Express Pharma (Vol.10, No.23) October 1-15, 2015

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Market IPM clocks `8281 crores in Aug 2015 Research The journey from cow to consumption

1-15 OCTOBER 2015,` 40

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CONTENTS MARKET Vol.10 No.23 OCTOBER 1-15, 2015 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

32

Pg

Bengaluru Neelam M Kachhap

12

DOP RECOMMENDS FOOLPROOF SYSTEM TO CURB ADRS

13

AJANTA PHARMA IN NSE’S NIFTY MIDCAP 50 INDEX

14

DEPARTMENT OF PHARMACEUTICALS’ REVAMPED WEBSITE LAUNCHED

15

SUN PHARMA SIGNS DEAL WITH STRIDES ARCOLAB

Pune Shalini Gupta DESIGN National Art Director Bivash Barua

RESEARCH

Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Harit Mohanty - West & East

P18: POST EVENT OPPI organises summit on HR Imperatives for Organisational Sustainability

Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Arun J Ajanta Sengupta Nirav Mistry

P28: INTERVIEW

PRODUCTION General Manager B R Tipnis

P36: INSIGHT

PHARMA ALLY

‘We plan to expand our reach to over 100 clinics’

44

‘KAMANI OILS HAVE MOST OF THE WELL-KNOWN FOOD AND PHARMA CUSTOMERS OF THE COUNTRY’

46

GATTEFOSSÉ OPENS TECHNICAL CENTRE IN MUMBAI

International politics and IPR

Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

P75: AWARDS Thomson Reuters honours Indian scientists at India Citation Awards 2015

40

TC BIOPHARM TO START PHASE II/III STUDIES OF IMMUNICELL IN OCTOBER

42

SCIENTISTS TURN TO ASPIRIN TO TURBO-CHARGE CANCER IMMUNOTHERAPY

43

CATTLE VIRUS LINKED TO BREAST CANCER

Express Pharma® Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2015. The Indian Express (P) Ltd. All rights reserved throughout the world.

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

EDITOR’S NOTE

Mainstreaming AYUSH

T

he last month saw a major milestone in the patent versus patient debate.

Turing Pharmaceuticals’ CEO Martin Shkreli was forced to back down after hiking the price of Daraprim, a 60-year-old drug, by 5500 per cent two months after acquiring the rights to the drug.

Outrage in the US and across the world was instant and visceral, and industry organisation BIO dropped the company from their membership lists. With Turing Pharma and Shkreli now branded as pariahs in the pharma world, have we finally settled the argument that market forces should not be left to determine medicine prices?

Not likely, but at least the hardliners on the pricing front were forced to rethink their position.

Just as drug price hardliners need to rethink their stance post the Turing episode, IPR experts in India now feel that on the Traditional Knowledge (TK) front, India needs to move from the closed access system of the Traditional Knowledge Digital Library (TKDL) to a form of open access, the Traditional Knowledge Docketing System (TKDS), where the rights to TK rest with the local community.

Kerala has proposed a Draft Bill on TK, which envisages the formation of people’s trusts for the protection of TK. However, it is at a very early stage and critics point out that there is as yet no clear definition of the terms of the common licenses and knowledge commons proposed by the Draft. Read more about this topic in our Oct 1-15, 2015 AYUSH special issue (See story: Battle against Bio-piracy, pages 25-27).

The world is evolving to an integrative therapyapproach, where AYUSH is complementaryto mainstream medicine.

To reap the benefits, the AYUSH Ministry should ensure that we do not miss this bus

Besides bio-piracy, the cover story section analyses the recent US Pharmacopeia directive that requires high performance thin-layer chromatography (HPTLC) fingerprinting for all herbal extract exports. As a move towards standardisation of herbal extracts, it is welcome but industry observers feel that the August 1 deadline was too steep for smaller companies to implement these guidelines. (See story: HPTLC Defining Herbal Inc pages 22-24).

Across the world, there are many examples of traditional foods being transformed into nutritional supplements, after gathering evidence to prove their clinical impact. The Sweden-based ColoPlus has done the same for cow’s colostrum, and with the Swedish consulate playing matchmaker, found an Indian partner in the Punebased Govardhan Milk Foods to launch the product in India post-Diwali. (See story: The journey from cow to consumption headline, pages 30-31) The cover section also spotlights homoeopathy, a branch of alternative treatment, which has its ardent supporters as well as critics (See story, Homoeopathy: Coming out of the shadow, pages 32-35).

All these issues prove that the world is evolving to an integrative therapy approach, where AYUSH is not alternative but complementary to mainstream medicine. If we want to reap the benefits, both for our patients as well as in terms of market share and profits, the AYUSH Ministry will need to ensure that we do not miss this bus.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET COMPANY WATCH

DoP recommends foolproof system to curb ADRs

US FDA reverses NDA nod for Sun Pharma’s anti epileptic drug

India should see that its drugs manufacturing and exports register manifold increase with no suspicion in their content and quality: Dr VK Subburaj DR VK SUBBURAJ, Secretary, Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, stressed the need for a foolproof system that can restrict, curb and even eliminate causes leading to adverse drug reactions (ADRs) as their reporting is hushed up or avoided to protect the reputation of hospitals and doctors.

Inaugurating a conference on ‘Pharmacology: R&D for Minimizing ADRs and Role of Pharmacists’ under the aegis of PHD Chamber of Commerce and Industry in New Delhi, Subburaj pointed out that in the next 10 years, the number of pharma manufacturing units will rise by six times from the current level of 12,000 units. Hence, it becomes all the more important for India to see that its drug manufacturing and exports register manifold increase with no suspicion in their content and quality.

“The US for example

According to Subburaj, no definite and effective statistics and estimates are available as to how many cases of ADRs happen each year in India has set out to address this issue way back in 1962 and consequently a small number of cases of ADRs have been reported there. Though India woke up to this fact in 1982, very little was achieved to contain ADRs. This is because it has not been able to create an effective mechanism to address the issue,” said Subburaj.

According to Subburaj, no definite and effective statistics and estimates are available as to how many cases of ADRs happen each year in India while in the US, such statistics are accurate. India needs to

emulate such a country to address the issue of ADRs with an effective monitoring system in place.

Dr GN Singh, Drug Controller General (India) said that ADR is a serious issue.

Authorities concerned are in a consultation process with functionaries of WHO. Representatives of 100 emerging economies are trying to find out ways and means for evolving a regulatory mechanism to contain the menace of ADRs. DCG(I) also said that the government will view it with an open mind. He also stressed on the suggestion

saying Pharm D graduate should be employed at district or sub-taluka level PHCs. He has also given a suggestion to classify the drugs into three categories i.e. the drugs (OTC) which consumers can take directly from medical store, few limited drugs which could be prescribed / suggested by pharmacists and the speciality drugs prescribed by medical doctors. This will also improve the access of healthcare services especially in areas where there is shortage of doctors while the pharmacists are available.

Now, NABH guidelines will also look at including the role of pharmacists for the accreditation, said Dr KK Kalra, CEO, NABH. Among others who were present on the occasion were Nishant V Berlia, Chairman, Health Committee, PHD Chamber and its Secretary General, Saurabh Sanyal.

SUN PHARMA Advanced Research Company (SPARC) announced that the US Food and Drug Administration (US FDA) has issued a Complete Response letter (CRL) to its New Drug Application (NDA) for Elepsia XR (Levetiracetam extended-release tablets 1000 mg and 1500 mg).

SPARC had earlier received a final approval from US FDA in March 2015 for this product and was evaluating several marketing partners for commercialisation.

However, SPARC has now received a CRL from the US FDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility was not acceptable on the date of approval.

Elepsia XR is to be manufactured at Sun Pharmaceutical Industries Ltd (SPIL)’s Halol facility. SPIL is working with US FDA in resolving the cGMP deviations at the facility and has taken several corrective measures.

EP News Bureau-Mumbai

EP News Bureau-Mumbai

Novartis launches access programme for 15 medicines Novartis Access to be launched first in Kenya, Ethiopia and Vietnam NOVARTIS HAS launched Novartis Access, a portfolio of 15 medicines to treat chronic diseases in low and low-middleincome countries. The portfolio addresses cardiovascular diseases, diabetes, respiratory illnesses and breast cancer. It will be offered to governments, NGOs and other public-sector

12

EXPRESS PHARMA

October 1-15, 2015

healthcare providers for $1 per treatment, per month.

“Novartis Access is a natural extension of two important contributions our company makes to society: developing innovative medicines that help people fight disease and working to get them to as many people as possible,” said Joerg Reinhardt, Chairman

of the Board, Novartis. “This programme takes a novel approach to addressing the rising tide of chronic diseases in parts of the world where people often have limited access to healthcare. We know we will need to keep an open mindset and learn as we progress on this journey.”

The Novartis Access portfo-

lio includes patented and generic Novartis medicines. It will be launched first in Kenya, Ethiopia and Vietnam. Over the coming years, Novartis plans to roll out Novartis Access to 30 countries, depending on demand.

The products included in the Novartis Access product portfolio have been selected based on

the World Health Organization’s Essential Medicines List and are among the most commonly prescribed medicines in these countries. Novartis expects this new approach to be commercially sustainable over the long term, enabling continuous support in those regions.

EP News Bureau-Mumbai

Ajanta Pharma in NSE’s Nifty Midcap 50 index The inclusion will take effect from October 19 this year

AJANTA Pharmaceuticals will be included in the NSE’s Nifty Midcap 50 index, replacing Aditya Birla Nuvo from the next month.

The inclusion will take effect from October 19 this year, according to a release

by India Index Services and Products Ltd (IISL), a subsidiary of NSE Strategic Investment Corporation.

Ajanta Pharma replaces Aditya Birla Nuvo, which will be excluded from the index Aditya Birla Nuvo, the holding company of Aditya Birla Group, will be excluded from the index.

“The Index Maintenance Sub-Committee has decided to make the replacement on account of proposed scheme of arrangement for transfer by way of a demerger of Madura Undertaking of Aditya Birla Nuvo to Pantaloons Fashion & Retail,” the release said.

The Nifty Midcap 50 index consists of stocks with an average free float market capitalisation ranging from ` 1,000 crores to ` 5,000 crores at the time of selection.

PTI

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EXPRESS PHARMA

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October 1-15, 2015

MARKET

Department of Pharmaceuticals’ revamped website launched The website is compliant with the guidelines issued by the Department of Administrative Reforms and Public Grievances THE REVAMPED website of the Department of Pharmaceuticals was recently launched by the Minister of State for Chemicals & Fertilizers, Hansraj Gangaram Ahir in New Delhi. The revamped website is compliant with the guidelines issued by the Department of Administrative Reforms and Public Grievances.

According to a PIB reelease, the website has user-centric content, responsive pages, cloud environment and is bilingual in Hindi and English.

Ahir said that transparency is a vital component of good democracy and the digital initiative undertaken by the government under the leadership of the Prime Minister, Narendra Modi, which will benefit the people in this regard. He said

Hansraj Gangaram Ahir, Minister of State for Chemicals & Fertilizers, launching the revamped website of Department of Pharmaceuticals, in New Delhi. VK Subburaj, Secretary, Department of Pharmaceutical is also seen

that the revamped website is a good effort to provide information to the people and the pharma industry through a single window. Ahir said that the website will help in obtaining feedback from the people which will help the department in taking corrective steps, if

required. Ahir said that the government is committed to make available medicines at affordable rates and adoption of technology will facilitate the process.

Speaking on the occasion, Dr VK Subburaj, Secretary, Department of Pharmaceuticals,

said that it would be the earnest effort of the department to provide updated information on the website. It will provide a holistic view to the common man of the functioning of the department whose activities are significant and increasing.

EP News Bureau-Mumbai

Dr Reddy’s, BioMarin settle patent litigation on Kuvan tablets BioMarin will allow the Indian drug maker to market a generic version of Kuvan 100mg tablets in the US at a later stage THE CALIFORNIA-BASED BioMarin Pharmaceutical has entered into a settlement agreement with Dr Reddy’s Laboratories to resolve patent litigation in the US regarding Kuvan, the former’s 100 mg oral tablets.

According to a statement issued by BioMarin, the US drugmaker said it will grant Dr Reddy’s a non-exclusive licence to its patents on Kuvan (sapropterin dihydrochloride) allowing the Indian drug maker to market a generic version of Kuvan 100mg tablets in the US at a later stage, which is

14

EXPRESS PHARMA

October 1-15, 2015

expected to be more than five years from now.

Kuvan, which has clocked $203 million revenues for the company in 2014, is indicated for the treatment of hyperphenylalaninemia (HPA) in adults and children with phenylketonuria (PKU), who have been shown to be responsive to such treatment.

HPA is the most frequently inherited disorder of amino acid metabolism.

“The settlement agreement recognises the strength of the intellectual property related to Kuvan and helps ensure that patients, who

depend on Kuvan to manage their phenylketonuria (PKU), will continue to receive the medication and the range of support services offered to patients for years to come,” said Jeff Ajer, Executive VicePresident and Chief Commercial Officer, BioMarin.

“This settlement is beneficial to patients, clinicians, BioMarin and our shareholders, as it removes the cost, distraction and uncertainty associated with this litigation,” he added.

On January 16, 2015, BioMarin had filed a lawsuit in the US District Court for the

southern district of New York, against Dr Reddy’s in relation to Kuvan (sapropterin dihydrochloride).

As required by law, BioMarin and Dr Reddy’s will submit the agreement to the US Federal Trade Commission and the US Department of Justice, the statement further said.

Kuvan tablets are commercialised by BioMarin in the US and Canada, and Merck Serono in the rest of the world outside Japan.

EP News Bureau-Mumbai

Pfizer to sell its Thane plant to Vidhi Research and Development All current workmen at the Thane plant shall be transferred to the buyer so as to facilitate manufacturing operations PFIZER HAS entered into a business transfer agreement to sell its Thane plant as a going concern to Vidhi Research and Development for ` 178 crores.

In a BSE filing, Pfizer said that it has entered into a Business Transfer Agreement (BTA) for the transfer of the company’s business at the Thane plant as a going concern to Vidhi Research and Development in accordance with the terms of the agreement for a lump sum consideration of ` 178 crores. “Upon the conclusion of the BTA, all current workmen at the Thane Plant shall be transferred to the buyer so as to facilitate manufacturing operations,” the filing said.

In July, Pfizer announced that it will close its over 50-year old Thane plant from September 16, 2015, which was lying idle since 2013. “The decision to close the site is based on an assessment of its long-term viability and its ability to achieve the needed production. There has practically been no production activity at this plant since 2013,” a Pfizer spokesperson had said.

The plant, which employed 212 workers, had offered a voluntary retirement scheme (VRS) last year. This was taken up by as many as 132 workmen.

The Thane plant was commissioned in the 1960s. It supplied drugs to both domestic and international markets.

PTI

MARKET

Sun Pharma signs deal with Strides Arcolab To transfer erstwhile Ranbaxy’s Solus and Solus Care divisions, along with employees to Strides SUN PHARMACEUTICAL Industries and Strides Arcolab have entered into a definitive agreement related to erstwhile Ranbaxy’s Solus and Solus Care divisions operating in the central nervous system (CNS) segment in India.

The agreement involves transfer of these two marketing divisions, along with employees to Strides for a consideration of `1,650 million. As per IMS July 2015 MAT report, all the products of these two divisions together accounted for approximately `920 million in sales.

During the divestment process, Sun Pharma was cognizant that the interests of its employees working in Solus and Solus Care divisions were not compromised.

Abhay Gandhi, Chief Executive Officer, India Business, Sun Pharma said, “The agreement with Strides is part of our strategy to firmly consolidate our CNS business in India. We have evaluated each and every therapy segment that we are present in and how these businesses can grow going forward.

Based on this evaluation, we firmly believe that the potential of Solus and Solus Care divisions can be greatly enhanced with the focus that Strides will put in growing them. The divestment will help these divisions, its customers and the team.”

Subroto Banerjee, President – Brands, India, Strides said, “The acquisition of Solus and Solus Care divisions is of strategic significance to the growth of our branded business in India. The rich product portfolio and capable teams of these two divisions will help us establish a strong footing in the fast growing CNS market of India.

The specialty nature of CNS products makes brand equity and customer relationships, key determinants of success.

The Solus and Solus Care divisions readily qualify for both these parameters. ”

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October 1-15, 2015

MARKET GROWTH TRACKER

IPM clocks ` 8281 crores in Aug 2015 Nine therapies have outgrown the IPM growth THE INDIAN Pharmaceutical Market (IPM) clocked ` 8281 crores in August 2015. It grew at 13 per cent in the same month.

Amongst the top 10, Lupin grew by 21.2 per cent followed by Pfizer at 19.5 per cent and Abbott at 13.7 per cent. 22 corporates have crossed the growth of IPM for the month of August 2015 amongst top 50.

Amongst the top 50 corporates, AstraZeneca had the highest growth of 55.7 per cent followed by Bharat Serums at 38.9 per cent and MSD at 34.2 per cent. 32 corporates have shown growths of more than 10 per cent amongst the top 50.

Amongst the 11-20 ranked corporates, Intas had the highest growth of 31 per cent followed

by Glenmark at 28 per cent and Torrent at 21.7 per cent.

Amongst the 21-30 ranked corporates, MSD had the highest growth at 34.2 per cent followed by Wockhardt 24.6 per cent and Novartis at 16 per cent.

Amongst the 31-40 ranked corporates, AstraZeneca had the highest growth at 55.7 per cent followed by Bharat Serums at 38.9 per cent and JBCPL at 19.3 per cent.

Amongst the 41-50 ranked corporates, Allergan had the highest growth at 21.8 per cent followed by Fourrts at 15.4 per cent and Walace at 15 per cent.

Amongst the 51-60 ranked corporates, Boehringer grew at 98 per cent followed by Eli Lilly at 41.7 per cent and Troikaa at 39.2 per cent.

Amongst the 61-70 ranked corporates, Fresenius Kabi grew at 39.6 per cent followed by TTK by 19.2 per cent followed by RPG at 14.8 per cent. Centaur has entered the ` 300-crore club on MAT basis.

For the month of August 2015, amongst the top 10, Lupin grew by 21.2 per cent followed

by Pfizer at 19.5 per cent and Sun Pharma at 15 per cent. 24 companies have crossed the growth of IPM amongst top 50.

16

EXPRESS PHARMA

October 1-15, 2015

Amongst the 21-30 ranked companies, Wockhardt had the highest growth at 24.6 per cent followed by Novo Nordisk at 22.5 per cent and Zuventus at 16.9 per cent.

Indian companies have grown at 12.4 per cent versus 15.1 per cent for MNCs in August 2015. Amongst the top 50 in MNCs, AstraZeneca grew at 55.7 per cent, MSD grew by 34.2 per cent followed by Allergan at 21.8 per cent. Under the NonNLEM category, Indian companies grew at 13.8 per cent whereas MNCs grew at 16.9 per cent.

The DPCO containing molecules market grew at 3.3 per cent whereas the non-DPCO market grew by 14.5 per cent and Non-Sch Para 19 Market at 15.2 per cent resulting in an overall growth of 13 per cent for August 2015. NLEM and Non NLEM category showed unit growth at -2.7 per cent and 2.4 per cent respectively. The NonSch Para 19 Market grew at 13.7 per cent from units perspective.

From therapy perspective, nine therapies have outgrown the IPM growth. The respiratory market grew at 2.7 per cent, gastrointestinal market grew at 15.3 per cent, pain and analgesics market grew at 10.8 per cent whereas anti-infectives grew at 2.2 per cent. The anti-diabetic market grew at 25.6 per cent and cardiac at 18.7 per cent in chronic business. The derma market grew by 19 per cent and urology market at 18.5 per cent.

From regional perspective, 13 regions have outgrown the IPM growth. The Tamil Nadu market grew the highest at 26.2 per cent followed by Mumbai city market at 23.4 per cent and Odisha market at 22.7 per cent.

Two regions had negative growth in August 2015. Amoxycillin + Clavulanic Acid Market grew at minus one per cent whereas Glimepiride + Metformin grew at 15.8 per cent at number two.

With Bonus Units at Full Value Val in Crs CORPORATE

Rank MAT

MAT Aug-15 MTH

Aug-15

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

92306

100.00

14.6

8281

100.00

13.0

IPM Sun + Ranbaxy

1

1

8193

8.88

14.6

703

8.49

11.1

Abbott + Abbott HC + Novo

2

2

5777

6.26

14.1

514

6.21

13.7

Cipla

3

3

4608

4.99

17.5

400

4.83

11.0

Zydus + Biochem

4

4

3870

4.19

10.5

346

4.18

10.6 5.8

Mankind

5

6

3253

3.52

15.0

287

3.47

Alkem + Cachet + Indchemie

6

5

3192

3.46

11.1

291

3.51

5.4

Lupin

7

7

3188

3.45

18.6

281

3.39

21.2

Glaxo

8

8

3070

3.33

5.2

267

3.22

-0.3

Pfizer

9

10

2775

3.01

20.4

244

2.95

19.5

Macleods

10

11

2675

2.90

21.4

243

2.93

9.4

Intas

11

9

2521

2.73

22.1

246

2.97

31.0

Emcure + Zuventus

12

12

2457

2.66

9.8

220

2.66

10.4

Sanofi

13

14

2314

2.51

17.7

207

2.50

17.0

Aristo

14

13

2293

2.48

18.4

211

2.55

12.0

Torrent

15

17

2167

2.35

23.7

187

2.26

21.7

Glenmark

16

15

2140

2.32

24.8

195

2.35

28.0

Dr. Reddys

17

16

2118

2.29

15.5

190

2.30

14.9

USV

18

19

1831

1.98

20.3

160

1.93

18.2

Micro + Bal

19

18

1722

1.87

6.6

163

1.97

12.6

Alembic

20

20

1248

1.35

16.0

117

1.42

21.2

Novartis

21

23

1208

1.31

6.9

110

1.32

16.0

Val in Crs

MAT Aug 15

Month Aug-15

Super Group

VAL IN CRS

GR%

VAL IN CRS

GR%

IPM

92306

14.6

8281

13.0

ANTI-INFECTIVES

14171

9.5

1288

2.2

CARDIAC

11545

15.4

1007

18.7 15.3

GASTRO INTESTINAL

10731

16.6

990

VITAMINS / MINERALS / NUTRIENTS

8329

13.7

756

11.8

ANTI DIABETIC

7378

26.7

664

25.6

RESPIRATORY

7197

13.4

579

2.7

PAIN / ANALGESICS

6375

12.1

591

10.8

NEURO / CNS

5647

13.7

503

18.4

DERMA

5491

18.9

495

19.0

GYNAECOLOGICAL

4570

10.7

407

13.1

VACCINES

1578

9.9

149

29.6

HORMONES

1551

10.6

137

11.8

ANTI-NEOPLASTICS

1546

16.7

145

16.3

OPHTHAL

1355

17.8

119

19.2

BLOOD RELATED

1068

11.3

101

12.8 18.5

UROLOGY

1006

24.7

91

OTHERS

1004

22.4

102

43.1

ANTI MALARIALS

540

1.8

54

-11.6

SEX STIMULANTS / REJUVENATORS

500

11.6

40

12.0

STOMATOLOGICALS

386

10.8

33

7.2

OPHTHAL / OTOLOGICALS

228

7.2

19

1.1

OTOLOGICALS

110

13.0

12

9.2

MARKET The markets of paracetamol grew at 8.4 per cent, Atorvastatin 10.3 per cent, probiotic microbes at 32.4 per cent, Cefixime -7.2 per cent, pantoprazole 15.1 per cent, montelukast + levocetrizine at 9.5 per cent, glimepiride + metformin + pioglitazone at 21.1 per cent, Vitamin-D at 36.8 per cent, hydroquinone + mometasone + tretinoin at 12.3 per cent, voglibose + metformin + glimepiride at 51.9 per cent, rosuvastatin at 27.7 per cent, protein supplements at 10.5 per cent, azithromycin at -9.8 per cent, calcium carbonate + Vit D3 market at 27.6 per cent.

Mixtard leads the pack with ` 39 crores followed by Corex, Monocef and Augmentin at ` 27 crores for August 2015. Corex grew at 46.1 per cent followed by Mixtard at 21 per cent amongst top five brands.

Few brands who have gained ranks include Chymoral Forte (+148), Trajenta (+65), Vertin (+58), Magnex (+48), Omez (+43), Huminsulin (+41), Betnovate C (+39), Janumet (+37), Betnesol (+29), Panderm Plus, Rosuvas (+28), Jalra (+24), Ultracet (+23), Jalra M (+20), Januvia, Istamet (+19), Betnovate N, Rantac (+17), Pantop, Tonact (+16), Shelcal, Telma (+15), Zoryl M (+14), Galvus Met, Pan, Levipil, Aztor, Galvus (+12), Pan D, Telma H, Dolo (+11), Corex, Pantocid D SR (+10) amongst top 100 Brands over August -14 Few brands that have moved up ranks fastest into Top 300 Brands for the month of August 2015 are Biovac V, Brilinta, Oframax, Vaxigrip, Omnacortil, Bevon amongst others. 300th biggest brand is Nexpro from Torrent.

A total of 229 brands and 368 SKUs were launched in August 2015. Top new brands for August 2015 are Aztolet, Qilib, New Asthalin. Biggest new launch by an MNC are Qilib, Metosan, Pentashield in August 2015.

tributors (AIOCD ) in a joint venture with Trikaal Mediinfotech.

AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind

AIOCD AWACS’ research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

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

Percentage GR per cent – Growth in percentage.

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

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 & Dis-

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MARKET POST EVENT

OPPI organises summit on HR Imperatives for Organisational Sustainability Discussions were held on HR policies and creation of sustainable work environment Usha Sharma and Sanjiv Das Mumbai ORGANISATION OF Pharmaceutical Producers of India (OPPI) recently organised a summit on ‘HR Imperatives for Organisational Sustainability’ in Mumbai. Ranjana Smetacek, Director General, OPPI, gave the inaugural address and welcomed the guests. She said the vision of OPPI is to ensure that patients get affordable medicines.

This was followed by a group discussion where Smetacek; Sharad Tyagi, Vice President, OPPI and Chairman, Governance and Human Resource Management Committee and Managing Director; Boehringer Ingelheim; Dr Shailesh Ayyangar, President, OPPI and Managing Director, India and Vice President, South Asia, Sanofi; Homi Khusrokhan, President, Bombay Natural History Society (BNHS); and Dr Mukund Rajan, Member—Group Executive Council and Brand Custodian, Tata Sons participated.

While setting the context of the conference, Tyagi mentioned that human resource (HR) is the nucleus core and ethos of an organisation and it plays an important role in longterm sustainability of an organisation. Explaining the reason behind the inclusion of nonpharma panelists in the conference, he said that some employee sustainability issues faced by other industries are similar to what the pharma industry also comes across.

Tyagi informed that the future editions of the event would see the presence of CROs as well, when queried by Express Pharma, on the lack of repre-

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Panelists at the summit

sentation by the CRO industry at the event.

Ayyangar, while giving the inaugural address, talked about the growth of BRICS countries and cited examples from an IMF report which mentions the growing trends in the Indian and Chinese markets and predicts that India is going to grow by leaps and bounds. He said, “The challenge for us is how to create an organisational ecosystem and a sustainable human resource policy.” He further said that there is a need to manage a distinctive talent pool. He talked about the digital aspects for both the pharma and the healthcare industry, the e-commerce platform and telemedicine, which are helping companies to grow.

Ayyangar said, “Doctors today are using intranet, social media to reach out for professional discussion.” He also elaborated on various government

initiatives where he cited examples of state chief ministers who are encouraging pharma companies to set up shop in their respective states.

Khusrokhan, in his special address, talked about development and conservation. He said that companies need a demonstrable commitment to sustainability as part of core values and strategy. He stressed upon CSR spending, environmental sustainablity, earning the trust of stakeholders and local communities.

He also talked about what HR department in companies can do to encourage employees to imbibe values that matter, ensure the company’s core values and sustainability.

Post lunch, the first panel discussion was on ‘Diversity and Inclusion.’ It was chaired by Ranjit Shahani, Vice Chairman and Managing Director, Novartis. The panelists were Harsha

Bhogle, media personality; Poonam Barua, Chief Executive Officer, WILL Forum and Dr Ritu Anand, Vice President and Deputy Head—Global HR, TCS. They discussed on wealth creation, sustainability, gender equality, and how equal opportunity can be helpful for everyone to get on the board. Bhogle said that there is a need for learning from each other, skills that could not have been developed otherwise, guru shishya kind of parampara and diversity. Discussions were also held on how to prevent attrition, what role should the HR play to retain the talent pool, favourable policies for women, networking, mentorship and sponsorship.

Meenakshi Priyam, Head—HR (Pharma and Corporate) Novartis, summed up the panel discussion.

Dr Rakesh Sinha, Gynaeco-

logical Endoscopic Surgeon, enlightened the guests with his motivational speech on ‘Science in decision making’.

The second panel discussion on ‘Compliance and Governance’ saw participation from Tyagi, Subhasish Biswas, Corporate Ombuds, Wipro; A Vaidheesh, Vice President, South Asia and Managing Director, GSK; and KN Vaidyanathan, Chief Risk Officer, Mahindra Officer, Mahindra Group.

Vaidyanathan stressed upon the need for accountability among stakeholders. Vaidheesh talked about the healthcare scenario in the country, role of its multiple stakeholders and the challenges in the pharma and healthcare industry.

The last panel discussion was on ‘Employee Value Proposition.’ The discussion was chaired by Ayyangar and the panelists were Yugesh Goutam, Group President HR, JSW G; Raju Mistry, Group Head: Talent Staffing, Employer Brand and Group Leadership Programmes, Aditya Birla; Ronald Sequeira, Executive Director, HR, GSK and Yashwant Mahadik, Executive Vice President and Global CHRO, Sun Pharma.

Mahadik talked about how other industries are communicating in terms of value proposition and the learnings for the pharma sector. He also mentioned that pharma leaders are slow to adopt social technology.

Milind Thatte, Director— Commercial Development, Merck Serono summed up the panel. The summit ended with a vote of thanks from Sameer Tamhane, Senior Director— Human Resources, MSD. u.sharma@expressindia.com sanjiv.das@expressindia.com

EVENT BRIEF OCTOBER - NOVEMBER 2015 8

Pharmaceutical Summit and Expo

PHARMACEUTICAL SUMMITAND EXPO Date: October 8-10, 2015 Venue: New Delhi Summary: OMICS International’s Pharmaceutical Summit and Expo, will be organised around the theme ‘Novel Strategies and Innovations in Global Pharmaceutical Market.’

Pharma Summit 2015 will have 13 tracks and 81 sessions designed to offer comprehensive sessions that address current issues in Pharma Summit 2015.

Contact details Tel: 040-47482222-47482200

CPHI WORLDWIDE Date: October 13-15, 2015 Venue: IFEMA, Feria de Madrid, Spain Summary: CPhI Worldwide will host 2,500 plus exhibitors and more than 36,000 plus attendees from 150 plus countries. Visitors will meet international pharma companies, stay informed about the latest industry trends and remain one step ahead of a constantly changing pharma market.

The event will be co-located with ICSE, P-MEC and InnoPack.

Through all CPhI channels, and live at CPhI Worldwide 2015 in Madrid, the Pharma Forum will open up both known and unknown business opportunities to all pharma professionals of the pharma industry, in one central place. The forum will offer the chance to connect with influential players in the pharma industry.

Contact details UBM India Kumudini Bodha Kumudini.Bodha@ubm.com

4TH ANNUAL PHARMA LEGALAND COMPLIANCE SUMMIT Date: October 16, 2015 Venue: The Leela, Mumbai Summary: Lex WITNESS will organise the 4th Annual Pharma Legal and Compliance Summit. Demystifying compliance will be the key mandate and also the focus at the key note sessions.

The session will encompass various aspects right from the manufacturing hubs to the doorstep of pharmacists.

The summit will be an unique platform to get together and share the regulatory and legal developments and challenges in the areas of the industry.

Discussions will also be held on ‘unleashing the sciences of trademarks

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& copyright’, ‘M&A and FDI rides of the Indian pharma sector’, ‘An insight into the current patent scenario in India’ and ‘The regulatory sagas and the challenges within.’

Contact details Bhupinder Kaur email: Bhupinder@ WitnessLive.in Tel: +91-9654155065

2ND ANNUAL DATA INTEGRITY & QUALITY METRICS WORKSHOP Date: October 29 - 30, 2015 Venue: The Westin Mumbai Garden City International Business Park, Oberoi Garden City, Mumbai Summary: The workshop at CPhI will focus on the issues related data integrity, reliability and also on quality metrics and pilot programmes in the US. Experts from Lachman Consultants will be conducting the workshop. The organiser for the event is UBM. Contact details UBM India E-mail: suvidha.shetty@ubm.com Web: http://globalformulation.com

OTC PE CHARCHA Date: November 27, 2015 Venue: Sofitel, Mumbai Summary: Cube X, a division of Sorento, will organise ‘OTC Pe Charcha.’

Visitors at this year’s OTC conference will come face-to-face with first-hand consumer insights, expert views and successfully executed strategies in the OTC arena.

The key note speaker will be Nicholas Hall, Chairman and Chief Executive Officer, Nicholas Hall Group of Companies. Other speakers are Ambi Parameswaran, Advisor, Ex-Executive Director, FCB Ulka, India, Ajay Macaden Executive Director, Nielsen India, Nandini Dias, Chief Executive Officer, Lodestar UM, India, Dinar Mhatre, Head Integration, Johnson and Johnson Consumer, India, Gerard Fernandes, Consumer Healthcare Head, Boehringer Ingelheim, India, S Raghunandan, Director and CEO, Jyothy Laboratories, India, Ajay Rawal, National Marketing Head, JK Ansell, India, etc.

Contact details Prashansa Bora email: pbora@cubex.co.in, Tel (D): +91 022 4036 2037 (B): +91 022 4036 2000

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20 EXPRESS PHARMA October 1-15, 2015

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THE MAIN FOCUS

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I

ndia is one of the main hubs for herbal extracts and exports these products to all over the world. The offerings have a reputation of being good quality products. Today, there are several small, mid-sized and big companies that manufacture ayurvedic medicines and the majority of these companies export products to regulated countries like the US and EU. Hence, any regulatory changes or amendments which become effective in these countries, need to be followed by the Indian herbal manufacturers as well. As Shaheen Majeed, Director, Sami Direct explains, “Indian origin-based dietary supplements are a major portion of the dietary supplements market in the US, hence any regulations affecting the US dietary supplement market, directly affects the Indian herbal industry.”

The dietary supplement market in the US has marked 20 years under Dietary Supplement Health and Education Act of 1994 (DSHEA). The law was set up to regulate the dietary supplement industry as a special class of foods, distinctive from the drug and food regulations. It was intended to ensure consumer access to a variety of safe and effective health supplements.

However, the dietary supplement industry recently had to bear the ire of the New York Attorney General who took action against some of the major retailers who sell, among many other products, herbal supplements.

Yet, United States Pharmacopeia (USP), a central body for determination of appropriate tests, methodologies, and standards for drugs as well as food and dietary supplements, has described various test procedures to help the manufacturer identify the raw material, in a bid to avoid any ambiguity in the working of the dietary supplement segment. These tests methods, described in Chapter <563>, deal with the identification of articles of botanical origin. This chapter

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HPTLC DEFINING HERBAL INC USP has recently introduced HPTLC as one of the techniques to be used in chemical fingerprinting of raw material in herbal products. Industry players share their views on this development and seek government support in implementing this technology as it requires considerable investment

BY USHA SHARMA

HPTLC is an automated technique and the recording of the data and its retrieval for future reference, is much simpler than with TLC Shaheen Majeed Director, Sami Direct

The proposed guideline of USP, focusing on HPTLC for herbal drugs, is a welcome one V Hariharan CEO and Managing Director, Phytotech Extracts

Incorporation of the HPTLC method may help to resolve problems faced by the herbal drug industry Dr Rahul Singh Head - CQA (HCD) and R&D (Analytical), Emami

also discusses the various techniques for identification of botanical raw material, including identification of plant species by ascertaining the macroscopic characteristics as well as histological features, chemotaxonomy, which includes studying the active principles and marker compounds, and DNA finger printing methodology for identifying unprocessed raw material.

However, to provide a more definitive, routine identification methodology, USP has recently introduced High Performance Thin Layer Chromatography (HPTLC) as one of the techniques to be used in chemical fingerprinting raw material. This technique seeks to avoid violation of 21 CFR 111.75 and resulting warning letters from the US FDA. It has been implemented since August 1, 2015; and USP mandates that documentation is necessary to record the results in an auditable manner to comply with current good manufacturing practices (cGMP).

What is HPTLC? HPTLC is a more advanced technique than traditional Thin Layer Chromatography (TLC). While TLC is able to identify only the presence or absence of certain marker compounds in a raw material or extract, HPTLC can help to establish the identity of the raw material and extract by comparing it from, not just a single marker compound, but in fact the fingerprint of an entire range of natural plant compounds present.

However, HPLTC is an advanced form of technology which requires huge investment. Before introducing HPTLC to test the assay of the herbal drugs, the analysis was done either by Gravimetry, titration or UV method.

Dilip Charegaonkar, Managing Director, Anchrom Enterprises informs, “The new USP chapters describe a set of parameters to be followed in the practice of HPTLC, so that reproducible results can be obtained by anyone perform-

ing the test. Chapter <203> provides these parameters to be followed, and Chapter <1064> describes the reasons as to why the parameters were chosen. The chapters together cover every aspect of HPTLC, from sample preparation, sample application, development, humidity control, documentation, system suitability testing etc. HPTLC being a visual technique, there is an emphasis on photo documentation of HPTLC plates.”

Comparing the benefits of HPTLC against TLC, Majeed says, “HPTLC can be used for obtaining the chromatogram for herbal fingerprinting of the raw material, which can help in identifying the species of the raw material. The sampling procedures do not require cumbersome preparation and use a very small amount of the raw material. In contrast to TLC, HPTLC is an automated technique and the recording of the data and its retrieval for future reference, is much simpler than with TLC.” Dr Pulok K Mukherjee, School of Natural Product Studies, Dept of Pharmaceutical Technology, Ja-

davpur University also mentions, “HPTLC is extremely versatile and sensitive for the identification of many herbal drugs and is especially useful for the detection of adulterations, often with a very high degree of sensitivity. One of the most obvious orthogonal features of the two techniques is the primary use of reversed phases in HPLC versus unmodified silica gel in HPTLC, resulting in partition chromatography and adsorption chromatography respectively.”

Dr Rahul Singh, Head - CQA (HCD) and R&D (Analytical), Emami explains how HPTLC will be instrumental in enhancing the quality and safety of herbal products and says, “The WHO Guidelines for quality assessment of plant materials are not followed by most of the 8,500 licensed manufacturers of herbal formulations, since most of them are small-scale manufacturers with limited resources and knowledge. However, a few medium and large scale manufacturers undertake some quality control testing of herbal materials. In the case of herbal drugs it is

STATUS OF HPTLC IN VARIOUS PHARMACOPOEIAS AS OFAUGUST 2015 USP: In addition to the two existing chapters <621> “Chromatography”and <201> “Thin-Layer Chromatographic Identification Test”three new chapters have been drafted and published for comment in PF 40(3) and adopted: <203> High-Performance Thin-Layer Chromatography Procedure for Identification of Articles of Botanical Origin <1064> Identification of Articles of Botanical Origin by High-Performance Thin-Layer Chromatography Procedure <202> Identification of Fixed Oils by Thin-layer Chromatography (Note: this chapter describes a TLC method and an HPTLC method).

All chapters will be official in March2015 in the Dietary Supplement Compendium 3 and in October 2015 in the USP 38 NF 33 First Supplement PhEur: Chapter 2. 2.27 “Thin-Layer Chromatography”describes both TLC and HPTLC conditions.A general chapter 2.8.xx“Qualitative High Performance ThinLayer Chromatography of Herbal Drugs and Herbal Drug Preparations”was drafted and will be published in the next Pharmeuropa.The content is equivalent to

that of USP <203>.

With PhEur 7.0 all monographs for plants include either identification by TLC and HPTLC, or only HPTLC. ChP: Appendix VI “Thin-Layer Chromatography”describes both TLC and HPTLC conditions. Up to ChP2010 there are no monographs with HPTLC.The 2005 HPTLC Atlas features HPTLC results for 150 plants.A new project “HPTLC Atlas 2015”was launched by the Pharmacopoeia Commission JP17-II: The general chapter 2.03 ThinLayer Chromatography features only simple TLC. On December 4, 2014 a proposal to update the chapter to match USP 621 was adopted.That means HPTLC will now be introduced. Further details are not yet know.

IP: Guidance Manual for Monograph Development of Herbs, Processed Herbs/Herbal Extracts and Herbal Products describes both Thin Layer Chromatography and High Performance Thin Layer Chromatography under chapters 15 & 16 respectively

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(Source: Emami)

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cover ) different since no standard pharmacopoeial methods are available for their identity, when they are in multi-herbal formulations and more so when the extracts of herbs have been used in the formulations. However, regular botanical identification and phytochemical testing shall be of immense help if carried out for both raw materials as well as for the formulations. Incorporation of HPTLC method may help to resolve these problems faced by the herbal drug industry.”

He elaborates further, “As HPTLC is widely used for botanical identification to monitor the quality of articles of botanical origin on an increasingly globalised level, it seems important to thoroughly standardise the involved analytical procedures. Currently, laboratories in different countries can make the parameter selection widely within the framework of the USP general chapters; however, guidance about how to achieve specific HPTLC results in a reproducible manner is not available. A standardised procedure as proposed in 203 could fill this gap and serve as a basis for harmonisation of results obtained in different laboratories. “

So, is it affordable and justifiable?

Today, India is home to several herbal companies of good repute and global reach. Majority of these big players are largely dependent on small and medium sized players and they do not have strong financial support. So, the question that arises is: How can these small and medium sized players adopt HPTLC if it is not financially feasible?

V Hariharan, CEO and Managing Director, Phytotech Extracts expresses his concern, “I am sure that the new draft guideline of HPTLC is likely to impact exporters of herbal ingredients and herbal drugs. I am afraid that many herbal extracts producers may not have HPTLC as the requisites from major customers are test reports from

24 EXPRESS PHARMA October 1-15, 2015

The detailed guidelines shall enable even a novice analyst to follow the procedure with adequate control of various variables affecting the separation within permissible limits Dr PD Sethi Pharmaceutical Analyst

TLC and HPLC. Who has foreseen that they have to add the HPTLC method of analysis in their testing methods and that too in such a short time?

Here, the implementation time is an important factor.

MSME sector exporters and companies may not be able to afford investing the amount of `2.5 – `3 million plus immediately for HPTLC as this amount would not have been budgeted.”

SMEs do not have enough financial backing to installed such advanced technologies.

Vikas Jain, Director, MMV Nutrient Products informs, “The herbal raw material is prone to a lot of variations due to many factors. Seasonal variation is the most important one. Our herbal drug manufacturers are mainly SMEs, who don't have sophisticated technology like HPTLC to ensure that their products meet this specification.”

Beside considering the financial assistance in adopting HPTLC technology companies also need to address other issues which are linked with the technology upgradation. Jain informs, “One needs to plan for purchasing of such expensive instruments. They need to plan a lot of allied things such as the right standards of the ingredients, qualified and well trained staff who would be proficient to operate the HPTLC and study the results and so on.”

When companies make such a huge investment they would like to see return on investment as well. Rationalising the benefits behind making investments for advanced

technologies like HPTLC, Hariharan highlights, “Once HPTLC is in place working would be quite easy and cost effective. Some of the independent laboratories and a few companies may have invested on HPTLC and one could seek the help from them to get the product tested initially as investing a large amount for an HPTLC may not be feasible immediately.

The testing time and the expenses are not high with HPTLC.” However, the industry remains sceptical about the suggested changes, as Hariharan points out, “US FDA may come out with new test regulations from time to time for herbal drugs. They may ask the companies to implement the same within a very short time and the companies may envisage such methods of analysis and be prepared for it. Let it not be a shock as they have financial implications for purchase of instruments and so on.”

Moving towards a new era Quality assurance of herbal medicine is an important factor and considered as a basic requirement for herbal as well as other drug development industries. There are several problems which influence the quality of herbal drugs. Rationlising the importance of HPTLC, Hariharan emphasises, “The proposed guideline of USP, focusing on HPTLC for herbal drugs, is a welcome one. The accuracy of identification of impurities and the active ingredients are well established. Quite a few overseas customers have

identified many impurities in the extracts due to faulty production techniques or the use of adulterated solvents or may be like certain Chinese producers, some intentionally add adulterants to reduce cost of production.”

Jain stresses on why herbal manufacturers need to have HPTLC and how it will help them in expanding their business footprints, “The problem faced by the buyers of these herbal drugs are having a presence of minute quantity of active principle in the product. HPLTC would be useful for its detection. Another issue is that at times lack of knowledge regarding dosage calculation due to varied concentration of active constituent from same amount of raw material may also result in different values.

So, to avoid this, it is very necessary to make the HPTLC fingerprints of herbal drugs compulsory according to the guidelines.

Clarifying the necessity for switching from traditional methods to HPTLC, Hariharan also says, “As assay levels are not so accurate and also non-identification of individual components by these techniques, the customers have started analysing assay by HPTLC which was more accurate, then after they started demanding for that. However, the initial identification of the relevant ingredient is being done by TLC method. Subsequently, the demand has come to identify the residual solvents, heavy metals and thereafter pesticides. Many companies get these done by Gas chromatography (GC)

from other laboratories who have already invested in GC. These have now become mandatory for any herbal extract or drugs.”

Voice of experience Dr PD Sethi, Pharmaceutical Analyst, shares his experience and recalls the techniques used earlier, “The guideline describes standardised HPTLC procedure for end use. Considering my personal experience of almost four decades with the use of TLC/HPTLC for identification and quantitative analysis of pharma formulations, I can confidently say that these are the best drafted, scientifically sound, practical guidelines.

The detailed guidelines shall enable even a novice analyst to follow the procedure with adequate control of various variables affecting the separation within permissible limits.”

Agreeing to Sethi, Majeed comments, “While USP has issued the draft guidance of using HPTLC as one of the techniques for identification of botanical raw materials and extracts, this technique, because of its robustness, ease of sampling and low running costs, can make HPTLC an essential tool for the industry.

With the eyes of the industry, and the media on herbal supplements, utilising the best ‘fit for purpose’ testing tools must become common practice.”

Rising to the challenge Sethi concludes, “I feel we should accept this challenge and prepare ourselves to meet these specifications if we intend to export our medicines.

In fact, it shall be logical if the USP guidelines are included in Ayurvedic Pharmacopoeia of India as well as in Indian Pharmacopoeia which contains numerous monographs on herbal drugs. Any relaxation in the specification of herbal medicines for use in India as compared to specifications for export shall imply a compromise with the health of our people.” u.sharma@expressindia.com

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BATTLE AGAINST BIO-PIRACY An overview of Indian IPR laws and their effectiveness in preventing bio-piracy of traditional knowledge

BY SACHIN JAGDALE

D

uring the recent meeting with CEOs of Fortune 500 companies in New York, Indian Prime Minister, Narendra Modi, assured them the protection of their Intellectual Property Right (IPR), if they invest in India. The PM's assurance holds significance since India is always considered as a country where IPRs are not properly protected. However, India also has a story to tell where the country itself is a victim of IPR breach. In India, knowledge about medicinal plants have existed for hundreds of years in the form of local folklore and passed on from one generation to another. According to Natural Medicinal Plants Board (NMPB), about 960 species of medicinal plants are estimated to be in trade of which 178 species have annual consumption levels in excess of 100 metric tonnes. However, due to improper documentation of this traditional knowledge (TK), parties who came into the possession of this knowledge much later, are trying to patent it.

India's stand against bio-piracy Modern medicines still enjoy supremacy in the global market.

However, over the years, disease patterns have changed enormously. Though allopathy offers quick relief, it also comes with

several side effects. In the quest to find effective medicines which are free from side-effects, the global population started turning towards the ancient forms of Indian medicine. However, such global interest also led to a rise in bio-piracy. Efforts were made to patent indigenous plants like Kumari, Amaltas, Kala Jeera, Harad, Aswagandha, Neem, Turmeric etc.

“Bio-piracy was more prevalent in the 80s and 90s. India enacted the Biodiversity Act, 2002 and Biodiversity Rules 2004 much ahead of all other countries of the world. India has also come out with the 'Traditional Knowledge Digital Library' (TKDL), incorporating millions of formulae, claims for treatment and cures of diseases found in the ancient texts of ayurveda, siddha etc. In early international cases involving neem for use as pesticide, India had to deal with the lack of adequate documentation of prior knowledge (India succeeded eventually). This was the trigger for initiating work on TKDL,” informs Dr Gopakumar Nair, Chief Executive Officer, Gopakumar Nair Associates.

He adds, “India does not allow patenting of plants or medicinal plants or indigenous medicinal plants. Only the US grants plant patents. India allows grant of protection of new plant varieties under Plant Varieties and Farmers Protection Act.”

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Lack of ammunition?

India does not allow patenting of plants or medicinal plants or indigenous medicinal plants.

Only the US grants plant patents Dr Gopakumar Nair Chief Executive Officer, Gopakumar Nair Associates-

Though India is a big victim of bio-piracy, it is not the only country to have faced these issues. “Approximately 90 per cent of the world’s biodiversity is concentrated in the tropical and sub-tropical regions within developing countries, specifically in India, Sri Lanka, Mexico, Brazil, Indonesia, Australia, and Democratic Republic of Congo,” informs Shashank Sandu, Director, Sandu Pharmaceuticals. According to Sandu, countries like Mexico, Peru, Ecuador, El Salvador, Brazil, Argentina, Chile etc too have been affected by bio-piracy.

Over the last few decades, repeated attempts were made to patent Indian TK. India had to fight many cases in the international courts to get back what originally belongs to the country.

However, the question that arises is how did somebody from outside the country manage to invade the Indian property, in the first place? Don't we have a capable or strong enough IPR system to safeguard our medicinal plants?

Nair highlights, “India’s Intellectual Property Law has Section 3(p) reads as follows: Sec. 3 Inventions not patentable : (p) an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components.”

He says, “India is far ahead of all countries of the world having introduced the Biodiversity Act and Traditional Knowledge Digital Library (TKDL) to protect India’s natural resources, in addition to 3(p). While the Nagoya Protocol for Biodiversity was signed by member countries of WTO only in 2014, India has enacted a much stricter Biodiversity Act, purportedly for encouraging 'benefit sharing', but in practice, virtually preventing benefit generation, through impractical royalties and premature financial claims.”

In contrast to general belief that India is not doing enough to protect its TK, Nair makes a striking statement and says, “India is overprotecting, not lagging behind.” Nair is an authority in the field of IPR. Hence, his observation is not just going to raise eyebrows in the industry but is also likely to generate a meaningful debate.

Sandu explains the issue further, “India was the first to raise the fundamental issue at the World Intellectual Property Rights Organisation (WIPO) as to why the TK based system should not be treated at par with the industry-based system. Until and unless our TK is protected, the country would have to fight for patents claimed by other countries as in the case of Haldi, Neem and Basmati. Unfortunately, public awareness about protecting our TK is very low. Indigenous people are all too often unaware of the value of their knowledge.”

He adds, “In order to protect India’s sovereign rights of the indigenous communities and the indigenous bio-wealth and Indian TK, Indian government, under the Ministry of AYUSH, has taken the initiative of digitalising the available TK through TKDL. Due to this, many patent claims world over have been rejected.”

He also predicts that many other patent claims would also be rejected as the Indian government has given access to TKDL to all

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cover ) patent offices of other countries.

This will also ensure that no frivolous patent claims are made.

An interesting fact that came to light while researching this issue is that there are many Indian-origin applicants among those who seek patents for medicinal plants. So, it indirectly suggests that though India is pulling up its socks to protect its TK, ironically, there are Indian hands which are playing a significant role in handing over Indian wealth to some other country.

Approximately 90 per cent of the world’s biodiversity is concentrated in the tropical and sub-tropical regions within developing countries, specifically in India, Sri Lanka, Mexico, Brazil, Indonesia, Australia, and Democratic Republic of Congo Shashank Sandu Director, Sandu Pharmaceuticals

However, coming back to protection of TK, there are international IPR laws as well. Nair explains, “Developed countries like the US and Europe are not keen to enact laws for protecting bioresources. The US, Europe and other developed countries are very liberal in granting patents for patentable inventions (novel and inventive) based on natural products and bioresources. Globally, India has the strictest Intellectual Property Laws (Patent Act, Biodiversity Act, TKDL etc.), for restricting

26 EXPRESS PHARMA October 1-15, 2015

SOME EXAMPLES OF BIO-PIRACY OF TRADITIONAL KNOWLEDGE TURMERIC (CURCUMA LONGA LINN.) The rhizomes of turmeric are used as a spice for flavouring Indian cooking. It also has properties that make it an effective ingredient in medicines, cosmetics and dyes. As a medicine, it has been traditionally used for centuries to heal wounds and rashes.

In 1995, two expatriate Indians at the University of Mississippi Medical Centre (Suman K Das and Hari Har P Cohly) were granted a US patent (no.5, 401,504) on use of turmeric in wound healing.The Council of Scientific & Industrial Research (CSIR), India, New Delhi filed a re-examination case with the US PTO challenging the patent on the grounds of existing of prior art. CSIR argued that turmeric has been used for

NEEM (AZADIRACHTA INDICA A. JUSS.) Neem extracts can be used against hundreds of pests and fungal diseases that attack food crops; the oil extracted from its seeds can be used to cure cold and flu; and mixed in soap, it provides relief from malaria, skin diseases and even meningitis. In 1994, European Patent Office (EPO) granted a patent (EPO patent No.436257) to the US Corporation W.R. Grace Company and US Department of Agriculture for a method for controlling fungi on plants by the aid of hydrophobic extracted Neem oil. In 1995, a group of international NGOs and representatives of Indian farmers filed legal opposition against the patent.

They submitted evidence that the

BASMATI RICE (ORYZA SATIVA LINN.) Rice Tec. had applied for registration of a mark “Texmati” before the UK Trade Mark Registry.

Agricultural and Processed Food Exports Development Authority (APEDA) successfully opposed it. One of the documents relied upon by Rice Tec as evidence in support of the registration of the said mark was the US Patent 5,663,484 granted by US Patent Office to Rice Tec on September 2, 1997 and that is how this patent became an issue for contest.

This US utility patent was unique in a way to claim a rice plant having characteristics similar to the traditional Indian Basmati Rice lines and with the geographical delimitation covering North, Central or South America or Caribbean Islands. The US PTO granted the patent to Rice Tec on September 2, 1997. The said patent covered 20 claims covering not only novel rice plant but also various rice lines; resulting plants and grains, seed Source; Traditional Knowledge Digital Library

thousands of years for healing wounds and rashes and therefore its medicinal use was not a novel invention.

Their claim was supported by documentary evidence of traditional knowledge, including ancient Sanskrit text and a paper published in 1953 in the Journal of the Indian Medical Association. Despite an appeal by the patent holders, the US PTO upheld the CSIR objections and cancelled the patent. The turmeric case was a landmark judgment case as it was for the first time that a patent based on the traditional knowledge of a developing country was successfully challenged.

The US Patent Office revoked this patent in 1997, after ascertaining that there was no novelty; the findings by innovators having been known in India for centuries.

fungicidal effect of extracts of Neem seeds had been known and used for centuries in Indian agriculture to protect crops, and therefore, was unpatentable. In 1999, the EPO determined that according to the evidence all features of the present claim were disclosed to the public prior to the patent application and the patent was not considered to involve an inventive step. The patent granted on Neem was revoked by the EPO in May 2000.

EPO, in March 2006, rejected the challenge made in 2001 by the USDA and the chemicals multinational, W. R. Grace to the EPO’s previous decision to cancel their patent on the fungicidal properties of the seeds extracted from the neem tree.

deposit claims, method for selecting a rice plant for breeding and propagation. Its claims 15-17 were for a rice grain having characteristics similar to those from Indian Basmati rice lines. The said claims 15-17 would have come in the way of Indian exports to US, if legally enforced.

Evidence from the Indian Agricultural Research Institute (IARI) Bulletin was used against claims 1517. The evidence was backed up by the germplasm collection of Directorate of Rice Research, Hyderabad since 1978. Central Food Technological Research Institute (CFTRI) scientists evaluated the various grain characteristics and accordingly the claims 15-17 were attacked on the basis of the declarations submitted by CFTRI scientists on grain characteristics.

Eventually, a request for reexamination of this patent was filed on April 28, 2000. Soon after filling the reexamination request, Rice Tec chose to withdraw claims15-17 along with claim 4.

or even blocking almost all patenting of natural product or bioresource-based patenting.

Nagoya Protocol based biodiversity protection is yet to be enacted by countries other than India.”

However, Vikram Naharwar, Director, Amsar, has a different opinion to offer. He feels that the Indian legal system is weak and there are several loopholes which allow offenders to get away scott-free. He says, “The Indian courts are a mess, no international company has any fear of Indian courts as it takes forever to have a case heard and settled. There needs to be a special court to handle such medicinal plant patent related issues.”

Goa-based Amsar is an Indian herbal extraction company with a wide range of products in botanicals, nutraceuticals, ayurvedic medicines and herbal personal care.

Are we too demanding?

As mentioned before, few decades back bio-piracy was at its peak. India fought the legal cases and managed to reverse many patents. However, this aggression by foreign parties made India work on a strategy to safeguard its TK, which is often misappropriated, because it is conveniently assumed that since it is in public domain, communities have given up all claims over it.

After years of hard work, TKDL constituting thousands of pages was developed. TKDL compiles Indian systems of medicine, namely, Ayurveda, Unani, Siddha and Yoga available in public domain. Attempts to patent TK never stopped, though such incidents reduced considerably due to initiatives like TKDL. However, according to industry experts, sometimes genuine patent seekers get unnecessarily punished due to the stringent laws.

Nair explains, “Most attempts to patent Indian TK overseas (even in India) are being opposed by India through the Council of Scientific and Industrial Research (CSIR). However, even genuinely patentable inventions are also being opposed by CSIR, based on TKDL. Biodiversity Authority based in Chennai is claiming five per

( cent royalty upfront for giving no-objection or permission to patent office to grant patent based on natural products or bioresources. This is highly counter-productive. It prevents Indians from protecting Indian research on Indian bioresources, but leaves open developed countries to conduct research on them.”

Though TKDL is now in place, Sandu points out that TK is still at threat. He feels that modern intellectual property law is capable of protecting innovations produced by industries based mainly in the developed world, however, it is unable to adequately protect innovations produced in the developing countries. Hence, unequal distribution and concentration of patent ownership and the unequal share of benefits obtained from industrial use of biogenetic resources are closely related. “It has been observed that Indian TK is at threat on account of loopholes in the patent laws existent in the developed countries, like, the patent claims TK in the form in which it was acquired.

The patent covers a refinement of the TK, patent covers an invention based on TK and other modern/traditional knowledge,” says Sandu.

According to Nair, India is fully aware of Indian TK and is keen to protect the same. While the entire ongoing discussion on TK protection is within the ambit of IPRs, the large majority of think tanks and policy makers want to keep TK protection outside intellectual property.

While explaining the solutions to secure TK, Nair adds, “To protect India’s TK, India should take proactive action. I am strongly and vehemently proposing that Indian Government (Central or States or their designated agencies) should systematically protect all the TK and biodiversity and create a protected data bank. The agency handling the protected data bank may grant or issue permissions to use or utilise this protected knowledge or even assign or licence to those applicants who wish to avail or use these knowledge and/or the bioresource therein. Kerala Govern-

ment is reportedly moving in this direction, which is welcome and appreciated.”

Through measures like

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TKDL, India has taken a strong step towards protecting its TK. However, fight against bio-piracy is not just the prerogative of the

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Indian government. Unless the people of India, who are the true owners of TK, are educated about its importance, the fight

against bio-piracy will remain half won. sachin.jagdale@expressindia.com

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cover ) I N T E R V I E W

‘We plan to expand our reach to over 100 clinics’ Jiva Ayurveda recently opened its first telemedicine centre in Pune and plans to serve patients in regional languages through it. The company has a chain of 45 ayurvedic clinics and over the next few years has plans for extensive expansion. Madhusudan Chauhan, Director, Jiva Ayurveda, in an interview with Usha Sharma, talks about the company’s growth prospects

Tell us about Jiva Ayurveda.

How has the company established its niche in the Indian market?

Jiva Ayurveda was started with a vision of helping people live a healthier, happier life by bringing authentic ayurveda to every home. So it's not as much a niche as it is mass. Dr Partap Chauhan founded Jiva Ayurveda in 1992 as a small clinic on the outskirts of Delhi.

To make ayurveda more accessible, he launched the world's first ayurvedic clinic online. In 2000, Jiva TeleDoc Project was undertaken. It created a successful model of bringing high quality ayurvedic advice to the remotest villages and deliver the treatment at the patient’s doorstep. This project was a part of the Media Lab Asia, in collaboration with the Government of India. Jiva’s TeleDoc Project went on to win the World Sumit Award by the UN at Geneva, Switzerland in 2004. Jiva continued to pioneer the use of technology to set up the world's first ayurvedic telemedicine centre. Today, the organisation reaches out to thousands of patients every day, delivering customised, personalised ayurvedic treatment in over 2,000 towns and villages across the nation.

28 EXPRESS PHARMA October 1-15, 2015

Recently, the company has opened its first telemedicine centre in Pune. Tell us more about its activities.

Jiva Ayurveda runs the telemedicine centre consulting over 6,000 patients daily, with a large number of these patients coming from small towns and villages. The centre in Pune is extended to serve patients in Marathi language in addition to Hindi and English.

The company is known for delivering customised medicines to nooks and corners of India. What challenges did it face and how were they mitigated?

Jiva Ayurveda has done a great deal of work in standardising the practices, but not the treatment, thereby championing the cause of keeping ayurveda’s authentic approach of personalised treatment intact while making the services available to a large number of people. To ensure quality and effectiveness of treatment, Jiva has evolved best in class training and quality practices, putting multiple feedback and check points in place. This always ensures that the patient and patient-relief become primary.

Another challenge we faced

when we started out was that ayurveda was not the first choice of treatment. While people may have had belief in ayurveda, it was, in many instances, the last resort. Jiva and Dr Chauhan, Director, Jiva Ayurveda have emphasised greatly on the need of continuously educating people on what ayurveda does and how it works. This increases the understanding that people have about Ayurveda, clears the misconceptions and increases credibility.

The future is going to about how better quality healthcare can be delivered by innovative technology integrations

Which disease profiles are you working on?

Jiva Ayurveda focuses mainly on diseases that are classified as chronic and lifestyle disorders. There are great treatment options and outcomes that ayurveda has to offer to people suffering from disorders such as diabetes, joint pains, skin disorders, digestive problems, etc. An ayurvedic doctor understands the root cause of the disease and offers a customised treatment to the patient.

A lot of discussions are being held on online pharmacies in India and the government is in the process of formulating guidelines for it. Do you think

the concept will work in India?

In a country as big and diverse as India, bringing healthcare to all is a great challenge. A lot needs to be done in terms of infrastructure and manpower to make good quality healthcare accessible and affordable to all. With technology, a number of these challenges can be met. Online pharmacies have lately been in discussion. While it will be wonderful to provide improved access and availability of medicines to people, it requires a dialogue between the industry and the government to ensure that the regulations around it are sound enough to protect the interest of the patient while providing enough space for innovation to take place. The future is going to about how better quality healthcare can be delivered by innovative technology integrations.

The company started its 'online clinic' way back in 1995. Why did you feel the importance of adopting this method? Tell us about the success mantra of the clinics?

If ayurveda is to become globally accepted, it is important to establish the

( wonderful science behind ayurveda and explain it in a logical way. Most people try to mystify ayurveda, whereas by demystifying it, it creates more acceptance and clarifies doubt.

The online clinic was started with the intention of reaching out to more people and helping them understand how ayurveda can help them live a balanced and healthier life. Jiva Ayurveda has a deep belief in reaching out to people directly and educating them, for which reason online and a direct-topatient method was adopted.

Our success mantra has just been that we have remained very patient-focused consistently, trying to innovate to make the best of Ayurvedic treatment available to the patient.

clinics and the largest ayurvedic telemedicine practice. Over the next few years, we plan to expand our

reach to over 100 clinics and serve patients in most regional languages in the country through the telemedicine

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practice. We are focusing tremendously on research with a commitment towards delivering even better

treatment outcomes and quality treatment of the highest standard to our patients. u.sharma@expressindia.com

Tell us about Jiva Ayurvedaâ&#x20AC;&#x2122;s marketing strategy.

Jiva believes in the concept of educating. Ayurveda is not just about treating a disease, it is a way of life. Jiva runs a number of educational and awareness programmes that promote the concept of healthy, natural, wholesome living based on simple principles of Ayurveda.

We receive peoplesâ&#x20AC;&#x2122; responses on how they have made small changes in their lives based on the shows that they saw on television and the huge difference it has made in their lives. There is no better cure than prevention. We reach out to people through television, social media and on-ground camps, among other things.

Do you have an alliance with the government?

The government's agenda is to promote both ayurveda and telemedicine. Jiva is a leader in both the causes. Currently, we do not have an alliance with the government, however, we are looking at some initiatives of the government that can strengthen the reach of our telemedicine services.

What are the company's plans for the current fiscal?

What strategies have been adopted to achieve them?

Jiva Ayurveda currently runs a national chain of 45 ayurvedic

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EXPRESS PHARMA

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October 1-15, 2015

cover ) THE JOURNEY FROM COW TO CONSUMPTION Post Diwali, ColoPlus sachets will be launched in India, thanks to a collaboration between ColoPlus and the `1,450 crore Pune-based Parag Milk Foods. Viveka Roychowdhury speaks to Conny Hagman, Chief Executive Officer, ColoPlus and Shirish Upadhyay, Senior Vice President – Strategic Planning, Parag Milk Foods to get more details Go ColoPlus concept pack shot

T

he benefits of colostrum, the milk produced just before and after pregnancy, are well known and new mothers are encouraged to breast feed their babies as soon as possible after birth and as frequently in the few days after birth. In fact, traditional sweets made from bovine colostrum are part of Indian cuisine, in an attempt to extend the benefits to other age groups as well.

This traditional knowledge has stood the test of time and science. It has been proven that the main benefits of colostrum are due to the high levels of immunoglobins, vitamins and other nutrients present, which increase resistance to disease and today, is not just newborns who benefit from colustrum.

Observational field studies done by Sweden-based ColoPlus AB, a company active in developing and clinical studies of medical food products based on colostrum, in children with HIV showed a marked strengthening of the immune capacity as well as a significant improvement of the nutritional state and quality of life thanks to a reduction of symptoms such as diarrhoea, related to the immune deficiency.

Come November, ColoPlus products will be available in India, thanks to an agreement signed on February 12, 2014 between the Swedish company and Pune-based dairy firm, Parag Milk Foods. For the makers of the Govardhan and GO range of

30 EXPRESS PHARMA October 1-15, 2015

(L-R) Shirish Upadhyay, VP, Parag Milk Foods, Conny Hagman, Chief Executive Officer, ColoPlus, Devendra Shah, Chairman, Parag Milk Foods, Gowardhan, and BM Vyas, Director of Board, Parag Milk Foods

milk products, this marks a deeper foray into the valueadded health and nutrition business, which already reportedly contributes 80 per cent of the turnover. The two-decade plus dairy major is also reportedly planning an IPO and will file a Draft Red Herring Prospectus (DRHP) by end September.

According to Shirish Upadhyay, Senior Vice President – Strategic Planning, Parag Milk Foods, the launch strategy will be ready by end September in time for a post Diwali launch, in the form of single serve sachets as well as probably 200 gm and 500 gm SKUs. The Pune-based firm has aggressive plans and is reportedly targeting a turnover of ` 2,100 crore in 2015-16 against ` 1,450 crore in the last financial year.

Besides counting celebrities like Amitabh Bachchan and Sachin Tendulkar as clients for its ` 80 per litre ‘happy’ Holstein cow milk under the ‘Pride

of Cows’ brand, the group also has plans for the other segments of the market. The ColoPlus product will be marketed under the GO range, along with other value-added products like whey-based drinks, powders and supplements.

A new take on tradition According to Conny Hagman, Chief Executive Officer, ColoPlus, the decade-old company was started based on scientific work done on colostrum by Dr Lidia Elfstrand PhD, a food/pharmaceutical technologist. In terms of product positioning, they realised that a dairy-based product for the non-healthy elderly and children with decreased immunity should have good taste, long shelf-life and be easy to prepare.

They realised that most colostrum products were either capsules or pure powder and not food.

Securing the natural bioac-

tive benefits from colostrum called for controlling both the processing of colostrum as well as administration/composition of the final product. As Hagman puts it, the challenge was to develop a food product tasty enough to eat, yet with all the benefits of colostrum preserved from ‘cow to consumption.’

Hence, the industrial processes for colostrum and its products needed to be adjusted in order to preserve its very sensitive components. Thus the processing avoids fractionation, high temperatures and pressure. Additionally, transport time in intestine must be controlled and long enough to allow maximum absorption.

Different lab studies ended in the product ColoPlus IMCARE, designed as a porridge (dry powder product mixed with water) because this format protected the bioactivities of colostrum from denaturation in the gastrointestinal (GI) tract

and showed superior function intestinally.

In addition, as Hagman points out, the porridge format allowed the company to add nutritional components to the mix, which made ColoPlus a combi solution, both bioactivity and nutrition. This form of controlled administration of immunoglobulins etc. (in colostrum) in combination with nutrition, was granted patents in several countries, including India as a food product and not a supplement.

In terms of patient populations, individuals with manifest or risk of immunodeficiency and/or malnutrition such as children, the elderly, patients with acquired immune deficiency, show the most clinical benefits from such a product.

Different variants of the product for these patient/consumer populations were prepared by varying the concentration of immunoglobulins (colostrum) and selected organic matter.

The proof of the product Once they developed the product, Hagman, with Elfstrand and two medical experts, professors Ingemar Ihse and Claes-Henrik Florén, all related to Lund University, Sweden, set out to prove the efficacy with international clinical studies. The first clinical study was conducted in Port Harcourt, Nigeria and published in the Scandinavian Journal of Gastroenterology.

This was followed by a second study conducted in Uganda, the results of which were published

( online in December 2011 in the Indian Journal of Gastroenterology. The latest study/programme was conducted once again in Uganda and covered 850 children, supported by IKEA Foundation, results of which were published in the June 2015 edition of the World Journal of AIDS. All three studies showed a marked strengthening of immune capacity as well as a significant improvement of nutritional state and quality of life in patients with acquired immune deficiency and malnutrition. A profound reduction of symptoms such as diarrhoea, related to the immune deficiency was also registered. These effects reflect the unique composition of ColoPlus ameliorating both the immune system and the nutritional state. Results are transferable to other medical conditions where a weak immune system and a state of malnutrition negatively influence health.

Beyond ColoPlus IMCARE, the Swedish company is looking at developing specific medical applications of colostrum-based therapeutic food, and getting these too ready for new clinical studies.

Tapping into traditionSupplements like ColoPlus will never replace medicines but have an important role to play in supplementing their action.

For instance, the authors of the June 2015 paper in the World Journal of AIDS point out that while Anti-Retroviral Therapy (ART) and Highly Active Antiretroviral Therapy (HAART) will remain the mainstay of therapy for HIV patients, these therapies may not be easily available in poverty-stricken areas. In such cases, colostrumbased food supplements could play a crucial role in sustaining CD4+ levels (an indicator of immunity) and could postpone the need for ART or HAART. This could result in considerable benefits in terms of healthcare spend by governments and NGOs as well.

Colostrum-based supplements could also act as adjuvants to the therapy, reducing diarrhoea, an AIDS defining condition, possibly by restoring

the intestinal immune system.

However, these studies were done without a placebo control and future randomised placebo

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controlled studies are needed to verify these results.

ColoPlus is thus a perfect example of the synergies that can

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be explored between traditional practices/remedies and new age technologies and science, using evidence-driven methods

to further fine tune the product and prove efficacy. viveka.r@expressindia.com

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cover )

32 EXPRESS PHARMA October 1-15, 2015

( Homoeopathy is one of the oldest systems of alternative medicine.

However, it has not been able to gain the same stature as its mainstream counterparts viz allopathy. It has been shrouded in debates of efficacy with critics saying that it is a placebo science, lacks standard operating procedures etc. Has homoeopathy failed to achieve its desired reach and potential under the shadows of allopathy and how potent are the claims doubting its safety and efficacy. Will the recent fillip to the AYUSH department translate into good times for homoeopathy practioners and even their integration into the country’s public health services?

What needs to be done to get homoeopathy to the forefront of medical care?

BY SHALINI GUPTA

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THE MAIN FOCUS

DR ESWARADAS Chairman, Global Homoeopathy Foundation (GHF), Former Consultant Advisor (Homoeopathy) GoI

THE NEWLYCREATED MINISTRYOFAYUSH HAS AN IMPORTANTROLE IN MAINSTREAMING HOMOEOPATHYAND EXPOSING ITS FULLPOTENTIAL IN CURATIVE,PREVENTIVE AND PROMOTIVE CARE

D

uring the last 65 years, homoeopathy has been successfully institutionalised in India. A highly commendable infrastructure in the form of 191 teaching institutions, about 2.5 lakh registered practitioners, 345 drug manufacturing units, an autonomous research council with 32 peripheral units, a regulatory council for quality education at university level, drug safety regulations, pharmacopeia laboratory, pharmacopeia committees, net work of primary and secondary healthcare facilities both in public and private sector are available in homoeopathy in the country.

Inspite of its public acceptance there is some scepticism on the scientific basis of the system from certain corners, the foremost being that the homeopathic remedies in ultra high dilutions do not contain any material substance. As per the existing knowledge anything without material content cannot be considered as a remedy. This is based on Avogadro’s number, that any dilution beyond 10-23 does not contain any original solute; whereas homeopathic remedies are available beyond this dilution. This is the basis of the placebo theory spread by the critics of homoeopathy. Homeo-

pathic remedies are not prepared merely on dilution, but through a highly scientific process called dynamisation/ potenisation. Scientific research has repeatedly demonstrated that homeopathic remedies even at 10-400 dilutions contain nano particles, hence the placebo theory doesn't hold true.

Another criticism homoeopathy facing is non-reproducibility of results and inappropriate standard operating procedures. This come from people who never tried to understand the philosophy and principles of the system and tried to find answers based on the science that they are familiar. Inferences are drawn based on the analysis of data based on the pa-

In homoeopathy, the concepts are individualisation and drug dynamisation

rameters fixed on wrong methodologies. In homoeopathy, the key concepts are individualisation and drug dynamisation.

Any evaluation of a homeopathic remedy for its therapeutic efficacy without following these core concepts is bound to give fallacy in results.

The Indian healthcare system shares one-fifth of the world’s diseases load. The Indian medical systems and homoeopathy are based on strong medical philosophies and prevailed the concerted onslaught by its detractors. The fact in the medicine is that every medical disciple can offer something in healthcare and no medical system can address the entire requirement that the patient need.

Holistic health is the one look into the need of the sick and provides customised healthcare, both promotive and preventive as well as curative, where ever possible. Understanding the patient is the cornerstone in holistic healthcare preached by homoeopathy.

The invasion of pharmaceutical conglomerates in deciding the health policy and political compulsions for its implementation had altered the holistic view practiced by homoeopathy and other Indian systems on wellness to disease-oriented patientcare services. Healthcare of the future shall be pluralistic, where in each of the recognised system is contributing its strength on a rational manner. Coexistence of different system is the strength of Indian healthcare delivery, which even the developed countries are looking up to. The newly created Ministry of AYUSH has an important role in mainstreaming homoeopathy and exposing its full potential in curative, preventive and promotive care. Homeopathic Medical Association, Indian Institute of Homeopathic Physicians and the Indian Homeopathic Medical Association have an important role to take the efforts of the Ministry of AYUSH at the grass root revel while we at the Global Homoeopathy Foundation are continuously making efforts to bring the mainstream basic and applied science in creating more evidences on the strength of it.

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cover ) DR BAHUBALI SHAH Dr Bahubali H Shah, President, Maharashtra Council of Homoeopathy, Mumbai

THE SHORTAGE OFHUMAN RESOURCES NEEDS TO BE ADDRESSED ATPHCS AND THATCAN BE DONE BYINTEGRATING AYUSH PRACTITIONERS INCLUDING HOMEOPATHS

H

omoeopathy is a modern science which holds a lot of potential which is conveniently neglected in India with no official

patronage from the government. Kerala is a fine example of the impact of homoeopathy on public health as well as its financial benefits to the gov-

DR PANKAJ AGGARWAL Senior Homeopath, Agrawal Homoeo Clinic

HOMOEOPATHYIS A21ST CENTURYMEDICINE IN THE WORLD AS ITIS SAFE ITMEANS NO SIDE EFFECTS AND COMES IN EVERYONE’S POCKET

34 EXPRESS PHARMA October 1-15, 2015

ernment. I feel there is a lack of vision behind the health policies which need to take into account- the need of the people, the resources available, and how to use them to the fullest. We are spending crores on public health but we are not getting the desired results because one particular science has hogged the limelight so far.

Allopathy was the most irrational science 300-400 years back, but as it has evolved, got government funding, gathered evidence and pharmaceutical backing, it has gained ground. Homoeopathy is the first evidence based science if you ask me, since the drugs results are proved on human beings, rather than trials and errors on mice and monkeys. With an independent charge minister being appointed for AYUSH and more responsible fund allocation, I feel that it is still insufficient keeping in mind the potential of alternative medicine. Since the formation of the state of Maha-

rashtra homeopathic doctors are practicising allopathy.

When an AYUSH doctor is working as a medical officer in a hospital, he/she can also do private practice, contrary to what allopaths say.

All big and small hospitals in metros, small cities and remote places including ICUs are run by AYUSH practitioners. Our national and state health policy should keep in mind the benefit of public, rather than being system based. No science is perfect, every science has limitations.

With limited funding, a policy which is inclusive would be best.

The shortage of human resources needs to be addressed at PHCs and that can be done by integrating AYUSH practitioners including homeopaths.

Homeopaths learn the allopathic point of view in several segments during the curriculum, only the pharmacology and its clinical application was missing which is being addressed by the government.

I have taken initiative for such

amendments and inclusions.

The government should take initiative to take this science to the public and let the public be benefitted by its potential. We should have atleast five regional government homeopathic colleges. Even one government college in the state can improve the level of education imparted as a whole, something which even private institutes look up to.

These institutes will also help promote research in homoeopathy, which is not there in the private sector. For instance, homoeopathy has worked excellently in the outbreak of chikungunya and dengue by some NGOs and private practitioners, but if it had been research based and the findings reported, the resultant exposure would have led to increased usage of the drugs. I would suggest setting up a separate directorate of homoeopathy and inclusion of homoeopathy as mainstream medicine in public health of India to alleviate its plight.

H

the holistic viewpoint started taking leap in every walk of life, as well as medical field.

AYUSH as a new ministry in India is doing its best for homoeopathy too. WHO records prove that homoeopathy is the second best popular system accepted around the world.

People have understood that allopathy is no good for any chronic conditions as well as

prevention. With huge expenses on health, people are still not healthy. Some alternative is needed and homoeopathy offers a solution. IRDA is already saying all mediclaim must include homoeopathy in plans people buy.

Over the period of time mindset made about health was person’s health in the hand of doctor. This needs to be changed. It means person’s health in his hand. Also, we call healthcare but so far its disease care. Let’s go and work on healthcare. This very change will put the holistic viewpoint in forefront so homoeopathy will also come in front. Homoeopathy is a 21st century medicine in the world as it is safe it means no side effects and comes in everyone’s pocket. So it has a great future ahead.

omoeopathy was discovered in 1796 in Germany. So it is about 220 years now. It does not seem to be very old comparing with other. But since homoeopathy has its roots in the vedic time so it becomes really ancient! Homoeopathy belongs to the holistic viewpoint as was in Vedic period for everything in life. But about 2000 years before, due to politically changing scenario, this holistic viewpoint changed to a reductionist viewpoint.

In medicine, this is called as biomedical viewpoint. In 1900, a big battery of scientists contributed to this biomedical viewpoint and the holistic viewpoint was almost setaside but never wiped off.

From 1920 onwards, with the discovery of subatomic physics (quantum physics),

AYUSH as a new ministry in India is doing its best for homoeopathy too

(

DR MUKESH BATRA Chairman and Founder, Dr Batra’s Healthcare Group

THE POPULARITYOFHOMOEOPATHYIS ONLY EXPANDING RAPIDLY,PRIMARILYBECAUSE OFITS PATIENT-CENTRED,INDIVIDUALISED APPROACH

H

omoeopathy is, by far, the most recent of medical sciences. It is also the fastest growing medical system in the world. It is used by over 500 million people and the second largest medical system across the globe as per WHO. The homeopathic industry is

purportedly growing at a whopping 20 per cent vis-à-vis conventional pharma, pegged at 12-14 per cent. Homoeopathy was founded by Dr Samuel Hahnemann, MD, a conventional physician and chemist, in 1796 — the same year that Dr Edward Jenner published his paper on vac-

cination, which also incorporates the homeopathic principle of ‘similars,’ or ‘likes cure likes’ precept.

There is certainly adequate proof that homoeopathy works.

Over 180 controlled and 120 randomised trials into homoeopathy have been conducted and corroborated by meta-analyses.

In a majority of instances, research has confirmed the healthy, biological and physiological healing benefits of homoeopathy. There are a number of ongoing research (evidencebased medicine) studies in the area too — augmenting the tangible benefits of homoeopathy in the clinical setting, besides patient-based evidence. For sceptics who resort to using phrases like placebo, dogma, and so on, for homoeopathy, they only need to look at themselves. Picture this. The respected British Medical Journal reports that just 11 per cent of all conventional treatments used today carry ‘actual evidence’ of medicinal, or clinical, efficiency.

The popularity of homoeopathy is expanding rapidly, primarily because of its patient-centred, individualised approach, not to speak of the growing side-

W

DR MANJU SINGH Homoeopathy Consultant with 1 mgAYUSH

R&D,CLINICALDATAMANAGEMENT,POOR DISTRIBUTION AND LACK OFWELL-FUNDED MANUFACTURING ORGANISATIONS ARE SOME OF THE AREAS IN WHICH THE SEGMENTIS LACKING

e believe that as a system of medicine that has stood the test of time, and given the level of trust that it has from patients across countries, it may be a bit harsh to reject homoeopathy.

There are many studies that show homoeopathy to be effective, and some studies that show otherwise.

Same could be said to be true for all other systems of medicine. Every system of medicine has it is own limitation and no one is complete in itself.

There are many studies and researches which point to the efficacy of homoeopathy and its working principles. In a study conducted by IITBombay it was concluded that homeopathic medicines con-

THE MAIN FOCUS

effect profile, including the dangerous spectre of iatrogenic (drug-induced) diseases, triggered by conventional medications and treatment. That the government recently elevated the erstwhile department of AYUSH to a full-fledged ministry is a welcome move. This will not only help increase the global and local footprint of traditional systems of healthcare, such as homoeopathy, but also duly promote cost-effective AYUSH services, while strengthening homeopathic education in colleges and universities, including clinical practice, aside from facilitating the availability of quality medicines.

We suggest that the key areas for the homeopathic health-

There are a number of ongoing research studies in the area too

care industry should focus on are awareness, product innovation, quality control and enhancement, accessibility, valueadded services, including homeopathic OTC products, and preventative care, not to speak of new research initiatives, while catering to the growing health requirements of people, right from the grassroots’ level, along with data analytics and technology as primary enablers. Besides, it is a given that health consumers will now see a range of cost-effective homeopathic health awareness campaigns emphasising on the importance of health insurance through homeopathic treatment. This will improve the penetration of health insurance policies within the country — including new innovations in the space of alternative health insurance products.

This will ensure, no less, that AYUSH reaches out to the remotest corners of the country with its clinics and hospitals and also provide exciting opportunities for players who are willing to invest and grow in the sunrise alternative wellness industry — for the good of everyone’s health and the country’s overall health too.

tain nanoparticles,so it may as well be considered as nano-medicine. Further, vaccines also work on the same principle that if we expose human body to a small amount of the attenuated pathogens then the body has inbuilt capacity to develop immunity against those pathogens in due course of time.

Research and development, quality education, clinical data management, poor distribution and lack of wellfunded manufacturing organisations are some of the areas in which homoeopathy segment is lacking and the same could be improved to make homoeopathy more popular and visible as its mainstream counterparts. There needs to be support from the govern-

ment for research and development and quality education;introduction and promotion of evidence based and trial supported products, double blind clinical trials, better clinical data management; Introduction of homoeopathy wing in each hospital with quality doctors to get homoeopathy to the forefront of medical care.

Some recent big initiatives of the government like setting up of AYUSH ministry, separate drug regulator for alternative medicines, promotion of alternate system of medicines through various channels and platforms would surely translate into good times for homeopathic as well as other alternate medicines practioners.

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MANAGEMENT INSIGHT

International politics and IPR

DR R SAHA, Senior Adviser, CII elaborates

Dr R Saha, Senior Adviser, CII elaborates on the robustness of India’s IPR regime particularly related to laws and the judicial system THE RECENT WTO’s Trade Policy Review (TPR) in respect of India has put to rest any misgivings about the robustness of India’s IPR regime particularly related to laws and the judicial system. The TPR covered the Indian IPR system in reasonable detail, describing the basic features of Indian IPR laws, administration, policy initiatives and important court judgments.

Nowhere does the TPR state that India is not compliant with TRIPS and WTO. India’s stand on its IPR laws being compliant with TRIPS is fully seconded by WTO. Surprisingly, agencies like United States Trade Representative (USTR) do not think that India’s IPR regime is TRIPS compliant. A close look into USTR’s findings reveals an element of partiality and a repetition of thoughts over years.

TPR has appreciated the progress made by India in designing and building its IPR regime in the last four years.

It has discussed Section 3(d) in the context of the Supreme Court’s decision but it does not find anything wrong with this provision of the Indian Patent Act. While quoting the compulsory license (CL) case (NATCO v Bayer), TPR also referred to requests for CL rejected by the Patent Office implying that India is taking a balanced view in the matter.

In his final remarks, the Chairman of the Review Committee expressed the concerns of some members regarding protection of trade secrets and test data but nothing to question India’s compatibility with TRIPS. Despite this, it may be flagged that in all future bilateral discussions, there would be ex-

36 EXPRESS PHARMA October 1-15, 2015

plicit pressure on India to have new laws on trade secrets and test data.

Indian laws, especially in relation to exclusions of inventions from patentability, have been keenly studied by many developing countries. Section 3(d) of the Indian Patent Act brings relief to patients from expensive drugs based on secondary patents by laying strict criterion of inventiveness /obviousness. Recently, the Federal Circuit of US Appeal Court invalidated Pfizer’s reissue patent on 'Celebrex', a medicine for arthritis, and declared it a case of obvioustype double patenting. The judgment would be a big relief to Lupin, the Indian pharma company as it opens the road to market the generics of Celebrex in the US. It is reported that Brazil and Argentina are contemplating introducing provisions similar to Section 3(d) in their

patent laws. Other developing countries may follow suit.

This may be a cause of concern for developed countries and their large corporations.

Could this be a reason for the developed countries taking a rather strict and unexplainable negative view on the Indian patent law? Absence of provisions like those in Section 3(d) would encourage secondary patents and follow-on drugs which tend to suppress the market of generics despite the generics being much cheaper. This usually happens through the active participation of prescribing doctors and health delivery systems which are influenced by big companies, through their powerful and wide marketing network in many countries.

Obviously, patients are made to spend more on medicines if the generics market is not allowed to grow. It may be noted that the problem of expensive

medicines will be faced by patients of all countries including the most developed ones.

This may apply more to medicines for cancer, AIDS etc. All nations have to address this issue seriously.

India’s support and commitment to multilateral arrangements for promoting and strengthening global trade and commerce has been acknowledged and praised in the TPR. Multilateral trade agreements address the needs of more than 150 countries.

Let us examine this with the trend being set up by a few select countries for promotion of non-multilateral IPR arrangements which is becoming a point of serious concern for the remaining member countries. In the past few years, three important developments have come to light namely, Anti-counterfeiting Trade Arrangement (ACTA), IP 5 and Trans Pacific Partnership (TPP). Most of the discussions in this respect have been held behind closed doors.

IP 5 is a step towards harmonisation of patent rules and practices among participating countries namely, the US, the EU, China, Japan and South Korea. It may become a supporting point for member countries of WIPO to support, at some point in time, the Patent Law Treaty (PLT) and the Substantial Patent Law Treaty (SPLT). India has not become a member of PLT and SPLT because there is considerable doubt on whether a level playing field would be available to developing and least developed countries.

China’s participation in IP 5 needs to be closely followed as it may influence discussions in

BRICS. It goes without saying that the existing multilateral arrangements like TRIPS may also undergo some changes due to arrangements like IP 5 which may not be in the interest of India and other developing countries.

The Anti-Counterfeiting Trade Agreement (ACTA) is an agreement to create new global intellectual property (IP) enforcement standards in respect of copyrights and related matters, and trademarks. The text of the ACTA is now available in public domain and it can be seen that it talks of severe damages, and of provisional measures to be adopted by authorities while disposing infringement suits.

The provisions are quite tough in regard to digital technologies. In order to avoid circumvention of effective technological measures, people and companies engaged in the manufacture, importation or distribution of devices including software used for circumvention would be subject to penalty. An important question to be pondered over is “Who are the designers and suppliers of such devices?”

Aren’t they from the developed countries? An ACTA Committee would oversee the functioning of the Agreement and will also be the settlement body in case of disputes. One does not know at this stage about the likely erosion of the importance of the Dispute Settlement Board (DSB) under WTO. All these are TRIPS plus provisions being pushed by a few nations and may become important features during negotiations on Free Trade Agreements (FTA). However, even the original signatories have not

Indian laws, especially in relation to exclusions of inventions from patentability, have been keenly studied by many developing countries

yet ratified the Agreement. The EU refused to ratify it in 2012. One view could be that if there is no unanimity among such a smaller number of countries, how could it possibly influence multilateral arrangements substantially or otherwise?

Details of discussions of TPP are not available in the public domain.

However, many reports do appear in media and Internet which have disclosed many important features of the trend in the thinking of countries participating in close room discussions. The 12 nations negotiating TPP are: the US, Japan, Mexico, Canada, Australia, Malaysia, Chile, Singapore, Peru, Vietnam, New Zealand and Brunei. This would represent 40 per cent of world trade, according to WikiLeaks.

Among many provisions, which may lead to a TRIPS plus situation, the important ones are listed here. TPP is aiming to have provisions that would help extending patent-term based on clinical data exclusivity including for biological vaccines and medicines. It is likely to facilitate secondary patenting by pharmaceutical companies (by completely removing provisions similar to those of Section 3(d) of the Indian Patent Act), which would block competition by more affordable generic drugs. Further, nations may be required to accede to the 1991 version of UPOV as well as provide for patenting of plants and genes in plants. Such provisions would be damaging to small farmers in developing countries and may also lead to a possible extinction of climate friendly plants developed by various farmer communities across the world. The beneficiaries would be large agricultural corporations.

TPP also favours declaring of trade secret violation as a criminal offence. It is interesting and intriguing that all the negotiating countries are not on the same page; apparently TRIPS plus requirementsare being pushed by Japan and the US.

Trade secrets are being discussed vigorously in many platforms within and outside India. Efforts are on to make trade secret violations a criminal offence so that the rules are in line with those of the US and Japan. Historically, the whole issue of trade secrets became a central point of late because of discussions in the Silicon Valley when emerging IT industries started facing the problem of quick attrition. Do we have a similar situation in India and other developing countries? We must anticipate that these developments e.g., trade secret violations being treated as a criminal offence, will find its way into future discussions in TRIPS Council and also in bilateral FTAs. Strong trade secret laws may have multiple benefits for companies and perhaps some governments too.

However, these can be used to stop easy flow of information in a democracy. Even journalistic freedom, so essential for democracies, may be seriously compromised. A careful and considered view needs to be taken whether India and other democracies need a separate law or not.

Developing countries need to be alert about these developments and take special note of the damaging stance taken by some developed countries especially in regard to public health and agriculture. Countries not having a developed drug industry may be big losers. The more complex issues relating to trade secrets, data exclusivity, digital rights management etc. may be better addressed through a common platform of developing countries. Authorities engaging in bilateral and plurilateral negotiations should not be happy winning an argument in a meeting or two but keep a long-term view in focus as well.

(The views expressed above are that of the author)

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MANAGEMENT INSIGHT DR NAVIN SAXENA, Chairman, Rusan Pharma

De-addiction with technology On the occasion of World Mental Health Day, October 10, Dr Navin Saxena, Chairman, Rusan Pharma opines that substance abuse/addiction is a mental illness. With 270 million Indians addicted to tobacco, the country needs the right combination of technology (newer delivery systems like transdermal patches) to offer more effective ways of dealing with the addiction THERE WAS a time when mental health meant just one diagnosis — mad. Those creatively inclined scraped through by calling themselves inspired, the rest were packed off to madhouses. These were spaces where ill-informed and an insensitive lot of people inflicted pain and misery on a misunderstood lot of people.

The end result was a gaping hole in the understanding of the human psyche, a lack of recognition of pattern and behaviour that would have enabled diagnosis. People were written off as ‘mad’, ‘hopeless’ cases whose lives were forever lost, their families to mourn them prematurely. In India, lack of information, education and research had created the dark ages and we lived within those times, uneasy of our actions, but unable to change our ways.

Until a handful of people recognised the patterns, started attributing behavioural anomalies to personalities and circumstances. They started looking at the complexities of the brain, only beginning to

38 EXPRESS PHARMA October 1-15, 2015

grasp the entire universe that the human brain is capable of producing. Chemical imbalances were first recorded, and ‘mad’ started to fade into clear categories with relatively evolved diagnoses. Mankind was moving into the age of enlightenment and his brain was finally taking the lead.

Freud and Jung’s theories helped to establish the rudimentary beginnings of psychology and eventually became the foundation on which numerous doctors later added theories to help navigate through human experience.

Today, mental health is far removed from the past. Every moment of our lives can be explained, and often our personalities and predispositions predict the trajectory of our lives. Personality tests are available online and within seconds you can delve into the details of your life and yourself. Self improvement is a career, with life coaches and armies of psycho-analysts out there determined to help. And yet, mankind falters in the face of new illnesses, new diseases.

Addiction as a mental health illness Disease teaches mankind to be stronger, more prepared, eventually evolving us into a better species. Illness, physical or mental, gives us an opportunity to look further into ourselves and find out what’s not making us tick. One of these illnesses is addiction. And yes, addiction is a mental illness. It changes the brain in a number of ways, turns priorities upside down, changes the very nature of our physiological and psychological selves.

And like all illnesses, there is a cure, there are ways to overcome it.

The mental health situation in India has not always been at par with the more evolved standards and methods in other countries. However, there are pockets where practices and concerns have led to innovative treatments and research.

Addiction can range from from teens being addicted to smoking and drinking to hard core drug addiction. The best way to tackle these problems would be catch them early on.

The upheavals in a teenager’s environment and body during

adolescence make him or her an easy target. Peer pressure, and nowadays pressure from external social media can lead them down paths that are difficult to return from. But, not impossible.

The pitfalls of addiction have been detailed ad nauseam.

High blood pressure, liver damage and type II diabetes are just some of the ill effects of excessive smoking and drinking. In India, studies have shown that teens have started consuming alcohol before they turn 15 and are five times more likely to develop alcohol dependence or abuse in a later stage in their life.

One of the most basic ways of tackling this is for parents to maintain open communication with their teenage children.

Children should feel comfortable enough to approach their parents to engage them and

sound them out on issues that disturb them. It’s imperative that parents instil a home of trust, confidence, comfort and nurture so that children never feel threatened to approach them on issues that might be troubling them. The ability to bring up a confident child, who cannot only remain unaffected by the habits of his or her peers, but also influence his friends to follow his example, is not an impossible task. The onus of this of course lies entirely on the parents. There are counselling services now available in India that help guide parents at every step and also act as mediators to help explain the benefits of addiction treatment to the patient.

In a lot of cases, addiction needs more help that just nurture. Addiction in its most aggressive form creates chemical imbalances in the

MANAGEMENT body, and while a clear and strong mind can help the healing process, often the body itself needs some outside help.

Technology in healthcare We live in a world driven by technology and therefore it is only natural that this time too, technology steps in to save the day. The application of technology in this sector is simple enough. World class laboratories around the world work tirelessly around the clock to develop clever drugs, potent mixes of chemicals to help those who want to help themselves.

The first step towards cure is acceptance of the problem which will drive the need to seek treatment and desire a better quality of life. This is often a combination of therapy, counselling, medicines and an equally controlled environment. Bad habits cannot be stopped overnight as the body needs to heal after a prolonged period of trauma.

Within this space, the Indian healthcare industry is a veritable giant. Innovative treatments and potent drugs are being churned out of laboratories every day. These are easily accessible and the services are only improving day to day. A playing field of both private and public players is levelling out problems and making transitions from lab to shop much easier. Conservative estimates have pinpointed the Indian healthcare industry at $65 billion that includes healthcare delivery, which includes hospitals, nursing homes and diagnostics centres, and pharmaceuticals, all of which constitute 65 per cent of the overall market. By 2017 it’s been predicted to grow to $160 billion and to $280 billion by 2020.

One of the main reasons for these numbers is the whole hearted acceptance of technology. It enables patients to instantly find a doctor nearest to them in just a few seconds through a website or an app. Technology is bridging the gap between the doctor and patient and making treatment provider’s information available at our fingertips. It enables the development as well as availability of healthcare services across the country, making it cost effective and consumer friendly. Simple but effective measures include systematised storage of patient records, measuring progress and enabling speedy and effective drug administration. Aggressive diseases like cancer require minute monitoring, tracking a patient’s progress over days, weeks, months and even years. This is where technology steps in, making it a seamless and easy

process, requiring minimum effort from hospitals or care givers. Sharing records between doctors and hospitals help consultants work to the best of their abilities, making diagnoses and treatment that much more efficient.

For higher patient compliance Technology helps in the smallest ways possible, to have major positive ramifications. To help the 270 million Indians addicted to tobacco, Rusan Healthcare recently launched India’s first 24 Nicotine Transdermal Patch, 2baconil. The product has been introduced in India for the first time as a form of Nicotine Replacement Theory.

The pharma company has created a more effective way of weaning people off cigarettes, working with advanced formulations and smart time-release technology that ensures a steady deliver of a therapeutic and sustained delivery of Nicotine into the body to curb the patients craving for tobacco. The therapy aims to reduce the physiological craving over a period of time, which enables the patient to focus on their psychological implications.

With six trillion cigarettes being smoked a year in India, the company’s vision vision has been to bring products into the Indian market which will be not just quality driven but also bring convenience to users, through newer delivery systems like the transdermal delivery systems, which ensures higher patient compliance and ease of use. If we are in knowledge of the fact that there are millions of Indians going to die, especially the youth, then our efforts need to be intensified and focused on saving their lives.

From the local chemist maintaining private patient files to doctors monitoring everyday movements and lifestyle of their patients, technology is breaking new barriers everyday. From a simple diagnosis of mental health to a detailed manystepped programme to recovery, it’s difficult to imagine a scenario where this was not always the case.

Healthcare in general has to evolve with or even faster than human beings. As the world changes around us, we are racing to catch up.

Within that sector, mental healthcare occupies a more specialised seat. The degree to which this segment needs to develop and stay ahead of the race is much higher. However, with the right combination of technology and critical thinking, it is evident that this is not just possible, but is already happening.

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RESEARCH NEWS

TC Biopharm to start phase II/III studies of ImmuniCell in October Currently focused on skin, renal and lung cancer, the platform has potential to treat all types of cancer tumours as well as viral infections like HIV, Ebola and severe influenza.

Viveka Roychowdhury reports SIXTEEN MONTHS after moving into an empty space in the Eurocentral business park in Lanarkshire, outside Glasgow, Dr Michael Leek, Chief Executive Officer, TC Biopharm (TCB) and his team have received all approvals from the UK regulator to move their first product, ImmuniCell, into phase II/III trials in October.

The Beatson West of Scotland Cancer Centre in Glasgow will be the first site to recruit cancer patients for this trial, followed by cancer centres of excellence in Southampton and Edinburgh. Additional clinical sites, possibly in London, Manchester, Swansea, Newcastle, Leeds, Oxford and Cambridge will join the study during 2016.

In collaboration with Japanese immuno-therapy company Medinet, TCB has an exclusive license to take the product through clinical development in the UK, European and North American markets. While Medinet clinicians have already proved that the process of using cancer patients’ white blood corpuscles (more specifically the gamma delta T cells) is safe, the Scottish company will scale up the process and take it through all clinical development phases, to get evidence-based data necessary for approval in the UK, EU and the US. The company got Medicines and Healthcare Products Regulatory Agency (MHRA) approval to produce human cell therapy products at its clinical manufacturing facility in Lanarkshire this January. More recently on September 9, TCB announced that it had received

40 EXPRESS PHARMA October 1-15, 2015

TC Biopharm’s 16-month journey

Clinical Trial Authorisation (CTA) from the MHRA. This comprised two main components — the Clinical Protocol detailing exactly how cancer patients will be treated and the Investigational Medicinal Product Dossier, which summarised drug-product manufacture, mechanism of action and safety.

TCB’s adaptive phase II/III clinical trial for this product is considered groundbreaking because it allows patients with three different types of cancer — melanoma, kidney and lung — to be treated simultaneously in a single study. The company reportedly worked closely with MHRA’s Protocol Advice service

to ‘ establish a pragmatic treatment framework which focuses on patient safety whilst maximising the potential for an efficacious outcome,’ according to a press release from Scottish Enterprise, one of TCB’s funding agencies.

The TCB team Speaking to journalists on a recent media tour organised by Scottish Development International, Leek said, “We expect to start studies in blood cancer next year but this platform technology has the potential to treat not just cancer but also be effective in viral infections like HIV, severe influenza and Ebola.”

ImmuniCell is a concentrated infusion of cancer patients’ gamma delta T cells. The multi-step process involves collection of samples, screening/activation and growth of gamma delta T cells in a culture medium for two/three weeks in TCB’s MHRA approved GMP compliant facility in Lanarkshire. The end result is an infusion of highly concentrated gamma delta T cells which are then infused back into the patient, where they recognise and target specific structures present on the surface of cancerous cells, and cells that have been virally infected. This triggers

the release of a potent toxin (granzyme) into the cancerous cell which results in cell death.

The therapy complements ‘new’ antibody-based cancer treatments such as CTLA-4 and PDL-1 inhibitors and TCB is hence attracting a lot of interest from pharma companies, according to Leek. Seen as a strong future acquisition target, with an attractive valuation with significant uplift potential,’ TCB is backed by experienced team members like Angela Scott, Operations and Site Director -GMP manufacture and facilities, who has 32 years in oncology research and regenerative medicine. Leek jokingly re-

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SPECIALISED IN STABILITY STORAGE & ANALYTICAL TESTING. Our Services: ferred to Scott as the ‘mother of Dolly the sheep’, as she was part of the team that cloned Dolly, a project that came to embody Scotland’s prowess in this field. Leek, a self professed ‘cell therapy junkie’, has taken 10 cell-based products from laboratory into clinic while Dr Karen Williams, Director of Clinical Studies, has had stints in Novartis and Pfizer.

Funding cancer therapy TCB managed to raise £3.3 million in seed funding and grants over the past 16 months, from investors like Scotland’s only female angel investment group Investing Women (£1.18 million in equity and grant funding in August this year) supported by a grant award of approximately £500,000 from Scottish Enterprise’s SMART:SCOTLAND programme.

Congratulating TCB for reaching this significant milestone of receiving all approvals from the UK regulator to move their first product into phase II/II trials Sharon McKendry, international sector head, life sciences, Scottish Development International, said, “Along with our partners, we have worked closely with TCB over the last three years to provide an integrated package of support that includes account management, international market support, assistance from our High Growth Start Up Unit and investment from SMART: SCOTLAND and the Scottish Investment Bank. We are pleased to be able to work with a company that is addressing significant public health issues and manufacturing a leading edge product in Scotland. We look forward to continuing to work with the company to help realise its ambitious growth plans.”

Commenting that commercialisation of this groundbreaking cancer therapy in Scotland further cements the country’s global reputation for regenerative medicine and stratified

In collaboration with Japanese immuno-therapy company Medinet, TCB has an exclusive license to take the product through clinical development in the UK, European and North American markets medicine, she pointed out that there is a clear and growing demand for improved cancer treatments, with the worldwide market for cell and tissue products forecast to almost $10 billion by 2017. According to her, over the last decade, Scotland has established the regulatory, manufacturing and clinical expertise to lead the world in developing new cell therapies to treat unmet medical needs and is well placed to maximise future opportunities.

Given that TCB’s product has already been ‘de-risked’ to some extent by the initial work done by Medinet, which has a significant shareholding in TCB, a clear route to exit by 2016/17 does seem plausible. Provided of course, all goes as per plan in the clinical studies.

(The author was in Scotland on the invitation of Scottish Development International) viveka.r@expressindia.com

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October 1-15, 2015

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RESEARCH RESEARCH UPDATES

Scientists turn to aspirin to turbo-charge cancer immunotherapy Immunotherapy promises to revolutionise cancer care but the new drugs do not work well in all cases GIVING CHEAP aspirin to cancer patients may turbo-charge the effectiveness of expensive new medicines that help their immune systems fight tumours, experiments on mice suggest.

Immunotherapy promises to revolutionise cancer care by offering a better, longer-lasting response with fewer adverse side effects than conventional treatment, but the new drugs do not work well in all cases. One reason is that cancer cells often produce large amounts of the molecule prostaglandin E2 (PGE2), which turns down the immune systemâ&#x20AC;&#x2122;s normal attack response to tumor cells, according to scientists at London's new Francis Crick Institute.

Aspirin blocks PGE2 production and the researchers found

that adding it to an immunotherapy treatment called anti-PD-1 substantially slowed the growth of bowel and melanoma cancers in mice when compared with treatment by immunotherapy alone. There is already some evidence that the findings in mice will apply to human tissue but there is still a long way to go before this is proven.

Still, the research adds to aspirin's reputation as a â&#x20AC;&#x2DC;wonder drug.â&#x20AC;&#x2122; First synthesised by a chemist at Bayer more than a century ago, the medicine is already used to prevent heart attacks and has previously been reported to reduce the risk of bowel and other cancers. Caetano Reis e Sousa, senior group leader at the London institute, hopes that adding aspirin or

other so-called COX inhibitor drugs will one day make a big difference to the benefits the patients get from immunotherapy.

"What we would like to do

next is set up a clinical trial," he said. "We will need to persuade a company to sponsor that and we have had some preliminary conversations." Merck and Bris-

tol-Myers Squibb both have recently approved anti-PD-1 drugs, while competing anti-PD-L1 medicines are in development at rival companies including Roche and AstraZeneca.

In the experiments on mice, details of which were published in the journal Cell recently, researchers used a mouse-specific anti-PD-1, but Reis e Sousa said he expected the aspirin effect to be similar with human medicines blocking PD-1, PD-L1 and another class of drugs targeting CTLA-4.

With future immunotherapy use widely expected to involve multi-drug combinations, adding aspirin to the mix would be one way to help keep a lid on soaring costs.

Reuters

Regeneron scientists discover key to excess bone growth in rare disease The protein Activin-A, which normally blocks bone growth, triggers hyperactive bone growth in patients with a genetic mutation that causes the disease SCIENTISTS AT US Biotechnology company Regeneron Pharmaceuticals researching a rare genetic disease that traps sufferers in a second skeleton have discovered a treatment that shuts down excessive bone growth in mice engineered to develop the illness.

Company scientists said the protein Activin-A, which normally blocks bone growth, triggers hyperactive bone growth in patients with a genetic mutation

42 EXPRESS PHARMA October 1-15, 2015

that causes the disease. The disease is known as Fibrodysplasia Ossificans Progressiva, or FOP. The researchers showed that an antibody that blocks Activin-A helped shut down the growth signal in genetically modified mice. The effect lasted as long as six weeks, according to the study, published in the journal Science Translational Medicine.

Aris Economides, executive director of skeletal diseases and co-founder of the Regeneron Ge-

netics Center, said the findings could eventually lead to a treatment for the disease. FOP is a lethal genetic disorder in which muscle and soft tissue gradually are replaced by bone, forming an extra skeleton that immobilizes and eventually suffocates patients.

The condition currently affects 800 people globally, including 200 in the US. FOP is caused by mutations in the gene ACVR1 which

makes a receptor that controls bone growth in cells. Regeneron discovered that this mutated receptor has an abnormal response in the presence of Activin-A, a growth factor often secreted by the immune system in response to injury and inflammation. Normally, Activin-A blocks the receptor, putting the brakes on bone growth. In individuals with the FOP mutation, Activin-A has the opposite effect.The finding

explains how abnormal bone forms in FOP patients, often in response to injuries or illness that cause tissue swelling or inflammation, he said. To test their finding, researchers developed a therapeutic antibody designed to block Activin-A. When injected in mice that developed a form of the disease, the drug blocked the formation of excess bone.

Reuters

RESEARCH

Cattle virus linked to breast cancer Evidence of exposure to bovine leukemia virus was found in breast cancer cells RESEARCHERS IN a new study found that a significant number of breast cancer cells from more than 200 women had evidence of exposure to bovine leukemia virus, or BLV. BLV infects dairy and beef cattle’s blood cells and mammary tissues, and was for a long time thought not to be able to infect humans.

Nearly all bulk milk tanks at large factory farms are infected with BLV, but only about five per cent of cows get sick if they have the virus, according to the US Department of Agriculture. The same group of researchers at the University of California Berkeley involved in the new study also found last year that BLV could be transmitted to humans.

“The association between BLV infection and breast cancer was surprising to many previous reviewers of the study, but it’s important to note that our results do not prove that the virus causes cancer,” said Dr Gertrude Buehring, a professor of virology in the University of California Berkeley, in a press release.

“However, this is the most important first step. We still need to confirm that the infection with the virus happened before, not after, breast cancer developed, and if so, how,” Buehring said.

Using donated tissue from the Cooperative Human Tissue Network, the researchers compared breast tissue from 239 women who either had breast cancer or did not.

They found that 59 per cent of breast cancer cells had evidence of exposure to BLV based on the presence of viral DNA in the cells. Cells from women who had not had breast cancer only had evidence of exposure 29 per cent of the time.

When researchers further analysed the data, they found the risk of developing breast cancer was 3.1 times higher if BLV was present in a woman than if it was not. Buehring said the odds ratio is higher than other well known risk factors for breast cancer, including obesity, alcohol consumption and hormones.

EP News Bureau-Mumbai

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PHARMA ALLY I N T E R V I E W

â&#x20AC;&#x2DC;Kamani Oils have most of the well-known food and pharma customers of the countryâ&#x20AC;&#x2122; Kamani Oil Industries manufactures speciality oils and fats with magnificent quality concept embeded in it. Prakash Chawala, Director, Kamani Oil Industries reveals more in a discussion with Sachin Jagdale about the companyâ&#x20AC;&#x2122;s growth prospects

What has prompted Kamani to get into comparatively more challenging pharma business?

We at Kamani Oil Industries manufactures speciality oils and fats with magnificent quality concept embeded in it, along these lines, meeting any technical and ingredient challenges in the production of pharma grade excipient oils and fats is not at all a challenge. Between this, exists a gap of an edge on typical grade ingredients to minimise the import of oils and fats needed for the pharma and cosmetic industry ahead.

Kamani has taken this opportunity to bridge the gap.

Can you give the details regarding the application of speciality oils in the pharma industry?

Speciality oil works as an excipient for making the pharma and cosmeceutical applications / formulations How much investment has gone into developing pharma unit?

The requirement of pharma products is a real challenge and it involves the delicate meeting of the stringent quality requirement of Schedule M of Drugs and

44 EXPRESS PHARMA October 1-15, 2015

All the innovation at Kamani are done at the DSIR approved R&D centre which will have a competitive edge over others Cosmetics Act, 1940. we made an investment of 3.5 to 4 crore for developing the pharma unit Do you already have tie ups with any pharma clients for the supply of specialty oils?

If yes, please give the details Kamani Oils have most of the well-known food and pharma customers of the country in its clientele list, with dedication and commitment of quality. We are now happy to supply them pharma/ IP/BP/USP/NF grade oils as per their requirement which was till now being imported.

Are you the only supplier of speciality oils to the pharma industry? If not, how will you differentiate yourself from your competitors?

Yes, in the best of our knowledge we are the first Indian vegetable oil company to work on creating such facility and supplying them oils of pharma grades. All the innovation at Kamani are done at the DSIR approved R&D centre which is going to have a competitive edge over others. In addition to this, we also provide high degree of customer service.

Which is going to be the biggest market for you, pharma or nutraceuticals?

Both the pharma and neutraceutical markets are big for us and their lies a potential ahead in both the industries.

What percentage of revenue growth do you expect with the launch of your pharma business over the next three years?

Although very important but this is a very small segment as far as value for business is concerned but it is expected to grow slowly and steadily in the years to come. sachin.jagdale@expressindia.com

PHARMA ALLY VENDOR NEWS

Gattefossé opens technical centre in Mumbai Spread across 3500 sq feet, the centre aims at facilitating the research and formulation work and consolidating the local assistance to customers GATTEFOSSÉ GROUP, a global provider of excipients and innovative formulation technologies for enhancing drug delivery, which is celebrating its 10th anniversary in India, has recently opened a technical centre of excellence in Mumbai. The new facility reinforces the activity of its affiliate, Gattefossé India, run by Sunil Bambarkar. The centre was inaugurated in the presence of Jacques Moyrand, Chairman, Gattefossé group, Ajit Singh, Chairman, AGC Worldwide Associated Capsule and Yves Perrin, The Consul General of France.

The centre has a FDA certified laboratory for pharma applications to facilitate the use of API’s in formulations as well as

a state-of-the-art personal care laboratory on surface area of 3500 sq ft. The new premise aims at facilitating the research and formulation work and consolidating the local assistance to customers.

Olivier Midler, Chief Executive Officer, Gattefossé group describes its vision for the future, said, “Our growth strategy for the company is based on two main pillars; innovation, by pursuing our significant investments in R&D and product applications, and geographical expansion by developing our business and expertise in new territories. All these efforts to ensure our customers a responsive and adapted service specific to their markets.”

EP News Bureau-Mumbai

Lallemand Health Solutions to launch innovative probiotics at CPhI Madrid In addition, the company will present a new range of probiotic strains to address targeted segments of the immunity market LALLEMAND HEALTH Solutions will be presenting a new concept in probiotics formulation at the forthcoming CPhI Worldwide trade show in Madrid, from October 13-15, 2015.

Probiotic 2.0 is the synergetic association of documented probiotic bacteria and yeast (S boulardii), for overall digestive health, from oral health to gut microflora balance. In addition, the company will present a new range of probiotic strains to address targeted segments of the immunity market, as well as its full line of ready-to-market probiotic formula and strains for

46 EXPRESS PHARMA October 1-15, 2015

custom formulations in other areas such as gut health, emotional equilibrium, women’s health or oral health.

Lallemand Health Solutions has the industrial ability and know-how to develop specific probiotic formulations combining pharma grade S boulardii yeast with documented probiotic bacteria. The company offers its partners a selected range of well documented bacteria strains to be combined with S boulardii to address overall digestive health, from oral health to gut health, for a new, holistic approach to digestive health.

The company offers its partners a selected range of well documented bacteria strains to be combined with S boulardii

The interactions between probiotics and immunity are increasingly well understood.

Thanks to a strong R&D programme dedicated to immunity, encompassing innovative in vitro, in vivo and clinical studies, scientists at Lallemand Health Solutions are able to draw a better picture of the pathways involved and the clear benefits of selected probiotic strains and strains combinations. On this basis, the company has developed a portfolio of probiotic strains and strains combinations to address various issues of immune health for different target population groups. They

are prevention of infections or atopic disorders in children; prevention of chronic or acute infections in at-risk adults (under chronic stress, athletes) and immune modulation in seniors susceptible to lower immune response or chronic inflammation (inflammaging).

These strains can be formulated into specific solutions, associated to certain vitamins or minerals for example, in formats adapted to each target population: capsules, convenient orodispersible sticks, sachets to dissolve in drinks or food etc.

EP News Bureau-Mumbai

PHARMA ALLY PRODUCT

Cole-Parmer launches Ismatec pumps COLE-PARMER has expanded its robust line of fluid handling and analysis products with the recent acquisition of Ismatec pumps from IDEX Health and Science.

The Swiss-engineered Ismatec pumps are renowned for their clocklike precision and manufactured according to strict ISO 9001:2008 standards. The independent channel control (ICC) pumps provide lower pulsation, better reproducibility and a longer tubing life. Variable flow and bidirectional capabilities in each channel add to their flexibility. The

uniqueness of the ICC allows for individual channel calibration.

A much desired feature, computer compatibility, enables users to monitor the pumps remotely, make adjustments, gather and analyse measurement data.

Ismatec pumps are ideal for dissolution testing in pharmaceutical dosing, chromatography applications, the addition of a reagent to a reactor and a variety of research and development purposes. One can select from 2, 3, 4, 6, 8, and 12 roller options.

Single-channel Ismatec Reglo

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Quick pumps offer quick tubing changes while flowmaster pumps are designed for heavy-duty processes and increased hygienic requirements.

Contact details Vinita Singh Cole-Parmer India Tel: +91-22-61394444 / 4410 vinita.singh@coleparmer.in

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PHARMA ALLY VALUE ADD

Akums: Continuous improvement with innovations Akums Drugs and Pharmaceuticals, a leading contract manufacturing pharma company in India, is contributing to the rapid growth of the Indian pharma industry LIFE EXPECTANCY has increased by several years during the millennium thanks to specific ailment-based medicines developed by scientists and produced by manufacturing companies. Medicines have quantifiable impact on the betterment of quality of lives and contributing towards a healthy lifestyle with preventive and curative measures.

The Indian pharmaceutical industry, the largest in terms of volume and 13th in value globally, has grown with leaps and bounds to become a global identity. It is estimated to grow at a CAGR of 12 per cent till 2020. The fast Indian pharma growth story is no wonder contributed by few leading marketing companies of the country but has also been contributed by Akums Drugs and Pharmaceuticals, a leading and one of the largest contract manufacturing pharma company of India.

Currently, most of the leading marketing companies in India as well as in global pharma market are outsourcing formulations and focus entirely on evolving marketing strategies and launching newer molecules.

Akums Drugs and Pharmaceuticals was established in 2004, which is a pioneer in setting new trends in Contract Research and Manufacturing Services (CRAMS) and offers innovative solutions developed by its R&D and F&D departments for complex and challenging health issues to the society through its marketing associates.

In a span of 11 years, Akums has become a highly reputed contract manufacturing pharma company of India for its high quality products and unique business acumen.

Currently, Akums is manufacturing more than 10 per cent

48 EXPRESS PHARMA October 1-15, 2015

of India’s total medicinal requirement. Products manufactured by Akums are being preferred by the medical fraternity because of their trust on efficacy, safety and quality of formulations. Over the years, Akums has become a brand in itself.

Akums, in the last one decade, has set up nine ultra modern manufacturing facilities of international standards in Haridwar, Uttarakhand for manufacturing formulations in the form of tablets, hard and soft gelatine capsules, dry and liquid orals, medicinal jellies, oral powder in jars and sachets, dry and liquid injectables in vials and ampoules, pre-filled syringes, large volume parenterals, lyophilised products, eye/ ear/ nasal drops (FFS & 3 piece packs),

ointments, creams, lotions, diskettes etc. covering most of the therapeutic segments including, hormonal, cardio-vascular, anti-diabetic, gynaecological, dermatological, nutraceutical, cosmeticeuticals herbal as well as OTC products.

Akums business covers Contract Research & Manufacturing Services (CRAMS) and is actively engaged in domestic, export and institutional business; formulation and development of Novel Drug Delivery System (NDDS) products and technical collaboration and joint ventures.

Akums’ unique competence lies in developing specialised new formulations, conducting stability studies, undertaking bio-equivalence

studies, clinical trials and obtaining DCG(I) (Indian FDA) approvals for manufacturing new fixed dosage combinations and molecules and thereby offering new formulations to its clients with Akums’ technology under their brand names. Akums has already got 500 DCG(I) approvals, which is highest in number awarded to any company in the country and a large number of applications are in the pipeline.

The facilities are accredited with WHO-GMP, ISO 9001-2008, ISO 14001-2004, HACCP, Certificate from NABL with ISO/IEC 17025:2005 and US-NSF,GMPAyush, Food Safety Systems: 1999 for its herbal and nutraceutical, Maxcure Nutravedic facility.

Akums has not kept itself

limited to the Indian domestic market and its facilities have been approved by various international regulatory bodies, like: ANVISA-Brazil, NAFDAC-Nigeria, PPB-Kenya, NDA-Uganda, FDB-Ghana, PMPB-Malawi, MOH-Libya, CD & DA-Sri Lanka, DPMIvory Coast, MOH-Vietnam, MOH-Cambodia, MOH-Myanmar, MOH-Belarus, DDANepal, MOH-Bhutan, MOHAfghanistan, MOH-Yemen etc Akums is exporting its internationally acknowledged formulations through its export subsidiary company Unosource Pharma from Mumbai to Libya, Nigeria, Ghana, Kenya, Uganda, Myanmar, Ethiopia, Liberia, Malawi, Phillipines, Vietnam, Sri Lanka, Nepal, Bhutan, Afghanistan, Malaysia, Venezuela, Belarus, Ukraine, Tajakistan, Honudrus, Francophone countries and many more.

Akums also manufactures a wide range of veterinary products in the form of bolus, liquid orals, injectables (dry/liquid), sprays, shampoos and feed additives in its different facilities with stringent quality control measures for leading Indian and multinational veterinary companies.

The cream of Indian pharma industries personnel in its QA & QC departments are the backbone of Akums.

Akums has received many awards and accolades for its services in the field of pharma manufacturing, such as the National Award in 2010 for Excellence in Product Quality, National Award – 2010 by the Government of India for Outstanding Entrepreneurship, Rashtriya Udyog Ratna Award 2012-2014, Business Leadership Award 2012, for India’s most promising pharma company in CRAMS to name a few.

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PHARMA PLANT AVAILABLE FOR SALE (ON “AS IS WHERE IS BASIS”) A fully integrated formulation plant, suitable for production of tablets, capsules and oral liquids, is available for sale near Village Kachivani Singaram, Ghatkesar Mandal, Ranga Reddy District, Hyderabad. Spread over 1½ acres land, the built up area of the plant is around 28,500 sq. ft. The plant can produce up to 10 crores of tablet/capsules per annum and 75 lakhs bottles of oral liquids per annum.

We are ready to sell the land & building and plant & machinery separately.

If Interested,

Please Contact: Mr. V. Narendra Rao at +91-95819 92861 54

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An orthogonal formulation development tool, automated size and viscosity measurements assessing both purity and injectability.

Counts, Weighs and Differentiates silicon and protein particles in a product, as increasingly advocated by the FDA.

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Reduce energy cost and raw material rejection with 100% fresh air cooling solutions

HMX-PCU-F

Reduce energy costs Indirect evaporative cooling Most energy efficient way of pre-cooling air for air-conditioned areas Works as a standalone unit or in conjunction with an existing system

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Reduction in TR load on existing air-conditioning system

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PHARMA LIFE AWARDS

Thomson Reuters honours Indian scientists at India Citation Awards 2015 Recognised for outstanding research and contribution to global R&D INDIA’S LEADING researchers were honoured at Thomson Reuters Research Excellence – India Citation Awards 2015 in New Delhi. The guest of honour for the event was Dr Soumya Swaminathan, Director General, Indian Council of Medical Research (ICMR) & Secretary- Department of Health Research. The keynote address was delivered by Dr H Purushotham, Chairman and Managing Director, National Research Development Corporation.

The India Citation awards study mines scientific research citations within Web of Science, the premier global search and discovery platform, to identify most influential researchers in the country.

The 2015 India Citation Awards winners were Dr Vinay Gupta, IUSSTF (Indo-US) University of California Scientist, Physics of Energy Harvesting, CSIR National Physical Laboratory; Dr A Ramachandran, Chairman, Dr A Ramachandran’s Diabetes Hospitals Pres-

ident, India Diabetes Research Capital; Dr A Banerjee, Fellow, Royal Society of Chemistry, UK, Professor- Biological Chemistry, Indian Association for the Cultivation of Science; Dr AK Srivastav, Visiting Scientist, US Army Laboratory, Maryland, USA, Professor- Analytical Chemistry University of Mumbai; Dr Prithwish Tribedy, Scientist Variable Energy Cyclotron Center, Kolkata; Dr Rahul Bannerjee, Principal Scientist, Physical and Materials, Chemistry Divi-

sion, CSIR-National Chemical Laboratory; Dr Rajeev Varshney, Director, International Crops Research Institute for the semi-arid tropics, Center of Excellence in Genomics; Dr S Ramaprabhu, Professor, Department of Physics, Indian Institute of Technology, Madras, Chennai; Dr Swagatam Das, Assistant Professor Electronics and Communications, Science unit, Indian Statistical Institute, Kolkata and Dr Vandana Bhalla, Assistant Professor, Gurunanak Dev Univer-

sity, Amritsar , Category- Organic Chemistry.

Arvind Pachhapur, South Asia Head, Intellectual Property & Science and Legal Business, Thomson Reuters said, “India has always been an important contributor to the global research output. The Thomson Reuters India Citation Awards aims to encourage and celebrate excellence in research by objectively identifying highly impactful work.”

EP News Bureau-Mumbai

AmeriCares India announces winners th for the 6 Spirit of Humanity awards This year, the impact sectors include – child health, diabetes, disability, eye care, education, livelihood, water & sanitation, and women empowerment SPIRIT OF Humanity Awards, an initiative by AmeriCares, announced its winners in eight categories recently. It was a culmination of three levels of short listing with ended with a grand awards evening. Reportedly, the programme, in its sixth year, received 400 registrations from NGOs across India of which 28 made it to the finale. The top eight were chosen after a live presentation in front of an eminent jury.

Until last year, the awards were predominantly focused on NGOs in healthcare; this year, it has extended to other categories namely - disability, livelihood, education and water & sanitation.

Only one best from the four

Sr. No.

Category

Organisation

Zone

1

Child Health

Mahan Trust, Melghat, Maharashtra

West

2

Diabetes

Aditya Jyot Foundation for Twinkling Little Eyes, Mumbai

West

3

Education

Sevalaya,Tamil Nadu

South

4

Water & Sanitation

Jal Bhagirathi Foundation,Jodhpur

West

5

Disability

Tamana, Delhi

North

6

Eye Care

Samarthanam Trust for the Disbaled, Banglore

South

7

Livelihood

RMD Pain And Palliative Care Trust, Chennai

South

8

Women's Empowerment

Drishtee Foundation , Delhi

East

zones (N-E-W-S), for each category have made it to the finals, through a process monitored by KPMG in India.

Spirit of Humanity, is organised in partnership with Abbott,

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Allergan, Castrol, Novartis, State Bank of India, Bharat Serums and Vaccines, Ericsson, The Hans Foundation, SPJIMR, Idobro, Guidestar and JW Marriott. AmeriCares is also associ-

ated with Bristol-Myers Squibb Foundation for significant projects on public health.

Talking about the change in awards this year, Shripad Desai, MD & Country Director, Ameri-

Cares said, “It gives me immense pleasure to bring the 6th edition of The Spirit of Humanity Awards this year. Over the years, this platform has evolved for better. This year, apart from recognising the healthcare NGOs we have extended nominations to other impact sectors as well. We are thrilled to receive such an encouraging response from all the participants.

We only hope and thrive to grow this platform further and encourage services of many in the future.”

The winner of the award received the prize amount of Rs one lakh, a certificate of excellence from the organisers and a trophy.

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PHARMA LIFE INITIATIVE

Cadila Pharma,Kaka-Ba Hospital organise free medical check-up and treatment camp Provide healthcare support to residents of local villages of Dholka Taluka in Ahmedabad CADILA Pharmaceuticals, as a part of its corporate social responsibility (CSR) initiative, and Kaka-Ba Hospital, run by KakaBa and Kala-Budh Public Charitable Trust, recently organised a free medical check-up and treatment camp to provide healthcare support to residents of local villages. The medical camp was organised at Sheth Shri D K Shah High School, Transad village of Dholka Taluka in Ahmedabad. More than 1000 people from Transad and nearby villages like Pisawada, Bhetawada, Virdi and

Ingoli were benefitted from this noble initiative.

A team of 20 doctors including gynaecologists, ophthalmologists, orthopaedics, dermatologists, paediatricians, ENT specialists, gastroenterologists, general surgeons and 15 paramedical staff from Kaka-Ba Hospital rendered their services in the camp. Patients underwent health checkups by a team of specialist doctors and were given consultations and medicine free of cost.

More than 100 patients have been identified for further treat-

ment related to cataract, gynaecology, orthopaedic, urology etc.

They will be treated at the KakaBa hospital free of cost in phased manner over the next three

months.

Dr Rajiv Modi, Chairman and Managing Director, Cadila Pharmaceuticals said “Cadila Pharmaceuticals is committed to-

wards inclusive and sustainable growth. Under the aegis of Kaka-Ba and Kala-Budh Public Charitable Trust, we use a holistic model of development and undertake a number of CSR activities in the larger interest of the community, especially in the area of health, education, women empowerment and childcare, apart from supporting a few other not for profit efforts.

Cadila Pharmaceuticals will continue to support more such CSR initiatives.”?

EP News Bureau-Mumbai

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HEAD OFFICE MUMBAI Rajesh Bhatkal The Indian Express (P) Ltd. Business Publication Division 2nd Floor, Express Tower, Nariman Point, Mumbai- 400 021 Board line: 022- 67440000 Ext. 527 Mobile: +91 9821313017 Email Id: rajesh.bhatkal@expressindia.com BRANCH OFFICES NEW DELHI Ambuj Kumar The Indian Express (P) Ltd. Business Publication Division Express Building, B-1/B Sector 10 Noida 201 301 Dist.Gautam Budh nagar (U.P.) India.

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