Express Pharma (Vol.11, No.5) January 1-15, 2016

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CONTENTS Vol.11 No.5 JANUARY 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

An analysis on the level of awareness about ageism, a form of discrimination against seniors, among Indian pharma firms and the measures taken to eliminate it | P36

DESIGN National Art Director Bivash Barua Asst. Art Director Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma, Vivek Chitrakar

P26: INTERVIEW ‘The engineering sector is the mother of the Indian pharma industry’

PHARMA ALLY

MARKET

Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Harit Mohanty - West & East Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Arun J Ajanta Sengupta Nirav Mistry PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

P27: INSIGHT Biosimilar trends in 2016

73

‘WE ARE LOOKING AT INDIA AS OUR BUSINESS HUB’

P30: RESEARCH UPDATES

12

Heartburn drugs affect gut bacteria

P39: NEWS KTR inaugurates Novartis Knowledge City

74

‘LABGUARD PRODUCTS ARE BACKED UP WITH EXPERTISE OF DESIGNERS’

P41: AWARD

75

LIGHTHOUSE USA LAUNCHES 1 CFM PORTABLE PARTICLE COUNTER

Bombay College of Pharmacy receives IndPact ‘MENTOR’ award

‘IT IS OUR JOB TO ENSURE THAT THE DRUGS MANUFACTURED IN TELANGANA MAINTAINS HIGH QUALITY’

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

WL dims Sun’s shine ... a bit

A

new year brings with it new hope but all indications are that 2016 is going to be a mixed bag for the pharmaceutical industry. As a new year gift, the Ministry of Health & Family Welfare accepted, with immediate effect, the new National List of Essential Medicines (NLEM 2015) on December 23. As recommended by the Core Committee headed by Dr VM Katoch, the NLEM 2015 brings 28 more medicines under price control, while deleting some others. An analysis of the NLEM 2015 by TwoFour Insight Group, shows that in line with past comments from the Modi government on making cancer care more affordable, anti-cancer medicines make up the bulk of the additions, followed by anti-retrovirals (ARVs) to treat HIV/AIDS and medicines for hepatitis B and C. In the area of chronic diseases, few new medicines were added.

But, despite the growth of diabetes in India, the anti-diabetes segment had only one new addition (glimepiride). Likewise, telmisartan was the sole addition to the cardiovascular area.

Though an initial analysis by AIOCD Pharmasofttech AWACS seems to suggest that there has been no major increase in the span of coverage on the overall Indian pharma market (IPM), individual companies might be affected.

With the strong possibility that the additions to NLEM 2015 could also be added to the DPCO 2013, the new year could see a few fiery debates.

This is sure to dampen the festive spirits of the pharma sector, which hoped to close the year on a rare high: crossing the `1,00,000 crore mark in the November IMS Health Market report, on the basis of Moving Annual Total (MAT).

But a deeper worry is warning letters (WL) and import alerts from the US FDA. Sun Pharma, on top of IMS Health’s November charts with a market share of a little over eight per cent, received a WL dated December 17 for its Halol, Gujarat facility. More than a year after the US FDA inspected the facility in September 2014, and after four communications from the company of remedial actions taken (October 10 followed by December 12, 2014 and February 10 and May 5, 2015), the US FDA remains sceptical. The December 17 letter refers to observations of water stains and buckets to collect water from leaks during the inspection conducted from September 8-19, 2014 in the parenteral manufacturing area personnel corridor. In addition, there were 483s related to sterility issues and computer system

The bad news is,it seems to be taking longer to close out WLs.Sun Pharma’s struggles are more visible as it is the market leader,even though the immediate impact on its bottom line is projected to be ‘limited if the situation does not worsen’

validation methods.

Sun Pharma’s Managing Director Dilip Shanghvi vowed to “continue to cooperate with the US FDA and undertake any additional steps necessary to ensure that the US Agency is completely satisfied with our remediation of the Halol facility.” A company release spoke of ‘significant investments in automation and training to enhance its Quality Systems’ as well as ‘working with external consultants to ensure its remediation activities have been completed in an appropriate manner.’

On a conference call, the company said it would respond to the US FDA warning letter within next 15 days and also pointed out that most of its other US approved facilities inspected

by US FDA over the last 15 months have not received any major observations, hinting that the company had the internal tech ops resources to sort out the issues at the Halol facility. A Motilal Oswal research reports points out that it is critical for the company to get the Halol facility back in the good books of the US FDA as it contributed seven to nine per cent of overall sales in FY15/16.

Besides Sun Pharma, other Indian pharma companies under the US FDA scanner include Dr Reddy’s, Ipca Labs, Wockhardt, and of course, Ranbaxy, which is now part of Sun Pharma. The good news is that December 24 brought the welcome breather that API manufacturer SMS Pharmaceuticals’ Andhra Pradesh unit had reportedly cleared a US FDA inspection without adverse comments. Sun Pharma too was proactive about sharing news of the WL. The bad news is, it seems to be taking longer to close out WLs. Sun Pharma’s struggles are more visible as it is the market leader, even though the immediate impact on its bottom line is projected to be ‘limited if the situation does not worsen’, according to the Motilal Oswal report. Could it be a case of miscommunication about the extent of remedial actions already taken, as hinted by senior Sun Pharma officials? Seems a bit of a stretch, considering that there were three follow up communications over 2015.

WLs and import alerts contrast sharply with PM Modi’s Make in India campaign. Our first cover story in 2016 is a reality check on the pieces that still need to fall into place. (‘Make in India: On the right track?’ pages 20-25, Jan 1-15, 2016). Let’s hope 2016 sees a pick up in momentum.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

10 EXPRESS PHARMA January 1-15, 2016

MARKET I N T E R V I E W

‘ITIS OUR JOB TO ENSURE THAT THE DRUGS MANUFACTURED IN TELANGANA MAINTAINS HIGH QUALITY’ Dr Akun Sabharwal, IPS, Director, Drug Control Administration, Telangana, Hyderabad has been working aggressively in streamlining the regulatory mechanism and maintaining transparency in the system, since he took charge of the Drug Control Administration, Telangana.In an interview with Usha Sharma, he unfolds his plans for the state DCA

You passed out as an IPS officer and now has been deputed as a director of the Drugs Control Administration of Telangana. Tell us about your experience so far. How demanding is your current

12

EXPRESS PHARMA

January 1-15, 2016

profile than previous one?

I took charge as the Controller of Drugs for Telangana State in March 2015. Although a regulatory job, this has been different than my previous assignments which revolved

MARKET

around policing. The last nine months have been a great learning and working experience. I lead a team of highly qualified people who are specialists in their chosen field. Within a short period, we have made efforts to improve the regulatory mechanism in pharmaceutical manufacturing and sales.

The Drug Control Administration (DCA) has conducted a series of raids in manufacturing facilities; corporate hospitals, online pharmacies, blood banks and pharmacies/drug stores across the state in which several violators have been booked. We have started an awareness campaign 'No Bill, No Pill' to curb issuing of medicines without prescription. This is to check development of antibiotic resistance due to indiscriminate use of medication.

It has been almost one and half years, since the new state of Telangana came into existence and hence the DCA of the state happens to be the youngest in the country. What challenges did you face?

Telangana is the hub of API (Active Pharmaceutical Ingredient) and vaccine manufacturing in India. The DCA has made efforts to ensure that the highest standards of quality manufacture, distribution and lab practices are followed in the state. In the last one and half years, Telangana has made major strides to emerge as one of the best regulators in the country.

Use of technology ❍ State-of-the-art hardware and a Wi-Fi campus. ❍ Computerised licensing

14

EXPRESS PHARMA

January 1-15, 2016

process ❍ Digitisation of our

laboratory using the eLabs software which ensures transparency and reduces human error ❍ Mobile App ‘DCA Inspection’ has been developed and our sales inspection is paperless ❍ Use of bulk SMS to inform changes Training of manpower ❍ In-house training from university and industry leaders ❍ By US FDA and CIPS ❍ CDSCO sponsored Reducing red-tape ❍ Introduced the concept of timelines. Thus, the licensing process is completed within the time limits mentioned on our website ❍ Self certification procedures Challenges we face ❍ Expansion to be able to take care of the needs of the growing industry especially the Pharma City. ❍ Manpower: Due to state bifurcation, 58 per cent of the manpower has gone to AP whereas the large part of the industry is in Telangana ❍ Training: The inspectorate staff needs to be trained with the best in the world The state has a total number of 468 manufacturing units which includes SMEs and MSEs units as well. What assurance would you like to give to ensure that the drugs manufactured from these facilities have maintained the quality requirements of the Indian as well as developed countries?

It is our job to ensure that the drugs manufactured in Telangana maintains high quality. We are the first regulatory set-up in India to

Within a short period, we have made efforts to improve the regulatory mechanism in pharma manufacturing and sales. The DCA has conducted a series of raids in facilities; corporate hospitals etc in which several violators have been booked

shift from an area approach to verticals as followed in the US. Thus, our drug inspectors are organised into six specialities viz 1.Drugs and APIs 2.Cosmetics 3.Veterinary and animal products 4.Blood and biologics 5.Vaccines 6.Medical devices This ensures better supervision and quality regulation.

The Centre has made a provision of ` 1750 crores to improve the drug regulatory mechanism, out of which ` 850 crore have been sanctioned for all the states. How much has the Drugs Control Administration of

Telangana demanded from the Centre and where are you going to invest it?

We have signed an MoU with the Union Health Ministry for ` 28 crores for upgradation and strengthening of the DCA in Telangana. Of this, 75 per cent i.e. ` 21 crores will be borne by the Government of India (GoI) and the rest by the state government.

This amount, to be used over a period of three years, will be used to equip the DCA team with better regulatory abilities and improve our laboratory.

You have proposed for the fresh appointment of joint director, assistance director vigilance and deputy director NT (Admin). How will these posts add value to the structure?

A post of joint director exists in Telangana. We have proposed another so that the work load is effectively divided between the two. An assistant director (Vigilance) is important to ensure that the corrupt and unethical practices do not take a ground in this department.

The administrative work of the department is increasing. Once the 'Pharma City' is set up, this will rise further. Thus, a deputy director (Administration) will be needed so that the other officers can devote their time to professional work rather than these matters.

Earlier this year, the Department of Health, Ministry of Health and Family Welfare have decided to redefine ‘Not of Standard Quality’ drugs and proposed certain changes in Section 36AC.

How many samples have your department received and out of the total, how many samples have been tested so far?

The officers of DCA, Telangana regularly pick up drugs for testing the quality.

On an average, an inspector has to collect five samples per month. These are then sent to Drug Control Laboratory, Hyderabad for analysis. From January 1, 2015 till date, around 5200 different samples of drugs/medicines have been analysed in Telangana. Out of these, 46 were found to be of 'Not of Standard Quality.’

The CDSCO has recently launched SUGAM website for online licensing system for upcoming pharma units, Your say on this This is a welcome move. The DCA, Telangana has already computerised most of its licensing work. Once the CDSCO also takes to this, the quality and time parameters will improve.

The CDSCO has allowed state authorities to issue the grant of no objection certificate (NOC) for conducting BA-BE studies in India. How positive and industry-friendly move is this?

This is a positive and industry-friendly move for a state like ours which has the human and material ability to regulate properly.

What are your expectations from the central government or the CDSCO? ❍ Better co-ordination. ❍ Training opportunities to state regulators. ❍ Support for NABL accreditation of DCLs. u.sharma@expressindia.com

MARKET GROWTH TRACKER

IPM registers ` 7954 crores in November 2015 10 therapies have outgrown the IPM growth THE INDIAN pharmaceutical market (IPM) clocked ` 7954 crores in November 2015 and has grown at 8.6 per cent.

Amongst the top 10, Cipla grew by 15.8 per cent, Alkem by 9.2 per cent and Macleods by 8.5 per cent. 23 corporates have crossed the growth of IPM amongst the top 50.

Amongst the top 50 corporate, Bharat Serums had the highest growth of 59.3 per cent followed by Wockhardt at 38.3 per cent and Hetero at 23.1 per cent. 20 corporates have shown growths of more than 10 per cent amongst the top 50.

Amongst the 11-20 ranked corporates, Alembic has the highest growth of 18.8 per cent followed by Intas at 16.3 per cent and DRL at 12.6 per cent.

Amongst the 21-30 ranked corporates, Wockhardt had the highest growth at 38.3 per cent followed by MSD 18.3 per cent and Cadila 17.6 per cent.

Amongst the 31-40 ranked corporates, Bharat Serums was at 59.3 per cent, Blue Cross and JBCPL at 15.7 per cent.

Amongst the 41-50 ranked corporates, Hetero had the highest growth at 23.1 per cent followed by Troikaa at 17.8 per cent and Janssen at 11.2 per cent. Amongst the 51-60 ranked corporates, Boehringer grew at 51.3 per cent followed

by Eli Lilly at 34.9 per cent and Centaur at 28.8 per cent.

Amongst the 61-70 ranked corporates, Fresenius Kabi grew at 69.5 per cent followed

by RPG at 13.7 per cent.

Amongst the top 10, Cipla grew by 15.8 per cent, Zuventus grew by 10.2 per cent, Micro Labs by 10.4 per cent, Indoco grew by 10.1 per cent amongst others.

Indian companies have grown at 9.1 per cent versus seven per cent for MNCs in November 2015. Amongst the

16

EXPRESS PHARMA

January 1-15, 2016

WITH BONUS UNITS AT FULL VALUE Val in Crs CORPORATE

Rank

MAT Nov-15

MAT

MTH

1

1

IPM Sun + Ranbaxy

Val (Cr)

MS%

95121 8406

Nov-15 GR%

Val (Cr)

MS%

100.00

14.4

7954

8.84

14.6

702

Oct-Nov - 15 GR%

Val (Cr)

MS%

GR%

100.00

8.6

16551

100.00

15.1

8.82

3.9

1431

8.64

10.5

Abbott + Abbott HC + Novo

2

2

5950

6.26

15.4

482

6.06

6.0

1004

6.07

14.5

Cipla

3

3

4741

4.98

16.1

411

5.17

15.8

837

5.06

18.4

Zydus + Biochem

4

4

3986

4.19

12.0

333

4.18

5.1

690

4.17

13.3

Mankind

5

6

3328

3.50

13.2

279

3.50

7.2

587

3.54

14.4

Lupin

6

8

3291

3.46

18.3

269

3.38

7.5

558

3.37

14.6

Alkem + Cachet + Indchemie

7

5

3290

3.46

10.9

285

3.59

9.2

601

3.63

14.7

Glaxo

8

7

3153

3.31

5.5

270

3.39

7.2

570

3.44

15.4 13.9

Pfizer

9

9

2866

3.01

16.2

233

2.93

3.5

489

2.95

Macleods

10

10

2754

2.89

16.9

226

2.85

8.5

476

2.88

15.7

Intas

11

11

2659

2.80

23.9

224

2.81

16.3

466

2.82

22.0

Emcure + Zuventus

12

12

2523

2.65

10.4

207

2.61

6.6

430

2.60

12.1

Sanofi India

13

15

2369

2.49

16.7

190

2.39

1.0

392

2.37

8.4

Aristo

14

14

2364

2.49

17.0

196

2.46

10.8

427

2.58

19.2

Glenmark

15

13

2252

2.37

25.8

198

2.49

11.5

415

2.50

26.2

Torrent

16

17

2234

2.35

22.8

177

2.23

5.3

365

2.21

12.3

Dr. Reddys

17

16

2187

2.30

16.8

186

2.34

12.6

372

2.25

16.7

USV

18

19

1878

1.97

18.8

153

1.93

8.2

314

1.89

11.6

Micro + Bal

19

18

1804

1.90

11.0

155

1.95

10.3

325

1.97

21.4

top 50 in MNCs, MSD grew by 18.3 per cent followed by AstraZeneca by 13.1 per cent and Janssen at 11.2 per cent. Under the non-NLEM category, Indian companies grew at 9.9 per cent whereas MNCs grew at 7.2 per cent. The DPCO containing molecules market grew at 4.8 per cent whereas the non-DPCO market grew by 9.3 per cent and Non-Sch Para 19 Market at 6.8 per cent resulting in an overall growth of 8.6 per cent for November 2015.

The NLEM and non-NLEM category showed unit growth at 0.3 per cent and 1.1 per cent respectively. The non-Sch Para 19 Market grew at 2.2 per cent from units perspective.

From therapy perspective, 10 therapies have outgrown the IPM growth. The respiratory market grew at 12.9 per cent, gastrointestinal market grew at 9.8 per cent, pain and analgesics market grew at 8.9 per cent whereas anti-infectives grew at 7.2 per cent. The anti-diabetic market grows at 16.1 per cent and cardiac at 8.2 per cent in chronic business.

Val in Crs

MAT Nov 15

Month Nov-15

Super Group

VAL IN CRS

GR%

VAL IN CRS

GR%

IPM

95121

14.4

7954

8.6

ANTI-INFECTIVES

14533

8.9

1247

7.2

CARDIAC

11910

15.6

980

8.2

GASTRO INTESTINAL

11077

16.4

881

9.8

VITAMINS / MINERALS / NUTRIENTS

8499

11.6

669

1.2

ANTI DIABETIC

7729

26.4

650

16.1

RESPIRATORY

7430

13.6

716

12.9

PAIN / ANALGESICS

6577

12.6

550

8.9

NEURO / CNS

5838

15.1

490

10.0

DERMA

5695

18.4

488

7.9

GYNAECOLOGICAL

4682

11.4

366

4.0

VACCINES

1662

15.5

134

19.4

HORMONES

1614

11.9

140

9.4

ANTI-NEOPLASTICS

1565

13.3

122

7.5

OPHTHAL

1386

14.5

110

0.5

BLOOD RELATED

1112

14.7

88

11.2

UROLOGY

1028

21.1

83

8.3

OTHERS

993

23.2

89

25.0

ANTI MALARIALS

554

3.0

47

-8.4

SEX STIMULANTS / REJUVENATORS

517

14.4

48

15.3

STOMATOLOGICALS

389

8.3

31

-1.4

OPHTHAL / OTOLOGICALS

220

-2.0

17

-11.9

OTOLOGICALS

109

6.9

10

4.1

MARKET The derma market grew by 7.9 per cent and urology market at 8.3 per cent. The gastrointestinal market crossed the ` 11,000 crore and moves fast to get close to the cardiac market value.

From regional perspective, 13 regions have outgrown the IPM growth. The south Andhra Pradesh market grew the highest at 22.6 per cent followed by Odisha market at 21.4 per cent and Jharkhand market at 19.8 per cent. Six regions had a negative growth in November 2015. Amoxycillin + clavulanic acid and glimepiride + metformin market grew at 9.7 per cent.

The paracetamol market grew at 27.2 per cent, atorvastatin 1.9 per cent, probiotic microbes at 22.7 per cent, cefixime 3.5 per cent, pantoprazole 5.1 per cent, montelukast + levocetrizine at 11.4 per cent, glimepiride + metformin + pioglitazone at 12.6 per cent, Vitamin-D at 13.6 per cent, hydroquinone + mometasone + tretinoin at -21.6 per cent, voglibose + metformin + glimepiride at 29.9 per cent, rosuvastatin at 13.4 per cent, protein supplements at 2.8 per cent, azithromycin at 13.1 per cent, calcium carbonate + Vit D3 market at -2.5 per cent.

Mixtard lead the pack with ` 31 crore followed by Corex at ` 30 crore, Spasmoproxyvon Plus at ` 28 crores, Glycomet GP at ` 26 crores.

Few brands who have gained ranks include Rotarix (+65), Zienam (+60), Meronem (+58), Betnesol (+49), Betnovate C (+40), Ultracet, Betnovate N (+25), Jalra M (+21), Spasmoproxyvon Plus, Calpol, Vertin (+20), Deriphyllin (+19), Budecort, Huminsulin, Galvus (+18), Rhoclone (+17), Panderm Plus, Istamet, Omez, Mucaine (+16), Monocef-O, Trajent (+15), Rantac (+14), Sinarest, Foracort, Aciloc, Januvia, Dolo (+12), amongst top 100 brands over November 2014. Caripill becomes a ` 12 crore brand in a period of five months.

Few brands that have moved up ranks fastest into Top 300 Brands for the month of November 2015 were Revital H, Havrix, Hucog HP, Imicrit, Plavix, Grafeel, Ocid,

EXPRESS PHARMA

17

January 1-15, 2016

Pradaxa amongst others. The 300th biggest brand is Quadriderm RF from MSD. Revital H is the 200th biggest brand in IPM. A total of 303 brands and 572 SKUs were launched. The top new brands were Tenepride, Accura, Hertraz.

Four Teneligliptin brands were launched in the same month. They were Tenepride,

Tenglyn, Dynaglipt and Tenuvia. Lupin had entered the Linagliptin market with Ondero. The biggest new launch by an MNC was Hertraz in November 2015.

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted

by AIOCD Pharmasofttech AWACS, a pharmaceutical mar-

ket 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/

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MARKET PRE EVENTS

International pharma exhibition PPPE 2016 to focus on technologies and trade Event to be held in Mumbai from April 27-29, 2016 PHARMA PRO & Pack Expo (PPPE) 2016 will be held at Mumbai Exhibition Centre, from April 27-29, 2016.

PHARMA LAB EXPO 2016 will also be held along with PPPE 2016. Organised by IPMMA, PPPE 2016 will be an international pharma exhibition on technologies and trade. 20,000 pharma

trade professional/decision makers are likely to take part in the event. It will see more than 250 industry majors who will exhibit their technologies/services.

Exhibitor’s profile includes pharma processing machineries (tablet / capsule / liquid / injectables / ointment / dry syrup), packaging machineries,

The event will see more than 250 industry majors participating

A P P O I N T M E N T

SIDVIM LIFESCIENCES PRIVATE LIMITED Sidvim a rapidly growing Healthcare and Pharma focused consulting company with operations in Mumbai is looking for experienced professionals in following disciplines: ● Formulation Development and Manufacturing ● API Development and Manufacturing ● Quality Assurance We are interested in two levels of specialists: ● Mid-career specialists: who must have minimum 10 years’ experience in the respective discipline with good domain knowledge primarily for high regulated markets, excellent analytical and communication/ presentation skills and overall understanding of Pharma business. This gives unique opportunity to the incumbents for enhancement of skills with an all-around exposure ● Young Veterans for empanelment as Advisors: this category would include recent retirees who still have the drive and interest to work in on a part time or fulltime basis on specific consulting projects. In this category we seek experienced professionals in each of the disciplines mentioned above with domain knowledge in high regulated markets.

The company provides challenging and differentiated opportunity in a rapidly developing field.

Interested candidates may contact Ashok Agarwal E- mail: ashok.agarwal@sidvim.com Mob. 9820091397

18

EXPRESS PHARMA

January 1-15, 2016

packaging materials and consumables, API, bulk drugs, additives, excipients, pharma finished products, formulations, lab reagents, glassware and equipment, analytical, R&D equipment and biotech instruments, environment control equipment and services, utilities products and services, turn-key contractors and project consultants.

Visitor's profile includes CEO and top management, corporate management, plant management, plant engineering, manufacturing/production officers, maintenance engineering, vendor development and purchase, QA, QC and R&D officers, pharmacists, contract manufacturer's, compliance and regulatory officers, equipment, machinery manufacture, sup-

pliers and distributors.

PHARMA LAB EXPO 2016 will be an international exhibition, which will focus on the world's fastest and strongest pharma economy. Exhibitor's profile includes analytical instrumentation and systems, instruments for physical and chemical analysis, chromatography, spectroscopy, microscopy and optical imaging, biotechnology, lab instruments and apparatus, lab planning and furniture, lab automation, lab glassware and balances, testing and measuring instruments, material and water testing, quality control in industries and research labs and educational lab products for all levels.

EP News Bureau-Mumbai

iPHEX 2016 to be held in Mumbai from April 27-29, 2016 400 overseas buyers from focus areas are likely to participate in the exhibition iPHEX 2016, an exhibition that brings together the drugs, pharmaceutical and healthcare industry, all under one roof, will be held at Bombay Exhibition Centre, Mumbai, from April 27-29, 2016. 400 overseas buyers are likely to participate in the exhibition.

Co-located with PHARMA Pro&Pack Expo 2016, a show for pharma machinery manufacturers, iPHEX 2016 will

offer the industry majors from India and all across the world a great platform to connect and do business.

The organisers for iPHEX 2016 are the Ministry of Commerce and Industry, Department of Commerce, Government of India and Pharmaceuticals Export Promotion Council of India.

EP News Bureau-Mumbai

EVENT BRIEF JANUARY 2016 - APRIL 2016 7

National Conference on Drug Discovery & Therapy

NATIONAL CONFERENCE ON DRUG DISCOVERY & THERAPY Date: January 7-8, 2016 Venue: Department of Biochemistry and Biotechnology, Annamalai University Summary: Department of Biochemistry and Biotechnology, Annamalai University will organise National Conference on Drug Discovery & Therapy (DDT-2016).

Contact details Dr N Rajendra Prasad, Assistant Professor, Dept of Biochemistry & Biotechnology,Annamalai University, Annamalainagar 608 002 Tamil Nadu Tel: + 91 4144 – 238343 Fax: +91 4144 – 239141

7

India Pharma 2016

Mob: + 91 9842305384 Email: drprasadnr@ gmail.com

INDIA PHARMA 2016 Date: January 7-9, 2016 Venue: Bangalore International Exhibition Centre, Bengaluru Summary: Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers, Government of India with FICCI will provide a platform to global investment community to connect with stakeholders in the pharmaceutical sector in India, central and state governments, leading business leaders and top executives from the industry, academics and experts from

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Asia Pharma Expo 2016

the world.

Contact details BK Nayak, Senior Assistant Director, FICCIT/ F: 080 22861949 Mob: 91 9945790735 email:nayak.bk@ficci.com

manufacturers. through participation at the exhibition.

Contact details Email: mail@AsiaPharma.org Website: www.AsiaPharma.org

ASIA PHARMA EXPO 2016

PHARMA PRO&PACK EXPO 2016

Date: January 28 to 30, 2016 Venue: Dhaka, Bangladesh Summary: Asia Pharma Expo 2016 (APE 2016), the 8th international exhibition on complete pharma manufacturing technologies, will be beneficial to all participants from local business associates to international machinery manufacturers and API / bulk active

Date: April 27-29, 2016 Venue: Mumbai Exhibition Centre, Mumbai Summary: IPMMA and GPE Expo will organise PHARMA Pro&Pack Expo 2016. The exhibitors profile include: machineries and equipment: Pharma processing M/c (tablet, capsule, injectable, ointment, dry syrup powder) packaging machineries lab

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PHARMA Pro&Pack Expo 2016

and biotech instruments, glassware, packaging materials, lab-wares and consumable, clean room and environment control products and services, utilities equipment and services, project consultants and turn key contractors.

Contact details PHARMA Pro&Pack Expo 2016 / Mumbai GPE Expo Global, 402-403, Abhijyot Square B/h Divya Bhaskar, SG Highway Ahmedabad 380 051 T: +91-79-40008233 / 40008253 E:mail@PharmaProPack.com W: www.PharmaProPack.com

The Standard of Comparison

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

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

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cover )

20 EXPRESS PHARMA January 1-15, 2016

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THE MAIN FOCUS

NIPUN JAIN Chief Executive Officer, Pharmchem

More than a year after the ‘Make in India campaign’ was launched, pharma manufacturers are divided on its impact. Will the enthusiasm fizzle out or will the sector build up momentum in 2016? A roundup of industry perspectives

BY USHA SHARMA

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‘Make in India’ is gaining momentum but a lot needs to be done T hough the 'Make in India' initiative is gaining momentum, the pharma sector is yet to see which new policies will be beneficial for it. However, the Department of Pharmaceuticals (DoP) has outlined some ambitious plans under the 'Make in India' initiative. The Ministry of Commerce has also introduced the Merchandise Exports from India Scheme (MEIS) since April 2015 and the subvention of interest for export will help pharma exporters.

Yet, a lot needs to be done to

help micro small and medium enterprises (MSME) pharma companies. Firstly, the introduction of bar coding by the Ministry of Commerce and Industry has put a great financial burden on MSME pharma exporters.

Secondly, lack of support from the government to improve infrastructure and technical skills of MSME pharma companies has left a big vacuum to match the continuously regulatory requirements of international guidelines.

Thirdly, majority of Indian companies, especially the MSMEs,

are supplying to public sector undertakings for the domestic market, but their payments get delayed leaving the MSMEs with a financial crunch in their cash flows, ultimately affecting their competitiveness. Fourthly, the Directorate General of Foreign Trade (DGFT) and the Central Board of Excise and Customs are not in sync with each other and a lot of harassment is faced by MSME companies due to this.

I understand ‘Make in India’ is gaining momentum, but a lot needs to be done.

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cover ) 'Govt should be more specific in the concessions being provided for attracting investment' T here is a tremendous opportunity for setting up dedicated pharma plants of global capacity and standards.

However, the large multinational companies have grown out of manufacturing and have largely been outsourcing manufacturing activities. It is therefore an opportunity for NRIs looking a India. They can help in promoting the 'Make in India' concept of our Prime Minister. With increasing quality standards, not only in the regulated markets but also in semi-regulated countries, the initiative would enable good manufacturing plants in In-

TS JAISHANKAR Managing Director, Quest Life Sciences

dia. It has become the pharma hub of the world with technologically-skilled manpower and the ability to handle regulatory compliance. India therefore will natu-

rally be the right choice for investment in the pharma sector, particularly formulations and R&D. The government has realised

the importance of supporting the API sector but has not announced any specific approach which will enable it to compete with China.

The government should be more specific in their concessions being provided for attracting investment. The substantial tax benefit for greenfield projects particularly in R&D activities would attract multinationals. Currently, the MNCs are not favouring R&D activities in India in view of confidentiality and the poor legal system. Even large companies like AstraZeneca have moved their

‘Make in India' will not be successful without special focus on MSMEs M

SMEs are considered the backbone of any country, it supports the nation in its economic growth. India also has a great pride in its industrial growth, which is aided

by MSMEs. Unfortunately, MSMEs, particularly in the pharma category, has not been treated well. Otherwise this segment has the potential

22 EXPRESS PHARMA January 1-15, 2016

BR SIKRI Co-Chairman – FOPE, Vice chairman – IDMA, Vice-President – IDMA Vice Chairman - CIPI

to do wonders.

I feel that the below mentioned factors obstruct the growth of the industry. If the government was so keen in launching the 'Make in India' campaign then they should have considered the following problems and planned some strategies to overcome them, otherwise it is a futile exercise.

R&D to China from India. The government should take cognizance of the opportunity being lost considering that investments in R&D globally is ever increasing. There are huge opportunities in financing small boutique R&D activities similar to the US module of biotech pharma companies. The Indian market by itself is steadily increasing. The Indian regulatory requirements are also gradually becoming stringent. This will be a good opportunity for sizeable investment into setting up dedicated manufacturing plants of global standards.

A) Earlier licencing was simple and with the introduction of schedule M it became an expensive exercise which forced many units to shut down B) Later Schedule 'L' was introduced which again became a financial burden on small and medium scale units, resulting in inviolability C) Now the government is

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talking of upgradation to WHO compliance, which will practically not be possible to afford without a huge investment E) We are hearing of upgrading units to Pharmaceutical Inspection Cooperation (PICs) compliance and bring them to the international level. In addition to this, the government proposes to introduce Good Distribution Practice, Goods Engineering Practice, Good AHU Practice etc. All these are going to add to the financial burden on the small scale sector F) As a result of compulsory bar coding on pharma packaging, the pharma industry is going to face another financial burden, resulting in non-profit making units. Across the globe, there are very few countries practicing it.

G) Fixed dosage combinations is another area where the industry is seeing a challenge. Various state governments have granted permission to small scale units and those combinations are in the market for more than a decade, without registering any side effects. Such combinations can be regularised and guidelines for future can be given. Such matters are pending in the court, these delays cause wastage of money and time for the industry as well as the government.

Our Prime Minister's vision of 'Sab ka Saath, Sab ka Vikas' will be completed only when the small scale industry is also taken into consideration.

The players in this sector need to be motivated to contribute to this journey.

Let all of us think about the betterment of our nation.

The PM's ‘Make in India’ initiative will not be successful unless special focus is given on the MSME sector.

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cover ) ‘We look forward to partnering with the government to bring about a healthy India and an innovative India’ T

here is indeed a potential for the ‘Make in India’ programme to improve the industrial and economic landscape of India.

During a New Delhi visit in November 2015, Ken Frazier Chairman and Chief Executive Officer, MSD, observed that Prime Minister Modi's 'Make in India' programme would be strengthened by the country’s capacity for healthcare innovation. This is critical to meet patients’ growing health needs and to enhance economic competitiveness. A

RANJANA SMETACEK Director General, OPPI

robust, innovation-friendly eco-system that enables technology transfer, stimulates research, helps create an advanced healthcare system and

provides access to new medicines and innovative therapies will encourage foreign direct investment (FDI).

Rising incomes in India

have led to longer life expectancy, but increased lifestyle related diseases that pose a huge challenge to our healthcare system. Innovation helps cure diseases that were once incurable and OPPI member companies continue to bring the fruits of their research for the benefit of patients in India.

Right now, PricewaterhouseCoopers (PwC) is assessing the innovation landscape in the pharma industry to suggest policy recommendations that will enable Indian

companies to move up the innovation value chain. Their initial findings highlight the need to strengthen four pillars of innovation: health infrastructure; financing; human resources; and legal, IPR and regulatory systems. Strengthening these areas will help create an environment that is conducive to innovation and attract FDI. We look forward to partnering with the government to bring about a healthy India and an innovative India!”

Make in India campaign is certainly a welcome move I

ndian pharma has seen substantial growth in last many years inspite of all odds. The pharma sector has to adhere totough regulatory norms, in the current times, the regulatory norms are getting stringent day- by-day. India has emerged as a strong player with its in-depth knowledge of science and documentation. Outside the US,

24 EXPRESS PHARMA January 1-15, 2016

ARCHANA DUBEY Vice President – Exports, Bal Pharma

India has the maximum number of US FDA approved facilities, along with the largest DMF filing.

The current 'Make in India' campaign is certainly a welcome move to our industry, as it will boost the image of the Indian pharma industry worldwide. Today, apart from quality and GMP, brand image has a huge contribution to-

wards acceptance and growth. 'Make in India' will definitely provide an edge to mid-sized players while small players need hefty investments to leverage the opportunity. Ideally, small companies can become the ancillary units to large players and extend support, This will help to sustain and grow as well. Today, by and large, all mid-sized

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group will have decent infrastructure and manpower to grow to the next level. Companies have updated themselves with respect to all regulatory requirement as per their focused markets. Bal Pharma has been a well recognised player in the Indian/global pharma industry with five strong manufacturing units of FDF and API. While API is already catering to reg-

ulated markets like Europe, Japan, Canada, Australia, Korea; FDF unit is in the pipeline to go through the regulatory audits. The company is regularly investing to upgrade and stay up to date with cGMP requirements. We would like to leverage the opportunities offered by the 'Make in India' campaign as we aspire to grow multifold in the coming years.

‘Make in India’ will gradually prove to be a boon for Indian pharma cos “I n my opinion, the ‘Make in India’ initiative will slowly and gradually prove to be a boon for Indian pharma companies. India is the third largest market for pharma globally and India exports 20 per cent of the global generic pharma products.

In the past years, a couple of reasons have been responsible for the drop in

sector. India imported APIs worth $3.9 billion in 2014-15, of which China accounted for $3.3 billion. To reduce this dependence on China for APIs, the government is planning to provide incentives to both state-run and privatelyowned companies to produce the active ingredients.

As far as MSMEs are concerned,

SURESH PAREEK Managing Director, Ideal Cures

exports. These include delayed regulatory approvals and depreciation in the currencies of the emerging markets.

Indian companies need to give importance and maintain strict GMP standards for manufacturing.

At present, India is totally dependent on China for 12 most important active ingredients used in the pharma

there are very few incentives for manufacturing in the pharma sector. I feel that even when the government is trying to boost the 'Make in India' initiative by introduction of incentives, schemes etc. the whole change will require time and active participation of the manufacturing pharma giants. u.sharma@expressindia.com

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cover ) I N T E R V I E W

‘The engineering sector is the mother of the Indian pharma industry’ Engineering Export Promotion Council (EEPC) India, the premier council of engineering exporters, is going to be the organiser of International RBSM at India Pharma 2016. Tarvinder Singh Bhasin, Chairman, EEPC India, explains how his organisation will benefit the participants of the event. He also talks about the contribution of engineering sector in the growth of the pharmaceutical industry, in discussion with Sachin Jagdale International reverse buyer seller meet (RBSM) at India Pharma 2016 is organised

by EEPC India. What targets did you set for it?

EEPC India is inviting major companies in the medical device and pharma machinery segment as sponsored buyers for the show at International RBSM. The main objective of this unique initiative is to meet the Indian exhibitors with profile at B2B Meetings. We are likely to have around 50 buyers.

How will EEPC India's presence at India Pharma 2016 benefit the participants of the event?

The Indian government has taken many steps to reduce costs and bring down healthcare expenses at affordable cost. Speedy introduction of medical devices and generic drugs into the market has remained in focus and is expected to benefit the Indian medical equipment and pharmaceutical companies.

In addition, the thrust on

26 EXPRESS PHARMA January 1-15, 2016

rural health programmes, lifesaving drugs and preventive vaccines also augurs well for both the segments. EEPC India, the premier council of engineering exporters, wishes to facilitate the growth and involvement of the said segments at India Pharma 2016.

How has the engineering sector transformed Indian pharma industry?

The engineering sector, particularly, the capital goods segment is the mother of the Indian pharma industry. This is more so in the medical devices and the surgical space, where the technological competence and precision engineering has helped out pharma industry compete with the global giants especially with respect to generics. This has been possible in conjuction with our IPR regime that has benefited out its ability to move ahead in the generics space.

Where does Indian pharma

industry stand in comparison with their foreign counterparts as far as engineering advancements are concerned?

So far as engineering advancement is concerned, our strength is in the quality segment rather than the volume segment of precision engineering and technical sophistication. This is largely because of the nature of the engineering industry which is concentrated in the MSME segment. There is also the need to move up the value chain and the need for technology advancement is critical. EEPC India is now concentrating in this aspect so that our industry can move up the value chain and help our pharma industry to carry out R&D to join the global league.

Does EEPC India have any tie-ups with pharma organisations in India?

We work closely with a large number of organisations dealing in the domestic pharma space. This includes,

among others, Association of Indian Medical Devices Industry(AIMED), Indian Pharma Machinery Manufacturers Association(IPMMA), etc.

Do you have any dedicated unit to look into the issues of pharma sector? If yes, mention in details?

As a trade and investment promotional council under the Union Ministry of Commerce and Industry, our role is that of a facilitator. As per our constitution, we have a medical devices and phama machinery panel which is dedicated to look into the issues facing this industry, particularly, from the exports point of view.

What percentage of your members deal with the pharma industry?

Three per cent of our 13000 membership strength deals with the pharma industry.

According to you, what will be the engineering related future challenges for the Indian pharma industry

and what will be the role of EEPC India in that scenario?

India is emerging as a reliable supplier of medical device, equipment and pharma machinery and several international companies are exploring partnership with India. Medical devices is the sunrise industry in India registering a CAGR of 15 per cent. India is now in the limelight in some of the segment of medical device and pharma machinery space.

The industry’s inherent engineering strength are being recognised by global majors who are looking to tap a wide range of products and services which are being offered by India at an affordable price. Medical tourism is another niche segment in the medical device sector which is putting India in front on the global map.

EEPC India with its motto 'Engineering The Future' would create a road map for the related engineering industries. sachin.jagdale@expressindia.com

MANAGEMENT INSIGHT

Biosimilar trends in 2016 Spurring the growth of biosimilars is the need to improve access to biologics and contain treatment costs and healthcare budgets, says Dr Charu Manaktala, Senior Medical Director & Head of Clinical Strategy, Strategic Drug Development, Quintiles Asia in this insightful article BIOLOGICS WITH patents expiring between 2015 and 2020 constitute the second wave of biosimilars. These include biosimilars of top selling products such as Humira, Enbrel, Rituxan/MabThera, Avastin, Herceptin and Remicade. One infliximab biosimilar (Celltrion/Hospira) is already approved and marketed in the European Union, and one etanercept biosimilar (Samsung) has very recently received positive opinion from the EMA’s Committee for medicinal products for human use.

There is a large pipeline of other biosimilars in different stages of development.

This area is already crowded, with more than 160 biosimilars reported in different stages of development for these six top selling biologics.

Till recently, we did not see any significant biosimilars development activity for the third wave of biologics with patent expiries beyond 2020 (e.g., Cimzia - certolizumab pegol, Lucentis - ranibizumab, Simponi - golimumab, Stelara - ustekinumab, Soliris - eculizumab). One important factor for this is the lower market value of these products (relative to the likes of Humira). Now early signs of interest in these biosimilars are beginning to emerge.

The coming years are likely to see biosimilars for these biologics feature in the clinical development pipelines of at least some of the companies.

Pricing of biologics and biosimilars: Price competition to continue Spurring the growth of biosimilars is the need to improve access to biologics and contain treatment costs and healthcare budgets. When the first biosimilars were launched in the European Union, they were

DR CHARU MANAKTALA, Senior Medical Director & Head of Clinical Strategy, Strategic Drug Development, Quintiles Asia

priced at a 20 to 30 per cent discount to the branded product, to start with. As the market has progressed, innovators are dropping their prices in order to retain their market share, and biosimilar manufacturers are dropping their prices even further – with discounts reaching as deep as 70 per cent of the innovator’s price in some cases.

This trend is likely to continue with the launch of more biosimilars.

Experience from Norway* shows that the uptake of biosimilars is strongly linked to the discount offered. As Remsima (Bs infliximab, Orion) discounts increased to 70 per cent from 40 per cent, the market share increased to 55 per cent from less than 10 per cent.

It will be interesting to witness the price competition for insulin, etanercept and other biosimilars in the coming year. Needless to say, the ultimate beneficiaries will be payers and patients.

More regulatory guidelines expected Since the first set of over-arching guidelines for biosimilars were released by the European Medicines Agency in 2005, there has been much development in this space.

The evolution continues, as earlier guidelines have been revised or are

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MANAGEMENT in the process of revision.

The US Food and Drug Administration (US FDA) released its first set of draft guidelines in 2012, which have since been finalised. Additional guidelines were released in 2014-15, and others are in the pipeline. US FDA guidelines in the pipeline are expected to cover interchangeability, statistical approaches to evaluation of analytical similarity, and labelling of biosimilars.

Furthermore, 'real world' post-marketing evidence from the first set of biosimilars approved in the EU has not revealed any unexpected or untoward experiences. Regulators are expected to be more open than ever to accepting leaner clinical development programmes tailored to the product in question, focusing on the totality of evidence for evaluation and approval.

Regulators will continue to focus on the quality comparability data as the cornerstone in the comparability exercise.

Product approvals in the EU and US The European Medicines Agency has approved biosimilars for somatropin, epoetin, filgrastim, follitropin, insulin glargine and infliximab over the last 10 years. A biosimilar for etanercept has recently received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (No-

vember 2015).

The US FDA has already approved biosimilar for filgrastim (March 2015) under the 315(k) pathway.

As of December 2015, enoxaparin, infliximab, etanercept, rituximab and pegfilgrastim biosimilars are under evaluation in the European Union.

Applications under assessment in the US include Sandoz’s etanercept biosimilar (October 2015), Sandoz’s pegfilgrastim biosimilar (November 2015), and Amgen’s adalimumab biosimilar (Nov 2015).

Approvals of more biosimilars for anti-TNF biologics, as well as biosimilars for oncology products, are anticipated for 2016.

Asian manufacturers have been successful in obtaining approvals in the EU [case- Celltrion, Intas, Samsung (positive opinion from CHMP-MA likely to follow soon)]. This trend is likely to continue. We expect more product approvals for Asian players in Western markets in the coming years especially given the rich pipelines for some of them.

Naming conventions/ interchangability: Areas continue to evolve Interchangability/substitution and naming are two important considerations in the uptake of biosimilars once they are launched.

The European Union has ap-

proved 21 biosimilars as of November, 2015. All these have been issued under the same nonproprietary name as for the reference product. Recently, the US FDA has issued draft guidance on the subject of non-proprietary naming of biosimilars. The US FDA guidance recommends that all biologicals and biosimilars have not only non-proprietary names but also a four-letter suffix to distinguish them from each other. The suffix would consist of four lower case letters and not carry any meaning.

While some industry associations have supported this proposal others, including the US pharmacopeia and the Generic Pharmaceutical Association's (GPhA) Biosimilars Council have opposed this approach.

In the US, the FDA, under the Biologics Price Competition and Innovation (BPCI) Act, has the authority to designate a biosimilar as interchangeable. To date, 15 states have passed legislation requiring prescriber communication and record-keeping for biosimilars. Most of the proposed legislation requires the retail pharmacist to communicate to the prescribing physician the identity of the product dispensed if an interchangeable product is available, regardless of which product (brand-name or interchangeable) was dispensed. These two areas are expected to evolve further in the coming years.

Partnerships and licensing routes to development With a few exceptions, most biosimilar manufacturers entered this space through partnerships. This is largely because biosimilar production and commercialisation demand many capabilities – biologic product development, manufacturing, regulatory and clinical development, specialised marketing, etc.

There were a number of high profile acquisitions and mergers in the biopharma space in 2015 Biosimilars portfolios and capabilities were considerations in several of these deals.

This trend will likely continue in coming years as companies use licensing and partnerships to achieve in the biosimilars arena what they could not do alone.

Biosimilars development in Asia Asian manufacturers have been successful in obtaining approvals in the EU [caseCelltrion, Intas, Samsung (positive opinion from CHMP-MA likely to follow soon)]. This trend is likely to continue, we expect more product approvals for Asian players in Western markets in the coming years especially given the rich pipelines for some of them.

We are beginning to see a change in the development strategy for some of the Asian cus-

tomers. Instead of the earlier approach of developing products for local/regional markets followed by the Western markets, some Asian companies are now planning to develop products for global markets right from the outset. This is supported by availability of regulatory framework and guidelines, as well as a better understanding of these requirements.

While Korean and Indian companies remain active in biosimilars development, there is significant surge in the number of Chinese companies that are exploring regional/global development of their biosimilars now as opposed to the earlier focus on domestic/regional markets. Late last year, China FDA released biosimilars guidelines which were finalised in March this year.

The Central Drugs Standard Control Organization (CDSCO) guidelines for biosimilars were released in 2012 and are in the process of revision currently.

These guidelines are expected to be released for stakeholder review shortly.

Reference *http://gabi-journal.net/norwaybiosimilars-in-different-fundingsystems-whatworks.html?utm_source=GONL 2&utm_campaign=017fce7c95GONL+V15K272&utm_medium=email&utm_te rm=0_92e3801e31-017fce7c9523226433

REPORT

Haemophilia Aand B treatment market value will reach $6.3 billion by 2024: GlobalData The increase represents a tepid CAGR of 1.52 per cent across Argentina and the seven major markets of the US, France, Italy, Spain, Germany, the UK, and Japan THE MARKET for haemophilia A and B recombinant therapies is set to experience limited growth, rising from $5.4 billion in 2014 to $6.3 billion by 2024, says research and consulting firm

28 EXPRESS PHARMA January 1-15, 2016

GlobalData.

According to the company’s latest report, this increase represents a tepid Compound Annual Growth Rate (CAGR) of 1.52 per cent across Argentina and the

seven Major Markets (7MM) of the US, France, Italy, Spain, Germany, the UK, and Japan, a product of high treatment rates and market saturation.

Fenix Leung, Analyst, GlobalData, covering oncol-

ogy and haematology, explains, “Despite the availability of new, long-acting products designed to reduce injection frequency, haemophilia patients in the US and five major European

countries are satisfied with established recombinant factor products. Overall, GlobalData expects modest uptake of long-acting Factor VIII products, while uptake of long-acting Factor IX

MANAGEMENT products will be higher owing to the substantial dosing interval increase.”

However, Biogen’s Eloctate and Alprolix are competitively priced, limiting the scope of premium pricing for pipeline long-acting products. Therefore, pricing barriers should render overall market growth slow.

Drivers of haemophilia A and B recombinant therapies include the disease’s growing prevalence and the increasing use of recombinant products and prophylactic regimens.

Leung elaborates, “New patients with severe haemophilia A and B in the 7MM and Argentina, except Germany, receive prophylactic recombinant factors. As these patients are likely to stay on recombinant treatment permanently, recombinant product use should rise,

Biogen’s Eloctate and Alprolix are competitively priced, limiting the scope of premium pricing for pipeline longacting products.

Therefore, pricing barriers should render overall market growth slow driving market growth."

In Argentina, the market is not as well-established as it is among the 7MM, leaving investment prospects more open. As such, Argentina’s haemophilia treatment market is projected to grow from $119 million in 2014 to $193 million by 2024, representing

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a greater CAGR of 4.9 per cent.

Leung explains, “Most haemophilia patients in Argentina have access to factor replacement products through private insurance plans or the national social se-

curity programme. However, the former are costly, and the latter only covers on-demand treatment and plasma-derived concentrates. Therefore, the number of patients receiving recombinant factor is low, as only 25 per cent and

27 per cent of haemophilia A and B patients, respectively, received recombinant replacement products in 2013.”

Despite low uptake, GlobalData expects that the Argentine market will use recombinant products more, offering

opportunities to convert patients currently using plasmaderived products to using recombinant ones. This will make Argentina a lucrative region in the crowded haemophilia treatment space.

EP News Bureau-Mumbai

RESEARCH RESEARCH UPDATES

Heartburn drugs affect gut bacteria The drugs may cause side effects like diarrhoea, nausea and vomiting COMMON DRUGS to reduce stomach acid and treat acid reflux also change the populations of microbes living in the intestines, which may help explain why they increase the risk of certain infections, according to a new study. Socalled proton pump inhibitors (PPI) like omeprazole (Prilosec) and esomeprazole (Nexium) can be available by prescription or over the counter and are among the top 10 most widely used drugs in the world. They may cause side effects like diarrhoea, nausea and vomiting, and some studies have linked them with an increased risk of the Clostridium difficile infection.

Clostridium difficile, or ‘C. diff,’ attacks the intestinal lining and causes severe diarrhoea and pain.

“I think mostly general practitioners and medical doctors should be aware of these side effects,” said lead author Floris Imhann of the

University of Groningen and University Medical Center Groningen in the Netherlands.

“Individual risk (of C. diff) is fairly low,” but PPIs are widely used, and often overused, Imhann told. The researchers analysed the gut bacteria

compositions of 1,815 adults in the Netherlands, some who were healthy and some with gastrointestinal diseases like irritable bowel syndrome.

Participants reported their current medication use and gut complaints in a question-

naire and provided stool samples. The researchers isolated microbial DNA from the stool samples.

Just over 10 per cent of the participants said they were using a proton pump inhibitor, including eight per cent of the healthy general population and 20 per cent of those with inflammatory bowel disease.

PPI users tended to be older and have a higher body mass index than others. Those using PPIs had less diversity of their gut microbes, the researchers reported in the journal Gut. They also had more bacteria usually found in the mouth and bacteria associated with infection in their stool samples.

This may be because PPIs reduce the acidity of the stomach, so more oral bacteria survive the journey from mouth to gut along with food. Using PPIs appeared to have a greater effect on the gut 'microbiome' than using antibiotics, the authors wrote.

“These PPIs, they are very good drugs, they work really well,” said senior author Dr Rinse K Weersma. But many people take them over the counter and about half the time, they’re not being taken appropriately, he said.

According to this study, people who take the drugs have beneficial bacteria in lower numbers and more harmful bacteria in higher numbers, he said. “Once they are started most people do not think about stopping them,” Weersma said.

In the Netherlands, PPIs are very widely used, and antibiotics are not as common as in the US, so PPIs cause a greater disturbance to the microbiome, Imhann said.

PPI use makes some infections 1.5 times as likely, he said. “Knowledge is lacking there, the perception is still that they’re relatively safe,” Weersma said.

Reuters

US FDA approves Eli Lilly’s Basaglar diabetes drug The drug, an injection known also as insulin glargine, is a long-acting, man-made version of human insulin THE US Food and Drug Administration approved Eli Lilly & Co’s diabetes drug Basaglar, a cheaper version of Sanofi’s top-selling drug Lantus. The drug, an injection known also as insulin glargine, is a long-acting, man-made version of human insulin. It is the first insulin product approved through a shortened review process based on its similarity

30 EXPRESS PHARMA January 1-15, 2016

to an existing drug.

The FDA determined that Basaglar was sufficiently similar to Lantus to justify approval based on the safety and effectiveness of Lantus as well as certain Basaglar-specific data.

In September Lilly entered a settlement agreement to resolve patent litigation with Sanofi over Basaglar, allowing Lilly and its partner,

Boehringer Ingelheim, to launch Basaglar in the US in December 2016. The FDA tentatively approved Basaglar in August 2014.

Greg Kueterman, a Lilly spokesman, said the company has not set a price for the drug, though he noted it will be cheaper than Lantus. Lantus generated sales in 2014 of more than $8 billion. Rivals have

been lining up to take advantage of the drug's patent expiry to launch cheaper versions.

Basaglar was approved in Europe as a biosimilar last year.

The FDA is calling the product a "follow-on" biologic rather than a biosimilar. There are some 30 million people with diabetes in the US. Reuters

Nasal spray flu vaccine safe for kids with egg allergies The live attenuated intranasal vaccine works well to prevent flu and eliminates the need for an injection THE INTRANASAL flu vaccine, which contains live but weakened flu virus and a small amount of egg protein, does not cause adverse reactions in young people, even those with egg allergies or mild to moderate asthma, according to a new study in the UK. The live attenuated intranasal vaccine works well to prevent flu and eliminates the need for an injection, so in 2012 it was made the standard recommended vaccine for kids aged two to 16 years. It seems to have a similar safety profile to injected vaccines containing inactivated virus, the study team writes in the BMJ. In the US, guidelines recommend the live attenuated spray or the inactivated injection, with no preference for one over the other. But according to the Centers for Disease Control and Prevention, children younger than two, adults age 50 and older, pregnant women and people with egg allergies should not get the nasal spray, while people with asthma are warned that wheezing may increase after getting the spray. There are similar warnings in the UK. Based on the study results, however, lead author Dr Paul J. Turner of Imperial College London said that even for kids with well-controlled asthma, the vaccine seems to be very safe.

“Most children will probably prefer a spray up the nose rather than a shot in the arm,” he added.

For the new study, the researchers included 779 kids aged two to 18 years with egg allergies, which affect two per cent to six per cent of preschool children. More than half of the kids also had doctor-diagnosed asthma or recurrent wheeze. The study participants were recruited from allergy centers and clinics and about a third had experienced a previous severe allergic reaction, known as anaphylaxis, to eggs in the past. Of these kids, one in five had respiratory or heart symptoms during those episodes.

The flu virus for vaccines is grown

in hen’s eggs, so the spray and the shot include a small amount of egg protein.

All study participants received the LAIV, most getting a total of two doses. With researchers observing them 30 minutes after vaccination and with follow-up phone calls 72 hours later, and additional follow-up one month later for certain kids, there were no reported systemic allergic reactions. Nine kids had mild symptoms, which may have been localized allergic reactions. About eight per cent of the kids experienced lower respiratory tract symptoms in the 72-hour window, with some having parent-reported wheeze, but none were admitted to the hospital.

“In terms of egg allergies there should be no concerns at all,” Turner said. “In terms of asthma, parents should consult with a person who knows the child and how well their asthma is controlled.”

The spray is very similar to the injectable vaccine in terms of safety, according to Dr Raja Rajaram, Global Medical Affairs Lead at AstraZeneca, maker of the intranasal spray vaccine.

“We do have a contraindication on the label, as do other manufacturers,” but these results will prompt discussions with policymakers about changing the warnings about egg allergy and asthma, Rajaram said. These are good topics to discuss with your doctor when you go to get the vaccine, Turner said – and flu season proper still hasn’t begun in the Northern Hemisphere of Europe, so it’s still a good time to go get the spray or the shot.

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RESEARCH

Array’s skin cancer drug US FDA lifts succeeds in late-stage study clinical hold on Data showed that patients with advanced NRAS-mutant melanoma treated with the drug, binimetinib, lived for a median of 2.8 months before their disease worsened

Advaxis’cancer compounds Advaxis will resume studies on the three therapies, which belong to a class of treatments that spur the body's immunity system against the disease

ARRAY BIOPHARMA said its experimental drug helped patients with a form of skin cancer live longer without their cancer progressing, in an ongoing late-stage study.

Data showed that patients with advanced NRAS-mutant melanoma treated with the drug, binimetinib, lived for a median of 2.8 months before their disease worsened, compared with 1.5 months for patients treated with the chemotherapy dacarbazine.

So far, there have been no drugs approved to specifically treat this mutation. Array is the first, and likely the only company developing an agent specifically to target this difficult-to-treat population - at least for the foreseeable future, Chief Executive Ron Squarer said.

The Boulder, Coloradobased biotechnology company in March regained the rights to the compound from Novar-

32 EXPRESS PHARMA January 1-15, 2016

tis. It had granted the Swiss drugmaker the license to develop and market binimetinib in 2010.

In a research note published last month, Wells Fargo's Matthew Andrews noted that former partner Novartis had originally designed the study expecting the drug to improve progression-free survival to roughly four months compared to dacarbazine. Nearly 74,000 new cases of melanoma and nearly 10,000 deaths from the disease are projected for 2015, according to Array. NRAS mutations occur in about 15 to 20 per cent of patients whose disease has advanced, which roughly translates into an addressable global population of 6,000-8,000 patients per year.

On average, those with the stubborn mutation live an average of 8.5 months once diagnosed.

Detailed results from the

402 patient trial "NEMO", which included patients who had first tried immunotherapy and those that not been previously treated, will be presented at a medical meeting next year. This data will determine what utility the drug has in both categories of patients, which in turn will shape Array's marketing application for NRAS melanoma, Squarer said.

He declined to provide any details on pricing. The drug is also being tested in separate late-stage studies in patients with BRAF-mutant melanoma and ovarian cancer. Array on said it plans to submit an application to market binimetinib to treat NRAS-mutant melanoma in the first half of 2016. If all goes well, the drug could hit the US market by the end of next year or early 2017, the company said.

DRUG DEVELOPER Advaxis said the US Food and Drug Administration had lifted a clinical hold on three of its experimental cancer therapies. The US health regulator had in October put on hold mid-stage trials of the company's lead therapy, axalimogene filolisbac, after a patient died.

Advaxis had then said the patient died due to progression of cervical cancer and that the drug played no role in the death. The FDA later placed a clinical hold on all three therapies in the company's pipeline.

Advaxis said that it would resume studies on the three therapies, which belong to a class of treatments that spur

the body's immunity system against the disease. The company said it had agreed to implement some risk mitigation measures, including revised study design, patient inclusion criteria and patient surveillance measures, following discussions with the FDA. Advaxis is testing axalimogene filolisbac in patients with head and neck cancer, cervical cancer and anal cancer.

The company is studying ADXS-PSA in prostate cancer patients in combination with Merck & Co’s blockbuster cancer drug Keytruda, and ADXS-HER2 in patients whose cancer is caused by a kind of mutation.

Reuters

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Reuters

RESEARCH

Kitov Pharma’s arthritis drug meets main goal in late-stage study The drug reduces pain without increasing the risk of heart diseases in patients with a type of arthritis

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KITOV PHARMACEUTICALS Holdings said its lead drug met the main goal of a late-stage study, reducing pain without increasing the risk of heart diseases in patients with a type of arthritis.

The drug, KIT-302, was tested in 152 patients with osteoarthritis (OA), a degenerative joint disease caused by ag-

ing joints, injury and obesity. The condition occurs most often in knees, hip, lower back and neck, small joints of fingers and bases of the thumb and big toe. Most of the widely used painkillers contain severe health warnings that link them to heart-related risks.

Israel-based Kitov said its drug does not need to be labeled with health warnings but will instead say it reduces the risk of cardiovascular events. Elevated blood pressure is a common side effect of stand-alone pain killers, which also increases the chances of heart problems. KIT-302, which belongs to a

class of painkillers called non-steroidal anti-inflammatory drugs (NSAID), is a combination pill that simultaneously treats joint pain and elevated levels of blood pressure.

There is no single medication to treat both osteoarthritis pain and hypertension and thus, KIT-302, if approved, will be the only NSAID for use in both conditions, Kitov Chief Medical Officer Paul Waymack said. Kitov, which debuted on the Nasdaq in November, uses US drugmaker Pfizer's FDA-approved drugs, celecoxib (Celebrex) for pain and amlodipine besylate for hypertension.

Most pain medications, including celecoxib, had global sales of $2.7 billion in 2014, Kitov said.

About 27 million Americans are suffering from osteoarthritis, according to the Arthritis Foundation. Data from the late-stage study showed that combination KIT-302 significantly reduced blood pressure and pain, compared with a placebo, and was also better than the two drugs given separately.

Kitov plans to apply for marketing of the drug in the second half of 2016, and expects to launch it in summer 2017 if approved, Kitov's Chief Executive Isaac Israel told. Israel, who is "highly confident" about the quality of data on the drug, said "there are highly fewer chances that the FDA does not approve KIT-302".

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RESEARCH

Acetaminophen may do no good for flu The new study found that four daily doses of the medicine did neither good nor harm ACETAMINOPHEN may not have an effect on the flu virus or its symptoms, according to a new study. International guidelines, including those of the British Infection Society, recommend anti-fever drugs like acetaminophen (also known as paracetamol) as they may help and are unlikely to cause harm.

But the authors of the new study found that four daily doses of the medicine did neither good nor harm.

In theory, reducing fever, the adaptive response to infection, could actually worsen flu, according to coauthor Irene Braithwaite of the Medical Research Institute of New Zealand in Wellington.

The researchers had expected that acetaminophen would reduce adults’ fevers, “resulting in higher levels of influenza virus for longer periods, and therefore worse symptoms of the flu for longer,” Braithwaite said. But instead, she continued, “compared to placebo, acetaminophen did not reduce fever, appeared to have no effect on influenza levels, and no difference in clinical symptoms of the flu.”

The researchers conducted a randomised controlled trial with 80 adults in New Zealand in 2011 and 2012 who had flu symptoms such as cough, sore throat, runny nose or headache.

Half of the patients received sets of two 500-mg acetaminophen tablets to take four times per day for five days, while the other half got placebo pills. The researchers measured viral load on days one, two and five, and recorded patient temperature and symptom scores daily for up to 14 days.

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Symptom scores, fever levels, time to recovery from flu and health status were similar in the acetaminophen and placebo groups, the authors reported online December 6 in

Respirology. “We do not know why acetaminophen had no effect on pain in our study,” Braithwaite said.

A single study in a sample consisting mainly of otherwise healthy young adults is not enough to draw generalised conclusions about the effect of acetaminophen on the flu for everyone, she said. “What this study does is raise some very serious questions about the real evidence base for using acetaminophen routinely for anyone that has the flu,” she said.

All the patients were also taking daily doses of the antiviral medication Tamiflu (oseltamivir), which may have skewed the results and makes it hard to draw any conclusions from the findings, said Dr Tom Jefferson of the Center for Evidence Based Medicine at the University of Oxford in the UK, who was not part of the study.

A 2014 Cochrane review

concluded that Tamiflu has few if any beneficial effects, and can have adverse side effects, like increased nausea and vomiting.

“Everybody was on Tamiflu (which could have interacted

with paracetamol, it certainly has the same properties) and could account for the lack of visible effect,” Jefferson said.

The study was also very small and took three years to go from completion to publication, which is strange, he said.

Tamiflu, which was still recommended for influenza when the trial was first designed, may not have affected the results of the study, since both groups included were taking it, Braithwaite said.

If the same trial were conducted today, it is unlikely she and her coauthors would have given the participants Tamiflu, she said. “Probably the best way to alleviate flu symptoms is to get vaccinated against the flu,” Braithwaite said. “This is highly recommended for those who are very young, very old, pregnant or who suffer from respiratory or other chronic illnesses.”

Reuters

US FDA approves Merck drug Bridion The drug reversed the effects of deep paralysis caused by rocuronium and vecuronium, muscle relaxants used at the beginning of surgery to help doctors insert a breathing tube MERCK & CO’S drug to reverse the effects of muscle relaxants used during surgery has won US approval.

The Food and Drug Administration said it approved the drug, Bridion, to reverse the effects of deep paralysis caused by rocuronium and vecuronium, muscle relaxants used at the beginning of surgery to help doctors in-

In 2008 the FDA declined to approve it, citing concerns about potential allergic reactions and bleeding. A 2013 advisory to discuss the drug was abruptly cancelled after the agency said it needed more time to review the company’s revised application. In a statement announcing its approval, the FDA warned that clinicians

In 2008 the FDA declined to approve it, citing concerns about potential allergic reactions and bleeding sert a breathing tube.

Analysts expect the drug, known generically as sugammadex, to generate annual sales of $557 million by 2020 according to Thomson Reuters data. Bridion’s path to approval has been rocky.

The product was originally developed by Organon BioSciences, which was acquired by Schering-Plough in 2007. Merck acquired the drug when it bought Schering-Plough in 2009.

"should be aware of the possibility of a hypersensitivity reaction or anaphylaxis and should intervene as appropriate."

The agency also noted that cases of abnormally slow heart action, in some cases resulting in cardiac arrest, have been reported within minutes of administration of the drug and that patients should be closely monitored.

Reuters

RESEARCH

Bayer forms gene editing partnership with CRISPR Therapeutics One of the challenges Bayer aims to tackle is how to bring the gene editing mechanism to the diseased cells BAYER WILL spend 325 million euros ($353 million) on research into a promising new gene editing technology as part of a joint venture with biotech firm CRISPR Therapeutics.

Under the deal, the German drugmaker will pay for the joint venture's research over the next five years, 300 million euros in total. The venture will be 50 per cent owned by the partners.

ways to fix malfunctioning genes in parts of the body that are at the origin of certain diseases, such as liver cells that fail to produce blood coagulation factors, the cause of haemophilia. If successful, such genetic therapy could cure chronic diseases that now require life-long drug treatments.

One of the challenges Bayer aims to tackle is how to bring the gene edit-

Bayer will buy a minority stake in CRISPR Therapeutics for 35 million euros. CRISPR Therapeutics, headquartered in Basel, Switzerland, with research operations based in Cambridge, Massachusetts, uses the so-called CRISPR-Cas9 technology, which has become the preferred method of gene editing in research labs due to its ease of use. CRISPR, which stands for clustered regularly interspaced short palindromic repeats, allows scientists to edit genes by using biological 'scissors' that operate a bit like a wordprocessing programme that can find and replace defects.

The joint venture will look into

ing mechanism to the diseased cells.

CRISPR Therapeutics will contribute its gene-editing technology, while Bayer will make its protein engineering expertise and knowledge about diseases available.

Bayer has the option to secure exclusive rights to use the joint venture's intellectual property in the areas of blood disorders, blindness and congenital heart diseases. CRISPR Therapeutics will have the exclusive rights to any technology for human use from the collaboration beyond the three disease areas, while Bayer will retain the rights for non-human uses, such as agricultural applications.

Reuters

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PHARMA LIFE

An analysis on the level of awareness about ageism, a form of discrimination against seniors, among Indian pharma firms and the measures taken to eliminate it BY USHA SHARMA

36 EXPRESS PHARMA January 1-15, 2016

A

form of discrimination and prejudice, ageism is faced particularly by seniors across work front. Coined by Robert Neil Butler in I969 to describe discrimination against seniors, ageism was not much discussed in India till now. However, the time has come to highlight the issue of ageism across sectors in India.

With many branded medicines of multinational pharma companies going off patent, a huge business opportunity awaits Indian pharma companies. Besides, looking for skilled and tech-savvy manpower, the pharma sector should also keep in mind, the old adage, ‘Old is Gold’ i.e. older experienced talent has its value. But the flip side is also true not to discriminate the elderly while recruiting the right talent. The industry, backed by the human science knowledge, however, needs to be abreast with revolutionised

technology and the key challenge will be to remain updated with today’s technology.

Do pharma companies need to have policies restricting the age of employees?

Global perspective As per the information available in public domain, the Age Discrimination in Employment Act (ADEA) is the US federal law governing age discrimination. Enacted in 1967, it is meant to promote the employment of older members of the workforce and prevent discrimination based solely on age rather than skills and abilities. The Act enables senior citizens to work and prohibits an employer from refusing to hire, fire, or otherwise discriminate against an employee aged 40 or older, solely on the basis of age. It also protects

senior citizens from an employer in denying an employee pay or any benefits just because the employee happens to be on the other side of the age divide.

So can such an Act work in India?

Informing about the Age Discrimination in Employment Act of 1967 in US, N Ahmedali, Managing Director, Cornucopia briefs, “In the US, accountability and being competent is of paramount importance and actions can be taken if an employee underperforms due to lack of commitment and willingness to work hard. Hence, if those above 40 does not perform he/she is likely to lose his/her job. In India it is not easy to relieve ‘under performers.’” The EU too protects the silver generation.

In his personal opinion, Amit Kumar Das, Director People and Organisation, Novo Nordisk India says, “Grouping

employees into sets on the basis of age and then depriving them of possible employment opportunities is also wrong in the eyes of ADEA. It is also worth noting that the European Equal Treatment Framework Directive No. 2000/78 also makes age discrimination laws compulsory throughout the EU.” Analysing the relevance of Employment Act of 1967 and its practice in the US and whether in India senior citizens need such protection, Ahmedali emphasises, “In India too, we need to protect the senior citizens and give them opportunity to work, though most companies and government undertakings have a retirement age of 58 or 60. They say ‘60’ is the new ‘40’, therefore ‘60+’ people are able to contribute to organisations. Therefore, there must

be agencies to find employment for such people. In my judgement bringing about laws in this respect may not work very well in India. We generally tend to misuse the provisions of law.”

Indian scenario In India there are no codified laws, which directly deal with the issue of age discrimination.

Das informs, “Article 15(1) of the Indian Constitution provides that “the State shall not discriminate against any citizen on grounds only of religion, race, caste, sex, place of birth or any of them.” Also, it is to be noted that the fundamental rights set out in the Indian constitution are available only against the State. The lack of a proper Indian legislation in this regard is not surprising given the fact

that the awareness of the need to prevent so-called 'ageism' is still quite low in the country.

However, there have been a few instances of ageism in Indian private sector as reported by the media but the claims still seem a tad lower compared to other forms of discrimination with respect to religion, race, caste, sex, place of birth.”

On being asked whether age discrimination will help companies to grow faster, Das replies and says that it cannot be answered in binary as a simple yes or no. He elaborates, “In some job profiles, we need to appreciate that “age is in fact NOT just a number!” The term ‘discrimination’ has a negative connotation but to be fair we should look into the circumstances a decision is made. Generally speaking, where there are reasonable grounds for discrimination on the basis of age, such as

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the nature of the job, location of the job, etc, discrimination may be justified, but can we call it discrimination?”

He says, “There are profiles which will definitely require older executives and the vast experience they bring to the table. But then we cannot call it a discriminatory practice, can we? I think this is where the real challenge lies. Moreover, private enterprises may argue they have all the right to hire who they want for a job. But I think we all agree, that if there is a discrimination solely because of age, with respect to compensation and promotion opportunities, once someone has already been hired, it is unjustified. Protection should be there in such cases but the burden of proof with respect to the adverse employment action will always lie with the victim who alleges discrimination.”

Judging an individual on his/ her age might be the wrong step, however, certain profiles demand such people. It all de-

pends upon portfolio requirements which need to have experienced or newer talent for the betterment of companies’ growth.

Das describes, “In a nutshell, companies will grow faster if they can develop the younger workforce around the older and much experienced workforce. After all, many research studies show that a diverse workforce leads to an improved bottom-line.”

Ahmedali too supports this reasoning saying , “I believe that experience which comes with age creates a lot of wisdom in the employees. This cannot be substituted merely by education, like an MBA. If companies can capitalise on the wisdom of seniors they can grow much faster.”

Continuous learning Learning is a constant process,

which has no age bar. Today, the pharma industry is facing a lot of challenges, and one among them is how to create a policy where senior professionals can work in sync with the new generation.

Ahmedali feels, “The older candidates or executives’ ability to learn and practice advanced high-end technology is limited and does not keep pace with the younger generation.

However, there are some exceptions. But, the ‘wisdom’ that experienced seniors bring will neutralise/exceed the search and researches by young tech savvy youngsters. Gen ‘Y’s fingers are on ‘Goggle’ before even the question is completely heard.”

Technological evolution coupled with the advancement in technology ensures the dilution of age boundaries and may make it possible for older executives to contribute much meaningfully at all levels and across all roles. Das confirms,

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PHARMA LIFE

“In this tech-savvy world all products are increasingly focussed on simple user interface that should not be complex for any age bracket. Moreover, technology should not be seen as a challenge and executives (be it older or younger) must keep abreast of the new technology at least to the extent that it helps their own cause.

Falling behind in terms of technology is reason enough to be discriminated against and rightfully so. Having said that, it is difficult to stay away from technology these days and older executives are no exception to the rule.”

Ranjit Madan, Chief Executive Officer, Life Sciences Sector Skill Development Council suggests, “An experienced executive in the team, who can bring into play their reservoir of knowledge and experience accumulated over the years, produces better results. An organisation’s image can only improve with this.”

The idea of having both the generations together looks an ideal but there will be always two sides to the argument.

I believe that experience which comes with age creates a lot of wisdom in the employees. This cannot be substituted merely by education, like an MBA N Ahmedali Managing Director, Cornucopia

Older workers tend to have knowledge that is invaluable and expertise that is not limited to theories in text books

An experienced executive in the team, who can bring into play their reservoir of knowledge and experience accumulated over the years, produces better results

Amit Kumar Das

Ranjit Madan

Director People and Organisation, Novo Nordisk India

CEO, Life Sciences Sector Skill Development Council

Moving forward Das emphasises, “Older executives bring a lot to the table and is not limited to the years of experience. Older workers tend to have knowledge that is invaluable and expertise that is not limited to theories in text books. Personally, I would hire older people for two very important reasons. Firstly, I would hire them because they have established long-term networks of clients and contacts which can be leveraged by any company irrespective of the sector they operate in. Secondly, older executives can be terrific mentors to the younger talent pool.”

He further elaborates, “I would like to highlight a few challenges associated with hiring older executives which I also feel can be easily mitigated through the use of advanced technology, hence I will not use

38 EXPRESS PHARMA January 1-15, 2016

Pic used for representational purpose only

the word ‘disadvantage’ for the same. Older employees may often require flexible working hours but some companies may find it difficult to provide that.

However, with the advent of virtual rooms and conferences, this should no longer pose to be a challenge. In fact allowing the executive to connect from his place of convenience can actually become a cost effective solution for a company in the long run. A common thing that we often get to hear against older employees is their inability to accept change as they might be set in their ways. But according to me this has more to do with bias than with reality.”

Ahmedali highlights, “The advantages of having older executives specially in the pharma and manufacturing industry is that their commitment, loyalty and wisdom gained through experience is far stronger. The disadvantage is of course they are slow in keeping up with new trends and technologies and therefore the market image of such companies is that they are ‘still in old age’. Indian pharma companies should not discriminate against older generation but instead seek opportunities to gain from the collective ‘wisdom’ of the seniors.”

Madan feels, “I believe Indian pharma companies are no exception. They should have a healthy mix of more experienced and relatively younger executives.”

Ultimately, it is the human resource department, which bears the responsibility of ensuring that the practice of ageism does not get encouraged within an organsiation.

And finally it is the human resource department which can play a crucial role.

As Das sums up, “I strongly believe that the human resources department has a strong role to play in ensuring that age never becomes a deciding factor for selecting or rejecting a candidate.” u.sharma@expressindia.com

PHARMA LIFE

NEWS

KTR inaugurates Novartis Knowledge City The Novartis Knowledge City in Hyderabad is clearly not just a testament to the value proposition offered by the Hyderabad NGSC. It is also a reminder that pharma companies are now willing to go that extra mile to attract and retain the right talent

By Viveka Roychowdhury

MID DECEMBER saw the formal inauguration of the Novartis Knowledge City in Hyderabad, a move to consolidate operations from two existing offices in the city’s Mindspace business complex.

Spread over nine floors, the new office with an area of 800,000 sq ft houses approximately 3500 associates of the India arm of Novartis Business Services (NBS), a global initiative started in 2014 to drive collaboration, efficiency and productivity gains across Novartis by providing centralised services.

Novartis Hyderabad is currently the largest of the five Novartis Global Service Centers (NGSCs) of the Novartis Group, the others being at Mexico City, Dublin, Prague, Kuala Lumpur, all of which were set up after Hyderabad. It provides high

quality services ranging from information technology, financial reporting and accounting, human resources services, data management, biostatistics, medical communications and scientific support services among others.

Reportedly the largest such facility by a pharma MNC in India, the new location was inaugurated by KT Rama Rao, Minister of Information Technology, Telangana who pointed out that Novartis was the latest in a line up of global corporations which had announced fresh investments into Hyderabad and Telangana. For instance, he mentioned that Google CEO Sundar Pichai had committed to build an over two million sq feet campus in the city which would be Google’s biggest campus outside of the US. Pitching for more

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PHARMA LIFE investments, he invited Novartis India to shift their manufacturing base to Telengana's upcoming Pharma City.

Speaking at the inauguration, Ranjit Shahani, Managing Director, Novartis India, recalled that he started this operation in Mumbai with 17 people way back in 2001. As the outfit grew beyond the capacity of the Mumbai head office, the search for a suitable city led to a long list of 23 cities, which was finally narrowed down to four. Hyderabad finally won over the other contenders (Gurgaon, Chennai and Pune) on parameters ranging from existing infrastructure, availability of a talent pool relevant to the business and space for future growth. “This is not a BPO,” he asserted, “but is much higher up on the totem pole.”

Emmanuel Puginier, Head, Product Lifecycle Services, NBS said that the Hyderabad NGSC has been a success story, and the past years have been an affirmation that Hyderabad was the right choice as it offered them a knowledge base of young smart talent, many of whom had chosen to “grow together” with the organisation over the past many years.

Naveen Gullapalli who heads the Hyderabad NGSC said, “The project was completed in two and a half years with several leading organisations coming together to deliver this state-ofthe-art work environment.”

Home away from home The Novartis Knowledge City in Hyderabad is clearly not just a testament to the value proposition offered by the Hyderabad NGSC. It is also a reminder that pharma companies are now willing to go that extra mile to attract and retain the right talent.

When it comes to creating futuristic work places, the IT industry has led the pack, setting impossibly high benchmarks. For ex-

40 EXPRESS PHARMA January 1-15, 2016

ample, the Internet had many articles dedicated to lists of employee perks at Google. Sample this for starters: Googlers can bring their pets to work, besides enjoying gourmet meals and snacks, as well as chefs ready to whip up customised health foods.

The Novartis Knowledge City in Hyderabad does not have a ‘bring your pet to work’ policy (as yet!) but does have quite a few bragging points. With open spaces with ample collaboration zones as well as silent zones (the latter is ideal for actioning 200 emails in one hour, testifies one employee), training and meeting rooms, innovation zones, interview centre, executive centre, the centre also has multi cuisine cafeterias, a crèche, meditation room, medical centre and a health club to help employees with their work-life integration.The facility has also applied for LEED certification as a green facility.

In fact, would employees feel too comfy to leave for home?!

Employees from the Mumbai head office who attended the inauguration were envious of the sheer space and amenities (the cocoon chair in the meditation zone was singled out in particular for wistful looks!) and even commented that maybe staff should actually pay to work here!

The accent on work place ambiance cannot be brushed aside in an industry perpetually hungry for talent. According to Shahani, about 50 per cent of Novartis India’s head count is based at the Novartis Knowledge City and though the company claims that its attrition rate is lower than industry standards, it’s clearly not taking any chances. viveka.r@expressindia.com (The author attended the inauguration as a Novartis India invitee)

PHARMA LIFE

AWARD

Bombay College of Pharmacy receives IndPact ‘MENTOR’award The award, introduced for the first time by AICTE-CII, was given for Best Industry-Linked Pharmacy Institute

THE RESULTS of the fourth edition of AICTE-CII Survey of Top IndustryLinked Technical Institutes 2015 were recently announced at the 5 th Global University – Industry Congress in New Delhi. Bombay College of Pharmacy received this award for the third time in a row. This in turn has helped Bombay College of Pharmacy to receive IndPact ‘MENTOR’ award for Best Industry-Linked Pharmacy Institute, introduced for the first time by AICTE-CII this year. The award was presented by Dr Anil Sahasrabuddhe, Chairman, AICTE and Vijay Thadani, Chairman, CII National Committee on

Higher Education and received by Principal-Dr MN Saraf.

Bombay College of Pharmacy popularly known as BCP was founded in 1957 by the Indian Pharmaceutical Association-Maharashtra State Branch (IPA-MSB) with financial assistance from the Government of Maharashtra and several pharmaceutical corporations. BCP has produced more than 3500 Pharmacists and 700 M.Pharm and 100 Ph.D graduates. BCP has modern laboratories equipped with state-of-the-art equipment and instruments.

EP News Bureau-Mumbai

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PHARMA LIFE CAMPUS BEAT

TIE Hyderabad declares TISC finalists The finalists were chosen from a total of 100 entries THE INDUS Entrepreneurs (TiE) Hyderabad, a non-profit organisation focused on fostering entrepreneurship, has announced the finalists of its Hyderabad Chapter’s TiE International Start-up Competition (TISC) – Student Track and Investor Track for 2015-16.

The finalists were chosen from a total of 100 entries.

The winners were declared

by Safir Adeni, President-TiE Hyderabad, in the presence of KT Rama Rao, Minister for IT & Panchayat Raj, Telangana, at an award function recently held in Hyderabad. The competition had a multi-stage evaluation up till the semifinals, thereafter 12 teams contested in the semifinals, of which seven teams made it to the final round.

Student Track is reportedly the world’s richest and largest student start-up competition with over $1.5 million prize money. RightBiotic, the winner

Shivani Gupta receiving the award from IT Minister KT Rama Rao at TiE Hyderabad, International Startup Competition held in Hyderabad

of the Student Track award, is an ultra-rapid test for determining antibiotic sensitivity of bacterial pathogens found in human urine in case of urinary tract infections (UTIs). This innovative technology enables faster and better treatment of UTI by reducing the urine cul-

ture testing time from 72 hours to four hours, thereby ensuring right antibiotic administration from the very start of treatment. Co-founder Shivani Gupta from BITS Pilani received the award.

The Investor Track offers mentorship as well as an oppor-

tunity to pitch ideas before successful entrepreneurs and investors at the renowned entrepreneurial conference, TiECon – Silicon Valley. The Investor Track award winner, Feel Good Innovation’s motorcycle seat add-on can prevent back pain, butt numbness and provide comfort.

Honouring the winners and congratulating TiE for their leadership, Rao said, “I am confident that this competition will add to our efforts of making Hyderabad the ‘Startup Capital’ and put our ambitious initiative, T-Hub into a global arena immediately. The Telangana Government is partnering with TiE in this international competition to ensure that we send our best start-ups to win million dollars.” He also informed that the Government of Telangana will soon unveil its start-up and innovation policy.

Declaring the results, Adeni

said, “Congratulations to this year’s winners, the standard of start-ups and their products continues to impress our judges each year. Our goal is to be the catalyst for the best-inclass start-up growth in the region and offer them a unique opportunity to compete for a trip to the US with a spot in the finals at the world’s richest business plan competition at Rice University or try for a trip to the ‘Start-up Capital of the World’, Silicon Valley to get mentored by TiE investors and mentors.”

The national level competition’s top three finalists will receive a booth at TiECon – Silicon Valley where teams will be able to pitch their companies to over 5000 attendees and have access to successful serial entrepreneurs and investors from all over the world.

EP News Bureau-Mumbai

SCOPVadgaon organises oral paper presentation competition Apart from this, competitions and events were held SINHAGAD COLLEGE of Pharmacy (SCOP) Vadgaon, recently organised an oral paper presentation competition as a part of 52nd National Pharmacy Week Celebration. Indian Pharmaceutical association, Pune branch along with all pharmacy institutes from Pune conducted various competitions and events.

The competition was planned by Dr KN Gujar, Principal Sinhgad college of Pharmacy to prepare the students for scientific presentations and

42 EXPRESS PHARMA January 1-15, 2016

focus their interest towards research and development. Dr Shilpa Chaudhari, Professor MMM college of Pharmacy and Revan Karodi, Professor DY Patil College of Pharmacy were the judges for the competition.

Around 50 students from different colleges took part in the competition representing their colleges.

SK Mandlik and VM Gambhire coordinated the event successfully.

EP News Bureau-Mumbai

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PHARMA ALLY I N T E R V I E W

‘We are looking at India as our business hub’ Nelson Corda, General Manager, Consumer Specialties, Ashland Specialty Ingredients, Asia Pacific excluding China, explains the features of Ashland's specialty chemicals, in discussion with Sachin Jagdale

How are specialty chemicals different from basic chemicals?

Like the name suggests, specialty chemicals are the chemicals that perform special functions. Unlike other basic chemicals they will have multiple applications. They will deliver only a special performance which is required in one particular field.

What are the growth drivers for your products in India?

When you look at any business what actually drives it, there are two things. You either go for a cost-effective solution or you go for a product which is not invented in the past. For the costeffective solutions you will focus on existing business, cut the cost and generate your profits. But if you look at the Western world they work in a very progressive manner.

They try to invent something which is better than the past.

They even try to focus more on customer needs. You look at the products like Apple.

The company comes up with new products after every six months. They aren't really worried about what other companies are doing.

Ashland works almost in the same manner. We try to come up with new molecules.

Aquasolve is our new solid

dispersion polymer. It provides better bioavailability of complex drugs which are very difficult to solubilise. Our polymers make impractical problems possible. That is why most of the times we are working on bio-availability and solubility enhancements.

How will you differentiate your products from your competitors?

We have realised that along with a product you also have to give a certain amount of service. We are not just selling our strong and innovative products but are also sharing with the customer our application knowledge and providing regulatory support. Without regulatory support you cannot file any ANDAs. This approach is very critical. We are a part of the pharma industry and if we compromise on quality then we are playing with people's lives. We provide quality product and quality support and this is where we are much ahead in the competition. Big companies have a lot of good scientists and they can manage their formulations on their own but for the mid-sized companies, we provide a lot of formulation knowledge which helps them deliver quality product in the market. Not just our products but our

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to Government of India’s Make in India campaign?

We are looking at investing in India. We have set up a lubricant plant in Ambernath near Mumbai, jointly with Rand Polymers. There are plans to expand our capacities. Last year, we opened a world-class Pharmaceutical Center of Excellence in Hyderabad. We are looking at India as a hub for servicing regional needs.

We are happy with the changing business environment in India. As far as the pharma sector is concerned, almost all the pharma companies in India are our clients.

We are not just selling our strong and innovative products but we are also sharing with the customer our application knowledge and providing regulatory support processes are also of great quality. We do not use substandard raw materials, even the equipment that we use are of international

standards. Packaging and testing standards are also of quality.

How are you contributing

What percentage of your revenue comes from the Indian market?

All businesses put together, around five per cent of our revenue comes from the Indian market.

What are your growth plans in India?

We are growing organically and are coming up with new technologies. Depending upon the opportunities we may grow inorganically as well. We are making investments in India. When we will be confident that the business environment is totally conducive, we will grow here in a big way. sachin.jagdale@expressindia.com

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PHARMA ALLY

I N T E R V I E W

‘Labguard products are backed up with expertise of designers’ Ajay Kanekar, Vice President, Operations, Labguard, talks about the company’s leadership position in fume hood and laboratory furniture market, in an exclusive interaction with Sachin Jagdale

How will you describe the role of design in the success of your fume hoods and laboratory furniture business?

Design plays a vital role for fume hoods and laboratory furniture. The entire performance of fume hoods and laboratory furniture depends on the design. Good design increases the efficiency of fume hoods whereas for laboratory furniture it increases the life cycle even in extreme conditions. Labguard products are backed up with expertise of designers who have experience of more than 30 years in sheet metal business. We as a registered member of the SEFA, USA (a prestigious association of global Scientific Equipment and Furniture manufactures) and the only company having fume hoods being tested as per ASHRAE110 and EN14175 norms are committed to bring world class quality fume hoods and laboratory furniture. Design needs to ensure that it should be easy to install, easy to operate, user-friendly and the most important thing is safety and protection of users. Labguard products have earned a reputation in each of the above features and this has really helped Labguard to accelerate our business with an annual sales growth of

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Labguard products are backed up with expertise of designers who have experience of more than 30 years in sheet metal business 30 per cent last year.

Which new designs were launched by you and how unique are they?

As a company of designers, we understand the importance of well designed lab furniture and reliable fume hoods in ensuring

smooth work flow and productive work environment for customers.

The key to our successful innovation is to constantly listen to our customers.

Guided by their needs, our dedicated automation and research team has developed and incorporated a number of useful features into our products due to which we were been awarded ‘India Design Mark-2014’ award for ‘Inventa’ series fume hood.

The award is conferred by India Design Council (a joint initiative between Govt. of India and NID, Ahmedabad in co-operation with Good Design Award, Japan) We have also launched two back to back new fume hoods which are, Polypro fume hood: These fume hoods are made from imported polypropylene UV protected sheet. We are the first company in India to manufacture a fume hood in PP structure. These fume hoods are made keeping in mind of highly corrosive environment like API, formulation, jewellery industry, mining industry, commercial labs etc. It has altogether opened a new sector for Labguard. Apart from being safe in highly corrosive environment it is safe to use and also costeffective in terms of longer life.

Adventa series fume hood:

This has recently been displayed at PMEC Exhibition – Mumbai. We have launched our new series of fume hood that is ‘Adventa fume hood. These are made considering the work space required by users inside the fume hood. They are easy to access in terms of their utility and electrical points for maintenance and servicing.

For furniture, we have launched ‘Flexis+ series’ of furniture. These special series of furniture have attracted attention in the market, The cabinets are movable in entire length and easily removable without disturbing the worktop, leg space can be adjusted with the help of movable cabinet.

In simple words, we can simply remove the cabinet, which is not required and insert the ones which we want to use at our work place.

All these above innovative products have made revolution in our kind of business. Customers now have a wide range of products to choose for their labs.

Do you have case studies to explain how your products are beneficial?

We do have lot of innovations that has helped our customers to get benefited.

Some of these are:

PHARMA ALLY

Customer required C frame with glass work top and under bench modules can be easily placed by user where required during the reactions : A)C-Frame furniture with glass work top and mobile under bench metal units – The under bench units are easily removable in this kind of furniture as those are on castor wheels. We can have easy access to utility lines and electrical cables for maintenance. It can also be used as individual table which is also one the additional features for this kind of furniture.

Customer required entire C frame which can be easily shifted along with the modules fixes in it: B)C- Frame mobile furniture – In this series of

Labguard products have earned a reputation in each of the above features and this has really helped Labguard to accelerate our business with an annual sales growth of 30 per cent last year furniture, C- frames are provided on castor wheels with individual table of length 1500 mm and the under bench cabinet is fixed below the worktop.

Advantages of this furniture is that we can easily move the table with the help of castor wheels which having features of levelers in it.

They could be moved to any required position when needed or could be fixed to the position with the help of levelers.

What is the approximate number of fume hoods you manufacture every year?

We are currently manufacturing 800 fume hoods in a year.

Which markets do you cater to?

R&D Centers, QC labs of pharma/chemical companies, educational institutes (Eg: IIT’s, IICT, UICT, colleges and schools etc.), Government originations (Eg: BARC, IISc, JNSCAR,

AIIMS, IIIM, etc) Tell us something about your team?

Team Labguard is guided and mentored by our MD, Prakash Sansare with Sales Heads Shyam Singh and Janardhan Mudaliar.A team of engineers having a vast experience in their respective fields and committed to the excellence with their exceptional products, have been the biggest brand ambassadors

for Labguard.

Where do you see Labguard in the next three years?

Labguard, an ISO 9001: 2008 certified company and one of India’s leading manufacturers of fume hoods and laboratory furniture, due to our consistent focus on quality and innovation. We have grown to become one of India's most respected fume hood and lab furniture manufacturers, with products on par with the best in the world. We are heading with a goal to be the world’s best company in our sector and are working on new innovations and designs. A lot more new products will be launched in near future. sachin.jagdale@expressindia.com

PRODUCTS

Lighthouse USAlaunches 1 cfm portable particle counter LIGHTHOUSE USA announced the launch of industry’s lightest (4.5 kg) and smallest (not only footprint, but also volume) 1 CFM portable airborne particle counter. It has external optional printer and also built in web browser. With the integrated web browser, users can access real time data locally or anywhere in the building on iPhone, iPad, android and windows tablet Data view ◗View current data ◗View five previous samples ◗View flow status ◗View date and time ◗View serial # ◗View model #

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◗View location ID ◗It has a laser life of 35 years, the longest in the industry.

Environmental compatibility ◗Casing is 304 grade stainless steel ◗Laser Block is H202 compatible ◗Protective flap to cover data connections ◗Sealed inlet Self diagnostics Comprehensive laser monitoring ◗Laser power supply: To assure that the voltage supplied to the laser driver is within specifications. Helps to tell if the laser or the electronics are

failing. ◗Laser current: The amount of current the laser is drawing.

If the laser is drawing an abnormal amount of current, that usually indicates a problem.

Laser power: This is the energy of the light being generated. To assure that the particles are illuminated with a constant power so the pulse response is consistent (in calibration).

Contact details Jyoti Gangwani Measuretest Corporation 94 Atlanta,Nariman Point Mumbai - 400021 ph:- 022-22027982 www.measuretest.com

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PHARMA ALLY

Gandhi Automations launches clean room doors in PMEC-2015 GANDHI AUTOMATIONS had displayed high speed doors, clean room doors, dock levelers, dock shelters, motorised rolling shutters, motorised gates and boom barriers, at P-MEC India.

Clean room doors will help pharmaceutical companies boost quality in their plant. One of the most important aspects of cleanrooms is the doors choosen for cleanroom facility.

Time for which the door is open will play a critical factor in avoiding dust, outside temperature, humidity etc.

Opening and closure of door has to quick enough to isolate the outside environment and internal facility. Clean room high speed doors are best suited for facilities where one needs controlled environment.

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

internal facility.

Clean room doors designed

by Gandhi Automations are engineered carefully with feature below:◗ Clean room high speed doors are designed for inside applications and protects the environment against humidity, dust and dirt ◗ Operating speed and superior sealing properties improve traffic flows and provide environmental control and savings on energy costs ◗ Concept of low air permeability in pressurised rooms with positive and negative air pres-

sure ◗ High door efficiency and low permeability values EN 12426 EN 12427 : < 12m3 / m2h ? 50 PA ◗ High leak tightness is due to curtain being tightly integrated in special SS 316 matt finish side guides ◗ Bottom safety edges and photocells combine to ensure operator safety at all times ◗ Heavy duty motor: 400V three phase, opening speed upto 1.5 m / s with inverter system ◗ Size upto: 4000 mm (W) X 4000 mm (H) Contact details Gandhi Automations Chawda Commercial Centre, Link Road,Malad (West), Mumbai - 400064 Tel: +91-22-66720200 / +91-22-66720300 (200 lines) Fax: +91-22-66720201

Waters GlycoWorks RapiFluor-MS Kit available in 24-sample format WATERS CORPORATION announced a new 24-sample option for its highly acclaimed GlycoWorks RapiFluor-MS NGlycan Kit. The new format

96-sample format. The RapiFluor-MS labelling reagent yields enhanced MS sensitivity that is 100 to 1,000-fold greater than current approaches. It

processes 24 samples, eight at a time, and opens the door further to laboratories that want to begin realising the benefits that RapiFluor-MS brings to glycan analysis.

Depending on a laboratory’s sample preparation needs, the Waters GlycoWorks RapiFluorMS N-Glycan Kit is now available in either a 24-sample or

also supports a simple, robust protocol for routine laboratory use that incorporates the ACQUITY QDa mass detector.

Contact details Waters CorporationBrian J. Murphy, +1 508-482-2614 Public Relationsbrian_j_ murphy@waters.com

VALUE ADD

‘We are open to design warehouse as per client’s specification’ Pravin Agarwal and Chandru Bhatia, Directors, IVY Integrated Logistics, elaborates on the company’s offerings for pharma warehouses and cold storages TELL US about the ongoing activities of IVY Integrated Logistics?

Currently, the warehouse is under construction and the foundation work is expected to be completed by January 2016. Apart from this, we are open to design the warehouse as per client’s specification and provide 3PL services to our prospective clients. We are also open to cold storage and a designated portion for the same can be allotted.

What services do you offer to the pharmaceutical sector?

The following services are offered to the pharma sector. They

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are: ◗ Clean and disinfect the storage area regularly. No food, drink, gum, tobacco, trash cans in the warehouse and storage area ◗ Record all inbound drugs’ temperatures. Inspect all incoming for spillage and packing condition ◗ Inspect empty cases, racks and pallets for rodent, insect activity or odours ◗ Proper designated storage areas for ‘High-risk’ drugs, Refrigerated/Frozen zone for ‘Lowtemperature drugs.’ ◗ Store the drugs in a manner accessible for first-to-expire, first-out distribution.

◗ Store drugs separately, away from insecticides, chemicals, old files, office supplies, and other ◗ Assure proper security. ◗ Making sure fire safety equipment is available and accessible.

◗ Temperature controlled storage ◗ On-site maintenance and support ◗ Distribution of goods on pan India level

What facilities you are going to provide to your clients?

We offer the following services to our clients. ◗ Automated inventory management system ◗ 24-hour CCTV surveillance ◗ Packaging and re-packaging ◗ Pick and pack services ◗ Barcode scanning ◗ Real time tracking of the shipment

How much market share do you plan to capture in the pharma segment with the launch of the ware-house.

What strategies have you planned for the same?

As the facilities would be customised for single customer, full utilisation of available capacity would be the target.

What is the advantage of hav-

ing board presence of M/s Meteoric Logistics Pvt & M/s Agarsons Road Carriers Corporation?

Ivy integrated Logistics will be having a major support in the field of transportation and distribution of goods from warehouse to pan India level as it will be having a supervision of M/s Meteoric Logistic and M/s Agarsons Road Carriers Corporation who have been active in the logistic industry for the past three decades. With their expertise and well established network the supply chain process will be smooth, efficient and cost effective to our prospective clients.

REGD.WITH RNI NO. MAHENG/2005/21398, POSTAL REGD. NO. MCS/164/2016 – 18,PUBLISHED ON 5TH / 20TH EVERY FORTNIGHT, POSTED ON 5TH, 6TH, 7TH & 20TH, 21ST, 22ND OF EVERY FORTNIGHT POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE, MUMBAI – 400001