Express Pharma (Vol.10, No.5) June 1-15, 2015 by Indian Express

VOL. 10 NO. 15 PAGES 74

www.expresspharmaonline.com

Management 2015 USTR Special 301: Report Reactions and the way forward Research Choppy waters

1-15 JUNE 2015,` 40

Core-Shell Technology

Which way are YOU going? HPLC

Kinetex core-shell columns will put the “ultra” into ANY system.

PA28601214_in

• 8 unique selectivities • 5 μm, 2.6 μm, 1.7 μm and 1.3 μm for versatility • Guaranteed performance gains

New Kinetex F5 Guide Here:

Achieve greater reproducibility than other PFPs

www.phenomenex.com/F5guide

CONTENTS

2015 USTR SPECIAL 301 REPORT: REACTIONS AND THE WAY FORWARD

Vol.10 No.15 JUNE 1-15, 2015 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

In the aftermath of this year’s USTR Special 301 Report,which retained India on the Priority Watch List, industry leaders comment on the Report’s result, as well as the overall IPR scenario in India | P26

Bangalore Neelam M Kachhap Pune Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma, Vivek Chitrakar 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 Arun J Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia

P22: ‘GREEN’ EVENTS Seminar on green chemistry emphasises importance of pollution prevention at source

PHARMA ALLY

P33: ANALYSIS

MARKET

SUVEN SECURES ONE PRODUCT PATENT EACH IN MEXICO AND SINGAPORE

PHARMEXCIL CONDUCTS INTERACTIVE MEET ON FOREIGN TRADE POLICY 2015-2020 IN MUMBAI

MANAGEMENT

UCPMP: ‘CODE’ WORD FOR PHARMA INDUSTRY

‘SPECIAL 301 REPORT ANNUAL SWAT AT INDIA’S IP POLICIES’

‘FIRST MAKE IMPROVEMENTS IN GOVERNMENT INFRASTRUCTURE THAT IMPLEMENT IPR LAWS’

Choppy waters

P34: RESEARCH UPDATES

THE ODOURMAP HAS VARIOUS MODULES – WEB-BASED, PHONE-BASED AND APP-BASED

ADDRESS ENERGY PROBLEMS WITH A SUSTAINABLE APPROACH

Researchers discover new ways to shut down signals involved in brain diseases

P41: VENDOR NEWS

CORRIGENDUM In the May 16-31, 2015 issue, on page 6, Ramesh Juneja’s designation should read as 'Chairman & Founder, Mankind Pharma' and on page 22, the second quote caption should read as 'Arjun Juneja, Director of Operations, Mankind Pharma'.

Merck develops Iriodin RMP for enhancing decorative rotational molded products

Scheduling & Coordination Mitesh Manjrekar

P68: AWARDS

CIRCULATION Circulation Team Mohan Varadkar

Susan Josi, Sorento Healthcare bags Distinguished Alumnus Award

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

Wish list for PM Modi’s second year

ow that the milestone of PM Modi's first year in office is over and done with, let's make a to-do list for his second year in office. What do we hope he and his government will accomplish by May 16, 2016? Just as 2015 is a make or break year for PM Modi, this will be a decisive year for the pharma sector as well. The pharmaceutical industry would be hoping that the government relooks price control and rethinks decisions to reduce healthcare spend. In a similar vein, the government has had a somewhat ambiguous stand where IPR is concerned. Can we hope for a clearer indication of this government’s stand on a key issue like IPR? As Sujay Shetty, Leader Pharma and Life Sciences, PwC India points out, much more needs to be done in the second year. But he concedes that the early indications are that the government is beginning to focus on health issues and is about to take steps to clear the clinical trial impasse. This could be a good development for the industry going ahead, is his overall analysis. On all the 18 foreign visits in his first year, PM Modi has been an ardent advocate of his government's flagship programme, 'Make in India' but these rebranding efforts need to be further bolstered with solid ground work at home. For instance, the roll out of the Goods and Services Tax, the new Foreign Trade Policy, etc and specific to the pharma sector, API and bulk drug policies, clinical trial regulations, price controls, etc need to be speedy, smooth and transparent. Pharma companies too will have to introspect, change their

Just as 2015 is a make or break year for PM Modi,this will be a decisive year for the pharma sector as well

business models to be in tune with the new legislations and move on rather than hoping for a roll back. But as the pharma industry gears up to catch the 'Make in India' wave, it has to ensure that it does not impact the environment. Our annual World Environment Day cover story in the June 1-15 issue reviews the attempts being made by pharma companies to adopt the Swachh Bharat philosophy in their daily activities. (See story: Swachh Pharma, Swachh Bharat, pages 18-21). Faced with more stringent action from central and state pollution control boards, many pharma companies are resorting to more frequent internal audits, improving their monitoring systems and switching to more efficient processes. But while PM Modi and the centre is keen on implementing the Swachh Bharat initiative, will the states follow through, without making their actions seem like a throwback to the restrictive inspector raj system? Maybe the Swachh Bharat mission needs to become a competition between states. This approach seems to be driving the ‘Make in India’ initiative. PM Modi took the chief ministers of three states (Maharashtra, Gujarat and Karnataka) to China during his recent visit, though each travelled separately and were not part of the official delegation. Each CM pitched for investment into their states. The Make in Maharashtra initiative has reportedly received a good response and it is only a matter of time before other states too announce similar projects. VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

NEW Digi-Sense™ Meters— designed for maximum productivity! Digi-Sense® Precalibrated Humidity and Temperature Indicator – Unique environment comfort indicator – Displays both temperature and humidity Buy Now at an introductory price of Rs. 2100*. Limited time offer. *Conditions apply.

EXPRESS PHARMA

June 1-15, 2015

+91-22-6139-4444

1-800-266-1244 response@coleparmer.in

ColeParmer.in/3125 4069A

MARKET COMPANY WATCH

Suven secures one product patent each in Mexico and Singapore These patents are the exclusive intellectual property of Suven and are achieved through internal discovery research efforts SUVEN LIFE Sciences (Suven) announced the grant of a product patent from Mexico (325948) and one from Singapore (180674), corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases and these patents are valid through 2029. The granted claims of the patents include the class of selective alpha-4-beta-2 compounds discovered by Suven and are being developed as therapeutic agents for major depressive disorder (MDD). With these new patents,

Suven has a total of 18 granted patents from Mexico and 20 granted patents from Singapore Suven has a total of 18 granted patents from Mexico and 20 granted patents from Singapore. These granted patents are exclusive intellectual property of Suven and are achieved through internal discovery research efforts. Products out of these inventions may be out-licensed at various phases

of clinical development like at phase-I or phase-II. “We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for major depressive disorder (MDD) with high unmet medical need with huge

market potential globally,” said Venkat Jasti, Chief Executive Officer, Suven Life Sciences. The company has 11 internally discovered therapeutic drug candidates, currently in pre-clinical stage of development targeting conditions such as ADHD, dementia, depression, huntington’s disease, parkinson’s disease and obesity in addition to phase II ready developmental candidate SUVN502 for and phase I candidate SUVN-G3031 for Alzheimer’s disease and schizophrenia. EP News Bureau-Mumbai

Strides inks agreements with Aspen Pharmacare Holdings To acquire a generic pharma business in Australia and related assets from Aspen for approximately A$380 million STRIDES ARCOLAB announced that Strides Pharma Global, Singapore and Strides (Australia) Pharma, Australia, both wholly-owned subsidiaries of Strides Arcolab have signed definitive agreements with certain wholly-owned subsidiaries of Aspen Pharmacare Holdings, a company listed on the Johannesburg Stock Exchange (Aspen), to acquire a generic pharma business in Australia together with certain branded pharma assets. The business and assets being acquired from Aspen have a current prescription market share that will rank Strides and its group entities as one of the top three generic

EXPRESS PHARMA

June 1-15, 2015

pharma suppliers in Australia and among the top 10 pharma companies in the Australian pharma market. The business, which will operate under the Arrow Pharmaceuticals brand, will sell approximately 140 generic prescription drugs and an extensive range of non-prescription pharmacy products. The business and the assets being acquired will give Strides group one of the largest pharma product portfolios in the Australian market. Strides’ previous business in the Australian generic pharma market, Ascent Pharmahealth, was sold to Actavis in January 2012 after a successful five-year investment

and growth strategy. The new Arrow Pharmaceuticals business will be led by Dennis Bastas, the previous founder and CEO of Ascent Pharmahealth. “The Australian generic pharma market has always been very successful for Strides. The Aspen Australian generic pharma assets are a valuable and unique platform for Strides to re-build its business in Australia. Strong local management, a market leading product portfolio supported by our in-house cost effective manufacturing, will be the key ingredients of our strategy for Australia,” said Arun Kumar, Founder and Group Chief Executive Officer, Strides Arcolab.

The acquired products had sales of approximately A$120 million in the past financial year (June 2014) with an EBITDA margin of approximately 31 per cent. The consideration for the acquisitions will be approximately A$380 million. The acquisition of the business will include access to the product pipeline that was under development by Aspen and includes a number of major product launches in the next six months. The transactions will be financed by a combination of internal accruals and debt financing. It will be EPS accretive immediately. EP News Bureau-Mumbai

Glenmark issues over one crore shares to Aranda, raises `945 crores RBI permits FIIs to buy up to 49 per cent stake in Glenmark GLENMARK PHARMACEUTICALS has raised `945 crores by issuing over one crore shares to Aranda Investments, an indirect subsidiary of Temasek Holdings. The preferential issue committee of the board of the company, allotted over 1.08 crore equity shares of the face value of `1 each at a price of `875 per equity share to Aranda Investments (Mauritius), on preferential basis, Glenmark Pharma said in a filing to the Bombay Stock Exchange. According to a PTI report, Mauritius-based Aranda Investments is a foreign portfolio investor and a whollyowned indirect subsidiary of Temasek Holdings, the investment arm of the Singapore government. Besides, the Reserve Bank of India permitted foreign institutional investors (FIIs) to buy up to 49 per cent stake in the homegrown drug major. The earlier limit was 40 per cent. The central bank said that FIIs, through primary market and stock exchanges, can now purchase up to 49 per cent of the paid up capital of Glenmark Pharmaceuticals under the Portfolio Investment Scheme (PIS). EP News Bureau-Mumbai

MARKET GROWTH TRACKER

IPM registers ` 8047 cr growth in April ‘15 North AP market grew the highest followed by Jharkhand and south AP market THE INDIAN pharmaceutical market (IPM) clocked ` 8047 crores in April 2015. It registered a growth of 17.2 per cent in the same month. Amongst the top 10, Cipla grew by 25.1 per cent followed by Macleods at 18.9 per cent and Sun at 18.4 per cent. 26 corporates have crossed the growth of IPM for the month of April 2015 amongst top 50. Amongst the top 50 corporate, Akumentis has the highest growth of 38.2 per cent followed by Allergan at 35.5 per cent and MSD at 34.9 per cent. 41 corporates showed growths of more than 10 per cent amongst the top 50. Amongst the 11-20 ranked corporate, Glenmark has the highest growth of 30.1 per cent followed by Torrent at 28.7 per cent and Aristo at 26.9 per cent. Amongst the 40-50 ranked corporates, Allergan has the highest growth at 35.5 per cent followed by Albert David at 34.2 per cent and Hetero at 27.2 per cent. Amongst the 51-60 ranked corporate, Centaur grew at 44.7 per cent followed by Eli Lilly at 42.3 per cent and Troikaa at 40 per cent. Amongst the 61-70 ranked corporate, Fresenius Kabi grew at 65.6 per cent followed by Boehringer grew by 86.2 per cent followed by Serdia at 31.9 per cent. Torrent entered the ` 2000-crore club, JBCPL and Akumentis entered the `500-crore club, BI entered the ` 200-crore club, Dr John’s in the ` 50-crore club as on April MAT 2015. Indian companies have grown at 17.1 per cent versus 17.5 per cent for MNCs in April

EXPRESS PHARMA

June 1-15, 2015

Without Bonus Units Val in Crs

Rank

CORPORATE

MAT

MTH

MAT Apr -15

Sun*

Abbott + Abbott HC + Novo

Apr-15

Val (Cr)

MS%

GR%

Val (Cr)

MS%

84756

100.00

14.3

7764

100.00

17.5

7603

8.97

13.4

707

9.10

19.3

5342

6.30

12.0

475

6.11

15.6

IPM

GR%

Cipla

4177

4.93

18.1

408

5.26

26.1

Zydus + Biochem

3439

4.06

8.6

301

3.88

6.3

Mankind

2716

3.21

19.1

248

3.20

18.2

Alkem + Cachet + Indchemie

2922

3.45

14.8

266

3.43

18.6

Glaxo

3033

3.58

4.3

272

3.50

13.3

Lupin

2904

3.43

17.4

254

3.27

3.9

Pfizer

2583

3.05

17.6

238

3.07

18.1

Macleods

2438

2.88

29.1

212

2.74

18.9

Emcure + Zuventus

2265

2.67

11.6

206

2.65

12.3

Intas

2293

2.71

19.3

215

2.77

23.6

Sanofi India

2182

2.58

16.4

197

2.53

25.3

Aristo

1928

2.27

18.4

179

2.30

24.6

Torrent

1980

2.34

18.9

194

2.50

28.8

Glenmark

1900

2.24

18.5

180

2.32

30.0

Dr. Reddys

1816

2.14

13.6

171

2.20

25.4

USV

1711

2.02

19.9

168

2.17

18.9

Micro + Bal

1602

1.89

8.1

137

1.76

6.2

Ipca

1151

1.36

18.9

1.26

14.8

Alembic

1152

1.36

13.9

103

1.32

19.9

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

MATApr 15 MATApr 15 88111 13983 10911 10138 7974 6952 6827 6129 5290 5111 4410 1484 1457 1430 1288 1055 981 943 554 479 379 229 106

Gr% 14.1 10.7 13.8 15.7 13.6 14.4 25.8 12.3 10.7 17.6 9.0 4.1 7.7 24.2 17.6 28.6 7.5 25.4 6.6 7.4 14.0 8.2 10.4

Month Apr-15 Month Apr-15 8047 1185 1019 973 726 606 645 552 491 476 416 134 130 132 126 109 90 91 38 44 34 20 8

Gr% 17.2 12.8 16.2 20.3 14.1 17.8 25.8 15.4 15.8 22.2 14.9 16.0 9.4 21.0 18.9 34.8 11.5 28.5 6.7 14.8 13.3 3.7 14.2

MARKET 2015. Amongst the top 50 in MNCs, Allergan grew by 35.5 per cent followed by MSD at 34.9 per cent and Merck at 30.6 per cent. Under the Non-NLEM category, Indian companies grew at 18.3 per cent whereas MNCs grew at 18.8 per cent. The DPCO containing molecules market grew at 11.1 per cent whereas the non-DPCO market grew by 18.4 per cent and Non -Sch Para 19 Market at 11.9 per cent resulting in an overall growth of 17.2 per cent for April 2015. NLEM and Non - NLEM category showed unit growth at 5.3 per cent and 9.6 per cent respectively. The Non-Sch Para 19 market grew at 9.6 per cent from units perspective. The DPCO 2013 portfolio for Pfizer grew at 16.7 per cent, Ranbaxy 17.3 per cent, GSK at 12.2 per cent and Abbott 13.5 per cent. From therapy perspective,

eight therapies have outgrown the IPM growth. Respiratory market grew at 17.8 per cent, gastrointestinal market grew at 20.3 per cent, pain and analgesics market grew at 15.4 per cent whereas anti-infectives grew at 12.8 per cent. The anti-diabetic market grew at 25.8 per cent and cardiac at 16.2 per cent in chronic business. Derma market grew by 22.2 per cent and urology market at 28.5 per cent. From regional perspective, 14 regions have outgrown the IPM growth. North AP market grew the highest at 31.1 per cent followed by Jharkhand market at 27.8 per cent and South AP Market at 25.2 per cent. One region had negative growth in April 2015. Amoxycillin + Clavulanic Acid Market grew at 16.7 per cent whereas Glimepiride + Metformin grows at 15.9 per cent

To subscribe: bpd.subscription@expressindia.com

at number two. The markets of paracetamol grew at 18.9 per cent, Atorvastatin 12.7 per cent, Probiotic Microbes at 12.2 per cent, Cefixime 19.2 per cent, Pantoprazole 22.7 per cent, Montelukast + Levocetrizine at 25.3 per cent, Glimepiride + Metformin + Pioglitazone at 19.6 per cent, Vitamin-D at 35.9 per cent, Hydroquinone + Mometasone + Tretinoin at 16.4 per cent, Voglibose + Metformin + Glimepiride at 58.1 per cent, Rosuvastatin at 21.4 per cent, Protein Supplements at 20.2 per cent, Azithromycin at 14.4 per cent. Glycomet – GP becomes the No 1 Brand for Apr-15 with a value of ` 29.53 crores and growth of 18.6 per cent with a MAT Value of ` 299 crores. Lantus grew at 37.3 per cent, Monocef at 36.6 per cent, Glycomet-GP grew at 33.3 per

cent, Dexorange at 34.7, Augmentin at 29.7 per cent and Becosules at 29.1 per cent amongst the top 10 Brands. Few brands which have gained ranks include Pentaxim (+1312), Janumet (+71), Betnovate –C (+60), Januvia (+58), Shelcal (+57), Panderm Plus (+49), Istamet (+35), Clexane (+31), Spasmo Proxyvon Plus (+29), Magnex (+28), Huminsulin (+26), Pantocid D SR (+25), Dolo (+22), Omez (+17), Zifi (+11), Zoryl –M (+10), Rhoclone (+9), Orofer – XT (+8), Storvas (+8), amongst top 100 Brands over April 2014. A total of 162 brands and 300 SKUs were launched in April 2015. Top new brands for April are Sovihep, Eliquis and Revital-H.

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

EXPRESS PHARMA

June 1-15, 2015

MARKET POST EVENT

Pharmexcil conducts interactive meet on Foreign Trade Policy 2015-2020 in Mumbai DGFT to go online for filing documents by June 30 this year Usha Sharma Mumbai PHARMACEUTICALS Export Promotion Council of India (Pharmexcil) has recently organised an interactive meet on Foreign Trade Policy 2015-2020 and its impact on the pharmaceutical sector in Mumbai. During the meet, experts from the industry, regulators and policy makers discussed different positive aspects of the new Foreign Trade Policy (FTP). Ashutosh Gupta, Chairman, Pharmexcil welcomed the dignitaries as well as Pharmexcil members. In his opening remarks, he said, “The present government has an industryfriendly approach and we should not forget that it has taken many positive and encouraging steps in favour of the industry. The new FTP has clubbed five different schemes under chapter 3 which would result in less paperwork and a hassle free environment. For the first time, our Active Pharmaceutical Ingredient (API) manufacturers are very happy with the new FTP 20152020 as it opens many avenues for them as well.” Dr Kavita Gupta, Additional DGFT, Mumbai graced the occasion as Chief Guest. She said, “Since we have a stable government at the centre, the good part of the policy is that it will not see changes so early except for midterm review process.” Dr Kavita Gupta elaborated and said that FTP 2015-2020 is notified by the Central Government of India under section 5 of FTDR Act 1992 and the latest FTP is in effect from April 1, 2015 till March 31, 2020. She urged industry stakeholders to remain extra cautious with the documentation process as many of the DGFT’s process are going

EXPRESS PHARMA

June 1-15, 2015

Dignitaries at the meet

digital. She informed about status holder certification application, which is available till June 30, 2015. In her presentation, she mentioned about various salient features of simplification and merger of reward schemes. She said that under chapter 3 merchandise goods scheme, which has merged into a single scheme. Merchandise Export from India Scheme (MEIS) benefits have been extended to the units located in different Special Economic Zones (SEZs). Double weightage is allowed only for one-star export houses especially for northern eastern states, Jammu and Kashmir and Sikkim for manufacturing units under Micro, Small and Medium Enterprises (MSMEs). While referring to the ‘Make in India’ programme in FTP 2015-2020, she said, “The government is trying to boost the ‘Make in India’ initiative and has reduced export obligation for domestic procurement under Export Promotion Capital Goods (EPCG) scheme. It has been reduced to 75 per cent to promote domestic capital.” It was also announced that Directorate General of Foreign

Trade (DGFT) will go online for filing documents by June 30, this year. There are plans to adopt paperless trade application 24X7. It has already introduced single window system, online inter-ministerial consultations where companies need to load one time export / import documents which will be presented as a reference for future activities. There are plans to start an online message exchange with Central Board of Direct Taxation (CBDT) and the Ministry of Corporate Affairs. It will provide detailed information related to foreign trade of other countries’ regulations. With new FTP, SEZs will be entitled to take chapter 3 incentives and LOP will initially be valid for two years to enable the unit to construct plants and install machineries. Dr Kavita Gupta said, “Fees and charges for processing chapter 3 scrip application will no longer be paid in rupee but in dollars. The earlier policy was governed by the points mentioned earlier and new policy will be governed by new policy specifications.” Discussions were held on

various norms followed by the DGFT and the Central Drugs Standard Control Organization (CDSCO) and issues related in export consignments. The industry requested Pharmexcil to take the issue more aggressively and convey its message to both the authorities and also streamline the process. Prof Ajit Shah, Consultant for Export-Import presented a bird’s eye view of FTP 20152020. He said, “The good part of the new FTP is that it has incorporated several circulars into the current policy.” Shah suggested companies should develop an error code system because everything is going online and each day is considered crucial for advance licensing. In this scenario, pharma companies should have National Informatics Centre’s contact details in place and know the process for filing complaints. Simultaneously, companies need to train themselves on advanced online technologies. Shah said, “Chapter 8 is a real eye opener for me. Now onwards, we have to strengthen our paperwork. Companies need to rework on proforma, invoice,

shipping bill, etc. format because our FTP is accessible globally and countries which are importing can easily identify points which are in their favour. I feel if companies need to take help from their lawyers or chartered accountants they should do so before it is to late.” He further said that though the new FTP is being seen as an obstacle and there are bottlenecks, there are always solutions to overcome problems and move ahead. Dr K Bangarurajan, Deputy Drugs Controller DDC(I), Central Drug Standards Control Organisation discussed the issues faced by the Indian pharma community. “As a regulator, we come across quality issues which need to be reduced as fast as possible because it is hampering the image of the Indian pharma industry in the global space as well as impacting the individual company’s performance. My advice to all Indian pharma companies is that whenever there is an export order, try to see that product confirms to the pharmacopoeia and additional parameters. Many less regulated pharma companies are also now strengthening their guidelines and procedures, so Indian companies should study all these before before venturing into it.” Raghuveer Kini, Executive Director, Pharmexcil delivered the vote of thanks and pointed out, “There are many instances when the industry had faced several issues in different countries not because of quality compliance issues but due to data integrity / inadequate documentation. We have initiated several bilateral talks with these countries’ regulatory agencies and hope to have positive outcomes.” u.sharma@expressindia.com

EVENT BRIEF JUNE -JULY 2015 18

InnoPack Pharma

INNOPACK PHARMA Date: June 18-19, 2015 Venue:ITC Maratha, Mumbai Summary: InnoPack, a global brand of CPhI Worldwide, into its fourth year, has established itself to be the platform for pharma packaging innovations. Visitors at InnoPack Pharma Confex will find all major categories of pharmaceutical packaging, learn about the latest innovations, technologies, trends and developments in pharma packaging at the conference, network and gain access to one of the world's fastest growing pharma markets. More than 20 suppliers and 250 pharma

3rd Annual Pharma Project Management Conference 2015

professionals will attend the exhibition. Contact details Suvidha Shetty suvidha.shetty@ubm.com +91 (0) 22 6172 7001

3RD ANNUAL PHARMA PROJECT MANAGEMENT CONFERENCE 2015 Date: June 29-30, 2015 Venue: The Westin Mumbai Summary: CPhI will host 3rd Annual Pharma Project Management Conference 2015. The key highlights of the event are as follows. Workshops and practical case studies, international pharma professionals, risk

To subscribe: bpd.subscription@expressindia.com

2nd Annual Advanced API Convention

identification and mitigation for NDDS projects, application of PMO in entering foreign markets, bridging cultural gaps in projects and showcasing issues that can be caused by misunderstandings of cultural differences. Contact details Suvidha Shetty suvidha.shetty@ubm.com +91 (0) 22 6172 7001

2ND ANNUAL ADVANCED API CONVENTION Date: July 20 - 23, 2015 Venue: Mumbai Summary: CPhI 2nd Annual Advanced API Convention

will focus on the development of high quality APIâ&#x20AC;&#x2122;s for the Indian pharma market. To counter Indiaâ&#x20AC;&#x2122;s 90 per cent dependency on China for essential drugs, this conference will focus on

quality, technology and cost efficiency in the processes for making the API drugs. Contact details Phone: +44 (0)20 7921 5000

EXPRESS PHARMA

June 1-15, 2015

cover )

Following PM Modi's vision of ‘zero defect’, ‘zero effect’, pharmaceutical companies supported the Swachh Bharat campaign. The government too is helping small-to-medium sized companies attain this objective through the cluster model but they need more enabling policies to toe the line BY USHA SHARMA

EXPRESS PHARMA

June 1-15, 2015

(

ne of Prime Minister Modi's mantras at the 2014 Independence Day Parade was: zero defect, zero effect. He said that India can become a big exporter if it does not compromise on two things: "No defects in manufacturing items and zero effect on our environment.". Thus the 'Make in India' and 'Clean India' campaign have put pressure on pharmaceutical companies in India to clean up their act. The pharma sector is one of the most polluting sectors which produces heavy biowaste. The cost of treating this waste is also expensive and adds to the capital investment in the drug development and manufacturing process. The Indian pharma industry is very fragmented, dominated by MNC pharma, big Indian companies as well as medium to small-sized enterprises. 250 of the largest companies account for 70 per cent of the Indian market. In this competitive market big pharma companies outsource their products to small-to-medium pharma players to cut labour and

production costs. Companies in the MSME bracket find it extremely difficult to comply with many of the regulatory requirements as this entails hefty investment. For example, having an effective effluent treatment plant (ETP) is mandatory for any pharma munufacturing unit in order to treat waste material generated during production. This entails a sizable capital investment. Often small pharma manufacturing companies do not have the enough financial backing nor the land for fulfilling these requirements. Nitin Kalothia, Director, Manufacturing & Process Consulting, Frost & Sullivan highlights, “The focus is shifting to investing into renewable energy and usage of clean fuels (briquette based boilers, gas based DG sets, etc) and waste recycling. Since water is a major resource for many pharma companies, tracking consumption, reduction and recycling have been well adopted by them. Treated water is used in non-manufacturing areas.” The situation is compounded by the fact that each company's compliance needs will depend on their product range. As a Glenmark spokesperson says, “Raw effluent from a formulation plant is relatively easier to handle and can be treated effectively using conventional ETPs. The typical conventional ETPs consists of oil and grease trap, equalisation tank, primary (i.e. physicochemical) treatment, biological (i.e. aeration tank followed by secondary clarifier) treatment, pressure sand filtration, activated carbon filtration and disinfection. These ETPs are relatively easy to install and operate and can be maintained by formulation plants irrespective of the size / capacity of the manufacturing units.” Similarly raw effluent from bulk drug units can be categorised either as high chemical

To subscribe: bpd.subscription@expressindia.com

oxygen demand (COD) and high total dissolved solids (TDS) or low COD and low TDS. Each category requires different treatment processes. Both these streams of effluent are much more complex and difficult to treat as compared with effluents of formulation plants. Though available, treatment of high COD and high TDS effluents but calls for higher capital investments and revenue budgets. “The technology is a combination of a stripper, Multi Effect Evaporator (MEE), multiple Reverse Osmosis (RO) units and Agitated Thin Film Drier (ATFD). Part of the output from MEE further requires to be treated along with low COD and low TDS stream using conventions ETP. Additionally, skilled manpower is required to operate this technology,” informs the Glenmark spokesperson.

Clustering for comfort Realising that MSME pharma companies do not have the required financial backing, the government has introduced a cluster model approach, wherein groups of pharma companies can share common facilities. While commenting on the cluster model and the benefits to pharma companies the Glenmark spokesperson comments, “The cluster approach will reduce the cost of treatment and ensure that controls are effective (leading to) better protection of the environment as compared to individual units. At the same time, treated effluent shall be recycled /reused to the maximum extent possible.” But are pharma clusters delivering the desired results? As Debabrata Gupta, Chief Operating Officer, USV puts it, “Pharma clusters are an important part of the solution. There are many such clusters - notably in Andhra Pradesh which are operating very well

THE MAIN FOCUS

and in a compliant manner. These are often run by private agencies, who in turn do a very good job of environment control. Since the operators charge the industries, based on volume as well as quality of effluent, this serves as a incentive for the industry to generate less effluent - both in terms of volume and quality of contaminants.” The efficiency of a cluster model would obviously depend on the thought and planning that goes into it. Pointing out the technical aspects which pharma companies need to understand, H Subramaniam, Chief Operating Officer, EverythingAboutWater mentions, “In a cluster-based ETP system for the pharma industry, it is essential to ensure that online real-time effluent monitoring systems are installed to ensure that the individual units follow the prescribed norm. The treatment plant also needs to be designed for shock loads and must handle a high COD level. Recovery of certain chemical streams is possible from the effluent through physic-chemical processes, which can be used back in the process or sold in the market. This builds the concept of pZLD (profit from zero liquid discharge) and improves the viability of the whole project. It also reduces the quantity of the sludge coming out of the unit, thereby reducing the disposal costs.”

Complexities galore In addition, new guidelines have put additional burden on manufacturers. As the Glenmark spokersperson points out, “The recent guidelines by the Central Pollution Control Board (CPCB) asking State Pollution Control Boards (SPCBs) to have online monitoring stations installed at such ETPs have escalated costs further. In short, this technology is costly and difficult to

There are not too many options available at this point in time, for usage of environmentally friendly or recyclable materials for construction Debabrata Gupta Chief Operating Officer, USV

In a cluster-based effluent treatment plant system for the pharma industry, it is essential to ensure that online real-time effluent monitoring systems are installed to ensure that the individual units follow the prescribed norm H Subramaniam Chief Operating Officer, EverythingAboutWater

EXPRESS PHARMA

June 1-15, 2015

cover ) maintain and hence not an easy choice for smaller units. In this situation, financially common ETPs and bulk drug clusters is a better choice,” he points out. ETPs can have the best technology but at the end of the day, they also need skilled manpower to run this technology in the right manner. Subramaniam opines, “Training of operators is essential to ensure that the plant is well maintained and continues to perform over the life cycle. The government should support such initiatives, to make it viable for small and medium pharma industries to reduce their environmental load and to also reduce their total water consumption. ”

HIGHLIGHTS OF COMPANIES FOLLOWING GREEN PRACTICES ◗ They have a structured programme in place (result driven and time bound) to identify and eliminate environmental impacts and eliminate potential risks. These projects are driven by an identified team and there is review mechanism in place. ◗ The major focus area in environment is towards energy, water and waste management. Energy conservation has been the first stepping stone for most companies since energy cost is significant for them, followed by effective disposal of hazardous waste. Slowly, the focus is shifting to investing into renewable energy and usage of clean fuels (briquette based boilers, gas based DG sets, etc) and waste recycling. Since

water is a major resource for many pharma companies, tracking consumption, reduction and recycling have been well adopted by them (Treated water is used in non-manufacturing areas). ◗ Companies are identifying and working with experts on alternate ways of testing the efficacy and effectiveness of drugs at the drug discovery stage and to eliminate / reduce clinical trials on various live species. ◗ As the pharma sector being driven by regulatory bodies, it requires volumes of documentation. As a green drive, few companies are looking at the 'paperless factory' concept by online documentation and control (though after due approvals from regulatory bodies). (Source: Frost & Sulivan)

Identifying the avenues It is a matter of record that India was possibly one of the earliest adopters of the Export Processing Zones (EPZs) model when the government set up Asia's first EPZ at Kandla in 1965. The Department of Industrial Policy and Promotion (DIPP) followed this up in April 2000 with the Special Economic Zones (SEZs) policy aimed at solving issues related to multiple controls and clearances, the absence of world-class infrastructure, and an unstable fiscal regime as well as to attract larger foreign investments in the country. Later, under the new excise policy in the year 2004, Central Excise Duty on pharma products which was levied on MRP created a compulsion for many small and big pharma companies in the country to relocate their business to excise free zones. Seizing the opportunity, many pharma companies opted to move these zones and started acquiring land in excise free zones. However once the terms of the tax incentives expired, these companies started moving away leaving behind sick units. Pharma companies started exploring other options for growth. As the Glenmark spokesperson rationalises , “Formulation units operating in excise free zone lose profitability once the tax incentives are over. Having shared facilities like ETP and Common Hazardous Waste Treatment Storage and Disposal

20 EXPRESS PHARMA June 1-15, 2015

Facility (CHWTSDF) may not be enough for companies to close factories and move to other locations where tax benefits are available. Such units may have to explore other options or new markets or product portfolios or export options through which the sales revenue may be improved for their sustainability.” “Such units may have to explore other options or new markets or product portfolios or export options through which the sales revenue may be improved for their sustainability. The principles of sustainability should be implemented in all three dimensions i.e. economic, environment and social. A broader approach towards sustainability of such units is the key rather than only looking at having common facilities,” he avers. So should state governments help provide other shared facilities like ETPs to prevent pharma companies moving away? Gupta opines, ”There are examples on both ends of the spectrum. While companies do set up units in the tax free zones to avail of the tax benefits, a majority of them do continue operations even when the tax incentives have lapsed. This is because there is a manufacturing capacity which has been created and shutting down of a unit will actually have a negative

impact on the supplies and therefore, on the business.”

Push from the government

Pharma sector being driven by regulatory bodies requires volumes of documentation. As a green drive, few companies are looking at "Paperless Factory" concept by online documentation and control (though after due approvals from regulatory bodies) Nitin Kalothia Director, Manufacturing & Process Consulting, Frost & Sullivan

Recently, a 45 member delegation comprised of CEOs, senior industry leaders and members of the FICCI Secretariat led by Harshavardhan Neotia, senior vice president, FICCI, and companies mainly from the renewable energy sector and in the urban development space, traveled along with PM Modi to participate in the Hannover Messe fair. This is in sync with the importance being given by the NDA government to the development of clean energy and sustainable development of cities with a focus on water, transport and waste management. Biotechnology was one of the potential areas of cooperation between India and Germany, the others being manufacturing, infrastructure, IT, ITeS, auto components, green technology, entertainment and vocational education and training. During five-day event, the members of the delegation reportedly attended a seminar organised by FICCI on renewable energy in partnership with the Ministry of Renewable Energy, Government of India as well as one on urban development in partnership with the Ministry of Urban

Development, Government of India, along with the respective ministries of the German government. The government is constantly trying to emphasise the need to reduce the burden on the environment and encourage industries to use renewable, green material. Recently, Dr Harsh Vardhan, Union Minister for Science and Technology, urged scientists and technologists to working on developing low cost building and structural materials to use renewable, green material for construction. The construction materials which are currently used in pharma manufacturing facilities conventionally use plastic and steel. Pre-fabricated materials have also found their way into the pharma construction business. However, as rightly pointed out, Gupta admits, “There are not too many options available at this point in time, for usage of environmentally friendly or recyclable materials for construction. Unless these technologies are developed, it will be difficult to assess their suitability for construction.

Rewards and recognition There is an urgent need to encourage and incentivise pharma companies to adopt an environment friendly approach. Rewards and awards are a time honoured way to do this. For instance, Frost & Sulivan's Green Manufacturing Excellence Awards recognise companies across sectors, including pharma, who have adopted a green/sustainability approach. As Kalothia comments, “The sustainability initiative in the country at large is a selective choice and a handful of big corporates are working on it. Few pharma companies, mainly the leaders in this sector, have also been a part of this journey and are driving sustainable development practices in their organisation.” So are pharma companies in India finally matching up to global standards? Analysing the trends, Kalothia says, “Not mentioning pharma companies in particular, but at an overall

(

THE MAIN FOCUS

level, since the focus on green practices in India has been quite new (about a decade old) compared to few developed nations where the journey started much earlier, we have a long way to go to catch up with them. Also, the environmental laws in developed nations are much more stringent compared to India which is driving.” But there are signs that more pharma companies are slowly realising the benefits of 'going green'. According

to Kalothia, “Representation of pharma companies in Green Manufacturing Excellence Awards is this year in the range of 10-12 per cent of the total applications as against five to seven per cent in the previous editions. These are mainly represented by large and medium pharma companies in the country.” Here's hoping that many more follow these leaders in the years to come u.sharma@expressindia.com

ACG leads ‘green’way Pithampur site was pharma industry’s first LEED India gold rated manufacturing facility IN THE past few years, ACG has shown the industry that its activities increasingly go beyond business and brains; one that works with its heart. Any new project that ACG takes up is one more ’green step’ ahead. Starting any green field project is always very challenging and requires efforts to settle down fast and start its operation within stipulated timelines with optimum utilization of assets. However, for ACG, this ecofriendly move has had the enthusiastic backing of an enthusiastic senior management team. Till date, using recycled water from effluent treatment plants, employing vermin-compost for agriculture, promoting ‘One Hut One Tree’ concept in villages near the factories and many other such initiatives have paid rich dividends. The jewel in the crown for ACG’s green initiatives is its state-of-the-art capsule manufacturing facility in Pithampur, near Indore, Madhya Pradesh where the company has incorporated green features during the design and layout stages of the facility. According to the company, every bit of care and precaution has been exercised while executing the green project. Sockets have been provided for charging electric vehicles in parking spaces and energy-efficient lighting fixtures have been included. The company has automated water efficient fixtures to an onsite ETP plant for 100 per cent water treatment and has highly-efficient HVAC

systems to CFC-free refrigerants and fire suspension systems. The company uses Forest Stewardship Council (FSC) certified wood and also recycles or reuses 95 per cent of construction waste. It has provisions for improving indoor air quality as per American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE) standards and uses low VOC content paints, sealants and adhesives. The green features at ACG’s Pithampur factory was recognised by the Indian Green Building Council in May 2014 as the first plant in the Indian pharma industry to be awarded Gold rating by LEED India. The certification emphasises ACG’s continued commitment towards sustainability and recognises the efforts in building sustainable sites, saving water, reducing energy consumption, recycling building material and improving indoor environmental quality. Selwyn Norohna, Chief Executive Officer, ACG Associated Capsules said, “ACG has always been steadfast in its social responsibilities, be it health and education-related initiatives or our long-standing environmental commitment. A Gold rating from esteemed and internationally recognised organisations such as IGBC and LEED acknowledges our efforts to build a sustainable future, not just for ourselves, but for our future generations as well.”

To subscribe: bpd.subscription@expressindia.com

EP News Bureau-Mumbai

EXPRESS PHARMA

June 1-15, 2015

cover ) ‘GREEN’ EVENTS

Seminar on green chemistry emphasises importance of pollution prevention at source Seminar in Hyderabad organised by GCF in collaboration with DoP, TSPCB and BDMA A TWO-DAY industrial seminar and exhibition on Green Chemistry & Green Engineering for pharma API industry was recently held in Hyderabad. The seminar was organised by Green ChemisTree Foundation (GCF), in collaboration with Department of Pharmaceuticals (DoP), Govt of India; Telangana State Pollution Control Board (TSPCB); and Bulk Drugs Manufacturers Association (BDMA). The seminar was supported by industry partners, like Excel Industries, Dr Reddy’s Laboratories, Newreka Green Synth Technologies, Novozymes, S-AMIT Specialty Chemicals, ROCHEM, Laurus Laboratories, NATCO Pharma, Indian Chemical Council and Express Pharma as media partner. The seminar was attended by over 100 R&D, plant, operations and EHS personnel from more than 50 pharma API and its intermediate manufacturing companies from across India. They were a mix of MNCs (20 per cent), large companies (30 per cent) and SME categories (50 per cent). Welcome addresses were made by dignitaries such as Jayanth Tagore, Managing Director and Chief Executive Officer, Synthokem Labs and President BDMA; Dr Raveendhar, Senior Environmental Scientist, Telangana State Pollution Control Board; Dr Vilas Dahanukar, VP, Dr Reddy’s Laboratories and Nitesh Mehta, Founder Director, Newreka Green Synth Technologies’ and Green ChemisTree Foundation. The dignitaries emphasised on the importance of pollution prevention at source and urged

22 EXPRESS PHARMA June 1-15, 2015

Glimpses from the event

the industry audience to go beyond awareness and work towards green chemistry implementation and its integration into current API and intermediate manufacturing practices. Dr (Prof) AV Rama Rao, Managing Director and Cgairman, AVRA Labs gave the keynote address. Rao kept his audience engrossed with rele-

vant anecdotes and experiences of industrial case-studies. An implementation-driven talk was given by Suhas Jawlekar, one of the best Process Engineers of DRL. He shared DRL’s success case-studies, and suggested methodical and adept approaches for integrating 'Green Engineering' practices in pharma API industry.

Prof B Bhanage, Head of Chemistry Department, Institute of Chemical Technology (ICT), shared his expertise on the 'Relevance of 12 Principles of Green Chemistry in the Pharma API manufacturing.' Bhanage’s presentation was a comprehensive consolidation of successful pharma. focused case-studies vis-à-vis the 12 principles of

green chemistry as reflected in each of the case-studies. The first day of the seminar concluded after a panel discussion on 'Barriers & Potential Strategies to Implement Green Chemistry in Pharma API Industry. The discussion was moderated by Tagore. Key stakeholders took part in the panel discussion. They included

(

THE MAIN FOCUS

Dr Rashmi Naidu, Director (Technical Services), SSS-Europe (expert on Regulations and National Chemical Policies); Dr JS Yadav, Former Director, CSIR-IICT, Hyderabad (representing Academia & Research); Dr Rakeshwar Bandichhor, Associate Director- R&D IPDO, Hyderabad (representing Industry); Dr Raveendhar, senior representative from Telangana State Pollution Control Board; Dr Dinesh Nair, Regional Manager, Novozymes South Asia and Nitesh Mehta, Founder Director, Newreka Green Synth Technologiesâ&#x20AC;&#x2122; (representing Solution Providers). Day-two of the seminar saw a session on 'Tools & Strategies' to implement green chemistry and green engineering in the pharma API industry. Dr Dhileep Krishnamurthy, Vice President & Global Head R&D-API- Pharma

on tools and technologies for integrating green chemistry and green engineering in the

production process stages. Day two of the seminar was dedicated to introducing

emerging tools and technologies as potential solutions for implementing green chemistry and/or

engineering practices in pharma API manufacturing. EP News Bureau-Mumbai

The seminar was attended by over 100 R&D, plant, operations and EHS personnel from more than 50 pharma API companies. They were a mix of MNCs , large companies and SME categories Solutions and Dr MG (Deepak) Palekar, Head & Strategy, STEP were the speakers. Krishnamurthy highlighted on the tools for incorporating 'green chemistry by design' at source during the route selection stage, while Palekar emphasised

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

June 1-15, 2015

MANAGEMENT UCPMP:

‘CODE’WORD FOR PHARMA INDUSTRY The Uniform Code of Pharmaceutical Marketing Practices (UCPMP), launched by the Department of Pharmaceuticals (DoP) has not roused much interest among pharma firms. If it becomes mandatory after DoP’s review post June, will UCPMP’s future implementation remain more on paper than practice? BY SACHIN JAGDALE

he pharmaceutical industry has always found itself in the docks with respect to ethical marketing practices. Though never accepted by industry, many companies have frequently been caught offering gifts to doctors to increase prescription and thus sales. This 'influential treatment' of doctors by pharma companies has kept them on the radar of government watchdogs as well. The Department of Pharmaceuticals’s (DoP) Uniform Code of Pharmaceutical Marketing Practices (UCPMP), which came into effect from January 1 this year, is aimed at detecting and stopping such malpractices.

So far, not so good Most pharma companies promised to adhere to the UCPM. But if industry observers are to be believed, the response to the Code is perhaps out of compulsion, not commitment and so far, it is not so good. According to them, the government is doing what it is supposed to do and

24 EXPRESS PHARMA June 1-15, 2015

pharma companies are doing what they need to do to keep business afloat. “The response from the pharma industry indicates a cautious outlook towards specific points. For example, there has been a drastic drop in sponsoring Health Care Practitioners (HCPs) to attend Indian and international conferences which has been specifically mentioned in the UCPMP guidelines. While Indian companies are relooking at the way they have been engaging with the doctors, MNCs are also re-looking at their HCP engagement policies to comply with the new guidelines laid by UCPMP,” opines Dr Somnath Datta, Business Unit Head - Critical Care Sales and Marketing, Mylan Pharmaceuticals. Initially voluntary for a period of six months, it will be up for review this June. Unsatisfactory compliance with the UCPMP (the Code) could force DoP to make it mandatory. However, will the transition from voluntary to mandatory make any difference?

Amit Karkhanis, Partner KayLegal and Associates LLP, says, “I personally feel anything that is voluntary does not work in India except for a few pharma companies who have been in business with international companies in the US. They follow the US FDA norms and may adopt this as most of the provisions are based on the US norms. However, small and medium size pharma companies who are part of the large unorganised sector, may not voluntarily follow the code. Hence, I feel that the code should be made mandatory.” The DoP had come up with the voluntary code of conduct for the industry in 2011 as well, which could not be implemented due to non co-operation by pharma companies. This apprehensive behavior by the pharma companies was an indicator of the fact that offering gifts has been an integral business policy within the pharma industry. It does not seem much has changed since 2011 and so, once again the success of the Code cannot be assured as pharma companies feel that it

will erode their business. Datta says, “In the short term, UCPMP will affect the business of pharma companies. If strictly implemented, this will entail a palpable change in the way marketing of prescription medicines happen throughout India. The HCPs will take time to understand this new way and certain companies with a highly “transactional” model of sales will find it difficult to sustain the sales revenues in the short term. Those companies who have not relied on scientific promotion as a base for ethical promotion will have to revamp their sales training and recruitment policies to hire sales representatives with better communication and convincing skills.”

Will the Code be effective? Even if DoP makes the Code mandatory, considered the most possible scenario once the voluntary period gets over, its success is doubtful. The strictest of laws will not be effective if pharma companies decide to find new ways of favouring doctors.

Datta says, “After the tobacco industry, the next most hated industry is pharma. I am certain that various countries are slowly realising the problem of conflict of interest brought in by the benefits pharma companies offer to HCPs. Innovative medicines would still need change in prescription behaviour which would mean advertising the benefits of the new therapy. However, unnecessary advertisement of generic medicines just to increase prescriptions should be curtailed. It is possible if government mandates all advertising and promotions to be approved by a central body before being implemented. Just as UK laws are making it difficult for individuals to find cigarettes in the newspaper stalls, companies will also get discouraged if they are mandated to take approvals from government every time.” Doctors share as much responsibility for making the Code successful. Lack of takers will obviously reduce the scope for givers. However, over the years, a large chunk of the doc-

tor community has supported this 'gift culture'. Commenting on the 'cordial' relations between doctors and pharma companies, a senior official from one of the largest organisations that represents doctors across India, on the condition of anonymity, sarcastically says, “It is not possible to stop pharma companies from offering gifts and doctors are also not going to stop accepting them. No diktat, either from the government or from organisations like ours, will work in this case.”

Global scenario “In foreign countries, pharma companies have to adopt strict disclosure norms. The parameters laid down by US FDA are very stringent and they govern not just the marketing aspect of pharma companies but manufacturing aspects as well. The US FDA carries out regular inspection

of factories of the pharma companies which operate in US and also factories located overseas. We have seen recently in the case of Ranbaxy as to how the US FDA has penalised Ranbaxy for maintaining units in India. Such stringent norms help build a transparent pharma sector which ultimately results through disclosing norms and the consumer benefits from the same,” informs Karkhanis. Comparing the UCPMP with its US and EU counterparts, Datta says that it is stringent enough but it lacks clarity in many important aspects. As he explains, “Both US and EU codes are already in place. The UCPMP code in its current format, is as stringent (if not more) as the US codes. However, it does differ in certain places. For example, the place of jurisdiction has not been mentioned in the UCPMP. This means, if an

To subscribe: bpd.subscription@expressindia.com

Indian company is caught flouting the UCPMP code in a foreign country, will the Indian Ministry take any action? Also, the penalties are not mentioned in the code. Without providing details of the penalty, I am sure the punishment for flouting the Code is left to interpretation and negotiation.”

Making it officially legal? If compliance with the Code is difficult for the industry, should the government consider legalising the practice of offering gifts? Datta doesn't think so. He asserts, “Offering gifts should not be legalised.” However, Karkhanis points out that some clauses in the Code are unjustifiably stringent and will do more harm than good. For example, updation of knowledge is a continuous process for doctors and if pharma companies sponsor them for conferences,

seminars or training sessions, it should not be termed suspicious. This updation of knowledge also benefits patients. Karkhanis opines, “I feel that totally banning gifts and benefits to doctors from pharma companies may not achieve the desired purpose. A complete ban may result in a cash economy which will be totally unregulated and beyond any control. Instead of encouraging (such a) cash economy, it is advisable to set a limit for pharma companies for giving gifts and benefits to doctors. A benefit of sponsoring doctors for conferences and seminars is worth considering as it is important for them to be in touch with latest technologies, knowledge and development s in science and medicine. Presently, the Medical Council of India’s (MCI) code of ethics prevents pharma companies from sponsoring doctors to attend these seminars and conferences which according to me is stringent and harsh and needs to be reconsidered as doctors need to understand the latest technology which shall help them compete globally.” Datta and Karkhanis both want some key changes in the Code. While Datta asserts that it should have differential treatment for innovative and generic medicines and the penalties for breach of code, Karkhanis feels that Section seven pertaining to relationships with HCPs is too harsh and needs to be diluted. A corresponding dilution in the MCI Code of Ethics is also required. The Code’s voluntary period will expire in June, after which DoP will have to take a call on whether to turn it into statutory code. However, before taking any final decision, DoP will have to answer a plethora of queries from the pharma industry.

I personally feel anything that is voluntary does not work in India except for a few pharma companies who have been in business with international companies in the US Amit Karkhanis Partner, KayLegal and Associates LLP

In the short term, the Code will affect the business of pharma companies. If strictly implemented, this will entail a palpable change in the way marketing of prescription medicines happens throughout India Dr Somnath Datta Business Unit Head - Critical Care Sales and Marketing, Mylan Pharmaceuticals

sachin.jagdale@expressindia.com

EXPRESS PHARMA

June 1-15, 2015

MANAGEMENT

2015 USTR SPECIAL 301 REPORT REACTIONS AND THE WAY FORWARD In the aftermath of this year’s USTR Special 301 Report, which retained India on the Priority Watch List, industry leaders comment on the Report’s result, as well as the overall IPR scenario in India BY VIVEKA ROYCHOWDHURY

‘OPPI WELCOMES THE CONTINUED FOCUS ON STRENGTHENING IPR IN INDIA’

RANJANA SMETACEK Director General, Organisation of Pharmaceutical Producers of India

26 EXPRESS PHARMA June 1-15, 2015

he Draft intellectual property rights (IPR) Policy is a positive step towards an IP regime that has the potential to support and drive a number of economic and socio-cultural benefits. Our country already has the elements required to realise the PM’s ‘Make in India’ vision: consistent growth, a highly educated workforce and established science-based research institutions. We can extend ‘Make in India’ to ‘Develop in

India’ and ‘Innovate in India’, if we develop a robust, predictabl, and enforceable legal framework for the protection of IPR. Our PM was pretty categorical in his view that India’s patent laws should be brought on par with global standards, to make Asia’s third largest economy a hub for outsourced creative services. He has been quoted on April 24, 2015 as saying, “If we don’t work towards bringing our IPR at par with global parameters, then the

THIS IS A POSITIVE STEP TOWARDS AN IP REGIME THAT HAS THE POTENTIAL TO SUPPORT AND DRIVE A NUMBER OF BENEFITS world will not keep relations with us. If we give confidence to the world on IPR, then we can become a destination glob-

ally for their creative work, when he spoke at the first Global Exhibition on Services (GES).

MANAGEMENT

‘WE SHOULD NOTAGREE TO ANYTHING THATIS TRIPS PLUS’

I DAARA PATEL Secretary-General, IDMA

ndia is already well aligned with all the requirements of TRIPS. India’s Patent Act 1970 as amended, is recognised as a breakthrough regulation which is also adopted and followed by many other leading countries in the world. Special mention should be made of the Section 3(d) of

our Patent Act which only allows genuine innovation and blocks evergreening of patents by minor improvements. A patent is granted only if there is a significant therapeutic improvement or advantage. This is also commended by leading international organisations like WHO, UN and leading global

NGOs like MSF, PEPFAR, Clinton Foundation etc. I would strongly recommend that we do not tamper with the provisions of our landmark Patents Law which is fairly balanced and pro-people. I would like to reiterate that we should not agree to anything that is TRIPS Plus!

WE SHOULD NOT TAMPER WITH THE PROVISIONS OF OUR LANDMARK PATENTS LAW

‘RELEVANCE OF3(D) IN ITS PRESENTFORM MAYBE OPENED FOR ADEBATE AND DELIBERATION’

I GOPAKUMAR G NAIR, As IPR Sub Committee Chairman, IDMA

ndia has positioned itself as a “Pharmacy of the World”. India is emerging or poised to emerge as a superpower. Divergence of views including in IPR and patents is only naturally expected, given the past, present and future of global economy and economies and current status of member nations or regions governing global treaties and trade in the past, treaties such as WTO and TRIPS emerged from extensive discussions, deliberations, debates and negotiations. Negotiations and the discussion process and the exchange of views associated with bilateral or multilateral negotiations help resolve distances and differences in positions and perceptions of issues and policies. Having successfully negotiated the WTO and TRIPS nearly 20 to 25 years ago, India needs to be prepared to discuss and deliberate on all contentious subject matters of mutual interest. Having faced the new product patent regime and surfed through the early turbulent waters, India should gain in self-

To subscribe: bpd.subscription@expressindia.com

confidence and move on from a highly defensive position and posture to one that befits a global leader of tomorrow. Extreme positions and views on IPR as in other areas, is not the order of the day. Over the past two to three decades, the institution and instrument of IPR especially patents have been monopolistically extended by the Big Pharma and the government supporting their views, so much so that the delicate balance which is so sacrosanct to the statute of patents between the rights of the users (patients) and the rights of the patentees (assignees/ licencees) have been unduly tilted in favour of extremely monopolistic interests. With the advent of WTO/ TRIPS, the balanced views of developing countries such as BRICS and India in particular, has come to be heard and debated globally. Unfortunately, examples such as that of Gleevec has been unduly and unfairly highlighted against India, even though Gleevec being a pre -95 molecule did not deserve ab-

solute monopoly in India. The most contentious subject matter of S.3(d) in its present form was most essential to prevent undue evergreening, especially in the transition phase. S. 3(d) has done its job and the international community has taken note of its contribution. Relevance of 3(d) in its present form may be opened for a debate and deliberation, even though it is India’s position that it is equally useful and adversely impacting incremental innovations of MNCs as well as research based Indian companies. Data protection and data exclusivity though not directly related to TRIPS, may continue to be discussed and the implications as well the extent of implementation be debated. These being related primarily to the regulatory framework of DCGI and CDSCO, the current initiatives to join as an observer on Pharma Inspection Council and Co-operations (PIC or PICS), may cover these subjects also on the regulatory front.

The threat of TPP and other non-multilateral and deliberately secret treaty negotiations, excluding India are on the anvil. Though such restrictive and non tariff barrier (NTB) blockades are as much detrimental to the people and patents of those negotiating members, being the ‘Pharmacy of the World’, India has equal responsibility and obligation to keep India’s generic medicines affordably accessible to patients of these developing as well as developed countries. To that extent, India must continue the dialogue and remove apprehensions that India’s IPR regime is not globally compliant to TRIPS or WTO. It is in this context that we at IDMA believe that there are common elements and threads between the PMO’s and the Commerce Ministry’s positions. India should do what is in the best interest of India. This will and should include the interests (including export –based, research-based, and also “Make in India” –based) of the Indian pharma industry.

EXPRESS PHARMA

June 1-15, 2015

MANAGEMENT

‘NEED TO LOOKATIPR AS AN OPPORTUNITY, NOTIMPEDIMENT’

T RANJIT SHAHANI Vice Chairman and Managing Director, Novartis India

he PM is absolutely right in saying “India needs to work on IPR guidelines matching global standards”. Bringing India’s IP regime in line with international agreements and practice will establish India as a destination for innovation. While we commend the progress India has made in advancing IPRs and the positive steps taken toward complying with the TRIPS Agreement, more needs to be done to align this increasingly important industrial country with international standards. We need to have a predictable and transparent system in place. For the research-based pharma industry, some areas of the law—patentability standards, lack of data protection, local working re-

quirements—undermine India’s ability to capitalise on the benefits of strong intellectual property rights protection. Effective patent systems help patients because incentives stimulate long-term research and development efforts needed to develop better medicines. We believe that changes in the patent law will also help India’s pharma companies. India is an emerging economy with a potentially world-class pharma industry. With additional improvements in its intellectual property regime, India is poised to make significant contributions to public health through innovation, not only within India, but around the globe. In the TPP, countries are seeking to establish a comprehensive framework that will encourage trade liberali-

INDIA IS AN EMERGING ECONOMY WITH A POTENTIALLY WORLD-CLASS PHARMA INDUSTRY

sation and economic growth. In the life sciences area, the TPP, through ensuring that partner countries adopt strong IP policies, will foster economic conditions that will provide proper incentives for innovative pharma companies to continue to make the

investments required to bring new therapies to market that improve the quality of patient care. Barriers, such as those I have outlined, discourage pharma innovation and impede investment and ultimately limit economic growth and access and are against our shared interest of delivering the most effective healthcare possible. Looking to weaken IP protection will certainly not resolve the many challenges that healthcare faces in India. Pro-innovation policies and increased access to medicines are not mutually exclusive; rather they are two sides of the same coin and together are in the interests of the patient. It is about time that we as a country look at world class IPR as an opportunity rather than an impediment.

‘INDUSTRYSHOULD NOTGET UNDULYCONCERNED ABOUTTHE USTR REPORT’

D G SHAH Secretary General of Indian Pharmaceutical Alliance (IPA) and CEO, Vision Consulting Group

28 EXPRESS PHARMA June 1-15, 2015

STR has essentially has been a mouthpiece of PhRMA and BIO. Joseph Stiglitz, Nobel Prize Winner in Economics, while talking to the TPP negotiators about IPR and medicines in New York had recently said that the USTR does not reflect the views of the American society. It is the only discordant voice in an otherwise growing friendly economic relationship between the two countries. The USTR blindly reiterates in its reports what a section of the US pharma and biotech industry writes to protect their narrow and

THE GOVERNMENT OF INDIA IS MINDFUL OF THIS AND IT APPEARS THAT IT HAS DECIDED TO FOCUS ON OTHER SECTORS OF THE ECONOMY SUCH AS DEFENSE PROCUREMENT AND LOCAL PRODUCTION, SMART CITIES, NUCLEAR REACTORS, ENERGY, ETC. TO NEUTRALISE THE USTR

short term commercial interests. The Government of India is mindful of this and it appears that it has decided to focus on other sectors of the economy such as defense procurement and local production, smart cities, nuclear reactors, energy, etc. to neutralise the USTR. The industry should also not get unduly concerned of these reports of the USTR. They are biased, lack objectivity and (are) without evidence.

MANAGEMENT

‘CONFUSION ON IPR POLICYPREVENTS INVESTMENT’

ROGER BATE Economist, Resident Fellow of the American Enterprise Institute

think what the discussion within India shows is that on the one hand India can just about defend its IP stance in court, but everyone knows that India’s IP regime provides uncertainty to investors (foreign and domestic) and this is what PM Modi was getting at. The spirit of TRIPS may not have been upheld with the Novartis Gleevec decision, but one can say that the letter of the law, as the Supreme Court was asked to interpret, was applied, but that doesn’t mean the decision was fair, or the best for investment or even patients. India needs to decide whether it really wants to encourage investment in domestic research or just maintain a copycat drug industry. Right now everyone is confused and confusion prevents investment.

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

June 1-15, 2015

MANAGEMENT INSIGHT

‘Special 301 Report annual swat at India’s IP policies’

BROOK K BAKER, Northeastern U School of Law, and Senior Policy Analyst, Health GAP

In an exclusive analysis for Express Pharma, Professor Brook K Baker, Northeastern U School of Law, and senior policy analyst, Health GAP rebuts 10 principal US 301 accusations and urges that the sooner India clarifies its anti-monopoly stance, the more secure the right to health will be THE OFFICE of the US Trade Representative continues to excoriate India’s pro-access IP policies and proposes multiple ‘solutions’ that will only benefit transnational monopoly profits, especially those of the bloated US pharmaceutical industry. Although the 2015 Special 301 Watch List Report politely drops India from the USTR’s Out-ofCycle review list, the Report details in minute detail the propharma, pro-IP-monopoly reforms the US seeks to coerce out of the Modi government. Readers often think IP is be-

yond their understanding, but when framed in a context that rebuts strengthened monopolyprotection and narrow US interests, the stakes for India should be clear. The table below sets forth principal US 301 accusations against India in the 2015 Special 301 Report and a rebuttal of such claims. (See table: Rebuttal to US 301 accusations against India) While continuing to press ameritless claims, based solely on the wish list of US IP industries, the USTR also gleefully praises some accommodationist

signals from the Modi government. For example, the USTR Special 301 Report praises the establishment of a domestic IPR-focused working on India IP Policy and the access the US has both to this policy undertaking and to a separate IPR Working Group Process where the US can directly engage Indian policy makers on the US IPR goals (p. 45-46). The Report also directly references Prime Minister Modi’s statement in April recommending that India align its patents laws with international standards and encourages India

expeditiously to undertake this initiative (p. 48). Finally, the Report favorably mentions what it considers to be positive development on the data exclusivity/monopoly front (p. 50). This may be a cat-and-mouse game, but make no mistake who is the cat and who is the cat’s master. The US will continue to playfully bat India around with its paws, seeking its acquiescence to the monopoly intentions of Big Pharma and other IP-based transnationals. At the same time, the cat is sizing up India to eliminate it as a competitor for the pleasure and

profits of the US’s IP behemoths. The Special 301 Report is an annual swat at India and other US trading partners signaling the strengths of IP monopolies and the US’s obedience to their demands. India’s interests, and the interests of people in India and elsewhere to more affordable access to medicines, agricultural inputs, and green technologies, are not served by capitulating to monopoly interests. The sooner India clarifies its anti-monopoly stance, the more secure the right to health will be.

REBUTTAL TO US 301 ACCUSATIONS AGAINST INDIA ACCUSATIONS

REBUTTALS

India along with China are the major sources of counterfeit pharmaceutical shipped to the US and elsewhere (pp.14, 51).

The technical meaning of a counterfeit is a product that is trademark infringing. Such infringement, especially with respect to medicines, is usually motivated by excessive pricing by monopoly rightholders. The actual larger concern globally is unsafe, substandard, and unregistered medicines – a problem that is not significantly IP related.

India is unfairly and unlawfully incentivising domestic innovation and discriminating against US and other foreign companies by means of local content/investment/production requirements, domesticpreference procurement, and other means (pp. 21-23). It also imposes unfair tariffs on medicines, pharmaceutical inputs, and medical devices (p. 24). “The United States remains concerned about actions and policies in India that appear to favor local manufacturing or Indian IPR owners,”citing the Drug Price Control Order and the provision in Section 84 of the Patents Act allowing compulsory licenses in some circumstances if a patented product is not manufactured in India.

The WTO TRIPS Agreement recognises the interest of developing countries to develop their technological capacities and to promote technology transfer. Encouraging domestic production via government procurement and other means, instead of allowing unbridled exploitation by foreign IP owners, is fully TRIPS-complaint and in India’s national interest. Likewise, instead of allowing unbridled monopoly pricing, governments retain sovereign rights, like those retained by the US Department of Defense and Veterans Affairs Department, to regulate prices. Similarly, there is an emerging expert consensus that governments’compulsory licensing strategies can promote local production instead of domination by monopoly-priced imports.

“[T]he United States continues to have serious concerns about the innovation climate for biopharmaceutical and other sectors, such as agricultural chemical and green technologies. Innovators in these sectors face serious challenges in securing and enforcing patents in India.”(p. 48)

The vast majority of patents granted in India are held by foreign patent holders, including those from the US. India has invested considerable resources in upgrading and modernising its patent offices, something that the US acknowledges, yet the US still whines about its favored industries.

30 EXPRESS PHARMA June 1-15, 2015

MANAGEMENT ACCUSATIONS “The United States continues to have concerns that Section 3(d) of India’s Patents Act, as interpreted, may have the effect of limiting the patentability of potentially beneficial innovations”, including those enjoying patent protection in multiple other jurisdictions (p. 49)

REBUTTALS India’s Section 3(d) lawfully restricts patenting on new uses of medicines and new forms without evidence of significant therapeutic impact. It deters filing of weak, secondary patents that merely serve to lengthen monopoly protections and supra-competitive profits off sales to elites. If anything, India should enforce Section 3(d) even more vigorously as many secondary patents are being improvidently granted.

“[T]he United States urges India to improve and streamline its patent Opposition procedures are directly referenced as permissible in the WTO TRIPS Agreement and the knowledgeable inputs of opposition procedures (p. 49). generic companies and other opposition filers assist patent examiners in making informed, evidence-based decisions on the merits of patent applications. Oppositions have succeeded in weeding out dozens of unworthy pharma patent applications over the past 10 years. “[T]he United States continues to monitor India’s application of its compulsory licensing law”both with respect to pharmaceuticals and green technologies (pp. 50, 27).

India has granted exactly one compulsory license thus far, fully in compliance with national law, the TRIPS Agreement, and most especially the Doha Declaration on the TRIPS Agreement and Public Health. The US has quietly issued government use licenses on hundreds on patents in the US, but hypocritically states that it supports the Doha Declaration while challenging India’s judicious use of CLs.

“The United States also notes with concern the continuing challenges involved with the enforcement of patent rights in India, including challenges that some patent holders reportedly face in securing injunctions … .”(p. 50)

The WTO TRIPS Agreement allows countries’courts to offer remuneration (royalties) in lieu of injunctions in enforcement actions. Moreover, the US Supreme Court has sanctioned similar royalty damages in the famous eBay case.

When approving marketing approval applications from generic companies,“Indian state government authorities reportedly do not have a mechanism to confirm whether the item to be manufactured is under patent (p. 50).

Well, neither does Europe and both Europe’s and India’s denial of patent-registration linkage are fully lawful under TRIPS. Accordingly, generics facing weak or invalid patents can obtain marketing approval and the drug regulatory authority does not have to act as patent police.

“[T]he United States continues to urge India to provide an effective system for protecting against unfair commercial uses, as well as the unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products.”(p. 50)

Big Pharma has consistently sought data/registration monopolies since it lost the battle for them in the negotiation of the TRIPS Agreement. The data exclusivity the US seeks, prevents the registration of generic equivalents by making the medicines regulatory authority blind to data previously submitted. Instead of being able to prove that a therapeutically equivalent generic should be expeditiously registered, the US data-monopoly proposal would require costly and unethical repetition of clinical trials to develop identical data to that already submitted.

The US is seeking enhanced enforcement measures including border India’s border control measures are fully TRIPS compliant, and India should not be forced to invest scarce government enforcement (p. 51). resources for public enforcement of what are private rights.

The Standard of Comparison

Pharmaceutical Grade Crystalline, Spray Dried, Anhydrous, and Inhalation Lactose • For more than 70 years, we have delivered the industry's most extensive Lactose portfolio

www.SheffieldBioScience.com

• The original patent for Anhydrous Direct Tabletting (DT) Lactose • Batch to Batch Consistency • Global technical service, regulatory and application expertise to ensure regional and global market compliance

Registered Oﬃce Address: 17th Floor, Nirmal Building, Nariman Point, Mumbai - 400021 Corporate Identiﬁcation Number: U15400MH2010PTC202946 Tel.: +91 22 27815003, Fax Number ; (022- 27815989) Email: Kerry-India.Info@kerry.com

MANAGEMENT INSIGHT

‘First make improvements in government infrastructure that implement IPR laws’

MILIND ANTANI, Partner in charge of pharma-life sciences and healthcare practice; Nishith Desai Associates

AJAY CHANDRU, Senior Member, IP team, Nishith Desai Associates

Milind Antani, Partner in charge of pharma-life sciences and healthcare practice, Nishith Desai Associates, Ajay Chandru and Aarushi Jain, Senior Members, IP team, Nishith Desai Associates elaborate on whether Indian IPR laws need to comply with international standards AARUSHI JAIN, Senior Member, IP team, Nishith Desai Associates

PM MODI recently stated that India needs to align with international IPR laws, but his Commerce Ministry head Nirmala Seetharaman says that India is in line with TRIPS. There are indications that the the mother organisation of PM Modi’s BJP party, the RSS, too are not in favour of changing India’s IPR laws. Although PM Modi made a statement that Indian IPR laws need to comply with international standards, the question to consider is: what exactly are these international standards? As such, there is only one international standard for protecting IPR, i.e the TRIPS Agreement, which India is a member of in any case. India’s IPR laws are complaint with the TRIPS Agreement. Seetharaman has also emphasised in her statement that India is complaint with TRIPS. Thus, if, any member country including the US believes that Indian laws are not complaint with TRIPS they have recourse to the WTO Dispute Settlement Body (DSB), being the relevant body having jurisdiction to determine if country’s laws are complaint with TRIPS or not. Making generic state-

32 EXPRESS PHARMA June 1-15, 2015

ments about India’s IPR laws not being up to the mark is unwarranted in that sense. It is no secret that Big Pharma believes that Section 3 (d) and compulsory licensing provision in the Indian Patent Act is not in complaint with the TRIPS Agreement. At the same time, India has taken a stand that Section 3 (d) of the Indian Patents Act and compulsory licensing provisions are TRIPS compliant and are in line with the flexibilities provided in the TRIPS agreement. Validity of these provisions is again a question for the WTO DSB to decide. There are certain other provisions such as data exclusivity and patent linkage provisions which are TRIPS plus provisions that have been heavily advocated by the Big Pharma lobby and US to be adopted by India. Adoption of these provisions is

solely at India’s discretion. India is already on a reformation track in relation to its IPR laws with the constitution of an IPR think tank last year which has created the draft National IPR Policy. The draft National IPR Policy has been heavily criticised by various stakeholders especially the public health advocates. This has reignited the debate on whether do we need a reformation of the IPR laws, when we are complaint with the TRIPS Agreement. This has also raised concerns that the reformation in IPR laws is being initiated at the behest of Big Pharma through the US Government and India might make certain concession in their IPR Laws and incorporate certain TRIPS Plus flexibilities to attract foreign investment. Any kind of reformation especially in patent laws, which will have an ad-

verse effect on the public health (by raising the prices of the life-saving drugs, for instance) is going to result in a huge public outcry. Further, any such changes to the patent law not only affect the people in India but also other developing and least developing countries to which the Indian generic industry exports these lifesaving drugs. Thus, the government should tread on this path very carefully. What then is the way forward for India on IPR policy, given that other pacts like the TPP, etc are also being negotiated? India and US are in the process of negotiating and inking a Bilateral Investment Treaty (BIT) and there is a possibility that BIT may require India to adhere to certain TRIPS Plus flexible standards. In the past US has

The best way to move forward on IPR Policy is first to make improvements in the government infrastructure that implement the IPR laws, which is the patent and trademark office

used such regional and bi-lateral trade agreement to force countries to enact TRIPS Plus standards. A BIT unlike a trade agreement also gives recourse to an individual investor to the dispute resolution mechanism as envisaged in the BIT, if the terms of BIT have not been implemented and the same has affected the investor’s investment in India whereas in case of most trade agreement it’s the member country, which has the recourse to the dispute resolution mechanism. However, it is pre-mature to comment on the effect of BIT in relation to the IPR until the draft of the treaty is released. The best way to move forward on IPR Policy is first to make improvements in the government infrastructure that implement the IPR laws, which is the patent and trademark office. As a priority, government should focus on improving the existing functioning and efficiency of patent and trademark offices, since these offices are understaffed and lack essential resources to dispense their duties because of which there is a huge of pendency of patent applications and trademark applications.

RESEARCH ANALYSIS

Choppy waters A new report reveals that 741 antibiotic candidates are in development, however, new antibiotic development is beset with problems. Shalini Gupta reviews recent reports and milestones on this front ANTIBIOTIC RESISTANCE is a much talked about topic, however, the road to developing newer antibiotics is tough. As pathogens continue to evolve, new antibiotics need to be discovered, researched and a robust pipeline developed. The development of antibiotics, particularly progression of drug candidates from discovery to human trials, is notoriously difficult. Data reveals why only 12 new antibiotics have been approved since 2000 and just four of these are firstin-class. A report released by Globaldata reveals that there are currently 741 products in development, generics dominating the lot. Information on disease targets is not available, however, analysis reveals that the most common diseases are those caused by bacterial species, which are becoming increasingly drug resistant. These include Methicillin-Resistant Staphylococcus Aureus(MRSA), tuberculosis and Pseudomonas aeruginosa in a decreasing order. Although AstraZeneca, Novartis and GSK (three dominant companies in the market) feature in the top ten, the majority of the pipeline is being developed by small, specialist companies. Some of these are Cellceutix Corporation, Cubist Pharmaceuticals, Melinta Therapeutics, Microbiotix, GlycoVaxyn and

Beijing Minhai Biotechnology Co. While it is interesting to note that only three of the top 50 pharmaceutical companies have antibiotics in the pipeline, companies have not yet specified which, if any, specific bacterial infections their pipeline drug is designed to treat. Additional information on whether those being developed are ‘qualified infectious disease products,’ (QIDPs) or being studied for serious or life-threatening infections and receiving benefits provided under the Generating Antibiotic Incentives Now, or GAIN, Act of 2012 is unavailable. “It is difficult to determine the exact number of pipeline products which target QIPDs, as many companies have not yet specified which, if any, specific bacterial infections their pipeline drug is designed to treat. However, initial interrogation reveals that at least 470 of the 741 pipeline products target a QIPD qualifying infection,” says Katie Noon, Senior Analyst, GBI Research. That makes more than half of the candidates in development. If approved, these drugs will get additional FDA exclusivity, or time free from generic competition—under GAIN. It needs to be noted though that so far, only four QIDPs have been approved. While the GAIN Act helped stimulate development of

While it is interesting to note that only three of the top 50 pharmaceutical companies have antibiotics in the pipeline, companies have not yet specified which, if any, specific bacterial infections their pipeline drug is designed to treat EXPRESS PHARMA

June 1-15, 2015

RESEARCH new antibiotics by increasing their commercial value for serious or life-threatening infection (it extends the period during which the drugs can be sold without generic competition by five years), much needs to be done. “The main issue with antibiotic development isn’t the failure of drugs in the pipeline; it is the significant lack of new antibiotics being developed. These include the exhaustion of natural sources from which the majority of antibiotics over the past few decades were derived, expensive drug development, low return on investment and complex regulatory pathways,” adds Noon. However, it looks like pharma companies are moving back into antibiotic development. While Merck will start final-stage trials this year for a drug that treats some types of carbapenem-resistant Enterobacteriaceae (CRE) infections, AstraZeneca’s antibiotic CAZ-AVI is being developed for some of the hardest-totreat drug-resistant infections. Merck even bought Cubist Pharmaceuticals last year, a company which charges

$2,000 and $4,500 for its therapies. In a recent development, AstraZeneca declared that it will spend $40 million to spin out its R&D business into a separate subsidiary. The standalone company will deal with early stage antibiotics R&D including the novel gyrase inhibitor AZD0914, currently in phase II for the treatment of gonorrhoea. The US seems to be taking it seriously. In September

2014, the President issued Executive Order (EO) 13676: Combating Antibiotic-Resistant Bacteria, which outlines steps for implementing the National Strategy on Combating Antibiotic-Resistant Bacteria and addressing the policy recommendations of the President’s Council of Advisors on Science and Technology (PCAST)’s report on Combating Antibiotic Resistance. Furthermore, the President’s FY 2016 Budget released earlier

this year proposed nearly doubling the amount of Federal funding for combating and preventing antibiotic resistance to more than $1.2 billion. The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause two million illnesses and approximately 23,000 deaths each year in the US alone. Even as the government and pharma companies are amping up, scientists need to

look into new approaches for antibiotic development. In a recent study published in the journal Nature, researchers, at the Northeastern University in Boston, Massachusetts, took soil and created a 'subterranean hotel' for the bacteria. One bacterium was placed in each 'room' and the whole device was buried in soil. While only one per cent of the microbes present in soil can be grown in the laboratory, scientists involved believe they can grow nearly half of all soil bacteria. Chemicals produced by the microbes, dug up from one researcher's back yard, were then tested for antimicrobial properties. According to lead scientist, Prof Kim Lewis, "The study shows uncultured bacteria do harbour novel chemistry that we have not seen before. That is a promising source of new antimicrobials and will hopefully help revive the field of antibiotic discovery," 25 new antibiotics have been discovered so far using this method and teixobactin is the latest and most promising one. There is hope for the future.” shalini.g@expressindia.com

RESEARCH UPDATES

Researchers discover newways to shut down signals involved in brain diseases The researchers now reveal NOS1AP binds to NOS-1 in a surprisingly complex manner A RESEARCH team based at the University of Eastern Finland and the Turku Centre for Biotechnology have found new ways to block a pathway that may be responsible for several brain disorders, which could open the door to developing better treatments. The protein NOS-1 generates nitric oxide, a chemical signal that is linked to neurological disorders from neurodegeneration, stroke and chronic pain

34 EXPRESS PHARMA June 1-15, 2015

sensitivity to anxiety and depressive disorders. The researchers involved in the new work previously found that neurodegeneration or brain lesions caused by NOS-1 requires it to bind another protein called NOS1AP (or CAPON). They asked if damage can be reduced by preventing binding of NOS1AP to NOS-1, as NOS-1 cannot directly be controlled by drugs. The researchers

now reveal NOS1AP binds to NOS-1 in a surprisingly complex manner, and developed two separate ways to prevent it. By studying precisely how NOS1AP binds to NOS-1 they found two separate sites of interaction, by demonstrating that two different parts of NOS1AP are required for binding to NOS-1 on separate sites. Each site could be blocked, one by a peptide previously developed by the team

and the other by a new synthetic protein generated for this study. The second site was completely unexpected as no similar interaction had been previously described and so nobody had known to look for it before. Blocking either site by itself reduced the damaging signals caused by NOS1 in brain cells. The results were replicated in several regions of brain tissue that are sensi-

tive to degeneration caused by NOS-1. This means that it is now easier to design drugs that control damaging signals from NOS-1 in the brain because it can be done in two different ways or both ways may be combined. This might lead to development of new drugs for several different neurological diseases and conditions. EP News Bureau-Mumbai

RESEARCH

Obesity and weight loss change splicing pattern of obesity and type II diabetes genes ALTERNATIVE SPLICING of obesity and type II diabetes related genes may contribute to the pathophysiology of obesity, according to research from the University of Eastern Finland. Obesity leads to changes in the splicing pattern of metabolically relevant genes such as TCF7L2 and INSR, resulting in impaired insulin action. However, weight loss, induced by either obesity surgery or a very low-calorie diet, reverses these changes. The findings, presented by Dorota Kaminska, MSc, in her doctoral dissertation, increase our understanding of splicing dysregulations in obesity and can result in a new, more targeted treatment and more accurate diagnostics of metabolic disorders. Both obesity and type II diabetes are complex diseases that are caused by a combination of genetic, environmental and lifestyle factors. Obesity is strongly associated with other metabolic complications including insulin resistance and type II diabetes, however the mechanisms linking the two conditions remain unclear. Alternative splicing is the process by which a single gene produces more than one protein. Almost all human genes undergo some form of alternative splicing, which compensates for the relatively low number of genes present in the human genome. The study focused on determining the effects of obesity and weight loss on alternative splicing of metabolically active genes (TCF7L2 and INSR). Furthermore, the study identified alternatively spliced genes in the genomic regions associated with obesity risk, demonstrating that splicing of the TCF7L2, INSR and MSH5 genes in subcutaneous fat is regulated by weight loss. The study also found that body mass index is a main determinant of TRA2B, BAG6 and MSH5 splicing in subcutaneous fat; however, the functional consequences of this finding require further investigation. The study carried out at the

EXPRESS PHARMA

June 1-15, 2015

Department of Clinical Nutrition of the University of Eastern Finland was based on data from the

Kuopio Obesity Surgery (KOBS), very low calorie diet (VLCD), Metabolic Syndrome in

Men (METSIM) and European Network on Functional Genomics of Type 2 Diabetes (EU-

GENE2) studies. EP News Bureau

RESEARCH

Scientists crack memory code for flu-killing ‘assassin’cells The virus was infecting more people rapidly and nobody had immunity A UNIVERSITY of Melbourneled research team has cracked the riddle of how flu-killing immunity cells memorise distinct strains of influenza, which could lead to novel cellular memoryimplant technologies resulting in a one-shot flu jab for life. The extraordinary breakthrough in how ‘killer’ CD8 + T cells - the body’s ‘army of hitmen’ tasked with taking out new viruses - retain memories of virus strains they encounter was published in the prestigious Nature Communications journal. University of Melbourne’s Associate Professor Katherine Kedzierska explained how the Australia-Sino collaboration began during the first outbreak of the avian-derived H7N9 virus in China in 2013. That contagion saw 99 per cent of people infected hospitalised, with a 30 per cent mortality rate. Patient zero was an elderly man who caught the virus from a chicken his wife asked him to buy at the local live bird market.

The extraordinary breakthrough in how ‘killer’ CD8 + T cells - the body’s ‘army of hitmen’ tasked with taking out new viruses retain memories of virus strains they encounter “We’d never seen anything like H7N9,” Associate Professor Kedzierska said. “The virus was infecting more people rapidly and nobody had immunity. Thankfully, we did manage to contain the virus but we knew we had come face-to-face with a potential pandemic that could kill millions of people around the world if the virus became able to spread between humans,” she said. “After collecting samples from infected patients we found that people who couldn’t make these T cell flu assassins were

dying. These findings lead to the potential of moving from vaccines for specific influenza strains toward developing a protection, which is based on Tcells,” she said. “From the 30 per cent mortality rate in China we knew the clock was ticking on the situation. Had the contagion spread broken out globally, we’re talking about a history-altering event on the Spanish Flu scale. As it turns out, boosting the T cell adaptive memory capacity is our way in,” Associate Prof Kedzierska said. “Our extraordinary break-

through could lead to the development of a vaccine component that can protect against all new influenza viruses, with the potential for future development of a one-off universal flu vaccine shot,” she said. “This work will also help clinicians to make early predictions of how well a patient’s immune system will respond to viruses so they can manage early interventions such as artificial ventilation more effectively, particularly in cases where the patient is at risk of dying.” Published in Nature Communications, the research paper - Recovery from severe H7N9 disease is associated with diverse response mechanisms dominated by CD8+T cells – was led by the University of Melbourne and the Shanghai Public Health Clinical Center and Fudan University in China, with scientists from St Jude Children’s Research Hospital, Memphis. Coauthor and Nobel Laureate Professor Peter Doherty from the University of Melbourne said,

"After spending the past 40 years working on the virus-specific ‘killer’ T cells, this is the first study from our group that shows their role in protecting people against a novel human influenza A virus." Professor Xu, who co-led the study from Fudan University, said that this study would significantly enlighten T-cell based vaccine development and immune intervention during severe influenza infection in the future. Professor Elizabeth Hartland, Head of the Department of Microbiology and Immunology at the University of Melbourne added that the international collaboration has brought together the immunological expertise in Melbourne and the clinical knowledge in Shanghai to produce a study of much higher impact than could be achieved individually. “It exemplifies the approach we are taking at the Peter Doherty Institute for Infection and Immunity,” she said. EP News Bureau-Mumbai

Bluebird’s gene therapyshows promise Beta-thalassemia results in lower levels of haemoglobin in the blood BIOTECH FIRM Bluebird Bio said its experimental gene therapy continued to exhibit a positive effect in an ongoing earlystage study of patients with rare types of blood disorders. The product, LentiGlobin, is being tested in patients with beta-thalassemia major and those with severe sickle cell disease (SCD), two hereditary conditions. The drugmaker said, two patients suffering from beta-thalassemia

36 EXPRESS PHARMA June 1-15, 2015

did not require blood transfusion at 14 months and 11 months, respectively, after receiving LentiGlobin. Beta-thalassemia results in lower levels of haemoglobin in the blood. One SCD patient, who had been receiving chronic transfusions prior to the trial, began to be weaned away from transfusions after day 37, the company said. The patient received the last transfusion on

day 88. The data also found that the patient achieved an anti-sickling haemoglobin rate of 31.6 per cent, which reduces or eliminates his risk of serious conditions associated with the disease. The patient has not had a post-treatment hospitalisation for a sickle cell disease-related event, the company said. “The SCD patient is showing everything we would want to see at

this point to demonstrate highly promising proof-of-concept,” JP Morgan analysts said. SCD is caused by an abnormal form of hemoglobin that results in a break-down of red blood cells. No patient experienced drug-related adverse event during the study so far, Bluebird said. The therapy involves the insertion of a functional human beta-globin gene into the patient's stem cells, which are then

transplanted back into the patient. It was granted breakthrough therapy status in February by the US Food and Drug Administration to treat betathalassemia, speeding up the development process. Breakthrough therapy designation is based on initial trial data and granted to drugs with the potential to treat serious diseases better than existing therapies. Reuters

PHARMA ALLY I N T E R V I E W

The Odourmap has various modules – web-based, phone-based and app-based Netherlands-based, ‘The Odournet Group’ started its business operations in India two years back. Odournet India recently inaugurated its laboratory in Goa. It is equipped with the latest technology to perform odour sensory evaluation and provide basic odour testing facilities to industries. The new facility will help in reducing the operational costs by more than 50 per cent. Rajal Shinkre, DirectorBusiness Development and Operations, Odournet India reveals her company’s future plans, to Usha Sharma

Experts in Pharmaceuticals, Cosmetics and Nutraceuticals Products

It has been two years since Odournet set up its office in India. Tell us about your learning experiences. Odour management and measurement is a new technology in India. In the absence of odour regulations in India, industries with odour issues are not willing to spend on odour specialist services unless it is an internal proactive improvement process or if there is community or political pressure on the industry. Companies that manufacture products and materials, for which odour is the final determinant in the product, are willing to invest resources to perform evaluation of their products whether it is for product development or optimisation or for claim support.

EXPRESS PHARMA

June 1-15, 2015

PHARMA ALLY While we have spent much time in creating awareness about our services and our company, we managed to make inroads in the Indian market and have already completed numerous projects in the environmental sector and in the product and material testing sector. We receive plenty of queries about our services and products. However, in India we find that converting a query to a project can take months or even close to a year due to administrative reasons. What kind of services do you offer to the pharma industry? Who are your clients? The pharma industry can be catered to in four distinct areas. The first being the evaluation and remediation of the environmental impact caused by production and specially waste water treatment plants. The second area is the evaluation of not only their products for odours, may they be desired or undesired, but also the packaging material. This promotes the clients’ perception of quality once in contact with the product. The third area is the training of in-house capabilities to execute the odour evaluation of their products. And the fourth being sale of equipment for sampling and measuring odour so as to enable building in-house odour evaluation capabilities. In the pharma industry, what kind of odour is generated in manufacturing facilities and while conducting research activities? What applications do you offer? The main environmental impacting sources of odour evaluated so far are related to waste water treatment plants and zero discharge systems. In most cases no equipment or installations are required, simple operational and maintenance changes are sufficient to solve the undesired odour

38 EXPRESS PHARMA June 1-15, 2015

We wish to launch the Odourmap in India and have already begun discussions with the Gujarat Pollution Control Board, as Gujarat is a highly industrialised belt of India. We will be providing a demo of the Odourmap so that they can understand the applications and usefulness of it. Once launched, we will then extend the opportunity to other PCBs and municipalities

emissions. If necessary, however, we can provide case specific solutions. What is the USP of your product, Odourmap? Odourmap is the only tool available in India for authorities and industries to come in contact with the community to understand the impact of odour emissions from industrial units. This can negate any kind of foul play or false allegations from the community for personal gains. The idea is to facilitate direct communication between all parties (Community, Industry and PCBs) in order to reduce stress between them and provide the community with the certainty that they are being heard. Moreover, it is a user-friendly application that allows the community to lodge a complaint by making a mere call from the landline. Of course those who are computer-savvy can lodge complaints online. The Odourmap has various modules – webbased, phone-based and appbased. Odournet has recently opened its odour testing laboratory facility in Goa. Tell us more about the facility? The laboratory in Goa was implemented with the goal of performing all types of odour sensory evaluation. Our laboratory is equipped with the latest technology to

perform odour sensory evaluation using the Olfactometer, the PureSniff device and presentation booths. Sensory evaluation gives better results in terms of odour evaluation than molecular analysis, and is a cheaper solution. However, if molecular analysis is desired we can rely on our centre of expertise located in Barcelona for in-depth highresolution testing with GCO and more. While our sampling technician can collect odour samples from the source, environmental agencies and labs can send odour samples to our lab for analysis and we can provide the data to them. Earlier the company used to procure technologies/applications from its global offices. After the inauguration of the Goa centre, will you be able to serve your clients better with cost effective measures? The aim of starting a laboratory in India is precisely to provide Odournet’s services to the Indian markets at a much lower price without altering the quality of these services and applications. The operational costs decreased more than 50 per cent after the implementation of the lab. The company is planning to work with different state pollution control boards. Can you put some light on the same? Which state pol-

lution control boards will get associated with the company and why? The State Pollution Control Boards have the mandate of regulating pollution from Industries. In the absence of national regulations for odour assessment and control in India, the PCBs rely on the Air Pollution Control Act to make sure that Industries are compliant. We have organised seminars on Odour Assessment and Control in India in association with the State PCBs including the Goa State Pollution Control Board, Gujarat Pollution Control Board and the Tamil Nadu Pollution Control Board. We have presented our services to numerous other PCBs including Maharashtra and Telangana and the CPCB, interacted with officials from PCBs at events and exhibitions in India. We are in talks with the CPCB, which is taking up the matter of framing regulations for odour in India. Odournet is a major player in framing regulations for odour worldwide. What are the marketing strategies chalked out for Odourmap. How does the app work and how beneficial will it be for the pharma sector? We wish to launch the Odourmap in India and have already begun discussions with the Gujarat Pollution Control Board, as Gujarat is

a highly industrialised belt of India. We will be providing a demo of the Odourmap so that they can understand the applications and usefulness of it. Once launched, we will then extend the opportunity to other PCBs and municipalities. Odourmap from the industry point of view exists to create direct access to community’s perception. The idea is for you (Pharma Industry) to know what the population is saying before it gets to the ears of regulatory agencies, so you can act before bigger consequences. Odourmap is tied to weather stations and with this information you can prove you are not the culprit for odour complaints, if that’s the case. It is especially beneficial for industry clusters, where finger pointing is a daily sport. Tell us about the company's corporate plans. The company is presently in its infancy and consists of a small team. In spite of the challenges faced by ‘startups’, Odournet India has been able to make a mark in the Indian market. Odournet India is also the arm of Odournet that serves the Asian market. We have plans to diversify into the field of food sensory testing, and also focus on product and material testing especially in the FMCG and pharma sector, while continuing to assist industries that have environmental odour issue. By starting the first-of-itskind odour laboratory in India, we have completed yet another milestone in our second year of operations in India. Odournet India intends not only to provide basic odour testing facilities but also to understand the needs of the Indian industries for odour and other sensory requirements, and be in a constant endeavour to cater to these needs and regularly upgrade the laboratory based on these needs u.sharma@expressindia.com

PHARMA ALLY I N T E R V I E W

Address energy problems with a sustainable approach Kamal Singh, Vice President, Power Electronics Division, Danfoss India highlights the impact of energy consumption by the pharma industry on the environment, in discussion with Sachin Jagdale

Which energy consuming processes are used in the pharmaceutical industry? Energy efficiency, like in any other manufacturing unit, is imperative in the pharma industry too especially with increasing focus on bottom lines and neck-to-neck competition on the rise. In this industry, a major portion of the spend goes into Heating Ventilation and Air Conditioning (HVAC) as strict protocol is followed to ensure safe manufacturing of pharma drugs. In this context, energy efficiency is instrumental to lowering operational expenses and increasing predictable earnings, especially in times of power fluctuations and high energy cost volatility. When it comes to HVAC application in the pharma manufacturing sector, air handling units and chillers consume maximum electricity. However, adopting variable frequency drives such as those by Danfoss can help lower the electricity, thereby reducing up front and operational costs, and maximising uptime in pharma industrial applications. On the process side, centrifuge pumps for various applications, inlet blower, exhaust blower, coating machine, rapid mixer and mixing vessels consume a lot of energy and here too there is

40 EXPRESS PHARMA June 1-15, 2015

a lot of potential to save energy and costs.

manufacturing plant at Goa where it chose the Danfoss VLT HVAC drives to control around 350 AHUs and 20 pumps for maintaining inside conditions and differential pressure in the manufacturing areas. The resultant savings is approximately 40 per cent of the energy compared to the full speed operation.

Is the pharma industry among the highest energy consuming sectors in the world? While energy consumption in the pharma industry is not among the highest, it does use considerable power which can alternately be saved given our countryâ&#x20AC;&#x2122;s energy security problems. The idea is to ensure that each industry is self-sufficient if it has to sustain itself in the long run. How is such energy consumption affecting the environment? Since the pharma manufacturing processes are highly automated as compared to any other manufacturing unit, it translates to a considerable share of energy consumption in the country. According to Indian Brand Equity Foundation (IBEF), pharma manufacturing facilities registered with US Food and Drug Administration (FDA) as on March 2014 is the highest for India, at 523 for any country outside the US. With India being the manufacturing hub for pharma, energy efficient practices, if implemented, will ultimately help in reducing the pressure on the already stretched

Educating stakeholders to shift to automated energy efficient solutions holds the key to a sustainable tomorrow resources in the country. Can you provide some case studies on the success of your solution in the pharma industry? One of our major pharma clients, Cipla decided to build a world-class drug

Who are your pharma clients in India? Our pharma clients are present in clusters of Gujarat, AP or present Telangana, Sikkim and Madhya Pradesh. How aware are pharma companies about energy conservation? What are your efforts for the same? Since manufacturing processes in the pharma industry deploy variety of automated technologies, the level of awareness on energy conservation is quite moderate. However there lies a window of opportunity to make the industry adopt more energy efficient technologies at a quicker pace to get lasting benefits. We provide energy efficient solutions such as the variable frequency drives which help in reducing operating costs and energy consumption. We help in reducing carbon footprint across sectors. For this, we ensure that there is strong

awareness on energy efficiency and the use of energy efficient products among stakeholders. With Indiaâ&#x20AC;&#x2122;s strapped resources, there is a need to address energy problems with a sustainable approach. We believe educating stakeholders to shift to automated energy efficient solutions holds the key to a sustainable tomorrow. Which other industries do you cater to? In addition to the pharma industry, we also cater to the textiles, chemicals and food processing sectors, etc. among others How do you rate your future prospects considering the threats like global warming that loom ahead? The future looks promising with the central nod for an action plan on climate change and the smart cities that will roll out shortly. With the setting up of an R&D and manufacturing facility in Chennai, we look at jointly developing products along with our customers to tailor products according to their needs and in the process, spread our sustainability story across different sectors in India. sachin.jagdale@expressindia.com

PHARMA ALLY VENDOR NEWS

Merck develops Iriodin RMP for enhancing decorative rotational molded products Innovative preparations are based on the classic Iriodin pigment MERCK IS revolutionising rotational molding (rotomolding) for short. With Iriodin RMP, the innovative preparations based on classic Iriodin, the company is making something possible that was previously impossible: giving rotomolded plastic parts an attractive pearl luster effect. With four products initially, Merck is paving the way for creative plastics manufacturers and designers to capture additional markets for innovative products: hollow plastic bodies with brilliant colour effects.

Standard products with a focus on function have dominated the rotomolding markets until now: large-sized hollow bodies such as water tanks, trash containers, rain barrels and recycling bins. Attempts to enhance rotomolded products with decorative pearl luster effects have consistently failed. The particles did not blend with the basic polymer as desired, but were concentrated on the inside of the product or unevenly distributed. No two parts resembled each other.

With Iriodin RMP, Merck has succeeded in processing pearl luster pigments for rotomolding applications such that reliable results are achieved. The preparations can simply be incorporated into the polymer, without affecting the production time. The particles disperse evenly and give the entire end product its characteristic and fascinating pearl luster. Four pigment preparations are being launched initially, with more expected to follow. Iriodin 119 WAY RMP (Polar White)

captivates with its silver-white pearl luster effect and excellent resistance against weathering effects and yellowing. By contrast, Iriodin 6163 RMP (Icy White Shimmer) offers an even more intensive glitter effect combined with all the advantages of a synthetic substrate. Iriodin 305 RMP (Solar Gold) gives plastics a touch of luxury, while Iriodin 504 RMP (Red) makes red stylings possible. The new series raises the procedure to new dimensions, thus capturing completely new markets. For

the first time, Iriodin RMP allows designers to create decorative hollow bodies with impressive effects in the rotation process that unite form, function and attractive design. There are virtually no limits to the imagination with regard to potential new market segments for rotomolding: With Iriodin RMP, the design of flower pots or rain barrels, chairs or seat cubes, lamps, canoes or balls, buoys and floating docks can be imaginative, appealing and individualised. EP News Bureau-Mumbai

TO ADVERTISE IN EXPRESS PHARMA, CONTACT: 2nd Floor, Whites Road, Royapettah, Chennai- 600 014 Board Line: 044- 28543031/2/3 044- 42285522 Mobile: +91 91 9940058412 Fax: 044- 28543035 Email id: arun.j@expressindia.com HEAD OFFICE MUMBAI Rajesh Bhatkal The Indian Express Ltd Business Publication Division 2nd Floor, Express Tower, Nariman Point, Mumbai- 400 021 Board line: 022- 67440000 Ext. 527 Mobile: +91 9821313017 Email Id: rajesh.bhatkal@expressindia.com

BANGALORE G.M. Khaja Ali The Indian Express Ltd Business Publication Division 502, 5th Floor, Devatha Plaza, Residency road, Bangalore- 560025 Board line: 080- 49681100 Ext. 108 Mobile: +91 9741100008 Fax: 080- 22231925 Email id: khaja.ali@expressindia.com

BRANCH OFFICES NEW DELHI Ambuj Kumar The Indian Express Ltd Business Publication Division Express Building, 9&10, Bahadur Shah Zafar Marg, New Delhi- 110 002 Board line: 011-23702100 Ext. 668 Mobile: +91 9999070900 Fax: 011-23702141 Email id: ambuj.kumar@expressindia.com

HYDERABAD E.Mujahid The Indian Express Ltd Business Publication Division 6-3-885/7/B, Ground Floor, VV Mansion, Somaji Guda, Hyderabad – 500 082 Board line- 040- 66631457/ 23418673 Mobile: +91 9849039936 Fax: 040 23418675 Email Id: e.mujahid@expressindia.com

CHENNAI Arun J The Indian Express Ltd Business Publication Division New No. 37/C (Old No. 16/C)

KOLKATA Ajanta Sengupta The Indian Express Ltd Business Publication Division JL No. 29&30, NH-6, Mouza- Prasastha & Ankurhati,

To subscribe: bpd.subscription@expressindia.com

Vill & PO- Ankurhati P.S.- Domjur (Nr. Ankurhati Check Bus Stop) Dist. Howrah- 711 409 Mobile: +91 9831182580 Email id: ajanta.sengupta@expressindia.com KOCHI Arun J The Indian Express Ltd Ground Floor, Sankoorikal Building, Kaloor – Kadavanthra Road Kaloor, Kochi – 682 017 Mobile: +91 9940058412 Email id: arun.j@expressindia.com COIMBATORE G.M. Khaja Ali The Indian Express Ltd No. 205-B, 2nd Floor, Vivekanand Road, Opp. Rajarathinam Hospital Ram Nagar Coimbatore- 641 009 Mobile: +91 9741100008 Email id: khaja.ali@expressindia.com

AHMEDABAD Rajesh Bhatkal The Indian Express Ltd 3rd Floor, Sambhav House, Near Judges Bunglows, Bodakdev, Ahmedabad - 380 015 Mobile: +91 9821313017 Email Id: rajesh.bhatkal@expressindia.com BHOPAL Ambuj Kumar The Indian Express Ltd F-102, Inner Court Apartment, 1st Floor, GTB Complex, Behind 45 Bungalows, Bhopal - 462 003 Mobile: +91 9999070900 Email id: ambuj.kumar@expressindia.com JAIPUR Ambuj Kumar The Indian Express Ltd S2, J-40, Shyam GHP Enclave, Krishna Marg, C-Scheme, Jaipur - 302 001 Mobile: +91 9999070900 Email id: ambuj.kumar@expressindia.com

IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express Limited. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications. We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

EXPRESS PHARMA

June 1-15, 2015

PHARMA ALLY

Sterigenics International completes recapitilisation with Warburg Pincus GTCR GTCR purchased Sterigenics in March 2011 STERIGENICS INTERNATIONAL has closed a recapitalisation with an affiliate of Warburg Pincus and GTCR, which was announced in March 2015. Terms of the transaction were not disclosed. GTCR purchased Sterigenics in March 2011. “We are energised to be partnering with Warburg Pincus and GTCR. Their commitment enables Sterigenics to accelerate our growth, invest further capital to serve customers and build out our global scale,” said Michael Mulhern, Chief Executive Officer, Sterigenics International. Sterigenics’ growth over the past several years has rein-

In 2014, Sterigenics acquired Nordion, the world’s largest provider of Cobalt-60, an isotope that produces gamma radiation and is a critical component of the gamma sterilisation process, creating the only vertically integrated sterilisation services company in the world forced its global market-leading position in the contract sterilisation services industry. In 2014, Sterigenics acquired Nordion, the world’s largest provider of Cobalt-60, an isotope that produces gamma ra-

diation and is a critical component of the gamma sterilisation process, creating the only vertically integrated sterilisation services company in the world. The acquisition of Nordion expanded the Sterigenics prod-

uct portfolio, service offering, and global footprint to better serve customers worldwide. Additional acquisitions in 2014 included the Florida-based gamma irradiation operator, FTSI, as well as Gammarad,

Italy’s leading gamma irradiation sterilisation company, which now serves as the company’s second gamma sterilisation facility in Western Europe. In February 2015, Nordion reached landmark partnership agreements with General Atomics and the University of Missouri Research Reactor Center (MURR) to establish a new, long-term supply of medical isotopes that will serve millions of patients around the world. Achieving a long-term supply of medical isotopes for global customers has been a strategic priority of Sterigenics since its acquisition of Nordion. EP News Bureau-Mumbai

Multisorb to focus on driving profitability through efficiencies at Pharmapack North America Since 2004, over 1,000 simulations have been completed MULTISORB Technologies will highlight how the efficiencies of its sorbent dispensing systems and simulation technology can help pharmaceutical and healthcare companies drive profitability at Pharmapack North America, June 9-10, 2015 at the Jacob K Javits Convention Center, New York, NY. On-site demonstrations of a dispensing unit will allow attendees to experience first-hand how Multisorb's technology results in cost savings. As a technology-focused conference and leading educational and networking forum for top suppliers of innovative packaging and advanced drug delivery devices, Pharmapack provides the ideal forum for companies to

42 EXPRESS PHARMA June 1-15, 2015

meet with Multisorb's technical experts to discuss their drug and healthcare packaging stability challenges, and how to leverage technological efficiencies and innovations to save money while maintaining quality. "Pharmaceutical and healthcare companies are facing global competitive market issues, while also navigating a changing climate for Payor reimbursements," said Adrian Possumato, Vice President, Multisorb's Healthcare Packaging Group. As a global leader in stabilising pharma products, Multisorb will also feature its proprietary calculations through operations simulation, which uses a QbDbased modeling programme to identify the optimal sorbent re-

Multisorb will also feature its proprietary calculations through operations simulation, which uses a QbD-based modeling programme to identify the optimal sorbent required to achieve the desired shelf-life for pharma formulation and dosage forms quired to achieve the desired shelf-life for pharma formulation and dosage forms. Since 2004,

over 1,000 simulations have been completed using this consultative service, helping pharma

companies reduce their development time by 6-12 months by eliminating costly sorbent ranging studies. By pairing the sorbent packets/canisters with their respective dispensers Multisorb delivers the most reliable and lowest-cost sorbent/dispenser system available on the market. Since the sorbent packets and dispensers are designed to operate together effortlessly at an efficiency exceeding 99.997 per cent, typical downtime issues related to incompatible system components are eliminated. The net result is the lowest total cost of ownership available for sorbent dispensing. EP News Bureau-Mumbai

PHARMA ALLY PRODUCTS

Bosch expands inspection portfolio BOSCH PACKAGING Technology has showcased two new pharmaceutical inspection machines at Achema 2015. The KHS 1 is a new development emerging from a cooperation of Bosch with Lighthouse Instruments. It is designed for container closure integrity testing of ampoules, vials, bottles, cartridges and syringes using laser headspace analysis (HSA). The AIM 3, in turn, is the new member of the well-established AIM series. It offers the possibility to perform both visual inspection and high-voltage leak detection (HVLD) for ampoules and vials on one single platform. Bosch collaborated with Lighthouse Instruments, a leading provider of non-destructive laser spectroscopy headspace analysis systems. This expertise in leak detection fits ideally with the highest quality requirements of the pharma industry. The KHS 1 is the new highend leak detection system from Bosch for closure integrity testing with laser headspace analysis. It measures the absorbed light passing through the headspace region

AIM 3

KHS 1

via laser spectroscopy. HSA is applicable to lyophilised products and medicines filled under vacuum or purged with inert gas. The new KHS 1

inspects both standing and non-standing containers at outputs of up to 600 per minute, and can combine HSA with optional near infrared

(NIR) measurement and container coding. In order to ensure the highest reliability and accuracy, a built-in automatic re-calibration is continuously

performed using certified reference containers. Bosch also launched AIM 3, which combines both visual inspection of the AIM series and high-voltage leak detection of the KLD series. It inspects ampoules and vials containing solutions and suspensions at outputs of up to 400 containers per minute. In order to sort out damaged containers before they enter the main inspection turret, the AIM 3 is equipped with a pre-inspection station. The core module features a high-resolution CMOS camera with high-speed interface for particle and cosmetic inspection, as well as a re-inspection function. The customisable platform can be retrofitted on site to add further visual inspection stations or the HVLD module. The latter delivers equivalent measurement results for all glass qualities, such as molded and tubing, as well as clear and amber glass. Both inspection steps are controlled via one common Human Machine Interface (HMI). Contact details Mahmoud Hamada phone: +49 7951 402-1620

Bry-Air launches adsorption chillers BRY-AIR (Asia), has launched adsorption chiller (range: 35 to 1180 kW). The Bry-Air adsorption chiller is based on an innovative green technology and is the first of its kind in India. It will be manufactured in India under license from Power Partners, USA. The Bry-Air adsorption chiller provides energy smart cooling using waste heat. It is first ever product being launched in India to tap the

abundant low grade waste heat available in process industries and use it for process cooling or air-conditioning (HVAC). A lot of low grade process heat (50°c– 100°c) generally goes waste, which now can be used for cooling. This eco-friendly solution also cuts down CO2 emission and reduces energy expenses. The adsorption chiller has unbeatable advantages like ultra-low electricity consumption, negligible noise

To subscribe: bpd.subscription@expressindia.com

and vibration, life expectancy of more than 20 years, negligible maintenance, etc. It is ideal for process industries like power plants, food and beverages, chemical manufacturer, etc. and for commercial areas like offices, building, hotels, malls, etc. Contact details Deepak Pahwa Managing Director dpahwa@pahwa.com

EXPRESS PHARMA

June 1-15, 2015

PHARMA ALLY

Cole-Parmer expands precision measurement instruments COLE-PARMER,EXPANDED its Digi-Sense line of precision measurement instruments. Digi-Sense, known for accuracy, durability, and reliability, has introduced several new instruments for convenient temperature measurement, equipment testing, and inspection. The 'Be Sense-ible' line from Cole-Parmer contains a full range of environmental and temperature instruments that includes thermocouple meters, thermistor meters, RTD meters and infrared thermometers—many with NIST-traceable calibration already completed and ready to use upon arrival.

◗ Digi-Sense precalibrated digital contact/photo tachometer ensures equipment is in optimal operating condition, eliminating costly repairs. ◗ Digi-Sense Borescope and Video Borescope are ideal for inspecting ductwork, wiring, piping, vehicles, and other hard-toreach areas. Contact details Vinita Singh Marketing Manager Cole-Parmer India 403, Delphi - A,Hiranandani Business Park, Powai Mumbai - 400 0076 Tel: +91-22-61394410 (Direct) Fax: +91-22-61394422 vinita.singh@coleparmer.in

The new items include: ◗ Digi-Sense precalibrated humidity and temperature indicator monitors humidity levels and displays temperature and time as well. The indicator contains a unique environmental comfort indicator. ◗ Digi-Sense precalibrated pocket thermometers in large head, pen style, and folding probe types take fast and accurate temperature measurements anywhere. ◗ Digi-Sense precalibrated pocket-size moisture meter measures the moisture level in wood products and hardened materials with one-handed operation.

Alfa Laval launches hybrid powder mixer MIXING AND PUMPING both wet and dry ingredients into a homogenous blend can — depending on viscosity — require up to four separate electric motors, consuming a lot of energy. The Alfa Laval hybrid powder mixer can accomplish the same using only a single motor drive, including efficient mixing in the associated production vessel, when used in combination with the Alfa Laval rotary jet mixer. The hybrid powder mixer combines pump and powder dissolving technologies in a single versatile unit. It is the only hygienic powder mixer capable of drawing powder into the unit while simultaneously pumping the resulting process liquid at pressures up to 4 bar, making the need for a

44 EXPRESS PHARMA June 1-15, 2015

◗ Maintenance costs: Service is simplified due to fewer components. ◗ Processing time: Fast and homogenous powder mixing at high dry matter concentration.

separate discharge pump obsolete. It effectively preblends the powder and liquid before the mixture enters the high-shear stage, which contributes to faster and more effective dissolution. While other inline powder mixers create mechanical shear in a small area, the hybrid powder mixer creates high dynamic shear in several different steps, which require less energy to ensure complete dissolution of the powder. The hybrid powder mixer can also be used as part of an efficient Cleaning-in-Place (CIP) system.

Benefits ◗ Installation costs: A unit with only one electric motor for powder mixing, pumping

and CIP. ◗ Operating costs: Low power

consumption, providing up to 50 per cent energy savings.

Contact details Alfa Laval (India) Head Office Country, Manufacturing Unit Office No. 301, Global Port Building Survey No. 45/1-10, Mumbai Bangalore Highway Baner Pune-411 045 India Phone: +91 206 734 11 00 Fax: +91 206 734 11 15 E-mail: india.info@alfalaval.com Web page: www.alfalaval.com

PHARMA ALLY

Mark Vi Trac Systems launches Weber Marking Solutions MARK VI TRAC Systems has launched Weber Marking Solutions in the Indian market. With its various Markoprint control systems, BluhmWeber is the world’s only producer able to provide central control systems for three different printing technologies. Innovative product and packaging coding solutions have been developed under the Markoprint name for over 40 years in close collaboration with the customers. In addition to the Hewlett PackarD printheads for small character high resolution coding and the proven Trident printheads for Large coding, newly developed LEXMARK industrial printheads are also now supported. Advantages of printers ◗ X1JET – A unique machine developed with 0.5” printhead

so that standard batch printing requires only a USB stick to transfer data from a laptop / desktop PC. It can be connected through the network using the ethernet cable. It has the option to print variable data and also can be upgraded later also. The controller is in-built on the printhead making it a very compact machine. ◗ The X-Box is the latest version of the X4jet Plus. It can be used to control upto four heads / eight heads depending on the requirement. ◆ Depending on configuration up to eight heads can be driven. By it´s unique capabilities also different technologies can enabled the same time. I.e. X-8 head ‘blackbox’ for to drive primary (TIJ HP ) & secondary ( Hi-Res Trident ) production line. ◆ Real time data processing –

i.e. 3000 variable 2D ECC 200 variable Datamatrix in 1 minute / 50 codes in a second !!! ◗ The body of the X-Blackbox is made out of stainless steel and is easy to clean ! ◗ The body of the printheads is anodised aluminium – industrial proof / grade. ◗ The print heads are available in three different version all utilising 'CNP' technology ◆ CNP – Click n Print assures that there are no weak parts on the print heads, no levers to be broken. ◆ One needs to simply click in the cartridge and print – Plug and Print. ◗ Weber systems are open, because Markoprint machines convince with it’s performance and highly advanced features. There’s no need to lock, cause our customer are very happy with machines and also

going to buy supplies from our network ◗ One unified software with some super beneficious characteristics – The difference for to drive is the software on the machine ◆ See / Feel the difference ◆ One for all – no more trouble / hazzle in getting into manuals ; unified firmware / ◆ Features for all machines. ◆ Real time, rock solid operating system ◆ High performance ◆ User-friendly German software development ◆ Open architecture ; cus-

tomer needs can be integrated into firmware as special software ◆ Open interface manual for easy integration in higher level systems Contact details Mark Vi Trac Systems, Office No 11, 1st Floor, Girnar Bldg, SV Road, Opp. Dahisar Police Station, Dahisar (East), Mumbai 400 068 Cell: +91 9820509630 / +91 7738536663 Office: +91 22 28977078

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

❒ We welcome information on new products and

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

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

46 EXPRESS PHARMA June 1-15, 2015

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

The Indian Express Limited, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021. Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 editorial.ep@expressindia.com

BUSINESS AVENUES

EXPRESS PHARMA

June 1-15, 2015 47

BUSINESS AVENUES

June 1-15, 2015

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

June 1-15, 2015 49

BUSINESS AVENUES

EXPRESS PHARMA

OSMOMETER 3250

Milk Cryoscopes Available

127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India

Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in 50

June 1-15, 2015

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

June 1-15, 2015 51

BUSINESS AVENUES

EXPRESS PHARMA

AAS, ICP, ICPMS Sample Preparation for Pharmaceutical Industry

AAF Ashing & Burn-Off Furnaces n 3, 7 & 18 litre models available n Specifically designed for ashing purposes n Elements are protected from carbon build-up by a hard wearing alumina liner n Large floor & optional racking system in the AAF 11/18 for large sample numbers n Preheated airflow for complete combustion n Optional over-temperature protection for unattended use

1100 째C Maximum Operating re Temperatu AAF 11/3

www.carbolite.com VERDER SCIENTIFIC PRIVATE LIMITED | 1-2-45/1, 2nd Floor, Street No: 2 Kakatiya Nagar Colony, Habsiguda | 500 007 Hyderabad, India Phone: +91 40 2717 2431 | Fax: +91 40 2715 4686 E-mail: info@verder-scientific.co.in

June 1-15, 2015

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

June 1-15, 2015 53

BUSINESS AVENUES

June 1-15, 2015

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

June 1-15, 2015 55

BUSINESS AVENUES

ABS

EXPRESS PHARMA

Pharma Equipments

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

Gelatin

Melter

Mixer

Multi mill

ary

et lan

Mix

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 :

Mr. Anup K. Nath Cell: 9890204833

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

June 1-15, 2015

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

June 1-15, 2015 57

BUSINESS AVENUES

June 1-15, 2015

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

June 1-15, 2015 59

BUSINESS AVENUES

EXPRESS PHARMA

Associates

Rotary & Fixed Spray Balls

Diaphragm Valves

Product Range : Associates

Powder Ventury Sanitary Manually & Triblender Pneumatically Butterfly Valve

Sanitary Fittings

Aseptic Sampling Valves

Drain Trap

Lobe Pump

Centrifugal Pump

Sight Glass :

Elliptical Manhole

Sanitary Pumps Sanitary Auto / Manual Valves

Steam Water Sanitary Mixing Battery Pneumatic Valve Manually Controlled

Sanitary Fittings Stainers

Safety Valve

Manholes Sight Glass

S. No. 28/27, Near Pari Company, Dhayari - Narhe Road, Pune - 411 041. Ph. : + 91 - 020 - 6500 1482 / 2469 0268 Fax : + 91 - 020 - 2469 0268 Mob. : + 91 90287 16622, + 91 99231 24949 Email : swastikpune@gmail.com / sales1swastik@gmail.com

Advertise in

Business Avenues Please Contact: ■ Mumbai, Ahmedabad: Rajesh Bhatkal 09821313017 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai: Arun J 91-9940058412 ■ Bangalore: Khaja Ali 09741100008 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580 60

June 1-15, 2015

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

Innovation is our culture… Preclinical Toxicology Services: Single dose (Acute ) toxicity studies Repeated dose (14, 28, 90 & 180 Days) toxicity studies • Skin, Eye Irritation / corrosion • Skin Sensitization • Pharmacokinetic studies on Beagle dogs • LD50 and maximum tolerated dose • Immunotoxicity • Genotoxicity Studies • •

Test Systems: • Mouse (Balb-C, Swiss-Albino, C57, Diabetic) • Rat (Sprague Dawley, Wistar) • Rabbit (New Zealand White, Non albino) • Guinea Pig (Hartley) • Canine (Beagle Dogs)

SERVICES Formulation Development. Microbiological Studies. Biological Studies. Pre Clinical Studies. Analytical Research. Bio-equivalence Studies. Clinical Trials. Dossier Preparation. Preclinical Pharmacopoeial Services.

Quality in our genes… Pharmacopoeial Services: (Accredited by NABL for ISO/IEC 17025:2005)

• • • • • • • •

Pyrogen Testing Abnormal Toxicity Undue Toxicity Bioassays Systemic Injection Test Intracutaneous Test Implantation Test Eye Irritation Test

Facility Infrastructure: Individually Ventilated Cages Designed as per GLP/ AAALAC Independent facility for Rats, Mice Rabbits and Beagle Dogs • Ultra modern Histopathology lab • Safety alarms/call to scientists • Online Recording of Observations • • •

ACCREDITATIONS USFDA registered cGMP control testing laboratory. DSIR approved R & D Centre. Drugs Controller General of India (DCGI). NABL accreditation for Chemical, Biological Medical Testing, Bioanalytical & Mechanical. Recognized by Bureau of Indian Standards. Drugs Control Administration (A.P). Department of Biotechnology approved Institutional Bio-Safety Committee (IBSC). NABL for ISO/IEC 17025:2005.

!"! $!%!&'('%" )*!+",+'- ,% ./012 324. !*' 5'-,&%'5 "6 '%-7*' "6"!8 ,%"'&*,"9: -'+7*,"9 !%5 ;!-"'-" *'"*,'<!8=

ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH

SIPRA LABS LIMITED Industrial Estate, Sanathnagar, Hyderabad – 500 018. Industrial Estate, Sanathnagar, Hyderabad – 500 018. Tel: 040-23802000, Fax: 040-23802005 Email:sipra@sipralabs.com web: www.sipralabs.com EXPRESS PHARMA

June 1-15, 2015 61

BUSINESS AVENUES

June 1-15, 2015

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

PharmaTainersTM-Clean containers

Single-Use Containers for Storage & Transportation of Vaccines, Biopharmaceuticals, Culture Media and other Biotech Materials (Polyethylene terephthalate (PET) & Polycarbonate (PC), with High Density Polyethylene (HDPE) closures) Details • • • • • •

Clean, sterile & ready-to-use Medically approved resins Molded and capped in an ISO Class 5 (class 100) environment, Precision, injection molded, flash and burr-free neck finish eliminate the primary cause of seal failure Unlined, double seal closure system PET PharmaTainersTM have excellent gas barrier properties; PC Pharmatainers are ideal for freezing applications Each container is printed with a unique serial number, batch number, expiration date and machine readable data matrix for unrivalled traceability troughout production and during use

•

Compliance 3

Certified to meet USP788, EP, JP compendia standards

Endotoxins tested

Packed in an ISO Class 7 (Class 10,000) cleanroom

Traceability

Double Seal Closure System

ULTRA LOW PARTICULATES USP788 EP2.9.19 JP 14 ed. part 1 sect 24. th

Raw Material

Sterility

Manufactured from 100% virgin ADCF resins that are approved for medical applications

Precision molded closures and necks have robust threads that provide secure engagement between cap and bottle. Closures seal at two points - inside the neck and on the rim of the neck to provide a leak proof seal.

Each container is printed with a unique serial number, lot number, expiration date and machine readable data matrix to provide unrivalled traceability through the production process.

PET

HDPE

medical use

Yes

USP Class VI

Yes

In-vitro cytotoxicity Test

Yes

DMF15205

DMF1562

DMF1646

Approved for

Drug master file ADCF*

Yes

Yes Yes Yes *Animal derived component-free

PharmaTainerTM Polycarbonate Bottles & Carboys

PharmaTainerTM PET Bottles & Carboys

Polycarbonate has a wide

PET provides excellent gas

temperature range of use.

barrier properties. Phar-

PharmaTainers

PC bottles

Pharma TainerTM product families sterility certification is based on a VDmax 25 sterilisation study performed according to “ISO11137-2:2007, VDmax 25 sterilisation of healthcare products radiation-part 2”, which demonstrates that a 25kGy irradiation dose achieves a sterility assurance level (SAL) of 10-6. Ongoing sterility assurance is maintained by bioburden assessments on every product batch and quarterly VDmax 25 dose audit studies.

maTainerTM PET bottles and

& carboys are ideal for frozen

carboys are ideal for long

storage.

storage of materials like culture media.

Volume : 125 ml, 500 ml, 1, 2, 5, 10 & 20 liters

Temperature range of use : -130°C to +120°C

Temperature range of use : -40°C to +60°C

Clear and easy-to-read graduations with an accurancy of +/- 2 %

Certified sterile and endotoxins tested

Genetix Biotech Asia Pvt. Ltd. 71/1, First Floor, Shivaji Marg, Najafgarh Road, New Delhi-110015 E-mail : info@genetixbiotech.com, Web : www.genetixbiotech.com

EXPRESS PHARMA

June 1-15, 2015 63

BUSINESS AVENUES

June 1-15, 2015

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

June 1-15, 2015 65

BUSINESS AVENUES

June 1-15, 2015

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

June 1-15, 2015 67

PHARMA LIFE AWARDS

Susan Josi,Sorento Healthcare bags Distinguished Alumnus Award Every year the institute awards distinguished alumni in three areas of entrepreunership, professional and young achiever SUSAN JOSI, Managing Partner, Sorento Healthcare, has received the Distinguished Alumnus Award from Institute of Chemical Technology (ICT). The award was presented to Josi by Professor GD Yadav, Director (Vice Chancellor), ICT

Susan Josi, Managing Partner, Sorento Healthcare, receives the award from Professor GD Yadav, Director (Vice Chancellor), ICT

recently. ICT popularly known as UDCT, Mumbai has a glorious history of 78 years, having produced many industrialists, academics, bureaucrats, Padma awardees, secretaries to government departments, directors of CSIR labs and over 500 first generation entrepreneurs. The institute has very strong linkages with industry and produced some of the topmost academics and industrialists. Every year the institute awards its distinguished alumni in three areas of entrepreunership, professional and young achiever. This year, Josi received the award in the entrepreneur category.

On receiving the award Josi said, “I still remember the day, 36 years ago, when I took my admission at UDCT. It was one of those remorseful moments of not getting a medical seat and therefore like a disgruntled kid I walked into this great institute then. And so a few weeks ago when I got the delightful news on this award, my mind raced back to the six wonderful years I spent here, filled with some nostalgic memories of how I was part of a noisy dozen batch of girls and just three odd men in our pharmacy class of 15.” EP News Bureau-Mumbai

Troikaa’s Dynapar QPS bags National Award The award was given to Troikaa’s novel technology for topical drug delivery which is commercialised under the brand name Dynapar QPS AHMEDABAD-BASED Troikaa Pharmaceuticals has bagged a National Award from Technology Development Board, Dept of Science & Technology, Govt of India for successful commercialisation indigenous technology. Dr Harsh Vardhan, Union Minister of Science & Technology & Earth Sciences, Government of India gave away the award to Ketan R Patel, Chairman

68 EXPRESS PHARMA June 1-15, 2015

Dr Harsh Vardhan, Union Minister of Science & Technology & Earth Sciences, Government of India gives away the award to Ketan R Patel, Chairman and Managing Director, Troikaa Pharmaceuticals

and Managing Director, Troikaa Pharmaceuticals on the occasion of Technology

Day Celebration in Delhi. The award includes a monetary prize of ` 10 lakhs.

The award was given for Troikaa’s novel technology for topical drug delivery which is

commercialised under the brand name Dynapar QPS. It provides quick and comprehensive penetration of the drug through the skin and has brought the paradigm shift in the musculoskeletal pain segment. This novel formulation is a game changer in treating pain in conditions such as osteoarthritis, rheumatoid arthritis, back pain, pain due to repetitive injury, sprains, sports injuries etc. and provides significantly enhanced pain relief as compared to any of the topical pain gels/ creams/ liniments on the market. Superior efficacy of Dynapar QPS enables doctors to substantially reduce the dose of oral NSAIDs thereby sparing the patients from their harmful effects on kidneys, liver and cardiovascular system. EP News Bureau-Mumbai

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

IDEAL CURES

BECOMES FIRST INDIAN COMPANY TO RECEIVE EXCIPACT

CERTIFICATE

Ideal Cures has received Excipact certification for two of its manufacturing plants.

CORPORATE OFFICE & R & D CENTRE - II Ideal Cures Pvt. Ltd. Unit No. A/223 to A/229, 2nd Floor, Virwani Industrial Estate, Western Express Highway, Goregaon (E), Mumbai - 400 063. Tel.: +91-22-42688741 Fax : +91-22-42688713 Visit us at : www.idealcures.com / www.idealcures.co.in