Express Pharma October 1-15, 2013 by Indian Express

VOL .8 NO.23 PAGES 76

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Market Clinical R&D: A lost opportunity? Management Searching for the silver lining Pharma Life HTIC to conduct fellowship programme at IIT Madras 1-15 OCTOBER 2013, ` 40

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VOL 8. NO. 23 OCTOBER 1-15, 2013

CONTENTS

Chairman of the Board Viveck Goenka

MANAGEMENT

Editor Viveka Roychowdhury*

Searching for the silver lining PG 27

BUREAUS

Patents in pharma industry in India PG 30

Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

RESEARCH Abbott’s high sensitive troponin test may

Bangalore Neelam M Kachhap

help doctors more accurately diagnose heart

Delhi Shalini Gupta

attacks in women: Study PG 33

MARKETING

Cancer drug may help treat

Deputy General Manager Harit Mohanty

diabetes: Study

PG X34

Obesity may increase migraine:

Senior Manager Rajesh Bhatkal

Study PG 35

PRODUCTION

PHARMA ALLY

General Manager B R Tipnis

Gunning for growth with GLP PG 36

Manager Bhadresh Valia

Considerations on skin medication

Sr. Executive- Scheduling & Coordination Rohan Thakkar

dispensing PG 40

Deputy Art Director Surajit Patro

Safeguarding products is top challenge for Asia’s healthcare executives: Survey PG 44

Chief Designer Pravin Temble

Carrier Transicold launches Citimax range of

Senior Graphic Designer Rushikesh Konka

LCV and truck refrigeration units PG 45

Photo Editor Sandeep Patil

Thermo Fisher Scientific introduces high performance gas chromatograph PG 46

Layout Rakesh Sharma

PHARMA LIFE

C I R C U L AT I O N

Dr Poonam Khetrapal Singh nominated as

Circulation Team Mohan Varadkar Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15 RNI Regn. No.MAHENG/2005/21398 Printed for the proprietors,The Indian Express Limited by Ms.Vaidehi Thakar at The Indian Express Press, Plot No. EL-208,TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011 The Indian Express Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

October 1-15, 2013

WHO Regional Director PG 71 HTIC to conduct fellowship programme at IIT Madras PG 71 Pharma sector sees low hiring

MARKET

in August 2013 PG 72

DCGI aims to bring more transparency in CT PG 13 Piramal Healthcare to invest $11 million at its UK facility PG 14 Debiopharm Group in research agreement with TCG Lifesciences PG 15 Biocon partners with CytoSorbents PG 16 IPM valued at ` 6357 crores in August 2013 PG 18 ‘We are expecting around 8000 plus delegates for 65th IPC’ PG 20 Indore to host 2nd edition of PharmaTech Expo 2013 PG 22 FEAPM and CIPI join PHARMA Pro&Pack Expo 2014 exhibition PG 23 IPCA executive council meeting held at New Delhi PG 24

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EXPRESS PHARMA

EDITOR’S NOTE Down but not out ... Ranbaxy's regulatory woes continued as the US FDA

company will “review the details and continue to fully

imposed an import alert on its third factory, the

cooperate with the US FDA and take all necessary

Mohali unit. The Paonta Sahib and Dewas plants were

steps to resolve the concerns at the earliest.” So also,

already under the scanner, and coming after

Mylan’s accquisition of Agila remains on track.

Ranbaxy’s assurances post the consent decree was

In fact, Ranbaxy continues to adopt a combative

signed in January 2012 as well as a hefty $500 million

stance when it comes to defending its Abbreviated

settlement paid this year, this latest regulatory slap on

New

the wrist is sure to cast more doubts on the company’s

challenged. The most recent challenge is Watson

commitment to clean up its act.

Laboratories’ Paragraph IV Certification Notice for a

It’s cold comfort that other pharma plants in India

Application

(ANDA)

filings

when

generic version of Absorica (isotretinoin capsules), a

regulatory

product that is licensed from Ontario-based Cipher

rebukes. Wockhardt’s Waluj facility recently received

Pharmaceuticals. Ranbaxy announced that together

a US FDA warning with inspectors listing serious

with Cipher, they intend to vigorously defend

non-compliance issues like finding torn data records

Absorica’s intellectual property (IP) rights and pursue

in washrooms. Agila Specialities, which had just

all available legal and regulatory pathways in defense

received the government’s nod to be acquired by

of the product. This stance is indicative of the tenacity

the US-based Mylan from its parent company

and fight-for-every-inch attitude required to survive

Strides Arcolab, too received a warning letter from

and thrive in today’s pharma industry.

too

TENACITY AND A FIGHTFOR-EVERY-INCH ATTITUDE IS REQUIRED TO SURVIVE AND THRIVE IN TODAY'S PHARMA INDUSTRY

Drug

are

the

receiving

end

Focusing on niche areas is but one of the strategies

the US FDA. The frequency of warning letters and import alerts

of pharma companies to build a differentiating edge

from the US FDA to pharma companies based in India

As the cover story in this issue, ‘Searching for the

has increased in the recent past for two major reasons.

silver lining’ analyses, geriatric medicine is finally

Firstly, the US FDA today has more inspectors in India

getting the attention it truly deserves. Even Google

than ever before, up from seven to 19. Secondly, these

has jumped on the healthy ageing bandwagon,

inspections are not by prior appointment as in the past

launching what is being dubbed as a search for

but surprise visits, giving manufacturers no time to

immortality. Google bosses seem to hope that their

cover their tracks.

superior data-mining skills will find new perspectives

Inspite of the increased regulatory scrutiny, not

to known facts on age-related diseases. For now,

just from the US FDA but other global regulators,

ageing might slow us down but that does not

Indian companies are not giving up without a fight.

mean we are out ...

Ranbaxy’s

press

statement

promised

that

the

Viveka Roychowdhury viveka.r@expressindia.com

6 EXPRESS PHARMA

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October 1-15, 2013

MARKET THE BUSINESS OF PHARMACEUTICALS

W H AT ’ S INSIDE

MANAGEMENT 27 RESEARCH 33 PHARMA ALLY 36 PHARMA LIFE 71 October 1-15, 2013

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N Not so long ago, India's might in clinical R&D was one of the most proudly discussed topics in the Indian pharmaceutical industry. However, The Gazette Notification (No:GSR 53 (E) dated January 30, 2013) issued by the Department of Health, Ministry of Health and Family Welfare, seriously instilled the sense of insecurity among the operators from this field in India. The red-tapism in the country and difficult-to-follow rules have made the Indian clinical R&D sector more vulnerable and less attractive visa-vis its other contenders.

Deciding the responsibility The shift of clinical R&D operations to other countries that are considered more hospitable than India can be perceived as a threat to India’s dominance in the clinical trial sector. As things have seriously gone wrong after the notification, should the government be blamed for its lack of foresightedness? “It doesn't portray the indifferent attitude of the Indian government towards the pharma industry problems, however, this definitely implies that law should be drafted with a view to regulate the research activities and not to restrict the same,” says Dr VVNKV Prasada Raju, Associate Vice President – Corp Strategy, Granules. Raju adds, “Since the implementation of the law in January 2013, the data shows that till April 2013, only 12 clinical trials have been approved by the authority as compared to the almost three digit figure in the last year. One of the reasons for the decrease is the

EXPRESS PHARMA

SUCHETH DAVULURI Chief Executive Officer, Neuland Laboratories

DR VVNKV PRASADA RAJU Associate Vice President – Corp Strategy, Granules

SM MUDDA Executive Director - Technical & Operations, Microlabs

The Government has to be transparent in terms of its policies for R&D. It has to set the expectations of how its going to protect the intellectual property of companies that do R&D in India

Since the implementation of the law in January 2013, the data shows that till April 2013, only 12 clinical trials have been approved by the authority as compared to almost three digit figure in last year

The recent criticism related to clinical studies conducted in India has led to virtual stoppage of approval for conducting trials by DCGI office

erratic nature of the regulatory timelines for clinical trial approval and the difficult-to-deal with demands of the authorities like protocol amendments, site selection etc. which in turn further increases the unpredictability and timelines associated with regulatory approvals. It is very unfortunate that these uncertainties in the regulatory framework and approval mechanism may lead India to lose its current position as an attractive clinical R&D hub.” SM Mudda, Executive Director - Technical & Operations, Microlabs says, “The recent criticism related to clinical studies conducted in India has led to virtual stoppage of approval for conducting trials by Drugs Controller general (India) DCGI office. The delay in the system approval has stopped new studies being conducted by multinationals in India.” According to Dr Manu Chaudhary, Joint Managing Director, Venus Remedies, and Director, Research,

VMRC, which is R&D driven company, the most important concern is that R&D based industry has to compensate for innovative drugs even if a patient is taking placebo or other concomitant medication. “As a result, patients suffering from life threatening problems are denied access to potential research-based new drugs. More importantly, this gazette will impact the future growth of R&D as well as development of low cost high quality medicines in the country,” opines Chaudhary.

try to move up the value chain and further cement its position as a pharma global hub. The GOI has taken a number of steps to boost the R&D culture in the country: weighted tax deduction of 200 per cent for R&D, initiatives to set up a ` 2000 crore venture capital fund to foster R&D, setting up institutions like BIRAC to stimulate biotech R&D are indicative steps in the positive direction.” He adds, “Government of India, at this stage should recognise that the need of the hour is to develop strategies for funding options (grants, loans and capital), collaborative R&D initiatives with the industry, incentivising R&D efforts and building a comprehensive R&D eco-system. Lessons can be learnt from similar programmes/strategies adopted in BRICS and the US to boost R&D initiatives; key references can be, Brazil, which has heavily invested in PPPs as a means to help the country improve its biotechnology innovation

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Market statistics The government’s notification has brought turmoil in the clinical R&D scenario, however, there is a silver lining to the cloud. To boost the R&D culture in India, Government of India (GOI) has come up with some concrete measures. Utkarsh Palnitkar, Partner and Head, Life Sciences, KPMG-India says, “The GOI realises that innovation is imperative for the domestic pharma indus-

October 1-15, 2013

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and bio-manufacturing capabilities and China which implemented five core incentives programmes designed to spur on research and development. These include reduced corporate income tax for high and new technology enterprise, super deduction for eligible costs, tax concessions for advanced technology service enterprise, custom duty and VAT exemptions / refunds for R&D equipment purchases, and tax concessions on technology transfers.” According to Palnitkar, it has been a roller-coaster ride for the Indian research industry. He informs, “India was poised to reach a billion dollar in contract research by 2010 and has the potential to become the second largest in Asia after Japan. However, the revised estimates suggest that the market is ~ $500-600 million currently and it may take three to five years to reach the billion dollar mark. The current HC-LS research mar-

October 1-15, 2013

ket in India is ~ 4 per cent of global addressable opportunity, thus presenting a huge potential to realise.”

Is the government support mandatory? From the perspective of

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current decline in clinical research activities in India, industrial associations need to join hands to understand the relevance of such regulations and try to come up with solutions for making the current system more

transparent and efficient, feels Raju. “Industry needs to initiate a positive dialogue with the government with the proposal in a way that the very essence of such regulations is met without impacting the

EXPRESS PHARMA

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growth of clinical research activities in India. The industry can propose some modifications in the regulations which can turn out to be a panacea from the commercial, legal, human and ethical perspective,” says Raju. “Pharma industry in the West collaborates with key stakeholders in the eco-system (academic, scientific research institutes), uses codevelopment initiatives and to an extent opens innovation initiatives. Both the administrators and Regulators (US Government, FDA etc.) do have clarity on the initiatives thus acting as facilitators in one context while acting as watch dogs in other. While these initiatives can be explored by Indian players, the key is customisation to Indian context and more important policy/regulatory clarity on these initiatives,” informs Palnitkar. Government, being a policy maker, will always have a say at any point of time in the functioning of any industry and pharma sector is not an exception. “As the drug approval process and clinical trial regime depends on the regulatory body and government policies, industry initiatives might not be a solution,” asserts Chaudhary. “The Government has to be transparent in terms of its policies for R&D. It has to set the expectations of how it's going to protect the intellectual property of companies that do R&D in India, they cannot be subjective. Companies should know what to expect. Apart from that, the government also has to facilitate investment in infrastructure that will enable R&D and it also needs to incentivise the companies by way of tax holidays, creation of pharma cities which can bring about a lot of

DR MANU CHAUDHARY

Partner and Head, Life Sciences, KPMG-India

General ManagerBiotechnology, Elder Pharmaceuticals

The most important concern is that R&D based industry has to compensate for innovative drugs even if a patient is taking placebo or other concomitant medication

GoI at this stage should recognise that the utmost need of the hour is to develop strategies for funding options (grants, loans and capital), collaborative R&D initiatives with the industry

The pharma city should be created under the PPP and must have world class infrastructure with state of the art environmental protection measures

focus and concentration of knowledge. The industry can focus on what it can do best and the government has to play its role by creating the right environment,” opines Sucheth Davuluri, Chief Executive Officer, Neuland Laboratories.

innovation. Raju says, “The concept of special pharma cities or SEZ provides enterprises and developers with a favourable and attractive framework of incentives and benefits. Thus, it definitely acts as a booster for R&D by offering a trouble-free business-friendly environment and world class infrastructure.” Sharad Dahatonde, General ManagerBiotechnology, Elder Pharmaceuticals, echoes Raju’s views. He says, “The pharma city should be created under the PPP and must have world class infrastructure with state-of-the-art environmental protection measures.” “Dedicated pharma cities and parks do promote an integrated ecosystem for innovation. However, it is imperative that industry and the government clearly defines, how do we measure the productivity of the dedicated cities/parks?, how many of the cities/parks are productive? how do we promote the culture of collaboration between various tenants in the cities/parks? and what are the lessons learnt from successful park/cities and how are the learnings disseminated?,” suggests Palnitkar. Chaudhary has a different set of views. More than the special pharma cities, if government focuses on

industry friendly policies, that would help the most to boost R&D, insists Chaudhary. “With the kind of clinical trial regime in India, special cities would not be the answer to boost R&D in the Indian pharma industry. Rather, better and transparent regulatory bodies at the government level and self regulation of pharma companies would be more effective. An autonomous body is the need of the hour, wherein regular participation of government bodies and pharma institutions would ensure effective and robust R&D process and procedures,” opines Chaudhary. There are some bones of contention between the government and industry. Chaudhary informs, “The new rule demands the new drug to be 100 per cent efficacious. This is practically impossible.” All said and done, the relationship between the industry and the government should be symbiotic. While framing policies or new rules, industry should also be kept in the loop. Current wave of resentment among clinical R&D players, if not pacified now, may not only lead to confrontation between industry and the government but will also make India’s journey towards innovation difficult.

Joint Managing Director, Venus Remedies, and Director, Research, VMRC

Pharma cities, the answer? Though R&D was never considered India’s cup of tea, India has slowly and steadily established itself as a force to reckon with in the field of clinical R&D. However, the recent notification has predominantly affected the clinical R&D sector and at the same time has sent negative vibes across the industry. Therefore, the government should look at the ways to reinstil hope among prospective R&D players. Special pharma cities is widely accepted concept which is expected to propel

THOUGH R&D WAS NEVER CONSIDERED INDIA’S CUP OF TEA, INDIA HAS SLOWLY AND STEADILY ESTABLISHED ITSELF AS A FORCE TO RECKON WITH IN THE FIELD OF CLINICAL R&D. HOWEVER, THE RECENT NOTIFICATION HAS PREDOMINANTLY AFFECTED THE CLINICAL R&D SECTOR 12

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UTKARSH PALNITKAR SHARAD DAHATONDE

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sachin.jagdale@expressindia.com October 1-15, 2013

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COMPANY WATCH DCGI aims to bring more transparency in CT Asks sponsor to provide details of payment to investigators

Usha Sharma Mumbai n order to bring more transparency in the clinical trial (CT) process in India, the Drug Controller General (India) (DCGI) has recently issued an order asking sponsors to provide details of agreements with investigators/institutions pertaining to payments for conducting CL. The Good Clinical Practice (GCP) guidelines provide that the sponsor should enter into a formal and legal agreement/contract with investigator(s)/institution(s) before the start of the trial on various terms of the trial. The agreement should also define the relationship between the investigator and sponsor in matters such as financial support, fees, honorarium, payments in kind etc.

Dr Arun Bhatt, President, Clininvent Research said, “We do not foresee any issues related to the order but our only worry is the time required for such approval. The submission process for CL-related agreement details require three to four months and with the new order, it may get further extended to another one or two months.” According to an ISCR spokesperson, “While many of the recent initiatives from the Ministry of Health are a step forward in this direction, we are concerned with the haste with which some initiatives are being introduced without a consultative process that involves discussion with and feedback from various stakeholders involved in the clinical research process.” Bhatt further said, “All investigators do not get

approved by the DCGI. Practically speaking, we cannot submit the agreement copies before a CL begins and this becomes another practical issue which will delay the approval process.” According to the order, it has been decided that the information with respect to the payments made by the sponsor to the investigator for the conduct CT should be made available. Dr Shreekant Sapatnekar, CEO, Savishree Consultants points out, “Principal investigator is conducting an ethical clinical trial and he/she must be compensated. This income will form a part of his/her gross income. If this information can be shared with the income tax authority (in an annual return format), why not with other government authorities. I feel that transparency and accountabil-

ity can not be given a go bye.” ISCR points out, “More importantly, we fail to understand the reason for requesting this information at the time of submission of a clinical trial application since the final selection of sites for a trial study is contingent upon the approval granted by the DCGI and post a review by the NDAC. It would therefore be premature for sponsors/CROs to enter into final agreements with investigators/sites prior to the grant of approval by the DCGI. Not only would the pre application process be time consuming and impractical, but if a site were not approved by the regulator, there would be additional time and investment in making these contracts null and void which could cause misunderstanding with Investigators/sites.” u.sharma@expressindia.com

34-year history of partnership with leading pharma companies

active pharmaceutical ingredients & its intermediates*

Commercial scale Macrolides

Antihypertensive

Pyrazinamide# * Isoniazid # *

Azithromycin Clarithromycin Erythromycin base # Erythromycin estolate # Erythromycin ethyl succinate+ Erythromycin oxime (intermediate) Erythromycin stearate #

Irbesartan # Losartan potassium Telmisartan Valsartan

Ganciclovir Valaciclovir Valganciclovir Maraviroc

Sedative, Hypnotic

Antidiabetic

Antifungal

Linagliptin Vildagliptin

Antihistaminic

Flucytosine #

Hypnotic

Antimalarial Artesunate Arteether Artemether # * Dihydroartemisinin Lumefantrine # * Piperaquine

Antiosteoporotic Alendronate sodium Zoledronic acid US DMF

Under Development

Antitubercular

WHO APIMF

CEP / COS

Cetirizine dihydrochloride # Hydroxyzine dihydrochloride Meclizine dihydrochloride+

Zopiclone

Antiretroviral

Antiepileptic

Eszopiclone

Valproic acid

Antithrombotic

Antidepressant

APProVED

Clopidogrel bisulphate

Venlafaxine hydrochloride

CTD ling under process

*The Technical and Physical manufacturing capabilities exist with us for the above APIs and their intermediates. However these products will be offered only to the markets where any product or process patents are not infringing. During the validity of a patent the research quantities for developing products for regulatory submissions will only be offered to countries where such exemption exists (Hatch Waxman Act / Bolar exemption). While Calyx offers to work with the clients on Patent Status Verification, the final responsibility rest with the buyer. Recipients are requested to make their evaluation and determination as to the patent status prior to their use of the information or materials in their respective jurisdiction. Products under patent offered only for exempted research, clinical and development purposes. Only non-infringing products and processes are offered, subject to patent status verification by client.

Calyx Chemicals and Pharmaceuticals Limited Reg. Office: Unit No.110, Marwah's Complex, Krishanlal Marwah Marg, Off. Saki Vihar Road, Andheri (East), Mumbai – 400072, Maharashtra, India. Tel: +91-22-28571191, Fax: +91-22-66466416, Email: sales@calyxindia.com, crams@calyxindia.com USA Contact : 11728 E. Imperial Highway, Norwalk, CA 90650, Tel - 213-291-7773, Email: sales@calyxusa.com, crams@calyxusa.com Website : www.calyxindia.com "Calyx Chemicals and Pharmaceuticals Limited (the “Company”) is proposing to make, subject to receipt of requisite approvals, market conditions and other considerations, an Initial Public Offering of its equity shares (the “IPO") and has filed the Draft Red Herring Prospectus (the “DRHP”) with the Securities and Exchange Board of India (“SEBI”). The DRHP is available on the website of SEBI at www.sebi.gov.in, the website of the BRLMs, i.e. PL Capital Markets Private Limited at www.plindia.com and YES Bank Limited at www.yesbank.in and is also available on the website of the Company at www.calyx-pharma.com. Potential investors should note that investment in equity shares involves a degree of risk. For details, please refer to the DRHP, including the section titled “Risk Factors” of the DRHP. This publicity material does not constitute an offer of securities in any jurisdiction, including the United States of America (“USA”). Securities may not be offered or sold in the USA without registration under the U.S. Securities Act of 1933 as amended, or an exemption therefrom. The Company has not and does not intend to offer any securities to the public in the USA”.

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Piramal Healthcare to invest $11 million at its UK facility P Triples the production capacity for hormonal products

iramal Healthcare will invest $11 million at its Morpeth, UK facility to triple the production capacity for hormonal products, including contraceptive pills and hormone replacement therapies. The expansion, which has been commissioned in response to customer demand and new business gains, will see the Morpeth site’s production capacity increase by around 2 billion tablets per annum. Work on the new suite, which will house formulation, packaging coating and tableting equipment, will commence at the end of 2013, with mechanical completion anticipated within 12 months and full operations expected to begin following a six month validation period. This latest investment follows Piramal Healthcare’s recent announcement that it is to invest $2.5 million at its FDA approved Grangemouth, UK, site to upgrade one of its antibody drug conjugate (ADC) manufacturing suites, from clinical phase to commercial grade, in response to customer demand. The upgrade will give Piramal

two commercial grade ADC suites at the Grangemouth facility, while retaining clinical phase manufacturing capacity in other suites on site. Vijay Shah, Executive Director and COO, Piramal Enterprises said, “The production of hormonal products is a highly specialised, niche area. The Morpeth facility is our Centre of Excellence for these products and this expansion will greatly enhance our offer and potential for growth in this space. The hormonal sector currently represents a $11 billion market globally and is growing at a pace of four to five per cent annually. With major competition limited to a small number of CMOs in Europe, Piramal sees major opportunities for growth in this area given our vast experience in this field, which spans more than 40 years.” With this expansion, Piramal aims to be one of the largest contract manufacturers in this niche segment which, as per the US FDA and MHRA regulations, requires a dedicated manu-

facturing facility for the handling of high potent molecules. The 13,000 sq ft Morpeth facility also houses Active Pharmaceutical Ingredient (API) production, general solid formulation production, and a range of clinical trial supply and research facilities, and was acquired by Piramal from Pfizer in 2006. Piramal Healthcare provides Late Phase API services on an integrated manufacturing model across North America, Europe and Asia. All its facilities manufacturing commercial phase APIs have been GMP certified and possess API finishing facilities. Piramal has a successful performance record of over 40 years for the supply of APIs to the US and European markets from its facilities located in Canada, India and the UK. With a reactor volume exceeding 500 KL, including pilot plants and multi-purpose plants, Piramal Healthcare is capable of executing the extensive API requirements of its client base. EP News Bureau-Mumbai

Sun Pharma announces US FDA approval for generic Prevacid Are indicated for shortterm treatment for healing and symptom relief of active duodenal ulcer un Pharmaceutical Industries announced that the US FDA has granted its subsidiary final approval for its Abbreviated New Drug Applications (ANDA) for generic version of Prevacid, Lansoprazole delayed-release capsules USP, 15 mg and 30 mg. Lansoprazole delayedrelease capsules USP, 15 mg and 30 mg are therapeutic equivalents of Takeda’s prevacid delayed-released capsules. These capsules have annual sales of approximately $430 million in the US. Lansoprazole delayed-release capsules USP are indicated for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer. EP News Bureau-Mumbai

US FDA approves first generic capecitabine of Teva Pharmaceuticals To treat colorectal and breast cancers

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he US Food and Drug Administration (US FDA) has approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill used to treat cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic), and metastatic breast cancer. Teva Pharmaceuticals USA has gained FDA approval to market generic capecitabine in 150 and 500 milligram strengths. “Generic drugs are important options that allow greater access to healthcare for all Americans,” said Kathleen Uhl, Acting Director of the Office of Generic Drugs in the FDA’s Center for

Drug Evaluation and Research. “This medication is widely used by people living with cancer, so it is important to have access to affordable treatment options.” In the clinical trials for Xeloda, the most commonly observed adverse reactions included: diarrhoea; vomiting; nausea; pain, redness, swelling, or sores in the mouth; hand-and-foot syndrome (pain, swelling, or redness of hands or feet that prevents normal activity); and fever or infection. It is important that the prescriber know if the patient is also taking a medicine used to thin the blood, such as warfarin. Capecitabine could www.expresspharmaonline.com

IN THE CLINICAL TRIALS FOR XELODA, THE MOST COMMONLY OBSERVED ADVERSE REACTIONS INCLUDED: DIARRHOEA;VOMITING; NAUSEA; PAIN, REDNESS, SWELLING, OR SORES IN THE MOUTH; HAND-AND-FOOT SYNDROME AND FEVER OR INFECTION increase the effect of this medicine, possibly leading to serious side effects. Capecitabine has a boxed warning to alert health care professionals and patients about this risk. Generic drugs approved by the FDA

have the same high quality and strength as brand-name drugs. Generic drug manufacturing and packaging sites must pass the same quality standards as those of brandname drugs. EP News Bureau-Mumbai October 1-15, 2013

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Debiopharm Group in research agreement with TCG Lifesciences To develop a novel class of antibiotics, a new strategic therapeutic area for Debiopharm ebiopharm Group, the Swiss-based global biopharmaceutical company and TCG Lifesciences (TCGLS) have announced the signature of an exclusive discovery collaboration to develop innovative antibiotics targeting drug-resistant bacteria for community hospitalacquired infections. Debiopharm is willing to become a key player in the area of antibacterials to fulfill the increasing need of new classes of antibiotics to overcome resistance to current treatment. Under the terms of the agreement, TCGLS will contribute its expertise in the discovery and optimisation of lead compounds whilst Debiopharm will provide drug development expertise and fund the development programme. “We foresee to increase our commitment in this field over the next few months through additional partnerships and investments on other innovative targets,” said David Deperthes, VP Business Development & Licensing. “We are enthusiastic about this partnership with TCGLS for the development of novel antibiotics, their extensive experience in medicinal chemistry and infectious diseases is a major asset for the development of Debio1348. This partnership is key to us to establish a leadership position in the area of antibiotics,” said Rolland-Yves Mauvernay, President and Founder, Debiopharm Group. Swapan Bhattacharya, Managing Director, TCG Lifesciences commented, “We are indeed excited about this programme which involves a challenging new target that could potentially address the vast incidence of nosocomial infections which plague

healthcare facilities all over the world. Debiopharm’s developmental expertise

combined with our medicinal chemistry capabilities and efficient discovery oper-

ations provide an attractive opportunity for accelerated discovery of novel drug

candidates for clinical development.” EP News Bureau-Mumbai

October 1-15, 2013

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Complies with Indian Pharmacopoeia (IP), United States Pharmacopeia (USP), National Formulary (NF), European Pharmacopeia (EP), Japanese Pharmacopeia (JP) and British Pharmacopeia (BP)

Offers various pack sizes to support formulation development from discovery to full-scale production

Avantor Performance Materials India Limited 1201-1206, 12th Floor, Pinnacle Business Tower, Shooting Range Road, Surajkund, Faridabad - 121009 Tel: +91-129-4267000, 4267100, 4267200 Fax: +91-129-4267299, 4267199 e-mail: pharma.india@avantormaterials.com web: www.avantormaterials.com

www.expresspharmaonline.com

EXPRESS PHARMA

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Biocon partners with CytoSorbents To market CytoSorb, a‘first-in-class’ therapy for Sepsis management iocon and US-based CytoSorbents Corporation have entered into a strategic partnership with an initial distribution agreement for India and select emerging markets, under which Biocon will have the exclusive commercialisation rights for CytoSorb, a novel therapy for the management of sepsis. CytoSorb is a safe and effective extracorporeal cytokine filter, designed to target the prevention or treatment of organ failure which is the cause of nearly half of all deaths in the intensive care unit. If left unchecked, ‘cytokine storm’ caused by excessive cytokine production can cause massive inflammation, organ failure and death in common life-threatening conditions such as sepsis, burn injury, trauma, lung injury, and pancreatitis. CytoSorb has CE Mark regulatory approval, and is clinically proven to control cytokine storm in critically-ill patients by reducing key cytokines in blood by 30-50 per cent. It also works easily with standard dialysis machines used in hospitals. Biocon and CytoSorbents will initially focus on the treatment of sepsis, the end result

apy for managing cytokine storm in critically ill patients. Very high levels of cytokines are known to cause multiple organ failure, which is often life threatening. Through CytoSorb, we offer a promising treatment option to high risk patients in their fight against sepsis and other critical illnesses. We are confident that this will be a revolutionary tool for critical care specialists in sepsis treatment.” Dr Phillip Chan, Chief Executive Officer and President, CytoSorbents, said, “We are pleased to enter into this initial agreement with Biocon and to bring our potentially life-saving therapy to the people of India and other emerging markets. Unlike any other previous approach, CytoSorb attacks sepsis from multiple angles, reducing cytokine storm, reducing many deadly bacterial toxins, and directing immune cells to target the infection while avoiding damage to otherwise healthy organs. When combined with Biocon’s critical care antibiotics, it is an ideal broad spectrum strategy to fight sepsis. Biocon is a perfect partner for CytoSorbents and CytoSorb as we share the

same commitment to help patients with sepsis, and other life-threatening conditions. We expect adoption and sales of CytoSorb to benefit from Biocon’s strong regional sales and distribution network across India, and extensive equity with key opinion leaders.” Chris Cramer, Vice President of Business Development, CytoSorbents said, "Biocon is an exceptionally strong partner for CytoSorbents with expertise in introducing innovative new therapies, like CytoSorb, into the hospital setting. Biocon’s network will enable rapid access, education, training, and support of physicians in the largest hospitals throughout India and other emerging markets. We are excited to be working with a leader like Biocon and look forward to supporting them in the successful launch of CytoSorb in these markets. This partnership has the potential to change the treatment of critical care illnesses such as sepsis, and we are confident that our work will lay the groundwork for an expanded partnership in the future.” EP News Bureau-Mumbai

Ranbaxy receives Paragraph IV certification notice from Watson Labs

Glenmark receives final ANDA approval for Desoximetasone ointment

Application filed to US FDA for generic version of Absorica

Is indicated for relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

anbaxy Laboratories has received a Paragraph IV Certification Notice of filing from Watson Laboratories of an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration for a generic version of Absorica (isotretinoin capsules), a product that is licensed from Cipher Pharmaceuticals (TSX: DND) (Cipher) of Mississauga, Ontario. RLI and Cipher intend to vigorously defend Absorica’s intellectual property rights and pursue all available legal and regulatory pathways in

of an excessive immune response to infection. The effective treatment of sepsis needs to address two components, the infection and the over-activation of the immune system. By combining Biocon’s critical care antibiotics to treat the infection that are also compatible with CytoSorb therapy to modulate the immune response, the two companies will be providing the most comprehensive solution for sepsis management in the market. Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon, said, “We believe our partnership with CytoSorbents will enable us to address the huge unmet need of sepsis management in India and emerging markets. CytoSorb is a ‘first-in-class’ therapy that can provide an effective solution to physicians to treat critically ill patients suffering from sepsis. This move reflects our commitment to bring differentiated products to India that will help address various healthcare challenges faced by millions of patients in our country.” Rakesh Bamzai, President Marketing, Biocon, said, “CytoSorb is a safe and well–tolerated innovative ther-

EXPRESS PHARMA

defense of the product. Absorica is currently protected by two issued patents listed in the FDA’s Approved Drug Products List (Orange Book), which will expire in September 2021. RLI shall take appropriate actions in response to the Paragraph IV notice letter, and FDA approval of the ANDA shall then be governed by the Hatch-Waxman Act. Absorica was approved by the FDA in May 2012, and granted a three-year market exclusivity period, which expires in May 2015. EP News Bureau-Mumbai www.expresspharmaonline.com

lenmark Generics, USA the subsidiary of Glenmark Generics has been granted final abbreviated new drug approval (ANDA) from the US FDA for Desoximetasone Ointment USP, 0.25 per cent their generic version of Topicort by Taro Pharmaceuticals USA and shipping will commence immediately. Desoximetasone ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. According to IMS Health sales

data for the 12 month period ending June 2013, Desoximetasone ointment garnered annual sales of approximately $ 40 million. Glenmark’s current portfolio consists of 89 products authorised for distribution in the US marketplace and 54 ANDA’s pending approval with the US FDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.. EP News Bureau-Mumbai October 1-15, 2013

M|A|R|K|E|T

GROWTH TRACKER IPM valued at ` 6357 crores in August 2013 10 therapies have outgrown the IPM growth With Bonus Units at Full Value

MAT Aug 13

GR%

Mth Aug 13

GR%

IPM

72500

8.2

6357

1.1

ANTI-INFECTIVES

12829

7.9

1154

-1.1

CARDIAC

8803

9.6

746

4.0

GASTRO INTESTINAL

8188

7.3

729

-3.8

VITAMINS / MINERALS / NUTRIENTS

6350

6.7

560

-0.9

RESPIRATORY

5631

9.8

484

6.2

PAIN / ANALGESICS

5287

5.6

458

-3.3

ANTI DIABETIC

4915

11.3

428

6.4

GYNAECOLOGICAL

4648

5.2

389

-0.4

n the month, where the rupee plunged to deepest of its lows, the pharmaceutical market has also had the growth shocker with the markets growing at 1.1 per cent, which is the lowest in years of the market existence. The last low growth experienced in the market was in November 2012 with that month registering 4.3 per cent. The anti-diabetic market grew a slight better than the previous month due to the lifting of ban on the pioglitazone and its combinations. The Indian Pharma Market (IPM) is valued at ` 6357 crores in August 2013. It has grown at 1.1 per cent in August 2013. For the month of August 2013, amongst the top 10, Sun Pharma has registered a growth of 14.9 per cent, Alkem at 5.9 per cent and Cipla at 4.9 per cent. 30 corporates have crossed the growth of IPM for the month of August 2013 amongst top 50. Amongst the top 50 corporates, Biocon has the highest growth of 34 per cent followed by Akumentis at 28.9 per cent and Glenmark at 21.8 per cent. Amongst the 11-20 ranked companies, Glenmark has shown high growth at 21.8 per cent followed by Emcure at 8.8 per cent and USV at seven per cent Amongst upcoming corporates, Corona Remedies has grown at 73.1 per cent, Akumentis at 28.9 per cent and Eris at 21.1 per cent. Khandelwal Labs and Comed have crossed the R`50-crore mark in the IPM. The DPCO 2013 containing molecules market was at -12.3 per cent whereas the non-DPCO market grew by 3.3 per cent resulting in an overall growth of 1.1 per cent for August 2013. The DPCO 2013 portfolio for GSK degrew at 30.4 per cent and Ranbaxy degrew by 21.1, whereas Sun Pharma had the least impact with its DPCO 2013 portfolio degrowing at 1.7. Amongst the various molecules with specific strengths under DPCO 2013, Amoxycillin - Clavulanic acid degrew at 4.2 per cent, Atorvastatin market degrew by 27.8 per cent, Paracetamol degrew by 20.1 per cent and Azithromycin degrew by 18.7 per cent. Not only value, the market has witnessed a negative growths in the units as well in both the categories. From therapy perspective 10 therapies have outgrown the IPM growth. The anti-infective market has a degrowth of 1.1 per cent whereas respiratory market is at 6.2 per cent growth. The anti-diabetic market has grown at 6.4 per cent and cardiac at four per cent in chronic business. From regional perspective, 13 regions have outgrown the IPM growth. Rajasthan has grown the highest at 11 per cent whereas Mumbai have registered low growth in August 2013. Eight regions have had negative growths in August 13.

NEURO / CNS

4454

9.6

382

4.7

About PharmaTrac

DERMA

3826

8.3

351

5.9

OPHTHAL / OTOLOGICALS

1294

7.9

115

5.5

HORMONES

1250

11.7

103

-3.8

OTHERS

982

9.0

13.8

ANTI-NEOPLASTICS

956

22.4

19.3

BLOOD RELATED

868

2.7

0.3

VACCINES

854

0.0

-10.9

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

ANTI MALARIALS

620

5.4

-12.1

SEX STIMULANTS / REJUVENATORS

423

12.7

4.1

STOMATOLOGICALS

322

7.6

2.8

Val in Crs

Rank

CORPORATE

MAT Aug -13

MAT

MTH

Abbott + Abbott HC + Novo

Sun Pharma

Cipla

Zydus + Biochem

Aug-13

Val (Cr)

MS%

GR%

Val (Cr)

MS%

72500

100.00

8.2

6357

100.00

1.1

4908

6.77

5.1

411

6.46

-4.6

3728

5.14

18.1

329

5.18

14.9

3666

5.06

7.0

312

4.91

4.9

3241

4.47

17.7

289

4.55

3.8

IPM

GR%

Glaxo

3114

4.30

-1.2

248

3.90

-17.6

Ranbaxy

2991

4.13

6.2

253

3.97

0.1

Mankind

2640

3.64

14.8

233

3.66

-3.0

Alkem + Cachet + Indchemie

2541

3.50

12.4

237

3.72

5.9

Pfizer + Wyeth

2184

3.01

2.3

184

2.90

-8.1

Lupin

2183

3.01

9.0

188

2.95

0.1

Macleods

1879

2.59

13.1

167

2.63

2.0

Intas

1807

2.49

13.9

155

2.44

6.4

Emcure + Zuventus

1748

2.41

12.3

165

2.60

8.8

Aristo

1712

2.36

11.1

163

2.56

5.4

Dr. Reddys

1600

2.21

10.1

137

2.15

2.0

Sanofi-Aventis + Universal

1548

2.14

4.2

131

2.07

-1.1

Glenmark

1480

2.04

15.0

146

2.30

21.8

USV

1317

1.82

16.4

115

1.81

7.0

Micro + Bal

1307

1.80

2.4

114

1.79

-0.2

Val in Crs Super Group

EXPRESS PHARMA

With Bonus in Crs

www.expresspharmaonline.com

Terminologies used MAT – Moving Annual TotalMTH – MonthVal(Cr) – Value in CroresMS per cent – Market Share in PercentageGR per cent – Growth in percentage For more information, visit http://www.aiocd.net October 1-15, 2013

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Lupin inks agreement with Onset Dermatologics To promote Locoid lotion to US pediatricians upin has signed a strategic co-promotion agreement with US-based Onset Dermatologics that grants Lupin exclusive rights to promote Onset’s Locoid lotion (hydrocortisone butyrate 0.1 per cent) to paediatricians in the US. Locoid is the most highly prescribed mid-potency steroid brand in the US. Locoid lotion is a corticosteroid indicated for the topical treatment of mild to moderate Atopic Dermatitis (AD)in patients three months of age and older. AD is one of the most common skin disorders in young children and has a prevalence of 10 per cent to 20 per cent in the first decade of life. It is a chronic illness that requires a multifaceted treatment strategy in the setting of limited therapeutic options. Between 1997 and 2004, paediatric patients with AD (newborn to 18 years of age) accounted for an estimated 7.4 million office visits in the US alone. AD, more commonly called eczema, now affects 10 to 20 per cent of children in the US and direct healthcare costs exceed $3 billion, according to the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Locoid lotion currently participates in a market that includes 17 per cent of school-age children in the US between the ages of five to seven years which is about 9.2 million children. The addition of Locoid

lotion will enable Lupin to strengthen its US brand business and expand its product portfolio for the US paediatrics segment. Lupin’s current paediatric portfolio consists of Suprax and Alinia for oral suspen-

sion and such the company is well positioned to capitalise on this opportunity. Onset has had minimal promotion of Locoid lotion to paediatricians. Lupin’s 160+ strong specialty sales force will promote Locoid lotion

with Onset providing strategic marketing support thus creating an opportunity for incremental revenues with minimal additional sales or marketing expenses. “We are pleased with the addition of Locoid lotion to

our brand portfolio and are committed to bring meaningful products to the US paediatric community,” said Vinita Gupta, Chief Executive Officer, Lupin Pharmaceuticals. EP News Bureau-Mumbai

LOCOID LOTION IS A CORTICOSTEROID INDICATED FOR THE TOPICAL TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS IN PATIENTS THREE MONTHS OF AGE AND OLDER October 1-15, 2013

www.expresspharmaonline.com

EXPRESS PHARMA

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‘We are expecting around 8000 th plus delegates for 65 IPC’ In the run up to the 65th Indian Pharmaceutical Congress to be held in New Delhi, Atul Nasa, President, Indian Pharmaceutical Congress Association (IPCA) reveals the preparations in order, in an interview with Shalini Gupta

INTERVIEW

EXPRESS PHARMA

What priorities have you set for yourself as the President of IPCA? Any goals in particular that you would like to accomplish? Besides thanking the members of IPCA for having elected me as the President, IPCA, I would like to add that the honour imposed and the opportunity given to preside over the 65th IPC is really appreciable. There is an urgent need to reinforce and rebuild the standards with statutory bodies and to restore the confidence of the pharmacy graduates. Quality of pharmacy education has to be improved and taken to higher levels of professionalism with industrial/hospital participation. There is a requirement to ensure right education and empowerment of pharmacy professionals to help them to assume higher responsibilities and leadership roles.

As has been highlighted in detail in the website www.65ipcdelhi.com, the registration of delegates and attendees have recently started. The first cut-off date for early registration is October 31, 2013 by when members / delegates planning to attend may register by paying a nominal fee. The online submission of papers for the scientific session started well in advance. The details of scientific sessions are available on the website, as well as on w w w. s c i e n t i f i c i p c a . o r g . Efforts have been made for inviting the President/ Prime Minister of India to be the chief guests. Further, regular meetings of the Local Organising Committee of 65th IPC are being held at New Delhi to review the progress report of various committees working for successfully organising IPC. At the IPCA Executive Council meeting held at Federation of Indian Chambers of Commerce and Industry (FICCI), Federation House, New Delhi earlier this month the representatives of Federation Associations of IPCA viz IPA, IPGA, APTI, AIDCOC and IHPA reviewed the preparation of 65th IPC.

Tell us about the theme of this years’ IPC. The theme of the 65th IPC, ‘Pharma Vision 2020Empowering Pharmacist,’ focuses on bringing pharmaceutical experts across the globe to a single platform where pharmacy education and practices and their development shall be the main issues for debate and deliberation. Empowering pharmacists implies developing leaders in the sector from diverse backgrounds, who shall provide their invaluable input in the growth of pharma as a profession and an industry. Historically, it can be seen that the various issues debated and discussed have been issues such as role of pharmacy, development of the industry, drug research, problems faced by the pharma industry, pharma education, regulatory measures, challenges and problems, role of pharmacist.

What would be the venue of the event? The venue of the conference is Amity University Campus, Noida, which is an international campus having all infrastructures for scientific sessions with state-of-the-art multi media facilities, spacious grounds for conducting exhibitions, hospitality, inaugural sessions and cultural events. The PHARMAceutical EXPO 2013 concurrent with the 65th IPC will be organised by FICCI. FICCI is playing a supportive and important role since 2001, having successfully organised a series of PHARMAceutical EXPO’s concurrent with 53rd IPC onwards. We are expecting participation from more than 250 exhibitors in various fields who will be displaying their machineries, equipment, technology, books etc.

What preparations have gone into the event so far?

How many delegates and attendees are you expecting? www.expresspharmaonline.com

What scientific sessions and presentations are of particular interest? There has been a considerable response from the interested delegates and attendees and the lists are being updated. We are expecting around 8000 plus delegates for 65th IPC. There will be plenary sessions, scientific sessions and scientific poster paper presentations. For plenary and other scientific sessions, we are expecting around 80 speakers out of which around 30 will be foreign speakers. As detailed in the website www.scientificipca.org, students can present their research papers in various scientific sessions viz, pharma technology, medicinal chemistry, pharmacognosy, indigenous drugs, herbal formulations and phytochemistry, pharmacology and toxicology, clinical research and pharmacovigilance, biopharmaceutics, pharmacokinetics and drug metabolism, pharmaceutical analysis and quality assurance, biotechnology and biotherapeutics, hospital, community and clinical pharmacy, pharma education and professional pharmacy, drug regulatory affairs, pharma management, pharmacoeconomics and pharmacoepidemiology. There has been a tremendous response from students willing to participate and make the event a success. Their energy and potential shall be effectively utilised in the conference. Various scientific symposiums will be held, which are: Presidents symposium on empowering pharmacists; Standardisation of biological products; Advances in regulatory sciences and education; Pharma industry: From here to where; Role of community pharmacist in implementing public health policy; Molecular cardiovascular pharmacology; Pharma policies and export; Empowering pharma students through leadership development; Drug development regulations; Strategies to strengthen practice services. The details of scientific programmes, speakers etc will be available on the website by October 15, 2013.

witnessed a lot of significant events in the last one year. How would the IPCA be working to address these issues and would they be part of IPC? Rather than focusing on development only in the past one year, it would be right to focus on the growth and development in the sector over the previous decade. The Indian pharma industry has witnessed a robust growth in the past decade moving from a turnover of approx $1 billion in 1990 to over $20 billion in 2010. Recognising the growth potential, Government of India has took up the initiative of developing the Indian pharma sector by creating a department which focuses on policy planning, development and regulation. India’s rich human capital is the strongest asset for the pharma industry which is a knowledge-led industry. We have various pharma research education institutes such as NIPER which have grown in number and work extensively to address the HR needs of the pharma sector including regulators’ training. Top MNCs are serviced by Indian pharmac companies for their highly regulated markets and meeting their stringent quality expectations. There is an effective control system to monitor the quality of pharma at all levels in India. India has been enjoying investments by foreign investment companies. The Asia-Pacific Region including India is also a new destination for generic drugs industry. In fact, a leading pharma company in India has evolved customer centric division within the company that will provide custom research and manufacturing services (CRAMS) for large, mid-sized and emerging pharma entities globally. India has shown a tremendous growth potential for development in the pharma sector. With the right guidance, monitoring and support, we can surely surge ahead as a great nation. The conference shall focus on various aspects which shall be of immense use to the entire fraternity. Hoping to see a massive participation and encouragement during 65th IPC.

The pharma industry has

shalini.g@expressindia.com October 1-15, 2013

VISIT Join pharma professionals from all over the world to network and do business with pharma machinery, equipment and technology suppliers @ P-MEC India 2013!

Pharma Machinery, Equipment & Technology

3-5 December 2013 Bombay Exhibition Centre, Mumbai, India P-MEC India is part of the largest and most comprehensive pharmaceutical industry event in South Asia. Focused on pharmaceutical machinery, equipment, ingredients, outsourcing and bio-solutions, this is your ultimate one stop pharma shop! As the pharma industry is increasingly looking towards India to source low cost, high quality pharma solutions, P-MEC India and co-located events provide the perfect place to initiate and explore partnerships with key pharma companies from India and abroad.

CPhI - Halls 1, 2 & 3 P-MEC - Halls 6, 7, 8, 5 & Open Bay Area of Hall 5

P-MEC is an excellent platform to see the latest products in action. Most of us would like to see the machine performance live and P-MEC is the best place to see the product and thus facilitates the decision making process. Hitesh Doshi, Indeus Life Sciences Pvt. Ltd.

This event is an excellent opportunity to keep abreast with new developments in the pharma industry. Dr Prakash U.Tahiliani, Prime Ever Ayurvedic Research Laboratories

www.pmec-india.com

Co-located with:

Organised By:

M|A|R|K|E|T

PRE EVENTS Indore to host 2nd edition of PharmaTech Expo 2013 P Event to be held from October 6-8, 2013, to share ideas about the recent technologies in pharmaceuticals

harmaTechnologyIndex. com, KNS group of company and Indian Drug Manufacturers' Association (IDMA) will hold the 2nd edition of PharmaTech Expo 2013. The event will be held from October 6 to 8 at Brilliant Convention Centre, Indore. PharmaTech Expo 2013 will be a platform to share about the recent technologies in pharmaceuticals. A seminar/workshop will be organised on the second day of the expo whose first session will be conducted by IDMA and will be sponsored by Newtronic Lifecare Equipments. The topics which will be covered incude: Latest developments in stability chambers, planning and preparing for FDA inspections and Corrective and Preventive Measures (CAPA). The second session will be conducted by MSME and the topic covered will be Barcoding Technology. The event is being held in association with Pharmexcil and supported by MP Small Scale Drug Manufacturer’s Association (MPSSDMA), MP Pharmaceutical

Manufacturing Association (MPPMO), Pithampur Audhyogik Sanghathan (PAS), and Indian Analytical Instrument Association (IAIA). The event is being held with IMA PG India as its industry partner. Last PharmaTech Expo, which was held in April 2011, was attended by visitors from various spheres of industries like CEOs, purchase officers, researchers, academicians, production and R&D professionals of various pharma organisations which had around 120 exhibitors and 3000 visitors. For the upcoming event, a press conference was recently organised where renowned and industry related people made their presence. Welcoming the guests, Daara B Patel, Secretary General of IDMA emphasised the fast pace at which Indore and the nearby cities are becoming a pharma hub. He expects the 2nd Pharma Expo to be more successful and well attended exhibition. Paresh Chawla, Organising Committee Chairman informed that IDMA is forming its 6th State

Board namely IDMA Madhya Pradesh State Board and this would surely give a better impetus to the seminar. He also informed that the PharmaTech Expo will not only be beneficial for the pharma industry but it will be a very good platform for the pharmacy students as they will have good exposure to all the major machines used by the pharma industry which will be on display during the exhibition and also good learning from the seminars. Ramesh Shah, PharmaTechnologyIndex.com addressed the conference and said, “Indore being the hub of various large and medium scale pharma companies like Ranbaxy, IPCA, Lupin, Piramal, Alpa Labs, Cipla, Zest Pharma will provide for a good gateway to the pharma industry to exhibit at Indore and enhance their business output. Moreover, Mylan and Teva are now coming up with their new projects at Indore in a very big way. It will be a great opportunity for machinery and equipment suppliers in all pharma sectors to showcase their products at such a level to these industries.”

Himanshu Shah, Joint Secretary – Organising Committee informed that Indore is an industrial city, where a big number of large medium and small-scale industries are located in close vicinity. He also mentioned, “MSME may reimburse cost of the stalls to the micro and small enterprises who will be participating in this exhibition under the Market Assistance Scheme.” PharmaTech Expo 2013 will be an ideal platform to showcase new products and advanced technology before buyers, dealers and suppliers. The visitors can gather latest information about emerging market trends, technological innovations, upcoming market needs, new scientific developments, updates on regulations in pharma and allied industries through the displays at the expo. The exhibitors can strengthen cooperation by networking with their customers. The exhibition covers a space of 50000 sq ft. The expo will witness attendance by many overseas visitors and exhibitors. EP News Bureau - Mumbai

DIA to host 8th Annual Conference: The New Clinical Research Environment in India: Implications and Opportunities The New Clinical D Research Environment in India: Implications and Opportunities conference to be held in Bangalore on October 24-26, 2013

EXPRESS PHARMA

rug Information Association (DIA) will host the 8th Annual Conference at Nimhans Convention Centre in Bangalore. The conference titled ‘The New Clinical Research Environment in India: Implications and Opportunities’ to be held on October 24-26, 2013 will provide a forum for academia, industry, regulators and researchers to come together to discuss the new environment for healthcare product development in India, the challenges and the opportunities. Participants will know

about how their peers are coping with new regulations and how they are planning to realise the promise of emerging opportunities. The keynote speakers for the conference are Prof Ranjit Roy Chaudhury, Chairman, Task Force for Clinical Research, Apollo Hospitals Group, India and Mukhtar Ahmed, Vice President, Product Strategy, Oracle HSGBU, UK. The conference will be chaired by Shoibal Mukherjee, Vice President, CMO (India) and Head Asia, Medical Sciences Group, Quintiles and Sairamkumar J, www.expresspharmaonline.com

Senior Vice President and Global Delivery Head, Cognizant Life Sciences. The guests of honour for the conference are BR Jagashetty, Drugs Controller, Karnataka State and HG Koshia, Commissioner, Gujarat FDCA. Discussions will be held on topics like: Direction, outlook and vision for health related research in India; Review of recent changes in regulations and their implications; Challenges to global development and commercialisation ex-India; New opportunities for India-centric global delivery solutions; Global

benchmarks in health care research regulations; Patientcentric endeavours for awareness and ethics of research. Professionals, researchers and clinicians involved in drug discovery and development and regulatory affairs, for example drug development and clinical research managers and associates; pharma physicians and medical directors; drug safety and drug surveillance personnel; professionals engaged in discovery research; clinical pharmacology scientists are likely to attend the conference. EP News Bureau - Mumbai October 1-15, 2013

M|A|R|K|E|T

FEAPM and CIPI join PHARMA Pro&Pack Expo 2014 exhibition Special pavilion for analytical instruments products and services he 2nd international exhibition on pharma manufacturing technologies, PHARMA Pro&Pack Expo 2014, Mumbai, has received a good response from the industry. The exhibition is going to be held from April 24 to 26, 2014 at Mumbai Exhibition Centre, Mumbai. More than 54 per cent of the exhibit space has been confirmed and booked by the 2013 exhibiting companies at the exhibition venue on the last day of the PHARMA Pro&Pack Expo 2013, Mumbai Exhibition. Over a period of time, more and more companies have started joining the exhibition by confirming their exhibit space. The successful exhibition has left a strong footprint in the Indian pharmaceutical sector and has provided the best opportunity and the ideal platform to the industry to promote the Brand India concept. With the show being initiated, promoted and organised by industry itself, it helped in providing a common platform to one and all with a micro scaled entrepreneur sharing and exhibiting alongside the industry giants and promoting their skills and services. Various trade associations have extended their nonfinancial support to the exhibition, which include Federation of East African P h a r m a c e u t i c a l Manufacturers (FEAPM) and Confederation of Indian Pharmaceutical Industry (CIPI). Joining of FEAPM and CIPI are major driving force through their role played in building up the pharma fraternity along with trade. A special pavilion has been allocated for the analytical instruments’ companies, especially the member companies of the Indian Analytical Instrument Association (IAIA), also one of the supporting association of the exhibition. Rajesh Shah, Chairman, Maharshi Udyog and President, Indian Pharma Machinery Manufacturers Association (IPMMA)

October 1-15, 2013

informed, “PHARMA Pro&Pack Expo exhibition has been well recognised in

its launch edition. Moreover, as being industry’s own show, PHARMA Pro&Pack

Expo 2014 offers an excellent branding and promotions opportunities for the entire industry in a cost effective manner. We could be able to

deliver successfully the highly admired show with overall and manageable costing for every participant.” EP News Bureau - Mumbai

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From the idea to turnkey production in the pharmaceutical and biotech industries

Headquarters: Glatt Ingenieurtechnik GmbH Nordstrasse 12, 99427 Weimar / Germany phone: +49 -3643 -47-0 fax: +49 -3643 -47-1271 eMail: info@glatt-weimar.de Indian Office: Glatt (India) Pharma Engineering Pvt. Ltd. 13 Ground Floor Palam Marg, Vasant Vihar New Delhi - 110057 / India phone: +91 -11 - 460 529 60 / 61 / 62 fax: +91 -11 - 460 529 64 eMail: info@glatt-india.com

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POST EVENT IPCA executive council meeting held at New Delhi Reviews the preparation of 65th Indian Pharmaceutical Congress and other issues related to the event

meeting of the Executive Council of the Indian Pharmaceutical Congress Association (IPCA) was recently held at FICCI, New Delhi to review the preparation of 65th Indian Pharmaceutical Congress and other issues related to the event. The meeting was attended by the representatives of the Federating Associations of IPCA, namely Indian Pharmaceutical Association (IPA), Indian Pharmacy Graduates' Association (IPGA), Association of Pharmaceutical Teachers of India (APTI), The Indian Hospital Pharmacist Association (IHPA) and All India Drugs Control Officersâ&#x20AC;&#x2122; Confederation (AIDCOC). At the outset, Atul Nasa, President, IPCA, welcomed all the members and congratulated Prof B Suresh, for being unanimously elected as President of Pharmacy council of India (PCI) for the consecutive third term. He also con-

gratulated Prof Mahesh Burande for being elected as President of Association of Pharmacy Teachers of India (APTI). He also thanked the members for their support and sparing their valuable time to attend the meeting. Dr TV Narayana, Secretary, IPCA, took up the agenda items for the meeting. The report on the scientific services was presented by Dr TK Ravi, Convener, Scientific Services, IPCA. The last date for the submission of scientific abstracts has been extended to September 30, 2013 and for further details members/students can visit the website i.e. www.scientificipca.org Various scientific symposiums to be held during the 65th IPC, Delhi NCR are as follows: Presidents Symposium on Empowering Pharmacists; Standardisation of Biological products; Advances in Regulatory sciences and education; Pharma industry from here to where; Role of

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Community pharmacist in implementing Public health policy; Molecular Cardiovascular Pharmacology; Pharma Policies and Export; Empowering Pharma students through leadership development; Drug development regulations; Strategies to strengthen practice services. Dr Arun Garg, organising secretary, 65th IPC 2013 Delhi NCR, presented the detailed preparations for IPC. He apprised that the registration brochures has already been send to the members of the federating associations and around 750 pharmacy colleges in India. He also informed that the web site i.e. www.65ipcdelhi.com is fully functional with web solutions for the conference and online registration payment gateway. The first cut out date for the early registration is October 31, 2013 and members/delegates planning to attend the 65th IPC may register preferably before the first cutoff

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date. He also apprised the members that the efforts have been made for inviting the President and Prime Minister of India as the chief guests. The response for PHARMAceutical EXPO 2013 is also good. He further added the LOC of 65th IPC will take care of all steps and parameters to make comfortable stay and hospitality to all the participating delegates. Dr B Suresh apprised the members that Pharmacy Council of India is celebrating the Pharmacy Day on September 25, 2013 at Sirifort Auditorium, New Delhi. Dr GN Singh, Drugs Controller General (India) expressed that the conference should provide the maximum scientific output and ensured full support for the conference. The meeting ended with the vote of thanks by Dr Kaushik Desai, Joint Secretary, IPCA. EP News Bureau - Mumbai

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October 1-15, 2013

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EVENT BRIEF PharmaTech Expo 2013 Date: October 6-8, 2013 Venue: Brilliant Convention Centre, Indore Summary: PharmaTechnologyIndex.com and Indian Drug Manufacturers Association are jointly organising the second edition of PharmaTech Expo 2013 in association with Pharmexcil. Contact details Keena Shah PharmaTechnologyIndex.com 702, Corporate House Opp. Dinesh Hall, Income Tax Ashram Road Ahmedabad - 380009 Tel: (079) 27541142/ 27540493 Mob: 09825698756 Email: kns@pharmatechnologyindex.com Website: www.pharmatechexpo.com

Customer Day India 2013 Date: October 9, 2013 Venue: The Westin Mumbai Garden City Summary: Gerrresheimer, Schreiner MediPharm and Datwyler will organise 'Customer Day'. All three hosting companies are involved with pharmaceutical packaging. With this event, the company aims to provide a forum for sharing experiences, knowledge and market trends within the pharmaceutical industry. Contact details Mob: 7738193046 email: n.phulwadhwa@gerresheimer.com

3rd International Fellowship on Health Technology Assessment Date: October 21-26, 2013 Venue: IIT Madras Summary: Healthcare Technology Innovation Centre (HTIC) will conduct the 3rd International Fellowship on Health Technology Assessment (HTA) at IIT Madras in collaboration with National Health System Resource Centre (NHSRC).The fellowship programme will feature international and national faculty giving lectures on various facets of HTA. Contact details Mohammad Ameel Consultant Biomedical Engineer Healthcare Technology Division (Medical Devices) National Health Systems Resource Centre Ministry of Health & Family Welfare, Govt. of India NIHFW Campus, Munirka

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New Delhi - 110067 Tel: (011) 26108982/ 84/ 92/ 93 Fax: (011) 26108994/ 83 Mob: 9971234320 Email: Mohammad.Ameel @nhsrcindia.org Website: www.nhsrcindia.org

6th Symposium on Nasal and Pulmonary Drug Delivery Date: October 24-25, 2013 Venue: Hotel Novotel, Juhu, Mumbai Summary: The Indian Pharmaceutical Association announces the 6th Symposium on Nasal and Pulmonary Drug Delivery with a theme â&#x20AC;&#x2DC;Global Regulatory Trendsâ&#x20AC;&#x2122;.This two-day scientific symposium is tailored specifically to nasal and pulmonary drug delivery and will welcome a panel of highly renowned scientists and technical experts for sharing knowledge about Orally Inhaled and Nasal Drug Products (OINDPs) Contact details SD Joag Indian Pharmaceutical Association Kalina, Santacruz (East) Mumbai - 400 098 Tel: (022) 26671072 Fax: (022) 26670744 Email: ipacentre@ipapharma.org Website: www.ipapharma.org

8th Annual Conference: The New Clinical Research Environment in India: Implications and Opportunities Date: October 24-26, 2013 Venue: NIMHANS Convention Centre, Bangalore, India Summary: The conference will provide a forum for academia, industry, regulators and researchers to come together to discuss the new environment for health care product development in India, the challenges and the opportunities.

Hamied, Chairman and Managing Director, Cipla and an exponent of IPR in pharma. A commemorative publication of fond memories of Margi Patel Choksi through short articles and photographs will be published on the occasion. Announcement will be made about the proposed Margi Patel Choksi Memorial IPR Foundation, which will be a registered Public Trust (to be known as Margi Memorial Foundation).

Tel: (0120) 6528801 / (011) 65378800 Mob: 9810303916 (Delhi) / 9167280126 (Mumbai) Email: atanu@crayon4.com Website: www.pharmabiotika.com

Contact details C/o. GNA Patent Gurukul 3rd Floor, Shivmangal Next to Big BazaarAkurli Road, Kandivli (East) Mumbai - 400101Tel: (022) 28872058 / 40895454

Venue: The Westin Mumbai Garden City, Goregaon, Mumbai

analytica Anacon India 2013 Date: November 12-14, 2013 Venue: Bombay Exhibition Centre, Mumbai Summary: The seventh international trade fair and conference for laboratory technology, analysis, biotechnology and diagnostics will have visitors from various domains like, pharmaceutical, chemical and petrochemical, health care, food, electrical engineering and electronics, medical laboratory, medicine, universities, research institutes and more. Contact details Anish Gangar Sr Manager - Marketing Communications MMI India 507/508, INIZIOCardinal Gracias RoadChakala, Andheri (East)Mumbai 400 099 Mobile: 98205 82197 Email: anish.gangar@mmi-india.in

PHARMAbiotika 2013 Date: November 21-23, 2013

Contact details Manoj Trivedi, Senior Manager Marketing and Program Development, DIA India Cell: +91-98-1977-7493 Phone: +91-22-6765-3226 Email: Manoj.Trivedi@diaindia.org

Margi Memorial Lecture

Venue: Hitex Exhibition Centre, Hyderabad Summary: Doctors, nursing homes and hospitals, formulation organisations, API organisations, machinery and packaging, laboratory and analytical equipments, diagnostics, contract manufacturers and clinical research organisations will take part.The event will be colocated with IndiaLabExpo 2013.

Date: November 9, 2013 Venue: Law College Complex at SVKM, Vile Parle, Mumbai Summary: The first Margi Memorial Lecture will be delivered by Dr Yusuf

Contact details Atanu Bhattacharya Director Human Crayon Management Services C-28, Sector - 4 Noida - 201301, India

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Innovation in OTC Business: From Concepts to Action Date: November 22, 2013

Summary: CubeX, in association with Nicholas Hall & Company is organising a one-day conference, Innovation in OTC Business: From Concepts to Action. Hear the expert views of Nicholas Hall himself on innovation as a significant growth driver for OTC industry. Also, network with other expert speakers who have developed innovative strategies, spanning across various aspects such as business models, products, processes, marketing and channel management, into real-life action. Contact details CubeX (A Division of Sorento Healthcare Communications) Unit No. 12, Garodia Estate3/A Udyog Nagar, S. RoadGoregaon (West) Mumbai - 400 064 Maharashtra Tel: (022)4036 2008 Email: rshriyan@cubex.co.in

CPhI India Date: December 3-5, 2013 Venue: Bombay Exhibition Centre, Mumbai Summary: CPhI India will bring pharma professionals from all over the world to Mumbai and facilitates initiating and closing business deals.Take this opportunity to showcase your products and services while enhancing your brand at South Asia's leading pharma industry event. Contact details Chaitali Patil UBM India Times Square Unit No 1 & 2, 'B' Wing, 5th FloorAndheri Kurla Road Marol, Andheri (East) Mumbai - 400 059 Tel: (022) 61727162 Fax: (022) 61727273 Email: chaitali.patil@ubm.com

October 1-15, 2013

MANAGEMENT INSIGHT FOR MANAGING PHARMA

W H AT ’ S INSIDE

Patents in pharma industry in India PG30

MARKET 9 RESEARCH 33 PHARMA ALLY 36 PHARMA LIFE 71 October 1-15, 2013

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E Ever since the United Nations General Assembly designated October 1 as International Day of Older Persons in 1990 and similarly observed 1999 as International Year of Older Persons, policy makers across the world have been preparing for what is being called a ‘social transformation’. Utkarsh Palnitkar, Partner & National Head, Pharma & Life Sciences, KPMG India, points out that while the global population is projected to increase 3.7 times from 1950 to 2050, the number of those aged 60 and over will increase by a factor of nearly 10. Among the elderly, the portion of those aged 80 and over, is projected to increase by a factor of 26. Consider the numbers in India. Extrapolating from the 2001 census, the proportion of India’s population above 60 years, which was just 7.4 per cent in 2001, will balloon to over 300 million, representing a whopping 17 per cent by 2051. “We will have the problems of the West with none of the resources to tackle them,” rues Ranjit Shahani, Vice Chairman and Managing Director, Novartis India and President OPPI, citing changing lifestyles, smaller families and the break-up of the joint family system as the major reasons for this situation. India has awoken quite late to this reality. In 2010, it was ranked at the bottom of the Economist Intelligence Unit's “Quality of Death” Index, a first ever attempt devised to measure how different countries provided for end-of-life care. While it was understandable that a developed nation like the UK topped the index, the survey commissioned by the Lien Foundation, a Singaporean philanthropic organisation,

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RANJIT SHAHANI

DR NATA MENABDE

UTKARSH PALNITKAR

Vice Chairman & Managing Director, Novartis India and President OPPI

WHO representative to India

Partner & National Head Pharma & Life Sciences, KPMG in India

We will have the problems of the West with none of the resources to tackle them

The challenge for India, as for all countries all over the world, is not just to add further years to life but to add life to years

From a quality of life perspective, geriatric care comprises more than medicines

was a damning indictment. Developed nations have had longer to deal with such issues as their demographic profiles started ageing two decades back. However, the speed of ageing in developing nations has taken most policy makers by surprise. A WHO background note to World Health Day (WHD) 2012, which focused on ageing issues, made the point that while it took more than a century for France’s 65+ population to double from 7 to 14 per cent, it will take countries like Brazil and China less than a quarter of a century to reach the same growth. To compound this situation, each country has unique problems. As Palnitkar says, “The needs of geriatric patients vary with the geographical location and lifestyle of the larger demographic. In India 63 per cent of men over 50, smoke, compared to ~11 per cent in Ghana. In China, 51 per cent of women over 50 have high blood pressure, compared with 27 per cent in India. Within countries too certain regions will need more attention. A June 2011 report from the Ministry of Statistics & Programme

Implementation, Government of India, titled ‘Situation Analysis Of The Elderly in India’, highlights that ageing will be uneven across states. By 2026, North India population would be younger compared to the South. Similarly, by this year, Kerala will have highest educated working people with average age hovering above (median age) 35 years whereas Uttar Pradesh will have uneducated and less educated working population with average age below 30 years. Although projections indicate that India’s population above 60 years will be double in size between 2001 and 2026, the elders will account for 12.17 per cent of overall population in 2026. Being a vast country India may face a different set of problems in the rural and urban areas. Palnitkar also underlines that women in India are far worse impacted especially in rural areas – due to limited accessibility of healthcare and lack of support from family members. Statistically, around 75 per cent of the elderly live in rural areas of which over 48 per cent are women and of this, 55 per cent are widows. Nearly three out of five single

older women are not self dependent. While the rights of the elderly are enshrined in Articles 41 and 47 of the Constitution of India, the National Policy on Older Persons was announced in 1999. Further, legislative measures like the Senior Citizen Act, 2007 also protect the rights of senior citizens by stating that a family has to take care of their elderly. The Ministry of Health and Family Welfare (MoH&FW) has also launched the National Programme for Health Care of Elderly (NPHCE) in the XI Five Year Plan in 100 districts with plans to scale it up to the entire country.

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Customising geriatric care As policy makers add legislative layers to cover the social issues faced by the elderly, other sectors too are changing their approach to address this sector. Palnitkar says that there is a need to customise the healthcare/pharma landscape to meet the needs of this strata of society. Geriatric medicines – medicines used in the treatment of disorders that impact the elderly majorly October 1-15, 2013

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(orthopaedic disorders, CVS and CNS problems, auditory and visual impairment etc) – form a major component of geriatric care. According to him, a decade ago the global market was growing at a CAGR of 10-14 per cent and estimated close to $57 billion. Assuming a similar growth trajectory the market for geriatric drugs today is likely to be worth $125- 150 billion. All major pharma companies already have a sizeable geriatric care focus. Palnitkar points out that for established disorders like diabetes, Alzheimer’s etc – companies like Pfizer, J&J, and Novartis etc have well established portfolios. GSK is investing heavily in translational research in the field of Alzheimer’s which while a developed world disorder still impacts a huge fraction of geriatric patients. Astrazeneca too is building a strong portfolio in diabetes. Merck and Pfizer are established players in the field of geriatrics. Giving a further glimpse into the Novartis pipeline, Shahani mentions that while his company’s pharmaceuticals division alone has 138 projects in clinical development, some of this research, which is at an advanced stage of clinical trials, are in areas that are of particular concern for the elderly for e.g. for L-dopa-induced dyskinesia in Parkinson’s disease, Alzheimer’s disease and choroidal neovascularisation macular edema. Regulatory guidelines like the geriatric medicines strategy of the European Medicines Agency (EMA) which were released in February 2011, have served to focus attention on the many challenges involved in the treatment of older patients. These range from co-morbidities, lack of clinical trial data on the elderly population due to the ethical issues of involving this population in trials as well as challenges of drugdrug interactions and noncompliance issues. Palnitkar says companies are aligning their research focus to develop drugs and drug delivery systems specifically to treat geriatric patients. Companies are also carrying out trials and studies to determine the best drugs for the treatment of geriatric disorders and endorsing their prescription over other drugs in the category. October 1-15, 2013

Speaking about the impact of the EMA’s guidelines Palnitkar says, “The EMA’s guidelines have enhanced the use and import of the “Summary of product characteristics (SmPC) and package leaflet which accompanies the medication on purchase. Both the SmPC and package leaflet aim to provide users with clear and concise information on drug use.” Considering the complexities involved in the elderly, Shahani reasons, “There is a need to work in close proximity with the regulators and also plan the approach based on emerging safety data like periodic safety update reports (PSURs). Innovative clinical trial designs ensure that important pharmacodynamics parameters like drug-drug interactions are appropriately covered." Analysing drug research in this area, Palnitkar says it is focused on drugs whose mode of action is more “regeneration” rather than “halt progression”. Companies are also focussing on innovation in drug delivery to increase compliance, palatability and other physicochemical properties more suited to the geriatric population. Some of the thrust areas that are of focus are geriatric endocrinology, urology, CVS and rheumatology.

More than medicines But Palnitkar cautions that from a quality of life (QOL) perspective, geriatric care comprises more than medicines, with management www.expresspharmaonline.com

of health as a priority rather than the mere treatment of the disorder. Elderly patients may not necessarily need medical treatment but mental stimulation and activities to keep them occupied, therefore he advocates that players investing in this space should consider these factors while building a comprehensive care model. For example, he points out that since the elderly face a number of issues associated with drug use - non-compliance/skipping doses being a major one - healthcare companies in the US and Europe have designed tools/devices which serve to remind patients when it’s time to take the medicine. He suggests that Indian companies may want to explore this space too. Beyond pure play pharma products, health supplements to boost mind activity, increase physical vigour, depression management etc are all being explored by companies focusing on the neutraceutical segment. The WHO's take on the ageing crisis, is to look at this ‘major social transformation’ as both ‘a complex challenge and a great opportunity.’ As Dr Nata Menabde, WHO representative to India said in her message on World Health Day 2012, “The challenge for India, as for all countries all over the world, is not just to add further years to life but to add life to years.” India has made a start on this front with laws like the Senior Citizens Act, 2007 striving to address the issue in holistic terms. But as

Palnitkar points out, “India has not achieved much in terms of geriatric care. The traditional tertiary set-ups are currently not prepared for the coming challenges of the increasing elderly population because of the sheer size and diverse needs of this ageing generation. These challenges include both physical and mental health care needs – with the latter issue even more largely neglected than the former. The Indian system of care is not patient centric and importance is being given to treatment rather than management.” Shahani too lauds measures like the National Programme for Healthcare of the Elderly and the Senior Citizen’s Act as steps in the right direction but cautions that we need to ensure that these do not remain on paper but are implemented in letter and spirit. If the pharma industry claims a lion’s share of the credit for increasing lifespans across the globe, it is indeed but fitting that the sector plays as major a role in improving the quality of life as well. But social models of care are better equipped to take care of the elderly than medical models reiterates Palnitkar, advising that companies should endorse this approach when dealing with this segment of the market. “Elderly care is a function of synergy between community, government and the private sector fuelled mostly by the family of the patient,” he concludes. viveka.r@expressindia.com EXPRESS PHARMA

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LEGAL EAGAL Patents in pharma industry in India An overview on patent applications by Tarun Bansal, Founder, Sagious Research ntellectual property (IP) filings worldwide grew significantly in 2010 after experiencing a considerable drop in 2009. The growth of IP filings was stronger than overall economic growth. After this drop, patent and trademark filings worldwide grew by 7.2 per cent and 11.8 per cent. China and the US, the two offices accounted for the majority of worldwide growth. In the case of China, IP growth rates were more than double its GDP. The upsurge witnessed is led by China, with a growth rate of over 29 per cent. The same figure stands at little over 11 per cent for India. Patent applications growth rate of India, though being higher than that of the whole world, i.e. just over 7.5 per cent, India accounts to only two per cent of the total number of patent applications made globally. This when compared to other countries with high growth rate is very nominal. China takes over approximately a full quarter of the total patent applications in 2011 where as the US stands next to China with ~23 per cent and Europe at ~16 per cent. In India, most of the patent filings are made by non-residents. On the contrary, the indigenous patent filings of rest of the world and China account to a majority chunk in patent filings. The graphs show the ratio of residents filing patents vs non-residents filing patents: globally, in China and in India. On comparing the graphs, it reveals that over 60 per cent of the patent filings are done by residents. This shows the development and the growth of the indigenous units. When it comes to China, the same number grows up to 79 per cent in 2011. In China, the patent filings by residents have grown from ~54 per cent in 2005 to ~79 per cent in 2011. The scenario seems completely opposite in India. Out of total patent filings that happen in India, residents filing patents account to just ~20 per cent whereas non-residents who file patents in India

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account to ~80 per cent. This figure has been merely changing to Indiaâ&#x20AC;&#x2122;s favour in recent times. From 19 per cent in 2005, the Indian residents have filed up to ~21 per cent in 2011. The current figures accrue to a high number of filings from non-residents, this portrays that the indigenous units are yet to come up to a level where they can compete globally. The non-residents look towards harnessing the Indian markets for their beneficiaries. This shall also impact the Indian economy adversely by way of slow GDP growth and the growth being overtly attributed to overwhelming rise of non-resident filings in India. This may lead to initial inflow of FDI, but in the long

term, it may result in capital outflows as well. To help the Indian economy be self-competitive, innovation and inventions amongst the domestic units should play a vital role. The ratio of domestic filings to non-residential filings needs to be reversed in coming time. Though the number of filings by domestic units has been growing constantly, the pace is not sufficient to beat the overt filings by non-residents.

Summary of pharma patenting statistics in India In Indian pharmaceutical sector, the number of patents filed have increased from little over 3500 in 2004-2005 to over 5000 in 2010-11, thus the compounded annual growth of patents being filed in this

industry in India was found to be around five per cent for the period 2004 -11. However, there has been a significant change in the number of patents granted. It has risen manifold from 263 in 2004-05 to 2364 in 2008-9 to approximately 1000 in the recent times. Thus it not only indicates a significant improvement in quality of patents being filed but also a seriousness among players about their IP. Another important statistic that might be worth looking at is how pharma patenting has increased vis-Ă -vis overall growth in the total number of patent filed in India. The graph below demonstrates that growth in pharma industry has been slower as com-

Total patent filings (2005-2011; X-axis: years, Y-axis: Number of patents filed)

(Source: WIPO-IP Statistics)

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October 1-15, 2013

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pared to overall growth of patenting in India. Further, it is to be noted that patent filing in pharma sector in India is being led by MNCs rather that indigenous companies, which is a serious threat to the interests of Indian companies.

Patent filings: Residents vs Non-residents

History of pharma patent law and trade practices in India During the last two decades, Indian patent regime has undergone humongous changes, complying with the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement to move hand in hand with the global patent scenario. The 1970â&#x20AC;&#x2122;s Patent Act was made with an objective to encourage the development of an indigenous Indian pharma industry and to guarantee that the Indian public had access to low-cost drugs. As per Indian Patents Act 1970 only process patents were allowed for chemical entities while pharma product patents were not entertained or admissible. The term of patent protection for even the pharma process patents was intentionally kept short so as to develop and test new drugs. This allowed Indian companies to practice reverse engineering. Such a patent act groomed the domestic industry to build up considerable competencies and offer a large number of cheaper generic versions of patented pharma products at lower cost as long as they used a production process that differed from that used by the patent owner. India signed the GATT on April 15, 1994, thereby making it mandatory to comply with the requirements of GATT, including the agreement on TRIPS. The Patent (Amendment) Act 2005, implemented the product patent regime in India. The Amendment granted new patent holders a 20-year monopoly starting from the date the patent was filed. Product patent regime encouraged significant numbers of foreign pharma companies to participate in the Indian market and, in 2005, foreign drug producers filed approximately 8,926 patent applications to cover their patented drugs sold as generics in the Indian market. However, patentability still remains lower in India than in other markets such as Brazil, Russia, the US, Europe. This is mainly because Indian patent law does not allow patenting October 1-15, 2013

India

(Source: WIPO-IP Statistics)

Growth of total number of patents filed in pharma industry (Includes drugs and bio-tech) â&#x20AC;&#x201D; Total patents â&#x20AC;&#x201D; Filed pharma

(Source: IPO

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of different forms such as salts, esters, ethers, polymorphs and isomers. These decisions are taken on a case by case basis.

Predicting the future Looking at the statistics in section one of this article, the number of patent filings are not still very high and CAGR growth is just ~5 per cent. This indicates that generic products shall continue to dominate the Indian market. While the patent law will encourage the launch of new and more patent protected products, the effort on innovation will still be led by the foreign players rather than indigenous companies. According to a prediction by McKinsey, the innovative products can capture up to a 10 per cent share of total market by 2015. These statistics can go in favour of Indian players only if they understand the value of R&D and innovation, else if they just keep going behind generics they will start losing their market shares slowly to innovators. A graph of similar prediction for some other developing countries shows that looking at Brazil’s case, we can definitely relate to what we predicted above as you can see that 14-15 per cent share is attributed to innovative products and out of that 65-70 per cent is the share of MNCs. Accordingly, if we do not groom indigenous innovation, Indian companies are going to lose the market to MNCs as innovative products capture more and more market. The good thing is that we can see that leading Indian companies are thinking in the same direction and are spending more on research and development of new molecules.

Rising R&D can be attributed to rising number of patents in pharma sector References ● WIPO: IP Statistics ● Annual Report of The Office of The Controller General of Patents, Designs,Trade Marks 2010-11. ● India Pharma 2015: Unlocking the potential of Indian Pharmaceuticals Market, McKinsey & Co. ● Competition Law & Indian Pharma Industry, CENTAD ● Product Patent Regime Posed Indian Pharma Companies to Change Their Marketing Strategies : A Systematic Review, Prashant B. Kalaskar and P.N. Sagar ● Current Status of Pharmaceutical Patenting in India, Rau. B. S, Dr. Nair G.G. and Dr. Appaji P. V

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R&D in pharma has been increasing significantly, from approximately $120 billion in 2007 to approximately a little over $135 billion in the recent times. With the kind of investment going into R&D by the key players, they would want to maximise their earning by patenting their process and products. We hope that even the small and mid-sized pharma companies start thinking in this direction so that Indian pharma industry as a whole can emerge as leader to the worldwide pharma industry.

10% of the Indian market is likely to be patent protected by 2015 Base case

Share of market Per cent

Scenario

‘Aggressive market expansio’

12.16

‘Maintaining strong growth’

10-12

‘Slowung momentum’

Size of pharmaceuticals market US$ billion

Number of molecules launched by 2015

3.0-3.5

2.0-25

7-8

0.8-10

Number of molecules >US$ million

300

100+

150

-40

Source: McKinsey India Patent Share Model

Developing countries have seen varying levels of success of patented drugs

Brazil

China

Poland

Reimbursement regime ● More than 90% self pay

MNC presence ● 65-70% share of MNCs ● 8 MNCs in top 10 25-30% share increasing MNC interest

●

75-80% share (including European Gx players)

●

Rapidly expanding insurance coverage (+20% of urban) ● Small but increasing number of patented products in reimbursement list Co-pay (-60% by patient) ● Very few patented products in reimbursement list additions very infrequent

Regulatory / Government support ● Patent law and implementation broadly in line with that in more developed markets Major revision in patient law in year 2000 to conform to WTO ● Active efforts by government to crack down on infringement

Share of patented drugs 14-15% share of patented products in 10 years

●

Patient law and implementation broadly in line with that in more developed markets

5% share in 4-5 years

<5% after 10-12 years

Source: Secondary research; expert interviews; McKinsey research

Growing investments in R&D by major companies (In Rs Crs – Y axis) Ranbaxy DRL Sun Cadila Glenmark Cipla 70060050040030020010002001

2002

2003

2004

2005

2006

2007

2008

2009

2010

(Source: Product Patent Regime Posed Indian Pharma Companies to Change Their Marketing Strategies : A Systematic Review, Prashant B. Kalaskar and P.N.

And with the stronger yet highly economic patent regime in India, they can be sure of protecting their interwww.expresspharmaonline.com

ests at least in their domestic segment. For markets outside India and to share the costs of clinical trials, etc - they can get

in to a JV with other companies and can out-license their patented molecules to MNC’s on their own terms. October 1-15, 2013

RESEARCH

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CLINICAL UPDATE

Cancer drug may help treat diabetes: Study PG 34

Abbott’s high sensitive troponin test may help doctors more accurately diagnose heart attacks in women: Study

Obesity may increase migraine odds: Study PG 35

To be beneficial for women, who may have different presenting symptoms and are often under-diagnosed bbott announced its promising preliminary results from a study presented at the ESC Congress 2013, suggesting that its high sensitive troponin test may help doctors improve the diagnosis and prognosis of patients presenting with symptoms of a heart attack.1 The test could be particularly beneficial for women, who may have different presenting symptoms and are often under-diagnosed.2 The study, which is being conducted by researchers at the University of Edinburgh, is evaluating Abbott's ARCHITECT STAT High Sensitive Troponin-I (hsTnI) test, which received CE Mark in January 2013. Cardiac troponin, a protein found in the heart muscle, is considered the preferred biomarker to identify suspected heart attacks, because it can detect injury to the heart.3 Abbott's hsTnI test can measure very low levels of this protein, which is especially important for women, who often have lower levels of troponin than men.4 Researchers shared data from the first 1,126 patients of the study presenting with symptoms of a heart attack. Early findings demonstrate that women have lower peak levels of troponin than men, contributing to the under-diagnosis and therefore undertreatment of heart attacks for women. "Whilst men and women are just as likely to present to the emergency department with chest pain, currently men are twice as likely to be diagnosed with a heart attack. By using the Abbott high sensitive troponin test and different diagnostic thresholds for men

References 1. Anoop S, Mills, N, Griffiths M, et. al. High-sensitivity cardiac troponin and the underdiagnosis of myocardial infarction in women. Study presented at the ESC

October 1-15, 2013

and women, the frequency of diagnosis of heart attacks in women increased and was comparable to men,” said Dr Nicholas Mills, one of the key study authors and cardiologist, University of Edinburgh. “The findings of our study, when completed, could change the way we diagnose heart attacks in women, potentially reducing inequalities in the treatment and outcomes, and enabling everyone to receive the best care.” When completed in 2016, this study will include more than 25,000 patients across 10 centres in Scotland, making it one of the largest studies to evaluate the impact of high sensitive troponin tests on patient care. The study was funded by a special project grant from the British Heart Foundation with Abbott providing the ARCHITECT STAT hsTnI assay.

Congress 2013, September 4, 2013. 2. Pope JH, Aufderheide TP, Ruthazer R, et al. Missed diagnoses of acute cardiac ischemia in the emergency department. New England Journal of Medicine. 2000; 342:1163-1170.

“While Abbott’s high sensitive troponin test benefits both men and women with earlier detection of heart attacks, the potential to increase the diagnosis among women is especially important,” said John Frels, Divisional Vice President, Diagnostics Research, Abbott. “This is the first time we have seen a test that can provide this kind of detailed information to doctors and has the potential to aid doctors with improving the odds of survival for women with heart attacks.” The ARCHITECT STAT hsTnI assay is commercially available in several countries in Europe, as well as Canada, Australia, New Zealand, and Brazil and runs on Abbott’s fully automated ARCHITECT family of analysers. The test is currently for research-use only in the US. EP News Bureau - Mumbai

3. Thygesen K, Alpert JS, Jaffe AS et al. Third universal definition of myocardial infarction. European Heart Journal. 2012; 33:2551-2567. 4. Abbott ARCHITECT STAT High Sensitive Troponin-I product insert (PI), January 2013.

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MARKET 9 MANAGEMENT 27 PHARMA ALLY 36 PHARMA LIFE 71 EXPRESS PHARMA

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UPDATES

FDA approves Botox Cosmetic to improve appearance of crow’s feet

Cancer drug may help treat diabetes: Study Suggest findings from research using mice

he cancer drug Zaltrap (aflibercept) could help treat diabetes, suggest findings from research using mice. Scientists say they have identified a molecular pathway (a series of interactions among proteins) involved in the development of diabetes, and also found that the drug can regulate this pathway. Zaltrap is approved in the US to treat metastatic (spreading) colorectal cancer and the wet form of the eye disease macular degeneration. The drug inhibits the vascular endothelial growth factor (VEGF) pathway, thereby blocking the growth of blood vessels into tumours and starving them of oxygen. The researchers, from the Stanford University School of Medicine, identified a series of proteins that link VEGF inhibitors and blood glucose levels. “We were surprised to find

that this drug currently used in patients for cancer treatment had beneficial effects on diabetes in laboratory mice and could, potentially, in humans,” Dr Calvin Kuo, a professor of medicine, said in a university news release. Scientists caution, however, that research with animals often fails to provide similar results in humans. "Proteins involved in this pathway could be targeted for the development of new diabetes therapies," Amato Giaccia, a professor of Cancer Biology and Director of Radiation Oncology, said in the news release. The findings appeared in two articles in the journal Nature Medicine. The researchers said there have been indications that VEGF inhibitors such as Zaltrap could influence blood glucose levels in people, but

Is the only FDA approved drug treatment option for lateral canthal lines

no human studies have been conducted. “Anecdotally, there have been reports that diabetic patients who have been prescribed VEGF inhibitors to treat their cancer are better able to control their diabetes,” Kuo said. Three co-authors of Kuo’s study are employees at Regeneron Pharmaceuticals, which makes aflibercept. EP News Bureau - Mumbai

Exercise, diet habits improving among youth: Study Surveys conducted in O middle and high schools ver the last decade, US kids and teenagers have started getting slightly more exercise and reduced their television watching, a new study suggests. Using surveys conducted in middle and high schools, researchers also found increases in the number of days youth reported having breakfast each week and in how often they ate fruits and vegetables. Those trends have corresponded to a levelling off in obesity rates, but not a decline, the study showed. “I would like to believe that all the public health efforts focusing on increasing physical activity and increasing fruit and vegetable consumption are having an effect, because that seems to be a pattern,” Ronald Iannotti, the lead author on the study from the University of Massachusetts Boston, said. “The fact that (obesity) is levelling off, that’s a surprise and a major change from the steady increase that we've seen over time," Iannotti, who worked on the study while at the Eunice Kennedy Shriver

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National Institute of Child Health and Human Development in Bethesda, Maryland, said. He and co-author Jing Wang analysed surveys given to a nationally-representative sample of students in sixth through tenth grades in 20012002, 2005-2006 and 20092010 as part of the Health Behavior in School-aged Children study. Each survey period included responses from between 9,000 and 15,000 adolescents. The researchers found "encouraging" trends on measures of most diet and lifestyle habits. For example, the number of days each week that kids reported being physically active for at least 60 minutes increased from 4.3 in 20012002 to 4.5 in 2009-2010, with similar trends among boys and girls. Likewise, youth reported eating breakfast on three school days each week on the first survey and 3.3 days on the last. The average number of hours students spent watching TV each day fell from 3.1 to www.expresspharmaonline.com

he US Food and Drug Administration (US FDA) has approved a new use for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe lateral canthal lines, known as crow’s feet, in adults. Botox Cosmetic is the only FDA approved drug treatment option for lateral canthal lines. The FDA approved botox cosmetic in 2002 for the temporary improvement of glabellar lines (wrinkles between the eyebrows, known as frown lines), in adults. Botox Cosmetic works by keeping muscles from tightening so wrinkles are less prominent. “This additional indication will provide people with a new FDA approved treatment option for those seeking a smoother appearance by temporarily minimising the appearance of crow’s feet at the sides of the eyes,” said Susan Walker, Director of the Division of Dermatology and Dental Products in the FDA’s Center for Drug Evaluation and Research. Botox Cosmetic is administered via intramuscular injections. Treatment for both frown lines and crow’s feet can be given at the same time. Botox Cosmetic’s safety and effectiveness for treating lateral canthal lines were established in two clinical efficacy and safety studies. The studies enrolled 833 adult participants with moderate to severe lateral canthal lines who were randomly assigned to receive Botox or placebo. Results showed that those treated with botox had greater improvement compared to placebo in the appearance of lateral canthal lines. FDA

2.4, with drops in both weekday and weekend viewing. Frequency of fruit and vegetable consumption also rose slightly over time - although it remained at less than one daily serving of each, on average and consumption of sweets and soft drinks fell. However, the proportion of survey participants who were overweight or obese, based on their own height and weight reports, did not decrease, the researchers wrote in Pediatrics. Rates of obesity, defined as body mass index, a measure of weight in relation to height, in the 95th percentile or higher, rose from 10.3 per cent in 2001-2002 to 12.7 per cent in 2005-2006, then held steady through the final survey. "This is encouraging, because at least it looks like things have kind of stabilised, and at least they're not going in the wrong direction," Marian Huhman, who studies health communication and health campaigns at the University of Illinois at Urbana-Champaign, said. Reuters Health

October 1-15, 2013

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Obesity may increase migraine Study found risk of painful headaches rose with body weight, especially in younger women and whites

pisodic migraines, the more common type of migraine, occur 14 days or fewer per month, while chronic migraines occur at least 15 days per month. Migraines involve intense pulsing or throbbing pain in one area of the head, according to the American Academy of Neurology. Symptoms can include nausea, vomiting and sensitivity to light and sound. Migraines affect more than 10 per cent of the population. In the study of more than 3,800 adults, those with a high body-mass index (BMI), a measure of body fat determined using height and weight, were 81 per cent more likely to have episodic migraines than those with a lower BMI. This was particularly true among women, whites and those under the age of 50. The cross-sectional study doesn’t prove that obesity causes episodic migraines, but it does demonstrate that people who are obese have an increased risk of having more of them, even low-frequency ones, said lead author Dr Barbara Lee Peterlin, Director of Headache Research, Johns Hopkins University School of Medicine, in Baltimore. “These results suggest that doctors should promote healthy lifestyle choices for diet and exercise in people

with episodic migraine,” Peterlin said in a statement. “More research is needed to evaluate whether weight-loss programmes can be helpful in overweight and obese people with episodic migraine.” The study was published in journal Neurology. The researchers also presented the findings in June at the International Headache Congress in Boston. Dr Gretchen Tietjen, Director of the headache treatment and research programme at the University of Toledo, in Ohio, said she found the findings interesting because previous studies had looked for connections between obesity and chronic migraines. “That the researchers were able to show an association between obesity and episodic migraine lends more credence to some of the earlier studies that found similar things,” she said. She pointed out, however, that it still isn’t known which came first, the obesity or the migraine. There are many possible scenarios, Tietjen said. “Maybe the person had the migraines first and then started taking medications like amitriptyline or valproic acid,” she said. “Those medications are associated with weight gain.” The possible connection between obesity and

migraines is still under debate. One theory supporting the link centres on inflammatory substances from fat tissue (adipose) that are released into the system, Tietjen said. Premenopausal women have more total adipose tissue in general than men, and women have more superficial and less deep adipose tissue, Peterlin said. But after menopause, adipose tissue is more similar between the two sexes. Adipose tissue secretes different inflammatory proteins based on how much tissue there is and where it is located. Since younger women and obese people have more adipose tissue, this could, at least in part, explain why they get more headaches. On the other hand, Peterlin also suggested that a possible connection may be related to the brain. “Previous imaging data in migraine patients have shown activation of the hypothalamus, a part of the brain that controls the drive to feed,” she said. Alternatively, it could be that people who have migraines may be more inclined to behaviours associated with weight gain, such as being less active. Would losing weight mean migraines will decrease

in frequency? Although weight loss is generally encouraged for people who are obese, that won't necessarily result in migraine relief, Peterlin and Tietjen said. At least two small studies have evaluated migraines in people who were obese and underwent bariatric surgery to lose weight, Peterlin said. Although these studies did find that some patients experienced fewer headaches, the studies were small and more research needs to be done to see if this is consistent. It’s possible that the lifestyle changes needed for weight loss cut the migraine frequency, rather than the weight loss itself, the experts said. People who eliminate processed foods, high-calorie foods and alcohol, all of which can be migraine triggers, could end up experiencing fewer headaches. Unfortunately, the opposite could also be true if dieters introduce new foods that are migraine triggers. Some people may develop migraines when they consume certain sugar substitutes, for example. There also is limited data suggesting that people with severe obesity who exercise may have fewer migraines, Peterlin said. EP News Bureau - Mumbai

Gene mutation may predict lung cancer survival in non-smokers The mutation, which R occurs in a gene that protects cells from oxidative stress, is found four times more often in women than in men

October 1-15, 2013

esearchers say they've identified a gene mutation that's associated with a higher risk of lung cancer in women who do not smoke, but a better chance of survival in female and male lung cancer patients. The mutation, which occurs in a gene that protects cells from oxidative stress, is found four times more often in women than in men, according to the study published in the journal PLoS One. The researchers analysed the DNA of lung cancer patients in Japan and found that nonsmoking women with two copies of the -617A mutation in the NFR2 gene had a much higher incidence of lung cancer than non-smoking men. The investigators also

found that both female and male lung cancer patients with this mutation had better survival rates than other patients. This is the first study to provide clinical evidence that this mutation is associated with lung cancer patient survival, said researcher Dr Toshihisa Ishikawa and colleagues at the RIKEN Center for Life Science Technologies in Japan. The study strongly suggests that the presence of this mutation "is a good prognostic biomarker for the assessment of the overall survival chances of patients with adenocarcinoma, as well as a practical tool for personalised cancer therapy,” Ishikawa said in a RIKEN news release. Although the study found an association between the www.expresspharmaonline.com

gene mutation and lung cancer survival, it did not prove a cause-and-effect relationship. Lung cancer is the leading cause of cancer-related deaths in many industrialised coun-

tries, according to background information in the news release. Smoking is the main cause of lung cancer, but 10 per cent to 15 per cent of cases occur in non-smokers. EP News Bureau - Mumbai EXPRESS PHARMA

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Considerations on skin medication dispensing PG 40 Safeguarding products is top challenge for Asia’s healthcare executives: Survey PG 44 Carrier Transicold launches Citimax range of LCV and truck refrigeration units PG 45 Thermo Fisher Scientific introduces high performance gas chromatograph PG 46 Avantor Performance Materials launches polysorbates products PG 47 Merck Millipore launches novel Clarisolve depth filters PG 48

MARKET 9 MANAGEMENT 27 RESEARCH 33 PHARMA LIFE 71 36

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PHARMA ALLY INSIGHT

Gunning for growth with GLP Aruna Deshmukh, Quality Manager in Life Science stream of Infosys gives an insight on the need for good laboratory practices and the advantages of adopting it to propel growth and progress in the pharma industry eed of Good Laboratory Practice (GLP) or similar organisational process, was always felt in the industry, for an assurance of quality. In the absence of any such process and due to commercial greed, products of questionable quality reached the markets and caused adverse effects or even deaths in humans. Since the early twentieth century, efforts were being made to put Government regulations in place, to assure quality and safety of products, before their marketing approval for human consumption. Needless to say that, these earlier regulations were weak and with in-built flaws. Therefore advantages were taken by the industries to make profits by releasing products for sale without, adequate verification of their quality or safety. Unfortunately most regulations were promulgated after the tragedies had occurred. Finally in June 1979, the US FDA implemented GLPs in the US. In spite of it, in the US itself as recently as in 2001, a case of serious violations was detected by the US FDA and it had issued a warning letter of disqualification to ‘Coulston Foundation’, because during its facility inspection by FDA, serious violations/flaws were detected in data integrity, which would have had wide spread consequences for human safety (Lepay, 1999). Even now we continue to encounter adverse events. For example, Cerivastatin and Rosuvastatin were withdrawn from the market due to Rhabdomyolysis. COX-2 inhibitors have shown cardiac and hepatic toxicity. These examples, beyond doubt reiterate that, there is

a ‘Need of GLP in Industry’ for absolute assurance of quality and safety of products, particularly in postGATT era of Global competition, when each industry is fiercely competing to bring its products ‘fast and first into market’.

History “We can never be fully in possession of a science until we know the history of its development” – Charles Greene Cumston, 1926. The making of GLP regulations was preceded by several tragic events, where human life was either lost or compromised. Finally enforcement of the GLP regulations in 1979, was culmination of several such events. Although, it is not the complete list, following are just a few examples of the tragic events that occurred in the last 100 years. ● 1901 (US): Diphtheria antitoxin got contaminated with tetanus and 130 children died.

1930 (EU): In Germany, BCG vaccine was contaminated causing 75 deaths and 160 injuries.

●

1930 (US): Lyndol oil was used in ‘Jamaican ginger’ resulted in spinal cord injury, causing irreversible paralysis to over 50,000 people.

●

1937 (US): Sulfanilamide elixir, containing diethylene glycol, caused 107 deaths by renal toxicity, mostly children, due to commercial release of untested drug by M/s SE Massengill Co, in Bristol, Tennessee, (US). Company's chief chemist, Harold Cole Watkins, who had prepared the ‘elixir’

●

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committed suicide after learning of the effects of his latest concoction. In 1959, ‘Grey baby syndrome’ was reported due to Chloramphenicol toxicity responsible for deaths in new born babies even at therapeutic doses (Sutherland, 1959). Between 1956-61, ‘Thalidomide tragedy’ shook entire world and scientific community. Thalidomide was introduced in Europe, by a West German pharmaceutical company, Chemie Gruenthal, for the treatment of nausea in early pregnancy and as a mild sedative. It was sold as an OTC product by 1957 in Europe. About 12,000 children were born with phocomelia and many others with eye and ear defects (McBride, 1961). Thalidomide was never allowed to reach the US market. Thanks to the single handed efforts made by one lady, Dr Frances Kelsey, of US FDA (2001). She refused to grant permission to sell Thalidomide in US market and thus became ‘Bete Noire’ of M/s Richardson-Merrell Pharmaceutical Co, who had applied to FDA for permission to sell Thalidomide (named as Kevadon) in US. After the ‘Thalidomide tragedy’, several amendments in drug safety acts in US (Kefauver-Harris amendment, 1962) and EU were made requiring the pharma industries to give evidence of safety and even efficacy before marketing a new drug.

Principles of GLP During the year 1975, US FDA inspected Searle Pharmaceuticals and Industrial Bio-Test Laboratories to review and monitor the preclinical data submitted. Several examples

of irregularities and fraudulent practices were noticed. A few are given below (Dent, 2004). Results were found to be manipulated to suit the requirements, scientific findings were faked or suppressed, animals were given wrong doses or even wrong compounds, animals found dead on the previous page of the register, became alive on the next page and were found to be merrily living till end of the study, entire carcass of animals were preserved in fixatives and histopathology reports were submitted without microscopic examination of tissues. During FDA inspections, it had revealed many cases of badly managed studies by unqualified and untrained study directors and study personnel. The protocols were poorly designed and procedures were not followed properly. The equipment were not calibrated. Characterisation of test items and test systems and archiving were inadequate. There were discrepancies or no traceability or approval of raw data by responsible study personnel. Standard procedures were not laid down and animal husbandry was poor. In 1975-76, as a fall out of these inspections, the US FDA in collaboration with Searle Pharmaceuticals, drafted first GLP proposal October 1-15, 2013

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and published it in the Federal Register on 19th November 1976. Final draft rule 21CFR part 58 was published on December 22, 1978. It became a law on June 20, 1979. Final rule for industries was published in 1987 as ‘Guidance for Industry’ and it was last revised in 1997. In 1981 Organisation for Economic Cooperation and Development (OECD) adopted GLP guidelines, which were revised in 1997, cancelling and replacing the original principles adopted in 1981 (OECD, 1998). International Conference on Harmonization (ICH) was formed to harmonise GLP guidelines in Europe, Japan and the US (ICH, 1990). On November 26, 1997, Mutual Acceptance of Data (MAD) agreement was signed (OECD, 1997). The principle of GLPs has been to promote development of quality test-data. Comparable quality of test-data across the industries and countries, formed the basis of ‘MAD’ agreement. In India, National GLP Compliance Monitoring Authority was established by the Department of Science and Technology, Government of India, with the approval of the Union Cabinet on April 24, 2002. Presently, India enjoys the status of a provisional member of the OECD for GLP. India is an observer to the OECD’s Working Group on GLP and also a member of the OECD Test Guidelines Programme (DST 2005). Since the theme of this chapter is ‘Need of GLP in Industry’, it will be prudent to take a look at the short overview of the principles of GLPs to understand its ‘need’ in the industry. Through the salient features of this overview (US FDA 1997, OECD 1998 and OGLP 2000), we shall be able to appreciate that ‘GLPs’ have been prepared as ‘Guidance to Industries’ to assure quality of preclinical safety data. Needless to say, that the procedures described in these ‘guidance documents’ have been designed, especially for the pharma industries, which are engaged to discover, test, manufacture and market new drugs.

chemicals to obtain data on their properties and/or their safety with respect to human health or the environment. It also includes the work conducted in the field studies and these data are developed for the purpose of meeting the regulatory requirements. ➤ Definitions

of Terms

GLP: It is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. Please note the underlined words in the above mentioned definition of GLP. These words have specific meaning and refer to the respective functions, covered under GLPs. Any industry, aiming to be a GLP compliant facility, needs to address each issue, that has been elaborated in the following paragraphs. Study categories: These are toxicology, mutagenicity, ecotoxicology, environmental behaviour and bio-accumulation, residue analysis, impact on mesocosms and natural ecosystems, physical and chemical properties and analytical chemistry.

■

■ Test facility: It means the person/s, premises and operational unit/s, required for carrying out non-clinical safety studies.

The principles of good laboratory practices are applied to the testing of October 1-15, 2013

It is undertaken to ascertain that the test facility carries out processes and methods and data generated comply to GLP principles. www.expresspharmaonline.com

studies in the test facility. It helps for the assessment of work-load of study personnel and for the tracking of studies at the test facility. Test system: Any biological, chemical or physical system/agent or a combination thereof.

■

Sponsor: The entity, which commissions or supports conduct of non-clinical safety studies.

■

■ Inspection:

➤ Scope

Test facility management: The person/s having authority and responsibility for the functioning of test facility according to the principles of GLP.

■

Raw data: All original test facility records and documentation or verified copies thereof depicting results of original observations and activities in a study. ■

Study director: The individual responsible for overall conduct of non-clinical safety study. ■

Principle investigator: Acts on behalf of the study director for conduct of multisite studies.

■

■ Quality assurance programme: Test facility should have a documented quality assurance programme to ensure that studies performed are in compliance with the principles of GLP.

Standard operating procedures (SOPs): These are documented procedures describing about how to perform test or activities normally not specified in study plans or guidelines. ■

■ Study

plan: For each study, a written plan should exist prior to the initiation of study. It defines the objective and experimental design for the conduct of the study. It should be approved by dated signature of study director and verified by quality assurance personnel. The study plan should also be approved by the test facility management. ■ Master schedule: It is a compilation of information regarding all the ongoing

■ Specimen: Any material derived from a test system for examination, analysis and retention. ■ Experimental starting date: Date on which first study specific data are collected/recorded. ■ Experimental completion date: The last date on which data are collected from the study.

Study initiation date: The date on which study director signs the study plan.

■

■ Study completion date: It means the date study director signs the final report. ■ Test item: It is a substance (chemical or a mixture) which is under investigation.

Reference/control item: Any article used to provide a basis for comparison with test item.

■

■ Vehicle: Any agent serving as a carrier employed to mix, disperse or solubilise the test or reference item

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should be made available. Archives should have proper security and SOPs for its functions. Handling and disposal of wastes generated during performance of study should be carried out in a manner consistent with national/international regulatory requirements.

to facilitate administration / application to the test system. ➤ Organisation

and

personnel

■ Responsibilities of management: The test facility management has the authority and formal responsibility for the functioning of the test facility according to the principles of GLPs. It should enroll qualified, experienced and trained study directors and study personnel before initiation of the study. Provide appropriate facilities, equipment and materials for proper conduct of each study. The functions of each person should be clearly defined and where necessary training is given and its records are kept. It should put in place SOPs and a quality assurance programme with properly trained personnel. The management should also provide safety and health monitoring systems, for all study personnel, according to national/international regulations.

Responsibilities of the study director: Study director is the single point of study control. He has responsibility for overall conduct of the study. He should prepare study plans and get approval from the management, before each study start. He is responsible to document and record the raw data generated during the study as per study plan. At termination of the study, he should prepare final report and get it approved from quality assurance. The study director must archive the study plans, final reports, raw data and any other supporting material related to the study, at the termination of each study.

■

➤ Test

of personnel: All the study personnel should have adequate qualifications and training for conduct of study, noting down clinical observations and raw data recording. They should exercise safe working practice as per SOPs and should take proper health precautions to minimise risks to themselves and the test system for integrity of the study. Personnel having illness or any medical condition, that is likely to have any adverse effect on the study, should be excluded from the operations of that study until recovered medically.

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system

It is any biological, chemical or physical system/agent or a combination thereof used in a study. Suitable conditions are required to be established for maintenance and care of biological test system. Newly received animals/plant test system should be isolated until their health status has been evaluated. At the experimental starting date the test system should be free of any diseases, which might interfere with conclusion of the study. Records of its source, date of arrival and conditions at arrival, should be maintained. Biological test system should be acclimatised to the test environment for an adequate period before administration of test item for the first time. All information needed to properly identify the test system should appear on the labels of their housing or containers. ➤ Test

■ Responsibilities

Equipment: Equipment / apparatus of proper design and capacity used for the generation, storage and retrieval of data and for controlling environmental factors relevant to the study and validated computerised systems, should be suitably located. Any equipment used in the study should be periodically inspected, cleaned, maintained and calibrated according to SOPs. Record of these activities should be maintained.

■

and control items

Receipt, handling, sampling and storage: All the records regarding test item characterisation, date of receipt, quantities received and used in the study, should be maintained. Handling, sampling and storage procedures should be identified in order to ensure homogeneity and stability and to prevent contamination or mix-ups. Storage container should carry identification number, expiry date and specific storage condition/s.

■

■ Characterisation: Each test/reference item should be appropriately identified (CAS number, name). For each

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study, identity, batch number, purity, stability, composition, concentration or other characterisations should be defined for every batch with respect to test and control items. If the test item is administered in any vehicle, the procedure/s should be established for testing the homogeneity and stability of test item in that vehicle. A sample for analytical purpose from each batch of test item should be retained for studies in which the test item is tested longer than four weeks. ➤ Facilities

and equipment

Facilities: The test facilities of a suitable size, construction and location should be made available to meet the requirements of the study. Attention should be paid to minimise disturbances that would interfere with validity of the study. Design of the test facility should provide an adequate degree of separation of different activities to assure proper conduct of each study. It should have separate facility to house different test systems, individual projects and sufficient number of rooms having controlled temperature and humidity as specified (Guide for the care and use of laboratory animals, 1996). To prevent contamination and mix ups, separate rooms for receipt and storage of test and reference items and for mixing the test items with vehicles should be provided. Archiving facility of adequate size with appropriate separation for storage and retrieval of raw data, reports, samples, wet and dry specimens

➤ Standard

Operating Procedures (SOPs) General: SOP is a document, described as 'Write what you do and do what you write'. A test facility should have written SOPs approved by the management which are intended to assure quality and integrity of the data generated in preclinical safety studies. Each laboratory unit should have immediately available SOPs relevant to the activities performed. Text books, articles and manuals may be used as supplement to the SOPs.

■

■ Application:

SOP should be available for following categories of laboratory activities/functions: a. Test/reference items: Receipt, identification, labeling, handling, sampling, storage. b. Equipment / apparatus and reagents: Use, maintenance, cleaning, calibration, environmental control and preparation of reagents. c. Record keeping, reporting, storage and retrieval: Coding of studies, data collection, preparation of reports, indexing systems, handling of data and computerised data. d. Test system: Room preparation and its environmental conditions. Procedures for receipt, transfer, proper placement, identification and care of test system. Observations to be made before, during and at October 1-15, 2013

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termination of the study. Handling of animals found moribund or dead during the study. Collection, identification and handling of specimens including necropsy and histopathology. ➤ Performance

of the

study

■ Study plan: For each study, a study plan should exist in a written form prior to initiation of the study and it should be retained as raw data. All changes, modifications or revisions of the study plan should be documented, signed and dated by the study director and should be maintained with the study plan.

Content of the study plan: It should contain identification of the study, test and reference items and a descriptive title. A statement describing nature and purpose of the study. Date of agreement to study plan by signature of the study director and test facility management/sponsor. Proposed starting and completion dates. Reference of the test guidelines. Justification of test system and dosage. Method of administration and justification of its choice. Information regarding chronological procedures of the study, material and methods, type and frequency of analysis, observations and examinations to be performed.

■

➤ Reporting

and archiving

Reporting: A final report should be prepared for each study by the study director. The report should indicate extent of GLP compliance and validity of data. It should include identification of the study, test and reference items and a descriptive title. Information concerning the sponsor and the test facility and experimental starting and completion date. A quality assurance programme statement, listing the type of inspections made with dates and confirmation that the final report reflected the raw data. Description of material and test methods, details of the results including tables and determination of statistical significance, discussion and conclusion. Information regarding archiving of study plan, test and reference items, specimens, raw data, reports etc. ■ Archiving: Following should be retained in the October 1-15, 2013

RESULTS OF INSPECTIONS SHOULD BE PROMPTLY REPORTED IN WRITING TO THE MANAGEMENT AND STUDY DIRECTOR. A SIGNED STATEMENT SHOULD BE INCLUDED IN THE FINAL REPORT SPECIFYING TYPES OF INSPECTIONS MADE WITH DATES.THIS STATEMENT WOULD SERVE TO CONFIRM THAT THE FINAL REPORT CORRECTLY REFLECTED THE RAW DATA archives for the period specified by the authorities. Study plans, raw data, samples of test and control items, wet specimens and final report of each study. Records of all inspections performed by quality assurance programme and master schedules. Records of qualifications, experience, training, job description and health monitoring of study-personnel. Records of maintenance and calibration of equipment. Validation documents of computerised system, historical file of all SOPs, environmental monitoring record etc. Materials retained in the archives should be indexed to facilitate orderly storage and retrieval. Only personnel authorised by the management should have assess to archives. Movement of material in and out of the archives should be properly documented. ➤ Quality

assurance programme

■ General: The test facility should have a documented quality assurance programme to ensure that the studies performed are in compliance with the principles of GLPs. It should be carried out as per SOPs by trained individual or individuals designated by and directly responsible to test facility management and who are familiar with the test procedures. The individual should not be involved in conduct of the study being assured/audited.

Responsibilities of the quality assurance (QA) personnel: Maintain copies of all approved study plans, SOPs and master schedule. QA should verify study plans for compliance with the principles of GLPs and

■

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this compliance should be documented. Inspections should be conducted to determine that the studies were carried out in accordance with the study plans and SOPs. The inspections could be study based, facility based and process based. Records of such inspections should be retained. Final report should be inspected for accurate reporting of results and complete reflection of raw data of the study. Results of inspections should be promptly reported in writing to the management and study director. A signed statement should be included in the final report specifying types of inspections made with dates. This statement would serve to confirm that the final report correctly reflected the raw data.

Epilogue Events enumerated in the ‘History’ and ‘Introduction’ have proven beyond doubt that, regulatory guidelines were necessary for the industries, to establish proper systems to assure quality and safety of products before their marketing, to prevent man made disasters, due to negligence. After going through the overview of GLPs, it is quite evident that each step, therein, has been designed to address issues related to industries. The GLP ‘guidance documents’ are especially applicable to the pharma industries for assurance of quality, safety, truthfulness, validity and integrity of preclinical safety studies. It is a system which enables to reconstruct the events of preclinical safety studies, such as how and where the studies were conducted, how the data were

generated and archived, who was responsible, whether the raw-data and reports were audited, as per GLP regulations, by QA programme and a statement to the effect was issued by QA. In each industry, ‘Test facility management’ is supposed to have an authority and overall responsibility to implement principles of GLPs, appoint study-directors and study personnel with appropriate qualifications, experience and training. Arrange training programmes and maintain records of such programmes. In GLPs each step or process has been made auditable, such as characterisation of test and control items, their purity, stability, stability in vehicle, storage conditions etc. For test systems, methods for maintenance of culture for in-vitro systems and for in-vivo systems, proper housing conditions, adequate facilities with sufficient number of rooms for segregation of species and studies, specified temperature and humidity control in each room, clean and dirty areas, regular analysis of feed and water and documentation of records of reach activity to help the audit process during inspections. In post-GATT scenario, every industry, especially pharma industry, is looking forward to be an international player and to achieve this goal, GLP compliance has become not only necessary but almost mandatory. India has shown great potentials in every scientific field. Just like in IT industry, India is all set to be a global player in pharma industry, as well, and to achieve that goal, they need to comply with the principles of GLPs. Indian National GLP compliance monitoring authority has already taken a step forward in this direction and has commenced GLP inspections of the pharma industries, that carry out preclinical safety studies for filing of INDs and NDAs. Indian pharma Industry, with GLP firmly in place, soon would be the ‘numero uno’ and would be able to prevent commercial release of improperly tested new drugs, that may be responsible for yet another ‘Thalidomide’ like tragedy. EXPRESS PHARMA

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VALUE ADD

Considerations on skin medication dispensing Dr Stefan Hellbardt, Vice President, Business Development, Consumer Healthcare Division, Aptar Pharma, focuses on trends in topical skin medication, the impact on primary packaging and possible dispensing solutions

kin diseases are among the most common diseases worldwide. Approximately one third of the population is affected with a pathological skin problem during lifetime. In 2010, the total dermatology drug market has been valued at $26.8 billion and is estimated to grow at a CAGR of 3.7 per cent until 2015. This growth will slow down during subsequent years with the dermatology market reaching an estimate volume of $37.8 billion in 2026[1]. In contrast to that, Asian dermatology markets have enjoyed a growth at a CAGR of around 10 per cent over the last years, which is likely to continue. This is mainly driven by the big markets China (10.7 per cent) and India (10.5 per cent)[2]. In addition to the domestic region major Indian pharmaceutical companies are increasingly looking into opportunities to supply the North American market with branded or generic drugs. Up to 25 per cent of the worldwide total healthcare spending is for dermatology conditions. So dermatology is certainly not a niche market but a considerable part of the overall public healthcare burden. Currently, the market is dominated by drugs which require a prescription. Within the five largest European Union countries (EU5), close to 70 per cent of skin medication are prescription-only drugs. This split is considered to reverse within the next years in favour to over-the-counter products due to the following observations: The number of new drug molecules' entries into the dermatology market is not

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projected to increase, following the general trend in new drug submission and approval[3]. Price regulation and pressure will lead to increasing numbers of switches from prescription to overthe-counter (OTC) availability of medication. The OTC market still allows for more freedom in price positioning and consequently enables pharma companies to leverage consumer benefits of their products at higher price levels. As most skin diseases are not life threatening and often considered a 'nuisance' rather than a disease, many patients do not seek physician's help. Consequently there is considerable out-of-pocket spending by affected patients. Again, these expenses are not subject to government-driven price regulations. Besides the well documented use of medicated drugs, there is a huge market of non-medicated skin care products: emollients, skin cleansers, or hydration and protection products,

among others. These do not fall under a reimbursement schedule, but contribute to the overall disease related spending by individual patients.

Current packaging for skin medication In 2011 close to 500 million units of topical skin medication have been sold within the EU5 countries. More than 90 per cent of these products have been of semi-solid formulation such as lotions, creams, ointments, gel, paste or foams. The remaining share has been evenly split into liquids and powders[4]. What does this mean with respect to primary packaging? So far the most common packaging types for topical skin products are tubes, bottles and jars. Tubes are well established and often the first choice for most semi-solid drugs. The simplest and cheapest version is the single layer plastic tube. But barrier function (light, evaporation) is somehow limited. Increased barrier function requirements can be

Figure 1: Jar systems with means of a piston system pushed from the bottom either manually (left, Unguator) or using a turn system (right, aponorm)

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satisfied by use of aluminum or multilayer tubes. The latter combine the barrier function of an aluminum layer with the look-and-feel of a plastic tube making it the most advanced product in the range of tube packaging. Tubes can be combined with a wide range of closures with different design and functionality. Independent from the tube material, once a tube is opened its content is exposed to environmental influences; drying and discoloration can occur. Also dosing and emptying is greatly dependent on tube type and user experience. Especially aluminum tubes are prone to breaking and leakage if not properly stored and handled. The use of jars in topical dermatology is easily explained by the need for easy access to the final product. The use in pharmacy made formulations and reconstituted medications often requires a large opening. In turn this means also a large surface in contact with oxygen and allowing for evaporation. Some systems try to limit environmental influences. Additionally, attempts have been made to have better control while dispensing product (Figure 1). Liquids and low-viscous products are often filled into bottles. While coloured glass bottles offer best barrier functions (evaporation, light protection) plastic bottles are often preferred because of the lower risk of breaking. In order to increase barrier functions, special bottles incorporate a co-blow-molded multilayer bag inside. Basic screw and flip top closures are very common in combination with bottles but October 1-15, 2013

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bearing the risk of drying and discoloration of product around the orifice. The highend version of a bottle closure is the pump dispenser which helps to deliver a consistent dose of product with each actuation. Other primary packaging types used in skin medication include pouches, sachets or stick packs for single doses, airless dispensing systems, or aerosols including bag-on-valve (BOV) systems for multiple uses. Beside standard dispensing systems a range of specialised and often customised packaging solutions has been created. Understanding trends and requirements of the future topical dermatology marketplace is key for providers of primary packaging to be able to offer specialised or customised packaging solutions.

Trends in skin medication Some trends in the topical dermatological market start to change the way these drugs are packaged and delivered to the end consumer. Trends that drive this change and, therefore, are important to the pharma industry include: ● changes in life-style and demographics ● increased awareness of drug safety ● pressure from public healthcare systems to deliver

Figure 2: Dispensing systems preventing air intake. From left to right: flexible lips for dispenser heads or tube closures (Aptar), self-closing mechanisms by use of elastomer (Megaplast) or mechanical elements (Aptar) cost efficient treatments ● drying pipelines of drug innovation and, in consequence, ● pressure to differentiate existing products from competition. On top of these general challenges, skin medication requires a special focus on protection of mostly semisolid drug products, convenient dosing, access to difficult-to-reach body areas and lesion-directed treatment.

Protection from environmental influences It is likely that innovative and complex drug formulations will demand increased protection through primary packaging. Shelf-storage for up to three years is followed by an in-life period of a few

Figure 3: Microbial-tight dispensing systems. Aptar APFPLUS spray pump with spring controlled tip-seal mechanism and bacteria-blocking filter for venting air

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weeks. After first dispensing remaining product on the dispensing system tends to dry or potentially crystallise. This is particularly observed with viscous formulations where drying product can lead to clogging and subsequent malfunction of the dispensing system. Topical dermatology products often use fatty or oily auxiliary components to enhance the retention on and uptake of the drug substance through the skin. Such formulations are often sensitive to a variety of environmental influences. Exposure to sun light or oxygen can lead to deterioration of drug substance activity as well as development of unfavorable colour. Intake of moisture from the environment into the formulation or evaporation of water or solvents from the package will lead to changes of the concentration of active drug and potentially to a deterioration of content. Consequently diffusion has to be eliminated by use of appropriate packaging material providing sufficient barrier function. During the in use period, the orifice of any dispensing system is the most challenging region because here the content is in direct contact with the environment. Clogging due to drying product is actually the most often reported complaint. Standard pump systems represent a constant barrier to outside air in itself. However, at the outer part of the dispenser they will not avoid oxygen exposure or clogging due to evaporation. Modern pump dispensing systems are designed in such a way that the orifice is closed between the actuations. This prevents entry of

air into and drying of the medication within the system. Different technical options are available in the market. Flexible closing lips support clean dispensing and help protecting against air intake during periods of storage. Self-closing mechanisms can be designed into pump actuators to better protect dispensing orifices (Figure 2). If product is dispensed from a vented system, ambient air will replace the dosed volume in the container and consequently get in contact with the remaining product. This may be critical for oxygen sensitive drug products. In situations where oxygen contact needs to be avoided so called unvented or airless packaging systems should be used. In these airless systems moving parts (tow piston) or collapsing bags compensate for the volume of the dispensed product. In such systems the wall of the container must be able to barrier against oxygen diffusion. Alternative systems use a plastic or aluminum bottle to provide the desired outer shape and use aluminum or multilayer inner bags to contain the product.

Protection from microbial contamination To keep microorganism levels in the product low during the in use period, most often preservatives are used. But preservatives in skin medication are critically discussed by the medical community. Especially in patients with diseased skin preservatives are a potential source of additional irritation. Parabens (i.e., parahydrobenzoic acid esters) are used for anti-microbial protection in a variety of cosmetic and pharma skin EXPRESS PHARMA

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formulations. During the last years they have come under scrutiny after observation of contact sensitisation exacerbating in patients with inflamed or broken skin. Even if paraben levels nowadays are below limits where they are generally recognised as safe, they have been eliminated from most skin medications. However, the use of other preservatives that serve as replacement bears the same concerns about irritation. Therefore more and more preservativefree formulations are entering the market of skin medication. Primary packaging and dispensing systems that are able to handle non-preserved drug products need to prevent bacterial ingress into the drug product. These dispensing systems build a physical barrier to microbes at the interface to the outside. Sealing needs to be sufficiently strong to break product micro-films. Recently systems with self-sealing dispensing orifices have reached the market. These systems make use of elastomer elements or spring-loaded tips sealing the dispensing orifice. They can effectively protect nonpreserved formulations or allow for lower concentrations thereof. Another source of microbes is venting air. Whereas non-vented packaging prevents contamination by avoiding incoming air, sophisticated systems allow incoming air to pass through layers of filtering micro-membranes (Figure 3). All dispensing systems supporting preservative-free drug formulations have to prove the ability to resist microbial challenge testing simulating storage and use conditions.

Consumer convenience A substantial number of dermatological diseases require daily use of skin medication over a prolonged time. Dispensing systems for skin medication should be convenient supporting patients' adherence to longtime treatment. Smooth actuation and good control of product flow can be obtained from nonmetered systems (e.g., BOV, tube). Obtaining a consistent amount of medication as appropriate for the diseased skin area is very much user dependent. For non-metered dispensing systems concerns of under- or overdosing can only be minimised by dosing recommendations from drug manufacturers. Commonly these are either describing the thickness of product layer onto the affected area (e.g., 'Cover â&#x20AC;Ś with a thin film ofâ&#x20AC;Ś'), make use of comparisons to phalanges, or provide card box rulers together with the medication package. Metered dispensing systems for lotions or creams are available using precision pumps. Delivering a consistent dose per stroke from a metered pump system enables the patient to have the same amount of product used each day even over long time. Thereby the prescribed dose is ensured and safety concerns regarding overdosing are minimised.

Product dispensing and application In dermatological disease the skin is often inflamed or broken, and therefore sensitive to direct contact. Formulations that can be applied easily and homogenously are preferred. Target lesions might be anywhere on the body or even be very small. Therefore, packaging

Figure 4: Applicator systems to help with lesion directed dispensing. Digital Airless with finger-like applicator head. SofTips tube closure with soft touch silicone lips. (Aptar)

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Figure 5: Convenient dispensing systems for everyday use. Aptar Bag-on-valve and small piston system for carry-on that supports dispensing to difficult-to-reach body areas is appreciated. Liquids can be applied by continuous valve or metered pump dispensers creating a soft spray without any need to touch skin areas that are sensitive or inflamed. Likewise skin medication formulated as foam or mousse ensures smooth spread across the area to treat. Aerosol foams are commonly created by use of pressurised packages in combination with specialised foam actuators. More recently innovative mixing and filling techniques in connection with BOV systems allowing the generation of mousse from a semi-solid preparation has raised the interest of drug manufacturers. BOV technology does not require the use of a propellant as part of the drug formulation. Instead pressurised air in the outer container is used to deliver the bulk from a separated inner pouch. Pump foamers are non-pressurised systems that are mainly used in skin cleansing and care. Reach to body areas is greatly supported by dispensing systems that enable use at different device orientations. Not all delivery systems can be used

upside-down. All so called Airless Systems can be used at any direction thereby providing maximum flexibility during drug application. By using specialised applicators in combination with small volume pumps skin medication can be directly applied to a tiny target lesion. These applicators can be designed for dispensing medication on-the-spot avoiding the need for additionally use of finger tips (Figure 4). In situations where other persons give care to a relative or child this might be appreciated.

Life-style Stigmatisation of patients in need for medical treatment should be avoided. Especially for certain patient groups like teenagers with acne, peer group pressure can lead to treatment discontinuation and nonadherence. Ideally treatment regimen and dispensing should match a patientâ&#x20AC;&#x2122;s daily schedule, activity and capability. In consequence dispensing systems might be targeted to different user groups. Mobile and active life style or an increasingly aging population with e.g. limited dexterity, are two examples of related mega October 1-15, 2013

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trends in the western population. Medication that is handy at the time the patient needs to use it is more likely to be taken. Therefore dispensing systems need to be limited in size and robust enough to be carried around in a sports bag or purse. Small airless pump systems and bag-onvalves offer a convenient size, protect the medication from influence of air, leakage or damaging impact, and provide good control of dispensing (Figure 5). Dispensing systems that appear pleasant, trendy or look like 'just another cosmetic', are likely to enhance acceptance.

Figure 6: Aptar creative design for differentiated products. Innovative packaging for modern consumers: pen dispenser study, bottle design

Safety There is an ever increasing amount of information delivered together with pharma products. Despite efforts to improve readability and comprehension of printed patient information [5] it is common belief that most patients do not properly read this. Self-explanatory and convenient dispensing systems can support correct and safe use. Key instructions repeated on the dispensing system, symbols to guide the patient, and finger flanges providing tactile feedback during dispensing are only some examples that, if properly designed, help intuitive use. On the other hand such intuitive guidance should be introduced cautiously. Symbols may be interpreted differently in different regions of the world. Understanding of design features might not be the same with every cultural background. Consequently regional consumer input into innovation is key to develop successful dispensing systems that add value to the drug product. More recently products that are exceptionally potent or cause serious side effects have come under observation. To prevent contact with potentially harmful medication (e.g., hormones, minoxidil) by unattended children, special primary packaging incorporating child resistant features may become mandatory[6]. Push-andturn solutions that are used

References [1] Visiongain, 2009 (Dermatological Drugs: World market 2011-2026, Visiongain 2009)

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for tablet containers are already implemented as bottle or tube closure. Over-cap solutions that are known from e.g. household chemicals can be implemented in packaging for pharma. Locking mechanisms integrated into the dispenser head offer the benefit of not being accidentally separated from the medication package during use. Introducing safety features into pharma packaging always has to be balanced with accessibility. The megatrend of demographic shift will lead to increasing numbers of elderly consumers. Patients with limited dexterity or poor eyesight might have problems to access the drug product at all. Innovative packaging solutions can help to improve accessibility to medication and compliance to treatment schedules (e.g. triangleshaped closures or bottle shapes)[7].

Product differentiation The growing number of drugs that are put on the market has led to increased competition within every single treatment regimen. Presently several pharma companies are developing drugs using the same active molecule and wish to differentiate their product from competition. Brand recognition plays a major role in a situation where patients are well educated, have access [2] Euromonitor database 2013 [3] CDER, 2011 (Center for Drug Evaluation and Research, Novel new drugs report 2011, January 2012) [4] IMS health database 2011

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to multiple sources of information and are faced with increasing out-of-pocket expenses when buying their medicine. Next to efficacy and safety of a drug attractiveness of the package, convenience and differentiation together help to generate consumer loyalty. Currently, the dominant packaging forms are tubes, bottles with basic closure, and jars. Due to the number of medication on the market using similar packaging types there is little opportunity to differentiate a product beyond printed design or secondary packaging. Dispensing systems that offer additional characteristics will provide potential to stick out from the crowd. Innovative design in bottle or container shape will offer product recognition (Figure 6). The use of custom made applicator systems will not only enhance convenience but also help to create a dispensing experience that will last in the mind of the patient. Life cycle management of a drug changing from a more common to innovative packaging systems bears the opportunity to create a new brand image, to retain existing or attract new consumers, and to differentiate from competition.

Summary Traditional packaging of [5] CDRH, 2001, Guidance on Medical Device Patient Labeling; April 19, 2001 [6] CPSC, 2012 (Final Rule: PPPA Rule Requiring Child-Resistant Packaging for Imidazolines, CPSC Docket No. CPSC-

topical medication appears to be almost boring, but new delivery devices are on the horizon. Primary packaging systems for topical dermatological products face different challenges but at the same time are offering great opportunities. Depending on the needs, the content will be protected from environmental influences, like oxygen, light or drying and clogging. New systems are able to block microbial contamination and will help to reduce or even avoid the need for potentially harmful preservatives. Ideally innovative dispensing systems support long-term treatment schedules through attractiveness, convenience, intuitive design, and a match with the daily activity of the patient. Metered pump systems or continuous valves provide good control of product dispensing. Airless systems as well as BOV technology ensure all angle use enabling good reachability of body locations. Specialised actuators help in treating small lesions or avoiding finger contact with aggressive formulations. Early life cycle management by introducing innovative dispensing systems can help to differentiate drug products from competition, attract consumers and secure brand recognition. 2012-0005) [7] Packaging World, 2013, News 13FEB13, Jim Chrzan, Observations from Pharmapack Europe

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VENDOR NEWS Safeguarding products is top challenge for Asia’s healthcare executives: Survey Product security rises to top spot while regulatory compliance remains top concern

roduct protection, which includes security of high-value shipments and product spoilage prevention, is the top challenge for healthcare executives in Asia, according to UPS’s latest ‘Pain in the (Supply) Chain’ healthcare survey, conducted by TNS. The UPS ‘PITC’ survey, now in its sixth year globally and in its third year in Asia, revealed that 76 per cent of Asian executives are concerned about product security, significantly higher than their peers in North America (45 per cent) and Western Europe (47 per cent). Similarly, 67 per cent reported product damage and spoilage as a top concern, nearly double that of North America (38 per cent) and Western Europe (34 per cent). “Developing markets in Asia face varying degrees of infrastructural development, as well as rapid growth rates and non-harmonised regulations, all of which may have contributed to the concerns raised,” said Lim Bee Koong, Director, Healthcare Strategy, UPS Asia Pacific. “UPS’s dedicated facilities with its full range of temperature controlled environments are

equipped with technologies and processes to ensure business continuity. We place significant effort in this area, putting UPS at the forefront of product protection.” Along with ensuring product protection, regulatory compliance remained a top concern among all executives surveyed (70 per cent of Asian respondents). Consistent with other geographies, healthcare companies in Asia are making strategic moves to invest in technology, develop more partnerships with third party logistic providers, and increase internal expertise to help them address compliance issues. The survey revealed that Asian healthcare executives are still grappling with supply chain issues compared to their counterparts in North America, Western Europe and Latin America. These issues include product security, gaining access to global markets and new business channels; suggesting that there is a gap where third party logistic providers can step in to support with tailored solutions. Despite this gap, Asian healthcare executives are globally the most optimistic about the economy, with only 31 per

cent reporting that they are still feeling the effect of the recent years’ downturn (compared with North America - 57 per cent; Western Europe - 47 per cent; and Latin America 69 per cent). Among the Asian respondents, 74 per cent are also planning to expand globally in the next five years. Consistent with 2012’s results, China, India, Brazil and the US are the top four countries targeted for global expansion and investment in new technologies remains on top of the list for companies to improve competitiveness and enhance efficiency. “Industry experts estimate 25 per cent of healthcare products are time and temperature-sensitive and require specific cold-chain transportation and storage,” Koong, added. “To protect these highvalue products, manufacturers are looking to invest in technology and in third party logistic providers. We have invested heavily in temperature sensitive services such as UPS Temperature True which helps maintain shipment visibility and integrity, ensuring that shipments arrive in perfect condition.” EP News Bureau-Mumbai

Jubilant Clinsys launches TrialStat eClinical Suite TrialStat Orbit is an T electronic data capture solution used by a wide range of pharmaceutical and CRO customers worldwide

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rialStat, the technology division of Jubilant Clinsys, a full service global Contract Research Organization (CRO) and a subsidiary of Jubilant Life Sciences has launched TrialStat eClinical Suite. TrialStat Orbit is an electronic data capture solution used by a wide range of pharmaceutical and CRO customers worldwide, being utilised for complex Phase II and III studies. ORBIT was the industry’s first EDC platform to allow all aspects of a study to be configured, deployed and managed through a browser interface, enabling customers to start their studies quickly and cost-effectively. Orbit also includes advanced integrated

features such as IWR, Imaging, Coding and Electronic Patient Access. It has been successfully deployed in over 350 global studies. TrialStat CTMS is a Clinical Trial Management System designed to be fully integrated with Orbit, allowing for data entered into Orbit to trigger actions in the CTMS, thereby increasing visibility for critical management areas such as patient enrolment, monitoring management, and site payments. TrialStat Portal is a central database designed to provide seamless integration with all TrialStat products creating the ultimate study management tool through real-time visualisation of your study www.expresspharmaonline.com

data. The portal can be accessed by study sites, Sponsors and CROs for central communication and critical decision making. Nayan Nanavati, Chief Executive Officer, Jubilant Clinsys said, “TrialStat eClinical Suite is an innovative cloud-based platform providing an advanced set of features with a strong focus on usability enabling the power to manage your trial efficiently and providing our clients’ a robust platform for improving data collection and study management.” This eClinical suite uses the latest in today’s technology to revolutionise and redefine integrated clinical software. EP News Bureau-Mumbai

IMCD and Network Nutrition to tie up in Australia and New Zealand Will amount to the largest specialised natural ingredients provider in the region etwork Nutrition, a Sydney-headquartered distributor of botanical, nutritional and plant enzyme based raw materials, will join the IMCD Group. The integration of the Network Nutrition and IMCD businesses, along with the recent acquisition of Capitol Ingredients Australia, will amount to the largest specialised natural ingredients provider in the region. All Network Nutrition products will continue under the same brand names whilst employees will transfer to IMCD Australia and New Zealand. “We are thrilled to merge with a fantastic company like Network Nutrition,” said René den Hertog, Managing Director, IMCD Australia and New Zealand. “The IMCD operation will extend the reach of the Network Nutrition range in key target markets like Europe and Asia, where the value proposition they have demonstrated in the Australian and New Zealand market can also be leveraged. By aligning Network Nutrition’s strength in herbal extracts with the breadth of IMCD’s focus in the natural healthcare market, we are perfectly positioned to provide a comprehensive portfolio of products and innovative solutions to the market both here in Australia and New Zealand and internationally.” Ryan Gorman, Chief Executive Officer, Network Nutrition added that by merging Network Nutrition’s activities into the IMCD structure, the opportunities for growth and development of the existing portfolio are significantly amplified. EP News Bureau-Mumbai

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Carrier Transicold launches Citimax range of LCV and truck refrigeration units The Citimax units are ideal for LCVs and trucks carrying loads up to 30 cubic metres

arrier Transicold has launched the Citimax range of light commercial vehicle (LCV) and truck refrigeration units at the India Cold Chain Show 2013 in Mumbai. The Citimax units are ideal for LCVs and trucks carrying loads up to 30 cubic metres. Carrier Transicold helps improve global transport and shipping temperature control with a complete line of equipment for refrigerated trucks, trailers and containers. Carrier is a part of UTC Climate, Controls and Security, a unit of United Technologies Corp, US. In India, refrigerated road transport is crucial for the safe circulation of fresh and frozen perishables. The need for efficient and reliable cooling technology for urban deliveries is rapidly increasing. Carrier Transicold has designed the Citimax direct-drive range to meet these requirements and supply Indian customers with a unit combining cold chain protection with exceptional value. “Carrier Transicold is synonymous with quality and reliability in the Indian market,” said Ashok Mirchandani, Managing Director, Carrier Transicold Asia-Pacific region. “The new Citimax range reinforces this by providing customers with the refrigeration capacity and performance they need for urban applications at an affordable price.”

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Initially available in two versions, the Citimax 500, using nonozone-depleting refrigerants R134a or R404a, delivers refrigeration capacity up to 5100 watts in high ambient temperatures. The units also offer precise temperature control with set points maintained within one degree celsius of the pre-determined temperature, ensuring that perishable goods are maintained in the proper condition from depot to destination. Due to quick pre-cooling and rapid recovery after each door opening, the Citimax range is capable of reaching the set point 20 per cent faster than previous direct-drive units, enabling reduced load times. The Citimax range is an easy-toinstall and simple-to-use product that builds on Carrier Transicold’s experience in developing quality refrigerated solutions in line with market needs. The range was developed by Carrier’s Global Lead Design Centre, using proven components from the refrigeration industry. In addition, all parts are certified through quality processes and the units are tested before leaving the production site. Designed to operate in urban applications, Citimax units offer a standard and proven directdrive technology with power derived directly from the vehicle engine. EP News Bureau - Mumbai www.expresspharmaonline.com

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PRODUCTS Thermo Fisher Scientific introduces high performance gas chromatograph T hermo Fisher Scientific has launched a new gas chromatography system designed to deliver high performance, flexibility and economy under the challenging conditions found in many parts of India. The instrument, Thermo Scientific TRACE 1110 Series gas chromatograph (GC), is a multi-channel instrument designed specifically for the Indian market. Thermo Fisher Scientific designed and manufactures the instrument in India. The new TRACE 1110 GC offers up to four injectors and four detectors, allowing users to efficiently switch between different applications on the same GC. Compared to other Thermo Scientific GC instruments the TRACE 1110 GC reportedly provides higher reproducibility in terms of retention time and peak area. The TRACE 1110 GC is designed as a robust GC by accepted

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global standards, offering customised solutions for a wide range of applications in a cost-effective way. The instrument is intended for environmental, food testing, forensic and other analytical laboratories. Its features are as follows: ● New injectors intended to provide enhanced performance and increased sample throughput, even

with dirty matrices. detectors designed for enhanced sensitivity for trace level analysis. Latest generation of electronic pneumatics with improved pressure and flow control for more consistent retention time reproducibility. Turnkey analyser configurations for specific applications. Optional built-in uninterruptible power supply (UPS) to reduce effects of frequent power failures. Chrom-Card software and Thermo Scientific Dionex Chromeleon Data System for full control and operational simplicity.

set of application notes from Malvern Instruments demonstrates the sample integrity, flexibility and lack of cross contamination during automated, rapid screening of protein samples using the Zetasizer Auto Plate Sampler (APS) dynamic light scattering (DLS) system. Enabling automated measurements of multiple samples, the Zetasizer APS delivers the same high sensitivity, high specification DLS measurements as other systems in Malvern’s well-known

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Zetasizer series, making it ideal for protein applications. Easy data interpretation, using custom-designed results criteria, is supported by a colourcoded data quality display. Zetasizer APS allows the production of large amounts of high quality DLS data with no user intervention to maximize productivity in busy protein laboratories. The data display capability enables the operator to easily retrieve results of interest, without having to manually scan through all measurements. Additionally, a new plate navigator feature acts as a data mapping tool, allowing for rapid screening of results to retrieve the information of most interest and the subsequent in-depth investigation of any single data set. Setup and operation of the Zetasizer APS is straightforward and cleaning protocols ensure that no cross contamination occurs. The separate www.expresspharmaonline.com

ounting efficiency is an expression of the probability that a particle counter will sense and count a particle passing through its sample volume. This probability is a function of size up to a certain critical size above which all particles are normally sensed and counted. Unlike others, Lighthouse model 3350’s most sensitive threshold for 100 lpm flow rate is 0.3

Contact details Pradeep Kumar Marketing Communications Manager-India Chromatography & Mass Spectrometry Thermo Fisher Scientific Mob: +919967968164

Malvern Instruments’ Zetasizer APS dynamic light scattering system A

Lighthouse USA Model 3350 C

temperature controls of the plate holder and the measurement cell allow the Zetasizer APS to be used to maintain the protein samples in optimal condition until measurement. In addition, thermal trend measurements between 2°C to 90°C with 0.1°C degree precision can be defined. The plate scheduler allows the user to graphically set up size and thermal trend measurements of various samples from the same plate using a variety of different SOPs.

Contact details Stuart Wakefield Malvern Aimil Instruments Naimex House, BSEL Tech Park, B Wing – 906 Sector 30A, Opp Vashi Railway Station, Vashi, Navi Mumbai 400 705, Tel: + 91 22 3918 3596 Fax: +91 22 3918 3562 Stuart.Wakefield@malvern.com

www.malvern.com

microns. Lighthouse counting efficiency for 0.3 microns is 50 per cent and for 0.5 microns it is 100 per cent. Because other manufacturers cannot achieve this sensitivity, they have to offer you 75 lpm counters instead of 100 lpm flow rate. Coming to laser life, Lighthouse sensors have the industry’s longest laser diode life of 20+ years MTTF based on continuous 24/7 operation. So maintenance costs will be very low. An attractive feature of the Lighthouse portable counters is selective printing – one can print just two channels say 0.5 and 5 microns out of the six channels if desired. Sampling can be done in terms of time or volume.

Contact details MeasureTest Instruments 94, Atlanta Nariman Point Mumbai 400 021 Phone: 022-2202 7982 email: sheesh@mtnl.net.in October 1-15, 2013

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Avantor Performance Materials launches polysorbates products A

vantor Performance Materials has introduced a higher purity super refined grade of polysorbate products to improve solubilisation and stability in a variety of biopharmaceutical and small-molecule drug formulations. The new Super Refined grade products join Avantor’s current high-purity versions of the two most widely used types of polysorbate products: JT Baker brand Polysorbate 20 and Polysorbate 80. These products are commonly used in pharmaceutical formulations such as parenteral, otic, ophthalmic, oral and

The surface activity of polysorbates helps to stabilise proteins by reducing the alteration or aggregation of proteins during manufacturing, distribution and storage. With poorly soluble drugs, polysorbates provide improvements in solubilisation while enhancing the stability of emulsions. JT Baker polysorbates are vegetable-based, with a non-peanut origin, providing low endotoxin and other impurities, which is critical for formulation of biopharmaceuticals. The products meet the rigorous

topical preparations. Avantor’s high-purity and Super Refined grades of JT Baker polysorbates are manufactured under current Good Manufacturing Practices (cGMP) conditions in FDA-registered ISO 9000-certified facilities, and are supported by the company’s best-inclass quality systems. While Avantor’s existing highpurity grade of polysorbates offers low levels of impurities for better performance in formulations, the new Super Refined grade takes advantage of a proprietary flash chromatographic process that removes even more polar and oxidative impurities, such as peroxides and aldehydes, which can degrade active pharmaceutical ingredients.

multi-compendial requirements of the National Formulary (NF), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) or Japanese Pharmaceutical Excipients (JPE). The new Super Refined polysorbates are available in bottle sizes ranging from 200 mL up to 4 L, and are packaged under nitrogen to ensure premium product integrity.

October 1-15, 2013

Contact details Allison Hosak, Vice President, Global Communications, Avantor Performance Materials, Inc Office: 610-573-2661 Cell: 908-329-7281 allison.hosak@avantormaterials.com www.expresspharmaonline.com

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Merck Millipore launches novel Clarisolve depth filters erck Millipore, the Life Science division of Merck, has introduced the Clarisolve depth filter for single-stage clarification of pretreated feed streams. The Clarisolve depth filter is a novel clarification device with a gradient density structure specifically designed to the particle size distributions of pretreated feed streams. Delivering improved volumetric capacity and reduced turbidity over any currently available depth filtration technologies, Clarisolve depth filters process pretreated feeds in a significantly reduced footprint without the need for the secondary stage of clarification. The use of Clarisolve depth filters eliminates the need for centrifugation which enables implementation of a fully singleuse process train, and also considerably reduces the pre-use flushing require-

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ments. This technology was developed to address the shortcomings of traditional downstream clarification approaches when process-

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ing high cell density and high-product titer cell cultures.

Contact details

Pegeen DosSantos Phone: +1 781 533 5336 Email: pegeen.dossantos@emdmillipore.com

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Thermo Fisher Scientific continues to transform Mass Spectrometry hermo Fisher Scientific has introduced two additional systems designed to advance intact protein analysis and ‘quanfirmation.’ The new technology includes: Extended Mass Range (EMR) option for the Thermo Scientific Exactive Plus LCMS and Thermo Scientific Q Exactive Plus LC-MS. Apart from these, Orbitrap Fusion Tribrid LC-MS system and TSQ Quantiva triple stage quadrupole LC-MS system were also launched. All the products were displayed at 12th HUPO World Congress at the Pacifico Yokohama in booth 51. Thermo Scientific Exactive Plus LC-MS: Proteomics scientists have a tool for challenging high resolution accurate mass (HRAM) intact protein analysis such as investigating the structure, topology and architecture of targets. These include: impurities in monoclonal antibodies, antibodydrug conjugates, PEGylated proteins, oligomerised protein-based drugs, glycoforms and protein assemblies. The EMR option for the Thermo Scientific Exactive Plus LCMS includes: ● Extended m/z range of 350-20,000 ● Improved transmission of higher-mass ions for stronger signals ● Modified HCD pressure and controls for easier optimisation of experimental conditions ● Access to long transients for improved signal-tonoise ratio Thermo Scientific Q Exactive Plus LC-MS: The Thermo Scientific Q Exactive Plus LC-MS will further increase performance for applications such as bottom-

TSQ-Quantiva-Nanospray-Easy-nLC-Front

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up proteomics, lipidomics and high-confidence DMPK qual/quan screening studies. Enhancements include advanced Quadrupole Technology (AQT) which has been developed to improve precursor selection and transmission for more-accurate quantitation of low-abundance analytes in complex matrices. Sophisticated dataindependent acquisition (DIA) and parallel reaction monitoring (PRM) designed to deliver reproducible, highthroughput quantitation with very high confidence in qualitative results. Advanced active beam guide (AABG) has been designed to reduce noise and extend maintenance intervals. Optional protein mode designed to permit greater control over collision pressure and related parameters to improve analysis of intact proteins and protein complexes. Enhanced resolution option intended to increase ID confidence in top-down proteomics and lipidomics studies. Thermo Scientific Orbitrap Fusion Tribrid LC-MS system is a novel tribrid configuration which enables users to positively identify larger numbers of low-abundance proteins faster than previously possible with existing commercial instruments. Its unique architecture enables simultaneous precursor isolation, fragmentation, and data acquisition in both the Orbitrap and linear ion trap mass analysers. More high-quality data can be collected compared to previous instruments, expanding the range of possible experiments. Attributes include: A quadrupole for precursor selection at isolation widths down to 0.4 amu for excellent

Exactive Plus EMR LC-MS www.expresspharmaonline.com

Q Exactive Plus LC-MS

Orbitrap-Fusion sensitivity and selectivity; An ultra-high-field Orbitrap offering resolution in excess of 450,000 and scan rates up to 15 Hz for unsurpassed selectivity and speed of analysis; An ion routing multipole followed by dual-pressure linear ion trap providing MSn HCD, CID and ETD fragmentations and fast, sensitive mass analysis with scan rates of up to 20 Hz. Synchronous precursor selection enhances the instrument’s signal-tonoise performance. The new Thermo Scientific TSQ Quantiva triple stage quadrupole LC-MS system has been designed to transform quantitation experiments with extreme sensitivity, productivity, precision and usability. The TSQ Quantiva system breaks the attogram sensitivity barrier, thanks to its new Active Ion Management (AIM) design. It is also extremely productive, able to perform 500 SRM experiments per second and positive/negative polarity switching in 20ms with no signal loss. Thermo Scientific TSQ Endura triple stage quadrupole LC-MS shares much of

the advanced technology of the TSQ Quantiva MS, while also designed to deliver higher uptime than any competitive triple quadrupole instrument in workhorse applications requiring trace level quantitation. Thermo Fisher Scientific Pierce Tandem Mass Tag 10-Plex Isobaric Mass Tag Labeling Kits and Reagents for multiplexed protein identification and quantitative analysis by triple stage quadrupole mass spectrometry. Thermo Scientific myECL Imager, a powerful and easy-to-use blot and gel documentation instrument for sensitive, multimode image capture and analysis via an intuitive touch screen interface and advanced integrated software. Contact details Stuart Matlow Public Relations Manager Chromatography and Mass Spectrometry Thermo Fisher Scientific 355 River Oaks Parkway San Jose, CA 95134 (408) 965-6408 office (415) 407-5474 mobile stu.matlow@thermofisher.com www.thermofisher.com October 1-15, 2013

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Probiotics Saccharomyces boulardii Lactic acid basillus sporogenous

Circulatory Health Nattokinase

Bio Catalysts Immobilized Cal B

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

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APPOINTMENT Dr Poonam Khetrapal Singh nominated as WHO Regional Director WHO is expected to appoint Singh in January 2014 r Poonam Khetrapal Singh has been recently nominated as Regional Director for the WHO South-East Asia Region. She was nominated for a five-year term by the 11 member states of the region. The 32-member Executive Board of the World Health Organization (WHO) is expected to appoint Singh as the Regional Director in

Brundland’s cabinet who was WHO Director-General at the time. She served as the Executive Director for Sustainable Development and Healthy Environments in Geneva. From 2000 to 2013, as the Deputy Regional Director for WHO’s SouthEast Asia Region, she served as the principal advisor to the Regional Director, providing managerial, technical and programmatic support for WHO’s programmes. Singh served as a senior civil servant in India as a member of the Indian

January 2014, in Geneva. Singh is expected to take office at the regional office in New Delhi on February 1, 2014. Singh brings a vast repertoire of experience, having worked in the health sector for over three decades at both national and international levels. She served with the WHO for the past 15 years. She is the first woman to be nominated to this post in the region. Singh started her WHO career in 1998 as a member of Dr Gro Harlem

Administrative Services. She was Secretary and Joint Secretary Health and Family Welfare. She has also served with Health, Population and Nutrition (PHN) with the World Bank Mission in India, where she worked to improve the efficiency and effectiveness of the delivery of health services. Recently she has been working as an advisor in international health to the Ministry of Health and Family Welfare, Government of India. EP News Bureau-Mumbai

COURSE HTIC to conduct fellowship programme at IIT Madras Event to be held from October 21-26, 2013 in collaboration with National Health System Resource Centre

ealthcare Technology Innovation Centre (HTIC) will conduct the 3rd International Fellowship on Health Technology Assessment (HTA) at IIT Madras from October 21 to 26, 2013 in collaboration with National Health System Resource Centre (NHSRC). The fellowship programme

will feature international and national faculty giving lectures on various facets of HTA. Healthcare professionals like biomedical and clinical engineers; students pursuing public health management and health policy courses; patient safety officers and care providers; health economists; hospital and healthcare pro-

gramme managers; and professionals and providers who deal with healthcare technologies, are likely to be benefitted from the programme. HTA is a multi-disciplinary field of policy research that examines the clinical, economic, social and ethical implications, economic incremental value, diffusion and use of a medical technolo-

gy in healthcare and health systems integration. HTA acts as a bridge between the world of research and the decisionmaking process. It is a tool to improve healthcare delivery systems of India and will also help to improve the patient care in terms of related legal and ethical issues.. EP News Bureau-Mumbai

New modules added to Newcastle Univ’s e-learning courses 120 students registered N in 2012 from across the globe

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ewcastle University, UK, which launched the MSc Oncology for the pharmaceutical industry, as a part of the MSc Oncology and Palliative Care e-learning programmes in 2012, will have two new modules in the new academic year: Health Economics, and Cancer Drugs and Technologies. 120 students were registered across the three e-learning programmes (MSc in Oncology, MSc in Palliative Care and MSc in

Oncology for the Pharmaceutical Industry) in 2012. Students from Australia, Canada, Greece, Malta, South Africa, India, Singapore, Saudi Arabia, the US, Ghana, Kenya, Egypt and New Zealand, enrolled for the courses. The programme will enable students to gain an insider’s look into the hospitals’ expectations from the pharma industry and the impact of regulatory procewww.expresspharmaonline.com

dures. It will focus on the implications of legislation and economic environment, and how pharmacists need to adapt to the changing sector by developing business skills. Two new modules will be added to the programme for the new academic year: Health Economics, and Cancer Drugs and Technologies. Dr Charles Kelly, Degree Programme Director said, “Students will gain knowl-

edge that helps them build awareness of National Health Service (NHS) procedures. One of the main goals of the course is to help increase the understanding and cooperation between the pharma industry and NHS by helping students understand how decisions are made in adopting certain techniques, with the patient at the centre of the decision making process.” EP News Bureau-Mumbai EXPRESS PHARMA

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NAUKRI JOB SPEAK Pharma sector sees low hiring in August 2013 Dips by 14 per cent in August ’13 over July ’13

iring activity in the pharmaceutical sector has dipped by 14 per cent in August 2013 over July 2013. Uncertain economic conditions and low GDP growth in the country has marginally affected the hiring activity in the pharma sector in August 2013. The Naukri Job Speak index for

the sector at 1386 in August13 is 14 per cent lower than July 13. This indicates that recruiters of this sector are on a wait and watch mode and are certainly not going overboard with their hiring.

About Naukri.com Naukri.com, India’s No. 1 job site and the flagship

brand of Info Edge introduced the concept of erecruitment in India. Since its inception in 1997, Naukri.com has seen continued growth while outperforming its competitors in every sphere. Info Edge was the first Internet company to be listed in India. The site enjoys a traffic share consis-

tently over 60 per cent as per the Comscore data. Naukri.com is a recruitment platform that provides hiring-related services to Corporates/ recruiters, placement agencies and to job seekers in India and overseas. It offers multiple products like Resume Database Access, listings and Response

Management Tools. With 230000 jobs live at any point and over 33 million CV’s, Naukri.com serviced over 48000 corporate clients in 2012-2013. The company has over 2500 people operating through 57 offices in 36 cities in India and overseas offices in Dubai, Riyadh, Abu Dhabi and Bahrain.

Jobs from Naukri.com Pace Fit Facilitator Assistant Manager- Sale & Business Development

Company: Dr. Reddys Laboratories Exp: 1-3 Location: Hyderabad / Secunderabad Job Id: 220813000064

Company: GVK Biosciences Exp: 2-3 Location: Hyderabad / Secunderabad Job Id: 210813002875

Manager - Operations & Contract Manufacturing

Executive - Pharma Regulatory Affairs

Company: Enovate Biolife Exp: 4-8 Location: Mumbai Job Id: 310713002029

Company: PKG International Exp: 2-6 Location: Delhi Job Id: 050913005109

GM - Exports Computer Operator & Typist Company: Pharmaffiliates Analytics Synthetics Exp: 1-3 Location: Chandigarh Job Id: 100513001846

Company: Anglo French Drugs & Industries Exp: 10-14 Location: Bengaluru/Bangalore Job Id: 300813004223

Manager - Pharma FDA Liasoning Company: Naprod Life Science Exp: 5-10 Location: Mumbai Suburbs Job Id: 050913005007

Tech Lead Stat Programming Senior Manager - Global Pharmacovigilance Company: Wockhardt Exp: 10-20 Location: Mumbai Job Id: 260813002759

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Company: inVentiv International Pharma Services Exp: 8-12 Location: Gurgaon Job Id: 030413001593

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