Express Pharma September 1-15, 2014

VOL. 9 NO. 21 PAGES 72

www.expresspharmaonline.com

Cover Story Following in the footsteps Market Intas Pharma to roll out marketing strategies for its cancer drug Azadine Management Quality approach of pharma industry for 21st century 1-15 SEPTEMBER 2014,` 40

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CONTENTS MARKET Vol.9 No.21 SEPTEMBER 1-15, 2014

10

INTAS PHARMA TO ROLL OUT MARKETING STRATEGIES FOR AZADINE

12

NOVARTIS TIES UP WITH TB ALLIANCE

THE LEARNING CURVE

13

Employees lookat much more than just a paypackage from employers.Career growth and a culture of mentorship can foster leadership and ensure employees rise through the ranks | P22

IPM CLOCKS ` 7161 CRORES IN JULY 2014

15

PHARMEXCIL TO CELEBRATE 10TH

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

ANNUAL MEET WITH HOST OF EVENTS

16

UBM INDIA ANNOUNCES PHARMALYTICA INDIA 2014

17

ASIA PHARMA EXPO 2015 TO BE HELD IN BANGLADESH

Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West

P32: INTERVIEW

Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Yuvaraj Murali Ajanta Sengupta

P40: CLINICAL UPDATE

PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia

‘My teacher provided me with full freedom in my research projects’

MANAGEMENT

Novartis’ KAE609 shows promise as next generation treatment for malaria

P42: RESEARCH UPDATES

34

QUALITY APPROACH OF PHARMA INDUSTRY FOR 21ST CENTURY

38

MEDICAL TECHNOLOGY: VISION 2025 ROADMAP FOR THE WAY FORWARD

Low vit D levels may predict dementia risk

Scheduling & Coordination Rohan Thakkar

P43: PRODUCTS

CIRCULATION Circulation Team Mohan Varadkar

Osworld Scientific Equipments launches benchtop autoclaves

PHARMA LIFE

65

MERCK SERONO INDIA WINS FIVE AWARDS AT CMO ASIA AWARDS 2014

66

IBM LAUNCHES CLOUD-BASED HR SOLUTIONS

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

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

EDITOR’S NOTE

Adding bite to DCG(I)’s bark

O

n August 6, the quality assurance (QA) division of the CDSCO had released guidelines on the procedures to be followed by its inspectors during GMP inspections. The guidelines may not be too path breaking but this notice marks a significant step towards the adoption of uniform procedures during regulatory inspections across the country.

Whereas most notices have been instructions to industry, the August 6 notice from Dr GN Singh, Drug Controller General (India) is a clear message to his fellow regulators, that they will have to perform to these standards.

The notice has seven points where the DCG(I) has laid down specific guidelines. For instance, GMP inspections as well as that for Certificate of Pharmaceutical Product (COPP) need to focus mainly on Schedule M requirements to establish shelf life, validity studies and recalls besides the WHO GMP requirements. It also mentions that inspections should be conducted for two to five days, depending on the size of the manufacturing facility.

The DCG(I) is also clear that inspection reports have to be finalised ‘without delay’ when there are critical observations having a direct impact on the quality, safety and efficacy of products and which call for initiation of immediate regulatory action (i.e. drug recalls). The state drug control authorities have been asked to qualify inspectors for inspection based on experience and training and more importantly, to ensure that each inspector carries out a minimum of five GMP inspection in a year ‘to sustain performance’.

In effect, the DCG(I) is laying out annual inspection targets per inspector, as well as parameters to be followed to standardise inspection across states. Will these guidelines be enough to hold state inspectors accountable? Will these be enough to raise confidence in the standards of GMP inspections in India?

There has always been the view that inspections conducted by local regulators are less

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September 1-15, 2014

There is hope that the new Government will elevate the DCG(I)’s position so that his bark will have more bite,but until then, nothing much will change.Just as there needs to be a change in attitude,and a cultural shift towards quality in the industry,we need to see the same change among regulators

stringent than global inspectors. This is cited as the reason why pharma manufacturing plants in India have being slapped with warning letters from the US FDA. However, industry observers point out that these notices from the DCG(I)’s office seem merely “procedural and a formality”.

Until the DCG(I) is given more freedom to operate and actually crack down on errant inspectors, these will not be enforcable.

There is hope that the new Government will elevate the DCG(I)’s position so that his bark will have more bite, but until then, nothing much will change. Just as there needs to be a change in attitude, and a cultural shift towards quality in the industry, we need to see the same change among regulators.

Unfortunately, we are reactive rather than proactive. Regulations for clinical trials started changing only once a public interest litigation (PIL) was filed in January 2012 by Swasthya Adhikar Manch blowing the lid off many unethical practices.

Two years later, the matter is still being heard by the Supreme Court. Notwithstanding the industry’s lament that many trials, both global and local, are at a stand still and have also moved to other countries, the Government has gone ahead and bought clinical trials services within the ambit of service tax in the recent budget.

Which means that the additional 12.36 per cent tax will be added to the cost of conducting trials and therefore to the cost of drug development.

Industry associations like ACRO and ABLE are also worried that the Government's plan to use IT-enabled systems for clinical trials will discourage participation as patient privacy will be compromised.

As we go to press, we await yet another hearing on the drug pricing policy on August 29.

The authorities need to take a more rational and consultative stance on all these issues.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET COMPANY WATCH

Intas Pharma to roll out marketing strategies for its cancer drug Azadine The company is exploring the joint venture with companies in India and other countries Usha Sharma Mumbai AHMEDABAD-BASED pharmaceutical company, Intas Pharmaceuticals, which has recently launched cancer drug Azadine in India, is in the process of rolling out its marketing strategies for the product. The affordable cancer drug has been priced at 20 per cent of the imported brand Vidaza.

Commenting on the company’s marketing strategies for the product, Dr Vijayesh Gupta – India Head, Marketing and Sales, Intas Pharmaceuticals says, “Azadine will be launched as a pseudo-innovator as it is getting introduced for the first time in the country. The focus will be on increasing diagnosis, timely treatment and encouraging the patients to complete the treatment.”

Azadine will benefit millions of Indians suffering from

Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukaemia (AML) types of cancer. MDS and MDS progressed to AML is a life threatening blood cancer. It could lead to death of the patient depending upon how severe is the blood disorder (six months to four years). Incidence of elderly population is increasing day-by-day hence the MDS cases as well.

The company already has a dedicated team for haematology and oncology range of products. It consists of experienced professionals in the field of marketing and sales.

“This team also has medical professionals. The existing team has been trained to effectively communicate with the doctors as this drug also needs medico-marketing communication,” informs Gupta.

The treatment cost has been drastically brought down to a fifth of its imported variant (which is currently in

use). He continues, “We are also reaching out to oncologists and haematologists.”

Intas Pharma anticipates that Azadine will benefit millions of Indians suffering from MDS and AML types of cancer. The cost of treatment with the imported Azacitidine (Vidaza) is around ` 18 lakhs for the entire treatment while the cost of treatment with Azadine is around

` 3.7 lakhs for the entire treatment. This makes Azadine almost five times or 80 per cent less than imported brand Vidaza. More patients taking imported brand in India are likely to switch and benefit from Azadine (conforming to global standards) which is now available at such an affordable price.

Responding to a query asked by the Express Pharma, Gupta emphasises, “It is not revenue which is relevant in this case. There is a medical need and we feel our elderly population suffering from MDS/AML needs this drug in India. We hope that a few thousand patients will get benefitted with this drug in the first year of launch. I strongly feel that this would not just enhance our equity as an innovator and world class pharma company but also as an institution that is dedicated to the well being and making the medicines more

accessible to those who need them at affordable prices. We are aiming at a revenue of ` 15 crores during the first year. ” Commenting on the company’s plan to take the product to other markets, Gupta says, “We are exploring the joint venture with companies in India and in other countries to spread the benefit of this low cost treatment. We feel that as there is a large population which is suffering would immensely benefit from this drug. To achieve this objective, co-marketing and franchise models will be highly suitable.”

The company has initiated the development of its product in 2011. The scale up and technology transfer to plant scale was done in 2012, and got India manufacturing permission in May 2014 and the product was launched in June 2014 after DCG(I) approval. u.sharma@expressindia.com

Four Indian pharma cos make it to Forbes Asia list Ajanta Life Sciences, Suven Life Sciences, Caplin Point Laboratories and ADI Finechem are four of the 14 drug and biotech companiess on the ‘Forbes Asia’s 200 Best under a Billion’ list FORBES HAS released the ‘Forbes Asia’s 200 Best under a Billion’ where eight Indian companies made the cut. Among pharma companies, Ajanta Life Sciences, Suven Life Sciences, Chennai-based Caplin Point Laboratories and Ahmedabadbased ADI Finechem made it to the list this year. Drug and biotechnology companies are

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September 1-15, 2014

well represented in this year's listing with 14 from this industry featuring on the list.

While Ajanta Life Sciences and Suven Life Sciences are known names in the industry, the other two companies are lesser known entities. Chennaibased Caplin Point Laboratories manufactures a wide range of ointments, creams and other ex-

ternal applications in addition to the regular segments of pharma formulations while Ahmedabadbased ADI Finechem, manufactures specialised products for the neutraceutical industry.

The Forbes Best Under A Billion list highlights 200 top-performing Asia-Pacific companies with less than $1 billion in sales and consistent top- and bottom-

line gains. Their stories are testimony to the policies of Governments in this region, focused on promoting the small- and medium-sized enterprise sector to boost economic growth. Combined these 200 SMEs generated $42 billion in sales last year, grew an average 46 per cent the last three years and employ over 255,000 people, according to

Forbes.

This year’s list did see quite a few SMEs from India drop off the list, thanks to the deceleration of the Indian economy. The report pegs India's listing of eight companies as a new low compared to a previous all-time low of 19 last year.

EP News Bureau – Mumbai

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MARKET

Novartis ties up with TB Alliance Exclusive worldwide license from Novartis includes a novel class of drugs that is active against drug sensitive and multi-resistant strains of tuberculosis NOVARTIS HAS signed an exclusive worldwide licensing agreement with the Global Alliance for TB Drug Development (TB Alliance) for compounds to fight tuberculosis (TB) that have been discovered at the Novartis Institutes for Tropical Diseases (NITD).

“TB is one of the scourges of the developing world and new medicines are desperately needed to combat its continued spread,” said Mark C Fishman, President, Novartis Institutes for BioMedical Research.

“TB Alliance is well placed to take our discoveries and compounds through develop-

ment for the benefit of patients with TB.” “Our long-standing partnership with Novartis gives us confidence in the scientific underpinnings of the TB portfolio,” says Mel Spigelman, President and Chief Executive Officer, TB Alliance. “We look forward to advancing the most promising compounds into the clinic to meet the urgent need for new TB treatments.”

Under the terms of agreement, NITD will fully transfer its TB research and development programme to TB Alliance, which will take financial and operational responsibility

NITD will fully transfer its TB research and development programme to TB Alliance, which will take financial and operational responsibility for continued R&D and distribution of compounds in the portfolio for continued research, development, approval and distribution of compounds in the portfolio. Included is a novel class of

drugs called indolcarboxamides that are active against drug sensitive and multi-resistant strains of TB. One of these pre-

clinical compounds NITD304, blocks MmpL3, a protein essential for the TB bacterium’s survival. NITD304 was described last year in a paper published in Science Translational Medicine.

Novartis efforts in discovery of medicines specifically for the developing world continues, especially focused now on new therapies for treating parasitic diseases such as malaria, and human African trypanosomiasis (HAT) - also known as sleeping sickness, as well as viral disease such as dengue fever.

EP News Bureau – Mumbai

Glenmark enters oncology segment Claris Lifesciences GBR 1302 is Glenmark’s first clinical candidate targeting oncology indications GLENMARK PHARMACEUTICALS, a wholly-owned subsidiary of Glenmark Pharmaceuticals Ltd India (GPL), has discovered and initiated IND enabling studies of a novel clinical development candidate, GBR 1302, a HER2xCD3 bispecific antibody.

GBR 1302 was discovered and developed by the Glenmark Biologics Research Centre located in La Chaux-de-Fonds, Switzerland.

GBR 1302 is based on Glenmark’s innovative BEAT antibody technology platform which facilitates the efficient development and manufacture of antibodies with dual specificities, socalled bispecific antibodies. GBR 1302 is the first clinical development candidate based on the BEAT (Bispecific Engagement

by Antibodies based on the T cell receptor) technology. The company expects to obtain approval for the initiation of clinical studies

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EXPRESS PHARMA

September 1-15, 2014

during this financial year.

HER2, also known as HER2/neu, or receptor tyrosineprotein kinase erbB-2, is the target of the antibody cancer drugs trastuzumab, pertuzumab and trastuzumab emtansine and is involved in breast cancer and ovarian cancer.

GBR 1302’s mode of action is different from current HER2 targeting antibodies. It redirects cytotoxic T cells through its CD3 binding arm onto HER2 expressing cancer cells and induces the killing of the cancer cells. The killing of cancer cells

by GBR 1302 is more rapid, more complete and not subject to the same resistance escape mechanisms as competing therapies.

BEAT is a proprietary best in class platform of Glenmark. Engaging two targets with one bispecific antibody is an attractive concept to design new therapeutics. For the past 20 years, bispe-

cific antibodies have been a challenge to the industry since all bispecific formats developed so far have had stability and/or manufacturing issues.

With the invention of the BEAT technology Glenmark’s scientists have now overcome these bottlenecks and GBR 1302 is the first drug candidate based on this antibody engineering breakthrough technology.

Dr Michael Buschle, Chief Scientific Officer and President – Biologics, Glenmark Pharmaceuticals mentioned, “GBR 1302 is significant for Glenmark on multiple levels. It is our first bispecific antibody, it is our first antibody based on our proprietary BEAT antibody engineering platform and it represents the entry of Glenmark into the oncology innovator space, which has a huge commercial potential.”

EP News Bureau – Mumbai

gets UK MHRA approval for plant 2 CLARIS LIFESCIENCES received the UK MHRA approval for its newly commissioned plant (Plant 2). This will help in enhancing capacities to grow in the regulated markets, especially the European Union. The company’s specialty injectables business saw a growth of 30 per cent in the last quarter.

As on June 30, 2014, the company had approvals of 13 ANDAs in US, 14 molecules in the Europe and 11 molecules in Other Regulated Markets (ORM), additionally, there are 28 ANDAs in the US, eight molecules in Europe and 10 molecules in ORM, which are filed and awaiting approval. The company is currently functioning at high capacity utilisation and is adding capacities in Plant 2 to service future demands. To sustainably grow,

attaining the required regulatory approvals is one of the key growth drivers; and the company has a large pipeline of products; which includes the under approval and the products currently under development.

The company’s flagship plant (Plant 1) is already approved by UK MHRA. This is the first regulatory inspection and compliance approval conducted by UK MHRA in line with the EU GMP regulations for plant 2, this approval is for terminally sterilised products presented in glass ampoules manufactured in Line 1 of the Plant 2.

It has plans to install another line in this new plant (Plant 2) which will be ready for commercial production by the end of this year.

EP News Bureau – Mumbai

MARKET GROWTH TRACKER

IPM clocks ` 7161 crores in July 2014 From therapy perspective, 12 therapies have outgrown the IPM growth THE INDIAN Pharmaceutical Market (IPM) clocked ` 7161 crores in July 2014 and has grown at 7.2 per cent. In the corporate sector amongst the top 10, Sun Pharma grew by 14.2 per cent, Lupin by 13.2 per cent and Cipla by 9.5 per cent.

Macleods grew at 27.9 per cent to become the tenth biggest corporate for the month of July 2014. With the portfolio of Elder, Torrent is now placed at sixteenth rank in IPM. 24 corporates have crossed the growth of IPM amongst the top 50. Akumentis has the highest growth of 49 per cent followed by Ajanta at 41.2 per cent and Apex at 40.9 per cent. 16 corporates showed double digit growths amongst the top 50.

Amongst the 11-20 ranked corporates, Macleods has the highest growth of 27.9 per cent followed by Ipca at 21.2 per cent and Aristo at 16.2 per cent. Amongst the 51-60 ranked corporates, Panacea grew at 36.9 per cent followed by Troikaa at 22.3 and Systopic 20.3 per cent. Amongst the 61-75 ranked corporates, Lincoln grew at 43.7 per cent followed by Corona at 36.3 per cent and Serdia at 19.6 per cent.

Indian companies have grown at 9.1 per cent versus 1.5 per cent for MNCs in July 2014. Amongst the top 50 in MNCs MSD and Janssen grew at 6.9 per cent and Ranbaxy at 5.7 per cent. Under the non-NLEM category, Indian companies de-grew at 11.1 per cent whereas MNCs de-grew at 2.5 per cent.

The DPCO 2013 containing molecules market was at –0.7 per cent whereas the non-DPCO market grew by 8.9 per cent resulting in an overall growth of 7.2 per cent for July 2014.

NLEM category showed positive unit growth at 3.2 per cent. The DPCO

The Odisha market grew the highest at 18.6 per cent followed

by Mumbai market at 14.2 per cent, Telangana and Kolkata at 13.7 per cent

2013 portfolio for Pfizer degrew at 16.7 per cent, GSK de-grew at 7.9 per cent and Ranbaxy grew by 18.2 per cent.

From therapy perspective, 12 therapies have outgrown the IPM growth and eight therapies have double digit growths. The respiratory market de-grew at -1.4 per cent, gastrointestinal market grew at 7.6 per cent whereas the anti-infectives de-grew at 1.1 per cent. The anti-diabetic market grows at 28.3 per cent and cardiac at 10.6 per cent in chronic business. Derma market grew by 12.6 per cent and urology market at 24 per cent.

From the regional perspective, 14 regions have outgrown the IPM growth. The Odisha market grew the highest at 18.6 per cent followed by Mumbai market at 14.2 per cent, Telangana and Kolkata at 13.7 per cent. Three regions had negative growths in July 2014.

Amoxycillin + Clavulanic acid

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September 1-15, 2014

MARKET market grows at 9.30 per cent whereas Glimepiride + Metformin grows at 24.20 per cent at number two. The markets of Montelukast + Levocetirizine grew at 20.9 per cent, Atorvastatin grew by 12.7 per cent, Paracetamol at 10.8 per cent, Probiotic Microbes at 14.2 per cent, Vitamin D at 34.6 per cent, Voglibose + Metformin + Glimepiride market at 61 per cent, Paracetamol + Tramadol at 29.7 per cent, Rosuvastatin 25.7 per cent.

Glycomet-GP grows at 17.7 per cent, Mixtard at 14.9 per cent and Dexorange at 13 per cent amongst the top 10 brands.

Amongst the brands who have gained ranks include Thyronorm (+39), Dolo (+36), Skinlite, Losar - H & Lantus (+11), Shelcal (+10), Dexorange (+9), Liv -52 (+8), Glycomet-GP (+6), Clavam (+4), amongst Top 100 brands over July 13.

Amongst the top brands in the IPM, Galvus Met (47.6 per cent), Duphaston (29.2 per cent), Lantus (19.7 per cent), Pan (18.2 per cent), Glycomet GP (17.7 per cent), Skinlite (17 per cent) grew fastest amongst top 30 brands over July 2013.

A total of 232 brands were launched in July 2014. LNBeta, Graviderm and Zerodol PG were the top NIs for the month of July 2014. There is a new category launched in the market – Aceclofenac + Pregabalin .

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

Terminologies used MAT – Moving Annual TotalMTH – MonthVal (Cr) – Value in CroresMS per cent – Market Share in PercentageGR per cent – Growth in percentage.

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

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September 1-15, 2014

(Val in Crs)

With Bonus Units at Full Value Val in Crs CORPORATE IPM Abbott + Abbott HC + Novo Sun Pharma Cipla Zydus + Biochem Ranbaxy Mankind Glaxo Alkem + Cachet + Indchemie Lupin Pfizer + Wyeth Emcure + Zuventus Macleods Intas Sanofi India + Universal Aristo Torrent Glenmark Dr. Reddys Micro + Bal Ipca USV Wockhardt Novartis Alembic FDC Unichem MSD + Fulford + Organon Cadila Indoco Remedies Franco Eris Himalaya

Rank MAT

MTH

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32

1 2 3 4 6 5 9 8 7 11 12 10 14 15 13 16 18 17 19 20 21 22 23 24 25 26 27 28 30 29 31 32

Val (Cr) 78902 4933 4269 3867 3397 3055 2790 2761 2698 2649 2289 2183 2152 2043 1956 1928 1744 1702 1679 1606 1420 1419 1237 1129 1066 820 798 784 679 600 579 575 481

Val in Crs

MAT July -14 MS% 100 6.25 5.41 4.90 4.30 3.87 3.54 3.50 3.42 3.36 2.90 2.77 2.73 2.59 2.48 2.44 2.21 2.16 2.13 2.04 1.80 1.80 1.57 1.43 1.35 1.04 1.01 0.99 0.86 0.76 0.73 0.73 0.61

GR% 6.4 3.2 15.7 5.9 5.8 1.8 4.9 -16.4 7.2 12.3 4.1 12.7 14.8 14.4 -1.9 14.3 3.0 15.8 7.2 11.0 21.8 8.4 5.6 -2.5 9.1 2.5 8.3 11.4 16.6 6.5 11.2 21.0 5.6

Val (Cr) 7161 443 387 344 295 266 272 244 248 249 200 192 223 185 178 188 169 150 154 148 133 126 103 99 92 74 72 67 59 54 55 52 44

MAT July 14

Jul-14 MS% 100 6.19 5.41 4.81 4.12 3.72 3.80 3.40 3.46 3.47 2.80 2.68 3.11 2.59 2.49 2.63 2.36 2.10 2.15 2.06 1.85 1.76 1.43 1.38 1.29 1.04 1.00 0.93 0.83 0.75 0.76 0.73 0.62

GR% 7.2 5.4 14.4 9.5 5.6 5.7 9.1 -9.5 1.0 13.2 1.4 5.4 27.9 12.9 4.0 16.2 12.6 9.6 11.9 12.4 21.2 8.2 7.9 -2.5 4.7 0.5 13.1 6.9 3.9 3.3 6.9 8.1 8.1

Month July-14

Super Group

VAL IN CRS

GR%

VAL IN CRS

IPM

78902

6.4

7161

GR% 7.2

ANTI-INFECTIVES

12739

-1.2

1160

-1.1 10.6

CARDIAC

9727

8.6

870

GASTRO INTESTINAL

8999

6.5

869

7.6

VITAMINS / MINERALS / NUTRIENTS

7093

6.8

661

7.5

RESPIRATORY

6119

8.0

473

-1.4

ANTI DIABETIC

5718

18.0

541

28.3

PAIN / ANALGESICS

5653

4.8

533

8.5

NEURO / CNS

4856

6.8

436

8.5

DERMA

4571

14.4

419

12.6

GYNAECOLOGICAL

4087

1.7

377

6.4

OPHTHAL / OTOLOGICALS

1420

9.9

132

10.3

HORMONES

1324

3.6

114

4.9

ANTI-NEOPLASTICS

1295

26.9

111

29.0

VACCINES

1161

-7.8

85

-19.1

BLOOD RELATED

1019

4.9

91

-1.1

OTHERS

936

5.4

86

12.1

UROLOGY

779

14.1

78

24.0

ANTI MALARIALS

619

0.2

55

-9.2

SEX STIMULANTS / REJUVENATORS

434

2.7

36

3.4

STOMATOLOGICALS

354

10.1

33

10.7

MARKET PRE EVENTS

Pharmexcil to celebrate 10 annual meet with host of events th

Minister of Commerce, Government of India, senior officials from Department of Commerce, Pharmaceuticals, Health, DCG(I), Science & Technology, AYUSH, officials of the state governments, state FDAs are likely to participate PHARMACEUTICALS Export Promotion Council of India will celebrate its 10th Annual Meet on September 18 and 19, 2014. The council will celebrate the event by organising a number of activities.

Nirmala Sitharaman, Minister of Commerce, Government of India, senior officials from Department of Com-

merce, Pharmaceuticals, Health, DCG(I), Science & Technology, AYUSH, officials of the state governments, state FDAs are likely to participate during the event.

Technical conferences on Regulatory and Drugs for Rare Diseases (Orphan Drugs) will be organised on September 18 and 19, 2014.

Conferences will be held on 'Best – Practice Pharmaceutical Quality System (The way Forward for Quality Culture and Compliance)', where eminent speakers from US FDA, UK MHRA, WHO, UNISCO, GMP Consultants, industry will make presentations and 'Rare Diseases and Orphan Drug Development Initiatives

in India' and experts from rare disease research, USA and other eminent researcher in the field will be making presentations.

On September 19, 2014, CEO’s conclave will be held where all CEOs of the pharma industry will be invited to deliberate on export-related issues every year. Export and

patent awards for outstanding performance in exports and patents will be distributed for year 2013-14. All past chairmen of the council will be felicitated on this occasion. On September 19, 2014, the statutory annual general meeting will be held.

EP News Bureau – Mumbai

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MARKET

UBM India announces PharmaLytica India 2014 To be held in Bangalore from September 25 to 27, 2014 UBM INDIA, host of CPhI / PMEC India, announced the maiden edition of its second pharma show in India, PharmaLytica 2014. The event will be held at BIEC, Bengaluru from September 25-27, 2014. The event is exclusively supported

by Karnataka Drugs and Pharmaceuticals Manufacturers’ Association (KDPMA). PharmaLytica has also received support from India Pharmaceutical Association (IPA), Confederation of Indian Pharmaceutical Industry (CiPi) and Association of Contract Research Organization (ACRO).

PharmaLytica 2014, along with the exhibition and conference, will see a congregation of R&D heads and decision mak-

ers from pharmaceuticals, contract research, clinical trials, and biotechnology. Serving as an industry platform, the event will connect the pharmaexpertise from India and international markets with the pharma manufacturers, outsourcing solution providers, including clinical trials, contract research, custom manufacturing, biotech, IT and analytical services from across India and select global markets.

Over 100 exhibitors including industry leaders like Aditya Birla Group of Science & Technology, Thermax, Newtronic Lifecare Equipment, Borosil Glass Works, Thermolab Scientific Equipments, Millipore India, KNF Pumps + Systems (In-

The event will see a congregation of R&D heads and decision makers from pharma industry, contract research and clinical trials

dia), Peak Scientific Instrument (India), Clearsynth Labs, Integrated Cleanroom Technologies and Eureka Forbes amongst others will participate.

Joji George, Managing Director, UBM India said, “PharmaLytica 2014 will form a backdrop for all the key players in the Indian pharma sector congregate to connect, share and ideate. Against the Indian landscape for the pharma industry, with Karnataka leading the biotechnology revolution and attracting large investments in the sector, UBM India has opted for the state capital to host PharmaLytica 2014. The choice of city as a venue for the event has been further validated by the fact that the state

has over 180 biotech companies in India, amongst which, over 130 companies are based in Bengaluru.”

Jatish Sheth, President, KDPMA said, “UBM India and KDPMA are working closely to bring in participation of industry players at the inaugural event of PharmaLytica 2014.

Through this industry event, we look forward to showcase Karnataka and southern region of India as a upcoming pharma hub with great potential to build business opportunities within India as well as globally, thus making Karnataka, the preferred destination for the pharma sector.”

EP News Bureau – Mumbai

LexWitness to host 3rd annual edition of The Pharma Legal & Compliance Summit The summit will be an initiative to cut through legal and regulatory challenges being faced by the Indian pharma industry LEX WITNESS will hold the 3rd annual edition of The Pharma Legal & Compliance Summit. The summit, which will be held on September 19, 2014 in Mumbai, will have brainstorming sessions with the leaders and veterans of the industry.

The summit will have fourfocused panel discussions broadly for; Compliance and Best Practices; M&A & FDI; IPR - Wining the Wars | Challenge the Challenges; Comprehending Regulations to Drive Strategic Moves– NPPA DPCO 2013 and Clinical Trials.

The Indian Pharma industry is struck hard by the regulators' stringency. The commotion in industry is mostly because of lack of understanding of various

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The summit will have fourfocused panel discussions broadly for; Compliance and Best Practices; M&A & FDI; IPR Wining the Wars | Challenge the Challenges; Comprehending Regulations to Drive Strategic Moves– NPPA DPCO 2013 and Clinical Trials pharmaceutical players in the country towards increasing regulations and strictness towards such regulations. Both domestic

and international regulators are keeping a stringent watch on pharma regime.

With 100 per cent brownfield

and greenfield investments in Indian pharma; the market stands to see an enormous growth in times to come; this growth seems to be promising enough keeping in mind what the European Commission and US FDA have opined recently. It has also raised the scopes of M&A & FDI to the heights that once seemed uncertain. These transactions seem to be promising a lot of international interest which at the same time calls for a lot of housekeeping for the India players, right from legal best practices to marketing strategies. There also remains a need for a clear understanding of check points for acquiring assets overseas.

While being compliant was

still a challenge the increasing complications that the industry has been facing, the US FDA’s increase in issuing notices; has further stressed upon its dire need. The NEW COMPANIES ACT 2013 has further added on to its intricacies. A close watch on all trade and product promotion practices has become yet another vigil act amidst the pharma players.

Various aspects of IPR still has a lot of grey air around it.

Ever greening of patents remains a debate. Moreover, increasing compulsory licenses and increasing need of patent linkage has created more uncertainty in the industry.

EP News Bureau – Mumbai

MARKET

Asia Pharma Expo 2015 to be held in Bangladesh More than 470 exhibiting companies from 28 countries will participate ASIA PHARMA Expo 2015 (APE2015), the 7th international exhibition on complete pharma manufacturing technologies, is an acknowledged business platform for all companies currently having business ties with Bangladesh. Asia Pharma Expo 2015 is scheduled to be held from January 8 to 10, 2015 at the Bangabandhu International Conference Centre in Dhaka, Bangladesh.

Asia Pharma Expo 2015 will be beneficial to all participants from local business associates to international machinery manufacturers and even API / bulk active manufacturers get benefits from participation in the exhibition. The APE 2015 will have more than 470 exhibiting com-

panies from 28 countries along with 8,500 square metres of floor space and 9,000 trade professionals are expected to visit the show.

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

Bangladesh is one of the fastest growing economies of the

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In Bangladesh, the pharma sector is one of the fastest growing sectors

world and pharmaceutical segment has always been top priority for the nation. There are more than 300 pharma multinational corporations operating in

the country producing 97 per cent of the local demands for drugs. With an annual double digit growth rate, the pharma industry in Bangladesh is heading towards complete self sufficiency in meeting local demand.

There is a surety of steady growth in investments and sustained future development in the pharma industry in Bangladesh.

In Bangladesh, the pharma sector is one of the fastest growing sectors. In 2008 the total size of the pharma market in Bangladesh was estimated to be $700 million and is growing at a steady rate. The pharma sector is the second highest contributor to the national exchequer and the largest white collar labour intensive employment sector of

the country. There are 245 registered pharma manufacturing companies in Bangladesh.

Today, the Bangladesh pharma industry successfully exports APIs and a wide range of products covering all major therapeutic classes and dosage forms to 71 countries. Beside regular forms like tablets, capsules and syrups, Bangladesh is also exporting high-tech specialised products like HFA Inhalers, CFC Inhalers, Suppositories, Nasal Sprays, Injectables and IV Infusions. These products have been well accepted by medical practitioners, chemists, patients and regulatory bodies of all importing nations.

EP News Bureau – Mumbai

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EVENT BRIEF SEPTEMBER -OCTOBER 2014 17

Kenya Pharma Expo 2014

KENYA PHARMA EXPO 2014 Date: September 17-19, 2014 Venue: Kenyatta International Conference Centre (KICC), Nairobi, Kenya Summary: Kenya Pharma Expo is a three-day exhibition dedicated to the professionals involved in the pharmaceutical industry of Kenya and abroad. The exhibition will open its doors to the trade business visitors in the capital city of Nairobi. The exhibition will be focusing mainly on the technologies that are used in industries situated in the eastern and southern parts of Africa. It presents an ideal platform for the exhibitors to talk and interact with prospective business visitors at a single place.

Professionals from pharma processing equipment, packaging machineries and materials, API such as bulk actives, lab

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3rd Annual Edition of The Pharma Legal & Compliance Summit

equipments like glass wares and consumables, utilities products and services, CRO and research, contract manufacturing, consultants and turn key contractors, trade promotion councils and trade publications will participate.

Contact details Tel: +91 7940008233/ 53 Mob: +91 8000481114 Email: ceo@ GPEexpo.com Website: Kenya PharmaExpo.com

3RD ANNUAL EDITION OF THE PHARMA LEGAL & COMPLIANCE SUMMIT Date: September 19, 2014 Venue: The Leela, Mumbai Summary: Lex Witness will hold the 3rd annual edition of The Pharma Legal & Compliance Summit. The summit will have brainstorming ses-

sions with the leaders and veterans of the industry. The summit will have four-focused panel discussions broadly for; Compliance and Best Practices; M&A & FDI; IPR - Wining the Wars | Challenge the Challenges; Comprehending Regulations to Drive Strategic Moves– NPPA DPCO 2013 and Clinical Trials.

Contact details: Bhupinder Kaur Manager Marketing Lex Witness - India's 1st Magazine on Legal & Corporate Affairs # 426, 2nd FloorMG Road, Ghitorni New Delhi - 110030 Tel: +91.11. 66569793 Mob: +91.9654155065 Email: Bhupinder@WitnessLive.in Website: www.witnesslive.in

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PHARMALYTICA 2014 Date: September 25-27, 2014 Venue: BIEC, Bangalore Summary: UBM India will host PharmaLytica 2014 in Bangalore. It will be a combination of a trade fair and conference where participants can pick up on the latest industry trends, techniques and methods. It is a platform connecting the pharmaceutical community with outsourcing solution providers, including clinical trials, contract research, custom manufacturing, biotech, IT and analytical services. PharmaLytica 2014 will spread over 2,000 sq mt featuring over 100 plus exhibitors.

The event will be supported

by Karnataka Drugs and Pharmaceuticals Manufacturers' Association (KDPMA). Also, India Pharmaceutical Association (IPA), Confederation of Indian Pharmaceutical Industry (CiPi)

PharmaLytica 2014

and Association of Contract Research Organization (ACRO) will support the event.

Contact details: Rahul Deshpande Sr. Manager - Projects Tel: +91 22 61727165 Mob: +91 98209 02476 Email: rahul.deshpande @ubm.com

9TH ANNUAL CONFERENCE OF DIA Date: October16-18, 2014 Venue: Mumbai Summary: DIA will organise 9th Annual Conference where national and international speakers are likely to participate. The theme of the meeting is ‘The Future of Indian Healthcare: Patients, Access and Innovation’ chaired by Prof Ranjit Roy Chaudhury, Chairman, Task Force for Research Apollo

Hospitals Group and Alexandra Pearce, Senior Vice President and Head Global Regulatory Affairs, Glenmark Pharmaceuticals. The programme will include sessions on topics including patient health safety and compliance for prescription medicine, patient participation in clinical trials, universal health coverage and health insurance, medicine pricing and reimbursement, compulsory licensing, innovations in healthcare solutions etc.

and scientists, policy makers, diplomats and foreign commercial corp, compliance, process engineering, corporate management, procurement department, custom manufacturing/ marketing services, purchase

officers, equipment suppliers and distributors, quality assurance/ quality control, maintenance engineering, R&D professionals, manufacturing/ production engineering, regulatory officers, operations man-

agement, validation, packaging engineering, vendor development, pharmacists.

Contact details: Indian Pharma Machinery Manufacturers’ Association

(IPMMA) 52, 1st floor, Suyog Industrial EstateLBS Marg, Vikhroli (West) Mumbai - 400 083 Tel: +91 22 6561 9272/ 2578 6007/ 2685 5108

Contact details: Drug Information Association A-303, Wellington Business Park - IMarol, Andheri - Kurla Road Andheri (East) Mumbai - 400 059 Tel: +91.22.67417625 Website: www.diahome.org

ASIA PHARMA EXPO-2015 Date: January 8-10, 2015 Venue: Bangabandhu International Conference Centre, Dhaka, Bangladesh Summary: Bangladesh Association of Pharmaceutical Industries will host international exhibition on South Asian Pharmaceutical industry, Asia Pharma Expo-2015. The exhibiting companies from more than 26 countries across the world are expected to participate. The expo will be accommodating 400 booths to the exhibitors. Major OEM suppliers from Asia, Europe and the US are likely to participate.

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

PHARMA PRO & PACK EXPO 2015 Date: May 13-15, 2015 Venue: Mumbai Exhibition Centre, Mumbai Summary: PHARMA Pro & Pack Expo 2015 will be organised by IPMMA. 20,000 pharma trade professional/ decision makers and 250 industry majors will exhibit their technologies/ services. Visitors' profile include biotechnology specialists, plant management, CEOs, engineers, technocrats

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cover )

FOLLOWING FOOTSTEPS IN THE

A SPECIAL LOOK AT MENTORING IN THE PHARMA INDUSTRY AS MENTORS AND MENTEES CONTINUE THE GURU-SHISHYA TRADITION

INSIDE INSIDE 20 EXPRESS PHARMA September 1-15, 2014

THE LEARNING FOLLOWING IN THE AMULTITUDE OF CURVE |22 FOOTSTEPS |25 GURUS |27

(

THE MAIN FOCUS

{

Teachers’ Day S P E C I A L

TEACHERS WHO TEACH STUDENTS TO THINK |30

THE EVOLUTION OF MENTORING |31

}

INTERVIEW: DR ARUN GARG |32 EXPRESS PHARMA

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cover )

THE LEARNING CURVE EMPLOYEES LOOK AT MUCH MORE THAN JUST A PAY PACKAGE FROM EMPLOYERS. CAREER GROWTH AND A CULTURE OF MENTORSHIP CAN FOSTER LEADERSHIP AND ENSURE EMPLOYEES RISE THROUGH THE RANKS. SHALINI GUPTA REPORTS

T

eacher student relationships have for long been a pivotal point in furthering learning in educational institutions.

However, workplaces are also an extension of the learning process.

Mentorship programmes that help train future leaders within a company do much more than that; they help increase organisational efficiency, bring in more clarity of the career path and boost employee morale.

However, the concept is still nascent in the pharma industry and yet to

22 EXPRESS PHARMA September 1-15, 2014

pick up

A long journey Commenting on the Indian scenario, Thammaiah BN, Country Director, Kelly Services India says that although mentoring as a concept is picking up in India, with large organisations seeing measurable RoI such programmes have, the concept of mentoring that is structured with a concrete progression plan for the mentee, does not exist in most of them. “Within the pharma space in India, we are now observing that there are companies with mentorship programmes to help employees have an overall development as a

professional. However, when compared to the other sectors, we still feel that it’s in its nascent stage and needs to evolve further to make it more inclusive.”

Sridhar Ganesan, Country Head, Hay Group India opines that Indian pharma companies are evolving when it comes to understanding the importance of robust people management systems as a critical lever to sustain growth. People development, as a broader umbrella, however, is gaining ground alongwith performance measurement systems going beyond just focusing on financial metrics to goals related to employee/team development, he feels. He shares Thammaiah’s stance when he says, “Mentorship in Indian pharma organisations is yet to establish its presence in its

true form. At present, there are instances of informal mentoring happening, but in pockets and across select entities only. Clearly, mentoring activities in Indian pharma are in no comparison to other sectors such as FMCG and IT where there are formal systems and processes enabling mentor mentee relationships. The Indian pharma indutry has to undertake a fairly long journey before they reach that level of process maturity.”

Clearly, the pharma industry is yet to be counted as one where a healthy mentorship culture thrives. However, a few multinationals operating in India have global programmes that run for the senior management. These are customised to India and have been quite successful.

Sudakshina Tyagi, Senior

( Consultant, Hay Group India, touches upon the mentoring programmes of Indian arms of MNC pharma companies mostly mandated by the regional and global teams and rolled out locally. She cites the case of an innovator organisation which has a structured mentoring programme for their key talent in mid to senior levels across functions. It enables them to seek inputs in the area(s) identified for development and groom themselves for greater effectiveness as well as build rapport with a senior colleague in the organisation for guidance and perspective. They had also initiated a local programme called ‘Mentor Minds’ for their front line sales (including field representatives and area man-

agers) to enable a rounded professional growth for mentees, she adds. Another leading Indian MNC with increasing global presence has initiated a mentoring programme focused on high potential talent thrown up by the performance management system. Right now it is focussed on a select few employees who have displayed exemplary potential to take on larger responsibilities.

Such programmes will help initiate atleast some momentum and their success or failure should be a learning experience to better developed programmes of the future.

Bag of benefits The pharma industry has been beset with a lot of challenges lately including tightening reg-

We see a lot of companies hiring coaches for their top executives from outside as these coaches bring in a neutral view without any prejudices Thammaiah BN, Country Director, Kelly Services India

THE MAIN FOCUS

ulations, changes in technology, government policy, consumer expectations coupled with globalisation, sagging economy and shrinking R&D budgets. Amidst all this, the ability to adapt to new environment becomes critical for pharma organisations. Mentoring can enable such a transition very smoothly, feel analysts. Ganesan feels that the success of a mentor-mentee relationship depends on the maturity levels of the participants to the process and hence serves its purpose best above mid management level.

“With so many issues surrounding sales effectiveness, sales as a function could be another area where mentoring can be strategically utilised to strengthen an individual’s

identification with the company and thus reduce turnover intentions. This, when, sales manpower is distributed, remote and has limited connect with the organisation at large,” he says.

Sales teams also need to scale levels of responsibility in an accelerated manner, he chips in. Mentoring helps digest the new accountabilities in a realistic manner. For instance, making a shift from a therapy intensive role to a general management role with different therapies in the portfolio requires different approaches to work. Mentor can help the protégé to make this transition much more seamlessly. However, there needs to be a fit between the mentor and the mentee, compatibility is the key

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cover ) It is surely difficult for seniors in this industry to take on additional mentoring responsibilities along with their current roles and responsibilities especially in the light of such swift changes in the external environment impacting an organisations’‘time to market’ Sridhar Ganesan, Country Head, Hay Group India

Overall maturity levels of people management process, resistance of identified managers to spend time on mentoring activities while balancing their work responsibilities, are some of the barriers we need to overcome to create a viable ecosystem Sudakshina Tyagi, Senior Consultant, Hay Group India

24 EXPRESS PHARMA September 1-15, 2014

Mentoring helps digest the new accountabilities in a realistic manner.

For instance, making a shift from a therapy intensive role to a general management role with different therapies in the portfolio requires different approaches to work here. “We believe that a mentor/mentee should be given the liberty to choose each other, as it is important to have a connect between the two for the mentorship to work. At the same time, every mentor should be involved and needs to provide sufficient space to the mentee to grow and absorb the skills being imparted by the mentor,” echoes Thammaiah.

The benefits of mentoring are clear, but the lack of its initiation as a formalised system and process in the Indian pharma industry is proof enough of the potential barriers for effective implementation.

“Overall maturity levels of people management process, resistance of identified managers to spend time on mentoring activities while balancing their work responsibilities, accessibility and approachability of mentors and institutionalisation of a mentoring culture which is enabled by employee maturity and supporting processes yielding consistent control and hence outcomes, are some of the barriers we need to overcome to create a viable ecosystem,” postulates Tyagi.

Leaders as mentors?

Often it is the senior leadership within an organisation that has to assume the role of mentors unless there is a sys-

tem of external mentors.

Clearly, they can’t do so, if they lack the qualities required to fit the role. It also needs to be understood that their plate is already full when it comes to the responsibilities they already shoulder and so how do they balance the two roles? Is mentorship an extension of leadership and is senior management in companies well equipped to take it up? Ganesan offers a reality check.

“It is surely difficult for seniors in this industry to take on additional mentoring responsibilities along with their current roles and responsibilities especially in the light of such swift changes in the external environment impacting an organisations’ ‘time to market’.

Mentoring is contingent on the level of seriousness both the mentor and his or her protégé impart to the entire process and requires time.

Quite often than not, in an organisation with formalised mentoring systems more true for another sectors, seniors sometimes display reluctance, viewing expectations around mentoring as an imposition or another drain of their time”.

Even as leadership effectiveness subsumes an ability to mentor one’s team to move further up in terms of their growth and develop-

ment, there is a need for a sustained effort to up-skill leaders in this aspect and enable them to carry this out with ease. Leaders need to display certain critical attributes in him/ her to be effective mentors. These include understanding and strongly exhibiting company values, having people development skills, problem solving ability and communication abilities.

They need to possess a sound knowledge of career paths inside, and even outside, the organisation as well as a sensitivity to the mentee’s needs and aspirations. Their efforts must be directed at enhancing the mentee’s career potential, while looking for ways the mentee’s potential can benefit the organisation.

In some companies, mentoring at the very senior level is conducted by well-known external coaching companies or individuals. The top executives are then expected to pass on the learning’s to their teams. “We see a lot of companies hiring coaches for their top executives from outside as these coaches bring in a neutral view without any prejudices. For midlevel managers, mentors are identified within the system to groom employees on particular skill sets. More often than not, these are mentors who already have a particu-

lar role in the organisation but are willing to take up this additional responsibility of mentoring. This ensures the mentee is comfortable and as the mentor is from within the system, and helps saves cost too,” says Thammaiah.

Thus, mentoring is a critical part of human resource development within a company and needs to be in tune with cost cutting strategy of companies even as they strive towards better talent development strategies. “Most companies find it difficult to balance cost cutting and talent development and more often than not end up impacting employee productivity while doing the same. There is also a growing recognition that mentoring compliments other employee learning activities. Thus, in the face of cost cutting when training related activities are on the decline, mentoring can act as one of the most cost effective tools especially if it is based on an internal model (internal mentoring) .

However, mentoring standalone may not be sufficient to drive an effective development agenda for an employee. It has to be part of a holistic people development architecture,” concludes Ganesan. shalini.g@expressindia.com

(

THE MAIN FOCUS

THE INDIAN PHARMACEUTICAL INDUSTRY HAS SEEN PROMOTERS LIKE SURESH KARE, CHAIRMAN, INDOCO REMEDIES HAND OVER THE BATON TO THE NEXT GENERATION. KARE AND HIS DAUGHTER ADITI KARE-PANANDIKAR, MANAGING DIRECTOR, INDOCO REMEDIES, ARE SET TO STEER THE FIVE-DECADE OLD COMPANY INTO THE NEXT PHASE OF GROWTH. SACHIN JAGDALE REPORTS

FOLLOWING IN THE FOOTSTEPS

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M

entorin g is all about picking up a right brain and spotting a ear to listen. Suresh Kare, Chairman, Indoco Remedies, was lucky that he found both in his daughter Aditi KarePanandikar, who is now also Managing Director (MD) of the company he founded.

It is very clear that the pharma industry, like most sectors, is facing tougher times today. During the year 2013-14, Indoco clocked a 15.44 per cent growth, with the total income amounting to ` 72946 lakhs as compared to ` 63189 lakhs in the previous year. With Profit Before Tax (PBT) at ` 7211 lakhs as compared to ` 4837 lakhs in the previous year (a 49.08 per cent increase), Indoco has managed to increase PBT and Profit After Tax (PAT) mainly due to reduction in input and other costs but there is no doubt that the general slowdown in global economic growth combined with more stringent regulations in India are a double whammy.

But in tune with the company's tagline of 'Constantly evolving.

Consistently excelling', both father and daughter, along with the management team seem confident about their strategy

for the future.

Parents, the natural mentors It all started at home for Aditi.

She grew up observing a father who is considered a visionary in the Indian pharma industry. Her entire childhood and growing up years were a learning process for her.

School and college taught her text book lessons whereas her father taught her from the book of real life experiences.

Aditi says, “Parents are the greatest and most natural role models that children learn from and mimic as they grow.

Growing up, children are exposed to the outside world, the extended family, friends, teachers, etc., in whom they then try and find mentors or persons to idolise. In my case, I was very fortunate to have found a mentor in my father.

The early childhood nurturing continued through my school and college years and later at work as well.”

She adds, “The greatest benefit of having a parent as a mentor is that the learning never stops. To be able to observe at close quarters, a father in professional capacity and a boss in personal life has been an invaluable experience.

To date, my ability to switch hats from MD of a company at work, to a mother, wife, homemaker, daughter and sister at home and vice versa is entirely because I had the opportunity

to see my father balance his work and home very successfully.”

Lessons to remember The real life lessons that Aditi learned from her father proved instrumental in grooming her into a successful entrepreneur. She has spent enough time as MD of the company but this journey was never a cake walk as one would have thought. However, thanks to her father's mentorship, Aditi managed to sail through difficult situations independently.

“Benjamin Franklin’s quote, 'Tell me and I forget, teach me and I may remember, involve me and I learn', has been used much too often. But frankly it embodies Kare’s mentoring to the core. His mentoring has been more of a coaching of the mind than for a specific situation and that I am most thankful for. Today the business environment for the pharma industry is extremely dynamic. To survive and grow in these times, quick decision making and judgement coupled with a deep understanding of one’s business are a necessity. I give a lot of credit to my father for how he groomed me within the organisation,” says Aditi.

According to Aditi, her father has some great personal qualities like a great work ethic, passion for excellence, high moral standards and respect for the individual.

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cover ) Aditi Kare-Panandikar, Managing Director, Indoco Remedies

Normally one hears of friction amongst two generations but it is this largely adaptive mentoring adopted by my father that has allowed our relationship to grow from strength to strength

These are qualities that never go out of fashion for any leader.

Still a mentee After a successful stint of many decades, Kare passed on the baton to Aditi and now she has stepped into the shoes of a mentor to her staff. However, Aditi believes that learning is a continuous process and one really does not ever stop being a mentee.

Even today she continues to be mentored by her father as the situation demands. As she says, “Like everything else, our mentor-mentee relationship too has evolved over time from a very telling style adopted by him in my childhood to a selling style in my teen years to participative in my youth to that of complete decentralisation today. Normally one hears of friction amongst two generations but it is this largely adaptive mentoring adopted by my father that has allowed our relationship to grow from strength to strength. For me it has meant a selfless and unconditional lifelong presence of a friend, mentor and guide.”

According to Aditi, an indepth understanding of your organisation is key, if you have to command respect from and earn the trust of your employees. Both these are fundamental for any good leader. Aditi’s stint of two decades at Indoco in various capacities and across most departments before she was appointed the MD of the company inculcated leadership qualities in her. Today, life has come a full circle for her as she herself takes

26 EXPRESS PHARMA September 1-15, 2014

on a mentorship role.

Aditi opines, “The principal job of the MD of any organisation is to manage it effectively and drive the people within to achieve the set goals and desired objectives. Strategic decision making, leadership and team building gain primary importance and success is largely dependent on the leader’s ability to create followers. In that respect, I guess an MD is a mentor of sorts.”

People look at Kare as Aditi’s mentor, however, she believes that his mentorship role was never ever confined to her. From a handful of people he started with in 1963, the Indoco family today encompasses over 5500 people, who look up to him for inspiration. Aditi infroms, “Kare’s greatest strength is his ability to carry people along. This has resulted in creation of successful management teams at every level at Indoco. Today amongst the senior management, besides Sundeep Bambolkar, Joint Managing Director, who has worked with Kare for over three decades, there are many others at Indoco who have benefited from his mentoring and have successfully risen in their career.”

Steering the next gen The highlight of Kare’s mentoring is he never tried to fit Aditi into his own image. Rather he gave her the opportunity and the space to create a niche for herself. Kare goes down the memory lane to describe how for

Aditi, pharma was always the first choice as a career.

Kare narrates an interesting story about Aditi from her childhood. He says, “As a child, Aditi was keenly interested in business. Once, while driving past an MNC office in Worli, she had commented that one day she wanted to see Indoco become larger than the MNCs in India.

She would regularly accompany me to our Andheri manufacturing plant and sometimes sit on the packing lines, on the laps of the packing girls. Her relationship with the company had started back then. Having shown a desire to join the business, it was but natural for her to pursue an education in pharmacy.”

He adds, “During vacations, she would work in the quality control laboratory to get a firsthand experience of an industrial lab. When she decided to pursue further education in the US, she chose to do her masters in pharmaceutical administration at the Ohio State University in Columbus, Ohio. Being fiercely independent by nature, she refused to let me accompany her on her journey to the US. It turned out to be a very exciting trip, which

she later related in a letter to her mother and me.”

As managing people was the most important skill required to manage a corporate, Aditi majored in HR Management and returned to India in December 1992. She joined Indoco in January 1993.

“I have always been more of a friend than a father to my daughters. That has made it easier to talk freely and discuss things even if there are disagreements. In our family, dinner time would be an interesting and eagerly awaited time of the day, when we would deliberate upon matters relating to Indoco. This camaraderie that we shared helped in a big way and the generation gap was never an issue,”points out Kare.

Challenges for Aditi The old days of the 1960s when Kare started his company were quite different. The company was a small setup and was still to carve a space on the larger canvas. When Aditi came on board, she found herself at the helm of a stable venture but one that faced challenges of a different order. It needed to grow to the next level if it was to face future challenges.

Kare informs, “When I took over as MD in 1963, we were a small company with an annual turnover of ` 3 lakhs. There were only 30 employees and mounting losses. In the early days, my main challenge was finance.”

He adds, “By the time Aditi joined, the company had become

relatively financially stable with a presence across the entire country. On her very first day, en route to office, I told her that she would experience a very different Indoco from what I had experienced in my initial years. I had the liberty of making mistakes and getting away with them while she did not. A mistake made by her could cost the company dearly and hence it would be her responsibility to make correct decisions. I told her that in order to maintain a sustained growth, it was important to aim at growing at a rate twice that of the inflation rate in the country.”

Aditi always understood the limitations of expansion in view of the not so comfortable financial position of the company.

However, both father and daughter agreed that they had to grow consistently to maintain a respectable position in the Indian pharma industry.

“Her biggest challenge was to increase the per man yield, which at that time was low as compared to other fast growing pharma companies. For a sustained growth, the company required to invest in R&D and international business.

Accordingly, our R&D centre at Navi Mumbai came up in 2004.

By this time, Aditi had a firm grip on the company’s business.

She ensured that we had a well equipped centre manned by highly qualified scientists and state-of-the-art equipment.

Continued on Page 32

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THE MAIN FOCUS

DR GOPAKUMAR G NAIR, IPR CONSULTANT AND FOUNDER CEO, PATENT GURUKUL, GOPAKUMAR NAIR ASSOCIATES RECALLS THE MANY GURUS WHO MENTORED HIM ALONG HIS PATH

A MULTITUDE OF GURUS

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H

aving moved abruptly from the (virtual) fundamental research corridors of National Chemical Laboratories, Pune and the Indian Institute of Technology, Powai, Mumbai into the then ‘harsh realities’ of the Indian pharmaceutical industry in the late sixties, I had a multitude of gurus.

Ajit Singh of Associated Capsules (of whom I remained an admirer of his astute management acumen), MK Rangnekar, the then Drugs Controller of Maharashtra State (he became a Ph.D later, but came into some disrepute), SK Borkar, the then Drugs Controller of India (a very hardened nationalist and firm believer of the future potential of Indian pharma industry), Bhai Mohan Singh of Ranbaxy who was the later President of IDMA in the early seventies and in whose house at Delhi we always used to meet when the IDMA delegation was going to Delhi to meet the then nationalist government under Prime Minister Indira Gandhi, Dr Nityanand, the then Director of Central Drug Research Institute and later Director of Ranbaxy, the list of my gurus are endless, all the more, because I entered the pharma industry as a novice.

I still remember (have a series of anecdotes to cherish) when Ajit Singh and his brother Jasjit Singh brought a ‘capsule filling machine’ (hand operated), which we (BDH – Bombay Drug House) had ordered, to our then Mahim factory in the ‘dicky’ of their car and demonstrated its operation to us, including me. The (Annual) ‘pharmacy week’ was a great time for me, because all the stalwart gurus, used to come together, on such occasions.

GP Nair and Dr Abraham Patani: First pharma gurus However, all said and done, my prime teacher was none other than GP Nair, JP (Justice of Peace), who was the then Managing Director of Bombay Drug House. who was the President of Indian Drug Manufacturers’ Association (IDMA) from its early days of 1961 to 1971, a full 10 plus years. He along with the then Founder Secretary of IDMA, Dr Abraham Patani (he has always been my favourite guru), were the prime movers of the now famous 1970 amendment of the (Indian) Patents Act, 1911 (leading to the Patents Act, 1970 and the Patents Rules 1972). On the foundation of the strong national spirit of Indira Gandhi, IDMA could get the Act amended, but IDMA being a Mumbai-based fledgling association did not have the ‘muscle’ power or ‘wherewithal’ to get the Patent Rules passed through

the various department of the Ministries involved. That is when, GP Nair and Patani came up with the idea of inviting Mohan Singh to become the President of IDMA. No sooner did Mohan Singh became President of IDMA, he managed to get the Patent Rules tabled in Parliament (it was mandatory then) and the now famous Patents Act, 1970 came into force in 1972. He was one of the immediate beneficiaries of the new Patents Act, because his branded generic product Calmpose (Diazepam which was the generic version of Valium of innovator, Roche) which grew (along with Ranbaxy) by leaps and bounds.

The other leading beneficiaries were Unichem (Padma Bhushan Amrut Mody), Dr Shanti Patel (Themis who had an alliance with an East European Pharma group), Ramanbhai Patel and AV Modi of Cadila and the triumvirate of Lyka (led by Easwarabhai Gandhi and Pannalal Choksi) and others.

Having moved from pure and fundamental research (NMR in Organic Chemistry) into pharma, I had a lot to learn from GP Nair. I still remember his parting words at the IDMA Annual Day, when he stepped down as the President. Patani and many speakers had praised him for his unstinted support to the Indian drug industry. In reply, he said, “I don’t really feel that what I have done is all that great. But I do know, for sure, what I have not done. I have

EXPRESS PHARMA

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September 1-15, 2014

cover ) After doing my Post Graduate Diploma in Patent Law and Practice I became the Dean of IIPS in Hyderabad and had the opportunity to work with the stalwarts of the pharma Industry in Hyderabad. The then Matrix (which has now evolved into Mylan) was born at the same time

never made use of the platform of IDMA for any personal gain or self-enrichment.” This was a lesson I learned from him.

Throughout my association with IDMA from the early seventies till today, I had learned from him, how not to misuse ones public office for personal gains. In this respect (and in many others including the high degree of nationalism and selfreliance), he is always remembered by me as my first guru in the pharma industry.

It is hard to remember GP Nair without his Indian pharma (junior) twin Patani.

The camaraderie between them for the national cause was immense and intense. Without hurting the sentiments of any other stalwarts, I dare to say that Indian pharma industry is what it is today, because of selfless self-reliant agenda pushed through by Patani with help from GP Nair. In later years, Patani became a mentor for me, not only in IDMA, the then Chemexcil (Export Promotion Council), on many overseas government delegations and in the evolution of IDMA Bulletin and the refinement of “Indian Drugs,” the now famous publications of IDMA. “To be a

28 EXPRESS PHARMA September 1-15, 2014

self-reliant nationalist to the core” is something I have learned from these two stalwarts. Even today, I admire Patani and adore him as my ‘guru’ in nationalism.

On Dr Yusuf Hamied and his protégés Another stalwart whom I admired and appreciated from early days is Dr Yusuf Hamied. On his return from

abroad after his studies, I met him first time in IDMA around the time he took over the mantle of Cipla from his illustrious father Dr Khwaja A Hamied (with whom I had a

good acquaintance) in early seventies. Yusuf was (and is even today) the most brilliant organic chemist and pharma chemist in India. Combining his chemistry with the burning ‘Fire in the Blood’ of true nationalistic spirit, he (and Cipla) always remained the backbone (and backbencher, forsome unusual inexplicable reasons) of Indian pharma industry.

Yusuf had this uncanny ability to bring out the best in people for a common cause.

Dr AV Rama Rao, my erstwhile colleague in NCL and who is presently the Managing Director, AVRA Laboratories, Dr (Late) Vedaraman, the then Controller General of Patents, BK Keayla of the National Working Group in Delhi and many others could, in part (other being IDMA) be termed as the ‘finds’ or protégés of the national cause by Yusuf.

In later years, NH Israni who was earlier part of the MNC bandwagon had joined the national sector through his own Blue Cross Laboratories. I consider it my proud privilege to have worked with him as well at close quarters.

Veteran turns student under Late Margi Patel-Choksi In later years, when I took the ‘reverse plunge’ out of the pharma industry, to jump into the ‘patent’ pool of the post Uruguay Round WTO/TRIPs, I had the unique experience of finding my modern era guru. The post-1970 cool and calm ‘patent waters’ was turning turbulent by the mid-nineties. In the late nineties, with my colleague in IDMA, Dr Dinesh Patel (the then President, IDMA) being the Vice President of SVKM (Shri Vile Parle Kelavani Mandal), a new institution, Institute of Intellectual Property Studies, was born. I had the privilege of being the first registered student and was also proud to meet Patel-Choksi, a fresh LLM from UK, whose assistance IDMA (under guidance from NH Israni) had taken for help in policy making. My post-sixty association with Margi Patel-Choksi, who was then in her twenties, and her working and management style, helped transform meimmensely. When all around, I had been treated as a veteran, PatelChoksi treated me purely as a ‘student’ and subjected me to all the blatant and (almost brutal) criticism and guidance a student deserves.

After doing my Post Graduate Diploma in Patent Law and Practice, under the encouragement of Patel-Choksi, I became the Dean of IIPS in Hyderabad and had the opportunity to work with the stalwarts of the pharma Industry in Hyderabad. The then Matrix (which has now evolved into Mylan) was born at the same time.

Patel-Choksi and Dwivedi, my co-student at IIPS and Principal of the then JC Law College (now the Pravin Gandhi five-year Law College) persuaded me to do my LLB, through which I am proud to have become a practicing lawyer and Patent Attorney post retirement from the pharma industry after nearly 40 years of active association. Patel-Choksi (she expired one year back) remains my youngest and fondest of the long line of gurus who made an impact in my life and because of whom I cherish and enjoy my association with the Indian pharma industry.

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Sishya turned guru: Arun Kumar, Founder and Group Chief Executive Officer, Strides Arcolab Last but not the least, I just missed naming a guru, who is in fact a sishya (protégé) turned potential guru for no fault of the guru, but because I have failed to emulate this guru. I am referring to Arun Kumar, Founder and Group Chief Executive Officer, Strides Arcolab whom I admire and wish to learn from, but in his domain, I have no ability to learn and emulate.

(With inputs from Usha Sharma)

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September 1-15, 2014

Wireless Technology

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cover ) PROF ROOP KRISHEN KHAR, PRINCIPAL, B S ANANGPURIA INSTITUTE OF PHARMACY, FARIDABAD, NCR IS A MENTOR HIMSELF TODAY BUT FEELS OVERWHELMED WHILE RECOLLECTING HIS OWN MENTORS / TEACHERS

TEACHERS WHO TEACH STUDENTS TO THINK

I

have been a student for many years in India and abroad. Teachers at every stage have played an important role in shaping my overall personality from my school days. The role of a teacher is cardinal, however, it has assumed more importance in the present context due to current times of competition and the ever expanding technology-driven pharmaceutical industry.

Students have to become continuous learners and keep abreast with newer trends and advancements. Hence a teacher has to not just play a routine role but discharge the more meaningful responsibility of being a role model to train the students, in different ways. A teacher has to not just transfer information to them, but should be able to provoke in him a process of thinking and develop it on a continuous basis by raising the quotient of ‘spirit of enquiry’ in his students.

Paying tribute to Prof Sri Nath Sharma Teachers have played a very definite role in shaping my career and destiny at every stage. In this regard, I need to mention the place of honour to my mentor/guide/teacher, who has been a constant source of inspiration to me. It is none other than Prof Sri Nath Sharma, longest living professor in pharmaceutical sciences

30 EXPRESS PHARMA September 1-15, 2014

today. We had the proud privilege of celebrating his 90th birthday at Gurgaon on August 10 this year.

My initial years at Dr H S Gour Vishvavidhyalaya Sagar (Madhya Pradesh) have laid the sound foundation in my career. I was always impressed by the immaculate and eloquent communication skills of my mentor and out of box teaching methodology adopted in mid 70s. He taught us the importance of basic concepts, clarity of thought process, sense of dress etc. He used to tell us to develop the ‘love for the printed word’, in order to have sound body of knowledge .

He also made us face challenges and problem solving techniques at a very early age.

Prof Sharma was keen that students develop skills of expression and pay adequate attention to extracurricular and professional activities. He forced me into games and sports as well, particularly indoor games like badminton and table tennis.

He also encouraged me to take up leadership roles in the University: that of Secretary of Pharmaceutical Society at Sagar University and Secretary World University Service (WUS) to develop the experience of working in a team and grooming leadership talents in me. Under his stewardship, I have grown not only during my Sagar University stint of 1967-73, but later as well when he came to Delhi in 1986. To date, I have his constant patronage and guidance. He is an institution in himself and I love

his honesty, integrity and passion for excellence.

Advice to students The pharma profession has undergone a sea change in the last five decades. We started with some 12-15 colleges in the mid 70s and now we have more than 1200 pharmacy institutions including six National Institute of Pharmaceutical Education and Research (NIPER) institutions. Nearly 60-70 per cent of these institutions are in the private sector.

The quantity is growing as per current needs but the quality has taken lower priority. We need to have better quality control mechanisms to ensure the standards of educational institutions so that students are employable as per the current demand and actual industrial and professional needs.

Students need to understand clearly that the degrees they carry will have no meaning, unless they are backed by the ‘true value’ which means proper industrial and professional skills, coupled equally with the overall personality traits of ‘ASK’ i.e. Attitudes, Skills and Knowledge. Interestingly, knowledge comes last which should also not be mere information but coupled with specific and tangible ‘core skills’ related to the specialisation and contemporary industrial needs. My humble advice to students is to be alert and discover their ‘intrinsic abilities’ which are lying dormant.

Continued on Page 32

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THE MAIN FOCUS

MENTORING HAS A SPECIAL ROLE TO PLAY IN INDUSTRIES LIKE THE PHARMA SECTOR, WHERE KNOWLEDGE IS MORE INTERPRETATIVE , SAYS V SURESH, EXECUTIVE VP AND NATIONAL HEAD SALES, NAUKRI.COM

THE EVOLUTION OF MENTORING

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T

oday every industry is looking for candidates who are employable.

And when you consider the kind of candidates being hired, at the entry level or beyond, there is a gap between the time they are employed and the time they are 'billable'. That is where the concept of mentoring comes in. Earlier, freshers from campus were put through a fair amount of of organised training programmes like mock calls, role plays, etc. A lot of time was given to these activities.

But today, due to the rising pressures of productivity, competitiveness, cost cutting, the pressure on businesses to perform and the bench strength not being too huge (especially in the BPO/KPO arena), there is pressure on business leaders to hire and train people quickly, put them on the job and then constantly mentor them on the job. The time to train has shortened and instead, there is on-the-job-training, on-the-job-feedback and grooming of talent. In a world of social media, where there is instant gratification, patience levels are dropping so there is no time to get the fresh recruits job ready. Mentoring has become inevitable due to these factors and we see this trend in the pharmaceutical industry as well.

One more aspect is that

technology is changing very fast. The impact of technology is not restricted to the IT industry but is felt across all industries. If you look at the pharma industry, there are mobile app companies which are developing apps which are helping doctors and patients.

For instance, take the app which helps patients find alternative medicines brands to the one prescribed.

So technologies have become strategic enablers or disruptive innovations because of which mentoring need not only be for freshers/juniors.

Mentoring may be required even for middle- and senior management as well as they will have to learn about these technologies from others in the company who are 'early adopters' or have adapted themselves to these technologies. So that is the framework of mentoring today.

Mentoring by example Consider the specific challenges facing the pharma industry today. Firstly, it is a niche industry. All and sundry do not get into the pharma industry. A large number of entry level positions are at the medical representative (MR) level and these MRs have to imbibe skills and knowledge from their seniors while they are 'on call', visiting doctors to give them information about their company's products.

They have to understand each doctor's psyche and this kind of information is not available from text books because it is both an art as well as a science.

Each MR then develops his

own style of developing a rapport/ relationship with a set of doctors. This is one area which in very unique to the pharma industry.

Another example unique to this industry is the research teams in pharma R&D labs.

Teams of younger scientists, possibly on fellowships to do their PhDs, work under senior scientists, sometimes working on a particular problem for five to seven years continuously. They live, eat and sleep thinking about their research.

During the course of this, the younger scientists start approaching research problems the way their guides do. They imbibe the thought processes and behavioural patterns of their seniors which then give them the confidence to explore unknown paths of research themselves. On the manufacturing side too, some skills can be picked up from manuals or during training sessions but most are learnt on the job.

Mentoring in the pharma industry is thus a very key process to pass knowledge from one generation to the next. People who enter the pharma industry generally do not leave because the knowledge gained is very specialised and specific to the industry.

Mentoring may not happen in a formal environment. Will a sales manager call his MR team into a conference room and give them tips on making cold calls to doctors? No, this happens on the field, as they travel to the doctors' clinics.

Once they are in the clinic' Continued on Page 32

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cover ) I N T E R V I E W

‘My teacher provided me with full freedom in my research projects’ Dr Arun Garg, General Secretary - IPGA and Prof and Head, School of Medical and Allied Sciences, KR Mangalam University, Gurgaon talks about the role played by his mentors and his message to his mentees, to Usha Sharma How important is it to have a mentor as a role model in today’s fast moving technology-driven society of the pharma industry?

It is of paramount importance to have a teacher/mentor in order to provide the right direction to th the fast developing pharma world. The teacher knows the strengths and weaknesses of the students which enables him to mould the student to gain skills for the global pharma business. He also serves as a role model to his

Continued from Page 30

students and provides knowledge, sills and other capabilities to face the fast developing pharma sector.

Could you share with us some details of how a teacher or mentor changed your life?

My teacher has provided me with full freedom in my research projects and also helpee fruitful research which enabled me to earn three prestigious research awards.

My teacher has been an eye opener and helped me face the challenges in life and attain

high positions in the pharma profession.

How did your mentor’s

leadership ignite your thoughts and help your ideas take shape?

My mentors, Prof B Suresh, Vice Chancellor of JSS University and Prof SS Agarwal, Pro Vice Chancellor Amity University Noida have always been guiding me with positive ideas which helped me attain leadership qualities to be a successful pharma professional. Similarly as a mentor, I guide my students to attain high positions in pharma world.

Continued from Page 26

(With inputs from Usha Sharma)

32 EXPRESS PHARMA September 1-15, 2014

I strongly believe that R&D is the backbone of the pharma industry, especially when it comes to exports to the highly regulated markets of Europe and the US. Expanding R&D and the international business are going to be Aditi's main challenges in future and I mentored her accordingly,”opines Kare.

Women power India is a country where women empowerment is a widely debated topic. When asked about Aditi’s emergence as one of the leading women entrepreneurs in the country, Kare shoots back saying, “In our family, we never discriminated between boys and girls. Girls were always encouraged to take on responsibility and leadership roles.”

u.sharma@expressindia.com

Continued from Page 31

TEACHERS WHO... FOLLOWING IN THE...

They need to be nurtured in a proper environment and principally the initiative will have to be from you and you alone. Feel the change and progress by yourself to move ahead both horizontally and vertically. Self assess yourself every year to chalk out a clear-cut agenda continuously for your improvement. If you really make up your mind, you can eventually develop a specific goal for yourself which can be continuously nurtured and achieved. In the process through your commitment and hard work you will have a specific recognition for yourself which will evolve into a USP of your own. Once you reach this level, success will automatically flow with you.

With this, I wish you “HAPPY TEACHERS DAY” Let us be good teachers and responsible students.

Any tips/suggestions to the next generation of pharma professionals, who may be mentees today.

Today, the students want to attain or gain success without persistent hardship and efforts. They use short-cuts in research and studies. My message to the young generation is that in order to be a successful pharma professional, one has to work hard with dedication and honesty.

Kare has full faith in his daughter's capabilities and Aditi has also always proved herself equal to the task.

Kare says, “ When it comes to entrepreneurship and management, I consider women equally capable as men, sometimes even better.

Aditi is well respected by all employees at Indoco, which speaks volumes of her acceptance as a leader. I have full confidence that under her able leadership, Indoco will grow to become a leading pharma company in India, even internationally.”

Aditi as a mentor Today Indoco has world class infrastructure and various international approvals for its different facilities.

However, Kare thinks that besides having qualified

THE EVOLUTION... staff to run these facilities it is also equally important to retain this human strength which is going to be the most challenging task for his daughter.

“Indoco has always valued inter-personal relationships when it comes to employees. During my 52 years at the helm of affairs at Indoco, not a single day was lost due to industrial strife.

The credit for this goes equally to both the employees and the management policies of the company. I always tell Aditi that this will be the greatest challenge she will face at all times and it will be her responsibility to maintain and carry forward the culture of the organisation which is the key to its sustained growth,” Kare signs off.

s reception, the process continues as they wait for permission to enter the doctor's examination room. This is a fairly unique gurukul experience; a modern day equivalent of the way students stayed with their gurus and learnt many things from them. For industries like the pharma sector, especially functions where knowledge is more interpretative and not cast in stone, mentoring thus has a very special role to play. It is more about behavioural patterns that are observed rather than classroom learning. And in research labs, where both the senior research leader and the junior scientists are working on the same problem, it might also happen that the roles are reversed as the junior scientist might be more in tune with the newer technological aspects. So eventually the learning is both ways.

sachin.jagdale@expressindia.com

(As narrated to Viveka Roychowdhury)

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MANAGEMENT INSIGHT

Quality approach of pharma st industry for 21 century

DR DEBABRATA ROY , Former Deputy Drugs Controller (India) CDSCO, Min of Health & FW Govt of India

Dr Debabrata Roy,Former Deputy Drugs Controller (India),CDSCO,Ministry of Health and Family Welfare Government of India,gives an insight on the goal of QbD,to bring quality medicine to patients in a more reliable way that will benefit all stakeholders

I

n any business ‘Quality’ means that the final product should have the ability to satisfy customer / consumer to the desired expectation and fulfil its intended purpose. Quality has no specific meaning unless it relates to a specific function or objective. Quality is a perceptual, conditional, and somewhat subjective attribute.

The meanings of quality have developed over time. The said concept of ‘Quality’ is also equally applicable for pharmaceutical products as a whole. In fact, ‘Quality’ concept initially started with final product testing followed by Statistical Quality Control (SQC) during the middle of the 20th century. But it was observed that SQC cannot minimise the inherent risk associated with the product during production as it failed to be detected by testing. Accordingly, Good Manufacturing Practice (GMP) was implemented and made mandatory by all drug regulation authority all over the world, including India, for manufacturing drugs and pharmaceuticals during the last decade of the 20th century.

Today, the primary objective of most of the pharma manufacturing units is to reduce operational costs while ensuring regulatory compliance. Cost pressures are increasingly acute as many pharma manufacturers face a dwindling product

34 EXPRESS PHARMA September 1-15, 2014

pipe-line associated with greater competition from generics.

Conventional approach to GMP in pharma manufacturing facility is rooted to batch processing, following SOP meticulously and subsequently labora-

tory testing on a few collected samples so as to evaluate the quality. Although this approach is successful to provide quality pharma to the public, however, significant opportunities and tools are available today to fur-

ther improve pharma manufacturing and quality assurance through innovation in the areas of product and process development, process analysis, and process control.

The pharma industry has presently failed to compete with other industries in terms of manufacturing efficiency and productivity due to high cost and burden involved in revalidating any process change, even though changes are warranted to improve the quality. Pharma manufacturers are reluctant to change process which are confirmed, validated, and accepted by the regulators.

The pharma industry’s commitment on maintaining status quo has produced inefficiency and higher wastage. It is estimated that worldwide potential cost savings from efficiency improvement in pharma industry could be as high as $90 billion dollars per year. On the other hand, it is a known fact that R&D are the major cost centre in pharma companies, while manufacturing accounts for more than twice the expenses of R&D, representing around 36 per cent of total costs. The true cost of manufacturing becomes apparent when one considers the nonvalue- added activities and waste which represent 80 per cent and 50 per cent respectively.

Impact on quality is evident

in an environment which does not accept changes as well.

From the available statistical data it was observed that the number of drug recalls has increased drastically on a yearly basis, 75 per cent of which are attributed to manufacturing defects. The reject percentage or ‘not-of-standard-quality’ (NSQ) in the pharma industry ranges from five to 10 per cent (indicates the working practice at around two sigma level) compared to 0.0001 per cent (six sigma level) in the semi conductor industry. The reject percentage cost to pharma industry ranges in between $4.5 – 9 billion per year which is quite a lot compared to $90 billion spent on manufacturing.

GMP has found its place in the field of pharma industry gradually. However, recent initiatives on scientific risk-based framework and Process Analytical Technology (PAT), which supports innovation and efficiency in a GMP environment, suggest a new way of thinking for the 21st century. In August 2002 US Food and Drug Administration (US FDA) launched a new initiative entitled ‘Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach.’

CURRENT AND THE FUTURE STATE OF QUALITY MANAGEMENT (THREE GENERATIONS OF QUALITY MANAGEMENT TOOLS (QMT)) (TABLE-1) Pharmaceutical industry today(Reactive) First generation QMT

Second generation QMT

Third generation QMT

Quality by Testing (QbT)

Statistical Process Control (SPC) / Statistical Quality Control (SQC)

Quality by Design (QbD)

Inspect, reject or accept

Examines historical output of a process to identify the limits of a stable process and sources of error

Prevents problems or defects from occurring and is a continuous real time quality assurance

COMPARISON OF QbD PROGRAMME WITH CURRENT STATUS IN QA (TABLE-2) Aspect

Current state (GMP)

Desired QbD state

Pharmaceutical development

Empirical; univariate

Systematic; multivariate

Manufacturing process

Validation on three batches; focus on reproducibility

adjustable within design space; focus on control strategy

Process control

In-process

PAT utilisation

Product specification

Based on batch data

Based on product performance

Control strategy

Intermediate and end product testing

Risk-based; real-time release

KEY CHALLENGES FOR QbD ADOPTION(TABLE-3) Challenges occur within companies

Challenges are directly related to the FDA

Internal misalignment

Inconsistency of QbD across DRA

Lack of belief in business case

Lack of tangible guidance

Lack of technology to execute

Regulators not prepared to handle

Alignment with third parties

Does not inspire confidence

Quality by Design (QbD) QbD is a systematic approach to pharma development which starts with predefined objectives and emphasises product and process understanding based on sound science and quality-risk management. It is a prospective approach-based on ‘Quality by Design philosophy’ unlike the present system of ‘Quality by Testing’ which is a retrospective approach.

A comparison of current state of manufacturing with QbD (Table 2) may apparently indicate that they belong to two conflicting families. One of the characteristics of a GMP manufacturing environment is the abundance of documented processes such as standard operating procedures (SOPs), testing methods, environmental controls and training programme. This documentation can be divided into technical standards and operational procedures. Technical standards, such as product specifications,

Pharmaceutical industry tomorrow (Proactive)

Misalignment of international regulatory bodies Current interaction with companies is not conducive to QbD

validated settings and production conditions, can only change following a change control exercise. Operational procedures, such as the way people interact with equipment and the way that product flows, are based on custom and experience, and will change regularly in response to deviation or safety concerns.

The challenge for the pharma industry to move towards QbD is to design new operational procedures that comply with all external regulatory requirements, but at the same time support continuous im-

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provement. In the GMP norms, critical specifications and technical standards are very well defined, deviations from which are obvious and thus action can be taken after change control. Operational procedures, however, are often light on detail and as a result, variations in these may not be detected. For example, the way an operator sets up a workstation may vary with respect to time and outcomes. A check sheet may ensure that critical steps have been completed, but the manner in which the end-result was achieved is

not noticeable. Work variation is possible if people use slightly different methods to achieve the same result.

The GMP environment is already rich in science. Science is used to develop the batch manufacturing process followed by laboratory testing and evaluate quality of the product to release into market. The employees who ‘handle’ the product have a defined role to produce product in a controlled and consistent manner.

Traditional improvements as per GMP norms are carried out

through change control to avoid frequent deviation from the SOP rather than to reduce the variation. The fear of change and the present systems to control it, together make hindrance for continuous improvement. However, some pharma plants already operate with well-controlled and optimum processes. For these plants the move towards QbD should not be such a challenge.

Implementation of risk-based approach is the main challenge for the pharma industry to move towards QbD, which is firmly based on science and engineering principles. However, recent changes in regulatory thinking made this challenge less problematic. The principles of Process Analytical Technology (PAT) initiative seems to be extremely well aligned with QbD thinking.

As per GMP norms, critical attributes and technical standards are well defined, however, operational procedures are often not in detail, as a result, variations in these may not be detected. Work variation thus possible if people use slightly different methods to achieve the same result. In a system of QbD, SOPs and other manufacturing instructions would be viewed as a means to expose problems and encourage improvement.

Technical standards will be identified and fixed in line with regulatory requirements; all other operational procedures would be reviewed on a systematic basis and standardised with respect to time, sequence, content, and outcome. The challenge for the pharma industry in turning to QbD is the design of new operational procedures that are consistent with all external regulatory requirements, but also support continuous improvement.

As per GMP norms, product manufacturing cycle time is quality driven; it may take longer time to release a batch than to produce it. Different departments usually have clear individual responsibilities and objectives. Departments have often separate responsibilities and objectives and working in isolation or in conflict with one another.

Individual departments may be unaware of the impact on overall product flow due to delays or

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MANAGEMENT problems from their part. However, as per QbD, cycle time and quality would be of equal importance. This overlaps with PAT framework of reducing production cycle time. When a deviation in cycle occurs, it may indicate potential quality issues. The moment product flow is interrupted, quality issues may immediately be identified otherwise the same might have been hidden from view or only detected during final release. For example, when an operator in a traditional pharma plant is required to produce a tablet to a specified disintegration time, the time it takes to set up the tablet press to produce tablets meeting the required technical standard is not controlled. In a QbD process, the operator would have a work time standard. If it is not possible to produce the tablet to the required disintegration specification within this time, a call for help would be made. This may expose a problem in the upstream process, in this case granulation, which would otherwise be masked.

The challenge for pharma industry to move towards QbD is to reduce the grey zones of responsibility, slow response, and late calls for help when problems occur, and move towards an environment where problems are immediately identified, shared and resolved across the plant.

(CPP) are process inputs that have a direct and significant influence on critical quality attributes when they are varied within regular operation range.

GLOSSARY

■ Design space

■ Target Product Quality Profile (TPQP) The target product profile (TPP) has been defined as a ‘prospective and dynamic summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality and thus the safety and efficacy of drug product is realised.’

Design space defines the relationship between critical quality attributes (CQAs) and critical process parameters (CPPs) and identifies acceptable operating ranges for CPPs. It is the region where acceptable product can be produced. It can be considered to be a snap-shot in time representative of the current process knowledge and also contains the proven acceptable ranges (PAR) for CPPs and acceptable values for their associated CQAs.

■ Critical quality attributes (CQA) A CQA has been defined as ‘a physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.’

■ Critical process parameters

(CPP) Critical process parameters

36 EXPRESS PHARMA September 1-15, 2014

The challenge for pharma industry to move towards QbD is to reduce the grey zones of responsibility, slow response, and late calls for help when problems occur, and move towards an environment where problems are immediately identified, shared and resolved across the plant

■ Risk assessment

Risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. It is a systematic process of organising information to support a risk decision to be made within a risk management process and con-

sists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.

■ Product Analytical Technology (PAT) A desired goal of the PAT framework is to design, analyse, and control pharma manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA) and to consistently ensure a predefined quality at the end of the manufacturing process.

The concept actually aims at understanding the processes by defining their CPPs, and accordingly monitoring them in a timely manner (preferably inline or on-line) and thus being more efficient in testing while at the same time reducing over processing, enhancing consistency and minimising rejects.

■ The long-term goals of PAT

Reduce production cycling time

●

● Prevent rejection of batches ● Enable real time release ● Increase automation ● Improve energy and material use ● Facilitate continuous processing Currently, NIR spectroscopy applications dominate the PAT projects. A possible next-generation solution is Energy Dispersive X-Ray Diffraction (EDXRD).

Conclusion QbD is a systematic approach which continuously improves the quality of a medical product by knowing better process and material understanding based on sound science and quality risk management. This means understanding the products, formulations, and processes in depth and submitting appropriate applications to the authorities using a more systematic development approach.

The goal of QbD is to bring quality medicine to patients in a more reliable way which benefits all stakeholders. Manufactures will see production improve-

ments with significantly reduced batch failures, stock-out etc.

Regulators have greater confidence in robust quality of products they are being asked to approve and will be able to reduce intensity of their regulatory oversight, again assisting the industry to innovate and improve continually. Patients will be benefited from a greater consistency in medicines they take and a reduced likelihood of unexpected product unavailability or withdrawal.

However, to adopt these new quality approaches, a comprehensive training programme for technical personnel is very much warranted at least by the pharma manufacturers of India. Launching training programme in a company is a strategic management decision which needs to be initiated by top level management. All the elements of the training framework as well as the formalised improvement strategy need top-level management commitment for successful execution.

Especially, without a strong commitment on the part of top level management, the training programme activities are seldom successful. It is pertinent to mention here that many pharma manufacturing organisations in India never seem to have time for training. Either these organisations do not properly prioritise training or they see it as an unnecessary expenditure of capital with no obvious correlation to revenue.

Although, the senior personnel in most of the big industries are well knowledgeable and acquainted with the modern day regulatory norms covering GMP aspects (may not be well conversant with the QbD approach), however, the new entrants from college and university are lacking technical knowledge and competency to face the challenges of present day stringent international regulatory norms.

This is an important issue and all stakeholders should come forward to make a comprehensive training platform for the technical persons associated with the pharma industry which may finally lead India as a number one nation in the ‘World of Pharmacy’.

MANAGEMENT REPORT

Medical Technology: Vision 2025 roadmap for the way forward Getting things right could lead to a $30 billion domestic market opportunity as well as setting up the right manufacturing capabilities could spur an additional $20 billion manufacturing opportunity for the Indian medical technology space.Boston Consulting Group and Confederation of Indian Industry’s white paper,Medical Technology: Vision 2025,highlights the opportunity for the medical technology industry in India.Excerpts from the report BOSTON CONSULTING Group and Confederation of Indian Industry after several months of deliberation has created a roadmap to create a $50 billion opportunity in the medical technology space in India.

Collectively, they have identified six areas to work on to create the right supporting ecosystem. BCG and CII have highlighted four ‘quick wins’ and two longer–term initiatives which will help develop this ecosystem.

Quick wins are initiatives which should be implemented within the next 12 months as these are crucial for the further growth of the medical technology industry.

ROADMAP FOR A VIBRANT MEDICAL TECHNOLOGY INDUSTRY IN INDIA

❑ Reward local and market relevant innovation

QUICK WINS ❑ Medical technology relevant regulation

Regulations should be in place that are dedicated, predictable, transparent, globally harmonised and appropriate for medical devices. It could preferably be based on a separate medical device regulatory act and governed by an independent regulatory body with specialised regulators. If that is not achievable in the short term, at the very least, it is being recommend that the Government should include industry inputs and pass the Drugs & Cosmetics Amendment Bill 2013, which can then provide a starting point to separate medical devices from drugs and pharmaceuticals.

A “one–window” institution

38 EXPRESS PHARMA September 1-15, 2014

discussions around training and accreditation, particularly when it comes to healthcare workers.

Source: Vision 2025 — CII brainstorming sessions held on December 2013 and April 2014. needs to be created to ease the regulatory burden for the industry and reduce the bureaucracy associated with approval for development, technology transfer and manufacturing.

The Government has to pro-

mote transparent and evidence-based pricing and reimbursement policies. It needs to develop a dynamic procurement mechanism for assessing the clinical outcomes and cost effectiveness of a medical tech-

nology to determine its merit for inclusion in public insurance schemes.

The Government should table discussions on a PPP framework for operationalisation of partnerships as well as

A national innovation policy linked to the disease profile is required and should be organised in a way that results in innovation which are locally relevant in India can be rewarded.

Initiatives like BIRAC to medical technology should be expanded; these initiatives should be broadened to cover more research and support more local innovation. These schemes should provide seed capital, viability gap funding, co-fund start-up projects and support the commercialisation of innovations.

The Government should create strong incentives for commercialisation of ideas by creating access to reimbursement in the Government funded schemes using a value based approach.

A longer-term view (10 years window) for 200 per cent weighted tax deduction on approved expenditure on R&D activities should be provided as the gestation period is high in this industry. ❑ Build manufacturing infrastructure

Streamline the process of setting up manufacturing facilities in India by designating medical technology hubs with the right

MANAGEMENT infrastructure in place to support complex medical technology manufacturing.

Create training hubs around these manufacturing hubs to ensure a ready supply of trained talent to support these hubs. Industry to assure recruitment from these hubs.

Manufacturing incentives for example, tax support, low cost funding should be provided to spur investments and to make the busi-ness case attractive. ❑ Collaborative partnerships

Close coordinated working with academic institutes to build global partnerships with medical technology companies who don’t have access to India.

Need to select three institutes which will drive this collaboration with industry.

Create industry sponsored programmes between local and

Initiatives like BIRAC to medical technology should be expanded. These initiatives should be broadened to cover more research and support more local innovation. These schemes should provide seed capital, viability gap funding, co-fund start-up projects and support the commercialisation of innovations global industry on joint collaboration projects using relationships with specific trade bodies and industry fora.

Address the capability shortfall in crucial areas holistically by building select partnerships in procurement, testing, calibration and clinical trials which limits the extent of investment in innovation in India.

INITIATIVES ❑ Capability

development

and training Industry and academia should jointly define the expectations from new graduates.

Based on these requirements, the academia must put together a curriculum designed at developing the desired skill sets.

Academia should cultivate a

culture of collaboration on campus by providing the necessary platforms for interaction with industry. Universities must facilitate interaction between the students of medical technology and business management to ensure cross–pollination of knowledge.

Healthcare sector skill council to take as a priority the development of the medical

technology skill set. This should form part of their mandate and drive the right talent development initiatives. Allocate funds to set up centres of excellence for medical technology training. ❑ Integrated stakeholder forum for meaningful engagement

Coordinated awareness effort of multiple stakeholders led by an industry body to ensure that the benefits of medical technol-ogy innovation in the country are well understood by all.

Global task force to promote India as a manufacturing and R&D hub globally through targeted specific fora to build bi-lateral dialogue.

CII will further need to coordinate between all stakeholders to take the Vision 2025 forward, and it is vital that this effort starts soon.

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RESEARCH CLINICAL UPDATE

Novartis’KAE609 shows promise as next generation treatment for malaria KAE609 is the first antimalarial drug candidate with a novel mechanism of action to achieve positive clinical proof-of-concept in over 20 years NOVARTIS’ KAE609 (cipargamin), a novel and potent antimalarial drug candidate, cleared the parasite rapidly in Plasmodium falciparum (P falciparum)and Plasmodium vivax (P vivax) in malaria patients[1]. The clinical trial result was published in the New England Journal of Medicine.

Novartis currently has two drug candidates in development. Both KAE609 and KAF156 are new classes of anti-malarial compounds that treat malaria in different ways from current therapies, important to combat emerging drug resistance. Novartis has also identified PI4K as a new drug target with potential to prevent, block and treat malaria.

“Novartis is in the fight against malaria for the long term and we are committed to the continued research and development of new therapies to eventually eliminate the disease,” said Joseph Jimenez, Chief Executive Officer, Novartis. “With two compounds and a new drug target currently under investigation, Novartis has one of the strongest malaria pipelines in the industry.”

Malaria is a life-threatening disease primarily caused by parasites (P. falciparum and P. vivax) transmitted to people through the bites of infected anopheles mosquitoes.

Each year it kills more than 600,000 people, most of them African children[2].

“KAE609 is a potential game-changing therapy in the fight against malaria,” said Thierry Diagana, Head, Novartis Institute for Tropical

40 EXPRESS PHARMA September 1-15, 2014

Novartis currently has two drug candidates in development. Both KAE609 and KAF156 are new classes of anti-malarial compounds that treat malaria in different ways from current therapies, important to combat emerging drug Novartis has also identified PI4K as a new drug target with potential to prevent, block and treat malaria Diseases (NITD), which aims to discover novel treatments and prevention methods for major tropical diseases. “Novartis has given KAE609 priority project status because of its unique potential of administering it as a single-dose combination therapy.”

In June 2012, 21 patients infected by one of the two main malaria-causing parasite types took part in a proof-ofconcept clinical study conducted in Bangkok and Mae Sot near the Thailand/Burma

border where resistance to current therapies had been reported. Researchers saw rapid parasite clearance in adult patients (median of 12 hours)[2] with uncomplicated P. vivax or P. falciparum malaria infection including those with resistant parasites.

No safety concerns were identified, however the study was too small for any safety conclusions.

“The growing menace of artemisinin resistance threatens our current antimalarial

treatments, and therefore our attempts to control and eliminate falciparum malaria,” said Nick White, Professor of Tropical Medicine at Mahidol University in Thailand and lead author of the NEJM article.

“This is why we are so enthusiastic about KAE609; it is the first new antimalarial drug candidate with a completely novel mechanism of action to reach phase II clinical development in over 20 years.”

KAE609, the first compound in the spiroindolone

class of treatment, works through a novel mechanism of action that involves inhibition of a P-type cation-transporter ATPase4 (PfATP4), which regulates sodium concentration in the parasite. Because KAE609 also appears to be effective against the sexual forms of the parasite, it could potentially help prevent disease transmission. The clinical trial was done in collaboration with the Wellcome Trust-Mahidol University Oxford Tropical Medicine Research Programme. Research was supported by the Wellcome Trust, Singapore Economic Development Board, and Medicines for Malaria Venture.

KAE609 represents one of two new classes of antimalarial compounds that Novartis has discovered and published in the last four years. [3],[4] This drug candidate has shown potent in vitro activity against a broad range of parasites that have developed drug resistance against current therapies. KAE609 is currently being planned for phase IIb trials.

References [1] http://www.nejm.org/doi/ full/10.1056/NEJMoa1315860 [2] World Health Organization, http://www.who.int/mediacentre/factsheets/fs094/en/ [3] Spiroindolones, a Potent Compound Class for the Treatment of Malaria, KAE609, Science, Sept. 2010 [4] Imaging of Plasmodium liver stages to drive next generation antimalarial drug discovery. Science Express, Nov. 17, 2011

RESEARCH UPDATES

US FDAapproves The Medicines Co’s Orbactiv Will help in the treatment of acute skin infection drug THE US Food and Drug Administration (US FDA) has approved The Medicines Co’s single-dose intravenous drug to treat acute bacterial skin infections, the agency’s third approval for the same condition this year. All the three drugs target acute bacterial skin and skin structure infections (ABSSSI), caused by the Gram positive strain of bacteria. These infections involve deep tissue or are associated with an underlying disease such as dia-

petition.

The regulator in recent months approved Cubist Pharmaceuticals' Sivextro and Durata Therapeutics' Dalvance for the same condition.

Sivextro, available for intravenous and oral use, is administered once daily for six days. Dalvance, an intravenous drug, is given in two doses, eight days apart.

Jefferies & Co analyst Biren Amin told Reuters he expects Orbactiv to be

betes. Medicines Co’s treatment, Orbactiv, is in the same class of drugs as generic vancomycin, the standard-ofcare for methicillin-resistant Staphylococcus aureus (MRSA), a serious Gram-positive infection.

ABSSSI, which leads to hospitalisation of about 5.2 million patients in the US and Western Europe each year, often involves intravenous therapies that require hospitalisation over multiple days, the company said.

A single 1200 mg dose of Orbactiv comprises a full course of therapy, unlike vancomycin which requires twicedaily intravenous infusions for seven to 10 days, giving it an edge over com-

launched in the fourth quarter and estimated peak US sales of $150 million by 2021.

Orbactiv, known generically as oritavancin, was found to be non-inferior to vancomycin in 1,959 patients in latestage trials. Patients on the drug most frequently reported adverse events that included nausea, headache, vomiting and diarrhea.

The antibiotic received an expedited review by the FDA and was designated a qualified infectious disease product, qualifying it for an extra five years of marketing exclusivity.

Reuters

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RESEARCH

Lowvit D levels may predict dementia risk Researchers used data from an existing study of heart disease risk among 1,658 elderly adults ELDERLY PEOPLE with less vitamin D in their blood may be more likely to develop dementia and Alzheimer’s disease than those with more, according to a new analysis of data from the mid-1990’s.

Severe vitamin D deficiency, and the associated increased risk for dementia, was rare in the study, however. Only four per cent of the older people included were ‘severely deficient’ based on their blood samples.

“It is too early to tell whether improving vitamin D levels helps to delay or prevent dementia. Clinical trials are now urgently needed,” said senior author David J Llewellyn of the University of Exeter Medical School in the UK. Researchers used data from an existing study of heart disease risk among 1,658 elderly

adults. When the study began in 1993, none of the participants had dementia, heart disease or stroke, and all gave blood samples for analysis, which were then stored in a lab at the University of Vermont.

In 2008, researchers at the University of Washington retested the samples for circulating vitamin D levels. Most people in the study did have sufficient vitamin D levels in their blood samples, defined as at least 50 nanomoles of the vitamin per litre of blood (nmol/L).

But about 30 per cent of people had less than that: 419 people were deficient, with more than 25 nmol/L but less than 50, and 70 people were ‘severely deficient,’ with less than 25 nmol/L. By 1999, 171 people in the study did develop dementia, including 102 cases of

Alzheimer’s disease.

People who had been severely deficient in vitamin D at the start of the study were more than twice as likely to develop dementia in the coming years than people with sufficient levels, according to the results published in Neurology.

The researchers did not test whether taking vitamin D supplements or changing diet plans would have affected dementia risk.

“The study does not provide any specific advice for older people in relation to vitamin D status,” said Cynthia Balion of the Canadian Longitudinal Study on Aging and a clinical biochemist at Hamilton Regional Laboratory Medicine Program in Ontario.

“It only shows there is data to support its importance in

cognitive function, but therapy trials are needed to determine its clinical significance,” said Balion, who was not part of the new study. Previous studies have suggested that vitamin D supplements may help protect some older adults from fractures or falls.

Aside from supplements, eating a balanced diet including oily fish and regularly venturing outdoors as part of an active

lifestyle can help boost vitamin D levels, he said.

The absolute change in risk in this study is somewhere between five and 12 per cent, Balion said by email. Only 10 per cent of the group as a whole developed dementia, which increased to 15 and 22 per cent of vitamin D deficient and severely deficient people, respectively.

Reuters

Aspirin intake significantlycuts cancer rates Rates of oesophageal and stomach cancer were cut by 30 per cent and deaths from these cancers by 35 to 50 per cent TAKING A small daily dose of aspirin can significantly reduce the risk of developing or dying from bowel, stomach and oesophageal cancer, according to a large review of scientific studies.

Researchers who analysed all available evidence from studies and clinical trials assessing benefits and harm found that taking aspirin for 10 years could cut bowel cancer cases by around 35 per cent and deaths from the disease by 40 per cent.

Rates of oesophageal and stomach cancer were cut by 30 per cent and deaths from these cancers by 35 to 50 per cent.

42 EXPRESS PHARMA September 1-15, 2014

Professor Jack Cuzick, head of the centre for cancer prevention at Queen Mary University of London, said the evidence showed that, to reap the benefits of aspirin, people need to take a daily dose of 75 to 100 milligrams for at least five years and probably up to 10 years between the ages of 50 and 65.

No benefit was seen while taking aspirin for the first three years and death rates were only reduced after five years, he and his team reported in a review in the Annals of Oncology journal.

“Our study shows that if everyone aged between 50 and

65 started taking aspirin daily for at least 10 years, there would be a nine per cent reduction in the number of cancers, strokes and heart attacks overall in men, and around seven per cent in women,” Cuzick said about the research.

But the researchers also warned that taking aspirin longterm increases the risk of bleeding in the stomach: among 60year-olds who take daily aspirin for 10 years, the risk of digestive tract bleeding increases from 2.2 per cent to 3.6 per cent, and this could be life-threatening in a small proportion of people,

they said.

“Whilst there are some serious side effects that can’t be ignored, taking aspirin daily looks to be the most important thing we can do to reduce cancer after stopping smoking and reducing obesity, and will probably be much easier to implement,” Cuzick said.

Aspirin, originally developed by the German drugmaker Bayer. The drug reduces the risk of clots forming in blood vessels and can therefore protect against heart attacks and strokes, so it is often prescribed for people who already suffer

with heart disease and have already had one or several attacks.

Aspirin also increases the risk of bleeding in the stomach to around one patient in every thousand per year, a factor which has fuelled debate over whether doctors should advise patients to take it as regularly as every day. Cuzick said the risk of bleeding “depends on a number of known factors which people need to be aware of before starting regular aspirin” and advised people to consult a doctor before embarking on daily medication.

Reuters

PHARMA ALLY PRODUCTS

Osworld Scientific Equipments launches benchtop autoclaves OSWORLD SCIENTIFIC Equipments has launched Osworld benchtop autoclaves, which are widely used in various departments of hospitals and medicinal and pharmaceutical research like microbiology, medicine, veterinary science, mycology, dentistry, etc.

Front loading benchtop autoclave- Touch Screen Type – Model No OAT-FL ●

Class B, Class N/S Sterilizers from 20 to 50 litres capacity, Temp range 121 to 134 degC. Osworld front loading benchtop autoclave is CE certified, microprocessorbased digital display, LCD back lit display. The inner chamber has 3mm thickness and is made of stainless steel.

Outer cover is also made of mild steel/stainless steel; lid is made of thick stainless steel.

Initial auto water fill arrangement in external reservoir for steam generation, low water level alarm, automatic air exhaust cycle helps create partial vacuum in the chamber, vacuum pump for air removal with multiple pulsing, automatic door lock under pressure. A solenoid valve vents out air during the process of steam generation.

At a preset temperature, the valve automatically shuts and thereafter steam pressure builds up. The sterilisation process should continue almost 15-20 minutes. Once sterile time period completes the steam is automatically exhausted. Drying cycle provided optionally with print of entire cycle and PC interfacing software facility.

Front loading benchtop autoclave- touch screen type – Model No OAT-FL

Premium model autoclave- vertical type- top loading- single handle type – touch screen – model no OAT-SHE ●

Class B, Class N/S Sterilizers from 35 to 175 litres capacity, Temp range 121 to 134 degC. Osworld premium model autoclave used in microbiology, QC & Research laboratory – Pharma/Medical Industry.

Osworld Premium Model Autoclave is CE certified.

Consisting of microprocessor based digital temperature controller indicator or touch screen model. the autoclave construction is double wall type design, however, has the inner chamber for steam, outer as cover. Only steam enters inner chambers for sterilisation. The chambers are made of stainless steel of LM 304/316 grade and the steel is exclusively provided by Jindal Steel.

The equipment has all features

To subscribe: bpd.subscription@expressindia.com

required for Class B/S/N autoclaving.

Premium model autoclave- vertical type- top loading- single handle type – touch screen – Model no OAT-SHE

Large horizontal model autoclave- Front loadingRadial locking type or sliding door – Model no OAT-HR ●

Class B, Class N/S Sterilizers from 100 to 1000 litres capacity, Temp range 121 to 134 degC Osworld Horizontal Model Autoclave is CE certified and mainly used for large requirements. It is available in single door/double door model.

Contact details Osworld Scientific Equipments B44, New Empire Industrial Premises, Kondivita, Andheri East, Mumbai – 400059.

Tel: +91-22-28320880, 28390487 Email: info@osworldindia.com Web: www.osworldindia.com

Large horizontal model autoclave- front loading- radial locking type or sliding door – Model no OAT-HR

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PHARMA ALLY

Cognex introduces easy-to-use vision sensor for colour applications COGNEX CORPORATION has launched Checker 4G7C, an easy-to-use colour vision sensor that distinguishes parts by colour.

Checker 4G7C delivers 376 x 240 inspection resolution with ethernet support for industrial protocols and highintensity white LED illumination for the detection and inspection of parts and features at up to 800 parts per minute.

As part of the Checker 4G Series product line, Checker 4G7C includes the patented Checker internal trigger technology which provides several key advantages. It does not require additional sensors to determine if a part is present, detects parts by

locating a feature on a part, not just an edge, tracks parts along the production line without requiring precise part handling.

In addition to the new ability to inspect parts for colour, the Checker 4G7C provides the industry-leading features that the product line is known for including flexible optics, ease of set up, ability to add unlimited sensor tools to a job and intelligent pass/fail logic based outputs.US and Canada.

Contact details Sunil Vaggu Cognex Corporation +91 9881466003 vaggu.sunil@cognex.com

Image checker_4G7C_Beverage Application

Thermo Fisher Scientific launches hydrophobic interaction column MANY LABORATORIES analysing monoclonal antibodies (mAb) regularly encounter situations where they need alternative hydrophobic interaction chromatography (HIC) selectivity. Thermo Fisher Scientific has developed new column chemistry that separates many more of these challenging mAbs, antibodydrug conjugates (ADCs) and proteins.

The Thermo Scientific MAbPac HIC-10 HPLC column has been demonstrated to provide selectivity that is different from other commercial HIC columns, including separating many native mAbs, fragments, aggregates, oxidation variants,

44 EXPRESS PHARMA September 1-15, 2014

PEGylated mAbs and ADC. The column’s proprietary chemistry is designed to provide the new selectivity in a high-resolution column with excellent biocompatibility and

high recovery. The column is compatible with organic solvent and aqueous mobile phase. It is designed for rugged stability and very low carryover.

Contact details Stuart Matlow Public Relations Manager Chromatography and Mass Spectrometry Thermo Fisher Scientific

355 River Oaks Parkway San Jose, CA 95134 (408) 965-6408 office (415) 407-5474 mobile stu.matlow@thermofisher.com www.thermofisher.com

BUSINESS AVENUES

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September 1-15, 2014 45

BUSINESS AVENUES

EXPRESS PHARMA

We care for your family . . .

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

Probiotics Saccharomyces boulardii Lactic acid basillus sporogenous

Circulatory Health Nattokinase

Bio Catalysts Immobilized Cal B

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

Papain Pepsin Pancreatin Protease ( acid / alkali)

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

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Non-GMO ISO CERTIFICATION

GOTS CERTIFICATION

Products

WHO cGMP

FDA

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INDIA

TBH 125 TD

EXPRESS PHARMA Quality Through Experience

TBH 425 WTD

Multicheck 5.1

Leak Test Test Apparatus

New Bathless Dissolution T Tester ester 8 New Media Preparation Disintegration Tester Tester Station Unit

Manual System for Oxygen Analysis ECHO O2

GTB Granulate Flow T Tester ester

Kraemer Dedusting Puris Water Water Torque orque Measurement System & Deburring Purification System for for Bottle Cap Machines HPLC grade Water Water

Local Contact Erweka India Pvt Ltd. Plot No. 29, Survey No. 415, N. H. No. 8A, Sarkhej-Bavla Road Village-Moraiya, Tal. Sanand, Dist. Ahmedabad-382213 Tele: +91-9228022065 Email : sales@erwekaindia.com www.erwekaindia.com EXPRESS PHARMA

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CLEANING, SANITISING EQUIPMENTS CLEAN ROOM ACCESSORIES ASEPTIC PIPING , PW / WFI DISTRIBUTION LOOPS

Floor Drain Traps

Hand Sanitiser

Water Saver Cleaninng Nozzles(self-rotating) Nozzles

Shoe Cover Dispenser

Foot Sanitiser

Split Butterfly Valve

Pendents(Service Shafts) CIP/ SIP MODULE We also design & manufacture # IBC Washing/ Drying Modules # Containers/ Glass Ware Wash Modules # FBD Bag Washing/ Drying Modules # Cannisters Washing Modules # Drums Washing Modules 50

September 1-15, 2014

Wash Down Hose Station

SIP MODULE

8/B, Surat Singh Est ,SV Rd, Jogeshwari(W), Mumbai-400102 Tel; 022-26797941 Telefax:022-26798066 Cell: 9869231815 email: iewi@mtnl.net.in website : www.iewi.net

Top Tank / Reactor Sampler

Flush Bottom valve

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Leaders in Cleanroom Lighting

customised

500 + installations 2000 + across India variants

years... and still going strong

Latest in lighting technology for your Cleanrooms Energy efficient LED lighting now offered for Cleanrooms

visionLED

Business Office: Wipro Lighting, 5 floor, Godrej Eternia - C, Old Pune-Mumbai road, Shivajinagar, Pune - 411 005 helpdesk.lighting@wipro.com | Tel : 020-66098700 | Fax : 020-66098777 | www.wiprolighting.com Branch Offices:

New Delhi : 011-41708122-29/ 9971117364 | Hyderabad : 040-27176082/ 27178906 / 05 | Mumbai (Vikhroli): 022-67213755 | Pune : 020-25510583 / 25535081 | Chandigarh : 0172-5018734 / 2660714 | Bangalore: 080-41503260-68 | Chennai : 044-32518016 | Ahmedabad : 079-40073546 | Kolkata : 033-44045886

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For Vacuum/ Pressure Transfer of Powder/ Granul es/ Tabl ets Crystal l ize M aterial in Pharma, Bul k Drug, Food, Chemical , Pl astic & Paint I nds.

Dilute Phase Material Conveyor Capacity: 50Kgs.-5000Kgs/Hr.

Granulator-Shredder Capacity: 800Kgs./Hr

Dense Phase Type 50Kgs.-5000Kgs/Hr

Ribbon Blender 50Kgs.-5000Kgs./Hr.

In-line Rotary Sifter Vibro Sifter also avail.

Screw Conveyor 50Kgs.-5000Kgs/Hr.

Octagonal Blender 50Kgs.-5000Kgs./Hr Conical /V-type also avail.

Batch Weighing System Bag/Drum Fill-up

Other Products: Bag Dumping Station # Jumbo Bag/ Big Bag Loading-Unloading System # Bin Activators & Discharger # Flexible Screw Conveyor # Capsule Loading/ Tablet Press Loading/ Blender Loading System # Bunker with Loading/ Reactor Loading system # Lumps Breaker # SS/ MS Storage Silo/ Bunker # Rotary Valve # Powder Conveying System Mobile type…………

For more details, please contact to:

A L ! X automation syst em TM

B/17, Adke Compound, Suryanagar, Vikhroli-W, Mumbai-400083. INDIA

Tel/Fax: +91-22-25776356 / +91-22-25796851.

Mobile: +91-9833297671 / +91-9819030056 e-Mail: info@powder-transfer.com / powdertransfer@gmail.com

www.powder-transfer.com 54

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

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

Salient Features: v 100 products

program memory.

v Individual

phase and sensitivity setting for each program.

v Three modes

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

v Individual

g password setting for each programing mode Fault indication.

v Very high

sensitivity for magnetic and non magnetic metals.

v Audio visual

alarm to draw the attention

of operator. v De-attachable

and washable reject mechanism to avoid cross contaminations.

v Has extremely v Adjustable

low power consumption.

height.

Applications: l Tablets

& Capsules

Das Electronics

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

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ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH

Innovation is our culture…

Quality in our genes…

!"#$%&%'($%)# )& +"'),-%#(#$ .+)$"%#/ (/ ."+ 012 31415.(6"7 8"/$"+# -9)$7 2".$%!" ,(..%#6: ;#(9</%/ )& .+)$"%# %,.=+%$%"/ %# +"'),-%#(#$ .+".(+($%)#/ >"#" ?=(#$%&%'($%)# -< @A52B@ C9"'$+).D)+"/%/ /</$",/ E)9"'=9(+ /%F" !"$"+,%#($%)# 31CB: B9%#%'(9 -%)'D",%/$+< (#(9</%/ G".(+%# 7C#)H(.(+%#7 G=,(# 1"+=, ;9-=,%# (#(9</%/

I%)9)6%'(9 ;'$%J%$< 3 K( (#! (: BD(.$"+ LMNOP: 2<+)6"# A"/$%#6 3BD(.$"+ LONOP: I('$"+%(9 C#!)$)H%#/ 3BD(.$"+ LMNP: 1$"+%9%$< A"/$%#6 3BD(.$"+ LQOP: E"$D)! R(9%!($%)# (/ ."+ BG ;EC1 A"/$ (/ ."+ SCB4 TQO 2+"/"+J($%J" C&&%'('< A"/$ 3BD(.$"+LNOP: I%)9)6%'(9 @"('$%J%$< &)+ 2('U%#6 E($"+%(9 (/ ."+ 3BD(.$"+LMQP7LMMP:

BIOSIMILAR TESTING

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

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

4($( E(#(6","#$ .+('$%'"/ %# 1 2@; V;I1 (+" !"/%6#"! $) "#/=+" $)$(9 %#$"6+%$<7 /"'=+%$< (#! &(/$"/$ +"$+%"J(9 )& !($(W

SIPRA LABS LIMITED Industrial Estate, Sanathnagar, Hyderabad – 500 018.

Tel: 040-23802000, Fax: 040-23802005 Email:sipra@sipralabs.com web: www.sipralabs.com EXPRESS PHARMA

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VISCOMETER

127, Bussa Udyog Bhavan T.J Road Sewri Mumbai - 400015

Tel: 91 22 24166630 / 24173493 Fax: 91 22 66627766 E-mail: support@rosalina.in, www.rosalina.in

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

Microbial Detection & Identification

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

www.criverindia.com

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

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September 1-15, 2014

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PHARMA LIFE AWARD

Merck Serono India wins five awards at CMO Asia Awards 2014 Becomes most awarded pharma company in the digital and social media space in India MERCK SERONO India bagged five awards at the recently held CMO Asia Awards at Singapore. With this win, it becomes the most awarded pharmaceutical company in the digital and social media segment in India.

Merck Serono India won various digital and social media awards for their integrated digital campaigns. ‘Fertility Awareness Week’, a Merck Serono initiative, to spread awareness about fertility and help people Break The Silence won three awards - Best Mar-

keting Campaign in Healthcare, Digital Media Campaign Of The Year and Best Integrated Campaign. The Merck Serono India Blog won the award for the Best Corporate Blog and Merck Serono India –Social Media Channels won the Certificate of Merit for the Best Use of Social Networks.

Speaking on this success, Lawrence Ganti, Senior Vice President, Merck Serono said, “It is indeed a proud moment for all of us at Merck Serono India. This recognition is a testament to our business Innova-

Merck Serono India has used multi channel marketing approach to spread awareness on various therapeutic areas like fertility, anaemia, vitamins and bone and joint health tion and the innovative use of New Media - Social Media in pharma marketing. These

awards, coupled with the few we have already won, give us confidence to further engage

our audiences using novel channels of communication aligned with our business goals.”

Merck Serono India has used multi channel marketing approach to spread awareness on various therapeutic areas like fertility, anaemia, vitamins and bone and joint health.

These APAC level awards witnessed total 415 entries from more than 12 countries in the Asian Pacific region comprising various industries and sectors.

EP News Bureau-Mumbai

INITIATIVE

Cadila Pharmaceuticals organises ‘Freedom from Pain Walkathons’ Held across cities in Ahmedabad, Mumbai, Chennai, Kolkata, Hyderabad and Ambala CADILA PHARMACEUTICALS recently organised ‘Freedom from Pain Walkathons’, to increase awareness about osteoarthritis and problems faced by patients suffering from this disease. The walkathons were held across major cities of India, like Ahmedabad, Mumbai, Chennai, Kolkata, Hyderabad and Ambala.

“Osteoarthritis is a disabling disease which affects millions of Indians. At Cadila Pharmaceuticals, we continuously strive to increase awareness about this disease and alleviate the pain of osteoarthritis patients by using research and innovation to pro-

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vide affordable and quality medicines. At the ‘Freedom from Pain Walkathons’, we invited leading orthopaedic doctors from across the country, along with their patients and patients’ relatives to be a part of this initiative,” said Dr Rajiv Modi, Chairman and Managing Director, Cadila Pharmaceuticals.

“Walking and taking the stairs is necessary to keep our knee joints healthy. Swimming, sit-ups and Suryanamaskar also help to reduce joint pain,” said Mumbai-based orthopaedic surgeon, Dr Ram Prabhu.

EP News Bureau-Mumbai

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PHARMA LIFE NEWS

IBM launches cloud-based HR solutions Offers analytics and workforce science to identify top talent, deepen employee engagement and manage transformational change IBM HAS launched cloudbased solutions and a Talent and Change consulting practice to enable organisations to use analytics and workforce science to identify top talent, deepen employee engagement and manage transformational change to provide differentiated client experiences.

The new offerings are delivered through IBM’s Smarter Workforce initiative and draw upon the company’s 25 years of workforce science expertise, a discipline that helps clients apply proven behavioural science, statistical analysis and psychological principles to improve employee engagement and organisational performance.

In tandem with the new Talent and Change practice, which is backed by 1,600 change management experts, the offerings are also supported by more than 100 behavioural scientists dedicated to helping clients use social, analytics and digital experience technologies to identify top performers, evaluate workforce readiness, and guard against future talent attrition.

IBM’s new dedicated Talent and Change consulting practice helps clients prepare for the transformational change required to build a smarter, more connected workforce. The practice gives clients access to organisational change management methods, tools and expertise gained from thousands of client engagements and IBM’s own transformation initiatives. It addresses four key areas. They are organisational change, talent analytics, employee experience and HR Cloud, with an overall focus

66 EXPRESS PHARMA September 1-15, 2014

CLOUD-BASED SOLUTIONS BY IBM ◗

IBM Kenexa Predictive Hiring: Gives business leaders access to workforce analytics and behavioural assessments to understand individual, job, team and organisational traits that define top performers. These dynamic profiles help ensure the right candidates are hired and effectively deployed.

◗

IBM Kenexa Workforce Readiness: Enables clients to assess current workforce readiness to address existing and emerging business demands. It combines industry skills frameworks, role-based competency testing, project management tools and consulting services for greater precision in role and team design.

◗

IBM Kenexa Predictive Retention: Guards against future talent attrition by helping organisations compile and analyse high-volume workforce data, from exit interviews to real-time SaaS-based employee analysis, to understand risk factors, identify employees likely to leave and build new programmes to reduce the risk of attrition.

on helping clients use cloud to deploy, manage and access their HR solutions and assets to drive business results.

The new practice will help clients accelerate the adoption of IBM’s Smarter Workforce offerings, and embrace new technologies such as IBM SPSS predictive analytics to create a competitive advantage.

“Talent is our key strength and differentiator. We are delighted to partner with IBM to transform our employees into a smarter workforce, which will be critical to strengthen a competitive advantage in the dynamic marketplace. These tools will not only use analytics and workforce science to recognise leading talent but also enhance engagement with employees to manage the transformational change”, said Rajendra Ghag, CHRO, HDFC Life Insurance.

“People being the most important differentiator, successful Indian companies are beginning to realise the potential of workforce engagement. They are looking for solutions and new ways to attract and retain top talent, adding more precision to role and team design while driving the right organisational culture and adapt to new business opportunities. We have introduced new cloudbased offerings and a Talent and Change consulting practice with data-driven approach, designed to complement the expertise of business leaders and HR professionals,” said Anmol Nautiyal, Director, IBM Social Business and IBM Smarter Workforce.

EP News Bureau-Mumbai

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