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

VOL. 11 NO. 11 PAGES 54

www.expresspharmaonline.com

Market SDI, FICCI & Express Pharma discuss ‘Innovation & International Competitiveness’

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CONTENTS MARKET Vol.11 No.11 APRIL 1-15, 2016 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bengaluru Neelam M Kachhap DESIGN National Art Director Bivash Barua Asst. Art Director Pravin Temble

SDI, FICCI & Express Pharma discuss ‘Innovation & International Competitiveness’ The roundtable explored opportunities in life sciences that India and Scotland can leverage to complement each other | P13

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8TH ANNUAL MEDICO LEGAL REVIEW CONCLUDES IN MUMBAI

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IPM CLOCKS ` 8139 CRORES IN FEB 2016

Senior Graphic Designer Rushikesh Konka Senior Designer Rekha Bisht Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Ravindra Pawar - South Harit Mohanty - West & East Marketing Team Rajesh Bhatkal Ambuj Kumar E Mujahid Arun J Debnarayan Dutta Ajanta Sengupta Nirav Mistry

P24: INSIGHT Pharmacists’ registrations and renewals

RESEARCH

P LIFE

P30: INTERVIEW ‘Both India and Europe can learn quite a lot from each other based on very long herbal medicinal traditions’

P31: INTERVIEW ‘The Tesla platform includes comprehensive system management tools’

PRODUCTION General Manager B R Tipnis

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CAT STEM CELL TRIAL COULD LEAD TO HUMAN TREATMENTS

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GERMANY’S BAYER WINS US FDA APPROVAL FOR HAEMOPHILIA A THERAPY

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US MADE DENGUE VACCINE 100 PER CENT EFFECTIVE IN SMALL STUDY

Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan

P33: INSIGHT

CIRCULATION Circulation Team Mohan Varadkar

Selecting stoppers for moisture sensitive drug products

PFIZER’S XELJANZ MEETS GOALS IN ULCERATIVE COLITIS TRIALS

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INDIAN COMPANIES BAG AWARD FOR ADOPTING GREEN MANUFACTURING PRACTICES AND DEPLOYING SUSTAINABILITY

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

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

EDITOR’S NOTE

Weeding out the bad FDCs

T

he fixed dose combination (FDC) issue has been a contentious one for years and on March 10 came back to haunt pharma companies in India. A 288-page government notification listed 300-plus FDCs which were deemed to 'have no therapeutic justification' and therefore banned from manufacture, sale and distribution in the country.

What is the way forward? Do we throw the baby out with the bath water? The concept of FDCs does have its benefits. Patient compliance is better when there are fewer medicines to consume and FDCs are a practical way to achieve this. But there should be enough evidence that the FDCs are rational and safe. All regulators agree that the burden of proof is on the pharma company. Absence of ill effects should not be taken as proof of safety and efficacy, especially in a country like India where the pharmacovigilance framework is still very nascent.

SV Veerramani, National President, IDMA may be justified that a minimum of a year should be provided for phasing out such formulations unless they pose an imminent health risk. This time lag is to presumably allow stocks in circulation to be used up or called back. But IDMA's stance that these FDCs have been in wide use for decades without any adverse reports, either with regards to efficacy or safety, will not hold for long.

Other countries' regulators too undertake a periodic review of FDCs. For instance, in May 2015, the US FDA announced plans for a new regulation on FDCs and co-packaged drugs. The proposed rule would 'create a single set of regulations for prescription and OTC combination drugs, and codify existing policy on what kinds of studies are needed to show that the combination drug requirements are met.' FDA’s Transparency Initiative and FDA Transparency Results Accountability Credibility Knowledge Sharing (TRACK), which provides a list of FDA’s upcoming rulemakings, lists the projected publication date for this regulation (RIN0910-AF89 ) as April 30 this year.

Past guidances from the US FDA provide a clue to the agency's views on FDCs. A Guidance dated May 2004 titled 'Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV' is clearly motivated by concerns that the FDC concept is being abused and in fact singles out nonFDA evaluated FDCs 'being promoted in resource poor nations where HIV-1 has reached epidemic proportions.' Though the US FDA concedes that these FDCs 'may offer cost advantages and allow simplified dosing because two or three drugs are

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Self regulation and a review by each company over the years would have prevented the proliferation of irrational FDCs.But it is tough to stay on the narrow path when it is easier to evade the regulator

combined in one pill', the Guidance stresses that 'products whose safety, efficacy, and quality do not conform to expected standards may pose a threat to individual patients by increasing the chances of substandard performance, which may lead to not only treatment failure, but also the development and spread of resistant virus.'

MSF makes the same distinction, between rational and irrational FDCs, when it hails the March 10 notification, pointing out that 'the list of banned drugs includes several FDCs containing multiple antibiotics that have long been used injudiciously, contributing to the development of resistant strains of infection-causing bacteria.'

India's increasing burden of drug-resistant tuberculosis (DR-TB) is due to the easy access to irrational FDCs containing anti TB drugs such as quinolones (ofloxacin and levofloxacin) and linezolid, says the MSF release.

The main grouse of the industry to the March 10 notification is that so many FDCs were banned in one go. But the current crackdown on FDCs by the Indian authorities has been on the cards for quite some time. The regulator has been trying to net irrational FDCs since 1988, when the Drugs and Cosmetics Rules, 1945 (Rules), were amended to mandate prior permission from the Licensing Authority i.e., DCG(I) before import or manufacture of FDCs (See article by Abhijeet Das, Senior Associate, Singhania and Partners which analyses the FDC bans in the past, and the various legal arguments open to pharma companies. http://www.financialexpress.com/article/pharma/lates t-updates/dcgi-bans-344-drugs-constituting-fixeddose-combinations-but-will-it-hold/228027/) Clearly, the industry ignored the warning signals. Self regulation and a review by each company over the years would have prevented the proliferation of irrational FDCs. But it is tough to stay on the narrow path when it is easier to evade the regulator. Many companies have got stay orders on the ban, but pharma companies will incur increased litigation costs, while government will lose time, effort and resources attempting to enforce the ban. Courts too are giving contrary verdicts, with the Delhi High court staying the ban on while its Chennai counterpart refused to do so. On all sides, there is a further erosion of trust, which does not bode well for the future.

One hopes that this time around, there will be some closure, fast.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET POST EVENTS

8th Annual Medico Legal Review concludes in Mumbai Speakers discuss trends in cases of medical negligence registered against doctors and hospitals Usha Sharma Mumbai

I

nstitute of Medicine & Law recently organised the 8th Annual Medico Legal Review — 2016 in Mumbai. The event, supported by an educational grant from Emcure Pharmaceuticals, was attended by eminent doctors, hospital CEO’s, and others discussed trends in cases of medical negligence registered against doctors / hospitals.

Dr Pravin Shingare, Director, Directorate of Medical Education and Research, spoke about the grey areas in public and private healthcare sector and the problems being faced by the doctors. He spoke about the government’s action plan in identifying bogus doctors and punishing them and added that the government is working aggressively towards reducing the cases of medical negligence in Maharashtra.

Dr Atul Shah, Ex-Secretary, Association of Plastic Surgeons of India, Director Medical Service - Solace Hospital, spoke about the medico legal issues being raised at regular intervals in both the houses of the Parliament. He expressed concern that doctors are not well versed with medical laws and about the need to create awareness amongst doctors and to update them.

Advocate Mayank Kshirsagar, Advocate Supreme Court, highlighted that Punjab leads in the number of medico legal cases followed by West Bengal and Maharashtra which is just one per cent behind West Bengal. Surprisingly, Chhattisgarh had now entered the top five states in medical litigation. He also emphasised that the courts are generally lenient towards doctors in deciding cases against doctors and spoke about several cases

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where courts have dismissed cases where doctors have acted out of good faith and without any wrong intention and did their best to serve the patient.

He also pointed out towards the latest trends regarding patients suing hospitals ‘only’ and not doctors. Kshirsagar also informed that the doctors are not liable for administrative lapses in case of a hospitalised patient whereas hospitals are always liable for negligence of their nurses, paramedics, employees, doctors, and anesthetists whether they are permanent or visiting, full-time or part-time.

Besides these, he also shared some important do's and dont's for doctors and hospitals and emphasised the need for ‘documentation’ and to maintain proper records. While summing up, he raised a valid point on the need for doctor ‘judges’ who would be able to better appreciate the nuances in deciding such cases.

The keynote address was delivered by Mahendrakumar Bajpai-Advocate Supreme Court, and Director, Institute of Medicine and Law who highlighted some changes in deciding cases of medical negligence i.e.

◗ Concept of Eggshell Skull Doctrine applied in one case. ◗ Experience of the doctor specifically taken into account by the National Commission ◗ Commercialisation of medical services taken into account.

He also spoke about the right of hospitalised patients to buy medicines from any pharmacy outside the hospital. He emphasised that a patient cannot be forced to buy medicines from the hospital pharmacy. In all these cases, the hospital should keep a record for future reference so they are not held responsible for some

mishap due to wrong / spurious / improper medications. He also pointed out that the patients were unhappy with surgeons going on leave immediately after surgery which is reflected in many cases. While signing off, he pointed out that there are rising allegations of delayed/improper diagnosis, which have doubled against the previous year.

Ravindra Mangal, Associate Director - Strategic Initiatives, Institute of Medicine & Law delivered the vote of thanks. u.sharma@expressindia.com

SDI,FICCI & Express Pharma discuss ‘Innovation & International Competitiveness' The roundtable explored opportunities in life sciences that India and Scotland can leverage to complement each other AHMEDABAD RECENTLY played host to a executive round table on ‘Innovation & International Competitiveness’ with a focus on pharmaceuticals, clinical research, and medical devices/technologies. Presented by Express Pharma with Scottish Development International (SDI) as the Knowledge Partner and

Federation of Indian Chambers of Commerce and Industry (FICCI) as the Industry Partner, the panel discussion on ‘Innovation and International Competitiveness’ struck at the heart of the myriad challenges facing Indian companies as they strive to expand their geographical footprint.

Welcoming the attendees on behalf of SDI, Cherise Mascarenhas, Business Development Manager, SDI give a quick comprehensive overview of SDI’s role in facilitating investments into and out of Scotland.

Setting the scene for the panel discussion, the moderator of the Executive Round

Table, Viveka Roychowdhury, Editor, Express Pharma mentioned SDI's role in helping India-headquartered corporates like the Piramal Healthcare to set up substantial manufacturing operations in Scotland.

Kicking off the panel discussion, Roychowdhury asked Param Shah, Head, FICCI's

Gujarat State Council about his organisation’s role in helping member companies find the right fit in terms of a global partner. He expanded on FICCI’s vision document for the lifesciences sector and initiatives like the Millennium Alliance.

A very interesting perspective was shared by Vi-

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MARKET ranchi Shah, Vice Chairman, Indian Drug Manufacturers' Association (IDMA),Gujarat State Board who as Director at Ahmedabad-based SAGA Laboratories, has had first hand experience of trying to find the right overseas partner. He stressed on the importance of understanding the local nuances of the each country for which the right local partnership is crucial.

Giving the perspective of a large Indian pharma company, which already has collaborative partnerships, Dr Manjul Joshipura, Vice President Medical Services at Cadila Pharmaceuticals mentioned that their experience is that start ups spun out from academia make for very good collaborations as they do good work without having huge budget outlays. He opined that in pharma R&D, the R (research) could be done abroad while the D (development) can be done in India.

As a global CRO, Dr Kiran Marthak, Vice President, Member of Board of Directors and Global Head – Clinical Development, Lambda Therapeutic Research spoke about how his company has found expanded through clinical sites/CROs in promising geographies and looks forward to exploring the same in Scotland.

Sharon McKendry, International sector head for life and chemical sciences, SDI explained how Scotland’s leadership position in life sciences went much beyond the successful cloning of Dolly the sheep. Her presentation touched on Scotland’s history of drug discovery excellence and Scottish scientists, mentioning highlights like the discovery of the world’s first vaccine against viral Hepatitis B, the Nobel prize winning discovery of beta blockers as well as other blockbusters like Atracurium (the world’s bestselling muscle relaxant), Salbutamol ( the world’s bestselling asthma treatment) and Zantac (for peptic ulcers).

Scotland's USP is the infrastructure to support early lead identification and validation, which saves pharma companies both time and money.

14 EXPRESS PHARMA April 1-15, 2016

Her presentation sparked numerous queries from the audience, seeking details on

the process of technology transfer and commercialisation support being offered by

SDI to pharma and medical devices companies looking to set up a base in Scotland. The

evening ended with a networking dinner.

EP News Bureau-Mumbai

MARKET GROWTH TRACKER

IPM clocks ` 8139 crores in Feb 2016 The Odisha market grew the highest followed by Punjab and Vidarbha THE INDIAN Pharma Market (IPM) clocked ` 8139 crores in February 2016 and has grown at 12 per cent. Amongst the top 10 corporates, Mankind grew by 27.7 per cent, Sun Pharma by 19.3 per cent and Lupin at 18.6 per cent.

In February 2016, amongst the top 10, Mankind Pharma grew by 27.7 per cent, Sun by 19.3 per cent and Lupin at 18.6 per cent. 16 corporates have crossed the growth of IPM amongst top 50. Amongst the top 50 corporates, Bharat Serums has the highest growth of 36.3 per cent followed by DRL at 32.5 per cent and Mankind at 27.7 per cent. 23 corporates have shown growths of more than 10 per cent amongst the top 50.

Amongst the 11-20 ranked corporates, DRL has the highest growth of 32.5 per cent followed

by Intas at 22.5 per cent and USV at 20.1 per cent. Amongst the 21-30 ranked corporates, Novartis has the highest growth at 16.7 per cent followed by Ipca at 11.5 per cent and Eris at 10.1 per cent. Amongst the 31-40 ranked corporates, Bharat Serums grew at 36.3 per cent followed by JBCPL at 18.7 per cent and Hetero at 11.8 per cent.

Amongst the 41-50 ranked corporates, Systopic has the highest growth at 25.8 per cent followed by Panacea at 13.8 per cent and Wallace at 13 per cent.

Amongst the 51-60 ranked corporates, Boehringer Ingelheim grew at 57.1 per cent followed by Fresenius Kabi at 32.2 per cent and Corona at 16.3 per cent. Amongst the 61-70 ranked corporates, RPG grew at 25.4 per cent followed by Shreya, which grew at 23.8 per cent and Geno at 19. Amongst the 71-80 ranked corporates, Samarth grew at 44.3 per cent followed

by Lincoln at 29.7 per cent and Walter Bushnell at 23.2 per cent. Amongst the 81 -90 ranked corporates, Galpha grew at 48.7 per cent followed

by Veritaz grew at 37.5 per cent

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followed by Dabur at 37.2 per cent. Amongst the 91-100

ranked corporates, Gland grew at 34.9 per cent followed by

Serum Institute at 20.3 per cent and Jenburkt at 18.8 per cent.

The 100th biggest corporate is overseas and 150th biggest cor-

MARKET porate is UTH in the IPM. Boehringer Ingelheim entered the ` 300-crore club, Samarth Life Sciences the ` 150crore club, on MAT Basis. Innovcare a new company made its presence felt at 213th rank with a turnover of ` 12 crores.

Indian companies have grown at 14 per cent versus five per cent for MNCs in February 2016. Amongst the top 50 in MNCs, Novartis grew at 16.7 per cent followed by Merck at 11.5 per cent and Janssen at 9.6 per cent. Under the Non-NLEM category, Indian companies grew at 12.4 per cent whereas MNCs grew at 1.1 per cent.

The NLEM containing molecules market grew at 6.9 per cent whereas the non DPCO market grew by 12.9 per cent and Non -Sch Para 19 Market at 15.3 per cent resulting in an overall growth of 12 per cent for February 2016. The NLEM and Non-NLEM Category showed unit growth a 3.4 per cent and 3.3 per cent respectively. The Non-Sch Para 19 Market grew at 9.1 per cent from units perspective.

14 therapies have outgrown the IPM growth. The respiratory market grew at 5.8 per cent, gastrointestinal market grew at 16.4 per cent, pain and analgesics market grew at 9.7 per cent whereas the anti-infectives grew at 5.3 per cent. The anti-diabetic market grew at 18.1 per cent and cardiac at 17.3 per cent in chronic business. The derma market grew by 16.8 per cent, urology at 17 per cent and neuro/CNS at 18.9 per cent.

14 regions have outgrown the IPM growth. The Odisha market grew the highest at 22.2 per cent followed by Punjab at 20.8 per cent and Vidarbha market at 18.5 per cent. No regions had negative growth in February 2016.

Amoxycillin + Clavulanic Acid market grew at 2.8 per cent and Glimepiride + Metformin Market grew at 19.3 per cent.

The markets of paracetamol grew at 14.4 per cent, Atorvastatin 11.7 per cent, Probiotic Microbes at 39.7 per cent, Cefixime -4.8 per cent, Pantoprazole 17.6 per cent, Montelukast + Levocetrizine at 7.0 per cent, Glimepiride + Metformin + Pioglitazone at 19.1 per cent, Vitamin-D at 22.0 per cent, Hydro-

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quinone + Mometasone + Tretinoin at 12.8 per cent, Voglibose + Metformin + Glimepiride at 46.9 per cent, Rosuvastatin at 22.8 per cent, Protein Supplements at 6.9 per cent, Azithromycin at -6.4 per cent, Calcium Carbonate + Vit D3 market at -0.1 per cent, Paracetamol + Phenylephrine + Chlorpheniramine at -4.6 per cent, Meropenem at 48.3 per cent, Montelukast + Fexofenadine at 22.6 per cent, Diclofenac at 21.5 per cent. The 50th biggest market was Voglibose + Metformin + Glimepiride and 100th biggest market is Levofloxacin.

Mixtard lead the pack with ` 36 crores followed by Glycomet GP & Augmentin at ` 28 crores. On MAT basis, Glycomet GP is ranked now at number two.

A few brands who have gained ranks include Unwanted Kit (+75), Meronem (+54), Electral Powder (+51), Aciloc RD (+32), Betnovate C (+29), Rabipur (+27), Mifegest Kit (+25), Voveran, Omez (+22), Telma (+21), Rosuvas, Vertin, Trajenta (+20), Thyronorm, Betnovate N, Rotarix, Aztor, Deriphylin (+18), Istamet (+17), Storvas (+16), Galvus Met, Jalra M, Levipil, Eltroxin, Atorva, Pantocid D SR, Cardace (+15), Gluconorm G (+14), Gemer, Susten, Duphalac (+13), Ultracet (+12), Pan, Synflorix, Budecort, Glycomet, Mucaine (+11), Rantac (+9), Orofer XT (+8), amongst top 100 brands over February 2015.

Lonopin, Razo D, Brilinta, Zerodol P, Enterogermina, Econorm, Zerodol P, Finecef, Metpure XL, Omez D are few brands which have gained ranks in 101-200 ranked brands.

A few brands that have moved up ranks fastest into Top 300 brands for the month of February – 16 are Revital H, Lonopin, Ocid, Similac, Candiforce, Razo D, Glimestar M, Brilinta, Gabapin NT. The 300th biggest brand was Reditux from DRL. A total of 224 brands and 409 SKUs were launched in February 2016. The top new brands were Pegclear, Azacytin, Epilyno.

One brand was launched in Sofosbuvir + Ledipasavir category – Sofocruz LP from Torrent. Within the VMS category, AIOCD sees GB 29 Total (Corona), Maxical Plus

(Mankind) & Ensame (Icarus Healthcare), within anti-diabetic, Glytrin (Medley), Glimipack M, Voglipack ( Koye), within respiratory, Acemont (Avis Life Care), Ranmotel C (Sun), Vitaresp AB (Alembic), within Anti – Infectives we see Tygaray ( Mylan), Sofocruz LP (Torrent) & Kartel (Saffron), within cardiac, Modlip D (Torrent), Benipack (Koye) & Supertel (Gland) and in gastro intestinal, Pegclear (Zuventus), Eco All Z (Hetero) & Glinzo D SR (Glenmark). The biggest new

Val in Crs CORPORATE IPM Sun + Ranbaxy Abbott + Abbott HC + Novo Cipla Zydus + Biochem Mankind Lupin Alkem + Cachet + Indchemie Glaxo Pfizer Macleods Intas Emcure + Zuventus Aristo Dr. Reddys Sanofi India Glenmark Torrent USV Micro + Bal

launch by a MNC was Tygaray in February 2016.

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted

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

AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind AIOCD AWACS’ research tools to

With Bonus Units at Full Value Rank MAT Feb-16 MAT MTH Val (Cr) MS% 98042 100.00 1 1 8644 8.82 2 2 6022 6.14 3 3 4886 4.98 4 4 4136 4.22 5 5 3656 3.73 6 6 3405 3.47 7 7 3376 3.44 8 8 3198 3.26 9 11 2872 2.93 10 9 2829 2.89 11 10 2771 2.83 12 13 2558 2.61 13 16 2425 2.47 14 12 2421 2.47 15 17 2358 2.40 16 14 2347 2.39 17 15 2272 2.32 18 18 1952 1.99 19 19 1872 1.91

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

MAT Feb 16 MAT Feb 16 GR% 98042 13.8 14963 9.6 12250 14.7 11535 16.4 8602 10.5 7930 22.1 7738 13.8 6763 12.3 6040 15.3 5879 17.0 4902 11.6 1661 13.0 1659 12.1 1591 10.4 1417 12.8 1154 17.0 1069 17.6 1064 25.3 546 -1.4 544 13.3 402 8.4 219 -2.4 115 10.0

reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

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

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

GR% 13.8 14.3 12.8 15.0 13.0 19.8 18.0 11.5 6.2 10.7 12.6 23.6 9.6 15.8 25.3 10.1 24.5 17.5 18.2 12.8

Val (Cr) 8139 730 497 425 341 315 277 271 249 232 247 234 209 188 215 184 200 192 167 154

Feb-16 MS% 100.00 8.97 6.10 5.22 4.19 3.87 3.40 3.33 3.06 2.85 3.03 2.87 2.57 2.31 2.64 2.26 2.45 2.35 2.05 1.90

GR% 12.0 19.3 6.4 11.6 9.5 27.7 18.6 9.7 3.8 5.1 8.6 22.5 7.1 3.4 32.5 -0.7 19.6 10.2 20.1 12.3

Month Feb-16 Month Feb-16 GR% 8139 12.0 1213 5.3 1060 17.3 941 16.4 690 10.3 670 18.1 702 5.8 535 9.7 519 18.9 488 16.8 409 14.1 119 -12.7 141 13.7 121 -1.0 119 13.8 88 13.7 87 17.0 97 31.0 31 -10.5 50 13.0 33 12.7 18 5.8 8 16.2

EVENT BRIEF APRIL-NOVEMBER 2016 13

Optel Vision’s CMO seminar

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2nd Edition of Asia Labex

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PHARMA Pro&Pack Expo 2016

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CPhI and P-MEC India

OPTELVISION’S CMO SEMINAR Date: April 13, 2016 Venue: Goa Summary: Optel Vision, in collaboration with Conval Group and TraceLink is organising a common platform for the Indian pharma industry to understand various strategies that can be implemented for global T&T deployment.

The event will see more than 100 national and international speakers and delegates.

Supported by industry bigwigs Apotex, Fresenius Kabi, Par Pharmaceutical and Domino amongst other renowned pharmaceutical brands, the event will see attendance of top executives from the pharmaceutical industry. A platform for exchange of knowledge, the congress will have delegates from engineering, project management, IT, QA and supply chain functions across the industry. The one-day event will feature presentation, case studies, strategic roundtable discussion and cover various issues related to serialisation global compliance plus various approaches for facing them.

Contact details http://www.serialisationcmo.in/

PHARMA PRO&PACK EXPO 2016 Date: April 27-29, 2016 Venue: Mumbai Exhibition Centre, Mumbai Summary: IPMMA and GPE Expo will organise PHARMA Pro&Pack Expo 2016. The exhibitors profile include: machineries and equipment: Pharma processing M/c (tablet, capsule, injectables, ointments, dry syrup powder) packaging machineries lab and biotech instruments, glassware, packaging materials, lab-wares and consumable, clean room and environment control products and services, utilities equipment and services, project consultants and turn key contractors.

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

E:mail@PharmaProPack.com W: www.PharmaProPack.com

2ND EDITION OFASIA LABEX Date: September 22-24, 2016 Venue: Gujarat University Convention & Exhibition Centre, Ahmedabad Summary: Asia Labex is a premiere exhibition and conference on laboratory, analytical, scientific, diagnostic, biotechnology, research and testing instruments and consumables. The exhibition will be organised by Fenza Exhibitons.

Contact details: Fenza Exhibitions Plot No 1, 2nd Floor, GT Karnal Road, Opposite PNB Bank, New Delhi – 110033

CPHI AND P-MEC INDIA Date: November 21 – 23, 2016 Venue: Bombay Exhibition Centre & MMRDA Grounds, BKC, Mumbai Summary: The event will be an ideal congregation for companies to pick up on the latest trends and innovations the market has to offer. CPhI India is also co-located with P-MEC India, the pharma machinery show in Asia. This year, the expo has grown from a three day exhibition to a show spanning a week, Pharma Week, (November 17 to 23, 2016).

The Pharma Week will hold more than 12 events that will take place across the city of Mumbai focusing on business, knowledge, leadership, innovation and recognition in the field of pharma. With two venues this year, Bombay Exhibition Centre and Bandra Kurla Complex in Mumbai, CPhI & P-MEC 2016 will include exhibitor showcase, innovation gallery, speed meetings, live entertainment and much more.

Contact details UBM India TIMES SQUARE Unit No 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol Andheri (East) Mumbai - 400 059 Tel.: +91 22 61727272 Fax. +91 22 61727273

To subscribe: bpd.subscription@expressindia.com

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cover )

S

ocial media’s impact is very evident in today’s world. It has disrupted and changed the norms of communication. Different sectors are putting it to great effect through various initiatives.

However, the pharma industry in India seems reluctant to embrace the power of social media. Why is it so? One reason could be that the pharma sector deals with life and death, hence it is one of the most regulated industries in the world. Fear of getting trapped in regulatory norms always looms on the horizon of the pharma industry However, industry experts are of the opinion that even with the risks and regulations faced by the pharma industry, it needs to leverage the potential

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of social media platforms to engage with its target audience.

Social media can serve as a great tool for the pharma industry to stay connected with its consumers. Thought leaders also believe that the risks could be transformed into opportunities if a sound strategy is put into place.

Brimming with potential...yet fears remain “People in India are rapidly adapting to the Internet. Today, India has the third-largest internet user base in the world with more than 300 million users, of which more than 50 per cent are mobile-only Internet users. It is also estimated that in 2017, there will be around 197 million social network users in India. Social

media can thus be a great tool for the pharma industry to stay connected with its consumers in India. Just a few of them have tried to some extent, and some are considering now, but majority of them have yet to understand the positive impact it can have on their business,” informs Priti Mohile, Co-Founder and Managing Director, Media Medic Communications.

Pharma companies too have adopted social media, but in a limited way. Only a select few, renowned names in the industry are making use of social media with significant effect.

Nilofer Memon, Digital Marketing Manager, Sorento Healthcare Communications, informs, “In India, pharma companies like Abbott, Sanofi,

Merck Serono, J&J among others are using social media in delightful ways such as corporate branding, talent acquisition, OTC product promotion and likewise unbranded initiatives to build awareness on disease conditions. These companies have succeeded in clearing bottlenecks and establish their social media presence. But, due to compliance restrictions and legal hurdles for Rx brands, multinational pharma companies, prefer not to aggressively promote themselves online. Pharma companies are not active enough, but they are changing at a faster rate than, say, five years ago.”

Benefits galore There is more to social media

than just sharing product information and promotional material. With a huge percentage of patients active on the social media it becomes even more necessary for the pharma companies to engage with them through this digital platform.

Benefits offered by various social sites are significant. As Mohile says, “It needs to be understood first that connecting with consumers does not necessarily mean promoting brands.”

Dr RB Smarta, Managing Director, Interlink Marketing Consultancy, says, “The business model in the industry today is shifting from being productoriented to being patientoriented. The needs of the patient in current times are the epicentre with services wrapped

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Though social media has proved its mettle across different sectors, the Indian pharma industry is still in wait and watch mode

BY SACHIN JAGDALE

around those needs. Apart from sharing just product information and promotional material, social media can be actively used to keep in touch with all the stakeholders of the industry like pharmacists, doctors, managers, stockists, hospitals as well as patients and can also be used for active networking.”

A pharma veteran with over 50 years in the industry, Subramanian Vaidya, Director, BlissGVS Pharma and ChairmanMSME committee, IDMA, offers a unique perspective. He opines that social media can be beneficial in enhancing pharmacovigilance. He says, “After 1970, when the Drug Price Control Order was passed, slowly and steadily the packs sold have been stripped of information leaflet

and today one buys naked strips without any information. No one including the regulatory and the medical profession seem to be bothered about it in either way as the doctors have an advantage over patients not knowing anything at all and being totally ignorant of what is being administered. Because of this, pharmacovigilance activities have taken a backseat in our country. So, if you ask me, one should make an ardent attempt to reach out when such a media is available.

In fact, we would even want social media sites in different regional languages and the access to them encouraged so as to reach out to the masses. This will have a different dimension and create a far reaching impact in the healthcare area.”

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Keeping patients as the core of the discussion, Memon says, “There are numerous opportunities for pharma companies in India. These companies have to determine the channels and tools that suit their brand and organisation. Market leaders can build on their reputation, disease awareness using social media tools. Further, companies can help patients find the right doctor, since more than 70 per cent patients do an online search prior to the doctor’s appointment. They can also involve doctors in their online communication e.g. Youtube video channels by experts. With increasing online trends in India on health, pharma companies must proactively provide correct materials online;

since consumers are seeking information on health condition, disease symptom, medicine, physician etc.”

Mohile says, “The Indian consumer is largely ignorant about health issues. He has depended on the doctor in totality for decades together. With the advent of the Internet, he/she has suddenly awakened to the availability of information. But, this information is not always authentic and balanced. The pharma industry has the greatest opportunity of providing the right information in a manner that will be understood, at the right place where they are seeking it, and provide the right guidance to connect with the doctor at the appropriate time. With more and more people looking

for health-related information online and the ability to identify and reach them, this opportunity cannot be ignored by the pharma industry.”

She adds, “From the very basics of networking with likeminded colleagues, vendors or customers to digging deep into social media to understand unmet patient needs that will help better product development; developing protocols for clinical trials; as well as communicating research efforts, clinical outcomes or educating about using a product/device correctly etc, social media can be used by every department.”

Taking a leaf out of Mohile’s book, Memon says that the Indian pharma manufacturers can use social media platforms

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cover )

Social media can be a great tool for the pharma industry to stay connected with its consumers in India. Just a few of them have tried to some extent

Apart from sharing just product information and promotional material, social media can be actively used to keep in touch with all the stakeholders of the industry

In India, pharma companies like Abbott, Sanofi, Merck Serono, J&J among others are using social media in delightful ways such as corporate branding, talent acquisition, OTC product promotion

Priti Mohile

Subramanian Vaidya

Co-Founder and Managing Director, Media Medic Communications

Dr RB Smarta

Nilofer Memon

Managing Director, Interlink Marketing Consultancy

Digital Marketing Manager, Sorento Healthcare Communications

as a B2B connect tool for business partners, product announcements, trade groups etc.

She elaborates, “LinkedIn is a very powerful networking site for B2B communication. The manufacturers can create and join trading or pharma manufacturing groups and continuously be updated on the global and Indian new product launch, technology and techniques. The company can also project the standards and processes they follow to make good quality products which builds reputation. Online research would help in R&D operations; social media listening and conducting surveys on social media can educate the company on consumer needs. Further, social media is a two-way street that not only allows you to publish content about your company or industry, but also gives you a chance to listen to your customers and prospects.”

Memon adds, “Pharma companies can use social media to update doctors and clinical study agencies on upcoming clinical studies using exclusive closed group channels. Besides

huge advantage for marketers, social media is a great tool for acquiring talent which could be a superior support for HR developments. Social media can be used in all the aspects of business operations by pharma companies, the stakeholders need to plan strategically the same.”

Patients active on social media can also pass on the positive as well as negative feedback regarding a particular pharma product to the concerned pharma company. Such genuine feedback will only help the company to make required changes in the product and rework on its future strategies.

Vaidya explains, “Social media can definitely print varied experiences of individual patients in different age groups and gender who have used a certain product. They can indulge in even praising a product for giving that exact relief from the symptom of a certain disease thus enabling many in the medical profession take cognizance of. Through this, the medical profession will also learn about the side effects suffered in whichever gravity the patient

experiences. In fact this is the actual material information which goes into pharmacovigilance reporting. A well informed patient of the social media can be a great complimenting factor in conveying the adverse reaction of a particular product and the gravity of the same when used. This is very important.”

Social media has a role to play in a pharma company’s day to day operations as well. Internal communication and collaboration tools are quite common in tech companies with Slack, Yammer, Lync and Jive leading the race. However, it is not the case in Indian pharma firms. Dr Somnath Datta, Key Account Leader, Business Insights and Analytics, IMS Health Information and Consulting Services India, points out that within the Indian pharma companies picking up the telephone and talking it out is still considered the best way followed by emails to align, follow up and keep scores. However, he strongly feels that like any other industry, pharma industry too will see the strategic advantages of using social media for in-house operations.

20 EXPRESS PHARMA April 1-15, 2016

In fact, we would even want social media sites in different regional languages and the access to them encouraged so as to reach out to the masses Director, BlissGVS Pharma and Chairman-MSME committee, IDMA

Moreover, in-house use of social media doesn’t invite any risk or scrutiny of the regulatory authorities.

Datta lists down some of the key benefits offered by in-house use of social media. “Social media will help in understanding and engaging internal employees better. It will also help in providing a window for the individual contributors to understand and shape the thinking of the top management. Grievances can be better understood and tackled through social media even for employees. Email can be replaced with chat groups, many tech companies have already started moving out of emails.

Mobile apps can be developed to engage various stakeholders to come together for fun or for serious collaboration – they can also be used for gathering clinical data (Apple suite).”

Challenges to conquer Regulatory norms were always considered as the major reason behind pharma industry’s reluctance to adopt social media in a big way. As Mohile says, “The challenge is mainly to work

I have not seen any company initiate a proactive social media do-gooder campaign to keep their corporate image intact and shine amidst all the ruckus Dr Somnath Datta Key Account Leader, Business Insights and Analytics, IMS Health Information and Consulting Services India

within the regulatory norms.

Regulatory norms are meant to protect the consumer. The industry knows how to operate within the norms, but does not understand this new medium. If both these are understood well, it is possible to work within the boundaries. For this, however, one must work closely with the MLR teams and agencies who understand both these aspects.”

However, legal barriers is just one of the reasons. Another one is the lack of knowledge where social media concerned. Many are still unaware about the most effective ways and means to use it.

Smarta informs, “The challenges for the pharma industry in using social media lies maybe in coming across incorrect and irrelevant information. There is a need for reliable and at the same time regulated information.

With regulated information, knowledge sharing with doctors, patients, etc, would be quite possible. Other challenges would be people not being comfortable while using social media, making content available and that too consistently, keeping people

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consistently engaged on the social media platform and skepticism regarding the information available on the social media platform.”

Datta feels that pharma industry is also a part of the problem. He explains, “More than regulatory obfuscation, it is the lethargy of pharma companies to change their business model and look for innovative ways of engaging customers. For example, we have seen more negative articles about pharma failing quality checks, failing ethical marketing practices, defending banned irrational combinations - all within the span of few months. I have not seen any company initiate a proactive social media do-gooder campaign to keep their corporate image intact and shine amidst all the ruckus.”

s

Way ahead Amidst the debate over the role of social media in the pharma industry there is consensus over the fact that the right approach will help pharma players use the medium effectively and responsibly. Social media is here to stay and grow. While other industries are making full use of this digital platform the pharma industry is not expected to be the mute spectator.

Mohile concludes, “There is no need to fear it. By its very nature, social media multiplies any message. This can be used to advantage if done pro-actively, cautiously and with complete understanding. If one approaches social media with a clear perspective that the pharma industry is here to ‘improve lives’ and use the best practices within the regulatory framework, responsibly, it is possible to stay engaged with it. The best possible way will be to define a specific problem and then find how this can be resolved using the digital and social media. It is far beyond mere gimmicks, it has to be strategic and integrated with the offline medium that pharma is so used to. It also has to be longterm. As in fact, the possibility of social media usage, especially marketing and PR, is immense.”

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cover ) INSIGHT

Role of social media in pharma industry Dinesh Chindarkar, Co-Founder of MediaMedic Communications, elaborates on how pharma marketing is undergoing a paradigm shift with the advent of social media

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he Indian pharmaceutical industry is one of the largest and steadily growing industries. Inspite of this growth, the method of traditional pharma marketing has not changed much. It has always focused on promoting their brands and products to the doctor, who is the centre-piece of this industry, through their medical representatives. All marketing efforts including communication channels, strategies, CRMs, policies etc are devised keeping the doctor in mind. However, with changing times of emerging media and technology in people’s life, does this need to change?

Influence of technology on marketing With the advent of globalisation in the 90’s, the ball of digital revolution set rolling with the Internet boom followed by the entry of mobile phones in the late 90’s.

With a population of 1.20 billion people today, India boasts of over 900 million mobile phones in the country. Smart phones are fast replacing standard mobile phones and every single service provider is offering deals on mobile Internet connectivity with their 3G and 4G offerings.

Consumers are thus increasingly exposed to a gigantic pool of information at their fingertips.

Social platforms like Facebook, WhatsApp, Twitter, Instagram, YouTube etc are playing an important role in how information is consumed. Therefore, it is extremely difficult for any industry to overlook social media as a means of communication with their consumers.

Power of social media As per a recent report, close to 400 million Indians are active

22 EXPRESS PHARMA April 1-15, 2016

Internet users which is up 20 per cent from previous year. A year back we recorded the highest social networking growth of over 35 per cent. It is also estimated that India will have the highest Facebook population in the world. Interestingly, as one delves deeper into the ocean of social media and specifically in healthcare, there are over thousands of pages dedicated to health on Facebook.

Another report suggests that nearly 16 per cent mobile Internet users in 35 top cities in India closely follow or use health related applications.

With this awareness about wellness and lifestyle diseases, people are increasingly seeking more information about health and wellness. According to a study published in Social Marketing Quarterly, people above the age of 18 revealed that Health Pages on Facebook had positive influences on them and motivated them to engage in healthy behaviours. The study concluded that Facebook may be an effective medium to help people live a healthy and adopt a healthy lifestyle.

Evolution of patients and thus, doctors Decades ago, patients would consult a doctor for their illness and when the doctor prescribed a drug for treatment, they would not doubt it. However, this phenomenon has undergone a massive transformation with the advent of ‘Dr Google’.

Now before consulting the doctor, most patients would have already made attempts to understand the symptoms by asking Dr Google and landed in a frenzy about its interpretation.

Many patients search the

DINESH CHINDARKAR, Co-Founder, MediaMedic Communications

prescribed medicine online to get convinced of its efficacy. Patients also have the weapon to make or break the image of the doctor and hospital with the help of several platforms that offer reviews and feedbacks of doctors. This rise of the e-patient is pushing the doctor ecosystem to understand the power of digital and adapt to it.

Moreover, as the doctor-medical representative relationship too is getting digitised, it has opened an opportunity for the industry.

How can pharma industry score a goal here?

The two important aspects of pharma communications are the direct customer i.e. doctor communication, and the end user i.e. the patient communication. Now beyond the medical representative as a channel, newer avenues are opening out such as creating focused groups of doctors on a closed but verified social media platform.

Some pharma companies and healthcare start-ups have realised the power of creating their own communities and are working around this framework. Also, standard social media platforms like Facebook connects patients and doctors together, where the pharma industry can take advantage to leverage their image and branding in the minds of both the

doctor and patient.

On the other hand, consumers including patients and their caregivers are increasingly talking about various health conditions, exchanging thoughts about a condition and increasingly influencing behaviour by leaving strong digital footprints. Focused groups in various health conditions including woman’s health, diabetes, cardiovascular health and other lifestyle conditions are showing increasing conversations. There are very interesting communication threads of healthcare questions and answers that run in hundreds of forums and discussion groups.

Some of them have become referral points on various health conditions. With the newer algorithms on Google search engine crawlers, these are thrown up on top of search results and influence health behaviour as well.

All this offers various opportunities to pharma companies, lets look at some of them: Social media listening – There are literally millions of health conversations on the web and they are increasing each day. These conversations can give an excellent insight into understanding patient psychology. There are discussions around various categories, pharma brands, their associated conditions, side-effects etc and interpreting this data will give the pharma industry an opportunity to fine tune and customise their brand strategy. Detailed analysis using tools can throw up various trends from various perspectives including geography, age-groups, gender etc. Analysis of this data and drawing insights will be key in

the future.

Closed loop marketing –Another excellent way to engage the doctors and patients is with the help of closed loop marketing (CLM) which is slowly gathering speed within the industry.

Here, the company can engage the end users as well as doctor with customised information and if planned and strategised well and integrated with the field force efforts, closed loop marketing can deliver impressive results.

Digital marketing – This actually means marketing in the digital world. Right from mobile phone applications to right usage of digital tools, digital marketing can integrate well with the existing marketing efforts.

From tools that help in counting calories to keeping a track on the amount of steps taken in a day, from being the first in providing doctors personalised information of their interest areas like the latest articles online to their smartphone to creating an active group, there is a lot that pharma companies can do get in close touch with their customers and consumers. If pharma can give a helping hand to the doctors by partnering with them in providing customised information to patients, it can help save doctorpatient interaction time.

Understanding the space and creating solutions around it is an opportunity.

Social media community building – With the increasing online users, pharma can partner to build and own a community around their interest health condition. So, all the patient education initiatives can turn social. If the effort is taken with empathy to give real world

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The two important aspects of pharma communications are the direct customer i.e. doctor communication, and the end user i.e. the patient communication solutions, the engaged community itself can help grow the community and take it to the next level. Also running campaigns on social media platforms to increase awareness about a particular disease or illness is an opportunity to drive traffic to doctors and expand the market. Various category leaders need to look at this opportunity to bring in patient-centricity in its true essence. By celebrating health days such as World Cancer Day, World Diabetes Day etc, pharma companies can help spread information about wellness to consumers with subtle branding.

With help from domain experts in the field of social media marketing, pharma companies can easily take their brand strategy to the next level with excellent ROI.

A social media campaign that made an impact – #Finding60inIndia is a good example of using social media to convey information about Progeria – a ultra-rare pre-mature ageing disease. The campaign, in association with the Progeria Research Foundation was aimed to build awareness about Progeria, as well as identifying the 60 estimated kids throughout India. A digital platform was created with the help of the hashtag #Finding60inIndia. Simultaneous Twitter and Facebook campaigns with Progeria survivor and fighter Nihal Bitla gave headway to bring this campaign in public attention. Nihal became the face of the campaign as Team Nihal and was backed by social media initiatives.

From print to radio to online portals, all came together to spread the word about the campaign and this fatal disease. This led to a solid penetration of the campaign in people’s mind so much that five more kids suffering from Progeria were located from remote places of India. This campaign not only helped find several kids suffering from Progeria, but also gave a

sense of security to the parents of these kids that they are not alone.

This campaign has undoubtedly been a success and recently the Delhi Government announced to form a sub-committee to develop policy to tackle rare genetic diseases such as Progeria. If an ultra-rare disease can have this impact, imagine what opportunity lies in managing lifestyle diseases.

Making healthcare exciting with digital support – Social media cannot be looked into isolation. A complete e-Marketing initiative with a strong digital strategy needs to be drafted. At the same time, it is very critical to understand the regulatory framework and work within the defined protocol and social media guidelines. Working with ‘Responsibility’ and ‘Care’ is critical while defining digital strategies that can oversee regulatory issues like Adverse Event Reporting etc.

Moving ahead, further penetration of smart phones and Internet and increased focus of pharma companies on social media, will lead to more interactive platforms coming up in this space. Companies like Abbott, Boehringer, J&J, Novartis, Pfizer, Sanofi, etc have taken the initial lead and there will be a lot to watch out for in the near future.

Social media is here to stay and has just gone through its infancy stage and will grow in the next few years.

How pharma marketers decide to take advantage of it, is for them to decide. Clarity of objective with a clearly defined ROI, will help shape up the future of pharma marketing in digital as well as social media. While the younger marketers may want to adopt for the glamour in it, if that is supported with the marketing experience of the grey hairs, pharma marketing will undergo a paradigm shift in the time to come.

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MANAGEMENT INSIGHT

Pharmacists’registrations and renewals Mansi Shah, Clinical Pharmacist, in the first article of a two-part series elaborates on review regulations on the issual of a certificate of good standing by state pharmacy councils in India and finds that it needs several amendments

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he profession of pharmacy in India is regulated by the Pharmacy Act, 19481, amendments thereof, Pharmacy Practice Regulations 20152, and the Pharmacy Council of India3,4,5,6 (PCI, a statutory body under the Ministry of Health and Family Welfare, Government of India) in association with State pharmacy councils. State pharmacy councils manage pharmacists’ registrations and renewals.

Earlier this year I happened to review regulations in India on the issual of a certificate of good standing7 by state pharmacy councils. This certificate is often requested by pharmacists when applying to register as a pharmacist in a different state or country or for academic purposes as proof of professional qualification, competence and overall good standing. This is required to be issued by the pharmacy council in which an individual is already registered and to be submitted to the council or regulatory and registering body in which the pharmacist desires to be additionally registered or an academic institution.

It came forth as a surprise to find in person at a state council that when a pharmacist requests a certificate of good standing, (s)/he is required to surrender the original pharmacist’s registration certificate to the state pharmacy council.

She/he is not allowed to renew registration till circumstances change, as when the individual has permanently returned to India and that state, if had moved out in the first place. I cross checked this information for Gujarat and Maharashtra state pharmacy councils8,9 and wrote to the PCI. I truly appreci-

24 EXPRESS PHARMA April 1-15, 2016

In India, there is no interim provision and neither is there any for allowing one to maintain registration in more than one country. These procedural changes may also likely be due to the large section of pharmacists’ fraternity in India looking to and moving out of the country but may instead lead to a situation where a pharmacist may not be allowed to work in any country, at least for a certain length of time ate that PCI responded in due course and forwarded my query to the state council. But, what since, and what now?

The original PCI guidelines10 do not have any indication of the need for pharmacists to surrender their original registration certificates and this amendment if present has come about in the past decade. In India, there is no interim provision and neither is there any for allowing one to maintain registration in more than one country.

These procedural changes may also likely be due to the large section of pharmacists’ fraternity in India looking to and moving out of the country but may instead lead to a situation where a pharmacist may not be allowed to work in any country, at least for a certain length of time.

Community pharmacists who are solely responsible for a pharmacy or owner of the pharmacy are not permitted to use their pharmacist registration certificate without attending the pharmacy. Display and use of a pharmacist registration certificate at more than one pharmacy also constitutes an

act of professional misconduct rendering the pharmacist liable for disciplinary action2. This does not seem appropriate for other clinical pharmacists. We are told by our state council office bearers to make a choice and work in India or a different country. Are all our office bearers at every level in the councils, pharmacists, or aware of the potential of clinical pharmacy practice? Though efficiency percolates through levels, are we not driving out some very good responsible pharmacists from our country while trying to control others in community?

Guidelines from the PCI to be used by state pharmacy council for issuing certificates of good standing to pharmacy graduates also state that the institute for which such a certificate is issued should be approved by PCI u/s 12 of Pharmacy Act, 194810. If so approved, then why does the pharmacy council in India not realise the worth of these pharmacists who are able and competitive enough to be registered in more than one country and support this? Support and of even a small percentage of the vast number of

these pharmacists towards developments in academia and practice can be significant.

From the council and inspection point of view these ‘regulations’ may likely be to control use of ones registration to make additional earning while pharmacists are away. This ‘socalled’ drive to control misuse of pharmacists’ registration certificates is overruled by suggestions of state pharmacy councils to display photocopies as an interim arrangement if in India and working. Pharmacy council needs to realise that it is unlikely that every pharmacist who has applied for good standing is going to immigrate. The ones who do are also unlikely to do so the very same day.

It would be more appropriate to check if the pharmacist requesting such a good standing certificate is responsible for a community pharmacy and if not, the area of practice. This will lead to better applicability of the diverse specialties and services that pharmacists’ can render. Incorporating a supplementary document or a sentence in the existing certificates being dis-

MANSI SHAH, Clinical Pharmacist

played at workplaces may present a clear picture of professional standing. This should indicate the said pharmacist (name) has taken a good standing certificate for the said (name, state, country) regulatory and/or licensing authority. It should clarify that the Pharmacy Council of India or the said (name) state pharmacy council is not responsible for registration or removal from register of that council. The PCI should be informed in case of entry in to and removal from any other pharmacy council. Pharmacist with license in a country other than India is also not allowed to own a pharmacy or work in community pharmacy as primary or sole pharmacist.

Pharmacists working in clinics and hospitals cannot perform clinical duties and endorse when not present. These clinical pharmacists and clinical pharmacy teacher-practitioners are at the forefront of development and delivery of pharmaceutical care in the country.

And this should be a global drive and our council should support global practice and experience to teacher practitioners and clinical pharmacists working independently in hospitals and clinics. As healthcare professionals providing clinical services, the Pharmacy Council should amend these regulations in view of other professional councils, e.g., Medical Council of India only requires an attested copy of the permanent registration certificate11.

Our state pharmacy councils are efficient enough and maintain enough paperwork for the ‘n’ number of pharmacists in our country. A statement approved by the PCI and required to be included in the registration

certificate in brief with details on the reverse would prove as simple as the name change procedure for pharmacists. This will not only avoid use of photocopies, it will keep state councils informed and PCI and pharmacists and the public aware of pharmacists competence and experience as relevant. It will give PCI and state councils a strong backing to support and promote responsibility and professionalism for pharmacists. In turn with this the council would be aware of pharmacists with their original registration in India and either practicing in India or elsewhere. Needless to add, the PCI can take advantage of this to help enhance their moto of ‘making better provision for the regulation of the profession and practice of pharmacy’3.

Registration authorities in other countries like the UK permit a registered pharmacist to maintain registration in the UK in addition to other countries if they continue to be competent and maintain CPD and their appraisal fulfills requirements to remain on the practicing register12. Need we have one single register for every pharmacist?

With the varied pharmacy programmes acceptable for registration, it would be more appropriate to have different registers for diploma, bachelor of pharmacy degree and other degrees, and for overseas pharmacist, dual registration pharmacists. Assessment and appraisal of pharmacists towards registration and renewals is an important aspect to be discussed separately. At the same time, it is incorrect to assume that learning is only in other countries but so is it to believe that we can have it all in India. Wider experience and focused learning will further enhance our competence and skills, support better teaching-learning, research and improve our practice and patient care. In this time of global healthcare management and globalisation, such a move for a healthcare professional in clinical role seems an inappropriate call.

References 1. The Pharmacy Act, 1948 (http://www.ipapharma.org/pdf/Pharmacy_act_1948.pdf) The Pharmacy Act, 1948 is meant to regulate the profession of Pharmacy in India. Accessed via: The Indian Pharmaceutical Association website under Regulations and Guidelines http://www.ipapharma.org/Regulations.aspx (accessed 02.12.2015) 2. Gazette of India. Pharmacy Council of India (2015) Pharmacy Practice Regulations, 2015. Accessed via: http://www.pci.nic.in/Circulars/Phar-

macy%20Practice%20Regulations.pdf (accessed 02.12.2015) 3. Pharmacy Council of India (2015) Accessed via: http://www.pci.nic.in (accessed 20.04.2015) 4. Pharmacy Council of India. Accessed via: Notification of Pharm D Regulations framed under section 10 of the Pharmacy Act, 1948. Accessed via: http://www.pci.nic.in/PDF-Files/14126circular.pdf (accessed 02.12.2015) 5. Pharmacy Council of India. Accessed via: Guidelines for Pharm D Internship.

Accessed via: http://www.pci.nic.in/PDFFiles/Guideline%20for%20Pharm.D.P DF (accessed 02.12.2015) 6. Pharm.D. Regulations 2008. Published in The Gazette of India, No.19, PART III, SECTION 4] Ministry of Health and Family Welfare (Pharmacy Council of India) May 10, 2008. Accessed via: http://pci.nic.in/PDFFiles/PharmD-Revised-A.pdf (accessed 02.12.2015) 7. Pharmacy Council of India. Policy Circulars: Accessed via: http://www.pci.nic.in/PolicyCirculars/Circulars.aspx. Guideline for issue of Good Standing Certificates to Pharmacy Graduates by State Pharmacy Council (22/09/2011). Accessed via: http://www.pci.nic.in/Circulars/1210%20&%20app-v.pdf (accessed 21.04.2015) 8. Gujarat State Pharmacy Council (2015) Procedure for acquiring good standing certificate. Accessed via: http://www.gujaratstatepharmacycouncil.org/goodStanding.htm (accessed 20.04.2015) 9. Maharashtra State Pharmacy Council (2015) How to obtain letter of good standing for a foreign country. Accessed via: http://www.mspcindia.org/ Forms/GoodStanding.aspx# (accessed 05.05.2015) 10. Pharmacy Council of India. Policy Circulars (2011) Guidelines for issue of Good Standing Certificates to Pharmacy Graduates by State Pharmacy Council: To All State Pharmacy Councils / Registration Tribunals. Accessed via: http://www.pci.nic.in/Circulars/1210%20&%20app-v.pdf (accessed 21.04.2015) 11. Medical Council of India (2015) Application form for obtaining a certificate of good standing. Accessed via: http://www.mciindia.org/helpdesk/do wnload/Certificate_of_Good_Standings.pdf (accessed 01.05.2015) 12. General Pharmaceutical Council (GPhC) (2015) Accessed via: https://www.pharmacyregulation.org/r egistration/working-abroad (accessed 15.04.2015)

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RESEARCH RESEARCH UPADATES

Pfizer’s Xeljanz meets goals in ulcerative colitis trials A similar proportion of patients in the tofacitinib and placebo groups reported serious adverse side effects, the company said

P

fizer said its Xeljanz rheumatoid arthritis drug succeeded in meeting primary and secondary goals of a pair of late stage clinical trials in ulcerative colitis, results that could help pave the way for an additional approval for the oral medicine. The largest US drugmaker said results of the two studies and data from two others will be used in its application to regulators seeking approval in ulcerative colitis (UC) for Xeljanz, known chemically as tofacitinib.

In the two Phase III studies, presented at a European medical meeting, Xeljanz reduced symptoms of moderate to se-

vere UC and induced disease remission at significantly

higher rates compared with a placebo. In one study, 18.5 per

cent of patients who received 10 milligrams of Xeljanz twice a day achieved remission, including no rectal bleeding, after eight weeks versus 8.2 per cent of patients who received a placebo. In another study, 16.6 per cent of Xeljanz patients achieved remission compared with 3.6 per cent for placebo, researchers reported. A significantly higher number of Xeljanz patients also experienced mucosal healing, a secondary goal of the trials.

A similar proportion of patients in the tofacitinib and placebo groups reported serious adverse side effects, the company said. "Ulcerative colitis can be a difficult disease to

manage, as many patients fail or become intolerant to conventional therapies," Dr Geert D’Haens, a study investigator, said in a statement, adding that improvement in symptoms was observed as early as week two.

The trials included patients who had been previously treated with commonly used injectable biotech drugs as well as those who were not. UC is a chronic, often debilitating inflammatory bowel disease that affects millions of people worldwide. Its symptoms can include abdominal pain, fever, weight loss and chronic, bloody diarrhea.

Reuters

J&J psoriasis drug Stelara eases Crohn’s disease in second trial The drug blocks two inflammation-causing proteins called IL-12 and IL-23 JOHNSON & Johnson's Stelara psoriasis drug has shown effectiveness against Crohn's disease in a second late-stage trial, the company said, bolstering prospects of its approval for the additional use.

The phase III study showed Stelara induced remissions in moderate to severe Crohn's disease patients who had previously failed to benefit from TNF inhibitors, a leading class of medicines for the inflammatory bowel disease. Those treatments include J&J's own Remicade and AbbVie’s Humira.

26 EXPRESS PHARMA April 1-15, 2016

J&J presented the favorable data at the 11th Congress of the European Crohn's and Colitis Organization in Amsterdam. In October, the company said Stelara was significantly more effective than placebo in another study of patients with moderate to severe Crohn's symptoms. Stelara is now awaiting US approval as a treatment for the condition, based on results of that earlier trial.

The drug, which works by blocking two inflammationcausing proteins called IL-12 and IL-23, is one of J&J's

The drug is approved in the US for adults with moderate to severe psoriasis

biggest, with sales last year of almost $2.5 billion. It is approved in the US for adults with moderate to severe psoriasis, an inflammatory skin condition caused by an overactive immune system.

Crohn's is a chronic inflammatory condition in the gastrointestinal tract, causing abdominal pain, diarrhoea, weight loss and fever. It affects about 700,000 Americans and nearly 250,000 Europeans, J&J said. Patients in the 741patient study received either of two intravenous doses of Stelara, or of a placebo. After six

weeks, 34 per cent of patients receiving either Stelara dose achieved a target reduction in Crohn's symptoms, compared with 22 per cent of those taking a placebo.

Similar incidence of side effects and infections were seen in the Stelara and placebo patient groups, J&J said. Researchers at the meeting said other studies were under way to show whether Stelara can maintain control of Crohn’s symptoms over extended periods.

Reuters

US FDA rejects Cat stem cell trial could lead to human treatments Eagle Pharma’s There are plans for human trials using stem cell therapy to treat inflammatory mouth disease as early as next year at UC Davis THE PAST five years of Smokey's life have been unbearable. Her owner recalls when her once playful and curious kitty's behavior changed. "It was the summer of 2011. I noticed that she started hiding and that she wasn't as social and then I noticed that her mouth was giving her problems," said Gail Salisbury.

A trip to the vet confirmed that Smokey had feline chronic gingivostomatitis or FCGS, a painful inflammatory mouth disease. "Chronic stomatitis is a common disease in the cat. It is very debilitating. Those cats are in great pain and it is a very enigmatic disease because no one has been able to reproduce it in experimental cats," said Dr Frank Verstraete, a professor of dentistry and oral surgery at the University of California, Davis.

Without being able to reproduce the disease, researchers have no idea what causes it or how to effectively treat it. Cats with FCGS usually have all their teeth removed, clearing up the inflammation in some but not all cases.

Smokey wasn't lucky. Her teeth were extracted but the disease persisted. That's when she

blood thinner

The regulator requested for additional information, the drugmaker said THE US Food and Drug Administration (US FDA) rejected Eagle Pharmaceuticals' drug to prevent blood clots in certain patients undergoing heart surgery. The drug, Kan-

was enrolled in a clinical trial.

Researchers used stem cells derived from their feline patients with the hope of reducing inflammation and promoting tissue regeneration. "I would say that most of our cats, if I have to give a number 60 to 70 per cent have responded favorably to the treatment either by complete resolution or substantial clinical improvement without complete resolution at six months," said Arzi. A higher percentage of cats showed signs of recovery after six months, as was the case with Smokey, who began responding to the treatment more than a year after she was injected with stem cells.

The researchers say these trials are shedding light on these

types of inflammatory diseases - and that could potentially have significant implications for humans. "There are two other species that can get chronic inflammation of the mouth. The first one is the dog and obviously we would like at treatment for dogs as well, but even more importantly humans also get inflammation of their oral cavity," said Verstraete. There are plans for human trials using stem cell therapy to treat inflammatory mouth disease as early as next year at UC Davis. As for Smokey, she's cured, but is in need of a diet. Her owner doesn't think so. "She has been through enough, whatever she wants she can have."

Reuters

blood clots in patients undergoing percutaneous coronary intervention (PCI) or angioplasty, a procedure to widen narrowed or obstructed arteries in the heart. Heart disease

Angiomax must be reconstituted with water and then further diluted before it can be administered gio, is a ready-to-use version of The Medicines Co's blood clot preventer Angiomax, which is also to be taken with aspirin.

Kangio contains the same active ingredient as Angiomax, but eliminates the need for dilution. Angiomax must be reconstituted with water and then further diluted before it can be administered.

The regulator did not approve the marketing application for Kangio in its present form and requested additional information, the drugmaker said. Angiomax was approved in the year 2000 to prevent

is the leading cause of deaths in the US, accounting for one in every seven, according to the American Heart Association.

The Medicines Co has been struggling since it lost patent protection for its flagship drug, which led the company to review strategic options including a potential sale of the entire company. Eagle Pharma said it would work directly with the FDA to determine a path forward to address the health regulator's comments.

Reuters

Cholesterol pill boosts cancer immunotherapy, at least in mice Two new drugs from Bristol-Myers Squibb and Merck, Opdivo and Keytruda, help the body’s immune system fight tumours TWEAKING cholesterol levels with a simple pill may boost the effectiveness of new immunotherapy drugs that are starting to revolutionise the treatment of cancers, experiments in mice suggest.

Two new drugs from BristolMyers Squibb and Merck, Op-

divo and Keytruda, help the body’s immune system fight tumours and are already being used to fight lung cancer, kidney cancer and melanoma.

But such so-called checkpoint inhibitors, which are also being developed by Roche, AstraZeneca and Pfizer, do not

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work for all patients, prompting scientists to search for improvements. One option could be to modify cholesterol levels, since this can increase the anti-cancer activity of immune cells known as killer T cells, Chenqi Xu of the Chinese Academy of Sciences and colleagues reported in the

journal Nature.

In particular, they found that adding the drug avasimibe to checkpoint drugs that block a protein called Programmed Death receptor (PD-1) improved tumor inhibition and increased survival in mice.

Avasimibe was originally de-

veloped by Pfizer, which at one stage saw it as a potential contender to succeed its blockbuster cholesterol fighter Lipitor. But it was dropped from development after failing to treat cardiovascular disease as well as hoped.

Reuters

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RESEARCH

Germany’s Bayer wins US FDA approval for haemophilia Atherapy The therapy, Kovaltry, is designed to reduce bleeding in patients with haemophilia A when infused prophylactically two or three times per week THE US Food and Drug Administration approved Bayer’s therapy for the most common form haemophilia, the company said, about three weeks after the treatment was cleared for use in Europe.

The therapy, Kovaltry, is designed to reduce bleeding in patients with haemophilia A when infused prophylactically two or three times per week, and was approved by the European Commission recently. Due to a fault in a gene that regulates the body’s clotting mechanism, people with haemophilia are susceptible to spontaneous bleeding as well as severe bleeding following injuries or surgery.

Hemophilia has no cure. Pa-

tients typically require frequent injections of blood clotting proteins that can cost up to $300,000 a year for a single patient. A Bayer spokeswoman said the company could not specify a price for Kovaltry but added that it had already captured the second-largest share of the haemophilia A market in the US. The German drugmaker's established hemophilia A therapy, Kogenate, brought in global sales of about $1.30 billion last year.

Kovaltry will enter a crowded market. Existing products with varying dosing schedules include those from Baxalta , which is being acquired by Shire, Pfizer, Biogen and Novo

Nordisk A/S. But more convenient therapies, perhaps once-monthly regimens, from Roche Holding and Alnylam Pharmaceuticals Inc could reach the market as early as 2017, Morningstar analysts wrote in a note last month.

Since the faulty gene is carried on the X chromosome, haemophilia is almost entirely a disease of men, and affects about 20,000 Americans. Bayer estimates there are currently about 16,000 people living with hemophilia A in the US. "We have found that many haemophilia A patients are comfortable with their existing treatment, but there are always early adopters interested in new

therapies," said Olubunmi Afonja, Bayer's director of medical affairs for hematology.

About 75 per cent of the estimated 400,000 hemophiliacs around the world still receive inadequate treatment or have no access to therapy, according to the US-based National Hemophilia Foundation. Bayer, among others, is also exploring the use of gene therapy in hemophilia, which aims to achieve a cure by fixing the gene responsible for the largely inherited disorder.

The company has tied up with US biotech firm Dimension Therapeutics to develop such a therapy for hemophilia A. Reuters

Scientists develop new human stem cells with half a genome Derived from a female egg, the stem cells are the first human cells known to be capable of cell division with just one copy of the parent cell’s genome SCIENTISTS FOR the first time have generated a type of embryonic stem cell that carries a single copy of the human genome rather than the usual two, a development that could advance research in gene editing, genetic screening and regenerative medicine. Derived from a female egg, the stem cells are the first human cells known to be capable of cell division with just one copy of the parent cell's genome, according to a study appearing in the journal Nature.

The breakthrough is expected to reduce the complexity of identifying genetic abnormalities, which in turn could advance understanding

28 EXPRESS PHARMA April 1-15, 2016

of many diseases, researchers said. Human cells are considered diploid because they inherit two sets of chromosomes, 23 from the mother and 23 from the father. Reproductive egg and sperm cells are known as haploid because they contain a single set of chromosomes. They cannot divide to make more eggs and sperm.

"What is fundamentally new is we have cells that can divide and renew with a single genome. That is just unprecedented," said Dieter Egli of Columbia University Medical Center in New York, co-author of the study with Dr Nissim Benvenisty of The Hebrew University of Jerusalem.

The breakthrough is expected to reduce the complexity of identifying genetic abnormalities, which in turn could advance understanding of many diseases

The researchers, including scientists from The New York Stem Cell Foundation Research Institute, found the haploid stem cells capable of differentiating into many

other cell types, such as nerve, heart, and pancreatic cells, while retaining a single set of chromosomes. Sequencing of the human genome has yielded a wealth of new infor-

mation about myriad genetic variations and how they interact with each other. But isolating and understanding specific gene abnormalities is challenging with diploid cells because they typically have a copy that is normal and serves as a backup.

A next logical step in the research, Egli said, is to modify these haploid stem cells either to introduce new disease variances or correct those that are already there. "That should give us a way to better understand those many, many variances that are being identified in genome sequencing efforts that we think have something to do with disease."

Reuters

RESEARCH

US made dengue vaccine 100 per cent effective in small study

Gum disease may signal faster Alzheimer’s decline

Scientists expressed optimism that the approach they used for the dengue vaccine could work in creating a vaccine against the Zika virus

Gum disease may cause chronic low-grade inflammation in the rest of the body, and inflammation is associated with changes in the brain

A DENGUE vaccine developed

by US National Institutes of Health scientists protected everyone given the shot against the virus in a promising small study published, with the researchers saying it could become widely available by 2018.

The scientists also expressed optimism that the approach they used for the dengue vaccine could work in creating a vaccine against the Zika virus, which is in the same viral family and spread by the same mosquito species. Zika, linked to numerous cases of the birth defect microcephaly in Brazil, is spreading rapidly in Latin America and the Caribbean.

Researchers administered the single-dose vaccine, called TV003, to a group of volunteers and six months later exposed them to dengue-2, one of the four different strains of the virus. All 21 people given the vaccine were protected from infection. All 20 people given a placebo injection developed dengue infection after being exposed to the virus. Everyone in the placebo group had the virus in their blood, 80 per cent developed a rash and 20 per cent exhibited low white blood cell counts.

The results were very promising and inspired "great confidence" that the vaccine will protect people in areas where dengue is endemic, said vaccine researcher Dr Anna Durbin of the Johns Hopkins Bloomberg School of Public Health in Baltimore. Dengue, found in the world's tropical and subtropical regions, infects nearly 400 million people in more than 120 countries annually. Most survive with few or no symptoms,

FOR PEOPLE with Alzheimer’s disease, having gum disease is tied to faster cognitive decline, according to a new study.

“What we have shown is that regardless of the severity of dementia (within this mild to moderate impaired group) that patients with more severe gum disease are declining more rapidly,” said senior author Clive Holmes of the University of Southampton in the UK. In other studies, Holmes and his coauthors have found that conditions such as chest infections, urinary tract infections, rheumatoid arthritis and diabetes are associated with faster disease progression in Alzheimer’s, he said. “We hadn’t previously looked at gum disease because MDs tend to leave this in the hands of dentists but it is an important common low grade chronic infection,” Holmes told.

The researchers observed 60 people with mild to moderate Alzheimer’s disease living at home for six months.

The participants did not smoke, had not been treated for gum disease within the previous six months, and had at least 10 teeth. At the start, each participant completed a cognitive assessment, gave a blood sample, was examined by a dental hygienist and their main caregiver was interviewed to provide a medical and dental history. The same tests and interviews were repeated six months later.

Of the 60 people in the study, 22 had moderate to se-

but more than two million people annually develop dengue hemorrhagic fever, which kills more than 25,000 people each year. "Control of dengue has certainly been a public health priority for many years, but getting there hasn't really been very easy," said virologist Stephen Whitehead of the NIH's National Institute of Allergy and Infectious Diseases, who spearheaded development of the vaccine.

The vaccine was made from a mixture of four live, weakened viruses targeted to each of the four different strains. The volunteers were exposed to a genetically modified version of dengue-2 virus isolated in Tonga in 1974 that was known for causing only mild illness.

Based in part on this study, in February Brazil's Butantan Institute launched a large Phase III clinical trial to confirm the effectiveness of the vaccine against naturally occurring dengue, with 17,000 people due to take part, Durbin said.

Another trial in Bangladesh is scheduled to begin in the next couple of months, Durbin added. If the trial in Brazil goes well, Butantan Institute could have the vaccine widely available by 2018, Durbin said. One

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dengue vaccine is currently licensed, Sanofi’s Dengvaxia, with Mexico in December becoming the first country to give it approval. But the three-dose vaccine was approved only for use in a limited population, people ages nine to 45 who live in areas where the disease is endemic, meaning younger children and tourists could not get it, and questions remain about its effectiveness.

Whitehead said Merck and Co has exclusive rights to the new vaccine in the US, Canada, China, Japan and the EU and can export it to any country except Brazil, where the Butantan Institute has exclusive rights.

Two Indian companies, Serum Institute of India and Panacea Biotec, have non-exclusive rights to develop the vaccine for India and for export to other countries except where Merck and Butantan have exclusive rights, Whitehead said. A Vietnamese company, Vabiotech, has a non-exclusive license to produce it locally in Vietnam and for export to other nations except where Merck and Butantan have exclusive rights, he added. The research was published in the journal Science Translational Medicine.

Reuters

vere gum disease at the beginning of the study. By six months later, one participant had died, three had withdrawn from the study and three were lost to follow-up.

Cognitive score declined more for those who had periodontitis to begin with than for those who did not, as reported in PLoS One. According to one theory, cognitive impairment leads to adverse oral health due to inattention to routine oral hygiene and care, said Dr James M Noble of the Taub Institute for Research on Alzheimer’s Disease and the Aging Brain at Columbia University Medical Center in New York City, who was not part of the new study.

Gum disease may cause chronic low-grade inflammation in the rest of the body, and inflammation is associated with changes in the brain, he said.

“It is known that gum disease is associated with increased markers of inflammation,” Holmes said.

But the new study indicates a connection between gum disease and cognitive decline, not necessarily that one causes the other, he said.

Further studies need to assess whether treating the gum disease would also slow cognitive decline. “Periodontitis has been associated with heart disease and stroke among other conditions,” Noble said. Based on this and other studies, “it seems to be good advice to brush and floss,” Noble said Reuters

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April 1-15, 2016

PHARMA ALLY I N T E R V I E W

'Both India and Europe can learn quite a lot from each other based on very long herbal medicinal traditions' Dr Rainer Kunz, Area Sales Manager, Europe and Middle East, Finzelberg, talks about key features of company's plant extracts in a discussion with Sachin Jagdale

Which diseases are targeted by your extracts?

Practically all kind of indications are covered by Finzelberg extracts. In focus are cough and cold, digestion, veins, urology, sexuality, CNS (stress, mood, sleep).

Explain the technologies employed to get these extracts.

The following technologies are employed. They are classical technologies like maceration ('tea – like' extraction), percolation ('coffee – like' extraction) and more modern techniques like counter current extraction, liquidliquid extraction or adsorption techniques.

Do you use any ayurvedic plants for extraction? If not, are you planning to do so?

We see candidates from the ayurvedic area for extraction definitively, taking into account the very long Indian tradition on herbals. Our aim is to combine the benefits of the two leading herbal traditions both from India and Europe.

We offer standardised high quality extracts which go with an excellent documentation

Where do you export these extracts globally?

We export to all continents.

What is your global share in

30 EXPRESS PHARMA April 1-15, 2016

the plant extract market?

Difficult to say. We estimate it to be around 20 per cent.

What are the benefits offered by these extracts?

We offer standardised high quality extracts which go with an excellent documentation, guaranteeing our business partners a maximum of purity and safety (and trustability).

What kind of regulatory support do you provide to your clients?

As a standard, we can offer a basic documentation. It covers the specification of the extract and the method used to standardise the extract.

Furthermore, we offer to our customers all-inclusive packages. They include the core documentation for the registration process as a herbal medicinal product (e.g.

3.2.S - part characterising the API and 3.2.P part characterising the part of the finished product in its galenic application, without any question in common CTDformat). On request, we can compile any documentation our clients are asking for.

What makes India the ideal market for you?

India has a very long tradition on herbals. Consequently, we

are expecting a high understanding in the population for our concepts in herbal medicines.

India has more than 5000year-old tradition of ayurvedic medicines. Does it pose a challenge for you?

In fact this poses a high challenge for us, but in a very positive way. We are convinced that both India and Europe can learn quite a lot from each other based on the very long herbal medicinal traditions.

Both the long experience in science and usage of herbals but as well the technical know how could be shared. In total, we are convinced that there will be a lot of synergetic effects.

It has to be noted that last year our company celebrated th its 140 anniversary. Since then we have been producing plant extracts to the pharmaceutical and health industry.

What targets have been set by you for the Indian market for the next five years?

Our target is to attain the number one position of the non -Indian suppliers of herbal ingredients for the production of health products in India. sachin.jagdale@expressindia.com

I N T E R V I E W

‘The Tesla platform includes comprehensive system management tools’ Vishal Dhupar, Managing Director, South Asia, NVIDIA Graphics and Dr Shyam Diwakar, Assistant Professor and Lab Director, Computational Neuroscience and Neurophysiology Labs, Amrita University, explain the benefits offered by NVIDIA Tesla Accelerated Computing Platform to Sachin Jagdale

What are the features of Accelerated Computing Platform?

Vishal Dhupar (VD): The NVIDIA Tesla Accelerated Computing Platform is the leading platform for accelerating big data analytics and scientific computing. The platform combines the world’s fastest Graphics Processing Unit (GPU) accelerators, the widely used CUDA parallel computing model, and a comprehensive ecosystem of software developers, software vendors, and data centre system OEMs to accelerate discovery and insight.

The Tesla platform includes comprehensive system management tools to simplify GPU administration, monitor health and other metrics, and improve resource utilisation and efficiencies. Many of the HPC industry’s most popular and powerful cluster and infrastructure management tools use NVIDIA system management APIs to support GPUs, including IBM Platform HPC.

Does NVIDIA Tesla provide training support to handle Accelerated Computing Platform? If yes, explain in detail.

VD: Yes, we offer training in two key programming languages - CUDA and OpenACC. Do you have any tie ups

The Tesla platform includes system management tools to simplify GPU administration, monitor health and other metrics

students are now interested in these coding strategies to develop their own programming case studies on such technologies

VISHAL DHUPAR, Managing Director, South Asia, NVIDIA Graphics

DR SHYAM DIWAKAR, Assistant Professor and Lab Director, Computational Neuroscience and Neurophysiology Labs, Amrita University

with hospitals? Elaborate more on the same.

VD: No. But we have a tie-up with research organisations in the world including India.

We also have tie-ups with over major institutions, including IIT Bombay and

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Amrita University.

What is the implementation cost of Accelerated Computing Platform?

VD: It varies on the number of nodes in a cluster and the

type of applications deployed.

What are the key transormations that NVIDIA has brought to laboratory operations?

Dr Shyam Diwakar (SD):

With GPUs, we are able to simulate millions of neurons and how they interact with several millions of synaptic connections when they compute what could be a sensory or motor signal in the brain circuits. We were also able to simulate what happens to these circuits when certain drugs were used to modify or remedy certain behavioural conditions.

Ordinary CPUs could be used for detailed simulations but in case of very large scale simulations of how neurons interact to perform functions, we are finding that GPUs make it more effective time-wise. With GPUs, most of the tools had to be created from scratch because the scale at which these experiments are performed is so unusual. We also guess this set of codes will be released as a library for anyone to simulate brain circuits and their properties under therapeutic or pharmacological conditions.

Besides, students are now interested in these coding strategies to develop their own programming case studies on such technologies.

Amrita School of Biotechnology has been teaching GPU programming to its bioinformatics students, functioning also as a GPU teaching and research centre. We also established our GPU supercomputer allowing students and faculty

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April 1-15, 2016

PHARMA ALLY members to solve large mathematical models in lesser time.

Which key discoveries/ achievements have been made using this technology at your lab?

SD: In our research based at Amrita School of Biotechnology’s Computational Neuroscience Lab, we used simple models of neurons to build largescale models of neural circuits. Such circuits are built by taking experimental data from slices of living brain tissue or directly recording from a human subject or an animal that is alive and anaesthetised and studying its responses to certain inputs like touch, grasp etc. Developing a GPU-based model allowed for more complex algorithms and sophisticated network simulations at much faster computational speeds. GPUs are composed of thousands of connected cores, each is capable of performing a

Amrita University has been instrumental in translating societally relevant problems from labs to villages, be it in modelling neurological disorders, predicting landslides in Western Ghats at our deployment locations, glaciers in Himalayas, smart agriculture etc significant amount of computation. So, in a way, GPUs resemble neural networks inside our brains, processing information in parallel. We implement both models of brain circuits in normal condition and how they dysfunction during diseased states. By allowing reconstructions, such modelling allows predictions of disease and normal function and on paradigms to treat them. We published some parts of the work defining how circuit functions and how disease models explain dysfunction

in several conferences and book chapters. Some of our major studies are also being prepared, given that our models have been in development less than three years ago.

What is your prediction regarding the future of accelerated computing platform in India?

SD: Amrita University has been instrumental in translating societally relevant problems from labs to villages, be it in modelling neurological disorders, predicting landslides in

Western Ghats at our deployment locations, glaciers in Himalayas, smart agriculture and technologyenhanced organic farming, novel biomedical devices for diabetes, voice synthesisers, most problems require crunching big data or running large sets of differential equations.

Advanced computing in its varieties and a national supercomputing machinery will essentially drive robotics, weather predictions, models of monsoon changes, farming patterns, crime analysis,

news popularity listings, social media diffusions, drug design, bioanalytical designs and testing, pharmaceutical product development, medical decision making, cryptology and cyberphysical interactions and a lot more. Today’s GPUs allow large scale parallel processing. Together with newer and advanced computing architectures, parallelisation will be seen as crucial from food processing, hospital networks, computer games to banking, planning, rehabilitation and even inventory processing in major funeral service industry. While academia will look into hybrid solutions combining supercomputing on a PC to large-scale petaflop clusters, joint industry-academia sectors may introduce changing trends with cloud computing and pervasive ubiquitous computing platforms. sachin.jagdale@expressindia.com

POST EVENT

Signet-Meggle’s seminar on DPI held in Mumbai The seminar provided in-depth information on DPI technology using properties of lactose powder SIGNET, DISTRIBUTOR of excipients to the Indian pharmaceutical industry along with Meggle, a leading producer of pharma lactose recently organised a one-day seminar on Dry Powder Inhalation (DPI) in Mumbai.

The seminar was held in association with Capsugel, Harro Hofliger, Team Consulting, Vamsi Labs, Aptar Pharma, Sympatec, Amcor Flexibles.

The scope of the seminar was to provide in-depth information on the DPI technology using the properties of lactose powder. Several topics were discussed like the role of Lactose in DPI; filling technologies; capsules for DPI; dispersion, de-agglomeration and

32 EXPRESS PHARMA April 1-15, 2016

nities.

The seminar was addressed by key speakers including Dr Mirjam Dogru, Project Manager Analytics, R&D BG excipients and technology, Meggle; Marco Laackmann-Business Unit Leader Inhalation, Harro Höfliger; Dr Karlheinz Seyfang-Principal Consultant (pharmaceutical technology), Harro Höfliger; Dr Sven Stegemann- Director of Pharmaceutical Business Development, Capsugel; David Harris- Head of Respiratory Drug Delivery, Team Consulting; Dr Ravindra Purohit-Director technical, Vamsi Labs. aerolisation – a particle’s perspective; development of lac-

tose-based DPI formulations: blending-filling-performance;

dry powder inhalers – regulatory challenges and opportu-

EP News Bureau-Mumbai

PHARMA ALLY INSIGHT

Selecting stoppers for moisture sensitive drug products

HEIKE KOFLER, Manager, Technical Customer Support EU, West Pharmaceutical Services

Heike Kofler, Manager, Technical Customer Support EU, West Pharmaceutical Services, elaborates on why pharma companies are increasingly turning to lyophilising in order to preserve the characteristics of a potentially unstable drug Glass has very low moisture vapour transmission rates, so when selecting a primary container for a moisture sensitive injectable drug product, glass vials are often used. However, to ensure optimised storage and moisture protection for an injectable drug product, pharmaceutical manufacturers should be aware of the design and feature options when selecting a stopper for the system, and consider the rubber formulation as well as its processing.

This becomes increasingly critical when lyophilising (freeze-drying). Pharma companies are increasingly turning to this process because it preserves the characteristics of a potentially unstable drug while enhancing product stability in a dry state, which enables rapid and easy dissolution of a reconstituted product as well as ease of processingi.

Lyophilisation is considered an ideal process for injectable drug products that may have limited shelf lives or sensitivities to exterior influences.

Some drug formulations are unstable in aqueous solutions; the molecules can interact and degrade quickly in water, so moisture sensitive drugs are often lyophilised not only to protect them from outside elements, but also to protect them from their own eventual decayii.

But there are drawbacks.

Maintaining stability of the lyophilised drug product during its shelf-life can be difficult for moisture-sensitive drug products, particularly if the elastomeric component selected for the primary contain-

ment system allows moisture vapour to migrate into the drug. Proper selection of the lyophilisation component and the rubber formulation can help to prevent risks and costs associated with degradation of the lyo cake, which can result in loss of drug product and patient confidence.

Lyophilisation closures: Igloo vs. Split models Igloo stoppers offer stable positioning in the freeze-drying phase due to their increased contact area with the glass vial orifice. They are also less flexible than split (or two-leg) designs. However, one drawback to this option is the asymmetric balance point. The stopper may get out of the vertical axis during application. This could lead to technical issues on the filling line, for example during camera inspection of the stopper as in-process-control or, in a worst-case scenario, by a closure displacement and the stopper falling off the vial.

The split design offers a more flexible option during stopper insertion, and its symmetric design keeps it horizontal during freeze-drying. However, the twinning effect, where the stopper legs could intertwine during processing, may cause issues during the filling line process, for example in the closure feeder bowl or on the transportation rails leading to the stopper insertion station.

Either option will work well for lyophilisation, as both offer a gate where water vapour can be released from the vial headspace during the freeze-drying process. Of greater concern to pharma manufacturers is that

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moisture can migrate through the rubber stopper itself during long-term storage of the freeze-dried drug product.

Therefore, selecting the right rubber formulation and processing steps for the lyophilisation closure are of utmost importance.

Rubber formulations to reduce moisture transmission in lyophilisation stoppers Moisture can reach a lyophilised drug product in a variety of ways. The simplest source of moisture ingress is a lack of seal integrity in the stopper-vial combination. If there is not a tight seal, moisture can travel easily into the vial and permeate into the freeze-dried drug product.

Residual moisture driven into the closure—mostly during steam sterilisation and not removed due to insufficient drying conditions—may affect the drug product, as the captured excess water vapour could be released from the rubber stopper into the vial headspace and permeate into the drug over time.

Water vapour also can migrate from the environment through the rubber stopper during long-term storage.

Every rubber formulation has a characteristic rate for water vapour to migrate through this material over time, called Moisture Vapour Transmission Rate (MVTR). This can be measured during development of a rubber formulation on a vulcanised rubber plate of specific thickness that is used as a permeation barrier in a humid chamber. The MVTR is ex-

pressed in [g/m2 x day], based on a 0.035 inch thick vulcanised test plate of a specific rubber formulation.

The negative impact of moisture on a drug product varies with the volume of a freeze-dried drug product and its contents. When moisture is driven into the elastomeric component during the washing and steam sterilisation processes, the rubber stopper acts like a sponge, taking in and releasing moisture. Each rubber formulation has its equilibrium moisture content under certain conditions, and the environment also influences the final moisture ingress into the vials. An environment with high humidity could affect the humidity in the headspace of the vial, which may influence the rate of moisture travelling time through the rubber closure during longterm storage.

Importance of reduced MVTR West Pharmaceutical Services, conducted a studyiii to determine whether various drying periods affected moisture uptake within the rubber component. In doing so, it was discovered that the MVTR was more important to long-term storage than initial dryness.

Residual moisture was studied on the content of a 100 mg lactose lyo cake and lyophilisation stoppers for a three-year period. Different rubber formulations were compared to each other and different drying periods for the closures after steam sterilisation were tested.

Seal integrity was tested on

all the vials using Helium-Leak detection. The results noted that moisture migrates from the environment into the stopper over time and that residual moisture in the stopper is dependent on its rubber formulation and applied drying time.

In fact, the drying conditions had an effect on the residual moisture content in the stoppers. It was noted that a onehour drying cycle is insufficient to remove the moisture driven into the stopper during the autoclave cycle. Drying for four hours returned the moisture content within the stopper back to the amount of moisture prior to steam sterilisation, but the best results were gained with an eight hour drying period at 105°C. The findings? Bromobutyl stoppers have more moisture from the start compared to a very dry butyl rubber, but they prevent moisture from reaching the lyophilised sample over time. In contrast, a very dry butyl type rubber formulation allows water vapour to travel through the elastomer more easily – so the moisture content measured after 36 months in the contained in these vialstopper systems was higher compared to the one in the bromobutyl sample. Elastomeric rubber formulations that have reduced moisture vapour transmission rates are better suited for keeping the drug product relatively dry after lyophilisation.

Residual moisture in elastomeric stoppers can cause degradation of lyophilised drug product. If the drying conditions for the stopper are not optimised, residual moisture

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PHARMA ALLY can migrate into the lyophilised drug product over time. Best practices for the elastomeric components include optimised drying time after the steam sterilisation process, and consideration of a rubber formulation with a reduced MVTR.

Bottom-line findings After drying correctly, and before introduction to the filling line, packaging must also be considered. The use of a moisture barrier bag, rather than a steam sterilisable bag, will help to maintain the achieved and specified residual moisture in the stoppers after steam sterilisation and appropriate drying process. Moisture barrier bags will help to keep the stoppers dry prior to use.

In order to select the best primary container system for a lyophilised drug product, pharma manufacturers must consider closures carefully.

The design should be selected to ensure dimensional fit of the

cle could not have been written.

Residual moisture in elastomeric stoppers can cause degradation of lyophilised drug product. If the drying conditions for the stopper are not optimised, residual moisture can migrate into the lyophilised drug product over time. Best practices for the elastomeric components include optimised drying time after the steam sterilisation process, and consideration of a rubber formulation with a reduced MVTR stopper to the vial, eliminating the possibility of a ‘misfit’ during the capping process, which would allow moisture to permeate through gaps between the vial and stopper. Rubber formulations with low MVTR should be selected to ensure optimised processing, and sufficient drying time should be allowed to help ensure that

long-term storage will not affect the drug product.

The final finding: There is no stopping the uptake of moisture over time, but with the right consideration given to the selection and preparation of the elastomeric components of a container closure system, lyophilised drug products will maintain stability with respect

to moisture sensitivity and related efficacy over the long journey to their use by the patient.

The author wishes to acknowledge that this article is based on a study conducted by Amy Miller and Jennifer Riter of West Pharmaceutical Services, without whose significant efforts this arti-

References i. U.S. Department of Health and Human Services, (2014).

Lyophilization of Parenteral (7/93) Guide to Inspection of Lyophilization of Parenterals. Retrieved from: http://www.fda.gov/ICECI / Inspections/InspectionGuides/uc m074909.htm ii. Mayberry, J. (2012). The New Scope of Pharmaceutical Lyophilization. Retrieved from: http://www.pharmpro.com/articles/2012/06/new-scope-pharmaceutical-lyophilization iii.H Kofler, et al. Evaluation of residual moisture in lyocakes and corresponding lyophilization stoppers of different rubber formulations. http://www.westpharma.com/en/support/Scientific%20Posters/Evaluation%20of%20residual%20mois ture%20in%20lyocakes%20and %20corresponding%20lyophiliz ation%20stoppers%20of%20different%20rubber%20formulations.pdf

PRODUCTS

Telstar to promote latest generation of SterilityTest Isolators at Interphex TELSTAR WILL promote the latest generation of Sterility Test Isolators integrated with the innovative ionised Hydrogen Peroxide (ionHP) bio-decontamination system at Interphex, to be held in New York from April 26-28, 2016.

The ionHP system is the latest leading-edge bio-decontamination technology for aseptic systems, developed to resolve some of the traditional difficulties associated with H2O2 bio-decontamination processes. Unlike conventional systems, the ionHP technology developed by Telstar increases the efficacy of the bio-decontamination process and reduces degradation of construction materials

34 EXPRESS PHARMA April 1-15, 2016

while using a very low concentration of H2O2. Reduced biodecontamination cycle times are possible since the process efficiency is not affected by temperature and humidity and therefore there is no need to pre-condition the chamber prior to H2O2 injection.

The ionHP bio-decontamination system incorporated in the new Telstar Pura will be promoted at Interphex. Telstar Pura is a range of two, three and four glove Sterility Test Isolators, with the option of a transfer chamber for batch or continuous sterility testing. It is designed to avoid the risk of false results and to protect the product from both the process and externally

generated factors that would compromise its quality. The Telstar Pura range is suitable for performing both Direct Inoculation and Filter Membrane sterility tests.

During Interphex, Telstar will also promote its latest innovations in the field of process equipment developed with lyophilisation, sterilisation and water and pure steam technologies, specifically directed at the pharmaceutical and biotechnological industry.

Contact details Palmira Cabañero Communications Dept.

Telstar E-mail: pcabanero@telstar.eu

PHARMA ALLY

Clean room high speed doors from Gandhi Automations BETTER QUALITY or better yield is the primary reason for investing in a cleanroom space.

It goes straight to the bottom line. Numerous manufacturing facilities now require a controlled environment in which the amount of dust and dirt is limited in the area of manufacturing. Medical instrument manufacturing and packaging, electronics and computer manufacturing, food preparation and some military applications are but a few of the instances that have strict requirements for maintaining a clean environment. Clean rooms have become integral part of pharma manufacturing facilities.

Gandhi Automations provides clean room high speed doors specifically designed for above purpose. The clean room high speed doors are best suited for facilities where there is a

columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with transparent PVC horizontal sections or vision windows ◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h Δ 50 PA . ◗ Control device enclosure in Stainless Steel SS 316

need for controlled environment.

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

High speed clean room doors designed by Gandhi automation are engineered carefully with the below mentioned features:

◗ Concept of low air permeability in pressurised rooms with positive and negative air pressure ◗ Designed to fit inside the

Contact details Corporate Office Gandhi Automations Chawda Commercial Centre, Link Road,Malad (West), Mumbai - 400064 +91-22-66720200 / 66720300 (200 lines)

TO ADVERTISE IN EXPRESS PHARMA, CONTACT:

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

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PHARMA ALLY VALUE ADD

Phenomenex India to celebrate its fifth anniversary Phenomenex India, located in Hyderabad, is proud to have been delighting customers in the local scientific community since 2011 PHENOMENEX India will mark the fifth year anniversary on April 26, 2016, an exciting milestone for the company, its employees, and customers worldwide.

Phenomenex, founded in 1982 and headquartered in the US, is a global technology leader committed to developing novel analytical chemistry solutions that solve the separation and purification challenges of researchers in pharmaceutical, industrial, clinical research, government and academic labs. With 850 employees in 16 companies around the world, three manufacturing sites located in the US, and a network of 60 distributors, the company is able to serve tens of thousands of customers in over 100 countries each year.

Phenomenex India, located in Hyderabad, is proud to have been delighting customers in the local scientific community since 2011. The office houses a specially trained team of technical specialists, operations and marketing support, and a warehouse that maintains high stock levels of thousands of products to allow for faster deliveries throughout India. In addition to a collection of award-winning products and technologies, 24/7 live assistance, hands-on training seminars, and a helpful technical support-based website, the team offers a refreshing and personalised customer experience unique to the industry. The office has achieved a 98 per cent customer satisfaction rate and shown record-breaking growth over the last five years, including a 14 per cent growth in 2015, doubling the industry average of 7.5 per cent.

“I am so proud of our team and all of the incredible successes they have earned through hard work and perseverance,” Fasha Mahjoor, President and CEO, Phenomenex remarks. “I am not surprised in the slightest, as the people who have been an

36 EXPRESS PHARMA April 1-15, 2016

integral part of the company since its beginning are outstanding leaders, team players, and the camaraderie in the office is palpable. This team has truly shown our customers what excellent technology, superior products and unparalleled service and support can be with fanatical attention to detail and a personalised approach to each customer need. The future of Phenomenex India is nothing short of brilliant.”

Having been there since the beginning, Kris Chu, Global Marketing Manager, Phenomenex remembers that when the office opened in 2011, “Our first priority was to provide our customers with world class technical support and excellent customer service.”

“With our team of highly educated chemists, biochemists and life scientists with advanced degrees (M.S. and Ph.D.), we were—and are—able to provide our customers with immediate onsite technical support and hands-on method development services for their most challenging applications,” she continued.

“With such positive feedback on the introduction of our training seminars and onsite demonstration seminars, Phenomenex has taken a step further by incorporating technology to deliver live and on-demand webinars for customers to learn more about HPLC/UHPLC, GC, and Sample Preparation method development and troubleshooting techniques.

"Being the industry leader in

chromatography, we want to continuously create resources for our customers so that we can help with their changing chromatography challenges.”

In addition to serving researchers with unlimited technical resources and support, Phenomenex India has been an industry game changer by introducing many new and innovative products to the market place since 2011. From their award winning patented Kinetex CoreShell HPLC/UHPLC columns for higher efficiency, improved resolution, and the ability to develop and transfer methods effortless between systems to a clever sample preparation product, Novum Simplified Liquid Extraction (SLE), a novel, patent pending synthetic alternative to traditional diatomaceous earth SLE (also known as supported liquid extraction) products that give customers a simplified approach to traditional liquid-liquid extraction (LLE). Additional technologies include Aeris CoreShell HPLC/UHPLC columns for bioseparations, SecurityGuard ULTRA to protect and extend UHPLC column lifetime, roQ QuEChERS Kits, Yarra Ultra-High Performance Size Exclusion columns, Zebron SemiVolatile and 5msPLUS GC columns, and Lux Amylose-1 chiral columns.

Not only has Phenomenex’s product line expanded; the India team has grown in leaps and bounds itself since 2011. Due to the vibrant culture, inspiring working environment, and

strong commitment to a corporate mission “to promote the well-being of those we serve – our customers, our employees, and humanity,” the office continues to have one of the lowest attrition rates in the industry. The majority of the original team members still remain passionate and energetic team members, infusing the same zeal and dedication they had five years ago into their work to this day.

“It has been an amazing experience to be part of this dynamic team within Phenomenex India,” says Brad Turek, Director of Sales and Marketing, Phenomenex. “The expectations for this office have always been extremely high, but the energy, determination, and ultimately success with which each and every individual exhibits has been inspiring. The transformation of our team into leaders of tomorrow is so motivating! The future for this office tomorrow and the next several years beyond is very bright to say the least. Thanks to everyone that supports us, each and every day—our customers, our support from headquarters, and beyond. We couldn’t do it without you, and we are extremely grateful.”

Perhaps one of the most intensely passionate endeavours of the Phenomenex India office over the past five years is their devotion to humanitarian causes. One such engagement is a commitment to the children at the Cheers Foundation, an orphanage in Hyderabad India.

The team serves the children

with hands-on, financial, and educational as well as emotional support—mentoring, teaching, and spending holidays celebrating with the children. Phenomenex also pays the tuition for each of the children to attend an excellent local private school and the children are all thriving.

Every team member is given paid time off each year for their own humanitarian projects, and encouraged to participate in company-sponsored events during the working days. One team member put it eloquently, “It is in the hearts of our employees here, but knowing that Phenomenex is supportive of this, and that we can use leave to do even more is really exciting,” From the individuals in the office who volunteer their time to hand out blankets and food to the entire office who gathers together to make the biggest impact possible with orphans, the environment, and other such passionate causes, everyone continues to work towards a better future for all.

As for the future Nick Mitchell, Managing Director, Phenomenex says, “It is really exciting to feel a new energy in India in 2016. With all this positive energy, we’d just like to say ‘thank you’ to all of our customers that support our company and our objectives. When we came to India in 2011, our goals were twofold; to increase our level of customer service and technical support, as well as to improve our product availability and reduce the lead time from our warehouse to our customer laboratories. I am pleased to have met so many customers over the past year that have echoed their appreciation of these accomplishments. You can rest assure, that with our culture of continuous improvement, we will not rest on our laurels, but look forward to even bigger and better improvements over the next five years. See you in 2020!”

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SPECIALIZED IN PLATINUM CURED SILICONE TUBES,BRAIDED HOSES & INFLATABLE SEALS/GASKETS 1st Indian Silicone Rubber Product Mfg. Co. certified with Clean Room of Class 10000 For high purity & intricate application of Vaccines & Injectables, most of the Pharma companies are insisting only AMIs Silicone Tubing & Braided Hoses, accredited by US FDA DMF No. 26201 with Extractable & Leachable Studies.

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FBD Inflatable Gaskets for Fluid Bed Dryer Silicone Tri Clover Gaskets, Rotary Rack Oven Gaskets Butterfly Valve Gaskets, Isolator Gaskets O-rings (Silicone, Viton, EPDM, Nitrile & Neoprene Silicone Solid Cords ( Round & Square type) Silicone Sponge Cords & Gaskets Silicone Extruded Door Gaskets “ON PRODUCT Silicone Diaphragms, Silicone Bellows LOT TRACEABILITY Silicone & Viton Sheets THROUGH PERMANENT Lypholization Door Gaskets LASER MARKING Silicone Endless Gaskets IS AVAILABLE Viton Cords & Tubes ON REQUEST Rubber Bellows & Expansion Joint Silicone sleeve for Corona Treater application Validation gaskets & Sensor TC “SMART” Gaskets

We’re Exhibiting April 26 - 28, 2016 Javits Center I New York City

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An ISO 9001:2008/14001:2004/18001:2007 & Clean Room Certified Co. DMF No. 26201 accredited by USFDA

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OSMOMETER 3250 Two great brands come together under Charles River to provide an even stronger testing solution for our customers.

Microbial Detection & Identification

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

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Milk Cryoscopes Available

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WANTED ASOUTH INDIAN PHARMACEUTICAL COMPANYhaving Marketing Network in South India,Maharashtraand parts of North India worth Rs 15 Crore is looking to sell its Registered and Non Registered Marketing BrandsApprox 100 Products.

Interested parties readyto invest more than 20 Crores Maysend their details to Email: medicalhub2016@gmail.com

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PHARMA LIFE AWARD

Indian companies bag award for adopting green manufacturing practices and deploying sustainability The highlight of the event was a panel discussion on the topic, 'Is environment consciousness an inhibitor or an inducer of innovation'

L

eading manufacturing units of renowned companies in India were recently honoured at the India Green Manufacturing Challenge (IGMC), hosted by the International Research Institute for Manufacturing (IRIM) in Chennai.

Among the 15 companies that were awarded, VE Commercial Vehicle (VECV), truck and buses manufacturer at Pithampur bagged the top award followed by Larsen & Toubro Rubber Processing Machinery in Kanchipuram and USV, a pharmaceutical company at Baddi, Himachal Pradesh, which received the first and second runner-up respectively.

Anand Louie, Director, IRIM, welcomed the gathering and spoke about the green manufacturing scenario in India and the need for companies to adopt green manufacturing practices in such a way that it could contribute to the organisation's

48 EXPRESS PHARMA April 1-15, 2016

(L-R) Anand Louie, Director, IRIM, S Kathir Kamanathan, Chief Financial Officer, Lanco Power, LP Shrivastava, Vice President, Works-J K Tyre & Industries, Abhay Srivastava -Vice President, Plant Operations-USV, Pankaj Upadhyay, Vice President and Head - Manufacturing operations-VECV, S Srinivasan, Business Head- L&T Rubber Processing Machinery

business growth.

The highlight of the event was a panel discussion on the topic, â&#x20AC;&#x2DC;Is environment conscious-

ness an inhibitor or an inducer of innovationâ&#x20AC;&#x2122;, featuring panelists, Pankaj Upadhyay, Vice President & Head, Manufacturing

Operations, VECV; Abhay Srivastava, Vice President, Plant Operations, USV; LP Shrivastava, Vice President, Works, JK

Tyre & Industries; S Srinivasan, Business Head, L&T Rubber Processing Machinery; S Kathir Kamanathan, Chief Financial Officer, Lanco Power.

IRIM, as an unbiased third party, evaluated and rated each company on its unique green manufacturing barometer. This rating was achieved through a structured assessment of the manufacturing facility on 15 indicators of IRIM's Green Manufacturing framework which are building blocks behind the calculation of this index. The assessment was customised to each facility, by assigning unique weightage to each of these indicators based on organisation's priorities to become more sustainable. IRIM has conducted this programme for the second time in India. Compared to the previous programme, there has been a 40 per cent increase in the number of participating companies.

EP News Bureau-Mumbai

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