Express Pharma (Vol.11, No.17) July 1-15, 2016

VOL. 11 NO. 17 PAGES 62

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Management Strides to sustainabilty

Pharma Infrastructure Special Pharma warehouse, a realistic business model 1-15 JULY 2016,` 40

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CONTENTS Vol.11 No.17 JULY 1-15, 2016 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bengaluru Neelam M Kachhap DESIGN

MARKET

Strides to sustainabilty

12

MANAGEMENT

Sustainability,as a concept is gradually gaining traction in Indian Pharma Inc with a growing realisation that it can have a positive impact on a company’s credibility,enhance shareholder perception and create short- and long-term value,finds Lakshmipriya Nair | 22

27

National Design Editor

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

GANYMED PHARMACEUTICALS’ IMAB362 MAY BRING HOPE FOR GASTRIC CANCER PATIENTS: REPORT

RESEARCH

Bivash Barua Asst. Art Director Pravin Temble

PHARMALYTICA 2016 TO BE HELD IN HYDERABAD

P28: INTERVIEW ‘There is a requirement for constant inflow of new drugs’

PHARMA INFRASTRUCTURE SPECIAL

Dr Amit Sharma, Head, Structural and Computational Biology Group, International Centre for Genetic Engineering and Biotechnology, New Delhi

P34: INTERVIEW ‘Rivigo has been able to develop many proprietary solutions that are industry first’ Sambit Sathapathy, Head, Rivigo

P56: INTERVIEW 'We hope to start similar skilling activity in Gujarat and Maharashtra as well' Ranjit Madan, Chief Executive Officer, LSSSDC

32

PHARMA WAREHOUSE, A REALISTIC BUSINESS MODEL

36

INDIA’S PATH TO GENDERLESS CONNECTORS

38

IDEAL CURES APPOINTS MIKE EASTERBROOK AS CHIEF TECHNICAL OFFICER

29

STUDY OBSERVES POTENTIAL BREAKTHROUGH IN TREATMENT OF HIV

30

MERCK’S KEYTRUDA PROLONGS LIFE IN BIG LUNG-CANCER STUDY

31

SCIENTISTS DECIPHER 11 SUBTYPES IN ACUTE LEUKEMIA GENE STUDY

Express Pharma® Regd. with RNI No. MAHENG/2005/21398,Postal Regd. No. MCS/164/2016 – 18. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2016. The Indian Express (P) Ltd. All rights reserved throughout the world.

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

EDITOR’S NOTE

Redrawing the Lakshman rekha

A

national IPR policy, new FDI norms, a possible revamp of the Drugs & Cosmetics Act, Brexit: the pharma sector in India has a lot to chew on.

Will these prove to be headwinds or

tailwinds?

Reactions to India's national IPR policy span the entire gamut: from experts who caution against a protectionist mindset to patient groups who remind the government that it needs to protect the rights of its citizens to affordable quality medicine. A month after it was released, the dust has settled but the differences remain.

The cover story in the July 1-15, 2016 issue of Express Pharma analyses the views of two experts, from opposite sides of the fence. Right now, a middle path doesn't seem possible but we need to look at the policy as a first step, and each judgement as an interpretation. (See story: A clash of IPR cultures, pages 16-20) IP lawyer Krishna Sarma, Managing Partner, CLG feels that if flexibilities like compulsory licensing (CL) or revocation, etc. though lawful in certain circumstances, are used routinely as legitimate policy measures to support industrial policy objectives aimed at protectionism or to contain costs, it will certainly discourage innovation and encourage free rides on someone else’s R&D. Academician/patent agent Prof Sankar Sundaram, Professor of Pharmaceutical Sciences, JSS University, on the other side of the spectrum, would view CLs as India's right to protect the interests of her population.

But India has made progress, however slight, on the IP front. The annual FICCI-Pinkerton India Risk Survey 2016 (IRS 2016) shows a marginal improvement in the rating of the country's IP as a threat to businesses in India. According to IRS 2016, IP theft had a 7.27 overall risk rating on a scale of 0-15. The overall risk ranking for IP theft slipped from 6 in 2014, to 8 the next year and to 9 in the latest survey. It is interesting to note that IP theft is the second risk in the eastern region of the country, while it does not figure at all in the top three risks in the other three regions.

The IRS 2016 also notes that compared to last year, India improved its score from 7.23 to 7.05 in 2016 in the US Chamber of Commerce’s Intellectual Property Index for 2016 and holds out hope that the national IPR policy will create the necessary conditions for improvement in tackling IP theft in the country. It also quotes a guide for Singapore companies venturing into India, where Singapore's Intellectual Property Office red flags patents for the biomedical industry and R&D in general, as well as trademarks for the healthcare sector as IP risks.

10 EXPRESS PHARMA July 1-15, 2016

Will the liberalisation of FDI in pharma redraw the Lakshman rekha and impact the delicate balance on the IPR front?

But, how much heed should the Indian government pay to rankings put together by other countries, which are meant to be pressure tactics?

And these pressure tactics do seem to work, if one reads the optics right. For instance, the recent move to further liberalise foreign direct investment (FDI) norms, coming just days after Rexit (RBI governor Raghuram Rajan's exit) is being seen as a clear move to deflect global criticism.

The question is, will the liberalisation of FDI in pharma redraw the Lakshman rekha and impact the delicate balance on the IPR front? The existing FDI policy in the pharma sector allowed 100 per cent FDI under automatic route in greenfield pharma projects but for brownfield projects, investors needed government approval.

This restriction was to prevent price escalation and creation of monopolies. FDI in brownfield pharma will now be allowed up to 74 per cent under the automatic route, with government approvals required beyond. While this will definitely attract more FDI, some concern areas remain. For instance, the ban on non-compete clauses stays, even below 74 per cent in brownfield projects, which would have allowed the acquirer to prevent the seller from using the sale proceeds in a similar venture. Foreign investors would be more comfortable with such non-competes in place, but clearly the government has other ideas.

Britain's historic exit from the EU will also have some impact on IP laws but as this will play out over the next two years, pharma companies from India with interests in EU markets will have time to adjust their sails.

In stark contrast to the noise around the formation of the IP policy over the last two years, India's central drug regulatory authority put out a very quiet notice on June 6 announcing a revisit of the Drugs & Cosmetics Act, 1940 and Rules, 1945. The reason stated was: “to match up with the current regulatory requirements related to safety, efficacy and quality of drugs, medical devices and cosmetics”. Industry observers like Dinesh Thakur, the ex-Ranbaxy employee turned whistleblower, hint at a conspiracy to keep this as silent as possible. (See his blogpost: http://dineshthakur.com/2016/06/20/revision-to-thedrugs-cosmetics-act-call-for-public-comment/) While the IPR policy was a good two years in the making, it is anyone's guess how long the revamp of the Drugs & Cosmetics Act will take. All in all, the stormy weather is set to continue for the pharma sector in India.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET PRE EVENT

PharmaLytica 2016 to be held in Hyderabad The conference on August 5 and 6, 2016 is likely to see more than 4500 visitors

P

harmaLytica 2016 will be held at the HITEX Exhibition Centre in Hyderabad on August 5 and 6, 2016. In the third edition of this international trade fair and conference, the pharmaceutical community can pick up on the latest industry trends, innovations and conduct business with analytical, bio tech, lab, pharma machinery

12

EXPRESS PHARMA

July 1-15, 2016

The industry focused conference will focus on latest pharma market insights, in-depth case studies, and exceptional networking opportunities

and outsourcing services.

PharmaLytica conference, collocated with the exhibition is the knowledge forum and important industry gathering that will bring an entire range of topics in analytical, outsourcing, laboratory, scientific and biotechnology sector. The conference will be held in a 3000 sq mt of business space where 150+ leading

local, regional, and international exhibitors will take part. 4500+ visitors are likely to take part in the event. The industry focused conference will focus on latest pharma market insights, indepth case studies, and exceptional networking opportunities.

Express Pharma is a media partner of the conference.

EP News Bureau-Mumbai

GROWTH TRACKER

IPM registers ` 8449 crs in May 2016 The Odisha market grew the highest followed by Mumbai City Market and Karnataka THE INDIAN Pharmaceutical Market clocked ` 8449 crores in May 2016 and has witnessed a growth of 7.7 per cent for the month of May 2016. Amongst the top 10, Mankind grew at 18.7 per cent, Abbott at 11.4 per cent followed by Alkem at 10.6 per cent. 18 corporates have crossed the growth of IPM amongst top 50.

Amongst the top 50 corporate, Bharat Serum registered the highest growth of 42.8 per cent followed by Wallace at 29.5 per cent and Eris at 24.4 per cent. 18 corporates have shown growths of more than 10 per cent amongst the top 50.

Amongst the 11-20 ranked corporates, Intas had the highest growth of 15.2 per cent followed

by Micro at 14.2 per cent and Alembic at 11.3 per cent.

Amongst the 21-30 ranked corporates, Eris had the highest growth at 24.4 per cent followed

by Novartis at 9.5 per cent and Wockhardt at 9.4 per cent.

Amongst the 31-40 ranked corporate, Bharat Serums grew at 42.8 per cent followed by Wallace at 29.5 per cent and Akumentis at 19.5 per cent. Amongst the 4150 ranked corporates, Systopic grew at 20.5 per cent followed by Janssen at 18 per cent and WinMedicare at 17.3 per cent.

Amongst the 51-60 ranked corporates, Boehringer grew at 52.5 per cent followed by Fresenius Kabi at 48.1 per cent and Corona at 28 per cent. Amongst the 6170 ranked corporates, Shreya grew at 21.6 per cent followed by RPG grew at 11.8 per cent and Tablets India at 9.3 per cent.

Amongst the 71-80 ranked cor-

porates, Dabur grew at 60.8 per cent followed by Samarth, which grew at 32.4 per cent and Danone at 17.7 per cent.

Amongst the 81 -90 ranked corporates, Paras grew at 44.2 per cent followed by Veritaz, which grew at 38.5 per cent followed by Galderma at 30.2 per cent.

Amongst the 91- 100 ranked corporates, Ind-Swift grew at 63.1 per cent followed by Ordain at 32.4 per cent and Curatio at 31.8 per cent.

Mercury entered the ` 50crore club on MAT Basis. The 100th biggest corporate is Ordain and 150th biggest corporate is UTH in the IPM. Abbott HC grew at 12.5 per cent whereas Abbott India grew at 13.1 per cent for the month of May 2016. Zuventus grew at 13.6 per cent. Indian companies have

grown at 7.9 per cent versus 7 per cent for MNCs in May 2016. Amongst the top 50 in MNCs, Janssen grew at 18 per cent followed by Abbott at 11.4 per cent and Novartis at 9.5 per cent.

Under the Non-NLEM category, Indian companies grew at nine per cent whereas MNCs grew at 7.1 per cent.

The NLEM 2013 containing molecules market grew at 2.6 per cent whereas the non DPCO market grew by 8.6 per cent resulting in an overall growth of 7.7per cent for May 2016. NLEM & Non - NLEM category showed unit growth of 0.8 per cent and 3.1 per cent respectively.

From therapy perspective, 14 therapies have outgrown the IPM growth. The respiratory market grew at 0.6 per cent,

gastrointestinal market grew at 5.9 per cent, pain and analgesics market grew at 5.1 per cent whereas anti-infectives grew at 2.7 per cent. The anti-diabetic market grew at 14.9 per cent and cardiac at 10.2 per cent, Neuro/ CNS at 10.3 per cent in chronic business. The anti-malarials grew at -13.2 per cent, VMS market at 9.8 per cent. The derma market grew by 8.6 per cent and urology market at 11.3 per cent.

From regional perspective, 15 regions have outgrown the IPM growth. The Odisha market grew the highest at 14.2 per cent followed by Mumbai City Market at 13.8 per cent and Karnataka market at 13.5 per cent.

One region had negative growth in May 2016.

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MARKET market grew at 2.8 per cent and Glimepiride + Metformin market grew at 20.2 per cent. The markets of paracetamol grew at 14 per cent, Atorvastatin -1.0 per cent, probiotic microbes at 17.1 per cent, Bacillus Clausii market at 27.2 per cent, Cefixime at 5.7 per cent, pantoprazole at 10.7 per cent, Montelukast + Levocetrizine at 0.3 per cent, Glimepiride + Metformin + Pioglitazone at -10.4 per cent, Vitamin-D at 18.9 per cent, Hydroquinone + Mometasone + Tretinoin at 7.8 per cent, Voglibose + Metformin + Glimepiride at 43.9 per cent, Rosuvastatin at 17.2 per cent, Protein Supplements at 13.5 per cent, Azithromycin at -9.1 per cent, Calcium Carbonate + Vit D3 market at 2.7 per cent, Paracetamol + Phenylephrine + Chlorpheniramine at -2.8 per cent, Meropenem at 34.1per cent, Montelukast + Fexofenadine at 8.1 per cent Diclofenac at 16.6 per cent, Telmisartan at 0.8 per cent, Levetiracetam at 19.6 per cent.

The 50th biggest market was Sildenafil and 100th biggest market is Paracetamol + Tramadol for May 16.

Mixtard led the pack with ` 37 crores followed by Glycomet GP at ` 31 crores, Lantus at ` 27 crores and Galvus Met at ` 25 crores for May 2016.

Few brands who have gained ranks includeRotarix (+366), Meronem (+70), Revital H (+67), Clexane (+39), Unwanted Kit (+39), Trajenta (+31), Mucaine (+28), Udiliv (+25), Rosuvas (+22), Minipress XL, Levera (+19), Synflorix, Budecort (+17), Duphaston (+16), Januvia, Ultracet, Novomix (+15), Volini, Istamet, Rantac (+13), Taxim O, Telma H, Eltroxin (+12),Galvus Met, Zifi, Levipil, Gluconorm G (+10), Pan D, Atorva (+9), Calpol (+8), Pantop (+7), Lantus, Voveran, Skinlite (+6), Cores, Phensedyl, Thyronorm, Gemer, Jalra M, Sinarest, Dolonex (+5), Betadine, Duolin (+4), Janumet, Clavam (+3), Pan (+1) amongst top 100 Brands over May 2015.

Razo D, Glimestar M, Lonopin, Acitrom, Kenacort, Cilacar, Practin, Phexin, Wysolone are few brands gained ranks in 101-200 ranked brands.

Few brands that have moved up ranks fastest into Top 300 Brands for the month of May – 16 are Mifty, Hucog HP, Imicrit,

14 EXPRESS PHARMA July 1-15, 2016

Plavix, Trajenta Duo, Rotarix, Razo D. The 300th biggest brand is Ferium XT from Emcure.

The total 360 brands and 608 SKUs were launched in May 2016. The Top 3 new brands for May 2016 were Sofocure, Panderm NM and Cabtana. Sanofi launched Lixisenatide – Lyxumia and Novartis launched Ruxolitinib – Jakavi. The three brands launched each in Teneligliptin Combination with Metformin – Tenepride M, Afoglip M, Ten M & 1 in Teneligliptin – Megagliptin. Within the VMS category, Able TO (MMC), Folactib-D (Vidakem), Bonmax CCM (Zydus) were launched followed by Lyxumia (Sanofi), Tenepride M (Micro) & Megagliptin (Aristo) within antidiabetic, Panderm NM (Macleods), Lipbless (Zydus) & Zocon KZ (FDC) within derma, Ferisome (Micro), Femozer Plus & Femozer (Leeford) within gynaec, XT Para Life (Unichem), Zeldinac (Leeford), Panzox ( Micro) in pain and analgesics category, Sinarest New (Centaur), Cuflit (Leeford), Lukostas HD (Intas) in respiratory, Exenta T, Exenta (Alembic), Telmeron AM (Saffron) in cardiac and Office OZ (Hetero), Unipan (Kontest), Rabiwok D (Wockhardt) in gastro intestinal. The biggest new launch by a MNC was Mydacla from Mylan in May 2016.

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted

by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech.

AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind AIOCD AWACS’ research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

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

For more information, visit http://www.aiocdawacs.com

With Bonus Units at Full Value Val in Crs CORPORATE

Rank MAT

MAT May-16 MTH

May-16

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

99476

100.00

11.1

8449

100.00

7.7

IPM Sun + Ranbaxy

1

1

8710

8.76

12.2

757

8.96

5.6

Abbott + Abbott HC + Novo

2

2

6140

6.17

10.4

538

6.37

11.4

Cipla

3

3

4933

4.96

10.6

403

4.77

6.4

Zydus + Biochem

4

4

4222

4.24

10.6

350

4.14

4.1

Mankind

5

5

3775

3.79

18.6

327

3.87

18.7

Lupin

6

7

3419

3.44

12.9

285

3.37

-2.8

Alkem + Cachet + Indchemie

7

6

3404

3.42

8.5

289

3.43

10.6

Glaxo

8

8

3251

3.27

1.7

259

3.07

0.3

Pfizer

9

11

2903

2.92

8.4

242

2.86

7.3

Macleods

10

10

2879

2.89

9.7

244

2.89

9.7

Intas

11

9

2859

2.87

21.4

250

2.95

15.2

Emcure + Zuventus

12

12

2648

2.66

9.3

225

2.67

6.7

Aristo

13

13

2432

2.45

9.8

203

2.41

2.7

Dr. Reddys

14

16

2401

2.41

17.7

189

2.23

4.5

Glenmark

15

17

2381

2.39

18.7

181

2.14

4.7

Sanofi India

16

15

2360

2.37

5.5

193

2.28

2.3

Torrent

17

14

2273

2.28

10.3

197

2.34

1.4

Val in Crs

MAT May 16

Month May-16

Super Group

VAL IN CRS

GR%

VAL IN CRS

GR%

IPM

99476

11.1

8449

7.7

ANTI-INFECTIVES

14935

6.0

1156

2.7

CARDIAC

12474

13.2

1093

10.2

GASTRO INTESTINAL

11683

12.8

1051

5.9

VITAMINS / MINERALS / NUTRIENTS

8813

8.9

798

9.8

ANTI DIABETIC

8199

19.2

741

14.9

RESPIRATORY

7654

8.1

524

0.6

PAIN / ANALGESICS

6914

10.0

575

5.1

NEURO / CNS

6209

14.9

539

10.3

DERMA

6016

14.2

516

8.6

GYNAECOLOGICAL

5008

10.2

446

8.4

HORMONES

1689

11.3

144

12.0

VACCINES

1654

9.3

134

4.2

ANTI-NEOPLASTICS

1542

2.0

133

1.3

OPHTHAL

1457

10.9

134

9.7

BLOOD RELATED

1166

12.9

104

8.5

OTHERS

1125

28.5

115

42.8

UROLOGY

1095

13.8

101

11.3

SEX STIMULANTS / REJUVENATORS

554

11.9

46

9.7

ANTI MALARIALS

550

-2.8

33

-13.2

STOMATOLOGICALS

409

7.7

37

13.8

OPHTHAL / OTOLOGICALS

218

-2.9

21

12.4

OTOLOGICALS

114

6.4

8

-4.0

EVENT BRIEF AUGUST 2016 5

PharmaLytica 2016

PHARMALYTICA 2016 Date: August 5-6, 2016 Venue: HITEX Exhibition Centre, Hyderabad Summary: The third edition of PharmaLytica 2016 will see the pharma community pick up on the latest industry trends, innovations and do business with analytical, bio tech, lab, pharma machinery and outsourcing services. PharmaLytica conference, co-located with the exhibition will bring an entire range of topics in analytical, outsourcing, laboratory, scientific and biotechnology sector.

The event is likely to witness 150+ leading local, regional, and international exhibitors, with 4500 expected visitors. It will be an industry focused conference with latest pharma market insights, in-depth case studies, and exceptional networking opportunities. Both the events are supported by Ministry of Science & Technology, Govt of India Contact UBM India Times Square Unit No 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol, Andheri (East) Mumbai - 400 059 Tel: +91 22 61727272 Fax +91 22 61727273

PHARMATECH EXPO 2016 Date: August 21-23, 2016 VENUE: Ahmedabad Summary: The 4th Edition of 'PharmaTech Expo 2016, a PharmaTechnology- Index.com venture will organise a pharma expo. The expo will be concurrently held with 'Pack & PrinTech Expo' and introduction of 'PIC India Expo.'

It will focus on pharma ingredients and chemicals, giving a large scale exposure to pharma machinery, pharma ingredients and chemicals, packaging, printing, lab and analytical equipment etc. More than 150 exhibitors are likely to participate in the event.

A special pavilion has been created for 'Track & Trace and Vision Inspection Equipment'

EXPRESS PHARMA

15

July 1-15, 2016

21

PharmaTech Expo 2016

to focus on the superior technologies available in India and the major industry players involved.

Contact Aarjav Shah PharmaTechnologyIndex.com (A Division of KNS Group)

Tel: +91 – 79 – 27540493 / +91 – 79 – 40306340, 879616665 E-mail: expo@pharmatechnologyindex.

com / events@knsmedia.com Web: www.PharmaTechExpo. com/ www.PackPrinTechExpo. com / www.SwarnimVision.com

cover )

India’s recently released national IPR policy has spurred fresh sparring between various lobbies. As international pressure to fall in line mounts, will ‘Creative India, Innovative India’ remain a slogan?

By Viveka Roychowdhury

16

EXPRESS PHARMA

July 1-15, 2016

(

A

few minutes into his speech to the US Congress on June 8, Prime Minister Narendra Modi took a tongue in cheek dig at his host. He pointed out that India had not yet claimed intellectual property rights (IPRs) on yoga, even though yoga has over 30 million practitioners in the US, with “more more Americans bending for yoga than to throw a curve ball.”

PM Modi’s quip may have been in a lighter vein, but no one missed the potent message. His address was less than a month after the approval and release of India’s national IPR policy on May 12 . Under the slogan, ‘Creative India; Innovative India’, the 29-page document seeks to be ‘an all-encompassing IPR Policy (that) will promote a holistic and conducive ecosystem to catalyse the full potential of intellectual property for India's economic growth and socio-cultural development, while protecting public interest. The rationale for the National IPR Policy lies in the need to create awareness about the importance of IPRs as a marketable financial asset and economic tool.’

The timing of the release made it very obvious that it was an attempt to ensure that PM Modi could show progress on this thorny issue. Reactions from representatives of various US lobbies have been cautiously optimistic but they are clearly waiting for India to walk the talk and follow through.

For instance, a statement from Patrick Kilbride, Executive Director of International Intellectual Property, at the US Chamber of Commerce’s Global Intellectual Property Center (GIPC) said they hoped that the announcement is a precursor to the concrete, structural changes that are necessary if India is to implement a strong IP-led innovation model. Welcoming the (Indian) government’s understanding that India’s innovative economy requires effective IP protection, they hoped this

commitment will lead to ‘decisive legal reforms.’

Spelling out their expectations further, the GIPC statement says that India must provide enhanced certainty for the rights of innovators in line with international best practice.

“We will be carefully reviewing this policy to determine whether this document creates the foundation for such steps. Regardless, IP will continue to be a central issue for any discussions between India and the international business community.” This is a clear indication that the India’s policy makers will have to do much more on this front.

Not innovative enough?

Critics within India have roundly panned the national IPR policy, possibly because expectations were high that it would be a landmark in the nation’s IP history. Criticising it as ‘an IP policy with no innovation’, Shamnad Basheer, founder of legal blog site Spicy IP and honorary research professor of intellectual property law at Nirma University, wrote that it is a 'sheer pity that none of that abundant creative energy (that the policy refers to) made it to this policy document, rendering it rather dreary.’

Basheer was part of the first think-tank put together by the government to formulate an IPR policy for the nation.

Even though this think tank was summarily disbanded, he has had a ring side view of the IPR policy making process at various stages. His editorial in a national daily pointed out various flaws in the policy which was finally released, describing it as a policy 'beset with banality, dogged by dogma, rife with ridiculous assertions, lacking in any credible empirical support, and written in language that, at best, mimics a masterful memo from one babu to another.'

Senior policy makers in India have been keen to reiterate the country’s commitment to remaining the pharmacy of the world. At a panel discussion on the sidelines of the UN High

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Level Meeting on HIV/AIDS in early June, Health Minister JP Nadda stated, “India is committed to maintaining TRIPS flexibilities to ensure access to affordable medicines.” Finance minister Arun Jaitley too was compelled to specify that compulsory licensing (CL) in public interest to meet contingencies, and Section 3(d) of the Indian Patents Act would stay, even though the released policy talks of an overhaul.

But critics find a flaw in these statements.

Krishna Sarma, Managing Partner, Corporate Law Group (CLG) points out that affordable medicines does not necessarily mean access is enhanced. Further, “a plethora of policy interventions including increase of the percentage of GDP spend on healthcare, novel financing schemes and deepening and spread of health insurance cover are required to address the problem at hand,” says Sarma. CLG has represented national and international trade associations like the US -based Pharmaceutical Research and Manufacturers of America (PhRMA) and multinational companies in areas like pharmaceuticals, biotechnology, among other sectors.

However, Professor Sankar Sundaram, Professor of Pharmaceutical Sciences, JSS University feels that India’s current stance will work to the country's advantage in the long run. “While there may not be any short-term changes in the incentivation and encouragement of the pharma sector, whether TRIPS flexibilities are included or excluded, in the long-term, (this stance) would definitely compel indigenous drug discovery, exclusively catering to the needs of treating tropical diseases.”

Hopes for relief ...

The OPPI’s position on the National IPR Policy is along the same lines, welcoming the release of the “long-awaited National IPR Policy”, and recognises the intent to foster a culture of innovation. “We hope that the policy will lead to

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an interpretation of the Indian Patent Act that respects innovation, encourages research and facilitates effective enforcement mechanisms,” says Kanchana TK, Director General, OPPI. The OPPI statement also expresses disappointment that while a previous draft recognised the need for patent cases to be adjudicated expeditiously, this policy does not cover the earlier recommendation of specialised benches in the High Courts of Bombay, Calcutta, Delhi and Madras, neither does it suggest designated district level IP courts.

The need for specialised patent benches and cutting down timelines is one common area of concern, where both the critics and cautious wellwishers of the national IPR policy agree on, The lack of such mechanisms creates bottlenecks and adds to the timelines. If the publicly stated intent of Nirmala Sitharaman, Commerce and Industry minister is to cut the waiting period for trademark and patent registrations which currently stretches beyond a year, to just a month by 2017, then the policy should have reflected this.

Sarma points out that earlier drafts of the National IPR Policy (of December 19, 2014 and April 18, 2015) recommended the establishment of such specialised patent benches. The need for such benches and fast decisions is crucial as pharma patents have limited validity. Secondly, such cases required an understanding of science and other technical issues. The final policy has “simply recommended adjudication of IP disputes through commercial courts ... (which) does not provide for creation of specialised patent benches and does not ameliorate the situation existing from before,” says Sarma.

Both sides agree that such courts are vital. Sundaram, who is a Registered Patent agent (IN/PA-666) in the Indian Intellectual Property Office (IPO) and has reportedly drafted more than 15 patents in this field, reasons that spe-

Despite there being subsisting and valid patents covering a product, the CDSCO/state FDAs issue marketing and manufacturing licenses to the patent holder and subsequent applicants Krishna Sarma Managing Partner, Corporate Law Group

While there may not be any shortterm changes in the incentivation and encouragement of the pharma sector, whether TRIPS flexibilities are included or excluded, in the long-term, (this stance) would definitely compel indigenous drug discovery, exclusively catering to the needs of treating tropical diseases Prof Sankar Sundaram Professor of Pharmaceutical Sciences, JSS University

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cover ) cialised patent courts, along the lines of the US, the EU and Japan, would make acceptance/rejection easier in the case of complex patent suits, involving especially, a patent’s validity.

But the assumption that members of the judiciary with a background in related fields like lifesciences, chemistry, etc would necessarily give more acceptable judgements depends on perception. For instance, Basheer of Spicy IP blogged about what he thinks are flaws in Deputy Controller of Patents & Designs Dr Rajesh Dixit's recent decision to award a patent to Gilead for Sovaldi/sofosbuvir.

He concedes that the Deputy Controller might meet some of the criteria on the technical expertise front, as he has a chemistry background and reading the decision also suggested that he had some degree of proficiency in the underlying science but questions his knowledge of the law and his powers of reasoning. Basheer acknowledges that he is perhaps being too harsh on the Deputy Controller and hopes that “with more such cases thrown his way and with more legal/judicial training, we will see better from him in the future.” (For more: http://spicyip.com/2016/05/thesovaldi-saga-a-novel-non-obviousstandard.html) The timing of this judgement, on May 9, just days before the approval and release of the national IPR policy, also suggests other pressures at play.

... a distant dream?

Given the number of vacancies at various levels of India's IP regulatory systems, specialised benches would seem like a distant dream. Critics allege that while the national IPR policy is well intended, it is the implementation that is weak, thanks to the lack of human resources, etc. Time delays are also cited as a miscarriage of justice.

Sundaram counters these charges saying that much is already being done by the Department of Industrial Policy and Promotion (DIPP) by way of recruitment of additional work-force to examine filed

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Given the number of vacancies at various levels of India’s IP regulatory systems, specialised benches would seem like a distant dream. Critics allege that while the national IPR policy is well intended, it is the implementation that is weak, thanks to the lack of human resources, etc. Time delays are also cited as a miscarriage of justice

patent applications. He estimates that the newly added IPR work-force would certainly reduce the time frame involved in a patent application’s acceptance or rejection, in the near future.

He also makes the point that as patent rights conferred are exclusive in nature, the scope of implementation, especially those measures related to a patent’s infringement, rests with the patentee himself/herself, which in turn calls for a well-informed patentee, with good resources. His reasoning puts the defence of IPR on patent holders rather than the policy per se.

Sarma highlights three other major areas where the national IPR policy could have done a lot more. The national IPR policy fails to address the present disconnect between the IPOs and the Central Drug Standard Control Organisation (CDSCO) and state FDAs. Though the policy (Clause 4.20.1) has “rightly recommended formalising a coordination mechanism between the National Biodiversity Authority (NBA), IPOs and departments like AYUSH in order to facilitate harmonious implementation of mandates of each of the agencies and statutes, ... it is conspicuous by its silence on providing a similar coordination mechanism between IPOs that grant patents and the CDSCO)/state FDAs that grant marketing/manufacturing approvals to drugs."

Explaining the consequences of this disconnect, Sarma says, “Today a situation

exists whereby despite there being subsisting and valid patents covering a product, the CDSCO/state FDAs issue marketing and manufacturing licenses to the patent holder and subsequent applicants. The same can only be possible with the establishment of a streamlined drug regulatory process which is fair, equitable and transparent and works harmoniously and in close coordination with IPOs.” The national IPR policy does in fact recommend enhanced coordination between various agencies as a step to strengthen enforcement mechanisms for better protection of IP rights, but is silent on providing a coordination mechanism.

The data exclusivity dilemma Protection of regulatory data has been another flashpoint.

“While the policy identifies trade secrets as one of the areas of study and research for future policy development which is indeed heartening, we wanted to point flag that for the life sciences sector, the protection of trade secrets will become meaningful when the laws are amended to provide protection for (the) regulatory dossier which includes not just per se protection but also is premised on not being relied upon by the regulatory authorities and competitors thereby giving unfair commercial gains to third parties. We sincerely hope that the policy enables development of law that is in consonance with TRIPS Article 39 including Article 39.3 and international best

practices,” says Sarma.

On this, Sundaram is clearly on the other side of the fence.

He recommends against committing to data exclusivity provisions, which although not IP rights by themselves, auger for the non-disclosure of valuable clinical data which he finds “ethically questionable”.

The fourth major concern raised by Sarma is that the national IPR policy delves into issues that go beyond the realm of IPRs, like for instance steps to reduce dependency on active pharmaceutical ingredients (API) imports and incentivising manufacture of APIs in India; revitalising public sector undertakings in healthcare sector (Clause 5.10.); measures against attempts to treat generic drugs as spurious or counterfeit (clause 6.2). She opines that such recommendations in the policy are extraneous issues and would send “mixed signals to all stakeholders”.

And the next round goes to ...

The national IPR policy is being seen as just the first small step in the right direction and pressure to do more is beginning to mount. While one camp views IPRs as key to insuring access to better medicines and similar gains in other sectors, the other see this IP maximalist position as a barrier, given India's sociocultural-economic realities.

While the first wants more clarity on the exact mechanisms, the second would prefer a case by case interpretation, based on the merits of each case. This approach has in fact proved to

also benefit MNC companies.

Gilead is the most recent beneficiary, for the IPO’s May 9 decision on Sovaldi/sofosbuvir which reversed a patent rejection of 2015.

Sarma hopes that the Indian government looks at implementing the provisions stated in the policy. These include upping the ante on IP awareness, bringing administration of IPR under DIPP, creating the Office of the Controller of IPRs, creating the Cell for IPR Promotion and Management (CIPAM) under the aegis of DIPP to facilitate promotion, creation and commercialisation of IP assets and so on. The main thrust of the policy seems to be towards facilitating innovation and generation and commercialisation of IPRs at all levels and linking of “Creative India; Innovative India” campaign proposed under the policy with other national initiatives such as ‘Make in India’, ‘Digital India’, ‘Skill India’, ‘Start Up India’, ‘Smart Cities’ and other new initiatives in the future.

Sundaram of JSS University takes a contrarian view, likening India’s current position to that of European countries immediately after World War II when all ammunition producing chemicals had to be converted to usable fertilisers or else face closure. Alluding to the need to change strategy in tune with current realities, he says, “In my opinion, indigenous drug-discovery needs to be incentivised, especially for those diseases, which are prevalent in our country. For this, the current reverse-engineering work-force, which is ample in our country now, should be immediately siphoned to drug-discovery labs, which need an urgent set-up.”

He recommends that the top priority of India's government should be to set up screening-facilities for various tropical diseases, where drugs can be validated and brought to the people of our country, with collaboration between chemistry and pharmacology teams. If the government does not act now, then he warns that our chemical-engineering work-force would simply vanish.

( Global pressures Pressure to fall in line comes from various initiatives. For instance, India was ranked second last, 37th out of 38 countries, for its IPR environment in the annual IP index conducted by GIPC and released by the United States Chamber of Commerce (USCC) this February.

Indonesia, Nigeria, Ukraine and Vietnam were ranked better than India. In the same vein, India remained on the US Trade Representative’s (USTR) Priority Watch List this year as well.

Industry observers point out that these barbs will slowly lose their sting. For instance, the USTR added Switzerland to the Watch List this year, so one might conclude that India is in good company. While Switzerland is generally a strong partner on IP issues, the USTR report stated that copyright holders have essentially been prevented from enforcing their rights against online infringers and the country has become an increasingly popular host country for infringing websites. The same report also announces out of cycle reviews (OCRs) for Colombia, Pakistan, Tajikistan, and Spain to promote engagement and progress on specific IPR opportunities and challenges identified in this year’s review, a situation that India went through in 2014.

There is also concern that IPR issues have negatively impacted investment inflows into the pharma sector in India.

According to a KPMG report released this June, titled 'India-US Trade - A formidable economic force', enforcement issues around IP protection, due to the usage of CL in the past, has shaken investors’ confidence. The report hails the the new IPR policy as a welcome step towards legislation related to IP laws in India and terms it 'a balanced approach towards innovation and public health.' While the new IPR policy is expected to help in effective protection of patents that can encourage MNCs to

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launch their products in India and further boost trade between India and the US, the report cautions that to further boost trade, the country needs

stronger protection of patents for pharma MNCs i.e. patent linkage, patent-term extension and data exclusivity.

There is no doubt that

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India's national IPR policy will be the battleground for many more skirmishes. Will India continue to defend Section 3(d), resist TRIPS plus

conditions and remain the pharmacy of the world? Or will it choose another path? viveka.r@expressindia.com

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cover ) INSIGHT

IPR in the Indo-US pharma trade relationship

PROFESSOR SANKAR SUNDARAM Professor of Pharmaceutical Sciences, JSS University

India has retained her place on the Priority Watch List of the US TR's Super 301 report. With the Cabinet approving the National Intellectual Property Rights Policy on May 12, Professor Sankar Sundaram, Professor of Pharmaceutical Sciences, JSS University analyses the status of America’s own pharmaceutical IPR policy. As a patent agent in India's Intellectual Property Office (Registration Number IN/PA 666), he comments on the practice of using IPRs as a key governing policy interplay in the Indo-US pharma trade relationship

O

ur National IPR Policy, unveiled recently, is a bold step in eschewing protectionism, fostering creativity from the farming sector to the cyber security sector, containing the appeasement of the overseas market, re-establishing our creative identity, stimulating progress of an academic-friendly industry, preventing exploitation of our traditional knowledge and above all, aligning the Indian mindset in tune with the globalised international economic paradigm. While being Trade-Related Aspects of Intellectual Property Rights (TRIPS) compliant, it aspires to curb the unfair brick batting currently faced by the providers of Indian goods and services in the global market. Thus, the aim of the National IPR Policy is to ‘integrate IP as a policy and strategic tool in national developmental plans.’

As per National IPR Policy, all forms of Intellectual Property (IP) have been brought under the aegis of the Department of Industrial Policy and Promotion (DIPP). The policy comprises significant provisions for the pharma sector which claim to: i) Encourage public funded R&D institutes and industry to develop affordable drugs relating to neglected diseases ii) Encourage R&D including open source based research such as Open Source Drug Discovery (OSDD) by the Council of Scientific and Industrial Re-

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Big Pharma fears that many countries would follow India’s practice of utilising the flexibilities in the TRIPS agreement and hence places demands such as refraining from compulsory licensing, demanding fast-track examination of patent applications by India etc search (CSIR) for new inventions for prevention, diagnosis and treatment of diseases, especially those that are life threatening and those which have high incidence in India iii) Ensure enhanced access to affordable medicines and other healthcare solutions iv) Streamline regulatory processes to ensure timely approval for manufacturing and marketing of drugs while maintaining safety and efficacy standards v) Make efforts to reduce dependency on active pharmaceutical ingredients (APIs) imports including incentivising manufacturing of APIs in India and revitalising public sector undertakings in the healthcare sector vi) Take strong measures against attempts to treat generic drugs as spurious or counterfeit vii) Undertake stringent measures to curb manufacture and sale of misbranded, adulterated and spurious drugs and viii) Remain committed to

the Doha Declaration on TRIPS Agreement and Public Health

The US' perception of India’s IPR practices The Big Pharma of the US perceives India’s independent patent examination system and India’s Section 3(d) of the Patent Act, 1970 as an unfair playground favouring our domestic drug industry. This had prompted the US Trade Representative (USTR) to place India in its 'Priority Watch List' and to subject India to an Out of Cycle Review in 2014 at its annual Super 301 report. Big Pharma fears that many countries would follow India’s practice of utilising the flexibilities in the TRIPS agreement and hence places demands such as refraining from compulsory licensing, demanding fast-track examination of patent applications by India etc.

Hopefully now, the enforcement of IP rights is deleted from the Big Pharma’s agenda.

Also, the Big Pharma should be happy after the Indian patent

issued for the drug Sofosbuvir — applied by Gilead Sciences — granted by the Indian patent office on May 9, 2016.

The US trade bodies have been giving veiled threats that should India not fall-in-line with the US’ wish list of its IP protection, then India needs to be restrained from exporting her duty-free products to the US under the Generalized System of Preferences. Big Pharma appears to feign ignorance about India’s export of her pharma products to the US (and so the practising of the USPTO norms) vis-a-vis India’s domestic IP-protection benchmark (which is governed by India’s IP Office norms).

Unlike consumer goods, healthcare is a social and human good, worldwide. Save for a handful of Indian elite, nobody in India can afford the patented /non-patented medicines of the US. Big Pharma needs to understand that India has 1.3 billion mouths to be fed. While Big Pharma is clearly erroneous in gauging the affordability of

health-related expenses by the majority of the Indian citizens, let us take a look at the US’ own domestic pharma front.

Domestic pharma front in the US Thrice within the last two decades, the US has been contemplating the imposition of march-in rights over the high price of patented drugs dictated by the free-market economy in the US. The first two were the case of the drugs Ritonavir and Latanoprost in 2004 where the National Institutes of Health (NIH) of the US had held a hearing to consider a march-in request or government-use licensing from the stakeholders. The third was the repeat case of the drug Ritonavir in 2013. And now for the fourth time, there is a request being placed to the Obama administration to hold a public hearing to determine if the NIH should intervene in the affordability for a prostate cancer drug Enzalutamide.

The march-in right, under the purview of the US BayhDole Act, allows any US government agency, which had funded private research - to require the drug maker to license its patent to another party in order to “alleviate health and safety needs which are not being reasonably satisfied,” or when the benefits of a drug are not available on 'reasonable terms.' Additionally, there also exists the government’s use/confirmatory licensing clause flexibility for

( exercising control on government-funded research outcomes. The government-use license provides the federal funding agency the provision of a “non-exclusive license to practice or have practised for or on behalf of the US any subject invention throughout the world.”

And to add insult to injury, if the price of patented-drugs soared in the US, the price of monopolistic non-patented drugs also touched new hitherto unattained heights. Important among them are the price increase of the drug Colchicine in the year 2009, the drug 17-alphahydroxyprogesterone caproate in the year 2011 and the drug Daraprim’s price-increase last year. To tackle this type of behaviour, the US is contemplating the process of creating a priority-review pathway for off-patent drugs and the institution of a voucher-system as an additional tool. Further, it has been recently (April 3rd issue) reported in the Forbes that as compared to the prevalent inflation rate in the US, the drug patents have resulted in an eight fold drug price increase. The US is averse to applying price-controls, fearing its impediment to new drug development.

The US government should demand clinical-information disclosure from Big Pharma for all the screened substances the Big Pharma have pharmacodynamic information on, for which the Big Pharma had been granted the investigational regulatory permission from the US Food and Drug Agency (FDA) and make it public. This would be an ethical gesture from the US to the world’s humanity.

It is actually the asymmetric government-interferences such as the 'closed-distribution' that the US regulators make, which cause issues of accessibility, and consequently, affordability of medicines, within the US. And the healthcare system in the US is corporate-funded. Thus, the US' own regulatory and exclusivity raaj is still evolving!

The way forward for India’s pharma goods/services It is said that ‘When in Rome

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do as the Romans do.’ And the Indian pharma industry does TRIPS compliant service.

Even so, within India, the impact on the affordability of many pharma products are becoming dearer. For instance, the anti tuberculosis drug Bedaquiline, India has become dependent on a single-source

manufacturer. When the access for more and more drugs used in the treatment of tropical diseases become scarcer, where would the patients go in case of an outbreak? Indian population is still financially dependent on their own pockets for meeting their healthcare needs (unlike the US

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where, mostly, health insurance companies handles the medical expenses). India has no option but to choose the reestablishment of its own government manufacturing units and also encourage the apothecary way of compounding nonpatented drugs. At the same time, it also needs to establish a

strong drug-discovery platform - especially for tropical diseases affecting India. The rupee is not equal to the dollar.

Both countries need to keep in mind that artificial restraints on the market to be meaningful, should be administered only when it is absolutely necessary.

MANAGEMENT

Strides to sustainabilty Sustainability, as a concept is gradually gaining traction in Indian Pharma Inc with a growing realisation that it can have a positive impact on a company’s credibility, enhance shareholder perception and create short- and long-term value, finds Lakshmipriya Nair

I

ndian Pharma Inc is battling myriad issues on different fronts like increasing pressures to cut costs, improving operational efficiency, dealing with complex regulatory environments, market volatility and managing reputations. In this backdrop, where the pharma industry is faced with unprecedented challenges, sustainability as a concept is gaining greater significance than ever before.

Moreover, as businesses which affect countless lives, it has become imperative for pharma companies to become more sustainable entities. This calls for a change in the goals and objectives, vision, mission, strategies, management practices, and operations in pharma organisations.

So, are pharma companies taking proactive steps to assimilate sustainability principles in their organisations?

Fortunately, to some extent, yes!

Whether it is implementing efficient processes through optimal utilisation of resources, ensuring regulatory compliance, developing tailored programmes to eliminate inefficiencies in their supply chain, better waste disposal systems, implementing measures to conserve energy and water, reducing carbon footprint or constructing greener buildings and facilities, there are some pharma players in India who are taking active strides towards being more environment-friendly. Here are a few examples.

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Dr Reddy's Laboratories – Leading by example Dr Reddy's Laboratories (DRL), a pharma major, is one of the few companies in India which releases a Sustainability Report as per Global Reporting Initiative (GRI) guidelines.

Reportedly, it was the first Indian pharma company to be registered under the GRI database. DRL's environmental measures comprise a gamut of initiatives like green chemistry; solvent recovery; waste reduction at source; water and energy audits; water harvesting and recycling.

DRL’s company spokesperson informed, “Our unique approach to sustainability, aligns our values to strategic actions that lead to measurable impact. Building on this steady foundation, we have backed innovative approaches to mitigate and minimise our impact on climate change, manage water resources and improve product stewardship.”

Elaborating on the initiatives, he added, “Through our sustainability programmes, we enhanced the share of clean energy in our energy mix, designed energy-efficient plants, consolidated our cooling towers and augmented our rainwater harvesting capacity. We have expedited our waste management efforts across the spectrum including design, manufacturing and safe disposal.”

DRL’s company website informs that its usage of freshwater per unit sale currently stands at about 35 per cent of what it was about a decade ago. It also informs that energy usage per unit sale has been reduced by 44 per cent, in ten years.

tainability,” states Quateel Ahmad, Chief Marketing Officer, ACG Worldwide as he explains the company’s move to build a green facility.

Sanofi India – Safeguarding the environment Sanofi India, in line with its mission of 'reducing carbon

footprint and using energy responsibly', has also adopted several sustainability intitiatives and practices. The company utilises renewable

sources of energy for its manufacturing operations. Its manufacturing facility in Ankleshwar, Gujarat has windmills installed to

ACG Worldwide – Taking the green route ACG Worldwide’s capsule manufacturing plant in Pithampur, Madhya Pradesh is an example of the company’s endeavours towards sustainable development.

Envisaged as an ecofriendly project, right from the design and layout stages, the factory boasts of several green features like sockets for charging electric vehicles in parking spaces, energy-efficient lighting fixtures, automated water efficient fixtures to an onsite ETP plant for water treatment, efficient HVAC systems, CFC-free refrigerants and fire suspension systems, Forest Stewardship Council (FSC) certified wood, steps to recycle or reuse construction waste, zero use of volatile organic carbons in the interiors, specially designed roofs with a high solar reflective index, improved indoor air quality as per American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE) standards, use of low VOC content paints, sealants and adhesives etc.

The green measures implemented at the ACG facility were recognised with a Gold rating by the Indian Green Building Council (IGBC) LEED, making it the first factory in the Indian pharma industry to receive this distinction.

“We opted for a green facility as a responsible corporate to reduce our energy footprint, learn optimal use and conservation of resources.

Building green facilities, conservation of precious natural resources, utilisation of locally available materials and renewable energy sources contributes positively to our sus-

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MANAGEMENT generate renewable power for captive consumption. Similarly, its manuafacturing site in Goa generates energy from agro waste. The company claims that effective utilisation of biomass has not only helped it in reducing steam cost and dependance on fossil fuels but also in creating jobs for the local residents.

In an earlier article titled, 'Going Green' published by Express Pharma in its June 115, 2016 issue, Aparna Thomas, Senior Director – Communications and CSR (India & South Asia), Sanofi India had highlighted the other eco-friendly measures adopted by her company, “At Sanofi, we have adopted the concept of recycling, reprocessing and recovery. Our manufacturing facilities are eco-friendly and undertake the following actions: waste water management, zero liquid discharge, recycling of treated waste water to conserve and reuse water, minimise air emissions, proper scrubbing, dust collector systems to protect the air from pollution, waste management (hazardous and non-hazardous) and disposal via incineration with heat recovery programme (e.g. power generation, water heating, etc.). In addition, we have rigorous inspection and maintenance procedures in place.”

“Safeguarding the environment has now become a greater responsibility for all companies. We are conscious of this and take a number of measures to ensure that we are not only compliant with current regulations, but have also taken adequate steps to run environment-friendly operations,” she further stated.

(Read: http://www.financialexpress.com/article/pharma/coverstory/going-green/273379/)

Building green facilities, conservation of precious natural resources, utilisation of locally available materials and renewable energy sources contributes positively to our sustainability

We have a team committed to best environmental compliance, not only for regulatory purposes but also driven by a personal commitment to make this world a better place for the next generation.

The new SEBI regulation will be extended to all listed companies in a phased manner and it will result in larger number of companies starting with their sustainability journey

Quateel Ahmad

Vishal Jajodia

Nitin Kalothia

Chief Marketing Officer, ACG Worldwide

Chief Executive Officer, Swati Spentose

Director, Sustainability Initiatives Practice, Frost & Sullivan

Swati Spentose – Success with zero-discharge Swati Spentose, a niche API manufacturer, also has a success story to report when it comes to sustainable initiatives. Its manufacturing units in Vapi, an industrial township in Gujarat, boast of high efficiency and environment-

24 EXPRESS PHARMA July 1-15, 2016

Lonza R&D facility: A green building designed by Venkataramanan Associates

friendly operations such as a high purifying water system etc, non-polluting captive effluent treatment facility and

full compliance with environment, health and safety guidelines. Even after manufacturing products like phenytoin

sodium, the company has achieved zero-discharge by implementing an effective effluent management system

at its manufacturing units.

This achievement has served as an example for other bulk drugs manufacturers in the highly polluted area of Vapi.

Vishal Jajodia, Chief Executive Officer, Swati Spentose recollects, “When our facility was built in 2007, Gujarat was in a major build up phase

by Narendra Modi, our current Prime Minister and former Chief Minister of Gujarat.

The government was very strict on environment compliances. They were not issuing any clearances to any facility even if they had environment clearance from Delhi, which we had incidentally. Hence, we were forced to find alternate solutions for zero discharge as a back up. As a result, we learnt and developed skills to create a zero-discharge platform using methods of ultrafiltration. Now, though we have got our load for effluent discharge sanctioned, we go into zero discharge mode once a month to keep us prepared for tomorrow.”

Jajodia feels that sustainability can be achieved only with a mindset change. Any pharma company which is serious about sustainability should identify core human issues like environment compliance or quality product manufacturing for human consumption and its leaders should commit themselves to not only lead these initiatives but also traverse a long journey until the objectives are achieved successfully.

He states, “We have a team committed to best environmental compliance, not only for regulatory purposes but also driven by a personal commitment to make this world a better place for the next generation.”

Thus these organisations have already begun their sustainability journey. Yet, these examples are exceptions and not the norm in the Indian pharma industry. Despite its importance, a significantly large number of corporates, inluding those in the pharma sector, have not embedded the principles of sustainability in their business practices.

It does not feature as a top priority in the CEOs' agendas.

MANAGEMENT

Vimta Labs: A green facility designed by Venkataramanan Associates

Zero-discharge system installed by Swati Spentose

Nitin Kalothia, Director, Sustainability Initiatives Practice, Frost & Sullivan points out, “India, as a country, has not been very proactive as compared to other developed and developing nations in adoption of sustainable practices. The pharma sector has not been an exception.”

So, what are the major deterrents to the adoption of sustainable practices in the pharma sector? Let's take a look.

The cost factor Green or sustainable measures require higher investments initially and take longer time for return on investments (ROI). This has seriously hindered their adoption at various levels. ACG Worldwide's Ahmad feels, “One of the deterrents could be the higher investments needed initially for a green facility.”

Naresh V Narasimhan, Architect – Principal, Venkataramanan Associates also points out, “There is a notion that very high additional capex is required in building a green facility. The pay back of the additional investment for a green facility is over the lifecycle of the project and is not immediate, this sometimes works as a deterrent especially in harsh economic conditions.” Vimta Labs facility and Lonza R&D facility in Hyderabad are LEED-certified green pharma facilities built by Venkataramanan Associates, a Bengaluru-based architectural firm.

Kalothia shares a similar perspective, “Presently, most organisations approve and implement projects with an ROI of less than three to four years. As a result, many projects that have the potential for higher savings are deferred

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MANAGEMENT or shelved due to its long ROI duration.”

However, Vishu Bhoosnurmath, Managing Director, Vishva Protech clarifies, “The initial capital investment may be marginally higher. However, the life-cycle costs for five years are much less in comparison to conventional solutions.” Vishva Protech is a green technology solutions like green fume hoods, ductless storage cabinets, disposable glove boxes, clean air lab enclosures, PCR workstations etc. Bhoosnurmath informs that his company's products are installed at pharma firms such as DRL, Biocon, Cipla and Mylan.

Lack of awareness “Knowledge and awareness of sustainable development practices amongst the employees is low and top management’s commitment to these initiatives is not adequate,” says Kalothia.

Narasimhan also points out, “There are cases where there is lack of and/or less awareness in the team working on the project or the stakeholders regarding the sustainability concepts and its advantages. This, in turn, breeds a mental block when green concepts are suggested to them resulting in adherence to the traditional methods only.”

Outdated practices Narasimhan believes that outdated notions and old habits are also preventing companies from initiating sustainability measures. He explains, “One of the prime advantages of a green facility is savings on the energy consumptions. However measures on saving energy always challenges the old engineering habits which is deep rooted in the industry. This is one of the main deterrents.”

He further advocates, “The potential of reaping benefits of a green facility is maximised only if the concepts are integrated at the design stage itself rather than finding methods after the system is built. Lack of foresight and not incorporating sustainable measures at the design stage

26 EXPRESS PHARMA July 1-15, 2016

The pay back of the additional investment for a green facility is over the lifecycle of the project and is not immediate, this sometimes works as a deterrent especially in harsh economic conditions

The initial capital investment may be marginally higher.

However, the lifecycle costs for five years are much less in comparison to conventional solutions Vishu Bhoosnurmath Managing Director, Vishva Protech

Naresh V Narasimhan Architect – Principal, Venkataramanan Associates

is one key reason the Indian pharma industry faces difficulties in creating green facilities. The other critical factor is not involving the installation contractors in the design stage to ensure that there is enough knowledge transfer happening and sufficient commitment is there to maximise the potential savings in a green facility. This is one of the main gaps which plague the Indian pharma industry.”

Lags in sustainability reporting Sustainability reporting is being adopted as a mainstream activity globally. However, it is not a widespread practice in India. Kalothia highlights, “1,250 companies in China and 630 companies in the US have a sustainability report compared to 170 companies in India.”

The Securities and Exchange Board of India (SEBI) has mandated that the top 500 (earlier 100) companies to be listed on BSE/NSE have to include business responsibility report (BRR) in their annual report. But the ground realities are quite different. “Among the 35

pharma companies that are required to publish a BRR, less than 25 per cent of these companies have a sustainability report in place today,” informs Kalothia.

Benefits galore Thus, there are several challenges that need to be addressed to propel more companies towards the sustainability route. However, the benefits of being more sustainable outweigh the risks and challenges.

A survey by Arthur D Little, a US management consulting firm, reveals that 83 per cent of global business leaders believe they can deliver significant business values by implementing sustainable development strategy and operations. The pharma sector too can gain out of embarking on a journey towards sustainability and creating awareness mongst the key stakeholders in the industry about the merits of its effective adoption and implementation.

There are several benefits that firms can accrue by embarking on a sustainability journey. They include:

Safeguarding the environment has now become a greater responsibility for all companies.

Hence we have taken adequate steps to run environmentfriendly operations Aparna Thomas Senior Director – Communications and CSR (India & South Asia), Sanofi India

Better risk management: One of the many advantages that organisations gain out of sustainability journey is the ability to identify and manage short and long term risks across economic, environment, operations, supply chain and society. The process drives organisations to identify all kind of risks that can impact its long-term sustainability and helps manage it better, says Kalothia.

Enhanced stakeholder perception and satisfaction: The journey ensures that the company gains more credibilty in the eyes of the stakeholders. Thus, organisations can create a higher level of satisfaction amongst the stakeholders.

Significant cost benefits: Companies can reduce operating costs by reducing energy consumptions per unit of production, by adopting efficient lighting systems, installing energy efficient processes and technology.

Many organisations have focused on waste management and are reducing, reusing and recycling waste to generate value out of it. Material management (yield im-

provement, scrap reduction, etc.) has also reduced the manufacturing cost for few companies.

Gaining competitive advantage: It can help create competitive advantages for organisations by creating eco-friendly products, processes and technologies which would differentiate them from their counterparts and give them a competitive edge.

In times to come So, what’s in store for the future for Indian pharma where environment sustainability is concerned? Kalothia is optimistic about the future.

He opines, “Adoption of green manufacturing practices has been a choice for corporates till date and continues to be so for most organisations, but then that seems to be changing with regulations pushing the agenda harder than before. The new SEBI regulation will push corporates to adopt sustainable development practices. The requirement will be extended to all listed companies in a phased manner and that will result in larger number of companies starting with their sustainability journey.”

Besides, with stricter environmental norms, putting effective sustainability practices have become a matter of regulatory compliance as well. For instance, the Indian government is encouraging pharma companies to explore lesser accessed zones like the North Eastern region to provide better healthcare services to the population.

While it is a great opportunity to expand their businesses, it is mandatory for the pharma companies to get clearance on several environmental and safety fronts before setting up their facilities/units in these regions.

Thus, in times to come, it is to be hoped that pharma players would become more accountable for their actions and pledge their allegiance towards global wefare by becoming more sustainable institutions. lakshmipriya.nair@expressindia.com

MANAGEMENT REPORT

Ganymed Pharmaceuticals’ IMAB362 may bring hope for gastric cancer patients: Report

NABL ACCREDIATED LABORATORY

WE UNDERSTAND VALIDATION AND CALIBRATION BETTER !

Incidences of the disease are set to increase to over 410,000 by 2024 across US, France, Germany, Italy, Spain, the UK, Japan, and China NEW DATA regarding Ganymed Pharmaceuticals’ drug IMAB362, presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, provides hope for a subset of gastric and gastroesophageal junction adenocarcinoma (gastric cancer) patients with an advanced form of the disease, according to an analyst with research and consulting firm GlobalData.

As explored in GlobalData’s gastric cancer report, incidences of the disease are set to increase to over 410,000 by 2024 across the

Ganymed is a small biopharma company that was spun off from the Universities of Mainz and Zurich eight major markets of the US, France, Germany, Italy, Spain, the UK, Japan, and China, which is indicative of the growing need for effective gastric cancer drugs, and the potential market open to IMAB362.

A randomised, open-label Phase II trial named FAST (NCT01630083) demonstrated that IMAB362, in combination with EOX (epirubicin, oxaliplatin, and capecitabine) chemotherapy, significantly improved patients’ progression-free survival and overall survival of previously untreated, claudin18.2positive advanced gastric cancer patients compared with EOX alone.

Progression free survival was 7.9 months with IMAB362, versus 4.8 months with EOX alone, while overall survival was 13.2 months versus 8.4 months. Indeed, IMAB362 is the first drug to have shown a survival benefit for gastric cancer patients in the first-line setting since the approval of Roche’s Herceptin (trastuzumab) in 2010.

Fenix Leung, DPhil, GlobalData's Senior Analyst covering Oncology and Hematology, explains: “The commercial potential of IMAB362 is huge, as the drug targets the first-line setting of advanced gastric cancer – the largest patient segment within the indication. Although only patients with claudine18.2-positive gastric cancer would be eligible for the drug, GlobalData anticipates that the eligible pool of IMAB362 will be greater than that of Herceptin, meaning it could have peak sales in excess of $1 billion, compared with Herceptin’s estimated peak sales of $402 million for the gastric cancer indication.”

Despite its potential success, certain risks will exist for IMAB362, as Ganymed is a small biopharma company that was spun off from the Universities of Mainz and Zurich.

Leung continues, “The company’s size means it may not be able to finance a Phase III study for IMAB362 before receiving further investment, possibly allowing a number of competitors, including Eli Lilly’s Cyramza and Merck’s Keytruda, to enter the market first. However, with its robust randomised Phase II data, IMAB362 thus far appears to be the most promising gastric cancer candidate.”

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EP News Bureau-Mumbai

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DOP/PAO Leak Testing

Air Flow Pattern (Smoke)Test

RESEARCH I N T E R V I E W

‘There is a requirement for constant inflow of new drugs’ Dr Amit Sharma, Head, Structural and Computational Biology Group, International Centre for Genetic Engineering and Biotechnology, New Delhi and winner of Infosys Prize 2015 for Life Sciences, talks about his research on pathogenesis of malarial parasite with Sachin Jagdale

Give details of your research work on pathogenesis of malarial parasite for which you have received the Infosys Prize 2015.

Our focus has been to unravel the atomic structures of key malaria parasite proteins that drive or contribute or are critical for pathogenesis.

We are exploring new enzyme families which can be targeted by small molecule inhibitors. We have focused on dissecting key structural attributes of parasite proteins with the overall aim of understanding and exploiting them for target and drug discovery. The laboratory has been able to contribute towards the atomic mapping of several key parasitic proteins, which we hope will provide platforms for anti-malarial drug development.

Our research has been successful in highlighting an enzyme family that we believe gives numerous opportunities for development of novel anti-malarials

28 EXPRESS PHARMA July 1-15, 2016

Species of malarial parasites may vary in given area. Is your research applicable to all such species?

Yes, the targets we have discovered are conserved not only in malaria parasite species but also in other infectious agents.

Anti malarial drug resistance has emerged as one of the greatest challenges in malaria control. Does your research provide solution to this problem?

There are a number of antimalarial drugs already available, mostly due to intense research efforts from many groups worldwide.

However, there are growing concerns about development of drug resistance, and hence there is a requirement for constant inflow of new drugs that target novel enzymes or pathways. Our research has been successful in highlighting an enzyme family that we

the targets we have discovered are conserved not only in malaria parasite species but also in other infectious agents believe gives numerous opportunities for development of novel anti-malarials.

Where does India stand on the global map as far as research on malarial parasite is concerned?

Which are the improvement areas for us?

We are at the forefront of highlighting specific protein translation enzymes from

malaria parasites as novel targets for discovering new generation of drugs against malaria. We along with several national and international groups have contributed significantly to validate our observations, and now there is indeed even stiff competition on many of the drug targets we had earlier described. Along with India, many other countries are also contributing to malaria research and together international efforts will bear fruit.

Do you have any association with pharma/biotech company/companies? If yes give details. If not, how will the involvement of pharma/biotech companies benefit this research?

We do not currently have an association with any company - perhaps, malaria drug discovery is not considered a profitable enough business.

How long will it take to generate the commercial benefits from your work?

We are not seeking any commercial benefits from our research in malaria. We are happy just to contribute to its understanding and possible elimination in coming time. I think India should consider itself to have arrived at the world stage if it can manage to eliminate malaria from its borders. sachin.jagdale@expressindia.com

UPDATE

Study observes potential breakthrough in treatment of HIV The study addresses the persistence of latent HIV reservoirs in patients who are on therapy A STUDY conducted by researchers at the San Francisco VA Medical Center (SFVAMC) observed that pharmacological enhancement of the immune systems of HIV patients could help eliminate infected cells, providing an important step in the ongoing quest to find a lasting HIV cure.

The study, titled ‘Stimulating the RIG-I Pathway to Kill Cells in the Latent HIV Reservoir Following Viral Reactivation,’ addresses the persistence of latent HIV reservoirs in patients who are on antiretroviral therapy. Latent HIV reservoirs are established during the earliest stage of HIV infection, and they are infected with HIV even though they are not actively producing

the virus. Although antiretroviral therapy can reduce the level of HIV in the blood to an undetectable level, latent reservoirs of HIV continue to survive.

When a latently infected cell is reactivated, the cell begins to produce HIV again. For this reason, antiretroviral therapy cannot cure HIV infection.

According to the study, HIV latency depends on immune system suppression, including immune system responses that detect viral pathogens and induce the destruction of infected cells.

The study shows that retinoic acid can stimulate the innate immune system into eliminating HIV-infected cells. In particular, acitretin, an FDA-approved retinoic acid derivative, can increase HIV transcription in the latent HIV reservoir and allow the innate immune system to target and destroy HIV infected cells.

“The current model of HIV treatment can help manage symptoms and increase the quality of life for patients, but it is not a cure,” says the study’s

lead author Peilin Li, Research Associate at SFVAMC, and an Assistant Adjunct Professor at the University of California, San Francisco School of Medicine.

“HIV patients on antiretroviral medications must take them for the rest of their lives, and they often experience adverse side effects.”

“It is important to strengthen the body’s defence system against the virus. This will help the antiretroviral drugs do their job,” says Dr. Li. “We want the immune system to recognise and kill the virus. By boosting immune response, the body will be able to kill cells in the latent HIV reservoir that are still capable of producing HIV.” EP News Bureau-Mumbai

FDA panel backs approval of Pfizer’s opioid painkiller The panel, however, had reservations about the drug’s ability to curb all forms of abuse A US advisory panel recommended approval of Pfizer’s long-acting opioid painkiller Troxyca ER, saying it dulls pain and its design could deter abuse by addicts in search of a quick high.

The panel, however, had reservations about the drug’s ability to curb all forms of abuse, voting against a claim that it deters oral abuse while endorsing claims of deterring injecting or snorting the drug.

Troxyca ER contains oxycodone and naltrexone, a drug designed to cancel the effect of oxycodone. When taken as directed, the naltrexone remains

hidden and does not diminish the effect of the oxycodone, which is released over time.

The product is designed to deter addicts from crushing the pellets to release the oxycodone for a quick high. When crushed, the naltrexone is released along with the oxycodone. The panel concluded that addicts could use certain solvents to extract oxycodone and only limited amounts of naltrexone, though they said it would be harder to take the additional steps needed to snort or inject it. The FDA is not obliged to follow the advice of its panels, but typically does

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so. The panel concluded that a different long-acting opioid made by Teva Pharmaceutical Industries was likely to deter abuse whether addicts sought to swallow, snort or inject it.

Panelists were more conflicted about Pfizer’s drug, voting 9-6 to recommend approval of the product but voting 9-6 against the claim that it deters oral abuse. They voted 11-4 that the drug deterred nasal abuse and 9-6 that it deterred intravenous abuse.

"The committee is in a quandary about Troxyca ER," Dr Raeford Brown, Jr, a professor of anesthesiology and

paediatrics at the University of Kentucky, said, summarising the views of the panel.

"The data are not clear." Panelists also wrestled with their role in recommending approval for any high-dose opioid at a time when opioid abuse has reached epidemic proportions. The Centers for Disease Control and Prevention estimates that 78 Americans die every day from opioid overdose. Music superstar Prince died from an accidental overdose of an opioid painkiller in April.

Dr Jeanmarie Perrone, a professor of emergency medi-

cine at the University of Pennsylvania, described the entire discussion as one of "whether we should approve another high-dose opioid with maybe a bit of abuse deterrence." A number of panelists said Pfizer met current standards for approval, but said they would like to see those standards raised. Companies that make abuse-resistant opioid painkillers are supposed to conduct subsequent studies to prove whether they reduce abuse in the real world. None of those results have come in so far.

Reuters

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RESEARCH

Merck’s Keytruda prolongs Lilly’s Jardiance life in big lung-cancer study slows kidney Merck hopes the new data will allow its injectable drug to be used earlier as a treatment for the most common form of lung cancer

ADVANCED LUNG cancer patients who took Merck’s Keytruda immuno-oncology medicine in a large trial and were previously untreated went longer without their disease worsening and showed a survival advantage over those given standard chemotherapy, the drugmaker said.

An independent data monitoring board recommended that the late-stage trial be stopped due to the favourable

results, Merck said, thereby allowing patients who were taking chemotherapy to switch over to the company's treatment. Keytruda, which takes the brakes off the immune system by blocking a protein called PD-1, is already approved for patients who have undergone previous chemotherapy for advanced non-small lung cancer. Patients enrolled in the trial had tumours with high levels of

PD-L1, a related protein whose presence may help identify which patients are most likely to respond to Keytruda and similar drugs called checkpoint inhibitors.

Merck hopes the new data will allow its injectable drug, which has a list price of about $150,000 a year, to be used earlier as a treatment for the most common form of lung cancer. Bristol-Myers Squibb’s approved rival Opdivo is also being tested as a so-called first line treatment for NSCLC, with data expected later this year. Opdivo’s studies have enrolled patients regardless of their PD-L1 levels, helping assure its wider use and greater sales than Keytruda.

John Boris, an analyst with Suntrust Robinson Humphrey, forecast that Keytruda will generate annual sales of $7 billion by 2021. But he predicted Keytruda will have only 25 to 30 per cent of the first-line NSCLC market, while Opdivo commands a 65 to 70 per cent market share.

Reuters

FDA approves Allergan’s combination therapy for hypertension THE US Food and Drug Administration approved Allergan’s treatment for high blood pressure or hypertension, the company said. The therapy, Byvalson, is a fixed-dose combination of two FDA-approved blood pressure lowering agents, Nebivolol and Valsartan. The two drugs fight hypertension using different mechanisms of action and are administered

30 EXPRESS PHARMA July 1-15, 2016

once a day.

Byvalson was tested against a placebo in two late-stage trials and also showed patients given the drug had a statistically significant reduction in blood pressure than those given either just Nebivolol or Valsartan, Allergan said. Hypertension often has no warning signs or symptoms, and has been associated with serious cardiovascular risks, such as

stroke, heart failure, and myocardial infarction.

Allergan said lowering blood pressure in such cases reduces the risk to the heart, but there are no controlled trials showing that Byvalson could reduce such risks. The treatment is expected to hit the market by the second half of 2016, the company added in its statement.

Reuters

disease progression in diabetics The once-daily pill is a member of a new class of diabetes drugs called SGLT-2 inhibitors, which work by eliminating glucose through urine ELI LILLY and Co’s Jardiance diabetes drug slashed the risk of progressive kidney disease in adults with type II diabetes in a large trial that had already proved the medication’s ability to greatly reduce cardiovascular deaths and hospitalisations for heart failure. Jardiance, developed in partnership with privately held German drugmaker Boehringer Ingelheim,

adults with type II diabetes that had a history of heart disease.

Moreover, there was a 55 per cent reduction in the need for renal replacement therapy, such as dialysis, in the Jardiance group. The results are significant, Lilly and Boehringer said, because more than one third of patients with type II diabetes develop kidney

was approved by US regulators in August 2014 to lower blood sugar in adults with type II diabetes. The once-daily pill is a member of a new class of diabetes drugs called SGLT-2 inhibitors, which work by eliminating glucose through urine.

Researchers said data from the 7,000-patient study showed that worsening of kidney disease was seen in 12.7 per cent of patients taking Jardiance and standard treatments, compared with almost 19 per cent in patients taking only standard treatments, which included statins and blood pressure drugs. That translated to a 39 per cent reduction in risk of developing or worsening of kidney disease in

disease - which itself greatly increases risk of heart disease.

The number of serious side effects in the trial was similar in both patient groups, although a higher incidence of genital infections was seen among those taking Jardiance.

Findings were presented at the annual scientific meeting of the American Diabetes Association, being held in New Orleans. The three-year trial created a stir last August when Lilly and Boehringer released data showing Jardiance cut overall deaths by 32 per cent and slashed cardiovascular deaths by 38 per cent, when compared with standard treatments.

Reuters

RESEARCH

Scientists decipher 11 subtypes in acute leukemia gene study The findings may improve clinical trials for testing and developing new AML drugs and change the way patients are diagnosed SCIENTISTS UNPICKING the gene faults behind an aggressive blood cancer called acute myeloid leukemia (AML) have found it is not a single disease, but at least 11 different ones with important differences for patients’ likely survival chances. The findings, from the largest study of its kind, could improve clinical trials for testing and developing new AML drugs and change the way patients are diagnosed and treated in future, according to the international team of researchers.

"We have shown that AML is an umbrella term for a group of at least 11 different types of leukemia," said Peter Campbell, who co-led the study from Britain's Wellcome Trust Sanger Institute. "We can now start to decode these genetics to shape clinical trials and develop diagnostics."

"What we can clearly see is that a large proportion of what will happen to a patient is written and encoded in the genetic profile of that patient's leukemia," he said at a London briefing.

AML is an aggressive form of blood cancer that develops in cells in the bone marrow and can affect people of all ages.

Estimates from the World Health Organization’s 2012 GLOBOCAN project suggested some 352,000 people worldwide had AML, and the disease is becoming more prevalent as populations age. Treatment often involves months of intensive chemotherapy in hospital, but there are large variations in patient survival rates - something doctors and scientists had wanted to investigate. For this study, published in the New England Journal of Medicine, the team analysed 1,540 patients with AML. They studied more than 100 genes known to cause leukemia and aimed to seek out common genetic themes behind the development of the disease. They found the patients could be divided into at least 11 major groups, each with different constellations of genetic changes and distinctive clinical features. Despite identifying common themes, the team also found that most patients had a unique combination of genetic changes driving their leukemia. This genetic complexity helps explain why AML shows such variability in survival rates, they said.

"For the first time, we untangled the genetic complexity seen in most AML cancer genomes into distinct evolutionary paths," said Elli Papaemmanuil, who co-led the study at the Memorial Sloan Kettering Cancer Centre in New York.

She said having full knowledge of the genetic make-up of a patient's leukemia substantially improved the ability to predict whether that patient could be cured with current drugs. Such information could also be used to design new trials to develop the best treatments for each AML subtype, she said.

Reuters

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PHARMA INFRASTRUCTURE SPECIAL

Pharma warehouse,a realistic business model The government has been proactive in promoting warehouse services within the pharma sector. and the industry needs to focus on establishing an organised warehousing sector, reports Usha Sharma

T

he warehousing industry in India is one of the most lucrative and consumer-driven industry, where it plays a major role between manufacturers and the end consumers. As per KPMG India analysis, in 2015, the total warehousing demand was about 550 million sq ft, which is expected to grow at a compound annual growth rate (CAGR) of 8–10 per cent until 2020, resulting in a demand of approximately 800 million sq ft.

Jaideep Ghosh, Partner and Head, Transport and Logistics, KPMG in India says, “Currently, pharma logistics constitute merely five per cent of the total logistics industry. However, it is expected to grow to seven to eight per cent of the total logistics industry in the next five years.”

Manish Panchal, Senior Practice Head — Chemicals & SCM at the TATA Strategic Management Group says, “Presently, the Indian warehousing industry is pegged at nearly ` 750 billion excluding the inventory holding costs and had been growing at a healthy rate of about 10 per cent annually in the recent past. Of this, the pharma sector contributes to about ` 50 billion.”

Government initiatives In the last couple of years, the government has undertaken significant investments and initiatives in infrastructure development to select and set up logistics parks across India. For example, government subsidies

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To serve the global market in addition to India, pharma products require climate cGMP warehouses which will reduce product losses in storage and transit for the companies

The pharma logistics industry is expected to grow to seven to eight per cent of the total logistics industry in the next five years

Manish Panchal

Jaideep Ghosh

Senior Practice Head – Chemicals & SCM at the TATA Strategic Management Group

Partner and Head, Transport and Logistics, KPMG in India

for pharma manufacturers in Sikkim, Baddi and other locations, port upgradation projects in Visakhapatnam by 2020 and road connectivity enhancement from Chandigarh to Baddi (fourlane) clearly indicate government’s interest and support.

Indicating the Goods and Services Tax (GST) implementation and its impact on warehousing, Panchal informs, “The government has come up with policy initiatives revolving around setting up logistics parks in various parts of India which would house pharma products also. In addition, due to implementation of GST in the near fu-

ture, the current set-up may undergo a major change to get economies of scale.”

Ghosh opines, “The implementation of GST is also expected to be a positive step for the pharma industry. The subsuming of sales tax as well as inter-state taxes within GST is expected to facilitate companies to consolidate and operate from a few centralised warehouses to distribute goods to the rest of the country.”

Warehousing plays an important role in pharma logistics as well. It helps pharma companies to deliver quality medicines to the end consumers. However,

The warehouse industry is yet to form the standards required in serving at the micro level of operations Dinesh Kothari Director, Rajsons Pharma

Warehousing is an important qualitative factor which needs to focus on demand for high-quality and hi-tech warehousing that’s temperature sensitive and product specific Gulshan Bakhtiani Director, Wellness Forever

the pharma warehousing segment in India is highly fragmented. The Indian pharma distribution chain consists of three layers. a) Pharma companies with their own national/regional warehouses, which supply product to Carrying and Forwarding Agents (CFAs) in each state in order to operate within the current Central tax-State tax regime b) Bigger companies have two to three exclusive CFAs, while some CFAs may carry products of multiple smaller companies c) The CFAs then supply to

the wholesalers/distributors in each district/city who service the retail pharmacies.

Commenting on the government's involvement in the process, Panchal says, “The government’s involvement in the pharma sector is in production and distribution of products from their own plants to the market as well as procurement from the market through tender operations for various Central and State government medical service organisations. There are government-owned warehouses for pharma products in India.”

Moreover, the government is also helping companies to set up

pharma zones/hubs.

What will be the regulatory requriements for setting up pharma warehouses in India?

Pharma zones for warehousing Explaining this further, Ghosh suggests, “Pharma warehouses need to adhere to all regulatory compliances, which harp on product quality, safety, security and traceability. To achieve all of these, a few important aspects from a regulatory standpoint are appropriate GxP compliance, fire safety and fire-fighting equipment, safety and quality trained champions on-site, technology to support traceability, awareness and expertise of products being handled on-site, proper disposition of expiry stocks, i.e. waste management, and more. The absolute value of logistics spend to revenue is five to seven per cent in the Indian pharma sector; however, considering the delays in handling, clearances and other system inefficiencies, the value of logistics spend increases to 10–12 per cent.”

Gulshan Bakhtiani, Director, Wellness Forever, has a pharma warehouse which ensures zero error product handling and disbursement in Mumbai. He informs about the key elements which need to be considered before setting up any pharma warehouses. He says, “There are multiple licensing, storage and compliance requirements for setting up a pharma warehouse.

Pharma warehousing is broadly classified into two – CNF agents and distributors – both of which, often times, work on per-palletper-day basis and their primary focus is cost optimisation.”

He suggests, “Two broad areas of focus while designing a pharma warehouse are quality control and process automation.

There are many other factors that can help warehouses achieve reliability. Automation also helps in reducing costs and staying competitive in this pricesensitive and heavily regulated industry.”

Suggesting the features which need to be considered while designing a pharma warehouse to make it competitiveness and reliable, Ghosh empha-

Post 2017, the Indian pharma industry will see more opportunities, as many patented drugs will go off patent creating more opportunities for generic drug manufacturers and opening new avenues for exports sises, “An effective cold chain management system, RFID and GPS technology for tracking, along with trained personnel, would be essential for effective functioning of a warehouse.

These features would result in making a warehouse reliable and compliant to handle goods, which if positioned well, could enhance the overall competitive offering of a logistics provider.”

He elaborates, “While designing a pharma warehouse, it is important to choose a strategic location from consumption and distribution point of view.

Further, it needs to be identified that proper approach roads, parking bays and other factors are aligned to GxP requirements for a warehouse. Also, the GxP requirements recommend appropriate flooring, storage-box design, handling procedures,

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temperature monitoring, for example, data loggers with appropriate number of docks and material storage rack design for pallets, boxes, units (as required), labour changing and washing rooms, and many more.” Apart from this, the growth of pharma warehousing industry also depends on good logistics services and therefore meeting regulations and quality standards in logistics is a must.

Logistics, a driving force Dinesh Kothari, Director, Rajsons Pharma expresses, “The warehousing industry is one of the top happening subject in any industry for matter as many existing key players like DHL, VRL, DTDC, etc. have been serving the best while meeting the requirements from various industries across nation and

globe. The warehouse industry is yet to form the standards required in serving at the micro level of operations.”

Many logistics players have set up pharma zones at their warehouses. With a focus on various government-run initiatives, it is a need of the hour to have well structured organised warehouse. Then, how to ensure the quality of the products?

Ghosh suggests, “The team on ground must be trained on products knowledge, handling and storage specifications. Also, the usage of technology, such as GPS, data loggers and supervision cameras, software — Warehouse Management System, telematics and others — which can trigger important notifications to people for deviations would help ensure to track, trace, monitor and measure the

activities being performed on products during their logistics movements.”

Since the pharma warehouse industry is largely dominated by the unorganised players, there are many steps which needs to be taken into consideration for the future.

Bakhtiani emphasises, “Warehousing is one such important qualitative factor which needs to focus on demand for high-quality and hi-tech warehousing that’s temperature sensitive and product specific.”

Post 2017, the Indian pharma industry will see more opportunities, as many patented drugs will go off patent creating more opportunities for generic drug manufacturers and opening new avenues for exports. This in turn will create more demand for organised warehousing facilities.

Panchal says, “To serve the global market in addition to India, pharma products require climate cGMP warehouses which will reduce product losses in storage and transit for the companies. It will thus help to reduce the price of the drug.”

The need of the hour is to focus on establishing an organised warehousing industry. u.sharma@expressindia.com

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July 1-15, 2016

PHARMA INFRASTRUCTURE SPECIAL I N T E R V I E W

‘Rivigo has been able to develop many proprietary solutions that are industry first’ Serving more than 100 clients across segments like E-commerce, white goods, FMCG, auto components and pharma, Rivigo has been instrumental in reducing the turnaround time by 50-70 per cent on long haul routes. Sambit Sathapathy, Head, Rivigo in an interaction with Usha Sharma, elaborates on Rivigo's growth prospects

Rivigo is a technologyenabled logistics company.

Tell us more about the company. How many people have partnered to form the company? What made you feel to venture into the pharma space?

Rivigo was co-founded one and half years back by Deepak Garg and Gazal Kalra, ex McKinsey professionals. The company’s mission is to solve some of the most fundamental problems of the logistics industry with the aid of technology. Surface logistics though accounts for over 70 per cent of the total freight movement in India, the sector is mired with tremendous inefficiencies. In the traditional logistics set up, most truck drivers spend around 25 days in a month away from home whereas under the aegis of Rivigo’s unique ‘Driver Relay model,’ the drivers get back home on the same day (or within 24 hours). Besides this, the model has been instrumental in reducing the turnaround time by 50-70 per cent on long haul routes.

These advantages of the Rivigo model has helped the company to get great traction both from clients

34 EXPRESS PHARMA July 1-15, 2016

and driver community. In the last one and half years, Rivigo has scaled to around 1000 truck operations. ◗ Today, Rivigo has three distinct service lines; ◗ Rivigo Prime – Full Truck Load (FTL) service; ◗ Rivigo Green – Cold chain business ◗ Rivigo Zoom – Part-Truck Load business.

We currently serve more than 100 clients across segments like E-commerce, white goods, FMCG, auto components and pharma.

Transition to pharma was a natural choice as we saw a great fit of our responsive supply chain model with the requirements of the pharma sector.

The company is focusing on expanding its base in the technology team to add IoT, automation and data sciences. Throw some light on the same.

Technology has been infused in the entire ecosystem of Rivigo and it is the backbone on the basis of which Rivigo has been able to develop many proprietary solutions that are industry first.

Rivigo’s vehicles are GPS enabled and the intelligence overlay on top of location

tracking enables Rivigo’s control tower to track all the vehicles on a real-time basis.

Every day thousands of hand-offs take place between drivers. For the ‘Driver-relay model’ to work smoothly, all those hand-offs should happen seamlessly.

Technology makes that possible for Rivigo. The company has also invested in getting various data like fuel, RPM, engine oil temperature, brake oil pressure etc from the vehicles on a real-time basis.

These data gets processed to aid us in decision making for predictive maintenance and mileage improvement.

Rivigo reefer trucks are well equipped to maintain the temperature integrity of temperature sensitive pharma goods

What percentage of medicines are transported through airways, roads and ship. Which is the most effective way and route to opt for and why?

Domestically, a significant proportion of medicines move on road. Reliance on airways is there to transport temperature-controlled products and other niche products. For exports, companies rely on a combination of air and ship.

There are several logistical challenges being faced by the pharma

industry. Acute segment product demand has lot of seasonality. Government regulations create additional uncertainty owing to implementation of price control, neurological product distribution and FDC bans.

Coupled with that, the skewness in product demand and large number of product SKUs create severe strain on the supply chain.

Companies end on spending in expensive airshipment as traditional surface transport has not been able to match the transit time expectations.

The government is encouraging pharma companies to set up facilities in less accessed zones like north eastern states. How well versed and ready are you to grab the upcoming business opportunity?

Due to the tax benefits, many pharma facilities are set-up in less accessed areas like north-east and Himachal Pradesh whereas the consumption locations are more in southern and western parts of the country.

Rivigo’s low transit time model is very suitable for this industry. E.g. Rivigo’s fleet

PHARMA INFRASTRUCTURE SPECIAL covers Guwahati to Delhi in 2.5 days which normally takes eight to 10 days. Rivigo through its operational efficiencies is able to cover Zirakpur to Chennai in four days which normally takes eight to 10 days. This enables companies to reliably serve the distant markets.

Tell us about the company’s ‘Driver relay model’ and how it is unique?

Rivigo’s ‘Driver Relay model’ has fundamentally changed the lifestyle of truck drivers.

Traditionally truck driving involved being away from home for 15-20 days at a stretch to deliver a cargo and return. Language and harassment by various agencies becomes a big barrier. In this model, the driver can effectively come back home the same day. It is ensured that after every 200250 km, the driver changes over and he hands over the vehicle to the next driver.

Effectively a driver drives for five to six hours, then takes rest and comes back to the starting point driving a return truck. Rivigo has 40 hubs across the country which serves as the driver change-over points. Drivers love this model which has resulted in almost zero

Rivigo from the beginning has focused in handling temperature-controlled products through refrigerated trucks. The thrust has been to ensure a best-in-class temperature integrity system

voluntary attrition. On the client side, the model has reduced transit time by 50-70 per cent. Typically a driver drives for eight to 10 hours a day and thereby covers 300350 km/ day. In our model as the drivers keep changing, the vehicles run for almost 22-23 hours a day thereby covering almost 1000 km/ day. No other company has been able to do at this scale because of the complexity involved in managing the hand-offs while ensuring accountability.

The pharma industry requires temperaturecontrolled logistics solution providers. Which technologies have been implemented and what cost control measures have been adopted?

Rivigo from the beginning

has focused in handling temperature-controlled products through refrigerated trucks. The thrust has been to ensure a best-in-class temperature integrity system. The company has tied-up with India’s best refrigerated container manufacturers and refrigeration unit manufacturers. Rivigo’s pharma specific reefer vehicles are validated by reputed agencies. With 40 service-hubs spread across the country, Rivigo has the widest service network. The reduced transit time model helps companies to reduce reliance on air and courier shipment.

How do you monitor the real time temperature?

All vehicles are equipped with GSM compliant remote

temperature monitoring sensors. We’ve a 100-member control tower time that monitors vehicles 24x7.

Going forward, the company is also piloting with technologies that would allow us to remotely manage/ change temperature thereby eliminating the risk of abuse by drivers.

Vaccines need to be stored at a certain required temperature. Are there any challenges being faced by you?

Vaccines need to be maintained within two to eight degree temperature range. Vaccines lose their potency if any part of the cold chain gets broken. Oral polio vaccine may lose four to 13 per cent of its potency per day at 25 degree centigrade and 26-37 per cent of potency

at 37 degree centigrade.

Rivigo reefer trucks are well equipped to maintain the temperature integrity of temperature sensitive pharma goods. Also, the technology implemented in the reefer trucks restricts the drivers from fiddling with the temperature of the reefer trucks.

The company offers its service at much cheaper cost than air cargo. How do you manage to operate it?

Air cargo, having higher freight charges (both fixed and variable) has huge cost implications vis-a-vis surface transportation of goods.

Despite the higher costs, pharmaceutical companies have relied on air cargo for shipping high value temperature sensitive pharma goods as the traditional logistics network doesn’t ensure an efficient, reliable and fast surface transport network. Rivigo on the other hand through its unique business model, technology implementation and overall operational efficiencies has been able to move shipments matching the speed of air cargo at one third the costs. u.sharma@expressindia.com

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

❒ We welcome information on new products and

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

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

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EXPRESS PHARMA

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July 1-15, 2016

PHARMA INFRASTRUCTURE SPECIAL INSIGHT

India’s path to genderless connectors Todd Andrews, Global Sales & Business Development Manager, Bioprocessing, CPC, elaborates on how genderless sterile connectors lead to more flexibility, faster changeovers and reduced costs SINGLE-USE technology is fast evolving as the new future of biologics manufacturing.

Recognising the high potential of this technology, the biopharmaceutical industry has responded with dynamic initiatives that advance the design and flexibility of existing technologies that will soon become the standard in the industry. As single-use systems develop, it is also well set for a proliferation in emerging markets in Asia that are struggling to stay ahead of the global competition.

In Asia, new start-up companies have the advantage over established Western companies by having the flexibility of being able to choose proven single-use systems without being hindered by the sunk-costs from the replacement of obsolete stainless steel systems1.

India, as one of the fastest growing biopharma markets in Asia, is currently the third largest in terms of quantity and the 13th in terms of value2 and they are looking to further develop and invest in their large local talent pool to ride on the industry’s exponential growth.

We also witness the flourishing of single-use technology as India seeks out its competitive edge by choosing to upgrade manufacturing operations.

Genderless sterile connectors — with their ability to interconnect with each other without male/ female limitations — can enhance the flexibility of single-use systems in a wide range of bioprocessing applications. Genderless connectors reduce system complexity, which in turn lowers requirements for inventory management, simplifies operator training and reduces misconnections in the manufacturing suite. In fact, it’s

36 EXPRESS PHARMA July 1-15, 2016

possible this new connector design will drive industry change similar to the transition from stainless, reusable systems to single-use. How can something as small as a tubing connector have this impact? The answer starts with a bit of history.

Bioprocessing began with reusable stainless steel systems, purpose-built processing plant schemes with steel vessels and permanent connecting piping. This plant approach offered large-scale biopharmaceutical manufacturers the ability to process larger quantities of product, but the downside was twofold: the cost and time associated with building these processing plants and the difficulty of making process changes once the plants were constructed. As the industry grew, so did the pressures on biopharma manufacturers to develop more and different drugs, to bring them to market faster and to reduce costs.

Something had to change to facilitate shorter production runs with more changeovers.

Single-use systems, consisting of bags, tubing, connectors and filters, delivered the operational flexibility needed to meet industry demands. One of

Figure 1: MPC/MPX back-to-back adapters give end users the flexibility of connecting single-use systems that feature identical coupling connections at the end of their tubing

the benefits of single-use connectors is that design manufacturers can purchase them clean and pre-sterilised, effectively ‘outsourcing’ the cleaning and sterilisation activities required in a traditional stainless steel operation. This not only reduces validation and operations expenses, it also improves the speed and safety of drug development and delivery.

Single-use initially gained acceptance in sterile cell culture media and process buffer storage applications, where the first sterile media bags were used. Following this, engineers developed single-use bioreactors that have quickly moved

from research and development labs into pilot plants and production facilities. To illustrate, a recent online survey reported that 50 per cent of respondents agreed stainless steel pilot-scale 50L to 500L bioreactors/fermenters are increasingly obsolete due to the emergence of single-use pilotscale solutions (Aspen Alert, April 23, 2015).

For many research and small-to medium scale operations, single-use systems are the way to go. These facilities need the ability to easily add new products to the mix, rapidly convert processes and quickly make process

TODD ANDREWS, Global Sales & Business Development Manager, Bioprocessing, CPC

adjustments as needed. Large operations are also seeing the benefits of incorporating single-use systems, and hybrid systems (a mixture of stainless steel components with singleuse components) are popular alternatives for manufacturers with existing stainless steel equipment. Regardless of size, all bio processors need to be able to adapt processes and execute changeovers while meeting required time-to-market and efficiency goals. There are also a number of drug and contract manufacturers focusing on internal projects to standardise single-use designs across their processes and facilities to reduce the complexity of single-use systems manufacturing.

This brings us to tubing connectors, an often overlooked but critical component in single-use and hybrid bioprocessing systems. Single-use systems need secure, reliable, leak-free connections between various components and processes. These connections are used in conjunction with the silicone or thermoplastic tubing that serves as inlets and outlets throughout a processing system. Single-use

Figure 2: Female-male, male-male and female-female tube sets generate three times the SKUs as genderless tube sets, adding inventory costs and increasing complexity. In contrast, genderless connectors enable stocking just one tube set

PHARMA INFRASTRUCTURE SPECIAL connectors can be the first and last line of defense in a singleuse system. Even with the best bag, the best filter and the best tubing, it is all pointless without a reliable and robust connector.

How gendered connectors led to the advent of genderless While gendered connectors have been a key building block in the implementation of singleuse technology, using typical gendered connectors can lead to unintended consequences that genderless connectors eliminate.

Many processors can relate to the frustration of getting different single-use systems from multiple suppliers with the same gender connections (one system comes in with a male half, and the other system also has a male half). The inability to connect system halves is particularly frustrating because the problem often goes unnoticed until the point of use.

This means the user has to quickly create some sort of adapter piece to go between the two systems because the connection is needed now. For instance, if a processor received the two systems as described above (each system with a male connector half), he or she would need to obtain two female connectors, a short piece of tubing and something to secure the tubing to the connector (i.e., cable tie, barb retainer, etc.). Then the processor would need to assemble the two female halves to the tubing, secure the tubing, and autoclave the final assembly inhouse.

This time-of-use jerry-rigging leads to several negative impacts for the processor: ◗ Adds material and labour costs to create the adapter assembly; ◗ Adds labour costs to assemble the adapter; ◗ Adds costs for autoclaving the assembly in-house; ◗ Delays the usage of the singleuse systems until the adapter has been created and sterilised; ◗ Introduces additional risk of leaks or contamination.

Another way to deal with the same-gender issue is to use a connector adapter, such as the back-to-back adapters

CPC’s interchangeable AseptiQuik genderless connectors enable tubing transitions between tubing of different sizes, from ¼” to ¾” flow

available from CPC (see figure 1). However, this solution requires anticipating the problem — and adapters are not presently available for gendered sterile connectors.

Inventory issues Any time a component requires a specific mating component, finished-goods inventory needs can more than double, or even triple. As an example, consider an assembly as simple a basic transfer line with sterile connectors on each end. There are three possible configurations depending on the application set-up: a female-to-male version, a male-to-male version and a female-to female version (see figure 2).

Other inventory issues include: ◗ Increased ordering complexity because the processor needs to define which tube set works with which part of the application; ◗ Greater demands on singleuse systems manufacturers because they need to be able to produce and stock three different assemblies; ◗ Longer lead times because systems suppliers are making

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lower volumes of multiple SKUs as opposed to higher volumes of one SKU; ◗ Increased stocking requirements for end users.

In contrast, using genderless connectors on the same tube set results in only one possible tube set.

Moving from gendered to genderless sterile connectors The inherent simplicity of genderless sterile connectors is easy to grasp, but the idea of transitioning to genderless raises questions from systems designers and processors. Here are some frequently asked questions: ◗ What obstacles might I encounter when transitioning to genderless connectors?

One obstacle can be the design of the genderless connector itself. It is critical to select a connector that is truly easy to use, robust and does not require additional hardware to assemble.

Some connectors are not easy to use because they require many assembly steps to make the final connection; the more steps there are for assembly,

the higher the chance an operator will make an error. If the connector requires hardware not integral to the connector to secure the connection (e.g., triclover clamps), operators can misplace or forget to install the added components. A reliable connector should not need additional hardware, and an easyto-use, robust connector has the greatest chance of being used correctly. ◗ What needs to change in my facility to make genderless connectors work? If a processor is already using another connector, the biggest obstacle is the change control process.

Even though something can be significantly better and provide efficiency savings, the process of revalidating a new connector can be cumbersome and slow.

Once validated, however, the change to genderless connectors usually results in process improvements, cost savings, reduced training requirements and fewer quality issues on the manufacturing floor. ◗ Can I mate two genderless halves that have different hose barb sizes? Yes, as long as the connectors are from the same product family. CPC’s genderless design allows this type of connection. For instance, one side with a ¾” hose barb can mate with a ¼” hose barb on the other side. This also includes mating a ¾” sanitary to a ½” with a hose barb.

This capability eliminates the need to install reducer fittings somewhere else in the system, an extra step that increases component and labour costs. ◗ Are genderless connectors a step toward standardisation? It is next to impossible to attend a conference on singleuse without hearing about standardisation. While standardisation can cover several topics, one of the most common discussion topics is connector compatibility (e.g., interchangeability). Research reported in ‘BioPlan Associates, April 2014, Biotechnology Industry Council Analysis of Single Use Connectivity’ showed that 88 per cent of respondents viewed standardising connector compatibility as important. This same study reported a 73 per cent preference for genderless connectors over gendered

connectors. End users are identifying easy-to-use, robust genderless connectors as an answer for both standardising single-use systems and eliminating many of the headaches experienced at facilities using single-use technology.

Applications for genderless connectors Genderless connectors can be utilized in all transfer applications where gendered sterile connectors are found, including suite-to-suite, seed train and formulation/final fill. The difference is that genderless connections significantly reduce system complexity in all of these processing applications.

Because component configurations within transfer lines vary as much as the options for tubing, connectors and filters, viable connection technologies require flexibility. Multiple termination options provide the flexibility needed to meet today’s mounting and flow requirements. For instance, a basic transfer line could be as simple as silicon tubing with two genderless sterile connectors, or it could be more sophisticated, incorporating tubing, SIP connectors, sterile connectors and sterile filters.

When changeovers need to occur, end users can pull stock and connect components and processes with genderless connectors, resulting in increased flexibility. No matter the processing stage, genderless connectors for maximum flexibility.

Just as single-use technology emerged in response to market demands, so too have genderless single-use connectors. Systems designers and processors have maximised the benefits of single-use and hybrid processes — those of increased flexibility, faster changeovers and reduced costs. Now the bioprocessing industry can also benefit from the reduced components complexity afforded by genderless connectors.

References 1. http://www.contractpharma. com/issues/2011-06/view_features/single-use-trends 2. http://www.ibef.org/industry/ pharmaceutical-india.aspx

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July 1-15, 2016

PHARMA INFRASTRUCTURE SPECIAL VENDOR NEWS

Ideal Cures appoints Mike Easterbrook as Chief Technical Officer Easterbrook will provide technical information, training and support IDEAL CURES has appointed Mike Easterbrook as Chief Technical Officer, a stalwart in the film coating technical arena with more than 40 years of experience. His addition strengthens the existing team of professionals at Ideal Cures and its aggressive strategy to support its international cus-

tomer base with best-in-class products, technologies, services and sales.

“Easterbrook with his strong background in film coating and excipient technologies will elevate the technical support experience of our customers globally,” says Suresh Pareek, Managing Di-

rector.

“Ideal Cures is standing up to be counted as an emerging innovative global supplier of services and coatings by bringing Mike on board,” stated Kamlesh Oza, President – Global Business Development. “The strategy to be a global supplier of reckoning is

playing out with our enhanced technical services support for the product portfolio” Easterbrook has held various positions at Colorcon from 1983 to 2006 such as Technical Manager in the UK responsible for Europe, Africa and Asia Pacific; Technical Director in Singapore responsible

for the Asia Pacific region.

Easterbrook in his new role will not only interact with customer’s senior management but also achieve business success by providing technical information, training and support.

EP News Bureau-Mumbai

PRODUCT

Fire rated rolling shutters by Gandhi Automations FIRE SHUTTERS play a vital role in fire safety of buildings and industrial premises.

Correct specifications, installation and use is of paramount importance for those who use the facility.

When a fire breaks out, the fire shutter must fulfill its role as an engineered safety device, in order to hold back the spread of fire and smoke and to save lives and property.

Fire rated doors / shutters are set up in various places such as industrial, commercial, institutional, and retail projects where fire protection is required. All parts need to be regularly checked without compromise.

A jobbing builder or small contractor should be able to install a complex engineered fire safety device. All the components need to work together to ensure that the shutter assembly will work effectively in the event of a fire. Certified fire shutters with proper fitting is necessary to avoid any damage to

38 EXPRESS PHARMA July 1-15, 2016

tem thus eliminating lateral movement of the profiles. Fire shutters / doors designed by Gandhi Automations can resist fire up-to four hours.

Gandhi and Warringtonfire (AUSTRALIA) comply with BS 476: Part 22: 1987 standards for stability and integrity for up to four hours.

Maintenance Frequent inspection / maintenance of the components are of utmost importance. At Gandhi Automations, the maintenance team checks that all parts continue to function correctly without compromise.

property and lives.

Fire shutters / doors by Gandhi automation are engineered carefully with feature below:-

Auto-closing mechanism Fire doors / shutters designed

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mechanism. Upon sensing a temperature of 74°C, the fusible link mechanism releases the brake of the motor and allows it to descend by gravity.

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Sturdy construction Fire doors / shutters are constructed from cold rolled galvalume / galvanised steel / stainless steel laths with a minimum thickness of 0.9 mm.

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

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PHARMA LIFE I N T E R V I E W

‘We hope to start similar skilling activity in Gujarat and Maharashtra as well’ Life Sciences Sector Skill Development Council (LSSSDC) recently introduced the Skilladder programme for medical sales representatives to enhance their skills. Ranjit Madan, Chief Executive Officer, LSSSDC discusses more about the programme with Usha Sharma Tell us more about LSSSDC’s recently launched initiative called Skilladder?

Apart from skilling youth for specific jobs, the government rightly desires that skills acquired by those through onthe-job training (OJT), instead of formal skilling, should also be assessed and recognised. This is under the Recognition of Prior Learning (RPL) initiative.

Under this initiative, LSSSDC has recently launched ‘Skilladder’, aimed at already employed ‘medical sales representatives’ or MSRs, which at approximately 200,000 represent over a quarter of the life sciences sector workforce. The product has e-content required for skilling a MSR, being made available on a mobile app— recognising that MSRs are on the field, and unlikely to be available for any classroom based up-skilling, should that be required. The initiative is in three stages. The first is an assessment to ascertain skill gaps, if any. Those clearing the assessment are certified formally as MSRs. Those falling short in any area, have the option to upskill themselves, using ‘Skilladder’. The final stage is re-assessment to certify that the MSR is now fully skilled.

Why do working MSR of the pharma companies need such programmes?

It is highly desirable that skills, acquired on the job, of all those who are currently employed, are recognised and certified. In the process, those who have any skill shortfalls should be able to

56 EXPRESS PHARMA July 1-15, 2016

up-skill themselves, This includes MSRs. This, whilst increasing the self-worth of such workers and aiding them in their career progression, will serve to raise productivity of the workforce, and significantly benefit the employers.

Why aren’t many opting for MSR as a career opportunity and how will the Skilladder programme enhance it further?

As a minimum education qualification, MSR requires minimum graduate degree/diploma, preferably in Science. Students with such qualifications prefer other career options- such as IT. A major part of the challenge lies in creating awareness regarding the career opportunities including salaries and commissions that this job entails; where industry must play the leading role. Skilladder, by providing an avenue to enhance skills of those currently employed as MSRs, can only catalyse the process.

Till now, how many MSRs have enrolled for this programme?

This is a recently launched initiative. So far 11 major Indian and MNC organisations have participated in the RPL initiative, involving 600 MSRs. We expect many more organisations to participate in this, as the word spreads.

Presently, the Indian pharma industry is facing a lot of, will there be also technical assistance in the Skilladder as well? How much detailed

other associations joining us.

knowledge will be given to MSR in the cGMP area?

MSR is not a QC/Mfg job, and hence GMP does not apply here. However, the qualification pack and national occupations standard relating to MSR, and derived from it the curriculum and content that we have developed—with inputs from Industry—cover the required Uniform Code for Pharmaceutical Manufacturing Practises (UCPMP). Going forward, we are exploring similarly making available econtent for other technical job roles (other than MSR) on the mobile app.

Which associations/pharma companies are acting as the governing bodies? And why is ISCR not a member of the governing body?

We have all the major and actives associations such as IDMA, BDMA, IPA, OPPI, CIPI, Pharmexcil, ABLE, ACRO, Indian Pharmaceutical Association represented on our governing body. We can examine the value addition of

Give us a broad perspective of the global skilling scenario and what is the growth percentage?

Although India has the youngest demographic profile and is therefore well poised to reap significant demographic dividend, it stands at the bottom of the ladder when it comes to workforce formally skilled. Countries like South Korea have 97 per cent, and others such as China, Switzerland, Germany, Australia, Canada, Japan, the UK, the US have between 50-90 per cent of its work force formally skilled. India is under five per cent. Hence, the dire need to skill its workforce. With this backdrop, the government has taken upon itself the challenge of rapidly skilling youth in various job roles, across various sectors.

Tell us more about the industry cluster-based game plan and how are you going to execute it?

Life Sciences (pharma, bio tech and clinical research) activity is highly clustered. Approx 65 per cent is in five clusters i.e. Baddi in Himachal Pradesh; Hyderabad, Telangana and Vishakhapatnam in Andhra Pradesh; Bengaluru, Karnataka; Mumbai, Pune and Aurangabad in Maharashtra and Ahmedabad, Vadodra, Ankleshwar in Gujarat.

Accordingly, for all technical job roles (and most others except MSR fall under this), we are focusing on these major clusters. Skilling in such job

roles e.g. production chemist, QC Chemist, QA Chemist, requires practical training on shop floor and lab equipment— which is very expensive. Also, it requires experts to demonstrate the use of such equipment. We are therefore proceeding cluster by cluster, locating suitable training partners and involving industry—who will support practical training, and subsequently hire those certified. In Baddi, we have Abbott, Cipla, Fresnius and Sentis participating; in Hyderabad it is DRL, Granules, Aurobindo and Biologicals E; in Bengaluru, Biocon, Merck and Shasun have come forward for this. The first batches of production chemists and QC chemists (being the major job roles) have begun to be skilled.

Importantly, most of the students have already received placement, subject to being certified by LSSSDC upon completion of their skilling module.

What are the new programmes you plan to commence at LSSSDC? Major organisations who can afford it, and in the face of an inadequate supply of skilled workforce, have been doing ‘inhouse’ skilling. For convergence and synergy, we are encouraging such organisations to join hands with us. Cadila is the first major company to have done so, and its skilling centre in Ahmedabad is now accredited to us. Wockhardt will be the second organisation. u.sharma@expressindia.com

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