect Dis 2012; 12:136–41.

7 World Health Organization.

Global networks for surveillance of rotavirus gastroenteritis, 20012008. Wkly Epidemiol Rec 2008; 83:421–5.

8 Mwenda JM, Tate JE, Parashar UD, Mihigo R, Agócs M, Serhan F, et al. African rotavirus surveillance network. A brief overview. Pediatr Infect Dis J2014; 33:S6–8.

9 Sherchand JB, Nakagomi O, Dove W, Nakagomi T, Yokoo M, Pandey BD, et al. Molecular epidemiology of rotavirus diarrhea among children aged less than 5 years in Nepal: predominance of emergent G12 strains during 2 years. JID2009; 2000(Suppl.

1):S182–7.

10 Alam MM, Khurshid A, Shaukat S, Naeema A, Sharifa S, Angeza M, et al. Epidemiology and genetic diversity of rotavirus strains in children with acute gastroenteritis in Lahore, Pakistan.

PLoS ONE 2013; 8(6):e67998.

11 Kamiya H, Nakano T, Kamiya Hi, Yui A, Taniguchi K, Parashar U. Rotavirus associated acute gastroenteritis hospitalizations among Japanese children aged less than 5 years: active rotavirus surveillance in Mie Prefecture, Japan. Jpn J Infect Dis2011; 64:482–7.

12 Kang G, Arora R, Chitamber SD, Deshpande J, Gupte MD, Kulkarni M. Multicenter, hospital based surveillance of rotavirus disease and strains among Indian children aged less than 5 years. J Infect Dis 2009; 200 (Suppl.

1):S147–53.

13 Census of India. Govt. of India Ministry of Home Affairs, Official web-site. Table C-10: population attending educational institution by age, sex, and type of educational institution (Census of India 2001); 2001.Available at: http://www.censusindia.gov.in/Ta bles Published/C-Series/C-Series link/c10 india.pdf. Accessed 15 Sept 2014.

EP News Bureau-Mumbai

Promethera Biosciences receives approval in Belgium To enroll patients in the imminent HEP002 Phase IIb/III clinical trial BELGIUM HAS authorised the conduct of a trial by a Belgian biotechnology company Promethera Biosciences, which has developed Promethera HepaStem, a cell-based therapy for the treatment of both orphan liver-based metabolic diseases and acquired liver diseases. The trial has been designed to treat paediatric patients with urea cycle disorders (UCD) in a phase IIb/III study (HEP002).

This first agreement officially opens the start of the second clinical trial conducted by the company. Belgian patients will be recruited and treated in Cliniques Universitaires Saint-Luc in Brussels.

Most young patients affected by these very rare diseases have limited therapeutic options and may die at an early age. UCD are a group of eight inborn errors of metabolism that affect the transfer of nitrogen into urea. Although each specific disorder results in the accumulation of different precursors, hyperammonemia and hyperglutaminemia are the common biochemical hallmarks of these disorders. UCD are rare diseases, with an incidence between 1 in 8,000 and 1 in 44,000.

HEP002 is a prospective, open label, multi-centre, efficacy and safety study with Promethera HepaStem.

The primary objective is to assess the efficacy of Promethera HepaStem in patients with urea cycle deficiencies during the year following treatment. In the first clinical trial HEP001 Promethera HepaStem demonstrated to be a safe treatment that can result in functional metabolic improvement in UCD patients.

“We are excited to pursue the development of this promising disease-modulating therapy. It is urgently needed by the children living with these disabling metabolic diseases,” said Dr Béatrice De Vos, Chief Medical Officer.

Promethera Biosciences.

Professor Etienne Sokal, Chief Scientific Officer and Founder, Promethera Biosciences, paediatric hepatologist at Cliniques Universitaires

DOP/PAO Leak Testing Air Flow Pattern (Smoke)Test

Saint Luc and Director of Cell Therapy Research Lab (in Belgium) said, “This is a new important achievement in the process of transferring original clinical research to industry and giving access to this innovative therapy to the maximum number of children.”

Eric Halioua, Chief Executive Officer and Co-founder, Promethera Biosciences said, “Obtaining the first authorisation for our phase IIb/III trial in Belgium is a new major milestone reached by the company. Only five years since the company started we are about to begin our second clinical trial.”

EP News Bureau-Mumbai

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RESEARCH

Akynzeo gets US FDAapproves first combination US FDA approval Akynzeo treats nausea and pill to treat hepatitis C vomiting in patients undergoing RESEARCH UPDATES

Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection THE US Food and Drug Administration has approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection. Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.

Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.

“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” said Edward Cox, Director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin.

Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.”

Harvoni is the third drug approved by the FDA in the past year to treat chronic HCV infection.

The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013. Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades.

Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to

36 EXPRESS PHARMA November 1-15, 2014

complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections and liver cancer.

According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 per cent of these people will go on to develop cirrhosis.

Harvoni’s efficacy was evaluated in three clinical trials enrolling 1,518 participants who had not previously received treatment for their infection (treatmentnaive) or had not responded to previous treatment (treatment-experienced), including participants with cirrhosis. Participants were randomly assigned to receive Harvoni with or without ribavirin.

The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured. In the first trial, comprised of treatment-naive participants, 94 per cent of those who received Harvoni for eight weeks and 96 per cent of those who received Harvoni for 12 weeks achieved SVR. The second trial showed 99 per cent of such participants with and without cirrhosis achieved SVR after 12 weeks. And

in the third trial, which examined Harvoni’s efficacy in treatment-experienced participants with and without cirrhosis, 94 per cent of those who received Harvoni for 12 weeks and 99 per cent of those who received Harvoni for 24 weeks achieved SVR. In all trials, ribavirin did not increase response rates in the participants.

The most common side effects reported in clinical trial participants were fatigue and headache.

Harvoni is the seventh new drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Harvoni was reviewed under the FDA’s priority review programme, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

Harvoni and Sovaldi are marketed by Gilead, based in Foster City, California. Olysio is marketed

by Janssen Pharmaceutical based in Raritan, New Jersey.

EP News Bureau-Mumbai

cancer chemotherapy THE US Food and Drug Administration has approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy. Akynzeo is a fixed combination capsule comprised of two drugs.

Oral palonosetron, approved in 2008, prevents nausea and vomiting during the acute phase (within the first 24 hours) after the start of cancer chemotherapy. Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase (from 25 to 120 hours) after the start of cancer chemotherapy.

“Supportive care prod-

were designed to measure whether the study drugs prevented any vomiting episodes in the acute, delayed and overall phases after the start of cancer chemotherapy.

Results of the first trial showed that 98.5 per cent, 90.4 per cent and 89.6 per cent of Akynzeo-treated participants did not experience any vomiting or require rescue medication for nausea during the acute, delayed and overall phases, respectively. In contrast, 89.7 per cent, 80.1 per cent and 76.5 per cent of participants treated with oral palonosetron did not experience any vomiting or require rescue medication for

Akynzeo’s effectiveness was established in two clinical trials of 1,720 participants receiving cancer chemotherapy. Participants were randomly assigned to receive Akynzeo ucts, such as Akynzeo, help ease the nausea and vomiting patients may experience as a side effect of cancer chemotherapy,” said Julie Beitz, Director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.

Akynzeo’s effectiveness was established in two clinical trials of 1,720 participants receiving cancer chemotherapy. Participants were randomly assigned to receive Akynzeo or oral palonosetron. The trials

nausea during the acute, delayed and overall phases, respectively.

The second trial showed similar results. Common side effects of Akynzeo in the clinical trials were headache, weakness (asthenia), fatigue, indigestion (dyspepsia) and constipation. Akynzeo is distributed and marketed by Eisai of Woodcliff Lake, New Jersey, under license from Lugano, Switzerland-based Helsinn Healthcare S.A. EP News Bureau-Mumbai

RESEARCH

Scientists find potential way to treat cold-triggered asthma Viruses that infect the airways are the most common cause of asthma attacks, accounting for 80 to 90 per cent of cases BRITISH SCIENTISTS have identified a sequence of biological events that could trigger life-threatening asthma attacks in people suffering from colds, a finding that holds the potential for developing more effective medicines.

In a study published in the journal Science Translational Medicine, the researchers found that a small molecule,

Bartlett, an expert at the Imperial College London's national heart and lung institute who co-led the study.

He said that by finding a drug to target the molecule at the top of the cascade, "we could potentially discover a much-needed new treatment to control this potentially life-threatening reaction in asthma sufferers".

Bartlett explained that the main

or 'cytokine', called IL-25 may play a central role in the effect that viruses causing colds have on people with asthma.

According to the WHO, 235 million people suffer from asthma worldwide and the condition is the most common chronic disease among children.

Viruses that infect the airways are the most common cause of asthma attacks, accounting for 80 to 90 per cent of cases. Although illnesses caused by rhinoviruses are usually relatively mild for most people, they can also infect the lungs and, in people with respiratory conditions like asthma, can trigger severe attacks, sometimes leading to hospitalization.

"Our research has shown that the cells that line the airways of asthmatics are more prone to producing a small molecule called IL-25, which then appears to trigger a chain of events that causes attacks," said Nathan

features of an asthma attack, including inflamed and obstructed airways and increased mucus, are part of type-II immune responses, which are more often seen in allergies and parasitic infections.

Until now, he said, it has been unclear how a rhinovirus infection can trigger these responses. But this study showed that IL-25 is induced by rhinovirus infection and is capable of instigating the production of other type2 cytokines, creating a 'cascade' that drives the type-II immune response.

Professor Sebastian Johnston, also of Imperial who co-led the work, said existing asthma drugs containing inhaled steroids were highly effective at controlling regular asthma symptoms but that those suffering from a cold during an attack could see a worsening of their symptoms and end up in hospital.

Reuters

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PHARMA ALLY POST EVENT

Brio Pharma,IMAorganise technical seminar on ‘Capsule Technology’ Provides detailed technical assistance for capsule manufacturing Usha Sharma Mumbai BRIO PHARMA in association with IMA Pharma recently organised a day-long technical seminar on ‘Capsule Technology’ in Mumbai. The seminar provided detailed technical assistance for capsule manufacturing and focused on high speed capsule filling, poly filling technology, containment technology to handle high potent molecules, inspection and quality aspects.

The seminar witnessed industry participation from operations, QA, projects, procurement and regulatory departments. The day-long event observed real time technical questions which were well

addressed by the speakers.

Shubham Mishra, Managing Director, Brio Pharma while speaking about the event’s objectives said, “This is for the first time that we have organised a technical seminar on capsule technology. We have realised the fact that there are limited number of workshops being organised in the capsule area and less interactive sessions are being held. The seminar will help the industry to discuss about the new trends, challenges and solutions.”

Paul Temoche, Area Manager, IMA Pharma explained the techniques of tablet coating machines and its functioning mechanism. He also spoke about the company’s Comprima model

Participants at the seminar

and mentioned that it is an unique product available in the market, which helps in discharging activities. He said, “We have strategically installed blow-fill system in the container which helps in cleaning the container.

These devices are in an automatic format and available in ro-

tation format.”

The pharma industry is trying to understand the different mechanisms of material handling. Angelo Airoldi, IMA Pharma Product Manager explained various aspects of Adopta machine which is developed by IMA. He also spoke

about dosing units and its various working principles.

Madan Joshi, Ex-Managing Director, Capsugel Healthcare presented the industry’s requirements. He emphasised on the need to understand the technical aspects of capsule machineries and said, “We need our people to be skilled and well informed about the new trends.

This will ease problems and train the workforce to measure raw materials at right time in order to avoid rejections during work flow period.”

The company also recently organised a similar session in Hyderabad and there are plans to conduct such seminars in the future. u.sharma@expressindia.com

AWARD

Quintiles wins Society for Clinical Research Sites’2014 Eagle Award Recognised for leadership and professionalism in site support two years in a row QUINTILES HAS received Society for Clinical Research Sites’ (SCRS) 2014 Clinical Research Organization (CRO) Eagle Award. The award, which recognises outstanding leadership, professionalism, integrity, passion and dedication, was presented during the annual SCRS Site Solutions Summit.

“It is such an honour to be recognised again and receive

38 EXPRESS PHARMA November 1-15, 2014

this award for the second year in a row,” said Lindy Jones, Senior Vice President, Integrated Site Services, Quintiles. “Our ambition of transforming clinical development and accelerating pipelines to achieve better patient outcomes is only possible through the dedication and hard work of our investigators and sites. I would like to thank the investigators who voted for

us. We will continue to look at how we can better partner together.”

“We are delighted to present the Eagle Award to Quintiles,” said Christine Pierre, President, SCRS. The award reflects the opinions of almost 2,000 investigative sites across the globe. Quintiles’ integrity in consistently demonstrating their keen interest in partner-

ing with sites landed them with this prestigious recognition.”

Prior to the Site Solutions Summit, SCRS members, which are investigative sites, were invited to nominate the sponsor and CRO they believe best demonstrates partnership commitment. The other criteria include: availability of qualified staff to support the sites, demonstration of collaboration,

protocol design and execution, financial consideration, and partnering with sites for future work. The finalists were those sponsors and CROs that ranked in the 75th percentile or greater of nominations received. Once the finalists were identified, voting was open to all sites globally.

EP News Bureau-Mumbai

VENDOR NEWS

Corden pharma inks pact with Signet Chemical Corporation Will accelerate strategic objectives of both the companies SWITZERLAND-BASED Corden Pharma has signed a distributor agreement with Signet Chemical Corporation, an excipient distributing company for their range of synthetic and MPEG-conjugated phospholipids.

Harish Shah, Managing Director, Signet said, “We are gratified to partner with Corden Pharma adding their phospholipid range to our rising product portfolio.

This addition will definitely accelerate our strategic objectives to service the pharma industry with this niche application and quality products and we very much look forward to this collaboration.”

“We are pleased to collaborate with a distinguished company like Signet, the paramount excipient distributors in India who not only service their customers with ware-

housing and distribution, but also provide excellent and timely technical guidance and regulatory support. We are confident that through Signet we will be magnificently reaching out to our prospective customers in India establishing our unique technology products,” said Dr Jurg Burger, Managing Director, Corden Pharma.

Corden Pharma offers cGMP manufacturing of pro-

prietary phospholipids, monoglycerols, diacylglycerols, sphingosines, ceramides and engineered cationic lipids.

They are diversified and excel in development and contract manufacturing, formulation and supply chain management. With multiple cGMP compliant facilities across Europe and the US, Corden Pharma is the flexible, efficient, and cost-effective solution for all synthetic

phospholipids.

Signet offers a wide range of excipient portfolio. They serve the Indian pharma industry by interpreting customer requests swiftly, reliably and with the highest technical and commercial level while providing the necessary regulatory and quality support required by the industry.

EP News Bureau-Mumbai

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PHARMA ALLY VALUE ADD

Laser diffraction and automated imaging: Complementary techniques for nasal spray development

STUART WAKEFIELD, Regional Manager - Middle East, and India/ Director - Malvern Aimil Instruments (India)

Stuart Wakefield, Regional Manager - Middle East, and India/ Director - Malvern Aimil Instruments (India) in the article reviews the use of laser diffraction and automated imaging coupled with spectroscopic identification in the development of nasal spray products, showing how the two techniques combine to provide the understanding and regulatory data required to develop and optimise nasal spray products in a cost and time-efficient way NASAL SPRAY products are increasingly valued for delivering systemic as well as locally acting therapies, most notably hormone and migraine treatments. The large surface area and rich blood supply of the nasal passages aid the rapid absorption of drug entities, with their close proximity to the central nervous system being of particular benefit.

The regulatory guidance for nasal sprays emphasises the importance of testing the device and the formulation together since it is in combination that they define the unique characteristics of the delivered dose. The success of drug delivery is strongly influenced by the particle size of the delivered droplets, and for suspension formulations the particle size of the suspended active as well.

According to the guidance, delivered droplet size ‘is an important property influencing the nasal deposition of aerosols and sprays.’ Very fine droplets, lying in the sub-10 micron range, are likely to be drawn into the lungs while those that are excessively large may remain at the front of the nasal passages rather than depositing at the intended site.

The particle size of a suspended active pharmaceutical ingredient (API) potentially influences dissolution rate in vivo, and also availability to sites of action within the nose. The recommendation is that particle size

should be measured pre- and post-actuation to ensure that requirements for clinical efficacy are met and that the API particles are unchanged by the delivery process.

Laser diffraction is the recommended technique for measuring droplet size, while imaging or microscopy methods are the usual choice for analysing suspended API, a task that can be complicated by the presence of visually similar excipient particles.

Developing nasal sprays Conventional nasal sprays usually consist of an API which is dissolved or suspended in an aqueous medium. They are selfadministered by the patient via the nasal cavity. Effective drug delivery depends on a number of factors: patient technique and physiology; the properties of the formulation; and the characteristics of the spray pump.

Nasal spray development focuses on optimising the device and formulation to deliver robust performance for the target user group, which may be very broad. In terms of droplet size the target range tends to be 20-120 μm. Droplets in this size range usually deposit beyond the nasal valve, in the posterior two thirds of the nasal cavity, thereby maximising therapeutic effect. Particles smaller than 10 microns are prone to inhalation into the

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Figure 1 Laser diffraction data tracking the evolution of particle size, Dv10, Dv50 and Dv90, and transmission, a measure of droplet concentration, during a nasal spray event

Figure 2: The evolution of droplet size (Dv50) during delivery via a nasal spray pump, for solutions of PVP in water

lungs, so their generation or presence necessitates an assessment of the clinical risks associated with pulmonary delivery of the API concerned.

Conversely, overly large droplets tend to remain in the front of the nose and fail to deliver API to the intended site.

In a nasal spray product, a metered spray pump atomises and delivers the drug dose and its performance depends on the physical properties of the formulation. The nasal spray developer’s task is to understand and control device-formulation interactions and manipulate the parameters that dictate performance with the goal of better clinical efficacy.

In terms of the device, key variables include: the action of the pump and pre-compression ratio; and the length, geometry and orifice size of the actuator.

Together these determine the shear force applied to the formulation during use. The response of the formulation to this applied shear is a function of its physical properties. Viscosity is a particularly important parameter and is routinely manipulated through the inclusion of modifiers and additives.

By tuning some or all of these variables, product developers can tailor nasal spray devices to deliver the required droplet size. Reliable and timely droplet size measurement supports this optimisation process.

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PHARMA ALLY Developing suspensionbased products is complicated by the fact that the size of both the API and the droplets in the delivered dose are important.

Formulating a stable suspension with particles of a size that will ensure the required dissolution rate and bioavailability in vivo, is one part of the development challenge. The other is to make sure that particle size is unaffected by the delivery process, a check that relies on measuring the particle size of the active, before and after delivery.

Introducing laser diffraction Laser diffraction is a non-destructive particle sizing technique, able to measure across a wide dynamic range (0.1 - 3000 microns), in real time. Suitable for characterising both wet and dry spray samples, and with minimal calibration requirements, it is applicable in the study of both dispersed particle size and spray formation and dynamics to ensure: ◗ Efficacy: To target a droplet size range that will maximise clinical efficacy. ◗ Quality: To verify the consistency of performance: over the lifetime of the product; ◗ From batch: To batch; or after storage ◗ Safety: To detect and quantify the presence of a sub-10 micron fraction.

Using laser diffraction, particle size is determined from the scattering pattern produced as particles pass through a collimated light beam. Small particles scatter light weakly at wide angles while larger particles give a stronger signal at narrow angles. Laser diffraction analysers detect the scattered light pattern produced by a sample and generate a complete particle size distribution from it.

Figure 1 shows typical nasal spray data measured using a laser diffraction particle size analyser configured for spray measurement (Spraytec, Malvern Instruments). Examining the results it is possible to observe three discrete phases in the delivery process: formation, fully developed/stable and dissipation.

Immediately post-actuation, all three size parameters and

42 EXPRESS PHARMA November 1-15, 2014

Figure 3: The evolution of droplet size (Dv50) during delivery with an Equadel (Valois Pharma) nasal spray pump, for solutions of PVP in water

Figure 4: Circle equivalent (CE) diameter is the diameter of a circle with the same area as the captured twodimensional image of the particle

Figure 5: The key dimensions of a particle can be used to generate a larger number of size and shape descriptors

transmission decrease steeply.

This is the formation phase.

Transmission, which is shown by the green line in Figure 2, is a measure of the source light that penetrates the sample, and therefore a measure of spray density. Transmission data during this phase therefore indicate a steady increase in spray density. Initially flow through the spray pump is low but it builds rapidly as the pump becomes primed. Droplet size decreases to a steady minimum as flow through the pump reaches a maximum steady rate, producing the stable, fully developed phase. This is the phase of most interest since most drug delivery occurs under these conditions. As the metering chamber of the device empties, flow rate decreases once more leading to an increase in droplet size during the dissipation phase that marks the end of the event.

For comparative studies, the US Food and Drug Administration (FDA) guidance recommends using data from the fully developed phase to provide statistically relevant droplet size information.

Case study: Using laser diffraction data to investigate the impact of device and formulation properties Figure 2 shows some laser diffraction data from experimental studies carried out to assess the impact of formulation viscosity on atomisation behaviour and delivered droplet size gathered using a typical commercially-available nasal pump spray. The solutions tested differ in terms of polyvinylpyrrolidone (PVP) concentration, PVP being an additive routinely used to modify the viscosity of suspension formulations. Solutions in the range 0 to 1.5 per cent by weight were assessed.

For solutions with a PVP concentration of 0.5 per cent and below, the droplet size profile observed exhibits a clear fully developed phase. However, with the higher viscosity solutions atomisation is less successful. Droplet size is much larger and, especially with the 1.5 per cent solution, the fully developed phase is less well defined. During each automatically controlled actuation,

PHARMA ALLY the pump applies the same levels of shear but with higher viscosity solutions this shear has less impact in terms of atomising the dose. Solutions of higher viscosity require greater energy input to achieve successful atomisation to an equivalent droplet size.

Figure 3 shows data for the same PVP solutions atomised using an Equadel pump (Aptar Pharma). These comparative data illustrate how changing the pump mechanism can be a successful strategy for achieving better atomisation with a more viscous formulation.

Changing the pump mechanism modifies the way in which the energy applied during actuation is released into the formulation, and has a pronounced effect on atomisation behaviour.

Introducing automated imaging For suspension nasal sprays it is essential not only to measure droplet size but also to obtain a reliable measurement of the API particle size distribution.

This creates a requirement for supplementary analysis that can differentiate the API from any other suspended solids present, and provide a statistically valid measure of its size.

The traditional approach is to use manual microscopy but this technique is both labour intensive and operator dependent.

Automated imaging is a more efficient alternative, a much faster way of gathering more statistically relevant data.

Over the last decade, automated imaging has benefited hugely from advances in camera technology and data analysis software. The technique involves capturing individual two-dimensional images of three-dimensional particles appropriately dispersed on a plate. Various size and shape parameters are then determined from the dimensions of each image. Principal among these, for size, is circle equivalent (CE) diameter, which is calculated by converting the captured image into a circle of equivalent area to give a single number (diameter) representation of particle size (Figure 4).

With respect to shape, an array of parameters may be developed from the defining di-

Figure 6: Particle size data for the API in a nasal spray formulation measured before and after spraying

Figure 7: Two unique particles distinguished by the correlation of their Raman spectra with reference spectra (shown in green)

Nasal spray development focuses on optimising the device and formulation to deliver robust performance for the target user group, which may be very broad. In terms of droplet size the target range tends to be 20-120 Îźm

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mensions of the particle (Figure 5) to build a complete picture.

Parameters such as convexity, elongation and circularity, describe not only the overall shape of particles but also the regularity of the shape, whether the perimeter is smooth or more convoluted.

Systems such as the Morphologi G3 from Malvern Instruments measure thousands of particles in just a few minutes to produce statistically relevant descriptors of size, shape, and transparency, that allow the identification and quantification of even very subtle differences.

For anyone looking to apply laser diffraction and imaging together, the preceding discussions highlight some important differences that need to be recognised and understood.

Laser diffraction analysis is an ensemble technique, meaning that it generates a single data point, a particle size distribution, for the entire sample. This distribution is volumetric i.e. it indicates the relative volume of sample in each size fraction.

With imaging on the other hand, number-based distributions of size and shape are built-up from measurements of individual particles. These distributions show the relative number of particles in each size or shape fraction. Imaging and laser diffraction data and specifications can be directly compared but these fundamental characteristics of the techniques need to be taken into account when doing so.

Case study: Investigating the impact of drug delivery on API particle size The particle size of the API in a nasal spray formulation was measured before and after drug delivery, using automated imaging, to determine whether the process of atomisation through the nasal spray pump was causing any change. Samples were appropriately dispersed on to a measurement plate and then analysed to gather both size and shape data for the formulation.

With this product the excipient and API are quite differently shaped and can be reliably differentiated on the basis of certain shape parameters. A shape

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PHARMA ALLY classification filter was therefore applied to the data, to identify the API population. Particle size data, CE diameter values, were then generated just for these particles (Figure 6).

The profiles indicate that spraying causes a slight shift of the particle size distribution towards finer sizes, suggesting that the shear applied to atomise the dose causes some particle size reduction. Such an effect could have an impact on the deposition of the API and its uptake in vivo and could therefore be influential in determining clinical efficacy.

curely identified as not being API and therefore do not require chemical analysis. Automatic classification on the basis of elongation would mean that only 3000 of the original 9000 particles would need to be chemically identified, reducing measurement times by 66 per cent. Directing chemical analysis on the basis of automated imaging in this way, efficiently streamlines measurement, enhancing the practicality of this approach for routine use in manufacturing and QC.

Looking forward Combining automated imaging and chemical identification techniques In nasal spray studies the parameters that imaging generates can be used to rapidly classify particle populations to identify and procure information for the API alone, as described. However, imaging and microscopy share the limitation of not being able to distinguish between API and excipients that are morphologically similar. One way of addressing this issue is to supplement imaging with a chemical identification technique such as a Raman spectroscopy. By collecting Raman spectra for particle populations of interest and correlating them with reference spectra it is possible to securely identify API particles and gather data uniquely for them.

An optimal way to apply such technology is to use the size, shape or transparency data to target the acquisition of Raman spectra - so called Morphologically Directed Raman spectroscopy. Doing so significantly reduces the time for measurements compared with conventional Raman mapping methods. In comparison with standard spectroscopy methods it also simplifies the measurement, as the position of the particles is automatically determined before analysis, removing any operator subjectivity.

Case study: Using morphologically directed Raman spectroscopy to verify the quantities of API in a formulation HITEPAPE Images for a suspension nasal

44 EXPRESS PHARMA November 1-15, 2014

Figure 8: Scatterplots for Raman correlation scores of API and excipient particles quantify the relative amounts of each constituent. Example images for the two classes indicate the potential benefit of shape classification

Figure 9: Comparison of particle shape distributions for API and excipient based on chemical classification shows that many particles can be secure identified as excipient on the basis of elongation (shape) alone, suggesting that morphological filtering will cut measurement times.

spray are shown in Figure 7 alongside reference spectra for the API and excipient present. Chemical spectra data for 9000 particles from a single scan area were gathered and compared with these reference spectra to chemically identify the population of API particles present and verify the proportion of API in the formulation; two example

spectra are shown.

Scatterplots of the correlation scores produced (Figure 8) chemically differentiate populations of API and excipient particles and show that of the 9000 particles analysed, 450 are classified as API. This suggests that the ratio of API to excipient in the formulation is 1:20 by weight, a figure consistent with the stated compo-

sition.

These data make it possible to compare the ingredientspecific particle size and shape distributions for the API and excipient, an exercise that suggests that the bulk of the excipient can be excluded from any analysis on the basis of shape alone (Figure 9). Particles with an elongation greater than 0.4 can be se-

The development and manufacture of clinically effective nasal sprays relies on understanding and controlling the atomisation processes that drive delivery, to ensure successfully targeted deposition and consistent in vivo behaviour. Laser diffraction provides the real-time droplet size data required to understand the dynamics of atomisation, supporting the optimisation of both device and formulation.

Automated imaging efficiently overlays such data with information relating to the particle size of any suspended active, and how it is affected by delivery. Supplemented with spectroscopy, imaging provides an extremely powerful tool for the insightful investigation of nasal spray products and enables the generation of objective, statistically sound data for the comparison of innovator and generic nasal sprays, as advocated by the regulators.

Together these techniques support drives towards the greater application of nasal drug delivery. One area of significant activity is exploitation of the nasal route for delivering a wider range of drug entities, another is the evolution of dry nasal powder products, a development that parallels the use of dry powder inhalers in the pulmonary area. The complementary application of these techniques holds value in all aspects of nasal spray development, as it does for many other pharma products, giving these technologies a central place in the industry's analytical armoury.

Mix with the world of pharma, products, people & solutions

2-4 December 2014

Bombay Convention & Exhibition Centre Mumbai, India

Visitor Registration is Now Open Register online now and do business with 32,000 pharma professionals from all over the world @ CPhI & P-MEC India 2014!

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Log on to: www.cphi.com/india/visit/register Benefits of Online Registration:

• Avail FREE entry to the exhibition on all the 3 days • Save Rs. 500 per person for onsite registration • Receive your personalized entry badge well in advance • Get fast track entry into the exhibition by avoiding long queues • Receive a free copy of the official show catalogue • Network and gain access to one of the world's fastest growing pharmaceutical markets

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PHARMA ALLY PRODUCTS

Waters launches SEC columns for protein-based biotherapeutics analysis WATERS CORPORATION has introduced new size exclusion chromatography (SEC) columns for the characterisation of proteins. For use with Waters Alliance HPLC, Waters ACQUITY UPLC HClass Systems and other HPLC/UHPLC instruments, the XBridge Protein BEH SEC Columns deliver optimal throughput and resolution for size-based separations of protein-based biotherapeutics.

The columns are available from Waters worldwide.

The XBridge Protein BEH SEC Columns are packed with 3.5 μm particles and are available in either 200 or 450 Å pore sizes for analysing proteins and other biomolecules ranging in molecular weight from 10,000 – 1,500,000 Da. The columns are designed to operate at higher flow rates and pressures than traditional silica-based SEC columns. These characteristics

a vial of either the BEH200 or BEH450 SEC Protein Standard Mixture for column and LC System benchmarking, method development, or trouble shooting. These standards are the same as those used for quality control testing of XBridge Protein BEH SEC batches. They may be used to verify the performance of each column upon receipt and to monitor their condition over time.

result in either increased sample throughput or, by using multiple columns in series, greater component resolution.

Use of Waters diol-bonded, BEH Technology particles delivers outstanding column longevity and Waters proprietary manufacturing process ensures

unmatched batch-to-batch and column-to-column consistency for reproducible results.

These new offerings complement Waters ACQUITY Protein BEH SEC columns and provide laboratories with the ability to seamlessly transfer methods from UPLC to HPLC

using columns containing particles differing only in their size. Each batch of XBridge Protein BEH SEC 200 Å and 450 Å, 3.5 μm material is extensively tested to ensure unmatched batch-to-batch consistency.

Each column is shipped with

Contact details Dayamani Santosh Administrative Officer Waters India 36A, II Phase Peenya Industrial Area Bangalore 560 058 [T] 080-49292200-03 [F] 080-49292204 [M] 9632786899 [W] www.waters.com [E] dayamani_santosh@ waters.com

Phenomenex introduces Kinetex EVO C18 PHENOMENEX HAS launched Kinetex EVO C18, the latest advancement in ultrahigh performance HPLC columns. The Kinetex EVO C18 column incorporates a patented organo-silica grafting process that utilises uniform stabilising ethane cross-linking to create a unique selectivity and ultimately, pH stability from 1-12. Kinetex EVO C18 has the performance advantages of Core-Shell Technology even at extreme low and high pH. This new advancement adds alkaline pH ruggedness and a highly versatile selectivity to

46 EXPRESS PHARMA November 1-15, 2014

the Kinetex core-shell family of HPLC, UHPLC and preparative LC products.

The EVO C18 columns are an extension of the Phenomenex Kinetex core-shell line, which delivers improved results, increased productivity, easy transferability and significant cost savings compared to traditional HPLC/UHPLC media. The wide pH 1 to 12 stability and improved peak shape for bases make the Kinetex 5 μm EVO C18 especially ideal for

analytical and preparative HPLC methods at a variety of challenging pH levels such as those in open access labs.

With the introduction of the 5 μm Kinetex EVO C18 particle, HPLC and preparative HPLC users can utilize 3 μm or better efficiencies and low backpressures to easily replace traditional hybrid materials and run at higher linear flow rates to compress long-run times.

Additional Kinetex EVO C18 core-shell particles, including those for UHPLC, are

scheduled to be introduced soon.

Contact details Raj Kiran .CH Marketing Communication Associate Phenomenex India Laxmi Cyber City, Ground Floor B Block, Survey no: 10 Kondapur, Hyderabad 500 084 Tel: 040-3012 2400 Fax: 040-3012 2411 Email: RajK@phenomenex.com Website: http://www. phenomenex.com

PHARMA ALLY

Vacuum and pressure transmitter by Libratherm Instruments VACUUM / PRESSURE Transmitter model VPX-3000 and DPX-3000 are designed using the temperature compensated, piezo-resistive silicon pressure sensor packaged in a dual-inline configuration and intended for cost sensitive applications where excellent performance and longterm stability are required.

Integral temperature compensation is provided over a range of 0-50°C using lasertrimmed resistors.

The

differential signal generated by the pressure sensor is converted to equivalent 4-20mA retransmission signal in the desired calibration range, for long distance transmission. The pressure transmitters VPX3000 and DPX-3000 are available in absolute or differential pressure ranges from 0-1 to 0-300 psi.

Features ◗ Built-in vacuum and pressure absolute / differential sensor.

◗ 4-20mA proportional output for each sensor ◗ IP 65 ABS plastic enclosure. ◗ Lockable fixture for standard 4 mm PVC pipes. ◗ Operates on 18 to 36VDC. ◗ Measurement range of 0 to 300 PSI (differential or absolute)

Applications ◗ Medical and pharmaceutical test equipment ◗ Altitude and air speed measurement

◗ Process control and factory automation ◗ Leak detection Contact details Libratherm Instruments 401- 403, Diamond Indl Estate, KP Road, Dahisar East, Mumbai-400068 Maharashtra Tel/Fax: 91-22-42555333, 28960569, 28964769 Email : sales@libratherm.com , enquiry@libratherm.com Web : www.libratherm.com

Thermo Fisher Scientific launches orbitrap-based mass spectrometer LABORATORIES performing food and environmental testing, clinical research, forensic toxicology, pharmaceutical/biopharmaceut ical measurements, and other applied analyses can now benefit from the performance of high-resolution accurate-mass (HRAM) orbitrap mass spectrometry using a new instrument designed for cost-per-samplesensitive workflows.

The new Thermo Scientific Q Exactive Focus LC-MS/MS is designed to make the qualitative and quantitative power of orbitrap-based instruments available to customers who use quadrupole time-of-flight (QTOF) mass spectrometry or

other technologies.

The Q Exactive Focus benchtop LC-MS/MS combines high-performance quadrupole precursor ion selection with an HRAM

To subscribe: bpd.subscription@expressindia.com

orbitrap mass analyser, providing excellent mass accuracy, sensitivity and fast polarity switching. This has been shown to selectively and accurately quantify and

confirm analytes with comparable sensitivity to triple quadrupole instruments.

The Q Exactive Focus is designed to deliver up to 70,000 resolution at m/z 200, and scan speed up to 12 Hz. Sub ppm mass accuracy has been achieved routinely in company and early access user laboratories.

The instrument is designed for quantitation experiments, with capabilities that include selected ion monitoring (SIM), parallel reaction monitoring (PRM), and data-independent acquisition (DIA). Full scan confirmation mode and parallel reaction monitoring (PRM) are designed for targeted screening combined with reproducible

quantitation results. Dataindependent acquisition (DIA) provides qualitative coverage for screening unknowns with supporting quantitative data for many of the unknowns identified.

Contact details Stu Matlow Public Relations Manager Chromatography and Mass Spectrometry Thermo Fisher Scientific, 355 River Oaks Parkway San Jose, CA 95134 Tel: +1 (408) 965-6408 Mobile +1 (415) 407-5474 email: stu.matlow@ thermofisher.com Web: www.thermofisher.com

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PHARMA ALLY

Remi walk-in chambers by Remi Elektrotechnik REMI WALK-IN stability chambers are designed for simulating, monitoring, controlling of temperature and humidity as per ICH, WHO, US FDA guidelines with temperature range 200C to 600C having uniformity of + 10C and humidity range 40 per cent RH to 95 per cent RH having uniformity of + 3 per cent RH. Remi walk-in

cold rooms are used for precise cold storage requirement in pharmaceuticals, biotechnology, food processing, dairy industry and healthcare for storage of bio-samples, raw materials.

Walkin chambers are made of double walled prefabricated modular stainless steel panels with PUF insulation and are easy to assemble on-site.

Being environment conscious company, the refrigeration system used is CFC free, split-type

48 EXPRESS PHARMA November 1-15, 2014

systems enables to place the compressor and condenser outside the lab, since it emits temperature.

The chamber has fans for forced air circulation to maintain uniform conditions throughout the chamber.

The chamber has been integrated with alarms for identification of failure of

utility or accessories. The biometric door access system in chamber has internal unlocking systems to open the door from inside, if locked accidentally and has intelligent PLC Controller for precise control of temperature and humidity. The chambers have standby accessories for refrigeration, humidity and sensor, which also has automatic switch over system in case of failures.

For accurate control of set parameters and direct display of humidity the

chamber has high quality Rotronic capacitance type sensor which helps in REMI ‘Datasoft’ Software helps in adhering to 21CFR part 11 guidelines.

The software provides multi-chamber data acquisition using data logger, secured audit trail report, user defined login, multilevel access rights along with passwords,

password ageing systems, electronic signature on reports, mobile alerts via Ethernet/RS-485.

Contact details MT D'Souza, Remi Elektrotechnik, 3rd floor, Remi House, 11 Cama Industrial Estate, Goregaon (E), Mumbai – 63 Cell: +91 9322213105 Tel: +91 22 4058 9888, Fax: +91 22 4058 9890, E-mail: sales@remilab world.com Website: www.remilab world.com

REMI MICROCENTRIFUGE AND REMI MINICENTRIFUGE REMI MICRO CENTRIFUGE The features of Remi Microcentrifuge are ◗ Microprocessor controlled with last run memory feature ◗ Large back-lit LCD display shows multiple parameters at a time ◗ Brushless DC motor - maintenance free,delivers better power to weight ratio and fit for extended runs ◗ Imbalance detection with auto cut off ◗ Better airflow design ensures lesser heat generation and less noise ◗ Lid lock safety – Lid opens automatically on run completion ◗ Intuitive simple interface for quick and

convenient setting ◗ 1 to 999 mins countdown timer with Min sec display ◗ One touch Short - Spin operation ◗ Extremely compact footprint saves valuable bench space - suitable for use in fume hoods or cold rooms ◗ Unique airflow design - ensures lesser heat generation and lesser noise ◗ Rotor,inner centrifuge lid and lid latch are made of metal for maximum operational safety ◗ Soft – touch lid closure for ergonomic lid locking

REMI MINICENTRIFUGE Powerful and easy-to-use RM 02 Plus mini centrifuges are small enough so that each workstation can be equipped with a personal centrifuge.

The features are:

Brushless DC (BLDC) Motor ◗ Unique Closed rotor reduces friction to ensure better airflow,low heat generation and whisper ◗ Max speed of 6000 RPM - 2000 x g can process upto 8 microtubes of 1.5/2 ml at a time ◗ Electronic brake for immediate stop on lid opening for user safety ◗ Save time by doing quick runs by simple opening and closing the lid ◗ Microprocessor controlled for greater efficiency - Next gen design with digital display ◗ Robust construction for long life under repeated usage

◗ Carbon isolation feature (dust does not enter rotor chamber) ◗ Replaceable strip rotor & adaptors for 0.2 ml & 0.4/0.5 ml microtubes ◗ Extremely compact footprint saves valuable bench space- suitable for use in fume hoods or cold rooms ◗ Settable speed (upto 6000 RPM) and time (upto 99 minutes) Contact Remi Elektrotechnik, Remi House, 11 Cama Industrial Estate, Goregaon (E), Mumbai – 63, Tel: +91 22 4058 9887, Fax: +91 22 4058 9890, E-mail: mktg@remilabworld.com, sales@remilabworld.com Website: www.remilabworld.com

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We care for your family . . .

Anti-Inflammatory Enzymes Serratiopeptidase Peptizyme (enteric coated serratiopeptidase granules) Trypsin Chymotrypsin mix ( 6:1)

Probiotics Saccharomyces boulardii Lactic acid basillus sporogenous

Circulatory Health Nattokinase

Bio Catalysts Immobilized Cal B

Digestive Aids Alpha amylase / fungal diastase / fungal amylase Alpha galactosidase Bacterial alpha amylase Bromelain Hemicellulase Lactase Lipase Ox bile

Papain Pepsin Pancreatin Protease ( acid / alkali)

Advanced Enzyme Technologies Limited Sun Magnetica, 'A' wing, 5th Floor, Accolade Galaxy, LIC Service Road, Louiswadi, Thane(W) - 400604, India Tel: +91 22 41703200, Fax: +91 22 25835159 • E-mail : info@enzymeindia.com • Website: www.enzymeindia.com

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Non-GMO ISO CERTIFICATION

GOTS CERTIFICATION

Products

WHO cGMP

FDA

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Manufacturer & Exporter of Metal Detectors, Check Weighers We have an experience of more than 15 years in there field of metal detection.

We have installed numbers of Metal detectors at the various locations in Pharma, Food & Garments Industries. The reliable performance and world class quality, prompt service are the keystone of Das Electronics, we are pioneer in Metal Detection solution for number of well known companies in th country.

Salient Features: v 100 products

program memory.

v Individual

phase and sensitivity setting for each program.

v Three modes

of programing i.e. General mode and supervisor mode and administration mode.

v Individual

g password setting for each programing mode Fault indication.

v Very high

sensitivity for magnetic and non magnetic metals.

v Audio visual

alarm to draw the attention

of operator. v De-attachable

and washable reject mechanism to avoid cross contaminations.

v Has extremely v Adjustable

low power consumption.

height.

Applications: l Tablets

& Capsules

Das Electronics

Bldg. No. 5-A, Gala No. 3, Sagar Industrial Estate, K N Dhumal Nagar, Waliv, Vasai (East) Thane - 401208 Maharashtra Tel : 0250 - 6451378, Mob.: 09322433394 / 09833989485 / 09930424671 / 09022876667 E-mail: daselectronic@gmail.com, Web: www.metaldetectormanufacturer.com, www.daselectronics.in, www.dasmetaldetector.com,

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Chemical & Biological Indicators

Chemical Indicators ² Bowie-Dick Test Pack & Sheet ² Autoclave Tape Steam & ETO ² Dry Heat Tape ² Class 5 Integrator & Class 6 Emulators ² Class 4 Multiparameter Indicator ² Container Seals

Biological Indicators ² Self Contained Biological Indicator ² Spore Ampoules ² Pro Amp Steam & Low Temp Steam ² Spore Suspension ² Spore Strips Steam & ETO ² SS Coupons

Other Range Of Products Filtration ² Filter Paper, Filter Pad, Filter Sheet ² Carbon Filter Pad ² Filter Bags ² Filter Cartridges ² Filter Housing & Sparkler Filter Press

CleanRoom ² Antistatic, Primary & Disposable Garment ² Lab Coat ² Autoclavable Goggle ² Sticky Mat, Sticky Roller ² Cleanroom Shoes ² Clean Room Paper, Pen & Marker

Sterile Packaging & Sealing ² Sterilization Reels & Pouches ² Crepe and Non-Woven SMMMS Paper ² Sealing Machine and Seal Check Strip

Kitten Enterprises Pvt Ltd. W 407, Rabale MIDC, Near “Hamara Mahanagar” Press, Navi Mumbai 400701, India.

Tel: + 91-22-27646464, M: 9930359882 I Fax: +91-27649299 I Email: bparekh@kitten.co.in Web: www.kitten.co.in EXPRESS PHARMA

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Two great brands come together under Charles River to provide an even stronger testing solution for our customers.

Microbial Detection & Identification

Charles River Laboratories India Private Limited Bangalore (Regd. Office): Phone: 080 25588175 / 76 / 77. Email: blroffice@crl.com Ahmedabad: Phone: 079 40194730. Email: ahdoffice@crl.com Hyderabad: Phone: 040 27179998. Email: hydoffice@crl.com Mumbai: Phone: 022 27810061. Email: bbyoffice@crl.com Mumbai - Accugenix Facility: Phone: 022 41270504 / 05 / 08. Email: CRLIaccugenix@crl.com

www.criverindia.com

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ABS

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Pharma Equipments

Manufacturers Of: Pharma, Cosmetic, Food Process & Allied Equipments Semi Drie

r

Gelatin

Melter

Mixer

ixer

Multi mill

ry M

ta ane

Pl

Fluid Bed Dryer Octagonal Blender

Vibro Sifter

ABS Pharma Equipments Gala No. 22/B, Star Industrial Estate, NaikPada, Waliv, Vasai (East), Dist. Thane - 401208 Maharashtra (India)Email: anupnath326@gmail.com / anupnath326@rediffmail.com Please Contact :

64

November 1-15, 2014

Mr. Anup K. Nath Cell: 9890204833

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2 0* ** 6 +* * 2 * 3

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4 5

&!&' - 06 0 2 2 *

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PHARMA LIFE NEWS

Savitribai Phule Pune University conducts research project competition The zonal level competition was held at Sinhgad Institute of Pharmacy, Narhe SAVITRIBAI PHULE Pune University (formerly University of Pune) recently conducted the research project competition at four different levels i.e. zonal, university, state and national in the categories of UG, PG, Ph.D. and teacher. The zonal level competition was held at Sinhgad Institute of Pharmacy, Narhe.

Dr Bhushan Patwardhan, Professor and Dean, Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, addressed the participants on research

orientation and enlightened on the problems faced during publications of research work. Participants from Sinhgad College of Pharmacy bagged prizes in UG and teachers category.

Prof Hemant Ranpise from teacher, and Rucha Vitonde from UG category presented their work for university level of research competition. Dr KN Gujar, Principal, and Prof Manisha Phoujdar, co-ordinator of avishkar competition guided the students.

EP News Bureau-Mumbai

DRLdonates ` 2 crores to Hudhud cyclone relief fund DR REDDY’S Laboratories (DRL) has donated ` two crores to Hudhud cyclone relief fund in a bid to help restore the lives of the people affected by the cyclone in Visakhapatnam. Dr Chandrasekhar Sripada, President and Global Head of HR, DRL and Dr V Narayana Reddy, Vice President - Head IR & Corporate Affairs, Human Resources, DRL, have handed over the cheque to Chandrababu Naidu, Chief Minister, Andhra Pradesh at the collector’s office in Visakhapatnam.

EP News Bureau-Mumbai

66 EXPRESS PHARMA November 1-15, 2014

REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE.

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